Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study.

BACKGROUND: Mitral valve transcatheter edge-to-edge repair (M-TEER) is an effective option for treatment of mitral regurgitation (MR). We previously reported favorable 2-year outcomes for the PASCAL transcatheter valve repair system. OBJECTIVES: We report 3-year outcomes from the multinational, prospective, single-arm CLASP study with analysis by functional MR (FMR) and degenerative MR (DMR). METHODS: Patients with core-lab determined MR ≥ 3+ were deemed candidates for M-TEER by the local heart team. Major adverse events were assessed by an independent clinical events committee to 1 year and by sites thereafter. Echocardiographic outcomes were evaluated by the core laboratory to 3 years. RESULTS: The study enrolled 124 patients, 69% FMR; 31% DMR (60% NYHA class III-IVa, 100% MR ≥ 3+). The 3-year Kaplan-Meier estimate for survival was 75% (66% FMR; 92% DMR) and freedom from heart failure hospitalization (HFH) was 73% (64% FMR; 91% DMR), with 85% reduction in annualized HFH rate (81% FMR; 96% DMR) (p < 0.001). MR ≤ 2+ was achieved and maintained in 93% of patients (93% FMR; 94% DMR) and MR ≤ 1+ in 70% of patients (71% FMR; 67% DMR) (p < 0.001). The mean left ventricular end-diastolic volume (181 mL at baseline) decreased progressively by 28 mL [p < 0.001]. NYHA class I/II was achieved in 89% of patients (p < 0.001). CONCLUSIONS: The 3-year results from the CLASP study demonstrated favorable and durable outcomes with the PASCAL transcatheter valve repair system in patients with clinically significant MR. These results add to the growing body of evidence establishing the PASCAL system as a valuable therapy for patients with significant symptomatic MR.

Impact of Transcatheter Mitral Valve Repair on Preprocedural and Postprocedural Hospitalization Rates.

OBJECTIVES: The objective of this study was to determine the effect of transcatheter mitral valve repair (TMVr) on hospitalization rates by assessing pre- and postprocedural hospitalization patterns. BACKGROUND: TMVr has emerged as the treatment of choice for selected patients with mitral regurgitation, but the impact of these procedures on hospital utilization remains unclear. METHODS: All patients who underwent TMVr in Ontario, Canada, between 2011 and 2017 were included in this observational study using population-based data. Hospitalization person-year rates were assessed in the years before and after TMVr and 4 predefined intervals: 1 to 30, 31 to 90, 91 to 182, and 183 to 365 days. Main outcomes of interest were all-cause and heart failure (HF) hospitalizations. Poisson regression models were used to compare incidence rates across all time periods. RESULTS: The study cohort included 523 patients. In the year preceding TMVr, 66.2% of patients were hospitalized compared with 47.4% in the year following. There were stepwise increases in both all-cause and HF hospitalization rates in the periods preceding the index procedure, and all postprocedural periods had significantly lower hospitalization rates. The adjusted rate ratios for all-cause and HF-related hospitalization in the year after TMVr were 0.65 (95% CI: 0.56-0.76) and 0.38 (95% CI: 0.29-0.51), respectively. All time periods had significant reductions in all-cause and HF hospitalization in the adjusted analysis. CONCLUSIONS: In this population-based study, significant reductions were observed in both all-cause and HF-related hospitalizations in all time periods after TMVr compared with the year prior. This suggests that TMVr has a sustained effect on hospitalization rates despite a high-risk population.

2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.

