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.