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The Journal of Heart and Lung Transplantation
International Society for Heart and Lung Transplantation.
ISHLT Guidelines| Volume 32, ISSUE 2, P157-187, February 2013

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The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: Executive summary

      Institutional Affiliations

      Co-chairs

      Feldman D: Minneapolis Heart Institute, Minneapolis, Minnesota, Georgia Institute of Technology and Morehouse School of Medicine; Pamboukian SV: University of Alabama at Birmingham, Birmingham, Alabama; Teuteberg JJ: University of Pittsburgh, Pittsburgh, Pennsylvania

      Task force chairs

      Birks E: University of Louisville, Louisville, Kentucky; Lietz K: Loyola University, Chicago, Maywood, Illinois; Moore SA: Massachusetts General Hospital, Boston, Massachusetts; Morgan JA: Henry Ford Hospital, Detroit, Michigan

      Contributing writers

      Arabia F: Mayo Clinic Arizona, Phoenix, Arizona; Bauman ME: University of Alberta, Alberta, Canada; Buchholz HW: University of Alberta, Stollery Children’s Hospital and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada; Deng M: University of California at Los Angeles, Los Angeles, California; Dickstein ML: Columbia University, New York, New York; El-Banayosy A: Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania; Elliot T: Inova Fairfax, Falls Church, Virginia; Goldstein DJ: Montefiore Medical Center, New York, New York; Grady KL: Northwestern University, Chicago, Illinois; Jones K: Alfred Hospital, Melbourne, Australia; Hryniewicz K: Minneapolis Heart Institute, Minneapolis, Minnesota; John R: University of Minnesota, Minneapolis, Minnesota; Kaan A: St. Paul’s Hospital, Vancouver, British Columbia, Canada; Kusne S: Mayo Clinic Arizona, Phoenix, Arizona; Loebe M: Methodist Hospital, Houston, Texas; Massicotte P: University of Alberta, Stollery Children’s Hospital, Edmonton, Alberta, Canada; Moazami N: Minneapolis Heart Institute, Minneapolis, Minnesota; Mohacsi P: University Hospital, Bern, Switzerland; Mooney M: Sentara Norfolk, Virginia Beach, Virginia; Nelson T: Mayo Clinic Arizona, Phoenix, Arizona; Pagani F: University of Michigan, Ann Arbor, Michigan; Perry W: Integris Baptist Health Care, Oklahoma City, Oklahoma; Potapov EV: Deutsches Herzzentrum Berlin, Berlin, Germany; Rame JE: University of Pennsylvania, Philadelphia, Pennsylvania; Russell SD: Johns Hopkins, Baltimore, Maryland; Sorensen EN: University of Maryland, Baltimore, Maryland; Sun B: Minneapolis Heart Institute, Minneapolis, Minnesota; Strueber M: Hannover Medical School, Hanover, Germany

      Independent reviewers

      Mangi AA: Yale University School of Medicine, New Haven, Connecticut; Petty MG: University of Minnesota Medical Center, Fairview, Minneapolis, Minnesota; Rogers J: Duke University Medical Center, Durham, North Carolina
      The field of mechanical circulatory support (MSC) has made tremendous progress in the past 15 years. Thousands of patients worldwide have undergone implantation of long-term MSC devices (MCSDs). Currently, management of patients with MCSDs has been guided by individual clinicians and center-specific protocols. There have been few randomized studies to guide patient selection and care of the MCS patient. Short-term success with MCS therapy largely depends on patient selection, surgical technique, and post-operative management. Long-term success depends on physician and patient engagement in excellent care of their device and personal health. The International Society for Heart and Lung Transplantation (ISHLT) has made a commitment to convene an international and multidisciplinary panel of experts in MCS care.
      The document results from the work of 5 Task Force Groups:
      • Task Force 1 addresses the important issue of patient selection for permanent pump implantation. This section covers (1) the referral of patients for MCSD implantation, (2) evaluation of patients considered for MCSD implantation, which includes clinical assessment of heart failure, heart failure etiology, anatomic considerations, (3) medical and psychosocial evaluation, and (4) assessment of operative risk. Relative vs absolute contraindications are discussed as well as ethical dilemmas associated with this topic.
      • Task Force 2 discusses the mechanisms that are important for patient optimization prior to device implantation. This section covers (1) management of cardiac and non-cardiac risk factors, (2) optimizing patients with relative contraindications and (3) informed consent and ethical issues as a continuum from Task Force 1. MCS patients once consented are members of their care team before implantation. Recommendations for multidisciplinary care, education, and psychosocial support are found in this Task Force.
      • Task Force 3 discusses the intraoperative considerations and immediate post-operative care in the intensive care unit (ICU) setting. This section covers (1) anesthesia, (2) implantation techniques, (3) explantation techniques, (4) complex anatomic considerations, and (5) early post-operative management in the ICU.
      • Task Force 4 addresses inpatient management during the post-operative phase, once the patient is out of the ICU through discharge, and during readmission to the hospital. This section covers (1) right ventricular (RV) and hemodynamic management, (2) anti-coagulation, (3) adjunct medical therapy, (4) driveline care, (5) psychosocial support and suitability for discharge to home, and (6) common reasons for hospital readmission and approaches to their management.
      • Task Force 5 discusses the long-term outpatient care of the MCS patient using a multidisciplinary approach. This section covers (1) the outpatient management of device-related issues, (2) patient medical management and monitoring, (3) psychosocial long-term support, and (4) continued education of the patient and family.
      It is important to note that every effort has been made to include as contributing writers cardiologists, cardiac surgeons, MCS coordinators, and other members of the multidisciplinary team. Because the guidelines are international, we also tried to balance perspective from different countries as best possible.
      As the reader of these guidelines will observe, most of the recommendations are level of evidence C or consensus agreement. Gaps in evidence are highlighted where appropriate. Because MCS is an evolving field, device availability varies from center to center. We aim to address general issues of long-term use and not to focus on nuances of individual devices. Each manufacturer has recommendations for its specific device. There are also different indications for MCS, depending on patient urgency, and often, short-term MCS is emergently utilized. The focus of this document is long-term device therapy with the goal of patient discharge from the hospital. There is limited mention of short-term MCS support for acute shock patients in Task Force 1, 2, and 3. Lastly, we hope that these guidelines will provide an impetus for organized dissemination of best practices from various centers with excellent outcomes into the literature to further the field of MCS.

      Task Force 1: Selection of candidates for MCS and risk management prior to implantation for fixed comorbidities

      Chair: Katherine Lietz, MD
      Contributing Writers: Mario Deng, MD; David Feldman, MD, PhD; Annemarie Kaan, MCN, RN; Salpy V. Pamboukian, MD, MSPH; J. Eduardo Rame, MD, MPhil; Jeffrey J. Teuteberg, MD
      Reviewers: Emma Birks, MD; Francis Pagani, MD; Michael G. Petty, PhD, RN; Abeel A. Mangi, MD

      Topic 1: Patient selection

      Recommendations for the evaluation process of MCS candidates:
      • Kirklin J.K.
      • Naftel D.C.
      • Kormos R.L.
      • et al.
      Third INTERMACS Annual Report: the evolution of destination therapy in the United States.
      • Park S.J.
      • Milano C.A.
      • Tatooles A.J.
      • et al.
      Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy.
      • Slaughter M.S.
      • Rogers J.G.
      • Milano C.A.
      • et al.
      Advanced heart failure treated with continuous-flow left ventricular assist device.
      • Kirklin J.K.
      • Naftel D.C.
      • Kormos R.L.
      • et al.
      Second INTERMACS annual report: more than 1,000 primary left ventricular assist device implants.
      • Stewart G.C.
      • Stevenson L.W.
      Keeping left ventricular assist device acceleration on track.
      • Teuteberg J.J.
      • Stewart G.
      • Jessup M.
      • et al.
      Strategies for LVAD therapy in INTERMACS: intent rate versus event rate [abstract].
      • Stevenson L.W.
      • Pagani F.D.
      • Young J.B.
      • et al.
      INTERMACS profiles of advanced heart failure: the current picture.

      Class I:
      • 1.
        All patients should have any reversible causes of heart failure addressed prior to consideration for MCS.
        Level of evidence: A.
      • 2.
        All patients referred for MCS should have their transplant candidacy assessed prior to implant.
        Level of evidence: A.

      Recommendations for the clinical classification of MCS candidates:
      • Stevenson L.W.
      • Pagani F.D.
      • Young J.B.
      • et al.
      INTERMACS profiles of advanced heart failure: the current picture.

      Class I:
      • 1.
        All patients being considered for MCS should have their New York Heart Association functional class assessed.
        Level of evidence: C.
      • 2.
        All patients being assessed for MCS should have their Interagency Registry for Mechanically Assisted Support (INTERMACS) profile determined.
        Level of evidence: C.