OBJECTIVES: This study reports 2-year outcomes from the multicenter, prospective, single-arm CLASP study with functional mitral regurgitation (FMR) and degenerative MR (DMR) analysis. BACKGROUND: Transcatheter repair is a favorable option to treat MR. Long-term prognostic impact of the PASCAL transcatheter valve repair system in patients with clinically significant MR remains to be established. METHODS: Patients had clinically significant MR ≥3+ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years. RESULTS: A total of 124 patients (69% FMR, 31% DMR) were enrolled with a mean age of 75 years, 56% were male, 60% were New York Heart Association functional class III to IVa, and 100% had MR ≥3+. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR ≤1+ was achieved in 78% of patients (84% FMR, 71% DMR) and MR ≤2+ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in New York Heart Association functional class I to II (p < 0.001). CONCLUSIONS: The PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients. Results showed high survival and freedom from HF rehospitalization rates with a significantly reduced annualized HF hospitalization rate. Durable MR reduction was achieved with evidence of left ventricular reverse remodeling and significant improvement in functional status. The CLASP IID/IIF randomized pivotal trial is ongoing.

1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.

OBJECTIVES: The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR). BACKGROUND: The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. METHODS: Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year. RESULTS: One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all). CONCLUSIONS: The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349).

Transcatheter Mitral Valve Edge-to-Edge Repair with the New MitraClip XTR System for Acute Mitral Regurgitation Caused by Papillary Muscle Rupture.

Treatment of patients presenting with cardiogenic shock due to acute mitral regurgitation related to papillary muscle rupture poses significant challenges, owing to the high risk associated with conventional surgery. We hereby report successful transcatheter mitral valve edge-to-edge repair with the new Mitraclip XTR device (Abbott Vascular, Santa Clara, CA) in a patient with acute myocardial infarction and cardiogenic shock. Although surgical intervention remains the standard of care, the new MitraClip XTR system offers a novel treatment option for patients with papillary muscle rupture by overcoming the anatomic challenges often seen in this pathology.

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study.

OBJECTIVES: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study. BACKGROUND: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated. METHODS: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days. RESULTS: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively. CONCLUSIONS: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349).

The state of transcatheter aortic valve implantation training in Canadian cardiac surgery residency programs.

BACKGROUND: The current state of transcatheter aortic valve implantation (TAVI) training for Canadian cardiac surgical residents is unknown. Our goals were to establish a national inventory of TAVI educational resources, elucidate the role of residents in TAVI programs, and determine the attitudes and perspectives of residents and program directors regarding the importance of TAVI technology and training. METHODS: We sent Web-based surveys and reminders to all Canadian cardiac surgical residents and program directors between February and July 2017. We used descriptive analyses to summarize data in an aggregate and anonymous manner. We analyzed patterned responses to open-ended survey questions using thematic analysis. RESULTS: Seventy-eight of 92 residents (85%) and 11 of 12 program directors (92%) completed the survey, with broad representation from across Canada. A minority of residents (14 [18%]) and program directors (4 [36%]) reported that TAVI training in their program was adequate. Only 3 program directors (27%) reported that their residents had access to TAVI simulation training. Although most residents (76 [97%]) and program directors (10 [91%]) agreed that TAVI was important to the trainee's future practice, about two-thirds (54 [69%] and 7 [64%], respectively) agreed that TAVI should be a focus of fellowship training. A perceived lack of interest from interventional cardiologists to teach surgical residents, competition from TAVI fellows and lack of formalized time during residency were identified as perceived barriers to TAVI training. CONCLUSION: As Canadian surgical residency training moves toward a Competence by Design curriculum, there remains a pressing need to create uniform learning objectives and expectations in the TAVI curriculum.

