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Late breaking trials of 2016 in structural heart disease and peripheral artery disease: Commentary covering ACC, EuroPCR, SCAI, TCT, VIVA, ESC, and AHA

Adnan K. Chhatriwalla MD PFO closure. Final results from the RESPECT trial were presented at TCT. The trial randomized 980 patients with a patent foramen ovale (PFO) and prior cryptogenic stroke to PFO closure with the AMPLATZER PFO Occluder versus medical management. Enrollment in the trial concluded after 25 ischemic stroke events occurred, and the final analysis included follow-up of 6.3 years in the PFO closure arm and 5.5 years in the medical management arm. Statistically significant reductions in recurrent ischemic stroke (HR 0.55, P 5 0.046) and cryptogenic stroke (HR 0.38, P 5 0.007) were observed in patients who underwent PFO closure as compared to medical management, in an intention-to-treat analysis. These data support the recent FDA approval of the AMPLATZER PFO Occluder for transcatheter PFO closure in adults with prior cryptogenic stroke. Mitral valve replacement. The First Global Registry of Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease with Severe Mitral Annular Calcification [1] was presented at EuroPCR. Data from 104 patients were available, comprising an extreme-risk cohort with an estimated surgical mortality of >14% as estimated by STS score. The vast majority of patients were treated with Edwards Sapien XT or Sapien 3 valves placed in the mitral position. Transapical, transseptal, and transatrial access routes were utilized. Procedural success was achieved in 75% of cases; however, the incidence of complications was high, including need for a second valve (12.5%), left ventricular outflow tract obstruction (10.5%), valve embolization (3.8%), conversion to surgery (3.8%), ventricular perforation (1.9%), and pulmonary vein perforation (0.9%). Thirty-day mortality was 25% in this high-risk cohort. These registry data provide further proof of concept support for transcatheter MVR in select patients with mitral annular calcification who are at extreme risk for mitral valve surgery. Hopefully future studies with dedicated devices and procedural refinement will demonstrate fewer complications. Left atrial appendage closure. Three-month results from the EWOLUTION Registry of left atrial appendage (LAA) closure with the Watchman device were presented at EuroPCR. Data from 1,025 patients were available: implant success was 98.5%, and successful sealing of the left atrial appendage was observed in 98.9% of patients by TEE at the time of first followup. The likelihood of first device success was higher at more experienced centers, but the rate of successful sealing of the LAA did not vary with experience. Furthermore, there was no difference in procedural complications between more and less experienced centers.