      Recommendations for risk stratification for consideration of MCS:
      • Levy W.C.
      • Mozaffarian D.
      • Linker D.T.
      • et al.
      The Seattle Heart Failure Model: prediction of survival in heart failure.
      • Goda A.
      • Williams P.
      • Mancini D.
      • Lund L.H.
      Selecting patients for heart transplantation: comparison of the Heart Failure Survival Score (HFSS) and the Seattle heart failure model (SHFM).
      • Levy W.C.
      • Mozaffarian D.
      • Linker D.T.
      • Farrar D.J.
      • Miller L.W.
      Can the Seattle heart failure model be used to risk-stratify heart failure patients for potential left ventricular assist device therapy?.
      • Kalogeropoulos A.P.
      • Georgiopoulou V.V.
      • Giamouzis G.
      • et al.
      Utility of the Seattle Heart Failure Model in patients with advanced heart failure.
      • Gorodeski E.Z.
      • Chu E.C.
      • Chow C.H.
      • Levy W.C.
      • Hsich E.
      • Starling R.C.
      Application of the Seattle Heart Failure Model in ambulatory patients presented to an advanced heart failure therapeutics committee.
      • Pamboukian S.V.
      • Tallaj J.A.
      • Brown R.N.
      • et al.
      Comparison of observed survival with assist device versus predicted survival without device using the Seattle heart failure model.
      • Aaronson K.D.
      • Schwartz J.S.
      • Chen T.M.
      • Wong K.L.
      • Goin J.E.
      • Mancini D.M.
      Development and prospective validation of a clinical index to predict survival in ambulatory patients referred for cardiac transplant evaluation.
      • Parikh M.N.
      • Lund L.H.
      • Goda A.
      • Mancini D.
      Usefulness of peak exercise oxygen consumption and the heart failure survival score to predict survival in patients>65 years of age with heart failure.
      • Goda A.
      • Lund L.H.
      • Mancini D.M.
      Comparison across races of peak oxygen consumption and heart failure survival score for selection for cardiac transplantation.
      • Green P.
      • Lund L.H.
      • Mancini D.
      Comparison of peak exercise oxygen consumption and the Heart Failure Survival Score for predicting prognosis in women versus men.
      • Lund L.H.
      • Aaronson K.D.
      • Mancini D.M.
      Validation of peak exercise oxygen consumption and the Heart Failure Survival Score for serial risk stratification in advanced heart failure.
      • Mancini D.M.
      • Eisen H.
      • Kussmaul W.
      • Mull R.
      • Edmunds Jr, L.H.
      • Wilson J.R.
      Value of peak exercise oxygen consumption for optimal timing of cardiac transplantation in ambulatory patients with heart failure.
      • Mehra M.R.
      • Kobashigawa J.
      • Starling R.
      • et al.
      Listing criteria for heart transplantation: International Society for Heart and Lung Transplantation guidelines for the care of cardiac transplant candidates—2006.
      • Stevenson L.W.
      • Miller L.W.
      • Desvigne-Nickens P.
      • et al.
      Left ventricular assist device as destination for patients undergoing intravenous inotropic therapy: a subset analysis from REMATCH (Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure).
      • Hershberger R.E.
      • Nauman D.
      • Walker T.L.
      • Dutton D.
      • Burgess D.
      Care processes and clinical outcomes of continuous outpatient support with inotropes (COSI) in patients with refractory endstage heart failure.
      • Krell M.J.
      • Kline E.M.
      • Bates E.R.
      • et al.
      Intermittent, ambulatory dobutamine infusions in patients with severe congestive heart failure.
      • Rao V.
      • Oz M.C.
      • Flannery M.A.
      • Catanese K.A.
      • Argenziano M.
      • Naka Y.
      Revised screening scale to predict survival after insertion of a left ventricular assist device.
      • Lietz K.
      • Long J.W.
      • Kfoury A.G.
      • et al.
      Outcomes of left ventricular assist device implantation as destination therapy in the post-REMATCH era: implications for patient selection.
      • Knaus W.A.
      • Draper E.A.
      • Wagner D.P.
      • Zimmerman J.E.
      APACHE II: a severity of disease classification system.
      • Schaffer J.M.
      • Allen J.G.
      • Weiss E.S.
      • et al.
      Evaluation of risk indices in continuous-flow left ventricular assist device patients.
      • Teuteberg J.
      • Ewald G.
      • Adamson R.
      • et al.
      Application of the destination therapy risk score to HeartMate II clinical trial data [abstract] [manuscript in press, JACC].
      • Boyle A.J.
      • Ascheim D.D.
      • Russo M.J.
      • et al.
      Clinical outcomes for continuous-flow left ventricular assist device patients stratified by pre-operative INTERMACS classification.
      • Cowger J.
      • Sundareswaran K.
      • Rogers J.
      • et al.
      The HeartMate II risk score: Predicting survival in candidates for left ventricular assist device support [abstract].

      Class IIa:
      • 1.
        Long-term MCS for patients who are in acute cardiogenic shock should be reserved for the following:
        • a.
          Patients whose ventricular function is deemed unrecoverable or unlikely to recover without long-term device support.
        • b.
          Patients who are deemed too ill to maintain normal hemodynamics and vital organ function with temporary MCSDs, or who cannot be weaned from temporary MCSDs or inotropic support.
        • c.
          Patients with the capacity for meaningful recovery of end-organ function and quality of life.
        • d.
          Patients without irreversible end-organ damage.
          Level of evidence: C.
      • 2.
        Patients who are inotrope-dependent should be considered for MCS because they represent a group with high mortality with ongoing medical management.
        Level of evidence: B.
      • 3.
        Patients with end-stage systolic heart failure who do not fall into recommendations 1 and 2 above should undergo routine risk stratification at regular intervals to determine the need for and optimal timing of MCS. This determination may be aided by risk assessment calculators and cardiopulmonary stress testing.
        Level of evidence: C.
      • 4.
        Heart failure patients who are at high-risk for 1-year mortality using prognostic models should be referred for advanced therapy including heart transplant, or MCS (bridge to transplantation [BTT] or destination therapy [DT]) as appropriate.
        Level of evidence: C.

      Topic 2: Risk management of comorbidities

      Recommendations for patients with coronary artery disease:
      • Pagani F.D.
      • Miller L.W.
      • Russell S.D.
      • et al.
      Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device.
      • Strueber M.
      • O’Driscoll G.
      • Jansz P.
      • Khaghani A.
      • Levy W.C.
      • Wieselthaler G.M.
      Multicenter evaluation of an intrapericardial left ventricular assist system.

      Class IIa:
      • 1.
        Patients being considered for MCS who have a history of coronary artery bypass grafting should have a chest computed tomography (CT) scan to provide the location and course of the bypass grafts to guide the surgical approach.
        Level of evidence: C.

      Recommendations for patients with acute myocardial infarction:

      Class IIb:
      • 1.
        If possible, permanent MCS should be delayed in the setting of an acute infarct involving the left ventricular (LV) apex.
        Level of evidence: C.

      Recommendations for the evaluation of MCS candidates with congenital heart disease:

      Class I:
      • 1.
        All patients with congenital heart disease should have recent imaging to fully document cardiac morphology, assess for the presence of shunts or collateral vessels, and the location and course of their great vessels.
        Level of evidence: C.
      Class IIa:
      • 1.
        Patients with complex congenital heart disease, atypical situs, or residual intraventricular shunts who are not candidates for LV support should be considered for a total artificial heart.
        Level of evidence: C.

      Recommendations for aortic valve disease:

      Class I:
      • 1.
        Functioning bioprosthetic valves do not require removal or replacement at the time of implant.
        Level of evidence: C.
      • 2.
        Replacement of a pre-existing aortic mechanical valve with a bioprosthetic valve or oversewing the aortic valve at the time of implantation is recommended.
        Level of evidence: C.

      Recommendations for aortic regurgitation:

      Class I:
      • 1.
        More than mild aortic insufficiency should prompt consideration for surgical intervention during device implantation.
        Level of evidence: C

      Recommendations for aortic stenosis:

      Class I:
      • 1.
        Patients with aortic stenosis of any degree that is accompanied by more than mild aortic insufficiency should prompt consideration for a bioprosthetic aortic valve replacement during MCS implant (see Section 3).
        Level of evidence: C.
      Class IIb:
      • 1.
        Patients with severe aortic stenosis may be considered for aortic valve replacement, regardless of the degree of concomitant aortic insufficiency.
        Level of evidence: C.

      Recommendations for aortic root disease:

      Class IIa:
      • 1.
        Patients with a history of vascular disease and/or coronary artery disease should have a pre-operative assessment of their ascending aorta for aneurysmal dilation and atherosclerotic burden with a CT scan prior to implant.
        Level of evidence: C.

      Recommendations for mitral valve:

      Class IIb:
      • 1.
        Severe mitral insufficiency is not a contraindication to MCS and does not routinely require surgical repair or valve replacement, unless there is expectation of ventricular recovery.
        Level of evidence: C.
      Class III:
      • 1.
        Routine mitral valve repair or replacement for severe mitral regurgitation is not recommended.
        Level of evidence: C.

      Recommendations for mitral valve stenosis:

      Class I:
      • 1.
        Valve replacement with a tissue valve should be considered if there is moderate or worse mitral valve stenosis at the time of left ventricular assist device (LVAD) implantation.
        Level of evidence: C

      Recommendations for mechanical mitral valves:

      Class III:
      • 1.
        Routine replacement of properly functioning mechanical mitral valve is not recommended.
        Level of evidence: C.

      Recommendations for tricuspid valve regurgitation:

      Class IIa:
      • 1.
        Moderate or greater tricuspid regurgitation should prompt consideration of surgical repair at the time of implant.
        Level of evidence: C.

      Recommendations for infective endocarditis:

      Class I:
      • 1.
        Device implantation in patients who have been bacteremic should have documented clearance of the bacteremia for at least 5 days on appropriate anti-microbial therapy. This anti-microbial therapy should include a total duration of at least 7 total days prior to MCSD implantation.
        Level of evidence: C.
      Class III:
      • 1.
        Acute valvular infectious endocarditis with active bacteremia is an absolute contraindication to MCS implantation.
        Level of evidence: C.
      • 2.
        Active infection of an implantable cardioverter defibrillator (ICD) or pacemaker with bacteremia is an absolute contraindication to MCS implantation.
        Level of evidence: C.

      Recommendations for intracardiac shunts:

      Class I:
      • 1.
        Atrial septal defects and patent foramen ovale should be closed at the time of MCS implantation.
        Level of evidence: C.
      Class III:
      • 1.
        An LVAD alone in the setting of an unrepairable ventricular septal defect or free wall rupture is not recommended.
        Level of evidence: C.

      Recommendations for intracardiac thrombus:

      Class IIa:
      • 1.
        Echocardiography or CT, with contrast when necessary, should be used pre-operatively to screen for intracardiac thrombus.
        Level of evidence: C.

      Recommendations for atrial arrhythmias:

      Class I:
      • 1.
        Atrial flutter or fibrillation is not a contraindication to MCS.
        Level of evidence: C.
      Class IIa:
      • 1.
        Patients with medically refractory atrial tachyarrhythmias may benefit from ablation of the arrhythmia or atrioventricular node (with subsequent ICD/pacemaker placement) prior to LVAD implantation.
        Level of evidence: C.

      Recommendations for arrhythmia therapy:

      Class IIa:
      • 1.
        Patients with treatment-refractory recurrent sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) in the presence of untreatable arrhythmogenic pathologic substrate (eg, giant cell myocarditis, scar, sarcoidosis), should not be considered for LV support alone, but rather biventricular support or a total artificial heart.
        Level of evidence: C.

      Recommendations for peripheral vascular disease:
      • Johnsson P.
      • Algotsson L.
      • Ryding E.
      • Stahl E.
      • Messeter K.
      Cardiopulmonary perfusion and cerebral blood flow in bilateral carotid artery disease.
      • Selim M.
      Angioplasty and stenting of asymptomatic carotid stenosis before cardiac surgery: more study is needed.
      • Lazar H.L.
      • Menzoian J.O.
      Coronary artery bypass grafting in patients with cerebrovascular disease.

      Class IIa:
      • 1.
        All patients with known atherosclerotic vascular disease or significant risk factors for its development should be screened for peripheral vascular disease prior to MCS.
        Level of evidence: C.
      Class IIb:
      • 1.
        Peripheral vascular disease may be a relative contraindication to MCS based on its extent and severity.
        Level of evidence: C.

      Recommendations for life-limiting comorbidities and multiorgan failure:
      • Kirklin J.K.
      • Naftel D.C.
      • Kormos R.L.
      • et al.
      Second INTERMACS annual report: more than 1,000 primary left ventricular assist device implants.

      Class III:
      • 1.
        Consideration of MCS in the setting of irreversible multiorgan failure is not recommended.
        Level of evidence: C.

