1. Electrophysiologic considerations in heart transplant candidates
1.1. Cardiac Re-synchronization Therapy With or Without Implanted Cardioverter Defibrillator as Part of Optimal Treatment
1.2. Cardiac Re-synchronization Therapy
- 1Potential transplant candidates with cardiac dyssynchrony and New York Heart Association (NYHA) Class III or IV symptoms, despite maximum medical therapy, should be strongly considered for cardiac re-synchronization therapy (CRT) (Level of Evidence: B).
- 2The use of an implantable cardioverter defibrillator (ICD), especially in patients with persistent NYHA Class III or IV symptoms, should be considered because it may further decrease mortality in this population (Level of Evidence: B).
1.3. Implantable (Primary and Secondary Prevention) and Wearable External Defibrillator as a Bridge Therapy to Heart Transplantation
- 1An ICD for secondary prevention should be always considered (Level of Evidence: A).
- 2An implanted or wearable ICD should be provided for Status 1B patients who are discharged home given that the wait for transplantation remains significant (Level of Evidence: C).
- 3Amiodarone should be used as the agent of choice when anti-arrhythmic therapy is necessary to prevent recurrent atrial or symptomatic ventricular arrhythmias despite its numerous side effects (Level of Evidence: A).
- 4Re-synchronization therapy in advanced heart failure patients should be considered together with a defibrillator (Level of Evidence: B).
- 1It is reasonable to consider placement of a defibrillator in patients with Stage D failure who are candidates for transplantation or LVAD destination therapy (see subsequent considerations for mechanical circulatory support device [MCSD] referral: bridge or destination) (Level of Evidence: C).
2. Relevant issues in heart transplant candidates considered for MCSD therapy
- 1In patients >60 years of age, a thorough evaluation for the presence of other clinical risk factors should be done (Level of Evidence: C).
- 2Age should not by itself be considered a contraindication to mechanical circulatory support (Level of Evidence: C).
2.2. Body Size
- 1The use of pulsatile intracorporeal devices (e.g., HeartMate XVE, Thoratec Corp., Pleasanton, CA; Novacor LVS, WorldHeart Corp., Oakland, CA) should be limited to patients with a body surface area (BSA) >1.5 m2. For smaller individuals, the use of paracorporeal or axial-flow devices should be considered (Level of Evidence: C).
2.3. Renal Function
- 1All patients evaluated for MCSD therapy should have their creatinine and blood urea nitrogen (BUN) measured. Patients with a creatinine >3.0 mg/dl are at higher risk. Patients with serum creatinine above this value may be considered MCSD candidates if renal failure is acute and renal recovery is likely (e.g., acute renal failure in young patients with previously normal renal function) (Level of Evidence: C).
- 1Patients dependent on long-term dialysis should not be considered MCSD candidates (Level of Evidence: C).
2.4. Pulmonary Function
- 1All patients evaluated for MCSD therapy should have chest X-ray and pulmonary function tests if feasible. Mechanical ventilation in the absence of significant pre-existing pulmonary dysfunction or inflammatory infiltrates is a risk factor but should not be considered an absolute contraindication to VAD support. A lung computerized tomography (CT) scan should be considered in select patients to rule out undiagnosed conditions at chest X-ray (Level of Evidence: C).
- 1Patients with severe pulmonary dysfunction contraindicating heart transplantation (e.g., forced expiratory volume in 1 second [FEV1] <1) should not be considered MCSD candidates (Level of Evidence: C).
2.5. Hepatic Function
- 1All patients evaluated for MCSD therapy should have liver function assessment. Patients with an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3-fold control values are at higher risk. Biventricular support may be considered the first option in cases of hepatic dysfunction associated with RV failure (Level of Evidence: C).
- 1Patients with cirrhosis and portal hypertension should be excluded from MCSD implantation (Level of Evidence: C).
2.6. Coagulation Disorders
- 1All patients evaluated for MCSD therapy should have complete routine coagulation tests performed. Patients with a spontaneous INR >2.5 are at increased risk of bleeding complications (Level of Evidence: C).
- 1Patients with heparin-induced thrombocytopenia are generally not considered MCSD candidates (Level of Evidence: C).
2.7. Infectious Diseases and Immunoinflammatory Activation
- 1All patients evaluated for MCSD therapy should have a thorough screening for infectious foci. Any ongoing infection should be identified and adequately treated before MCSD implantation. In particular, all conditions that might enhance the risk of fungal infection should be considered and properly managed (Level of Evidence: C).
