The incidence of cardiac perforation related to pacing and defibrillation leads is low. The use of active fixation leads is associated with an increased risk of cardiac perforation. We did not find any correlation between the perforation rate and any particular model of the implanted lead.

MVRS ePTFE cordal implantation can reduce the invasiveness and morbidity of conventional MV surgery. The device's safety profile is promising and prospective trials comparing the outcomes of the MVRS to conventional MV repair surgery are warranted. (CE Mark Study for the Harpoon Medical Device [TRACER]; NCT02768870).

BACKGROUND:Degenerative mitral valve (MV) disease is a common cause of severe mitral regurgitation (MR) and accounts for the majority of MV operations. Conventional MV surgery requires cardiopulmonary bypass, aortic cross-clamping, cardioplegia, and a thoracotomy or sternotomy and, therefore, is associated with significant disability, risks, and unpredictable rates of MV repair. Transesophageal echocardiography-guided beating-heart MV repair with expanded polytetrafluoroethylene cordal insertion has the potential to significantly reduce surgical morbidity. We report the first-in-human clinical experience with a novel preformed expanded polytetrafluoroethylene knot implantation device (Harpoon TSD-5) designed to treat degenerative MR. METHODS:Through a small left thoracotomy, the device was inserted into the heart and guided by transesophageal echocardiography to the ventricular surface of the prolapsed leaflet. Multiple expanded polytetrafluoroethylene cords were anchored in the leaflet and then adjusted to the correct length to restore MV leaflet coaptation and secured at the epicardium. RESULTS:Eleven patients with posterior leaflet prolapse and severe MR, with mean±SD age of 65±13 years and mean ejection fraction of 69±7%, were treated with 100% procedural success. Immediate postprocedural mean MR grade was trace. At 1 month, the mean MR grade was mild with significant decreases in end-diastolic volume (139 to 107 mL; P=0.03) and left atrial volume (118 to 85 mL; P=0.04). CONCLUSIONS:A novel device used for beating-heart image-guided MV repair demonstrates a significant reduction in MR with favorable left ventricular and left atrial reverse remodeling. This approach has the potential to decrease invasiveness and surgical morbidity. Further follow-up is necessary to assess long-term efficacy. CLINICAL TRIAL REGISTRATION: 190M itral valve disease is the most prevalent heart valve disorder and is 3 to 4 times more common than aortic valve disease. Significant mitral regurgitation (MR) affects ≈2% of the total population and 9% of the population >75 years of age.1 MR causes volume overload of the left ventricle (LV), which in turn can progress to ventricular dilation, decreased ejection performance, pulmonary hypertension, congestive heart failure, atrial fibrillation (AF), right ventricular dysfunction, and eventually death. Degenerative MR is the most common indication for mitral valve surgery in North America.2 Introduced clinically in 1986, mitral valve repair with expanded polytetrafluoroethylene (ePTFE) artificial cords has been shown to be equivalent to leaflet resection techniques 3 and is increasingly being used in conventional mitral valve repair operations. 4 Although effective, conventional mitral valve surgery requires cardiopulmonary bypass, aortic crossclamping, cardioplegia, and a thoracotomy or sternotomy. It is therefore associated with significant disability and risks, including stroke, renal failure, widely variable rates of mitral valve repair versus replacement, and death.5 As a result, the...