      Recommendations for pulmonary hypertension
      • Mikus E.
      • Stepanenko A.
      • Krabatsch T.
      • et al.
      Reversibility of fixed pulmonary hypertension in left ventricular assist device support recipients.
      • Uriel N.
      • Sims D.B.
      • Jorde U.P.
      Fixed pulmonary hypertension and mechanical support: an unclear opportunity.
      • Mikus E.
      • Stepanenko A.
      • Krabatsch T.
      • et al.
      Left ventricular assist device or heart transplantation: impact of transpulmonary gradient and pulmonary vascular resistance on decision making.

      Class I:
      • 1.
        All patients being considered for MCS should have an invasive hemodynamic assessment of pulmonary vascular resistance.
        Level of evidence: C.

      Recommendations for neurologic function:
      • Kato T.S.
      • Schulze P.C.
      • Yang J.
      • et al.
      Pre-operative and post-operative risk factors associated with neurologic complications in patients with advanced heart failure supported by a left ventricular assist device.

      Class I:
      • 1.
        A thorough neurologic examination should be performed on every patient being considered for MCS. Neurologic consultation should be obtained for patients with significant neurologic disease or dementia, or significant atherosclerotic vascular disease of their carotid or vertebral systems.
        Level of evidence: C.
      • 2.
        All patients being considered for MCS should have a carotid and vertebral Doppler examination as a screen for occult vascular disease.
        Level of evidence: C.
      • 3.
        CT scan or magnetic resonance imaging is warranted in patients with previous stroke to establish a pre-operative baseline study.
        Level of evidence: C.
      Class III:
      • 1.
        MCS is not recommended in patients with neuromuscular disease that severely compromises their ability to use and care for external system components or to ambulate and exercise.
        Level of evidence: C.

      Recommendations for coagulation and hematologic disorders:
      • Wadia Y.
      • Etheridge W.
      • Smart F.
      • Wood R.P.
      • Frazier O.H.
      Pathophysiology of hepatic dysfunction and intrahepatic cholestasis in heart failure and after left ventricular assist device support.
      • Levy J.H.
      • Winkler A.M.
      Heparin-induced thrombocytopenia and cardiac surgery.
      • Morel-Kopp M.C.
      • Aboud M.
      • Tan C.W.
      • Kulathilake C.
      • Ward C.
      Whole blood impedance aggregometry detects heparin-induced thrombocytopenia antibodies.
      • Warkentin T.E.
      • Greinacher A.
      • Koster A.
      Heparin-induced thrombocytopenia in patients with ventricular assist devices: are new prevention strategies required?.
      • Zucker M.J.
      • Sabnani I.
      • Baran D.A.
      • Balasubramanian S.
      • Camacho M.
      Cardiac transplantation and/or mechanical circulatory support device placement using heparin anti-coagulation in the presence of acute heparin-induced thrombocytopenia.

      Class I:
      • 1.
        All patients evaluated for MCS therapy should have a prothrombin time/international normalized ratio (INR), partial thromboplastin time, and platelet assessed pre-operatively.
        Level of evidence: C.
      • 2.
        Baseline abnormalities in coagulation parameters not due to pharmacologic therapy should prompt an evaluation to determine the etiology prior to implant.
        Level of evidence: C.
      • 3.
        Patients with a history of thrombophilia prior to MCS should have a hypercoagulable assessment before implant.
        Level of evidence: C.
      Class IIa:
      • 1.
        Patients with a clinical syndrome of heparin-induced thrombocytopenia should have confirmatory testing performed.
        Level of evidence: C.
      • 2.
        Thienopyridine anti-platelet agents should be stopped at least 5 days prior to surgery unless there is a compelling indication for continued use.
        Level of evidence: C.

      Recommendations for malignancy:

      Class I:
      • 1.
        Patients with a history of a treated cancer who are in long-term remission or who are considered free of disease may be candidates for MCS as BTT, with the involvement of an oncologist to determine risk of recurrence or progression.
        Level of evidence: C.
      Class IIa:
      • 1.
        Patients with a history of recently treated or active cancer who have a reasonable life-expectancy (>2 years) may be candidates for DT if evaluated in conjunction with an oncologist to determine risk.
        Level of evidence: C.
      Class III:
      • 1.
        MCS as BTT or DT is not recommended for patients with an active malignancy and a life expectancy of<2 years.
        Level of evidence: C.

      Recommendations for diabetes:
      • Butler J.
      • Howser R.
      • Portner P.M.
      • Pierson 3rd, R.N.
      Diabetes and outcomes after left ventricular assist device placement.
      • Topkara V.K.
      • Dang N.C.
      • Martens T.P.
      • et al.
      Effect of diabetes on short- and long-term outcomes after left ventricular assist device implantation.
      • Uriel N.
      • Naka Y.
      • Colombo P.C.
      • et al.
      Improved diabetic control in advanced heart failure patients treated with left ventricular assist devices.

      Class I:
      • 1.
        All patients should be screened for diabetes with a fasting glucose prior to MCS.
        Level of evidence: C.
      • 2.
        All patients with an abnormal fasting glucose or established diabetes should have a hemoglobin A1c assessed and be evaluated for the degree of end-organ damage (retinopathy, neuropathy, nephropathy, and vascular disease).
        Level of evidence: C.
      • 3.
        Patients with poorly controlled diabetes should have a consultation with an endocrinologist prior to implantation.
        Level of evidence: C.
      Class IIb:
      • 1.
        MCS is relatively contraindicated in the setting of diabetes-related proliferative retinopathy, very poor glycemic control, or severe nephropathy, vasculopathy, or peripheral neuropathy.
        Level of evidence: C.

      Recommendations for pregnancy:
      • Kolesar A.
      • Sabol F.
      • Luczy J.
      • Bajmoczi M.
      Use of left ventricle assist device in a pregnant woman with acute aortic and coronary dissections.
      • LaRue S.
      • Shanks A.
      • Wang I.W.
      • Ewald G.
      • Anderson D.
      • Joseph S.
      Left ventricular assist device in pregnancy.
      • Oles D.
      • Berryessa R.
      • Campbell K.
      • Bhatti M.A.
      Emergency redo mitral valve replacement in a 27-year-old pregnant female with a clotted prosthetic mitral valve, preoperative fetal demise and postoperative ventricular assist device: a case report.
      • Sims D.B.
      • Vink J.
      • Uriel N.
      • et al.
      A successful pregnancy during mechanical circulatory device support.

      Class I:
      • 1.
        Use of contraception in women of childbearing age after MCS is recommended.
        Level of evidence: C.
      Class III:
      • 1.
        MCS in the setting of active pregnancy is not recommended.
        Level of evidence: C.

      Recommendations for age:
      • Holman W.L.
      • Kormos R.L.
      • Naftel D.C.
      • et al.
      Predictors of death and transplant in patients with a mechanical circulatory support device: a multi-institutional study.
      • Adamson R.M.
      • Stahovich M.
      • Chillcott S.
      • et al.
      Clinical strategies and outcomes in advanced heart failure patients older than 70 years of age receiving the HeartMate II left ventricular assist device: a community hospital experience.

      Class IIb:
      • 1.
        Patients aged>60 years should undergo thorough evaluation for the presence of other clinical risk factors that may decrease survival or quality of life after MCS.
        Level of evidence: C.

      Recommendations for psychologic and psychiatric evaluation:
      • Cupples S.
      • Dew M.A.
      • Grady K.L.
      • et al.
      Report of the Psychosocial Outcomes Workgroup of the Nursing and Social Sciences Council of the International Society for Heart and Lung Transplantation: present status of research on psychosocial outcomes in cardiothoracic transplantation: review and recommendations for the field.
      • Eshelman A.K.
      • Mason S.
      • Nemeh H.
      • Williams C.
      LVAD destination therapy: applying what we know about psychiatric evaluation and management from cardiac failure and transplant.
      • Levenson J.L.
      • Olbrisch M.E.
      Psychosocial evaluation of organ transplant candidates. A comparative survey of process, criteria, and outcomes in heart, liver, and kidney transplantation.
      • Olbrisch M.E.
      • Benedict S.M.
      • Ashe K.
      • Levenson J.L.
      Psychological assessment and care of organ transplant patients.
      • Olbrisch M.E.
      • Levenson J.L.
      Psychosocial assessment of organ transplant candidates. Current status of methodological and philosophical issues.
      • De Geest S.
      • Abraham I.
      • Moons P.
      • et al.
      Late acute rejection and subclinical noncompliance with cyclosporine therapy in heart transplant recipients.
      • De Geest S.
      • Dobbels F.
      • Martin S.
      • Willems K.
      • Vanhaecke J.
      Clinical risk associated with appointment noncompliance in heart transplant recipients.
      • De Geest S.
      • Dobbels F.
      • Fluri C.
      • Paris W.
      • Troosters T.
      Adherence to the therapeutic regimen in heart, lung, and heart-lung transplant recipients.

      Class I:
      • 1.
        All patients should have a screen for psychosocial risk factors prior to MCS.
        Level of evidence: C.
      • 2.
        All patients should have a screen for cognitive dysfunction prior to MCS.
        Level of evidence: C.
      • 3.
        Family, social, and emotional support must be assessed prior to MCS.
        Level of evidence: C.
      • 4.
        Patients with a history of a significant psychiatric illness who are considered for MCS should undergo a thorough psychiatric and psychologic evaluation to identify potential risk factors.
        Level of evidence: C.
      Class III:
      • 1.
        MCS should not be performed in patients who are unable to physically operate their pump or respond to device alarms. In addition, an inability to report signs and symptoms of device malfunction or other health care needs to the MCS team, or patients who live in an unsafe environment are all contraindications to implantation.
        Level of evidence: C.
      • 2.
        MCS is not recommended in patients with active psychiatric illness that requires long-term institutionalization or who have the inability to care for or maintain their device.
        Level of evidence: C.

      Recommendations for adherence to medical therapy and social network:
      • De Geest S.
      • Abraham I.
      • Moons P.
      • et al.
      Late acute rejection and subclinical noncompliance with cyclosporine therapy in heart transplant recipients.
      • De Geest S.
      • Dobbels F.
      • Martin S.
      • Willems K.
      • Vanhaecke J.
      Clinical risk associated with appointment noncompliance in heart transplant recipients.
      • De Geest S.
      • Dobbels F.
      • Fluri C.
      • Paris W.
      • Troosters T.
      Adherence to the therapeutic regimen in heart, lung, and heart-lung transplant recipients.
      • Dew M.A.
      • Roth L.H.
      • Thompson M.E.
      • Kormos R.L.
      • Griffith B.P.
      Medical compliance and its predictors in the first year after heart transplantation.
      • Nagele H.
      • Kalmar P.
      • Rodiger W.
      • Stubbe H.M.
      Smoking after heart transplantation: an underestimated hazard?.

