Treatment of Heart Failure With Associated Functional Mitral Regurgitation Using the ARTO System: Initial Results of the First-in-Human MAVERIC Trial (Mitral Valve Repair Clinical Trial)

ObjectivesMAVERIC (Mitral Valve Repair Clinical Trial) reports the safety and efficacy of the ARTO system in patients with symptomatic heart failure and functional mitral regurgitation (FMR).BackgroundThe ARTO system percutaneously modifies the mitral annulus to improve leaflet coaptation in FMR.MethodsThe MAVERIC trial is a prospective, nonrandomized first-in-human study. Key inclusion criteria were systolic heart failure New York Heart Association functional classes II to IV, FMR grade ≥2+, left ventricular (LV) ejection fraction ≤40%, LV end-diastolic diameter >50 mm and ≤75 mm. Exclusion criteria were clinical variables that precluded feasibility of the ARTO procedure. Primary outcomes were safety (30-day major adverse events) and efficacy (MR reduction, LV volumes, and functional status).ResultsEleven patients received the ARTO system, and there were no procedural adverse events. From baseline to 30 days, there were meaningful improvements. Effective regurgitant orifice area decreased from 30.3 ± 11.1 mm² to 13.5 ± 7.1 mm² and regurgitant volumes from 45.4 ± 15.0 ml to 19.5 ± 10.2 ml. LV end-systolic volume index improved from 77.5 ± 24.3 ml/m² to 68.5 ± 21.4 ml/m², and LV end-diastolic volume index 118.7 ± 28.6 ml/m² to 103.9 ± 21.2 ml/m². Mitral annular anteroposterior diameter decreased from 45.0 ± 3.3 mm to 38.7 ± 3.0 mm. Functional status was 81.8% New York Heart Association functional class III/IV improving to 54.6% functional class I/II. At 30 days, there were 2 adverse events: 1 pericardial effusion requiring surgical drainage; and 1 asymptomatic device dislodgement.ConclusionsThe ARTO system is a novel transcatheter device that can be used safely with meaningful efficacy in the treatment of FMR. (Mitral Valve Repair Clinical Trial [MAVERIC]; NCT02302872)     

Persistence of Iatrogenic Atrial Septal Defect After Interventional Mitral Valve Repair With the MitraClip System: A Note of Caution

ObjectivesThe purpose of this study was to investigate the persistence rates of iatrogenic atrial septal defect (iASD) after interventional edge-to-edge repair with serial transesophageal echocardiography examinations and close clinical follow-up (FU).BackgroundTranscatheter mitral valve repair (TMVR) with the MitraClip system (Abbott Vascular, Abbott Park, Illinois) is a therapeutic alternative to surgery in selected high-risk patients. Clip placement requires interatrial transseptal puncture and meticulous manipulation of the steerable sheath. The persistence of iASD after MitraClip procedures and its clinical relevance is unknown.MethodsA total of 66 patients (76.7% male, mean age 77.1 ± 7.9 years) with symptomatic mitral regurgitation (MR) at prohibitive surgical risk (EuroSCORE II 10.1 ± 6.1%) underwent MitraClip procedures and completed 6 months of FU.ResultsTransesophageal echocardiography after FU showed persistent iASD in 50% of cases. Patients with iASD did not significantly differ from patients without ASD concerning baseline characteristics, New York Heart Association functional class, severity of MR, and acute procedural success rates (p > 0.05). When comparing procedural details and hemodynamic measures between groups, MitraClip procedures took longer in patients without iASD (82.4 ± 39.7 min vs. 68.9 ± 45.5 min; p = 0.05), and echocardiography after FU showed less decrease of systolic pulmonary artery pressures in the iASD group (−1.6 ± 14.1 mm Hg vs. 9.3 ± 17.4 mm Hg; p = 0.02). Clinically, patients with iASD presented more often with New York Heart Association functional classes >II after FU (57% vs. 30%; p = 0.04), showed higher levels of N-terminal pro-brain natriuretic peptide (6,667.3 ± 7,363.9 ng/dl vs. 4,835.9 ± 6,681.7 ng/dl; p = 0.05), and had less improvement in 6-min walking distances (20.8 ± 107.4 m vs. 114.6 ± 116.4 m; p = 0.001). Patients with iASD showed higher death rates during 6 months (16.6% vs. 3.3%; p = 0.05). Cox regression analysis found that only persistence of iASD (p = 0.04) was associated with 6-month survival.ConclusionsThe persistence rate of 50% iASD after MitraClip procedures is considerably high. Persistent interatrial shunting was associated with worse clinical outcomes and increased mortality. Further studies are warranted to investigate if persistent interatrial shunting is the mediator or marker of advanced disease in these patients.     

