Jean E. Morin

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.

Challenge of Informing Patient Decision Making

In the management of advanced heart failure, the option of long-term mechanical circulatory support (MCS) as destination therapy (DT), rather than as a temporary bridge to cardiac transplantation, is increasingly being offered to highly selected patients. Recent technological advancements in implantable devices, such as continuous flow systems and smaller pump sizes, have increased the possibility of survival with fewer complications. Informed consent before MCS is essential1–6 and is a fundamental aspect of patient-centered care. As a part of a quality decision-making process, the patient considering MCS and his/her informal caregiver(s) need to be aware of the current state of the scientific evidence, including what is known and unknown about outcomes and living with MCS and must navigate a series of interactions with clinicians before deciding on the treatment course.nnEditorial see p 13nnThe Institut National d’Excellence en Sante et en Services Sociaux is a health technology assessment and clinical guideline development organization in the province of Quebec (Canada) that provides multiple stakeholders (ie, government officials, hospital administrators, physicians, and patient organizations) with evidence-based information. In 2011, the Quebec Ministry of Health requested that the Institut National d’Excellence en Sante et en Services Sociaux provide recommendations on the use of implantable left ventricular assist devices in end-stage chronic heart failure. The current article extends the work submitted to the Ministry1 and focuses on MCS use in DT, within the framework of informed decision making.nnIn this perspective piece, we report on our review of the scientific literature concerning clinical outcomes in DT and on perspectives of DT patients and their caregivers, to provide a summary of currently available information and identify gaps in knowledge. Besides the use of MCS as a bridge to transplantation, we do not consider in this perspective the other clinical recourses to …

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.

CHARACTERISTICS OF PATIENTS WITH CORONARY ARTERY DISEASE TREATED WITH MULTIVESSEL PERCUTANEOUS CORONARY INTERVENTION IN HOSPITALS WITH AND WITHOUT ON-SITE CARDIAC SURGERY IN QUÉBEC: A PROVINCE-WIDE FIELD EVALUATION

s S147 186 EFFICACY AND SAFETY OF A ROUTINE EARLY INVASIVE STRATEGY IN RELATION TO TIME FROM SYMPTOM ONSET TO FIBRINOLYSIS: A SUBGROUP ANALYSIS FROM TRANSFER-AMI JJ Russo, SG Goodman, WJ Cantor, M Tan, B Borgundvaag, D Fitchett, V Dzavik, RT Yan, JJ Graham, SR Mehta, AT Yan