      Class I:
      • 1.
        Assessment of medical compliance, social support, and coping skills should be performed in all candidates for MCS device implantation.
        Level of evidence: C.
      Class IIa:
      • 1.
        Lack of sufficient social support and limited coping skills are relative contraindications to MCS in patients with a history of non-adherent behavior.
        Level of evidence: C.
      Class III:
      • 1.
        Poor compliance with medical regimens is a risk factor for poor outcomes related to MCS and death after heart transplantation. Patients who demonstrate an inability to comply with medical recommendations on multiple occasions should not receive MCS.
        Level of evidence: C.

      Recommendations for tobacco use:

      Class I:
      • 1.
        Patients considered for MCS implantation should receive education on the importance of tobacco cessation and reduction in environmental and second-hand exposure before device implantation and throughout the duration of device support.
        Level of evidence: C.
      Class IIa:
      • 1.
        Previous tobacco use should not preclude emergent pump implantation as a potential BTT. However, patients should not be made active on the transplant waiting list until 6 months of nicotine abstinence has been proven.
        Level of evidence: C.

      Recommendations for alcohol and substance abuse:
      • Dew M.A.
      • DiMartini A.F.
      • Steel J.
      • et al.
      Meta-analysis of risk for relapse to substance use after transplantation of the liver or other solid organs.

      Class IIb:
      • 1.
        The patient should be abstinent for a period of time as determined a priori by the program in order to be considered for MCS therapy.
        Level of evidence: C.
      Class III:
      • 1.
        Active substance abusers (including alcohol) should not receive MCS therapy.
        Level of evidence: C.

      Recommendations for caregiver burden:
      • Kaan A.
      • Young Q.R.
      • Cockell S.
      • Mackay M.
      Emotional experiences of caregivers of patients with a ventricular assist device.
      • Marcuccilli L.
      • Casida J.M.
      From insiders’ perspectives: adjusting to caregiving for patients with left ventricular assist devices.
      • Bunzel B.
      • Laederach-Hofmann K.
      • Wieselthaler G.M.
      • Roethy W.
      • Drees G.
      Posttraumatic stress disorder after implantation of a mechanical assist device followed by heart transplantation: evaluation of patients and partners.
      • Bunzel B.
      • Laederach-Hofmann K.
      • Wieselthaler G.
      • Roethy W.
      • Wolner E.
      Mechanical circulatory support as a bridge to heart transplantation: what remains? Long-term emotional sequelae in patients and spouses.

      Class I:
      • 1.
        Caregiver burden should be assessed prior to MCS implantation to assure that support will be available. Agreement on behalf of the patient is not sufficient.
        Level of evidence: C.
      Class IIb:
      • 1.
        Significant caregiver burden or lack of any caregiver is a relative contraindication to the patient’s MCS implantation.
        Level of evidence: C.

      Recommendation for the evaluation of patient's financial situation and insurance coverage:

      Class IIa:
      • 1.
        A mechanism must be in place to provide financial aid or support for post-operative care for those who have limitations to medical coverage. Depending on the country, this may be provided by the government, an insurance agent, or an individual’s family.
        Level of evidence: C.

      Task Force 2: Patient optimization, consent, and appropriate timing for MCS: Modifiable risk management prior to implantation

      Co-chairs: Emma Birks, MD; David Feldman, MD, PhD
      Contributing Writers: Katarzyna Hryniewicz, MD; Nader Moazami, MD; William Perry, RN; J. Eduardo Rame, MD; Benjamin Sun, MD; Jeffrey J. Teuteberg, MD
      Independent Reviewer: Francis Pagani, MD

      Recommendations for obesity:
      • Park S.J.
      • Milano C.A.
      • Tatooles A.J.
      • et al.
      Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy.
      • Raymond A.L.
      • Kfoury A.G.
      • Bishop C.J.
      • et al.
      Obesity and left ventricular assist device driveline exit site infection.
      • Zahr F.
      • Genovese E.
      • Mathier M.
      • et al.
      Obese patients and mechanical circulatory support: weight loss, adverse events, and outcomes.
      • Brewer R.J.
      • Lanfear D.E.
      • Sai-Sudhakar C.B.
      • et al.
      Extremes of body mass index do not impact mid-term survival after continuous-flow left ventricular assist device implantation.
      • Dhesi P.
      • Simsir S.A.
      • Daneshvar D.
      • Rafique A.
      • Phan A.
      • Schwarz E.R.
      Left ventricular assist device as ‘bridge to weight loss’ prior to transplantation in obese patients with advanced heart failure.
      • Thompson K.
      • Dhesi P.
      • Nguyen D.
      • Czer L.
      • Moriguchi J.
      • Schwarz E.
      Evaluation of the HeartMate II left ventricular assist device in obese heart failure patients: effects on weight loss.

      Class I:
      • 1.
        Obesity (body mass index 30–35 kg/m2), in and of itself, is not a contraindication to MCS, but surgical risk and attendant comorbidities must be carefully considered prior to MCS in the morbidly obese patient (body mass index≥35 kg/m2).
        Level of evidence: B.

      Recommendations for managing patient expectations:
      • Park S.J.
      • Milano C.A.
      • Tatooles A.J.
      • et al.
      Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy.
      • Butler C.R.
      • Jugdutt B.I.
      Mechanical circulatory support for elderly heart failure patients.
      • Rizzieri A.G.
      • Verheijde J.L.
      • Rady M.Y.
      • McGregor J.L.
      Ethical challenges with the left ventricular assist device as a destination therapy.

      Class I:
      • 1.
        A detailed informed consent should discuss the salient aspects of the MCSD placement, common expectations, and possible complications in the peri-operative and post-operative period.
        Level of evidence: C.
      Class IIb:
      • 1.
        Quality of life should be assessed before and after MCSD implantation to help guide patient decisions. Assessment tools, including Minnesota Living with Heart Failure questionnaire, Sickness Impact Profile, EuroQol, and others should be considered to help guide patient care.
        Level of evidence: C.

      Recommendations for palliative care:
      • Hunt S.A.
      • Abraham W.T.
      • Chin M.H.
      • et al.
      Focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the International Society for Heart and Lung Transplantation.
      • Brush S.
      • Budge D.
      • Alharethi R.
      • et al.
      End-of-life decision making and implementation in recipients of a destination left ventricular assist device.

      Class IIa:
      • 1.
        Palliative care consultation should be a component of the treatment of end-stage heart failure during the evaluation phase for MCS. In addition to symptom management, goals and preferences for end of life should be discussed with patients receiving MCS as DT.
        Level of evidence: C.

      Recommendations for managing renal function:
      • Sandner S.E.
      • Zimpfer D.
      • Zrunek P.
      • et al.
      Renal function and outcome after continuous flow left ventricular assist device implantation.
      • Butler J.
      • Geisberg C.
      • Howser R.
      • et al.
      Relationship between renal function and left ventricular assist device use.
      • Topkara V.K.
      • Dang N.C.
      • Barili F.
      • et al.
      Predictors and outcomes of continuous veno-venous hemodialysis use after implantation of a left ventricular assist device.
      • Ootaki C.
      • Yamashita M.
      • Ootaki Y.
      • et al.
      Reduced pulsatility induces periarteritis in kidney: role of the local renin-angiotensin system.
      • Sandner S.E.
      • Zimpfer D.
      • Zrunek P.
      • et al.
      Renal function after implantation of continuous versus pulsatile flow left ventricular assist devices.
      • Radovancevic B.
      • Vrtovec B.
      • de K.E.
      • Radovancevic R.
      • Gregoric I.D.
      • Frazier O.H.
      End-organ function in patients on long-term circulatory support with continuous- or pulsatile-flow assist devices.
      • Letsou G.V.
      • Myers T.J.
      • Gregoric I.D.
      • et al.
      Continuous axial-flow left ventricular assist device (Jarvik 2000) maintains kidney and liver perfusion for up to 6 months.
      • Russell S.D.
      • Rogers J.G.
      • Milano C.A.
      • et al.
      Renal and hepatic function improve in advanced heart failure patients during continuous-flow support with the HeartMate II left ventricular assist device.
      • Miller L.W.
      • Pagani F.D.
      • Russell S.D.
      • et al.
      Use of a continuous-flow device in patients awaiting heart transplantation.
      • Slaughter M.S.
      • Pagani F.D.
      • Rogers J.G.
      • et al.
      Clinical management of continuous-flow left ventricular assist devices in advanced heart failure.
      • Singh M.
      • Shullo M.
      • Kormos R.L.
      • et al.
      Impact of renal function before mechanical circulatory support on posttransplant renal outcomes.

      Class I:
      • 1.
        All patients should have their renal function monitored closely prior to MCSD implantation.
        Level of evidence: C.
      • 2.
        Patients with volume overload and/or poor output in the setting of renal dysfunction should have a period of hemodynamic optimization (with inotropic support if clinically indicated) combined with aggressive diuresis or mechanical volume removal.
        Level of evidence: C.
      • 3.
        Assessment of serum creatinine, blood urea nitrogen, and a 24-hour urine collection for creatinine clearance and proteinuria after patients are hemodynamically optimized should be performed in all patients being considered for MCS.
        Level of evidence: C.
      Class III:
      • 1.
        Permanent dialysis should be a contraindication for destination therapy.
        Level of evidence: C.

      Recommendations for nutrition assessment:
      • Holdy K.
      • Dembitsky W.
      • Eaton L.L.
      • et al.
      Nutrition assessment and management of left ventricular assist device patients.
      • Liszkowski M.
      • Teuteberg J.
      • Myers S.
      INTERMACS profiles of nutrition and organ function in relation to outcomes [abstract].

      Class I:
      • 1.
        All patients should have assessment of their nutritional status prior to MCSD implantation with at least a measurement of albumin and pre-albumin.
        Level of evidence: B.
      • 2.
        Patients who have indices of malnutrition prior to MCSD implantation should have an evaluation by a nutritional consultation service.
        Level of evidence: C.
      Class IIa:
      • 1.
        Patients who have evidence of malnutrition prior to MCSD implantation should be considered for nutritional interventions prior to implantation if the patient’s clinical status allows.
        Level of evidence: C.
      Class IIb:
      • 1.
        Patients who have evidence of severe malnutrition prior to MCSD implantation should consider having implantation delayed to maximize their nutritional status, if the patient’s clinical status allows.
        Level of evidence: C.

      Recommendations for managing infection risk:
      • Nunez J.
      • Minana G.
      • Bodi V.
      • et al.
      Low lymphocyte count and cardiovascular diseases.
      • Vardeny O.
      • Moran J.J.
      • Sweitzer N.K.
      • Johnson M.R.
      • Hayney M.S.
      Decreased T-cell responses to influenza vaccination in patients with heart failure.
      • Betjes M.G.
      • Langerak A.W.
      • van der Spek A.
      • de Wit E.A.
      • Litjens N.H.
      Premature aging of circulating T cells in patients with end-stage renal disease.
      • Stofkova A.
      Leptin and adiponectin: from energy and metabolic dysbalance to inflammation and autoimmunity.

