Ventricular assist device using a thoracotomy-based implant technique: Multi-Center Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy (HM3 SWIFT)

• Published in: The Journal of thoracic and cardiovascular surgery Vol. 168; no. 5; pp. 1474 - 1484.e12
• Main Authors: Gosev, Igor, Pham, Duc Thinh, Um, John Y., Anyanwu, Anelechi C., Itoh, Akinobu, Kotkar, Kunal, Takeda, Koji, Naka, Yoshifumi, Peltz, Matthias, Silvestry, Scott C., Couper, Gregory, Leacche, Marzia, Rao, Vivek, Sun, Benjamin, Tedford, Ryan J., Mokadam, Nahush, McNutt, Robert, Crandall, Daniel, Mehra, Mandeep R., Salerno, Christopher T.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.11.2024
• Subjects: Adult; Aged; Female; Heart Failure - mortality; Heart Failure - physiopathology; Heart Failure - surgery; Heart-Assist Devices; HeartMate 3; Humans; LVAD; Male; Middle Aged; minimally invasive; outcomes; Prospective Studies; Prosthesis Design; Prosthesis Implantation - adverse effects; Prosthesis Implantation - instrumentation; Prosthesis Implantation - methods; Prosthesis Implantation - mortality; Sternotomy - adverse effects; thoracotomy; Thoracotomy - adverse effects; Time Factors; Treatment Outcome; United States; Ventricular Function, Left; United States; RAP; AST; PRBC; PCWP; minimally invasive; HM3 SWIFT; LVAD; HM3; PAPi; INTERMACS; EPPY; MOMENTUM 3; outcomes; thoracotomy; ICU; HeartMate 3
• ISSN: 0022-5223; 1097-685X; 1097-685X
• DOI: 10.1016/j.jtcvs.2024.02.013

The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy. We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, −15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol. The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, −1.2%; Farrington Manning lower 1-sided 95% CI, −9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts. Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device.