Association of Transcatheter Mitral Valve Repair Availability With Outcomes of Mitral Valve Surgery.
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SUBMITTER: Alkhouli M
PROVIDER: S-EPMC8174333 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Importance:Pulmonary hypertension (pHTN) is associated with increased risk of mortality after mitral valve surgery for mitral regurgitation. However, its association with clinical outcomes in patients undergoing transcatheter mitral valve repair (TMVr) with a commercially available system (MitraClip) is unknown. Objective:To assess the association of pHTN with readmissions for heart failure and 1-year all-cause mortality after TMVr. Design, Setting, and Participants:This retrospective cohort study analyzed 4071 patients who underwent TMVr with the MitraClip system from November 4, 2013, through March 31, 2017, across 232 US sites in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry. Patients were stratified into the following 4 groups based on invasive mean pulmonary arterial pressure (mPAP): 1103 with no pHTN (mPAP, <25 mm Hg [group 1]); 1399 with mild pHTN (mPAP, 25-34 mm Hg [group 2]); 1011 with moderate pHTN (mPAP, 35-44 mm Hg [group 3]); and 558 with severe pHTN (mPAP, ?45 mm Hg [group 4]). Data were analyzed from November 4, 2013, through March 31, 2017. Interventions:Patients were stratified into groups before TMVr, and clinical outcomes were assessed at 1 year after intervention. Main Outcomes and Measures:Primary end point was a composite of 1-year mortality and readmissions for heart failure. Secondary end points were 30-day and 1-year mortality and readmissions for heart failure. Linkage to Centers for Medicare & Medicaid Services administrative claims was performed to assess 1-year outcomes in 2381 patients. Results:Among the 4071 patients included in the analysis, the median age was 81 years (interquartile range, 73-86 years); 1885 (46.3%) were women and 2186 (53.7%) were men. The composite rate of 1-year mortality and readmissions for heart failure was 33.6% (95% CI, 31.6%-35.7%), which was higher in those with pHTN (27.8% [95% CI, 24.2%-31.5%] in group 1, 32.4% [95% CI, 29.0%-35.8%] in group 2, 36.0% [95% CI, 31.8%-40.2%] in group 3, and 45.2% [95% CI, 39.1%-51.0%] in group 4; P?<?.001). Similarly, 1-year mortality (16.3% [95% CI, 13.4%-19.5%] in group 1, 19.8% [95% CI, 17.0%-22.8%] in group 2, 22.4% [95% CI, 18.8%-26.1%] in group 3, and 27.8% [95% CI, 22.6%-33.3%] in group 4; P?<?.001) increased across pHTN groups. The association of pHTN with mortality persisted despite multivariable adjustment (hazard ratio per 5-mm Hg mPAP increase, 1.05; 95% CI, 1.01-1.09; P?=?.02). Conclusions and Relevance:These findings suggest that pHTN is associated with increased mortality and readmission for heart failure in patients undergoing TMVr using the MitraClip system for severe mitral regurgitation. Further efforts are needed to determine whether earlier intervention before pHTN develops will improve clinical outcomes.
