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.

Off-pump epicardial ventricular reconstruction restores left ventricular twist and reverses remodeling in an ovine anteroapical aneurysm model.

OBJECTIVE: The loss of normal apical rotation is associated with left ventricular (LV) remodeling and systolic dysfunction in patients with congestive heart failure after myocardial infarction. The objective of the present study was to evaluate the effect of epicardial ventricular reconstruction, an off-pump, less-invasive surgical reshaping technique, on myocardial strain, LV twist, and the potential alteration of myocardial fiber orientation in an ovine model of LV anteroapical aneurysm. METHODS: LV anteroapical myocardial infarction was induced by coil embolization of the left anterior descending artery. Eight weeks after occlusion, epicardial ventricular reconstruction was performed using left thoracotomy under fluoroscopic guidance in 8 sheep to completely exclude the scar. The peak systolic longitudinal/circumferential strains and LV twist were evaluated using speckle tracking echocardiography before (baseline), after device implantation, and at 6 weeks of follow-up. RESULTS: Epicardial ventricular reconstruction was completed in all sheep without any complications. Immediately after device implantation, LV twist significantly increased (4.18 ± 1.40 vs baseline 1.97 ± 1.92; P = .02). The ejection fraction had increased 17% and LV end-systolic volume had decreased 40%. The global longitudinal strain increased from -5.3% to -9.1% (P < .05). Circumferential strain increased in both middle and apical LV segments, with the greatest improvement in the inferior lateral wall (from -11.4% to -20.6%, P < .001). These effects were maintained ≥6 weeks after device implantation without redilation. CONCLUSIONS: Less invasive than alternative therapies, epicardial ventricular reconstruction on the off-pump beating heart can restore LV twist and systolic strain and reverse LV remodeling in an ovine anteroapical aneurysm model.

Drug-eluting stents in preclinical studies: updated consensus recommendations for preclinical evaluation.

Coronary drug-eluting stents are commonplace in clinical practice with acceptable safety and efficacy. Preclinical evaluation of novel drug-eluting stent technologies has great importance for understanding safety and possibly efficacy of these technologies, and well-defined preclinical testing methods clearly benefit multiple communities within the developmental, testing, and clinical evaluation chain. An earlier consensus publication enjoyed widespread adoption but is in need of updating. This publication is an update, presenting an integrated view for testing drug-eluting technologies in preclinical models, including novel devices such as bioabsorbable coatings, totally bioabsorbable stents, bifurcation stents, and stent-free balloon-based drug delivery. This consensus document was produced by preclinical and translational scientists and investigators engaged in interventional technology community. The United States Food and Drug Administration (USFDA) recently issued a Draft Guidance for Industry Document for Drug-Eluting Stents. This expert consensus document is consistent with the Food and Drug Administration guidance. The dynamic nature of this field mandates future modifications and additions that will be added over time.