Abstract Objective The study objective was to assess the impact on follow-up outcomes of residual mitral regurgitation 2+ in comparison with ≤1+ after MitraClip (Abbott Vascular Inc, Santa Clara, ...Calif) repair. Methods We compared the outcomes of mitral regurgitation 2+ and mitral regurgitation ≤1+ groups among a population of 223 consecutive patients with acute residual mitral regurgitation ≤2+ who underwent MitraClip implantation at San Raffaele Scientific Institute (Milan, Italy) between October 2008 and December 2014. Results Residual mitral regurgitation 2+ was found in 64 patients (28.7%). Overall actuarial survival was 63.1% ± 4.4% at 48 months. Cumulative incidence functions of cardiac death in patients with mitral regurgitation 2+ was significantly higher (Gray test P < .001) compared with the mitral regurgitation ≤1+ group. The adjusted hazard ratio was 5.28 (95% confidence interval, 2.41-11.56, P < .001). Cumulative incidence function of mitral regurgitation ≥3+ recurrence in patients with residual mitral regurgitation ≤1+ and mitral regurgitation 2+ at 48 months was 13.3% ± 3.8% and 45.2% ± 6.8%, respectively (Gray test P < .001). Multivariate model showed that mitral regurgitation 2+ was the only factor associated with the development of mitral regurgitation ≥3+ at follow-up (adjusted hazard ratio, 6.71; 95% confidence interval, 3.48-12.90; P < .001). Mitral regurgitation cause was not associated with cardiac death and recurrence of mitral regurgitation ≥3+ at follow-up. No relationship between New York Heart Association class and follow-up time after MitraClip implant was found (odds ratio, 1.07; 95% confidence interval, 0.98-1.15; P = .11), and factors related to postoperative New York Heart Association also included residual mitral regurgitation 2+ ( P = .07). Conclusions Residual 2+ mitral regurgitation after MitraClip implantation was associated with worse follow-up outcomes compared with ≤1+ mitral regurgitation, including survival, symptom relief, and mitral regurgitation recurrence. Better efficacy should be pursued by transcatheter mitral repair technologies.
Objectives The aim of this study is to report the long-term outcomes (median follow-up time, 7 years; range, 1 month to 14 years) of patients who underwent surgery for paravalvular leak in our ...single-center experience. Methods From October 2000 to November 2007, 122 consecutive patients underwent surgery for symptomatic paravalvular leak (40 patients with aortic paravalvular leak; 82 with mitral paravalvular leak). In 7 patients (5.7%, all mitral), surgery was performed on the beating heart through a right thoracotomy. In 35% of patients, multiple paravalvular leaks were present. Results The mean age of patients was 62 ± 11 years, and European System for Cardiac Operative Risk Evaluation II was 7.2% ± 6%. Most of the patients were in New York Heart Association functional class III or IV (60%). Symptomatic hemolysis was present in 31% of the patients, and 41% of the patients had more than 1 previous cardiac operation. Paravalvular leak repair was feasible in 79 patients (65%), whereas in 43 patients (35%) prosthesis re-replacement was required. Thirty-day mortality was 10.7% (13/122 patients; 5% for aortic paravalvular leak and 13% for mitral paravalvular leak; P = .1); 2 patients (1.6%) with residual severe mitral paravalvular leak underwent successful redo surgery before discharge. Median length of stay was 7 days. Overall actuarial survival was 39% ± 6% at 12 years; freedom from cardiac death was 54% ± 7% at 12 years. Only 1 patient underwent redo surgery during follow-up. Multivariable analysis identified preoperative chronic renal failure (hazard ratio, 2.6; 95% confidence interval, 1.4-4.9; P = .03) and more than 1 previous cardiac reoperation (hazard ratio, 2.3; 95% confidence interval, 1.3-4; P = .03) as independent predictors of death at follow-up. Conclusions The operative mortality of surgical treatment of paravalvular leak is still high. Long-term outcomes remain suboptimal in these challenging patients, especially in the presence of multiple previous cardiac operations and associated co-pathologies. These results support the importance of alternative therapeutic options.
The aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)-in-TAVR using multidetector computed tomography.
Expanding TAVR to patients with longer ...life expectancy may involve more frequent bioprosthetic valve failure and need for redo TAVR. Coronary access after TAVR-in-TAVR may be challenging, particularly as the leaflets from the initial transcatheter heart valve (THV) will form a neo-skirt following TAVR-in-TAVR.
In 45 patients treated with different combinations of CoreValve and Evolut (CV/EV) THVs with supra-annular leaflet position and SAPIEN THVs with intra-annular leaflet position, post-TAVR-in-TAVR multidetector computed tomographic scans were analyzed to examine coronary accessibility.