| S-EPMC6902209 | biostudies-literature
Project description:ObjectiveMitral valve operations for failed transcatheter edge-to-edge repair (TEER) are increasing. This study investigated the indications, surgical procedures, and outcomes after surgery for failed TEER.MethodsWe analyzed records of patients who underwent mitral valve operations after TEER between January 2013 and September 2021. Patient characteristics, clip number and location, indications, timing, surgery type, and outcomes were evaluated.ResultsA total of 41 patients (median age, 77 years; 14 women; median Society of Thoracic Surgeons predicted risk of mortality score, 9.4% [5.6%-12.6%]; and previous cardiac surgery in 21 patients) underwent mitral valve surgery at a median of 8 months (range, 4-16 months) after TEER. One clip was implanted in 24 patients and 2 or more in 17 patients. Indications for surgery were severe mitral regurgitation in 33, severe mitral stenosis in 1 patient, and both in 7 patients. Operations were performed via sternotomy in 37 patients and lateral thoracotomy in 4 patients. The mitral valve was replaced in all patients (bioprosthesis in 35 patients and a mechanical valve in 6 patients). Concomitant procedures were performed in 30 patients. Operative mortality was 5% (observed to expected ratio, 0.53) and did not differ for primary procedures versus reoperations. Echocardiographic follow-up demonstrated no or trivial mitral regurgitation in 34 patients, mild mitral regurgitation in 5 patients, and moderate perivalvular mitral regurgitation in 1 patient with severe mitral annular calcification. At a median follow-up of 1.5 years (interquartile range, 4.7 months-2.7 years), the actuarial survival was 79%.ConclusionsMitral valve replacement can be performed safely after failed TEER with operative mortality lower than expected even in high-risk patients.Video abstract
| S-EPMC9366625 | biostudies-literature
Project description:ObjectivesAlthough clinical experience with transcatheter mitral valve interventions is rapidly increasing, there is still a lack of evidence regarding surgical treatment options for the management of recurrent mitral regurgitation (MR). This study provides guidance for a minimally invasive surgical approach following failed transcatheter mitral valve repair, which is based on the underlying mitral valve (MV) pathology and the type of intervention.MethodsA total of 46 patients who underwent minimally invasive MV surgery due to recurrent or residual MR after transcatheter edge-to-edge repair or direct interventional annuloplasty between October 2014 and March 2021 were included.ResultsThe median age of the patients was 78 [interquartile range, 71-82] years and the EuroSCORE II was 4.41 [interquartile range, 2.66-6.55]. At the index procedure, edge-to-edge repair had been performed in 45 (97.8%) patients and direct annuloplasty in 1 patient. All patients with functional MR at the index procedure (n = 36) underwent MV replacement. Of the patients with degenerative MR (n = 10), 5 patients were eligible for MV repair after removal of the MitraClip. The 1-year survival following surgical treatment was 81.3% and 75.0% in patients with functional and degenerative MR, respectively. No residual MR greater than mild during follow-up was observed in patients who underwent MV repair.ConclusionsMinimally invasive surgery following failed transcatheter mitral valve repair is feasible and safe, with promising midterm survival. The surgical management should be tailored to the underlying valve pathology at the index procedure, the extent of damage of the MV leaflets and the type of previous intervention.
| S-EPMC9270869 | biostudies-literature
Project description:This review outlines the first trial experience with transcatheter therapy for mitral regurgitation (MR), developed from the EVEREST II MitraClip trial in a trial population comprised predominantly of patients with degenerative mitral regurgitation (DMR). Subsequent experience with MitraClip and several other devices has been mostly in functional MR patients. At the same time, there has been ongoing experience with MitraClip in DMR, and a variety of other devices have been developed for catheter-based treatment of MR. Annuloplasty devices have been indicated for DMR, and the potential for transcatheter annuloplasty to be used, in conjunction with other catheter techniques, such as chordal replacement, as it is in standard mitral repair, is developing. Transcatheter mitral valve replacement will clearly have some role for MR of both functional and degenerative etiologies, when repair is not feasible or fails. This review will discuss the evidence base and future development of these mitral repair and replacement approaches for DMR.
| S-EPMC6288224 | biostudies-other