Long-Term Outcomes After Transcatheter Aortic Valve Replacement in High-Risk Patients With Severe Aortic Stenosis: The U.K. Transcatheter Aortic Valve Implantation Registry

ObjectivesThe U.K. Transcatheter Aortic Valve Implantation Registry reported 30-day and 1-year mortality rates of 7.1% and 21.4%, respectively, for patients who underwent transcatheter aortic valve replacement (TAVR) in the United Kingdom between 2007 and 2009. The study aim was to report long-term outcomes in this same cohort of patients.BackgroundThere are few data on outcomes beyond 3 years after TAVR in any notable number of patients.MethodsData from all TAVR procedures performed in the United Kingdom between January 2007 and December 2009 were prospectively collected. All-cause mortality status was reported in March 2014. Mortality tracking was achieved in 97.7% patients.ResultsThe minimal time from replacement to census was 4.1 years, and the maximal time was 7.0 years. The 3- and 5-year survival rates were 61.2% and 45.5%, respectively. Independent predictors of 3-year mortality were renal dysfunction (hazard ratio [HR]: 1.65), atrial fibrillation (HR: 1.36), logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥18.5 (HR: 1.33), respiratory dysfunction (HR: 1.28), and ventricular dysfunction (left ventricular ejection fraction <30%) (HR: 1.53). Coronary artery disease (HR: 1.28) and age (HR: 1.03) were additional independent predictors of mortality at 5 years. Stroke within 30 days of TAVR was the only independent procedural predictor of mortality at 3 and 5 years (HR: 2.17 at 3 years). Device type, access route, and paravalvular leak did not independently predict long-term outcome.ConclusionsIn the large U.K. Transcatheter Aortic Valve Implantation Registry, long-term outcomes after TAVR are favorable with 3- and 5-year survival rates of 61.2% and 45.5%, respectively. Long-term survival after TAVR is largely determined by intrinsic patient factors. Other than stroke, procedural variables, including paravalvular aortic leak, did not appear to be independent predictors of long-term survival.     

Long-Term Survival Benefit of Revascularization Compared With Medical Therapy in Patients With Coronary Chronic Total Occlusion and Well-Developed Collateral Circulation

ObjectivesThe purpose of this study was to compare the long-term clinical outcomes of patients with chronic total occlusion (CTO) and well-developed collateral circulation treated with revascularization versus medical therapy.BackgroundLittle is known about the clinical outcomes and optimal treatment strategies of CTO with well-developed collateral circulation.MethodsWe screened 2,024 consecutive patients with at least 1 CTO detected on coronary angiogram. Of these, we analyzed data from 738 patients with Rentrop 3 grade collateral circulation who were treated with medical therapy alone (n = 236), coronary artery bypass grafting (n = 170) or percutaneous coronary intervention (n = 332; 80.1% successful). Patients who underwent revascularization and medical therapy (revascularization group, n = 502) were compared with those who underwent medical therapy alone (medication group, n = 236) in terms of cardiac death and major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, and repeat revascularization.ResultsDuring a median follow-up duration of 42 months, multivariate analysis revealed a significantly lower incidence of cardiac death (hazard ratio [HR]: 0.29; 95% confidence interval [CI]: 0.15 to 0.58; p < 0.01) and MACE (HR: 0.32; 95% CI: 0.21 to 0.49; p < 0.01) in the revascularization group compared with the medication group. After propensity score matching, the incidence of cardiac death (HR: 0.27; 95% CI: 0.09 to 0.80; p = 0.02) and MACE (HR: 0.44; 95% CI: 0.23 to 0.82; p = 0.01) were still significantly lower in the revascularization group than in the medication group.ConclusionsIn patients with coronary CTO and well-developed collateral circulation, aggressive revascularization may reduce the risk of cardiac mortality and MACE.     

