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* Co-first authors contributed equally and are listed in alphabetical order.
David Feldman
Correspondence
Reprint requests: Amanda W. Rowe, International Society for Heart and Lung Transplantation, 14673 Midway Rd, Ste 200, Addison, TX 75001. Telephone: 804-873-2541; Fax: 817-912-1237
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:
Usefulness of peak exercise oxygen consumption and the heart failure survival score to predict survival in patients>65 years of age with heart failure.
Listing criteria for heart transplantation: International Society for Heart and Lung Transplantation guidelines for the care of cardiac transplant candidates—2006.
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).
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:
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.
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:
Pre-operative and post-operative risk factors associated with neurologic complications in patients with advanced heart failure supported by a left ventricular assist device.
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:
Cardiac transplantation and/or mechanical circulatory support device placement using heparin anti-coagulation in the presence of acute heparin-induced thrombocytopenia.
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.
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.
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.
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.
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:
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.
Psychosocial evaluation of organ transplant candidates. A comparative survey of process, criteria, and outcomes in heart, liver, and kidney transplantation.
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:
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.
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
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:
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.
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.
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.
Renal and hepatic function improve in advanced heart failure patients during continuous-flow support with the HeartMate II left ventricular assist device.
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.
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.
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.
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.
Renal and hepatic function improve in advanced heart failure patients during continuous-flow support with the HeartMate II left ventricular assist device.
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:
Multifactorial risk index for predicting postoperative respiratory failure in men after major noncardiac surgery. The National Veterans Administration Surgical Quality Improvement Program.
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:
Short-term mechanical support, including extracorporeal membrane oxygenation, should be used in acutely decompensated patients who are failing maximal medical therapy.
Efficacy and safety of percutaneous life support during high-risk percutaneous coronary intervention, refractory cardiogenic shock and in-laboratory cardiopulmonary arrest.
Survival after biventricular assist device implantation: an analysis of the Interagency Registry for Mechanically Assisted Circulatory Support database.
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.
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.
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.
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.
Right-to-left ventricular end-diastolic diameter ratio and prediction of right ventricular failure with continuous-flow left ventricular assist devices.
The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates.
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.
The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates.
Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: incidence, risk factors, and effect on outcomes.
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
Heartmate II implantation with right coronary bypass grafting in ischemic cardiomyopathy with “fixed” pulmonary hypertension: treatment strategy to protect right ventricular function.
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.
Post-operative heparin may not be required for transitioning patients with a HeartMate II left ventricular assist system to long-term warfarin therapy.
Triple bridge-to-transplant in a case of giant cell myocarditis complicated by human leukocyte antigen sensitization and heparin-induced thrombocytopenia type II.
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.
Inhaled NO and sildenafil combination in cardiac surgery patients with out-of-proportion pulmonary hypertension: acute effects on postoperative gas exchange and hemodynamics.
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 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.
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.
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:
Post-operative heparin may not be required for transitioning patients with a HeartMate II left ventricular assist system to long-term warfarin therapy.
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:
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.
Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America.
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.
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:
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:
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:
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