PP107 Harpoon™: A Novel Device For Transapical Mitral Valve Repair

• Published in: International journal of technology assessment in health care 2019, Vol.35 (S1), p.57-58
• Main Authors: Hijas-Gómez, Ana Isabel, Polo-DeSantos, Mar, Luengo-Matos, Setefilla, Sánchez-Gómez, Luis María
• Format: Article
• Language: English
• Subjects: Anchoring; Asset acquisitions; Bleeding; Clinical trials; Cords; Fibrillation; Heart; Heart valves; Mitral valve; Patients; Pleural effusion; Polytetrafluoroethylene; Regurgitation; Repair; Safety; Surgery; Technology assessment
• ISSN: 0266-4623; 1471-6348
• DOI: 10.1017/S026646231900237X

Copyright © Cambridge University Press 20192019Cambridge University PressIntroductionMitral regurgitation (MR) is the most prevalent heart valve condition in Western countries. Open-heart mitral valve reconstruction is the conventional surgical treatment for MR, whereby the valve's cords are replaced with expanded polytetrafluoroethylene cords. Novel devices have introduced minimally invasive alternatives, such as transapical beating-heart valve repair. Among these alternatives, the Harpoon™ Mitral Valve Repair System (Edwards Lifesciences LLC) may have potential advantages (a smaller diameter valve introducer to minimize bleeding and a different anchoring mechanism). This study aimed to assess the efficacy and safety of Harpoon in minimally invasive mitral valve surgery.MethodsAn early assessment of the technology was conducted by reviewing relevant literature from the following databases: PubMed, EMBASE, Web of Science, the Trip Database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, the Cochrane Library, and the Centre for Reviews and Dissemination. Relevant clinical studies published up to 30 January 2018 were included.ResultsOnly two publications, by the same research group, were included: an observational study of 11 patients and the prospective, nonrandomized TRACER trial (n = 30). During the procedure, MR was reduced from severe to none in 73 to 86 percent of patients and severe to mild in 14 to 27 percent. At one month, MR was rated as mild or lower in 82 to 89 percent of patients. At six months, MR had worsened to moderate or severe in 16 percent of patients from the TRACER trial. Safety issues within 30 days (18% to 27% of patients) included intraoperative conversion to open surgery, reoperation, pleural effusion, hemopericardium, and atrial fibrillation. There were no intra- or postoperative deaths.ConclusionsCurrent evidence on the Harpoon device is scarce. Although published studies showed improvement in MR in most patients, there are still issues regarding safety, lack of long-term results, comparability with other procedures, and costs. While promising, further research is required before recommending routine use of this technology.