      Class I:
      • 1.
        All patients should have all unnecessary lines and catheters removed prior to MCSD implantation.
        Level of evidence: C.
      • 2.
        All patients should have a dental assessment and any remedial treatment, if time and clinical status permits, prior to MCSD implantation.
        Level of evidence: C.

      Recommendations for managing active infection:

      Class I:
      • 1.
        Patients with active infections should receive an appropriate course of antibiotic therapy, as directed by an infectious disease specialist, prior to MCSD implantation.
        Level of evidence: C.

      Recommendations for antibiotic prophylaxis:
      • Acharya M.N.
      • Som R.
      • Tsui S.
      What is the optimum antibiotic prophylaxis in patients undergoing implantation of a left ventricular assist device?.
      • Holman W.L.
      • Skinner J.L.
      • Waites K.B.
      • Benza R.L.
      • McGiffin D.C.
      • Kirklin J.K.
      Infection during circulatory support with ventricular assist devices.
      • Saito S.
      • Matsumiya G.
      • Sakaguchi T.
      • et al.
      Long-term medical control of inflow cuff infection in a patient with a left ventricular assist system.

      Class I:
      • 1.
        Patients should receive pre-operative antibiotics with broad-spectrum gram-positive and gram-negative coverage, as appropriate, prior to MCSD implantation.
        Level of evidence: C.
      • 2.
        Routine antibiotic prophylaxis should include at least 1 dose prior to surgery administered within 60 minutes of the first incision, remain in the therapeutic range throughout the duration of their use, and not extend beyond 24 to 48 hours.
        Level of evidence: C.
      • 3.
        Patients should have a nasal swab to screen for methicillin-resistant Staphylococcus aureus and receive topical treatment if positive prior to MCSD implantation.
        Level of evidence: C.

      Recommendations for hepatic dysfunction:
      • Slaughter M.S.
      • Rogers J.G.
      • Milano C.A.
      • et al.
      Advanced heart failure treated with continuous-flow left ventricular assist device.
      • Wadia Y.
      • Etheridge W.
      • Smart F.
      • Wood R.P.
      • Frazier O.H.
      Pathophysiology of hepatic dysfunction and intrahepatic cholestasis in heart failure and after left ventricular assist device support.
      • Russell S.D.
      • Rogers J.G.
      • Milano C.A.
      • et al.
      Renal and hepatic function improve in advanced heart failure patients during continuous-flow support with the HeartMate II left ventricular assist device.
      • Miller L.W.
      • Pagani F.D.
      • Russell S.D.
      • et al.
      Use of a continuous-flow device in patients awaiting heart transplantation.
      • Gelow J.M.
      • Desai A.S.
      • Hochberg C.P.
      • Glickman J.N.
      • Givertz M.M.
      • Fang J.C.
      Clinical predictors of hepatic fibrosis in chronic advanced heart failure.
      • Matthews J.C.
      • Pagani F.D.
      • Haft J.W.
      • Koelling T.M.
      • Naftel D.C.
      • Aaronson K.D.
      Model for end-stage liver disease score predicts left ventricular assist device operative transfusion requirements, morbidity, and mortality.
      • Concha P.M.
      • Mertz K.V.
      [Perioperative risk among patients with cirrhosis].
      • Modi A.
      • Vohra H.A.
      • Barlow C.W.
      Do patients with liver cirrhosis undergoing cardiac surgery have acceptable outcomes?.
      • Frazier O.H.
      • Rose E.A.
      • Oz M.C.
      • et al.
      Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation.

      Class I:
      • 1.
        Patients with a history of liver disease, abnormalities of liver function tests, chronic right heart failure, or Fontan physiology should have an ultrasound assessment of their liver to screen for cirrhosis prior to MCSD implantation.
        Level of evidence: C.
      • 2.
        Patients who have suspected cirrhosis should receive further radiologic and tissue confirmation in conjunction with a hepatology consultation.
        Level of evidence: C.
      • 3.
        Patients with abnormal liver function and decompensated hemodynamics should receive aggressive therapy aimed at the restoration of hepatic blood flow and reduction of hepatic congestion.
        Level of evidence: C.
      Class II:
      • 1.
        Patients with an elevated INR not due to warfarin therapy should be considered for treatment prior to MCSD implantation, and efforts should be made to optimize nutrition and right-sided intracardiac filling pressures.
        Level of evidence: C.
      Class III:
      • 1.
        Patients with confirmed cirrhosis or an increased Model for End Stage Liver Disease (MELD) score are poor candidates for MCSD therapy.
        Level of evidence: B.

      Recommendations for pulmonary and thoracic assessment:
      • Khan M.A.
      • Hussain S.F.
      Pre-operative pulmonary evaluation.
      • Wright D.J.
      • Khan K.M.
      • Gossage E.M.
      • Saltissi S.
      Assessment of a low-intensity cardiac rehabilitation programme using the six-minute walk test.
      • Smetana G.W.
      Preoperative pulmonary evaluation.
      • Smetana G.W.
      • Lawrence V.A.
      • Cornell J.E.
      Preoperative pulmonary risk stratification for noncardiothoracic surgery: systematic review for the American College of Physicians.
      • Miller L.W.
      • Lietz K.
      Candidate selection for long-term left ventricular assist device therapy for refractory heart failure.
      • Miller M.R.
      • Crapo R.
      • Hankinson J.
      • et al.
      General considerations for lung function testing.
      • Pellegrino R.
      • Viegi G.
      • Brusasco V.
      • et al.
      Interpretative strategies for lung function tests.
      • Rady M.Y.
      • Ryan T.
      Perioperative predictors of extubation failure and the effect on clinical outcome after cardiac surgery.
      • Samuels L.E.
      • Kaufman M.S.
      • Morris R.J.
      • Promisloff R.
      • Brockman S.K.
      Coronary artery bypass grafting in patients with COPD.
      • Dimick J.B.
      • Chen S.L.
      • Taheri P.A.
      • Henderson W.G.
      • Khuri S.F.
      • Campbell Jr., D.A.
      Hospital costs associated with surgical complications: a report from the private-sector National Surgical Quality Improvement Program.
      • Bapoje S.R.
      • Whitaker J.F.
      • Schulz T.
      • Chu E.S.
      • Albert R.K.
      Preoperative evaluation of the patient with pulmonary disease.
      • Arozullah A.M.
      • Daley J.
      • Henderson W.G.
      • Khuri S.F.
      Multifactorial risk index for predicting postoperative respiratory failure in men after major noncardiac surgery. The National Veterans Administration Surgical Quality Improvement Program.
      • Canet J.
      • Gallart L.
      • Gomar C.
      • et al.
      Prediction of postoperative pulmonary complications in a population-based surgical cohort.
      • Kroenke K.
      • Lawrence V.A.
      • Theroux J.F.
      • Tuley M.R.
      • Hilsenbeck S.
      Postoperative complications after thoracic and major abdominal surgery in patients with and without obstructive lung disease.
      • Culver B.H.
      How should the lower limit of the normal range be defined?.

      Class I:
      • 1.
        Patients should have a chest X-ray and an arterial blood gas assessment prior to MCSD implantation.
        Level of evidence: C.
      • 2.
        Patients should have some assessment of thoracic anatomy prior to MCSD implantation or in the setting of prior surgery or suspected thoracic abnormalities. These may include a radiologic examination with CT or magnetic resonance imaging.
        Level of evidence: C.
      • 3.
        Positive airway pressure, early ambulation, induced cough, incentive spirometry, and effective pain control subsequent to surgery may all decrease post-operative complications.
        Level of evidence: C.

      Recommendations for management of patients with decompensated heart failure:
      • Kirklin J.K.
      • Naftel D.C.
      • Kormos R.L.
      • et al.
      Third INTERMACS Annual Report: the evolution of destination therapy in the United States.
      • Feldman D.S.
      • Elton T.S.
      • Sun B.
      • Martin M.M.
      • Ziolo M.T.
      Mechanisms of disease: detrimental adrenergic signaling in acute decompensated heart failure.
      • Pagani F.D.
      • Lynch W.
      • Swaniker F.
      • et al.
      Extracorporeal life support to left ventricular assist device bridge to heart transplant: A strategy to optimize survival and resource utilization.
      • Copeland J.G.
      • Smith R.G.
      • Arabia F.A.
      • et al.
      Cardiac replacement with a total artificial heart as a bridge to transplantation.

      Class I:
      • 1.
        Short-term mechanical support, including extracorporeal membrane oxygenation, should be used in acutely decompensated patients who are failing maximal medical therapy.
        Level of evidence: C.

      Recommendations for temporary mechanical support:
      • Pagani F.D.
      • Lynch W.
      • Swaniker F.
      • et al.
      Extracorporeal life support to left ventricular assist device bridge to heart transplant: A strategy to optimize survival and resource utilization.
      • Aziz T.A.
      • Singh G.
      • Popjes E.
      • et al.
      Initial experience with CentriMag extracorporal membrane oxygenation for support of critically ill patients with refractory cardiogenic shock.
      • Bagai J.
      • Webb D.
      • Kasasbeh E.
      • et al.
      Efficacy and safety of percutaneous life support during high-risk percutaneous coronary intervention, refractory cardiogenic shock and in-laboratory cardiopulmonary arrest.
      • Cleveland Jr, J.C.
      • Naftel D.C.
      • Reece T.B.
      • et al.
      Survival after biventricular assist device implantation: an analysis of the Interagency Registry for Mechanically Assisted Circulatory Support database.
      • Krabatsch T.
      • Schweiger M.
      • Stepanenko A.
      • et al.
      Mechanical circulatory support-results, developments and trends.
      • Thiele H.
      • Sick P.
      • Boudriot E.
      • et al.
      Randomized comparison of intra-aortic balloon support with a percutaneous left ventricular assist device in patients with revascularized acute myocardial infarction complicated by cardiogenic shock.
      • Engstrom A.E.
      • Cocchieri R.
      • Driessen A.H.
      • et al.
      The Impella 2.5 and 5.0 devices for ST-elevation myocardial infarction patients presenting with severe and profound cardiogenic shock: the Academic Medical Center intensive care unit experience.
      • Koeckert M.S.
      • Jorde U.P.
      • Naka Y.
      • Moses J.W.
      • Takayama H.
      • Impella L.P.
      2.5 for left ventricular unloading during venoarterial extracorporeal membrane oxygenation support.
      • Meyns B.
      • Dens J.
      • Sergeant P.
      • Herijgers P.
      • Daenen W.
      • Flameng W.
      Initial experiences with the Impella device in patients with cardiogenic shock—Impella support for cardiogenic shock.
      • Siegenthaler M.P.
      • Brehm K.
      • Strecker T.
      • et al.
      The Impella Recover microaxial left ventricular assist device reduces mortality for postcardiotomy failure: a three-center experience.