- 1Patients with an acute systemic infection should not be considered MCSD candidates (Level of Evidence: C).
- 1Biventricular support for recurrent sustained ventricular tachycardia or ventricular fibrillation should be considered only in the presence of untreatable arrhythmogenic pathologic substrate (e.g., giant cell myocarditis). Otherwise, appropriate medical anti-arrhythmic therapy, anti-bradycardia pacing, ICD implantation or ventricular tachycardia ablation can generally adequately control bradyarrhythmias or tachyarrhythmias during LVAD support (Level of Evidence: C).
2.9. Right Ventricular Function
- 1Evaluation of reversibility of pulmonary hypertension and RV performance should be performed before MCSD implantation. In the case of irreversible pulmonary hypertension, RV failure or multiorgan dysfunction, biventricular support should be considered. Patients >65 years of age with biventricular failure are at the highest risk for RV failure. Thus, they should be considered with great caution as MCSD candidates (Level of Evidence: C).
2.10. Valvular Diseases
- 1When using a completely unloading pulsatile MCSD, such as the Novacor, HeartMate I or Thoratec, the aortic valve should be sutured or replaced with a bioprostheses when more than mild aortic insufficiency is present. The replacement of a mechanical prosthesis with a bioprotheses should also be considered (Level of Evidence: C).
- 2Anti-coagulation therapy is strongly advised when a prosthetic valve is present (Level of Evidence: C).
- 3Severe mitral stenosis should be treated and, if weaning from MCSD is foreseen, significant mitral insufficiency should also be corrected (Level of Evidence: C).
2.11. Neurologic Function
- 1A thorough neurologic examination should be performed to determine potential neurologic risk factors and contraindications for MCSD implantation. Specifically, post-stroke motor deficits should be assessed to determine the ability of the patient to cope with the device. In emergency cases with uncertain neurologic recovery, a short-term MCSD, such as a paracorporeal centrifugal pump, should be adopted, allowing for recovery and full evaluation of long-term MCSD candidacy. A recent or evolving stroke is considered at least a temporary contraindication (Level of Evidence: C).
2.12. Nutritional Status
- 1Cachexia should be considered a strong risk factor with regard to MCSD implantation67(Level of Evidence: C).
2.13. Multiorgan Failure
- 1Multiorgan failure should be considered a strong contraindication to MCSD implantation70(Level of Evidence: C).
- 1Patients with potentially curable tumors may undergo MCSD implantation as a potential bridge to heart transplantation (Level of Evidence: C).
2.15. Psychologic and Psychiatric Conditions
- 1A thorough psychiatric examination should be performed to determine potential psychiatric risk factors and contraindications for MCSD implantation. Specifically, patients with a significant psychiatric history, alcoholism or drug addiction should be referred to a psychiatrist or therapist as early as possible to ensure that proper treatment is initiated or optimized (Level of Evidence: C).
- 1Active psychiatric disease is a contraindication for MCSD implantation as many psychiatric conditions can lead to non-compliance (Level of Evidence: C).
3. Relation between inotrope therapy and MCSD: Implantation as bridge to heart transplantation
- 1MCSD therapy should be considered when the patient requires incremental increases in inotropic or diuretic drug doses or additional parenteral agents, or deterioration in status occurs that includes signs of end-organ dysfunction despite these alterations (Level of Evidence: C).
- 1Weaning from inotropes should be attempted when stable clinical conditions are achieved, but repeated withdrawal should be avoided if dependence is well established (Level of Evidence: C).
- 1MCSD should be considered as a useful strategy to bridge patients to heart transplantation in those patients who are otherwise not considered transplant candidates as a result of the degree and persistence of pulmonary hypertension despite inotropic therapy (Level of Evidence: C).
- 1In challenging clinical cases, where it is hard to discriminate between heart failure (HF) progression and the unfavorable effect of medical therapy, it is reasonable to perform right-heart hemodynamic assessment to verify a patient’s volume status and cardiac output in order to tailor inotropic drug dose if prolonged administration is being considered (Level of Evidence: C).
- 2It is reasonable to consider right-heart hemodynamic assessment to demonstrate or to establish an association of the clinical and biochemical markers with measured hemodynamic deterioration after withdrawal of inotropic therapy (Level of Evidence: C).