Transcatheter Pulmonary Valve Replacement With the Edwards Sapien System: The Toronto Experience

ObjectivesThis study sought to review the outcomes for the Sapien and Sapien XT valves (Edwards Lifesciences, Irvine, California) for percutaneous pulmonary valve implantation (PPVI).BackgroundPPVI has emerged as a viable alternative to surgery in patients with right ventricular (RV) outflow tract dysfunction. Limited data are available for the Sapien and Sapien XT valves in this setting.MethodsRetrospective analysis was performed for all patients to have undergone PPVI using the Edwards Sapien system at a large quaternary center.ResultsTwenty-five patients (70% male, mean age 34 ± 8.9 years) were identified. Primary underlying diagnosis was tetralogy of Fallot (n = 15), Ross procedure (n = 5), and other (n = 5). RV outflow tract characteristics included: biological valve (n = 16) and homograft (n = 9). Technical success was 96%. One patient required elective surgical pulmonary valve replacement for a high residual gradient. Pre-stenting was performed in all cases (52% covered stents). Valve sizes were 23 mm (n = 8), 26 mm (n = 15), and 29 mm (n = 2). Procedural hemodynamics revealed a decrease in the mean RV-to-systemic pressure ratio from 0.64 to 0.36 (p < 0.001) and RV-to-pulmonary artery (PA) gradient from 39 to 9 mm Hg (p < 0.001). No patient had clinically significant pulmonary regurgitation (PR). At a mean follow-up of 3.5 ± 2.1 years (range 0.3 to 7.2 years), there were no deaths. One patient required reintervention (no PR evident immediately post-procedure but severe valvular PR at 1 year requiring a valve-in-valve procedure). There were no episodes of endocarditis and no stent fractures. There was preserved valve function during follow-up with no change in RV-to-PA gradient nor PR severity.ConclusionsThe Edwards Sapien system is a viable and durable option for PPVI in this single-center study.     

5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis

ObjectivesThe purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).BackgroundThere is a paucity of evidence on long-term durability of currently available transcatheter heart valves.MethodsStarting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria.ResultsAll-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were observed. Valve thrombosis or late valve embolization were not reported.ConclusionsTAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients.     

Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System

ObjectivesThe purpose of this study was to prospectively evaluate the safety and clinical performance of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system (Medtronic, Inc., Minneapolis, Minnesota) in a single-arm, multicenter pivotal study in high- or extreme-risk patients with symptomatic aortic valve stenosis.BackgroundAlthough outcomes following TAVR are improving, challenges still exist. The repositionable 14-F equivalent CoreValve Evolut R TAVR system was developed to mitigate some of these challenges.MethodsSuitable patients (n = 60) underwent TAVR with a 26- or 29-mm Evolut R valve. Primary safety endpoints were mortality and stroke at 30 days. Primary clinical performance endpoints were device success per the VARC-2 (Valve Academic Research Consortium-2) and the percent of patients with mild or less aortic regurgitation 24 h to 7 days post-procedure.ResultsPatients (66.7% female; mean age 82.8 ± 6.1 years; Society of Thoracic Surgeons Score 7.0 ± 3.7%) underwent TAVR via the transfemoral route in 98.3%, using a 29-mm valve in 68.3% of patients. All attempts at repositioning were successful. No death or stroke was observed up to 30 days. The VARC-2 overall device success rate was 78.6%. Paravalvular regurgitation post TAVR was mild or less in 96.6%, moderate in 3.4%, and severe in 0% at 30 days. Major vascular complications occurred in 8.3%, and permanent pacemaker implantation was required in 11.7% of patients.ConclusionsThe repositionable 14-F equivalent Evolut R TAVR system is safe and effective at treating high-risk symptomatic aortic stenosis patients. Repositioning was successful when required in all patients, with low rates of moderate or severe paravalvular aortic regurgitation and low permanent pacemaker implantation. (The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study; NCT01876420)     

Impact of Balloon Post-Dilation on Clinical Outcomes After Transcatheter Aortic Valve Replacement With the Self-Expanding CoreValve Prosthesis

