Should eligibility for heart transplantation be a requirement for left ventricular assist device use? Recommendations based on a systematic review.

Left ventricular assist devices (LVADs) are used in chronic end-stage heart failure as "bridge to transplantation" (BTT) and, more recently, for transplant-ineligible patients as "destination therapy" (DT). We reviewed the evidence on clinical effects and cost-effectiveness of 2 types of continuous-flow LVADs (HeartMate II [HM II] and HeartWare), for BTT and DT patients. We systematically searched the scientific literature (January 2008-June 2012) and identified 14 clinical studies (approximately 2900 HM II and approximately 200 HeartWare patients), and 3 economic evaluations (HM II) using simulation models. Data were, however, limited to 2-3 studies per outcome. We made policy recommendations on the basis of our systematic review. Although complications after implantation are frequent, LVAD therapy is often highly effective across transplantation eligibility status and device, with 1-year survival reaching 86% for BTT and 78% for DT (compared with 25% for medical therapy). Neither BTT nor DT currently meet traditional cost-effectiveness limits in models using historical data, although BTT is standard practice for a limited number of patients in many regions. We found that BTT and DT as implantation strategies tend to be no longer mutually exclusive. We conclude that evidence is sufficient to support LVAD use, regardless of transplantation eligibility status, as long as patients are carefully selected and program infrastructure and budget are adequate. However, evidence gaps, limitations in economic models, and the lack of Canadian data point to the importance of mandatory, systematic monitoring of LVAD use and outcomes.

Psychological impact of surveillance in patients with a defibrillator lead under advisory: a prospective evaluation.

BACKGROUND: Implantable cardioverter defibrillator (ICD) leads are subject to technical failures and the impact of the resulting public advisories on patient welfare is unclear. The psychological status of patients who received an advisory for their Medtronic Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and followed either by self-surveillance for alarm or home monitoring with CareLink was evaluated prospectively and compared to patients with ICDs not under advisory. METHODS: One hundred sixty consecutive consenting patients (90 alarms, 24 Carelinks, 46 controls) were recruited within 1.5 years of advisory notification. Advisory patients were seen immediately before being told that the automatic lead surveillance utilized since the advisory had been inadequate in warning of impending fracture, as well as 1 and 6 months after programming was optimized. Depression, anxiety, quality of life (QoL), and ICD-related concerns were assessed. RESULTS: Symptoms of depression and state anxiety were experienced by 31% and 48% of patients, respectively. QoL was impaired on all subscales. No significant group differences in distress and ICD-related concerns emerged at baseline or at follow-up. At baseline, alarm patients reported greater limitations because of body pain compared to controls (P < 0.05). All patients showed a significant reduction in body pain-related QoL at the final versus first two evaluations (P < 0.001). Advisory patients were significantly less satisfied with surveillance at follow-up than at baseline (P < 0.05). CONCLUSIONS: There was limited evidence for worse psychosocial functioning in those at risk for ICD lead fracture, irrespective of surveillance method. However, many control and advisory patients experienced chronic distress for which counseling may prove beneficial.

Summary: evaluation of the evidence on the HeartMate II® and HeartWare® ventricular assist devices for the treatment of chronic end-stage heart failure

CONTEXT: Heart failure is a complex syndrome that arises when the heart is incapable of pumping enough blood to respond to the metabolic needs of the body. Heart failure is often caused by defective contraction and relaxation of the myocardium, accompanied by elevated cardiac filling pressure. It represents the final stage of a number of cardiovascular diseases. Characterized by limitation in activities of daily living and progressive exhaustion at rest, heart failure is a disabling and life-threatening condition. Severe heart failure, defined as class IV using the functional classification scheme of the New York Heart Association (NYHA), is associated with a 1-year mortality of about 50%. Heart failure is a major public health problem, associated with high rates of morbidity and mortality. It is estimated that more than 80,000 people are affected in Quebec, and the incidence of heart failure is expected to increase as a result of ageing of the population. More than 75% of patients suffering from heart failure in