Efficacy and Safety of Implantable Left Ventricular Assist Devices for Destination Therapy: A Peruvian Health Technology Assessment

AIM: To evaluate the efficacy and safety of the HeartMate 3 (HM3) left ventricular assist device (LVAD) as a destination therapy (DT) for patients with end-stage heart failure (HF) ineligible for transplantation, from a Peruvian healthcare perspective. METHODS: A health technology assessment (HTA) was conducted, which included a systematic review of clinical effectiveness and safety, complemented by a critical appraisal of relevant evidence. Searches were performed in 3 databases, complemented by manual searches in HTA organizations and clinical practice guidelines (CPGs) repositories. The search included CPGs, HTAs, randomized clinical trials (RCTs), and high-quality observational studies evaluating LVADs for DT. Cost-effectiveness analyses and device costs specific to the Peruvian context were also reviewed. RESULTS: All the CPGs supported the use of the HM3 LVAD, emphasizing its significant survival benefits demonstrated in primary studies. The HM3 showed a 5-year survival rate exceeding 50%, compared to 25% at 1 year and 8% at 2 years with optimal medical therapy (OMT). Functional and quality of life outcomes also improved significantly. However, common adverse events included bleeding and infections. Cost-effectiveness analyses from high-income settings indicated that the HM3 exceeded conventional willingness-to-pay thresholds but highlighted its critical clinical benefits for high-risk patients with no alternative therapies. CONCLUSION: The HM3 LVAD offers significant survival and quality of life improvements for patients with end-stage HF ineligible for transplantation. Despite challenges in cost-effectiveness, the adoption of the HM3 as DT in Peru is justified to address a critical unmet clinical need, provided robust medical device surveillance is implemented.