After TAVR-in-TAVR, the coronary arteries originated below the top of the neo-skirt in 90% of CV/EV-first cases compared with 67% of SAPIEN-first cases (p = 0.009). For these coronary arteries originating below the top of the neo-skirt, the distance between the THV and the aortic wall was <3 mm in 56% and 25% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.035). Coronary access may be further complicated by THV-THV stent frame strut misalignment in 53% of CV/EV-in-CV/EV cases. The risk for technically impossible coronary access was 27% and 10% in CV/EV-first and SAPIEN-first cases, respectively (p = 0.121). Absence of THV interference with coronary accessibility can be expected in 8% and 33% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.005).
Coronary access after TAVR-in-TAVR may be challenging in a significant proportion of patients. THVs with intra-annular leaflet position or low commissural height and large open cells may be preferable in terms of coronary access after TAVR-in-TAVR.
Objective To assess the very long-term clinical and echocardiographic results of the edge-to-edge repair for mitral regurgitation (MR) due to isolated prolapse or flail of the anterior leaflet. ...Methods From 1991 to 2004, 139 patients (age, 54 ± 14.4 years; left ventricular ejection fraction 56% ± 7.8%, New York Heart Association class I-II in 68.9%, atrial fibrillation in 20.1%) with severe degenerative MR due to isolated segmental prolapse or flail of the anterior leaflet were treated with the EE technique combined with annuloplasty. MR had resulted from prolapse or flail of the central scallop of the anterior leaflet (A2) in 105 patients (75.5%) and scallops A1 or A3 in 34 (24.4%). Results No hospital deaths occurred. At hospital discharge, MR was absent or mild in 130 patients (93.5%) and moderate (2+/4+) in 9 (6.4%). The clinical and echocardiographic follow-up data were 97.1% complete (mean length, 11.5 ± 3.73 years; median, 11; longest duration, 21.5). At 17 years, the actuarial survival was 72.4% ± 7.89%, freedom from cardiac death was 90.8% ± 4.77%, and freedom from reoperation was 89.6% ± 2.74%. At the last echocardiographic examination, recurrence of MR grade ≥3+ was documented in 17 patients (17 of 135, 12.5%). Freedom from MR grade ≥3+ at 17 years was 80.2% ± 5.86%. At multivariate analysis, the predictors of MR recurrence grade ≥3+ were residual MR greater than mild at hospital discharge (hazard ratio, 7.4; 95% confidence interval, 2.5-21.2; P = .0001) and the use of posterior pericardial rather than prosthetic ring annuloplasty, which was very close to statistical significance (hazard ratio, 2.8; 95% confidence interval, 0.9-8.7; P = .06). Conclusions In patients with MR due to segmental anterior leaflet prolapse, the very long-term results of the edge-to-edge repair combined with annuloplasty were excellent.
COAPT-trial entry criteria are useful to identify patients with better outcomes after transcatheter edge-to-edge repair (TEER). However, up to one-half of real-world patients with secondary mitral ...regurgitation (SMR) undergoing TEER do not meet these highly selective criteria and no study has formally investigated them. The aim of this study was to evaluate the predictors of good outcome after TEER in COAPT-ineligible patients.
All consecutive patients with SMR and heart failure (HF) treated with MitraClip at 3 European centres were retrospectively screened. The presence of at least 1 COAPT exclusion criterion was used to define a COAPT-ineligible profile, allowing the inclusion in the study population. Freedom from all-cause death or HF hospitalisation was evaluated at 2-year follow-up (primary end point).
A total of 305 patients (47%) had a COAPT-ineligible profile. An overall 58% rate of all-cause death or HF hospitalisation was detected at 2 years. Patients with a single COAPT exclusion criterion experienced fewer adverse events than those with multiple criteria (55% vs 69%). At multivariable Cox regression analysis, New York Heart Association functional class II, younger age (< 75 years), lower serum creatinine (< 2 mg/dL), lower left ventricular end-diastolic volume (< 240 mL), and the absence of hemodynamic instability, atrial fibrillation, and chronic obstructive pulmonary disease were independently associated with good outcome.
In this real-world series of patients with SMR undergoing TEER, a COAPT-ineligible profile was common. The presence of only 1 COAPT exclusion criterion or the absence of hemodynamic instability were associated with the most favourable outcomes.
Les critères d’admission à l’étude COAPT (CardiovascularOutcomesAssessment of the MitraClipPercutaneousTherapy for Heart Failure Patients With Functional Mitral Regurgitation) sont utiles pour identifier les patients susceptibles d’obtenir de meilleurs résultats après une réparation mitrale percutanée bord à bord (RMPBB). Cependant, en contexte réel, jusqu’à la moitié des patients atteints d'insuffisance mitrale secondaire (IMS) qui subissent une RMPBB ne répondent pas à ces critères hautement sélectifs et aucune étude formelle ne les a formellement étudiés. La présente étude visait à évaluer les prédicteurs d’une issue favorable à la suite d’une RMPBB chez les patients non admissibles selon les critères de l’étude COAPT.