      Class I:
      • 1.
        The use of temporary mechanical support should be strongly considered in patients with multiorgan failure, sepsis, or on mechanical ventilation to allow successful optimization of clinical status and neurologic assessment prior to placement of a long-term MCSD.
        Level of evidence: C.

      Recommendations for assessing RV function:
      • Frazier O.H.
      • Rose E.A.
      • Oz M.C.
      • et al.
      Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation.
      • Feldman D.
      • Menachemi D.M.
      • Abraham W.T.
      • Wexler R.K.
      Management strategies for stage-D patients with acute heart failure.
      • Farrar D.J.
      Ventricular interactions during mechanical circulatory support.
      • Farrar D.J.
      • Compton P.G.
      • Hershon J.J.
      • Fonger J.D.
      • Hill J.D.
      Right heart interaction with the mechanically assisted left heart.
      • Dang N.C.
      • Topkara V.K.
      • Mercando M.
      • et al.
      Right heart failure after left ventricular assist device implantation in patients with chronic congestive heart failure.
      • Kavarana M.N.
      • Pessin-Minsley M.S.
      • Urtecho J.
      • et al.
      Right ventricular dysfunction and organ failure in left ventricular assist device recipients: a continuing problem.
      • Ochiai Y.
      • McCarthy P.M.
      • Smedira N.G.
      • et al.
      Predictors of severe right ventricular failure after implantable left ventricular assist device insertion: analysis of 245 patients.
      • Fitzpatrick 3rd, J.R.
      • Frederick J.R.
      • Hiesinger W.
      • et al.
      Early planned institution of biventricular mechanical circulatory support results in improved outcomes compared with delayed conversion of a left ventricular assist device to a biventricular assist device.
      • Tsukui H.
      • Teuteberg J.J.
      • Murali S.
      • et al.
      Biventricular assist device utilization for patients with morbid congestive heart failure: a justifiable strategy.
      • Kukucka M.
      • Stepanenko A.
      • Potapov E.
      • et al.
      Right-to-left ventricular end-diastolic diameter ratio and prediction of right ventricular failure with continuous-flow left ventricular assist devices.
      • Matthews J.C.
      • Koelling T.M.
      • Pagani F.D.
      • Aaronson K.D.
      The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates.

      Class I:
      • 1.
        All patients should have an echocardiographic assessment of RV function prior to MCSD implantation.
        Level of evidence: C.
      • 2.
        All patients should have invasive assessment of intracardiac filling pressures prior to MCSD implantation, with a particular emphasis on RV hemodynamics.
        Level of evidence: C.

      Recommendations for management of RV dysfunction:
      • Slaughter M.S.
      • Rogers J.G.
      • Milano C.A.
      • et al.
      Advanced heart failure treated with continuous-flow left ventricular assist device.
      • Kirklin J.K.
      • Naftel D.C.
      • Kormos R.L.
      • et al.
      Second INTERMACS annual report: more than 1,000 primary left ventricular assist device implants.
      • Pagani F.D.
      • Miller L.W.
      • Russell S.D.
      • et al.
      Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device.
      • Butler J.
      • Geisberg C.
      • Howser R.
      • et al.
      Relationship between renal function and left ventricular assist device use.
      • Kavarana M.N.
      • Pessin-Minsley M.S.
      • Urtecho J.
      • et al.
      Right ventricular dysfunction and organ failure in left ventricular assist device recipients: a continuing problem.
      • Ochiai Y.
      • McCarthy P.M.
      • Smedira N.G.
      • et al.
      Predictors of severe right ventricular failure after implantable left ventricular assist device insertion: analysis of 245 patients.
      • Matthews J.C.
      • Koelling T.M.
      • Pagani F.D.
      • Aaronson K.D.
      The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates.
      • Furukawa K.
      • Motomura T.
      • Nose Y.
      Right ventricular failure after left ventricular assist device implantation: the need for an implantable right ventricular assist device.
      • Fitzpatrick 3rd, J.R.
      • Frederick J.R.
      • Hsu V.M.
      • et al.
      Risk score derived from pre-operative data analysis predicts the need for biventricular mechanical circulatory support.
      • Kormos R.L.
      • Teuteberg J.J.
      • Pagani F.D.
      • et al.
      Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: incidence, risk factors, and effect on outcomes.

      Class I:
      • 1.
        Pre-operatively, patients with evidence of RV dysfunction should be admitted to the hospital for aggressive management, which may include diuresis, ultrafiltration, inotropes, intra-aortic balloon pump, or other short-term mechanical support. Once optimized, RV function should be reassessed.
        Level of evidence: C.
      • 2.
        RV dysfunction post-MCS should be managed with diuresis, inotropes, and pulmonary vasodilators, including nitric oxide or inhaled prostacyclin. RV dysfunction refractory to medical management may require placement of a short-term or long-term mechanical RV support device.
        Level of evidence: C.
      Class IIb:
      • 1.
        Phosphodiesterase 5 inhibitors may be considered for management of RV dysfunction in the setting of pulmonary hypertension after MCS.
        Level of evidence: C.

      Task Force 3: Intraoperative and immediate post-operative management

      Chair: Jeffrey A. Morgan, MD
      Contributing Writers: Marc L. Dickstein, MD; Aly El-Banayosy, MD; Daniel J. Goldstein, MD; Matthias Loebe, MD, PhD; Erik N. Sorensen, PhD; Martin Strueber, MD
      Independent Reviewer: Francis Pagani, MD

      Topic 1: Anesthesia-related issues

      Recommendations for managing anesthesia issues:
      • Chumnanvej S.
      • Wood M.J.
      • MacGillivray T.E.
      • Melo M.F.
      Perioperative echocardiographic examination for ventricular assist device implantation.
      • Osculati G.
      • Malfatto G.
      • Chianca R.
      • Perego G.B.
      Left-to-right systolic ventricular interaction in patients undergoing biventricular stimulation for dilated cardiomyopathy.
      • Mau J.
      • Menzie S.
      • Huang Y.
      • Ward M.
      • Hunyor S.
      Chronic septal infarction confers right ventricular protection during mechanical left ventricular unloading.
      • Smith A.M.
      • Elliot C.M.
      • Kiely D.G.
      • Channer K.S.
      The role of vasopressin in cardiorespiratory arrest and pulmonary hypertension.
      • Ootaki Y.
      • Kamohara K.
      • Akiyama M.
      • et al.
      Phasic coronary blood flow pattern during a continuous flow left ventricular assist support.
      • Tuzun E.
      • Eya K.
      • Chee H.K.
      • et al.
      Myocardial hemodynamics, physiology, and perfusion with an axial flow left ventricular assist device in the calf.
      • Voitl P.
      • Vollkron M.
      • Bergmeister H.
      • Wieselthaler G.
      • Schima H.
      Coronary hemodynamics and myocardial oxygen consumption during support with rotary blood pumps.
      • Letsou G.V.
      • Sdringola S.
      • Gregoric I.D.
      • et al.
      Myocardial perfusion as assessed by positron emission tomography during long-term mechanical circulatory support.
      • Xydas S.
      • Rosen R.S.
      • Pinney S.
      • et al.
      Reduced myocardial blood flow during left ventricular assist device support: a possible cause of premature bypass graft closure.
      • Forrester M.D.
      • Myers T.J.
      • Gregoric I.D.
      • Frazier O.H.
      Saphenous vein graft flow during left ventricular assistance with an axial-flow pump.
      • Sommer S.P.
      • Gorski A.
      • Aleksic I.
      • et al.
      Heartmate II implantation with right coronary bypass grafting in ischemic cardiomyopathy with “fixed” pulmonary hypertension: treatment strategy to protect right ventricular function.
      • Potapov E.V.
      • Sodian R.
      • Loebe M.
      • Drews T.
      • Dreysse S.
      • Hetzer R.
      Revascularization of the occluded right coronary artery during left ventricular assist device implantation.
      • Schroeder R.A.
      • Wood G.L.
      • Plotkin J.S.
      • Kuo P.C.
      Intraoperative use of inhaled PGI(2) for acute pulmonary hypertension and right ventricular failure.
      • Fattouch K.
      • Sbraga F.
      • Sampognaro R.
      • et al.
      Treatment of pulmonary hypertension in patients undergoing cardiac surgery with cardiopulmonary bypass: a randomized, prospective, double-blind study.
      • Riker R.R.
      • Shehabi Y.
      • Bokesch P.M.
      • et al.
      Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial.

      Class I:
      • 1.
        Patients undergoing MCSD placement should have insertion of a large-bore intravenous line, arterial line, and pulmonary artery catheter to allow for continuous monitoring and intravascular access.
        Level of evidence: B
      • 2.
        Cardiac anesthesia should be performed by those familiar with the clinical issues associated with MCSD placement, including considerations at the time of induction, during surgery, during separation from cardiopulmonary bypass, and at the time the MCSD is actuated.
        Level of evidence: B
      • 3.
        Intraoperative transesophageal echocardiography should be performed by physicians with advanced training in the intraoperative assessment of cardiac structure and function.
        Level of evidence: B

      Topic 2: Implantation techniques

      Implant techniques vary with pump type; readers are referred to the on-line document for a full discussion of these issues (available on the JHLTonline.org Web site).

      Topic 3: Special considerations for VAD implantation

      These considerations may vary with pump type; readers are referred to the on-line document for a full discussion of these issues (available on the JHLTonline.org Web site).

      Topic 4: Explantation techniques: Explantation of LVADs for heart transplantation

      Explant techniques vary with pump type; readers are referred to the on-line document for a full discussion of these issues (available on the JHLTonline.org Web site).