CONTEXTE: On ne connaît pas l'état actuel de la formation en implantation transcathéter de valvule aortique (ITVA) que reçoivent les médecins résidents dans les programmes canadiens de chirurgie cardiaque. Nous voulions dresser un inventaire national des ressources pédagogiques en ITVA, expliquer le rôle des médecins résidents dans les programmes d'ITVA et déterminer les attitudes et les points de vue des résidents et des directeurs de programme quant à l'importance de la technologie d'ITVA et de la formation en la matière. MÉTHODES: Entre février et juillet 2017, nous avons envoyé des sondages web et des rappels à tous les médecins résidents en chirurgie cardiaque et aux directeurs de ces programmes au Canada. Nous avons utilisé des analyses descriptives pour résumer les données de façon agrégée et anonyme. Nous avons analysé les réponses à des questions ouvertes et dégagé des tendances au moyen d'une analyse thématique. RÉSULTATS: Soixante-dix-huit des 92 résidents (85 %) et 11 des 12 directeurs de programme (92 %) ont répondu au sondage, avec une vaste représentation de partout au Canada. Une minorité de résidents (14 [18 %]) et de directeurs de programme (4 [36 %]) ont déclaré que la formation en ITVA offerte par leur programme était adéquate. Seuls 3 directeurs de programme (27 %) ont déclaré que leurs résidents avaient accès à une formation en simulation de l'ITVA. Bien que la plupart des résidents (76 [97 %]) et des directeurs de programme (10 [91 %]) soient d'accord pour dire que l'ITVA est importante pour la pratique future du stagiaire, environ les deux tiers (54 [69 %] et 7 [64 %], respectivement) sont d'avis que la formation à l'ITVA devrait faire l'objet d'un stage particulier. Un manque perçu d'intérêt de la part des cardiologues interventionnels pour l'enseignement aux médecins résidents en chirurgie, la compétition entre les stagiaires pour la formation à l'ITVA et le manque de temps officiellement réservé à ce volet pendant la résidence ont été identifiés comme des obstacles perçus à la formation en ITVA. CONCLUSION: À mesure que les programmes de résidence en chirurgie au Canada s'orientent vers une formation axée sur les compétences par conception, il demeure urgent de formuler des objectifs et des attentes d'apprentissage uniformes pour la formation en ITVA.

Year in review: transcatheter aortic valve replacement.

PURPOSE OF REVIEW: Transcatheter aortic valve replacement (TAVR) has been effective in prohibitive/high-risk patients. Expansion toward intermediate or even low-risk patients has been proposed. A review of recent developments will help understand current trends and issues. RECENT FINDINGS: The 5-year results from the PARTNER I trial and 2-year results of the CoreValve US Pivotal Trial, together with national registries, confirmed the long-term efficacy and durability of TAVR. Studies including PARTNER II, ADVANCE, and The German Aortic Valve Registry showed short-to mid-term success in intermediate-risk patients. Comparison of balloon-expandable and self-expanding valves in the CHOICE trial associated specific outcome differences with specific valve types, suggesting a more customized approach in valve selection. Short-term results of newer-generation valves have demonstrated excellent safety and efficacy with improved designs. Studies on TAVR-specific complications, such as conduction block and arrhythmia, paravalvular aortic regurgitation, and stroke, have renewed ideas about their prognosis, treatment, and prevention. Conscious sedation percutaneous TAVR has become more popular, with excellent outcomes and improved cost savings. SUMMARY: TAVR has been accepted as an effective treatment even for intermediate-risk patients. This article aims to review the most recent results and essential issues.

Coronary artery bypass in the context of polyarteritis nodosa.

A 46-year-old man with polyarteritis nodosa and multiple myocardial infarctions treated with multiple percutaneous coronary interventions presented again with atypical angina. Coronary angiography revealed triple-vessel coronary artery disease. This patient underwent four-vessel coronary artery bypass graft and recovered uneventfully. A review of the literature and discussion of the surgical management of this patient is presented.

Impact of clopidogrel use on mortality and major bleeding in patients undergoing coronary artery bypass surgery.

Patients who received clopidogrel prior to coronary bypass surgery are at increased risk for bleeding that must be balanced with risk of ongoing ischemia if coronary artery bypass grafting is delayed. This study aimed to evaluate the impact of clopidogrel on mortality and major bleeding in patients undergoing urgent coronary bypass surgery. We reviewed 451 consecutive patients who underwent urgent isolated coronary bypass surgery; 262 had not received clopidogrel, whereas 189 received clopidogrel < or = 5 days preoperative. The primary endpoint was in-hospital death, massive transfusion or massive blood loss. Patient characteristics were almost similar between groups. There was no difference in in-hospital death or massive bleeding indices between groups (clopidogrel: 7% vs. no clopidogrel: 6%, P = 0.9). No difference was observed even after adjusting for the date of stopping clopidogrel preoperatively. Multivariate regression analysis showed that clopidogrel or the duration it was stopped preoperatively, did not predict adverse outcomes. Significant independent predictors included preoperative renal dysfunction, hemoglobin level and peripheral vascular disease. clopidogrel, or the time it was stopped prior to surgery, was not a risk factor for in-hospital death, massive bleeding, or other poor early outcomes in patients undergoing urgent coronary artery bypass surgery.