Tous les patients consécutifs atteints d'IMS et d’insuffisance cardiaque (IC) traités au moyen d’un dispositif MitraClip dans trois centres européens ont été choisis de façon rétrospective. La présence d’au moins un critère d’exclusion de l’étude COAPT a été utilisée pour définir un profil non admissible selon les critères COAPT, et admettre les patients dans la population de la présente étude. L’absence de décès toutes causes confondues et d’hospitalisation pour IC a été évaluée après un suivi de deux ans (critère d’évaluation principal).
Au total, 305 patients (47 %) présentaient un profil non admissible selon les critères COAPT. Un taux global de 58 % de décès toutes causes confondues ou d’hospitalisation pour IC a été observé après un suivi de deux ans. Chez les patients présentant un seul critère d’exclusion de l’étude COAPT, la fréquence de manifestations indésirables a été plus faible que chez les patients présentant plus d’un critère d’exclusion (55 % vs 69 %). Dans une analyse de régression de Cox multivariée, la classe II de la classification de la NYHA, un âge moins avancé (< 75 ans), un taux sérique de créatinine faible (< 2 mg/dl), un volume télédiastolique faible dans le ventricule gauche (< 240 ml), et l’absence d’instabilité hémodynamique, de fibrillation auriculaire et de maladie pulmonaire obstructive chronique ont été des variables associées de façon indépendante à une issue favorable.
Chez cette série de patients traités en contexte réel qui étaient atteints d'IMS et qui ont été soumis à une RMPBB, un profil non admissible selon les critères de l’étude COAPT était une ca- ractéristique courante. La présence d’un seul critère d’exclusion de l’étude COAPT ou l’absence d’instabilité hémodynamique ont été associées aux issues les plus favorables.
Background Mitral regurgitation (MR) is frequent in patients with aortic stenosis (AS). Although primary MR is an established negative prognostic factor, whether different mechanisms of MR have ...different effects on outcome is currently unknown. The aim of this study was to evaluate the impact of the MR mechanism in patients undergoing transcatheter aortic valve replacement (TAVR). Methods and Results This is a retrospective observational study of patients who underwent TAVR for severe aortic stenosis in a high‐volume tertiary care center. Echocardiographic comprehensive MR assessment was performed at baseline and within 3 months post TAVR. The study population was divided into 4 groups according to MR mechanism: Group I: fibro‐calcific leaflet degeneration; Group II: prolapse/flail; Group III: ventricular secondary MR (functional MR); and Group IV: atrial functional MR. The study end point was a combination of death from cardiovascular cause and heart failure–related hospitalization. The study population included 427 patients (mean age 81.7±6.5 years; 71% primary MR; 62% ≥moderate MR). At 3‐year follow‐up, survival free from the composite end point significantly differs according to MR mechanism: it was higher in group IV (atrial functional MR, 96.6%) compared with group I (80.4%, P =0.002) and group II patients (60.7%, P =0.001), and group III (84.8%, P =0.037); patients with MR due to leaflet prolapse showed poorer prognosis compared with patients with functional MR (group III, P =0.023 and group IV, P =0.001) and with group I ( P =0.040). Overall, severe MR after TAVR identified patients with poorer prognosis and was significantly more frequent in group II (46.4%, P =0.001). Conclusions In patients undergoing TAVR, preprocedural identification of MR mechanism and mechanism provides prognostic insights.
Abstract
OBJECTIVES: A single MitraClip implant is often considered enough to achieve adequate mitral regurgitation (MR) reduction. The aim of this study was to compare MR recurrence in patients with ...an initial optimal result treated with a single clip versus those treated with two clips.
METHODS: From October 2008 to May 2016, 322 patients were treated with the MitraClip procedure at our institution. We retrospectively selected all patients treated for functional MR (FMR) and degenerative MR (DMR) aetiologies with residual MR ≤1+, excluding patients who required >2 clips. FMR and DMR were analysed separately.
RESULTS: In FMR, a single clip was used in 45 patients and 2 clips in 99 patients. The single clip group had smaller coaptation depth (1.1 ± 0.3 vs 1.3 ± 0.3 mm, P = 0.022) and jet extension (10.5 ± 2.1 vs 13.0 ± 3.6 mm, P = 0.026) as well as left ventricular end-diastolic diameter (64.4 ± 7.3 vs 69.0 ± 7.9 mm, P = 0.001). Freedom from MR ≥ 3+ after 4 years was 71.9 ± 8.9% in patients receiving a single clip vs 88.0 ± 5.2% in those receiving 2 clips, single clip use being an independent predictor of MR recurrence (HR 3.48, CI 1.24–9.81, P = 0.018). In DMR, a single clip was deployed in 24 patients and 2 clips in 30 patients. The single clip group had a smaller flail gap (3.6 ± 0.7 vs 6.8 ± 2.5, P = 0.002). Freedom from MR ≥ 3+ after 2 years was 82.5 ± 8% in patients with a single clip vs 100% in those with 2 clips, P = 0.014. The residual mitral area was reduced in patients with 2 clips compared with those with single clip, both in FMR (P = 0.015) and DMR (P = 0.039), but it was not associated with increased death rate during the follow-up period (all P > 0.05).
