These preliminary data suggest the feasibility and safety of autologous skeletal myoblast transplantation in severe ischemic cardiomyopathy, with the caveat of an arrhythmogenic potential. New-onset contraction of akinetic and nonviable segments suggests a functional efficacy that requires confirmation by randomized studies.
The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).
Background-Skeletal myoblast (SM) transplantation (Tx) in a post-myocardial infarction (MI) scar experimentally improves left ventricular (LV) ejection fraction (EF). Short-term follow-up (FU) studies have suggested that a similar benefit could clinically occur despite an increased risk of LV arrhythmias. Methods and Results-We report the long-term FU of the first worldwide cohort of grafted patients (n ϭ9, 61.8Ϯ11.6 years, previous MI, EF Յ35%) operated on (autologous SM Tx and bypass surgery) in 2000 to 2001 and evaluated before Tx, at 1 month (M1) and at a median FU of 52 (18 to 58) months after Tx (37 patient-years). NYHA class improved from 2.5Ϯ0.5 to 1.8Ϯ0.4 at M1 (Pϭ0.004 versus baseline) and 1.7Ϯ0.5 at FU (Pϭnot significant versus M1; Pϭ0.0007 versus baseline). EF increased from 24.3Ϯ4% to 31Ϯ4.1% at M1 (ϩ28%, Pϭ0.001 versus baseline) and remained stable thereafter (28.7Ϯ8.1%, ϩ18% versus baseline). There were 5 hospitalizations for heart failure in 3 patients at 28.6Ϯ9.9 months, allowing implant in 2 patients with a resynchronization pacemaker. An automatic cardiac defibrillator (ACD) was implanted in 5 patients for nonsustained (n ϭ1) or sustained (n ϭ4) ventricular tachycardia at 12.2Ϯ18.6 (1 to 45) months. Despite a beta-blocker/amiodarone combination therapy, there were 14 appropriate shocks for 3 arrhythmic storms in 3 patients at 6, 7, and 18 months after ACD implantation. Conclusions-In this cohort of severe heart failure patients both clinical status and EF stably improve over time with a strikingly low incidence of hospitalizations for heart failure (0.13/patient-years) and the arrhythmic risk can be controlled by medical therapy and/or on-request ACD implantation.
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