Project description:ImportanceThe US Centers for Medicare and Medicaid Services recently released an updated national coverage determination proposal for transcatheter aortic valve replacement (TAVR) that maintains a focus on hospital TAVR volume and percutaneous coronary intervention (PCI) volume, and the national coverage determination for transcatheter mitral valve repair (TMVr) also has PCI volume requirements. However, the associations between hospital PCI volume and TAVR and TMVr outcomes are unknown.ObjectiveTo investigate whether hospital inpatient PCI volume is associated with rates of risk-adjusted in-hospital mortality and 30-day hospital readmission after TAVR and TMVr.Design, setting, and participantsThis population-based cross-sectional study of the 2016 Nationwide Readmissions Database included procedures completed in hospitals with a minimum of 5 TAVR or 5 TMVr procedures between January 1, 2016, and November 30, 2016.ExposuresHospitals were divided into quartiles based on annual inpatient PCI volumes.Main outcomes and measuresPrimary outcomes were in-hospital mortality and 30-day readmission rates. The associations between hospital inpatient PCI quartile and outcomes were evaluated using Kruskal-Wallis tests. Risk adjustment for in-hospital mortality rates was done through inclusion of variables based on the Elixhauser comorbidity classification, and risk adjustment for 30-day readmission rates was done in accordance with the Hospital-Wide Readmission Measure methodology used by the Centers for Medicare and Medicaid Services for public reporting.ResultsThere were 283 hospitals that performed at least 5 TAVRs, with a median inpatient PCI volume of 386 (interquartile range, 299-571) procedures, and 125 hospitals that performed at least 5 TMVr procedures, with a median inpatient PCI volume of 451 (interquartile range, 326-651) procedures. There was no association between hospital inpatient PCI volume and median TAVR risk-standardized in-hospital mortality (median [IQR] rates: bottom quartile, 1.82% [1.77%-1.90%]; second quartile, 1.81% [1.76%-1.86%]; third quartile, 1.81% [1.75%-1.90%]; top quartile, 1.82% [1.76%-1.91%]; P = .75) or the 30-day readmission (median [IQR] rates: bottom quartile, 13.6% [13.2%-14.3%]; second quartile, 13.3% [12.7%-14.0%]; third quartile, 13.5% [12.7%-14.3%]; top quartile, 13.8% [12.8%-14.3%]; P = .10) rates. Similarly, there was no association between hospital inpatient PCI volume and median TMVr risk-standardized in-hospital mortality rates (median [IQR] rates: bottom quartile, 1.84% [1.47%-2.53%]; second quartile, 1.65% [1.21%-3.02%]; third quartile, 1.80% [1.52%-3.58%]; top quartile, 1.76% [1.33%-4.20%]; P = .71) or 30-day readmission rates (median [IQR] rates: bottom quartile, 13.4% [13.1%-13.6%]; second quartile, 13.1% [12.9%-13.5%]; third quartile, 13.1% [12.9%-13.5%]; top quartile, 13.3% [12.8%-13.6%]; P = .30).Conclusions and relevanceIn this study, there was no association between inpatient PCI volume and TAVR or TMVr outcomes. Further evidence is needed to support inclusion of PCI volume minimums in national coverage determination requirements for hospital TAVR and TMVr programs.
| S-EPMC7042824 | biostudies-literature
Project description:BACKGROUND:Renal disease is associated with poor prognosis despite guideline-directed cardiovascular therapy, and outcomes by sex in this population remain uncertain. METHODS AND RESULTS:Patients (n=5213) who underwent a MitraClip procedure in the National Cardiovascular Data Registry Transcatheter Valve Therapy registry were evaluated for the primary composite outcome of all-cause mortality, stroke, and new requirement for dialysis by creatinine clearance (CrCl). Centers for Medicare and Medicaid Services-linked data were available in 63% of patients (n=3300). CrCl was <60 mL/min in 77% (n=4010) and <30 mL/min in 23% (n=1183) of the cohort. Rates of primary outcome were higher with lower CrCl (>60 mL/min, 1.4%; 30-<60 mL/min, 2.7%; <30 mL/min, 5.2%; dialysis, 7.8%; P<0.001), and all low CrCl groups were independently associated with the primary outcome (30-<60 mL/min: adjusted odds ratio, 2.32; 95% CI, 1.38-3.91; <30 mL/min: adjusted odds ratio, 4.44; 95% CI, 2.63-7.49; dialysis: adjusted hazards ratio, 4.52; 95% CI, 2.08-9.82) when compared with CrCl >60 mL/min. Rates of 1-year mortality were higher with lower CrCl (>60 mL/min, 13.2%; 30-<60 mL/min, 18.8%; <30 mL/min, 29.9%; dialysis, 32.3%; P<0.001), and all low CrCl groups were independently associated with 1-year mortality (30-<60 mL/min: adjusted hazards ratio, 1.50; 95% CI, 1.13-1.99; <30 mL/min: adjusted hazards ratio, 2.38; 95% CI, 1.78-3.20; adjusted hazards ratio: dialysis, 2.44; 95% CI, 1.66-3.57) when compared with CrCl >60 mL/min. CONCLUSIONS:The majority of patients who undergo MitraClip have renal disease. Preprocedural renal disease is associated with poor outcomes, particularly in stage 4 or 5 renal disease where 1-year mortality is observed in nearly one-third. Studies to determine how to further optimize outcomes in this population are warranted.
