•A 19-study meta-analysis (7743 ​patients) found high Navitor technical/device success.•≥Moderate PVL was low: 1.3% at 30 days and 0.6% at 1 year.•Pacemaker implantation was 16.7% at 30 days and 20.4% at 1 year.•Thirty-day outcomes were favorable: all-cause mortality 1.5% and stroke 1.7%.

BackgroundFunctional mitral regurgitation (FMR) has limited effective treatment options. As a transcatheter indirect annuloplasty, the Carillon Mitral Contour System reduces FMR and improves symptoms, but long-term safety and effectiveness are incompletely characterized.MethodsThis prospective, multicenter CINCH registry enrolled heart failure patients with FMR treated with the Carillon Mitral Contour System across 22 centers in Germany. Main outcomes included change in New York Heart Association (NYHA) class and MR severity, heart failure hospitalization (HFH), all-cause mortality rates, and device- or procedure-related serious adverse events at 1 year. Median follow-up was 2.0 years (range, 0-5 years).ResultsAmong 228 patients (age 78 ± 8 years; 51% female; 51% with left ventricular ejection fraction ≥50%), Carillon implantation improved clinical and echocardiographic variables. The rate of NYHA class III or IV symptoms decreased from 81 to 29% at 1 year, and the rate of moderate-to-severe MR (grade 3+/4+) decreased from 84 to 9% at 1 year, with ≥92% showing stable or improved NYHA class and ≥97% showing stable or improved MR grade over 5 years. Decreases in MR grade were associated with improvements in NYHA class (p = 0.048). Kaplan–Meier estimates over 5 years were 54.0% for HFH, 46.9% for all-cause mortality, and 68.3% for the composite of HFH or death. The proportion of patients experiencing any serious device- or procedure-related serious adverse event at 1 year was 1.8%.ConclusionsThe CINCH registry provides real-world evidence supporting the long-term safety, effectiveness, and durability of the Carillon Mitral Contour System in treating FMR.

BackgroundTransfemoral (TF) access is the safest and guideline-recommended approach for transcatheter aortic valve replacement (TAVR). However, in patients with hostile aortic anatomies, the procedure may carry increased risks of vascular or cerebrovascular complications. The objective of this article is, therefore, to evaluate the safety and efficacy of using the extended-length DrySeal Flex introducer sheath (Gore, USA) for TF-TAVR in high-risk patients with challenging aortic anatomies.MethodsWe conducted a retrospective, single-center cohort study including all consecutive patients who underwent TF-TAVR with the 65-cm DrySeal sheath between 2021 and 2025. We analyzed the indications for sheath use and the following clinical outcomes: all-cause mortality, stroke, and major vascular complications as defined by Valve Academic Research Consortium-3 criteria.ResultsThe 65-cm DrySeal sheath was used in 200 patients (median age 80 years; median Society of Thoracic Surgeons score 5.4%) out of 2430 (8.2%) TF-TAVR procedures performed. This approach was selected to address challenges posed by aortic arch calcification (28%), heavily atheromatous or shaggy aorta (20%), acute aortic angulation (26%), tortuosity (36%), and aortic coarctation (8%). In this high-risk cohort, all-cause mortality was 0.5%, stroke occurred in 1.5% (including 0.5% with disabling stroke), and major vascular complications were observed in 1.0%. These outcomes were comparable to those seen in lower-risk patients undergoing TF-TAVR using conventional approaches.ConclusionsIn patients with hostile aortic anatomies, the extended-length DrySeal Flex introducer sheath facilitated safe and effective TAV delivery and was associated with a low rate of periprocedural complications, including cerebrovascular events. Its use may help mitigate the risks traditionally associated with hostile aortic anatomies.