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.

Transcatheter aortic valve implantation: recommendations for practice based on a multidisciplinary review including cost-effectiveness and ethical and organizational issues.

Transcatheter aortic valve implantation (TAVI) is a relatively new technology for the treatment of severe and symptomatic aortic valve stenosis. TAVI offers an alternative therapy for patients unable to be treated surgically because of contraindications or severe comorbidities. It is being rapidly dispersed in Canada, as it is worldwide. The objective of this article is to present our recommendations for the use of TAVI, based on a multidisciplinary evaluation of recently published evidence. We systematically searched and summarized published data (2008-2011) on benefits, risks, and cost-effectiveness of TAVI. We also examined ethical issues and organizational aspects of delivering the intervention. We discussed the soundness and applicability of our recommendations with clinical experts active in the field. The published TAVI results for high-risk and/or inoperable patients are promising in terms of survival, function, quality of life, and cost-effectiveness, although we noted large variability in the survival rates at 1 year and in the frequency of important adverse outcomes such as stroke. Until more data from randomized controlled trials and registries become available, prudence and discernment are necessary in the choice of patients most likely to benefit. Patients need to be well-informed about gaps in the evidence base. Our recommendations support the use of TAVI in the context of strict conditions with respect to patient eligibility, the patient selection process, organizational requirements, and the tracking of patient outcomes with a mandatory registry.

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

On-pump beating heart mitral valve repair in patients with patent bypass grafts and severe ischemic cardiomyopathy.

Re-operative mitral valve surgery in patients with poor ventricular function can be challenging especially in the presence of patent bypass grafts. We report the case of 11 patients with severe ischemic cardiomyopathy who underwent reoperative mitral valve repair through a limited right thoracotomy approach, on a non-fibrillating beating heart. All patients had their valves successfully repaired with no operative mortality and minimal morbidity. The technical aspects of the procedure are discussed, and the pertinent literature reviewed.

Brain death diagnoses and evaluation of the number of potential organ donors in Quebec hospitals.

PURPOSE: Faced with our inability to respond to the growing number of Quebec patients waiting for organ transplants, we sought to determine the number of potential organ donors (OD) in acute care hospitals. METHODS: A retrospective chart review of all acute care, in-hospital deaths in Quebec in the year 2000 was undertaken. Hospital record librarians provided statistics and completed questionnaires on each chart after applying exclusion and inclusion criteria. RESULTS: There were 24,702 acute care in-hospital deaths reported by 83 hospitals participating in the study on a voluntary basis. Analyzing 2,067 files meeting inclusion criteria, we identified 348 potential OD (1.4% of deaths). In hospitals not providing tertiary adult trauma care, the potential donor rate was 0.99% of all deaths. There were 4.5 times more potential donors in tertiary care adult trauma centers. Brain death was formally diagnosed in 268/348 patients, and organ donation discussed as an option with 230/268 families. Consent for donation was given in 70% of cases, although not all these patients proved to be suitable after evaluation. There were 125 actual donors in Quebec in the year 2000 (18 per million population). CONCLUSIONS: The gap between used and potential donors can be explained by several factors including failure to approach families for organ donation, family refusal, incomplete neurological assessment of patients, and medical unsuitability of some consented donors. There is room for improvement in the identification of potential donors and in the presentation of organ donation as an end of life option to families.

Le Réseau Québécois de Cardiologie Tertiaire/Quebec Tertiary Cardiac Network.

The Tertiary Cardiac Network of Quebec (RQCT) was created in 2000. Its mission is to advise the Minister of Health on measures necessary to ensure that all patients have access to safe and quality services within recommended time frames. In 2002-2003, the cohort of patients needing a diagnostic catheterization totaled 34,500. There were 14,000 angioplasties performed, a 54% increase over four years, and 7633 cardiac operations on adults, an 8% increase over the same four-year period. The waiting lists, both for diagnostic catheterizations and surgery, are gradually decreasing. The RQCT is now a recognized partner to the other organizations to assure that the population has the proper access to care within the recommended time frame.

Causes of increased length of hospitalization on a general thoracic surgery service: a prospective observational study.

OBJECTIVE: To characterize medical and nonmedical reasons for delayed discharge on a general thoracic surgery unit. DESIGN: A prospective observational cohort study. SETTING: A university-affiliated tertiary care institution. PATIENTS: Between February 1999 and July 2000, the in-hospital progress of 130 patients who had undergone an elective thoracic surgical procedure was evaluated prospectively. Baseline characteristics (age, sex, comorbid conditions and pulmonary function test results) were documented. MAIN OUTCOME MEASURES: Complications that delayed the time when the patient was medically ready for discharge. The day the patient was deemed fit for discharge (medically required length of stay) was compared with the actual day of discharge (actual length of stay). RESULTS: The 3 most frequent complications that prevented discharge by postoperative day 6 were persistent air leaks, pulmonary infections and atrial fibrillation. The presence of a persistent air leak increased the medically required length of stay by a mean of 13.1 days (95% confidence interval [CI] 11.0-15.2 d), pneumonia by 9.6 days (95% CI 4.96-14.2 d) and atrial fibrillation by 2.4 days (95% CI -2.6 to 7.4 d). The mean medically required length of stay was 6.9 days, and this differed from the mean day on which the patient was actually discharged (7.35 d, p < 0.01), which contributed 44 excess days of hospitalization per 100 patients. The 2 most common causes of this discrepancy were the lack of home support (10.2% of patients) and the unavailability of convalescent facilities (7.1% of patients). Prolonged hospital stay for nonmedical reasons was associated with increased mean age (67.4 v. 60.7 yr, p = 0.05). CONCLUSIONS: Length of hospitalization after elective thoracic surgery may be prolonged for medical or nonmedical reasons. Although complications like persistent air leak and pneumonia have an impact on medically required length of stay, social factors may also significantly delay discharge.