The Graft Imaging to Improve Patency (GRIIP) clinical trial results.

OBJECTIVE: This trial aimed to determine whether intraoperative graft assessment with criteria for graft revision would decrease the proportion of patients with 1 or more graft occlusions or stenoses or major adverse cardiac events 1 year after coronary artery bypass grafting. METHODS: A single-center, randomized, single-blinded, controlled clinical trial was designed. Patients were randomized to either of 2 groups: intraoperative graft patency assessment using indocyanine-green fluorescent angiography and transit-time flowmetry, with graft revision according to a priori criteria (imaging group), or standard intraoperative management (control group). Patients underwent follow-up angiography at 1 year. RESULTS: Between September 2005 and August 2008, 156 patients undergoing isolated coronary bypass grafting were enrolled (imaging, n = 78; control, n = 78). Demographic and angiographic characteristics were similar between groups. Operative, crossclamp, and cardiopulmonary bypass times were all nonsignificantly longer in the imaging arm. The number of grafts per patients was similar (imaging, 3.0 +/- 0.7; control, 3.0 +/- 0.7). The frequency of major adverse cardiac events (death, myocardial infarction, repeat revascularization) was not different between groups at 1 year postoperatively (imaging, 7.7%; control, 7.7%). One-year angiography was performed in 107 patients (imaging, 55 patients/160 grafts; control, 52 patients/152 grafts). The proportion of patients with 1 graft occlusion or more was comparable in the imaging (30.9%) and control (28.9%) groups (relative risk [95% confidence interval], 1.1 [0.6-1.9]; P = .82), as were other graft patency end points. The incidence of saphenous vein graft occlusion was high in both groups. CONCLUSIONS: Routine intraoperative graft assessment is safe but does not lead to a marked reduction in graft occlusion 1-year after bypass grafting. The incidence of saphenous vein graft failure remains high despite contemporary practice and routine intraoperative graft surveillance.

Troponin after cardiac surgery: a predictor or a phenomenon?

BACKGROUND: Increased cardiac troponin is observed after virtually every cardiac operation, indicating perioperative myocardial injury. The clinical significance of this elevation is controversial. This study aimed to correlate postoperative troponin levels with major adverse cardiac events (MACE). METHODS: The study included 1918 consecutive patients undergoing adult cardiac operations, including 1515 isolated coronary procedures, 229 valvular operations, and 174 combined coronary/valve procedures. Peak troponin T (normal value < 0.1 microg/L) was measured at less than 24 hours postoperatively. Excluded were 506 patients with a recent myocardial infarction (< 30-days of operation). The primary outcome was a composite of death, electrocardiogram-defined infarction, and low output syndrome (MACE). RESULTS: Mortality rates were 1.4%, 6.1%, and 7% in the coronary bypass, valve, and combined groups, respectively (p < 0.001). The rates of MACE were 17%, 35%, and 44% (p < 0.0001), and mean troponin T levels were 0.9 +/- 1.5, 1.2 +/- 2.9, and 1.3 +/- 1.2 microg/L (p < 0.001), in the coronary bypass, valve, and combined groups, respectively. All patients were divided into quintiles based on their peak postoperative troponin level (Q1, 0.0 to 0.39; Q2, 0.4 to 0.59; Q3, 0.6 to 0.79; Q4, 0.8 to 1.29; and Q5, > 1.3 microg/L). Adverse outcomes were similar and stable in the lower quintiles. A stepwise increase in adverse outcomes was observed in the higher quintiles. Receiver operating characteristic curve analysis revealed a troponin cutoff of 0.8 microg/L was the most discriminatory for MACE (area under the curve, 0.7). Multivariable analyses showed a troponin value of more than 0.8 microg/L was independently associated with MACE. CONCLUSIONS: Moderate elevations in troponin are common after cardiac operations; troponin is a well-described predictor of outcomes. Troponin levels exceeding 0.8 microg/L are associated with increased MACE in patients without a history of preoperative myocardial infarction within 30 days of operation.