3.1. Elective MCSD Therapy
4. MCSD as destination therapy
- 1Elective MCSD implant as destination therapy should be considered in non-transplant candidates who are dependent on long-term administration of intravenous inotropes to maintain a stable state (Level of Evidence: B).
- 1Despite the presence of a malignancy when a life expectancy of >2 years is foreseeable, mechanical assistance may be considered as destination therapy (Level of Evidence: C).
- 1Metastatic tumors should be considered an absolute contraindication to mechanical support (Level of Evidence: C).
- Stevenson L.W.
- Miller L.W.
- Svigne-Nickens P.
- et al.
5. Nurse and social worker management of MCSD candidates
5.1. Nurse Nutritional Status
- 1A thorough history should be taken of dietary habits as well as an updated assessment of bowel motility. It should be documented if patients have a history of previous abdominal surgery or malabsorption syndromes.
- 2Pre-albumin, albumin and transferrin should be measured with weekly follow-up until nutritional goals are reached.
- 3Work-up for diabetes (glycosylated hemoglobin [HbA1C]) and tight control of blood sugar is recommended.84,85
- 1Consider formal nutritional consultation for those patients who are significantly cachectic, obese, diabetic or have significant renal dysfunction.
- 2Supplement of micronutrients to include multivitamin, folate, zinc sulfate and Vitamin C (the latter to facilitate wound-healing).
- 1Measure C-reactive protein pre-operatively and at intervals post-operatively to monitor changes in inflammatory response.80
- 2Indirect calorimetry or other metabolic studies should be done to better define caloric needs.
- 3Institute parenteral nutrition if the enteral route is not feasible.83
- 4Continued follow-up with formal nutritional consultation should be done as indicated.
5.2. Social, Family, Religious and Personal Issues Assessment
6. When and how ultrafiltration techniques should be used
- 1Intermittent hemodialysis should not be used for removal of excess fluid because large fluid shifts in short periods of time may lead to hemodynamic instability and worsening of the overall clinical status. Intermittent hemodialysis should be instituted when patients meet criteria for end-stage renal disease, in which case the severity of intrinsic kidney disease precludes consideration for heart transplantation.
- 2The role of peritoneal dialysis for short-term management of refractory heart failure is limited to situations in which extracorporeal ultrafiltration is either impossible or unavailable. However, further investigation of the efficacy and safety of this approach is needed before specific recommendations can be made on the use of peritoneal dialysis in patients with advanced heart failure.
- 3Of the ultrafiltration approaches described, the most practical are veno-venous ultrafiltration techniques, in which isotonic plasma is propelled through the filter by an extracorporeal pump. These approaches avoid arterial puncture, remove a predictable amount of fluid, are not associated with significant hemodynamic instability, and, in the case of peripheral veno-venous ultrafiltration, do not require specialized dialysis personnel and can be performed in an outpatient setting.
- 4Ultrafiltration techniques have been used in patients with decompensated heart failure and volume overload refractory to diuretic therapy. These patients generally have pre-existing renal insufficiency (calculated creatinine clearance 30 to 90 ml/min) and, despite daily oral diuretic doses, develop signs of pulmonary and peripheral congestion (jugular venous distention ≥7 cm, pulmonary rales, paroxysmal nocturnal dyspnea or orthopnea, peripheral edema [≥2+], enlarged liver or ascites, sacral edema). Ultrafiltration and temporary cessation of diuretic may restore diuresis and natriuresis.
- 5Based on the well-documented relationship between increases of RA pressure and reductions of glomerular filtration rate (GFR), as well as the diuretic-induced decrease of GFR, a strategy of temporarily holding diuretics and reducing volume excess with ultrafiltration may seem logical in these patients..
- 6Patients should not be considered for ultrafiltration under any of the following conditions: venous access cannot be obtained; hematocrit is ≥40%; there is a hypercoagulable state; systolic blood pressure is <85 mm Hg or there are signs or symptoms of cardiogenic shock; if intravevous pressors are required to maintain an adequate blood pressure; or there is end-stage renal disease indicating the need for dialysis.
6.1. What is Ultrafiltration?
6.2. Clinical Methods of Ultrafiltration
6.2.1. Intermittent hemodialysis
6.2.2. Peritoneal dialysis
6.2.3. Intermittent isolated ultrafiltration
6.2.4. Peripheral veno-venous ultrafiltration techniques
6.2.5. Continuous ultrafiltration techniques
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