CONCLUSIONS: Despite favourable anatomical characteristics and an optimal initial result, implantation of a single clip was associated with an increased recurrence of MR compared with that of 2 clips, both in FMR and in DMR. Caution should be exercised with the implantation of a single clip.
Background This was a study to compare the results of mitral valve (MV) repair and MV replacement for the treatment of functional mitral regurgitation (MR) in advanced dilated and ischemic ...cardiomyopathy (DCM). Methods One-hundred and thirty-two patients with severe functional MR and systolic dysfunction (mean ejection fraction 0.32 ± 0.078) underwent mitral surgery in the same time frame. The decision to replace rather than repair the MV was taken when 1 or more echocardiographic predictors of repair failure were identified at the preoperative echocardiogram. Eighty-five patients (64.4%) received MV repair and 47 patients (35.6%) received MV replacement. Preoperative characteristics were comparable between the 2 groups. Only ejection fraction was significantly lower in the MV repair group (0.308 ± 0.077 vs 0.336 ± 0.076, p = 0.04). Results Hospital mortality was 2.3% for MV repair and 12.5% for MV replacement ( p = 0.03). Actuarial survival at 2.5 years was 92 ± 3.2% for MV repair and 73 ± 7.9% for MV replacement ( p = 0.02). At a mean follow-up of 2.3 years (median, 1.6 years), in the MV repair group LVEF significantly increased (from 0.308 ± 0.077 to 0.382 ± 0.095, p < 0.0001) and LV dimensions significantly decreased ( p = 0.0001). On the other hand, in the MV replacement group LVEF did not significantly change (from 0.336 ± 0.076 to 0.31 ± 0.11, p = 0.56) and the reduction of LV dimensions was not significant. Mitral valve replacement was identified as the only predictor of hospital (odds ratio, 6; 95% confidence interval, 1.1 to 31; p = 0.03) and overall mortality (hazard ratio, 3.1; 95% confidence interval, 1.1 to 8.9; p = 0.02). Conclusions In patients with advanced dilated and ischemic cardiomyopathy and severe functional MR, MV replacement is associated with higher in-hospital and late mortality compared with MV repair. Therefore, mitral repair should be preferred whenever possible in this clinical setting.
Octogenarians affected by mitral regurgitation (MR) are an increasing high-risk population. MitraClip repair is emerging as a promising option for this kind of patients. In this retrospective study, ...the outcomes of patients aged ≥80 years, affected by isolated degenerative MR, who underwent isolated transcatheter (n = 25) or surgical (n = 35, 29 repairs and 6 replacements) mitral intervention from September 2008 to February 2014 were compared. MitraClip patients had higher mean age (84.5 ± 3.2 vs 81.9 ± 2.0 years, p <0.01), median Logistic Euroscore 19.4 (11.1 to 29.0) versus 8.4 (7.0 to 10.1) (p <0.01), median Society of Thoracic Surgeons predicted mortality 5.3 (3.5 to 6.6) versus 2.7 (2.3 to 3.9) (p <0.01), and more advanced New York Heart Association class (III to IV in 68% vs 37%, p = 0.02). At 30 days, 1 death occurred in the MitraClip group (p = 0.2). MitraClip was associated with significantly less complications (p <0.05) but more residual MR >2 (p <0.01). Two-year actuarial survival rate was 90% for MitraClip versus 97% for surgery (p <0.01). Higher Society of Thoracic Surgeons mortality was associated with reduced follow-up survival rate (p = 0.01). Two-year actuarial freedom from MR >2 was 70% versus 100%, respectively (p <0.01). New York Heart Association class and quality of life improved after MitraClip and were similar to surgical patients. Recurrent MR >2 was not significantly associated with follow-up mortality in this elderly setting. After the introduction of MitraClip, octogenarian patients with isolated degenerative MR receiving mitral treatment significantly increased (p <0.01). In conclusion, MitraClip patients, despite being older, more symptomatic, and affected by more co-morbidities showed significantly reduced postoperative complications. Two-year mortality was higher in the MitraClip group likely because of co-morbidities. Transcatheter mitral repair resulted in more octogenarians being treated compared with the past.
PDF