      Topic 5: Early post-operative management: Hemodynamic management

      Recommendations for early post-operative hemodynamic management are presented in Table 1.
      • Singh M.
      • Shullo M.
      • Kormos R.L.
      • et al.
      Impact of renal function before mechanical circulatory support on posttransplant renal outcomes.
      • Andre A.C.
      • DelRossi A.
      Hemodynamic management of patients in the first 24 hours after cardiac surgery.
      • El-Banayosy A.
      • Korfer R.
      • Arusoglu L.
      • et al.
      Device and patient management in a bridge-to-transplant setting.
      Figure 1 provides recommendations for low pump output treatment. Early post-operative anti-coagulation management recommendations are presented in Table 2, Table 3, Table 4.
      • Warkentin T.E.
      • Greinacher A.
      • Koster A.
      Heparin-induced thrombocytopenia in patients with ventricular assist devices: are new prevention strategies required?.
      • Slaughter M.S.
      • Pagani F.D.
      • Rogers J.G.
      • et al.
      Clinical management of continuous-flow left ventricular assist devices in advanced heart failure.
      • Boyle A.J.
      • Russell S.D.
      • Teuteberg J.J.
      • et al.
      Low thromboembolism and pump thrombosis with the HeartMate II left ventricular assist device: analysis of outpatient anti-coagulation.
      • John R.
      • Kamdar F.
      • Liao K.
      • et al.
      Low thromboembolic risk for patients with the Heartmate II left ventricular assist device.
      • Morshuis M.
      • El-Banayosy A.
      • Arusoglu L.
      • et al.
      European experience of DuraHeart magnetically levitated centrifugal left ventricular assist system.
      • Slaughter M.S.
      • Naka Y.
      • John R.
      • et al.
      Post-operative heparin may not be required for transitioning patients with a HeartMate II left ventricular assist system to long-term warfarin therapy.
      • Hetzer R.
      • Krabatsch T.
      • Stepanenko A.
      • Hennig E.
      • Potapov E.V.
      Long-term biventricular support with the heartware implantable continuous flow pump.
      • Samuels L.E.
      • Kohout J.
      • Casanova-Ghosh E.
      • et al.
      Argatroban as a primary or secondary postoperative anticoagulant in patients implanted with ventricular assist devices.
      • Schenk S.
      • Arusoglu L.
      • Morshuis M.
      • et al.
      Triple bridge-to-transplant in a case of giant cell myocarditis complicated by human leukocyte antigen sensitization and heparin-induced thrombocytopenia type II.
      • Schenk S.
      • El-Banayosy A.
      • Prohaska W.
      • et al.
      Heparin-induced thrombocytopenia in patients receiving mechanical circulatory support.
      Table 5 provides guidelines for removal of invasive lines and drains in a stable post-operative MCS patient. Ventilation parameters for the early post-operative period are outlined in Table 6.
      • El-Banayosy A.
      • Korfer R.
      • Arusoglu L.
      • et al.
      Device and patient management in a bridge-to-transplant setting.
      • Brismar B.
      • Hedenstierna G.
      • Lundquist H.
      • Strandberg A.
      • Svensson L.
      • Tokics L.
      Pulmonary densities during anesthesia with muscular relaxation—a proposal of atelectasis.
      • van Belle A.F.
      • Wesseling G.J.
      • Penn O.C.
      • Wouters E.F.
      Postoperative pulmonary function abnormalities after coronary artery bypass surgery.
      • Pinsky M.R.
      Cardiovascular issues in respiratory care.
      Table 7 outlines suggested guidelines for feeding, mobility issues, and discharge preparation.
      Table 1Treatment Recommendations for Early Post-operative Hemodynamic Management
      Cardiac index (liters/min/m2)MAP (mm Hg)LV ejectionPrimary recommendationAlternative
      <2.2<65NoEpinephrineDopamine
      Vasopressin
      Norepinephrine
      YesIncrease pump speedVolume for low CVP
      >65NoDobutamineMilrinone
      YesIncrease pump speed
      >90NoMilrinoneSodium nitroprusside
      YesSodium nitroprussideMilrinone
      NitroglycerinNicardipine
      Hydralazine
      >2.2<65NoNorepinephrineVasopressin
      YesNorepinephrineVasopressin
      >65 and<90NoNo intervention
      YesNo intervention
      >90NoSodium nitroprussideMilrinone
      NitroglycerinNicardipine
      Hydralazine
      YesSodium nitroprussideNicardipine
      CVP, central venous pressure; LV, left ventricular; MAP, mean arterial pressure.
      Figure thumbnail gr1
      Figure 1Treatment algorithm for low pump output. AV, arteriovenous; CI, cardiac index; CVP, central venous pressure; Hgb, hemoglobin; LA, left atrium; LV, left ventricle; MAP, mean arterial pressure; PAOP, pulmonary artery occlusion pressure; PAP, pulmonary artery pressure; PRBC, packed red blood cells; PVR, peripheral vascular resistance; RA, right atrium; RV, right ventricular; RVAD, right ventricular assist device.
      Table 2Early Post-operative Anti-coagulation Management of HeartMate II
      Thoratec, Pleasanton, California.
      Patients Using Heparin
      TimingActionTarget
      After CBP—leaving operating roomComplete reversal of heparinNot applicable
      ICU admission—24 hoursNo action required, consider acetylsalicylic acidNot applicable
      Post-operative Day 1–2IV heparin or alternative anti-coagulation, if no evidence of bleedingPTT (40–60 seconds)
      Post-operative Day 2–3Continue heparinPTT (60–80 seconds)
      Start warfarin and aspirin (81–325 mg daily) after removal of chest tubesINR (2.0–3.0)
      CPB, cardiopulmonary bypass; ICU, intensive care unit; INR, international normalized ratio; IV, intravenous; PTT, partial thromboplastin time.
      a Thoratec, Pleasanton, California.
      Table 3Post-operative Anti-coagulation Management for Implantable Centrifugal Pumps
      TimingActionTarget
      After CBP—leaving operating roomComplete reversal of heparinNot applicable
      ICU admission—24 hoursNo action required, consider acetylsalicylic acidNot applicable
      Post-operative Day 1–2IV heparin or alternative anti-coagulation, if no evidence bleedingPTT (40–60 seconds)
      Post-operative Day 2–3Continue heparinPTT (60–80 seconds)
      Start warfarin and aspirin (81-325 mg daily) after removal of chest tubesINR (2.0–3.0)
      CPB, cardiopulmonary bypass; ICU, intensive care unit; INR, international normalized ratio; IV, intravenous; PTT, partial thromboplastin time.
      Table 4Post-operative Anti-coagulation Management for Pulsatile Mechanical Circulatory Support Devices
      TimingActionTarget
      After CBP—leaving operating roomComplete reversal of heparinNot applicable
      ICU admission—24 hoursNo actionNot applicable
      Post-operative Day 2Start IV heparin if no evidence bleedingPTT (40–60 seconds)
      Post-operative Day 3Continue heparinPTT (60–80 seconds)
      Start warfarin and aspirin (81-325 mg daily) after removal of chest tubesINR (2.5–3.5)
      CPB, cardiopulmonary bypass; ICU, intensive care unit; INR, international normalized ratio; IV, intravenous; PTT, partial thromboplastin time.
      Table 5Guidelines for Removal of Invasive Lines and Drains in the Non-complicated Post-operative Mechanical Circulatory Support Patient
      Type of line/drainTime to discontinuationNotes
      PA catheter24–48 hoursMust remain in place for severe right heart failure requiring high doses of inotropes
      Arterial line48–72 hoursMust remain in place until all vasoactive medications are weaned
      Central venous lineUntil no longer neededMust remain in place until all vasoactive medications are weaned
      Chest tubes48 hours or when drainage is<100 ml in the previous 6 hoursPreferably after patient has sat up to assure that drainage is not positional
      Pocket drain72 hours or when drainage is<100 ml for the previous 8 hoursMay be removed sooner if pocket communicates with left pleural space and if the left sided chest tube remains in place
      PA, pulmonary artery.
      Table 6Parameters for Post-operative Mechanical Circulatory Support Patient Ventilation
      • Raikhelkar J.K.
      Mechanical ventilation for cardiac support.
      ModeAssist/Control
      Rate10–12 breaths/min
      Tidal volume6–8 ml/kg
      Positive end expiratory pressure5 cm H2O
      Table 7Mobility and Feeding Guidelines
      ActivityGoal
      Out of bed to chairPost-op Day 1
      FeedingPost-op Day 1
      Discharge from intensive care unitPost-op Day 3–5

      Task Force 4: Inpatient management of patients with MCSDs

      Co-chairs: Stephanie A. Moore, MD; Salpy V. Pamboukian MD, MSPH; Jeffrey J. Teuteberg, MD
      Contributing writers: Francisco Arabia, MD; Mary E. Bauman, MScN, NP; Hoger W. Buchholz, MD; Ranjit John, MD; David Feldman, MD, PhD; Kathleen L. Grady, PhD, APN; Kylie Jones, RN; Shimon Kusne, MD; M. Patricia Massicotte, MHSc, MD; Martha Mooney, MD; Thomas Nelson, MD; Francis Pagani, MD

      Recommendations for the treatment of right heart dysfunction in the non-ICU post-operative period:
      • Tedford R.J.
      • Hemnes A.R.
      • Russell S.D.
      • et al.
      PDE5A inhibitor treatment of persistent pulmonary hypertension after mechanical circulatory support.
      • Matamis D.
      • Pampori S.
      • Papathanasiou A.
      • et al.
      Inhaled NO and sildenafil combination in cardiac surgery patients with out-of-proportion pulmonary hypertension: acute effects on postoperative gas exchange and hemodynamics.

      Class I:
      • 1.
        Inotropic support may need to be continued into the remote post-operative period (>2 weeks) when there is evidence for right heart dysfunction such as elevated jugular venous pressure, signs of venous congestion, decreased VAD flows (or low pulsatility in continuous-flow MCSD), or end-organ dysfunction. Once euvolemic, inotrope wean should be done cautiously, with ongoing examination for recurrent signs and symptoms of RV dysfunction.
        Level of evidence: C.
      • 2.
        Diuretics and renal replacement therapy, such as continuous venovenous hemofiltration, should be used early and continued as needed to maintain optimal volume status.
        Level of evidence: C.
      Class IIb
      • 1.
        Cardiac glycosides may be used to support RV function.
        Level of evidence: C.
      • 2.
        For patients with persistent pulmonary hypertension who exhibit signs of RV dysfunction, pulmonary hypertension-specific therapies, such as phosphodiesterase-5 inhibitors, should be considered.
        Level of evidence: C.
      • 3.
        Pacemaker therapy can be used if the heart rate is not optimal to support hemodynamics.
        Level of evidence: C.

      Recommendations for managing hypotension in the non-ICU post-operative period:

      Class I:
      • 1.
        A systematic approach to hypotension should be used, as shown in Figure 2.
        Figure thumbnail gr2
        Figure 2Algorithm for assessment of hypotension after implant. CVP, central venous pressure; JVP, jugular venous pressure; LVAD, left ventricular assist device; MAP, mean arterial pressure; PA, pulmonary artery; PCWP, pulmonary capillary wedge pressure; RV, right ventricular; VAD, left ventricular assist device.
        Level of evidence: C.

      Recommendations for neurohormonal blockade and the treatment of hypertension post-MCS implant:

      Class I:
      • 1.
        Pharmacotherapy with heart failure medications (angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, β-blocker, hydralazine, nitrates) is preferred for blood pressure management.
        Level of evidence: C

      Recommendations for echocardiography in the non-ICU post-operative period:
      • Hatano M.
      • Kinugawa K.
      • Shiga T.
      • et al.
      Less frequent opening of the aortic valve and a continuous flow pump are risk factors for postoperative onset of aortic insufficiency in patients with a left ventricular assist device.
      • Toda K.
      • Fujita T.
      • Domae K.
      • Shimahara Y.
      • Kobayashi J.
      • Nakatani T.
      Late aortic insufficiency related to poor prognosis during left ventricular assist device support.
      • Mudd J.O.
      • Cuda J.D.
      • Halushka M.
      • Soderlund K.A.
      • Conte J.V.
      • Russell S.D.
      Fusion of aortic valve commissures in patients supported by a continuous axial flow left ventricular assist device.