Long-term results of aortic valve replacement with the St. Jude Toronto stentless porcine valve.

BACKGROUND: Long-term survival and freedom from valve-related events of the St. Jude Toronto stentless porcine valve (SPV) are unknown. The aim of this study was to investigate late clinical outcomes after aortic valve replacement with the Toronto SPV. METHODS: Between 1992 and 2000, 200 patients (131 males, 69 females) underwent aortic valve replacement with the Toronto SPV. Mean patient age at implantation was 64.6 +/- 10.9 years (range 33 to 82 years). At the time of operation, 32%, 51%, and 17% of patients were in New York Heart Association class I/II, III, and IV, respectively. Aortic stenosis, aortic insufficiency, and combined lesions were present in 64%, 13.5%, and 22.5% of patients preoperatively. Concomitant coronary artery bypass grafting was performed in 34.5% of patients. RESULTS: Perioperative mortality occurred in 2.5% (5/200) of patients. There were 31 late deaths. Actuarial survival at 5 and 10 years was 89.2% and 68.0%, respectively. There was no significant difference in overall actuarial survival between isolated valve patients and valve plus coronary artery bypass grafting patients, 71% versus 62% respectively, p = 0.85. Actuarial freedom from valve reoperation at 5 and 10 years was 97.6% and 79.9%, respectively. Actuarial freedom from structural valve deterioration was 98.8% at 5 years and declined to 77.9% at 10 years. Freedom from structural valve deterioration was poorer in patients with preoperative aortic insufficiency or bicuspid disease. Actuarial freedom from embolic events and endocarditis at 10 years were 94.6% and 95.9%, respectively. CONCLUSIONS: Although early clinical results were excellent, a significant increase in hazard for structural valve deterioration occurred in late follow-up.

Why is off-pump coronary surgery uncommon in Canada? Results of a population-based survey of Canadian heart surgeons.

BACKGROUND: Off-pump coronary artery bypass (OPCAB) is proposed to improve clinical outcomes and decrease resource use. However, off-pump surgery is not widely used in Canada. The purpose of this study was to determine the current use of OPCAB in Canada and determine why surgeons have not adopted this technique. METHODS AND RESULTS: The study was a population-based survey of all adult Canadian cardiac surgeons in practice >1 year. Eligible division heads and surgeons were contacted by mail. Of 19 806 isolated coronary bypass surgeries performed by respondents in Canada last year, 3164 (16.0%) were performed off-pump. More than 50% of Canadian surgeons performed OPCAB in <5% of coronary cases, and only 17% of surgeons performed OPCAB in >25% of coronary cases. Only 4 responding centers performed OPCAB in >25% of cases. Respondents were divided into those who performed <5% of cases off-pump (nonadopters), 5% to 25% off-pump (intermediate users), or >25% off-pump (enthusiasts). Mean number of distal anastomoses in off-pump cases were 1.7+/-0.6, 1.6+/-0.6, and 3.3+/-0.5 for nonadopters, intermediate users, and enthusiasts, respectively (P=0.001). Eleven percent of nonadopters, 55% of intermediate users, and 81% of enthusiasts believed OPCAB improved clinical outcomes (P<0.0001). Only 23% of all respondents felt OPCAB use would increase in the next 5 years. CONCLUSIONS: Concerns regarding incomplete revascularization and lack of proven clinical benefit have limited OPCAB to being performed routinely by only a small number of surgeons in Canada.