ObjectivesThe aim of this study was to assess the incidence and clinical impact of balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR) with the CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).BackgroundBPD is a widely adopted strategy to reduce the degree of paraprosthetic regurgitation in case of transcatheter heart valve underexpansion. However, controversies still remain regarding its real effectiveness and safety.MethodsThe ClinicalService (a nation-based data repository and medical care project) dataset was analyzed. All patients were dichotomized according to the need for BPD during the index procedure.ResultsAmong 1,376 patients, BPD of the transcatheter heart valve was performed in 272 (19.8%). In 37% of cases, it was unsuccessful at reducing the paravalvular regurgitation to mild or less. No case of valve embolization, new intravalvular regurgitation, coronary occlusion, and aortic root injury occurred during BPD. There were no statistically significant differences between the 2 groups in the incidence of in-hospital all-cause and cardiovascular mortality, neurological events, myocardial infarction, bleeding, conversion to open-chest surgery, and the need for a permanent pacemaker. The need for BPD did not emerge as an independent risk factor for all-cause (adjusted hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 0.81 to 2.19, p = 0.264) and cardiovascular (adjusted HR: 1.48, 95% CI: 0.74 to 2.97, p = 0.265) mortality at 1 year after the procedure. In addition, BPD did not predispose to higher odds of neurological events during 12 months after TAVR (HR: 0.92, 95% CI: 0.45 to 1.88, p = 0.815).ConclusionsThis large study showed that BPD after TAVR was safe and not associated with increased rates of cerebrovascular events, mortality, myocardial infarction, and aortic root injury.     

Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial

ObjectivesThis study sought to compare the health status outcomes for patients treated with either self-expanding transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR).BackgroundIn patients at increased surgical risk, TAVR with a self-expanding bioprosthesis is associated with improved 1-year survival compared with AVR. However, elderly patients may be just as concerned with quality-of-life improvement as with prolonged survival as a goal of treatment.MethodsBetween 2011 and 2012, 795 patients with severe aortic stenosis at increased surgical risk were randomized to TAVR or AVR in the CoreValve US Pivotal Trial. Health status was assessed at baseline, 1 month, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short-Form 12 Questionnaire, and EuroQOL 5-dimension questionnaire; growth curve models were used to examine changes over time.ResultsOver the 1-year follow-up period, disease-specific and generic health status improved substantially for both treatment groups. At 1 month, there was a significant interaction between the benefit of TAVR over AVR and access site. Among surviving patients eligible for iliofemoral (IF) access, there was a clinically relevant early benefit with TAVR across all disease-specific and generic health status measures. Among the non-IF cohort, however, most health status measures were similar for TAVR and AVR, although there was a trend toward early benefit with TAVR on the Short-Form 12 Questionnaire’s physical health scale. There were no consistent differences in health status between TAVR and AVR at the later time points.ConclusionsHealth status improved substantially in surviving patients with increased surgical risk who were treated with either self-expanding TAVR or AVR. TAVR via the IF route was associated with better early health status compared with AVR, but there was no early health status benefit with non-IF TAVR compared with AVR. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)     

Initial German Experience With Transapical Implantation of a Second-Generation Transcatheter Heart Valve for the Treatment of Aortic Regurgitation

ObjectivesThis analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation.BackgroundExperience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus.MethodsTransapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed.ResultsImplantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI.ConclusionsAortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.     

Repeat MitraClip Therapy for Significant Recurrent Mitral Regurgitation in High Surgical Risk Patients: Impact of Loss of Leaflet Insertion

ObjectivesThe goal of this study was to assess procedural details and outcomes of repeat MitraClip therapy.BackgroundMitraClip implantation is a safe and efficacious percutaneous approach to treat significant mitral regurgitation (MR).MethodsOf 410 inoperable or high surgical risk patients treated with the MitraClip at our institution, 17 (4.1%) patients, as well as 4 patients initially treated at external institutions, underwent repeat MitraClip procedures. Mean age of the 21 patients (14 men [67%]) was 77 years; 15 patients (71%) had functional MR.ResultsRepeat procedures performed at a median of 6.3 months (range 0.7 to 34 months) after the index intervention were successful (discharge MR grade ≤2+) in 13 patients (62%), with a pronounced difference in success rate observed between the 13 patients with adequate leaflet insertion at the time of the repeat intervention and the 8 patients in whom loss of leaflet insertion (LLI) (leaflet tear/perforation or partial clip detachment) was present (11 of 13 [85%] vs. 2 of 8 [25%], respectively). The 21 patients were followed for a median of 8.5 (interquartile range: 2.3 to 18.6) months; 13 patients (62%), 8 with adequate leaflet insertion and 5 with LLI, died during follow-up.ConclusionsRepeat MitraClip intervention for significant recurrent MR appears to be a viable therapeutic approach in patients in whom leaflet insertion into the MitraClip is not compromised. LLI is strongly associated with repeat procedural failure.