      Class I:
      • 1.
        Echocardiography is an integral part of determining the revolutions per minute of continuous-flow pumps. Common goals include adequate LV unloading while maintaining the LV septum in the midline and minimizing mitral regurgitation.
        Level of evidence: C.
      Class IIb:
      • 1.
        Post-operatively, the revolutions per minute of continuous-flow pumps should be set low enough to allow for intermittent aortic valve opening.
        Level of evidence: B.
      • 2.
        Long-term, maintaining intermittent aortic valve opening may reduce the risk of aortic valve fusion and the risk of late aortic valve insufficiency.
        Level of evidence: B.

      Recommendations for anti-coagulation and anti-platelet therapy post-MCS:
      • Slaughter M.S.
      • Naka Y.
      • John R.
      • et al.
      Post-operative heparin may not be required for transitioning patients with a HeartMate II left ventricular assist system to long-term warfarin therapy.

      Class I:
      • 1.
        Anti-coagulation and anti-platelet therapy initiated post-operatively in the ICU setting should be continued with the aim of achieving device-specific recommended INR for warfarin and desired anti-platelet effects.
        Level of evidence: B.
      • 2.
        Bleeding in the early post-operative period during the index hospitalization should be urgently evaluated with lowering, discontinuation, and/or reversal of anti-coagulation and anti-platelet medications.
        Level of evidence: C.

      Recommendations for infection prevention post-MCS therapy:
      • Holman W.L.
      • Skinner J.L.
      • Waites K.B.
      • Benza R.L.
      • McGiffin D.C.
      • Kirklin J.K.
      Infection during circulatory support with ventricular assist devices.

      International Society for Heart and Lung Transplantation. A 2010 working formulation for the standardization of definitions of infections in patients using ventricular assist devices (VADs). http://www.ishlt.org/contentdocument/VAD.pdf. 2010.

      • Gordon R.J.
      • Quagliarello B.
      • Lowy F.D.
      Ventricular assist device-related infections.
      • Kimball P.M.
      • Flattery M.
      • McDougan F.
      • Kasirajan V.
      Cellular immunity impaired among patients on left ventricular assist device for 6 months.
      • Shoham S.
      • Miller L.W.
      Cardiac assist device infections.
      • Gristina A.G.
      • Dobbins J.J.
      • Giammara B.
      • Lewis J.C.
      • DeVries W.C.
      Biomaterial-centered sepsis and the total artificial heart. Microbial adhesion vs tissue integration.
      • Padera R.F.
      Infection in ventricular assist devices: the role of biofilm.
      • Gordon S.M.
      • Schmitt S.K.
      • Jacobs M.
      • et al.
      Nosocomial bloodstream infections in patients with implantable left ventricular assist devices.
      • Hanna H.A.
      • Raad I.I.
      • Hackett B.
      • et al.
      Antibiotic-impregnated catheters associated with significant decrease in nosocomial and multidrug-resistant bacteremias in critically ill patients.
      • Mermel L.A.
      • Allon M.
      • Bouza E.
      • et al.
      Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America.
      • O’Grady N.P.
      • Alexander M.
      • Dellinger E.P.
      • et al.
      Guidelines for the prevention of intravascular catheter-related infections.
      • Mangram A.J.
      • Horan T.C.
      • Pearson M.L.
      • Silver L.C.
      • Jarvis W.R.
      Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee.
      • Holman W.L.
      • Rayburn B.K.
      • McGiffin D.C.
      • et al.
      Infection in ventricular assist devices: prevention and treatment.
      • Darouiche R.O.
      • Wall Jr, M.J.
      • Itani K.M.
      • et al.
      Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis.
      • Edwards F.H.
      • Engelman R.M.
      • Houck P.
      • Shahian D.M.
      • Bridges C.R.
      The Society of Thoracic Surgeons Practice Guideline Series: antibiotic prophylaxis in cardiac surgery, part I: duration.
      • Harbarth S.
      • Samore M.H.
      • Lichtenberg D.
      • Carmeli Y.
      Prolonged antibiotic prophylaxis after cardiovascular surgery and its effect on surgical site infections and antimicrobial resistance.
      • Eyler R.F.
      • Butler S.O.
      • Walker P.C.
      • et al.
      Vancomycin use during left ventricular assist device support.
      • Engelman R.
      • Shahian D.
      • Shemin R.
      • et al.
      The Society of Thoracic Surgeons practice guideline series: antibiotic prophylaxis in cardiac surgery, part II: antibiotic choice.
      • Perl T.M.
      Prevention of Staphylococcus aureus infections among surgical patients: beyond traditional perioperative prophylaxis.
      • Rose E.A.
      • Gelijns A.C.
      • Moskowitz A.J.
      • et al.
      Long-term use of a left ventricular assist device for end-stage heart failure.
      • Holman W.L.
      • Park S.J.
      • Long J.W.
      • et al.
      Infection in permanent circulatory support: experience from the REMATCH trial.
      • Wilson W.
      • Taubert K.A.
      • Gewitz M.
      • et al.
      Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group.
      • Myers T.J.
      • Khan T.
      • Frazier O.H.
      Infectious complications associated with ventricular assist systems.
      • Pasque M.K.
      • Hanselman T.
      • Shelton K.
      • et al.
      Surgical management of Novacor drive-line exit site infections.
      • Zierer A.
      • Melby S.J.
      • Voeller R.K.
      • et al.
      Late-onset driveline infections: the Achilles’ heel of prolonged left ventricular assist device support.
      • Chinn R.
      • Dembitsky W.
      • Eaton L.
      • et al.
      Multicenter experience: prevention and management of left ventricular assist device infections.
      • Garatti A.
      • Giuseppe B.
      • Russo C.F.
      • Marco O.
      • Ettore V.
      Drive-line exit-site infection in a patient with axial-flow pump support: successful management using vacuum-assisted therapy.
      • Hravnak M.
      • George E.
      • Kormos R.L.
      Management of chronic left ventricular assist device percutaneous lead insertion sites.

      Class I:
      • 1.
        The driveline should be stabilized immediately after the device is placed and throughout the duration of support.
        Level of evidence: C.
      • 2.
        A dressing change protocol should be immediately initiated post-operatively.
        Level of evidence: C.
      • 3.
        Secondary antibiotic prophylaxis for prevention of endocarditis has not been studied in the MCS population but would be considered reasonable due to the risk of bacteremia in this group.
        Level of evidence: C.

      Recommendations for optimization of nutritional status:
      • Holdy K.
      • Dembitsky W.
      • Eaton L.L.
      • et al.
      Nutrition assessment and management of left ventricular assist device patients.
      • Baudouin S.V.
      • Evans T.W.
      Nutritional support in critical care.
      • Scurlock C.
      • Raikhelkar J.
      • Mechanick J.I.
      Impact of new technologies on metabolic care in the intensive care unit.
      • Scurlock C.
      • Raikhelkar J.
      • Mechanick J.I.
      Intensive metabolic support: evolution and revolution.
      • Khalid I.
      • Doshi P.
      • DiGiovine B.
      Early enteral nutrition and outcomes of critically ill patients treated with vasopressors and mechanical ventilation.
      • Aslam S.
      • Hernandez M.
      • Thornby J.
      • Zeluff B.
      • Darouiche R.O.
      Risk factors and outcomes of fungal ventricular-assist device infections.

      Class I:
      • 1.
        Consultation with nutritional services should be obtained at the time of implantation with ongoing follow-up post-operatively to ensure nutrition goals are being met.
        Level of evidence: C.
      • 2.
        Post-operatively for those unable to meet nutritional goals orally, feeding should be started early and preferably through an enteral feeding tube. Parenteral nutrition should only be started if enteral nutrition is not possible and under the guidance of nutritional consultation.
        Level of evidence: C.
      • 3.
        Pre-albumin and C-reactive protein levels can be monitored weekly to track the nutritional status of the post-operative patient. As nutrition improves, pre-albumin should rise and C-reactive protein should decrease.
        Level of evidence: C.

      Recommendations for health care provider and patient education:
      • Bond E.
      • Bolton B.
      • Nelson K.
      Nursing education and implications for left ventricular assist device destination therapy.
      • Stahl M.A.
      • Richards N.M.
      Ventricular assist devices: developing and maintaining a training and competency program.
      • Millhaem T.B.
      • Timm K.
      Identifying the educational needs of nursing staff: the role of the clinical nurse specialist in perinatal nursing.
      • Savage L.
      • Murphey J.
      • Joyce K.
      Developing and maintaining competency with circulatory assist devices: how to meet the challenge.
      • Andrus S.
      • Dubois J.
      • Jansen C.
      • Kuttner V.
      • Lansberry N.
      • Lukowski L.
      Teaching documentation tool: building a successful discharge.
      • Holmes E.C.
      Outpatient management of long-term assist devices.
      • Murray M.A.
      • Osaki S.
      • Edwards N.M.
      • et al.
      Multidisciplinary approach decreases length of stay and reduces cost for ventricular assist device therapy.
      • Stahovich M.
      • Chillcott S.
      • Dembitsky W.P.
      The next treatment option: using ventricular assist devices for heart failure.
      • Moroney D.A.
      • Powers K.
      Outpatient use of left ventricular assist devices: nursing, technical, and educational considerations.

      Class I:
      • 1.
        Health care providers should be trained in MCSD therapy with opportunity to attend refresher classes and ongoing assessment of competency.
        Level of evidence: C.
      • 2.
        Patient and caregiver education should be initiated shortly after surgery and reinforced by the nursing staff. Educational strategies should use written, verbal, and practical methods.
        Level of evidence: C.

      Recommendations for documentation of device parameters:

      Class I:
      • 1.
        MCS parameters should be recorded in the medical record at regular intervals with established criteria for parameters which require physician notification.
        Level of evidence: C.

      Recommendations for device monitoring:

      Class I:
      • 1.
        Normal values for device parameters should be established and recorded in the medical record with triggers for physician notification.
        Level of evidence: C.
      • 2.
        The patient and family members should be taught to track their device parameters and alert staff when changes are observed.
        Level of evidence: C.
      • 3.
        Changes in parameters outside of normal ranges should be thoroughly evaluated and treated appropriately.
        Level of evidence: C.

      Recommendations for psychosocial support while hospitalized post-MCSD implantation:
      • Eshelman A.K.
      • Mason S.
      • Nemeh H.
      • Williams C.
      LVAD destination therapy: applying what we know about psychiatric evaluation and management from cardiac failure and transplant.