Early Experience With a Novel Transfemoral Mitral Valve Implantation System in Complex Degenerative Mitral Regurgitation.

OBJECTIVES: The aim of this study was to evaluate the feasibility, procedural results, and 6-month outcomes of a novel transfemoral transcatheter mitral valve implantation (TMVI) system (Cephea) in patients with complex primary mitral regurgitation (MR). BACKGROUND: TMVI is emerging as an alternative to surgery in patients with severe MR. To date, the great majority of TMVI systems use the transapical surgical approach. METHODS: This study included consecutive patients undergoing transfemoral TMVI with the Cephea valve system. All patients were suboptimal candidates for catheter-based repair for anatomic reasons. Patients underwent clinical, echocardiographic, and computed tomographic angiographic follow-up at 6 months. Main outcomes were procedural success, peri-procedural complications, and valve hemodynamic status early and at 6-month follow-up. RESULTS: Three patients with severe primary MR (2 women, mean age 79 ± 3 years) at prohibitive surgical risk (mean European System for Cardiac Operative Risk Evaluation II score 13.8 ± 2.4%) were included. The valves were successfully implanted in all patients, with no procedural complications. Post-procedural echocardiography showed normal valve function in all patients (mean transvalvular gradient 3 mm Hg; range: 2 to 4 mm Hg), no moderate to severe valvular or paravalvular leak, and no clinically significant left ventricular outflow tract obstruction. At 6 months, all patients had improved quality of life (mean improvement vs. baseline 16.4 ± 12 points). All valve hemodynamic parameters were maintained. Computed tomographic angiography confirmed annular stability, proper valve geometry and no structural failure. CONCLUSIONS: The transfemoral delivery of a purposely designed mitral prosthesis (Cephea valve) was safe and feasible in prohibitive risk patients. Valve performance was sustained, and clinical outcomes improved at 6 months. Larger clinical studies are required.

Transcatheter aortic valve replacement: relative safety and efficacy of the procedure with different devices.

INTRODUCTION: Transcatheter aortic valve replacement (TAVR) is a well-established treatment for patients with severe aortic stenosis and intermediate-to-high surgical risk. The increasing clinical experience along with technical and design iterations of transcatheter valve systems have contributed to reducing adverse events and improving clinical outcomes. AREAS COVERED: Overview of the latest generation transcatheter heart valves (THVs), focusing on early safety and efficacy outcomes. EXPERT COMMENTARY: Improvements in valve repositionability, reducing the size of valve delivery systems, and antiparavalvular leak iterations have contributed to improving the safety and clinical outcomes following TAVR. However, while certain complications like major vascular events and residual paravalvular leaks have significantly decreased with the arrival of newer generation THVs, no major changes in thromboembolic events (particularly stroke) have been observed, whereas other complications like conduction disturbances requiring pacemaker implantation have slightly increased over time. Also, no major progress on device retrievability has been observed in the last years. The expansion of TAVR toward the treatment of younger and lower risk patients, as well as newer indications (e.g. asymptomatic patients) will likely require an extra-effort involving additional device iterations and complementary therapies (e.g. embolic protection, newer vascular closure devices) to further improve safety and clinical outcomes.

TAVI or No TAVI: identifying patients unlikely to benefit from transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) has spawned the evolution of novel catheter-based therapies for a variety of cardiovascular conditions. Newer device iterations are delivering lower peri- and early post-procedural complication rates in patients with aortic stenosis, who were otherwise deemed too high risk for conventional surgical valve replacement. Yet beyond the post-procedural period, a considerable portion of current TAVI recipients fail to derive a benefit from TAVI, either dying or displaying a lack of clinical and functional improvement. Considerable interest now lies in better identifying factors likely to predict futility post-TAVI. Implicit in this are the critical roles of frailty, disability, and a multimorbidity patient assessment. In this review, we outline the roles that a variety of medical comorbidities play in determining futile post-TAVI outcomes, including the critical role of frailty underlying the identification of patients unlikely to benefit from TAVI. We discuss various TAVI risk scores, and further propose that by combining such scores along with frailty parameters and the presence of specific organ failure, a more accurate and holistic assessment of potential TAVI-related futility could be achieved.