| S-EPMC6839891 | biostudies-literature
Project description:BACKGROUND:Mitral regurgitation is a heterogeneous disease. Determining which patients derive optimal outcomes from transcatheter edge-to-edge mitral valve repair (TMVR) remains challenging. We sought to determine whether baseline mitral valve anatomic characteristics are predictive of left atrial pressure (LAP) changes during TMVR with MitraClip. METHODS AND RESULTS:Consecutive patients with severe mitral regurgitation undergoing TMVR (n=112) underwent continuous intraprocedural LAP monitoring and retrospective echocardiographic analysis for specific mitral anatomic characteristics. Procedural success (optimal LAP reduction) was defined as ?40% reduction in left atrial V-wave pressure compared with baseline. Echocardiographic predictors of optimal LAP reduction and increased postprocedure mean diastolic gradient were evaluated. Mean age was 79±14 years, and 36 patients (32%) were women. Primary, mixed, and secondary mitral regurgitation were present in 78 patients (70%), 22 patients (20%), and 12 patients (10%), respectively. Baseline mean LAP and V-wave were 22±6 and 38±13 mm Hg; after TMVR, these decreased to 19±5 and 27±10 mm Hg, respectively (P<0.0001 for both). Independent predictors of optimal LAP reduction were the presence of a flail scallop, mitral regurgitation localized to a single scallop, and high-quality 3-dimensional echocardiographic imaging. Independent predictors of elevated postprocedure mean diastolic gradient were elevated preprocedure mean diastolic gradient, mitral annular calcification, and implantation of multiple clips. CONCLUSIONS:Mitral valve pathoanatomic features, including a flail leaflet and single jet, are predictive of optimal LAP reduction with TMVR. High-quality 3-dimensional imaging may help select patients with the highest likelihood of optimal hemodynamic results with TMVR. These data expand current knowledge about patient selection for TMVR and deserve further study in larger cohorts.
| S-EPMC5850157 | biostudies-literature
Project description:BackgroundTranscatheter mitral valve repair and replacement (TMVR) is a minimally invasive alternative to conventional open-heart mitral valve replacement (OMVR). The present study aims to compare the burden, demographics, cost, and complications of TMVR and OMVR.MethodsThe United States National Inpatient Sample (US-NIS) for the year 2017 was queried to identify all cases of TMVR and OMVR. Categorical and continuous data were analyzed using Pearson chi-square and independent t-test analysis, respectively. An adjusted odds ratio (aOR) based on the ordinal logistic regression (OLR) model was calculated to determine the association between outcome variables.ResultsOf 19,580 patients, 18,460 (94%) underwent OMVR and 1120 (6%) TMVR. Mean ages of patients were 63 ± 14 years (OMVR) and 67 ± 13 years (TMVR). Both cohorts were predominantly Caucasian (73% OMVR vs. 74.0% TMVR). The patients who underwent TMVR were more likely to belong to a household with an income in the highest quartile (26.1% vs. 22.0% for OMVR) versus the lowest quartile (22.1% vs. 27.8%). The average number of days from admission to TMVR was less compared to OMVR (2.63 days vs. 3.02 days, p = 0.015). In-hospital length of stay (LOS) was significantly lower for TMVR compared to OMVR (11.56 vs. 14.01 days, p=<0.0001). Adjusted in-hospital mortality taking into account comorbidities showed no significant difference between the two groups (OR 1.2, 0.93-1.68, p = 0.15).ConclusionPatients undergoing TMVR were older and more financially affluent. TMVR was more costly but was associated with a shorter hospital stay and similar mortality to OMVR.
| S-EPMC7262433 | biostudies-literature
Project description:ImportanceImprovements in symptoms, functional capacity, and quality of life are among the key goals of edge-to-edge transcatheter mitral valve repair (TMVR) for mitral regurgitation.ObjectiveTo examine health status outcomes among patients undergoing TMVR in clinical practice and the factors associated with improvement.Design, setting, and participantsThis cohort study used the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, which contains data on patients with severe mitral regurgitation treated with TMVR from 2013 through 2017 in 217 US hospitals.Main outcomes and measuresChange in disease-specific health status (Kansas City Cardiomyopathy Questionnaire-Overall Summary score [KCCQ-OS]; range 0-100 points, with higher scores indicating better health status) at 30 days and 1 year after TMVR. We also examined factors associated with health status at 30 days after TMVR, by means of multivariable linear regression using a generalized estimating equations approach to account for clustering of patients within sites.ResultsThe KCCQ data were available in 81.2% at baseline, 69.3% of survivors at 30 days, and 47.4% of survivors at 1 year. Among 4226 patients who underwent TMVR, survived 30 days, and completed the KCCQ at baseline and follow-up, the KCCQ-OS increased from 41.9 before TMVR to 66.7 at 30 days (mean change 24.8 [95% CI, 24.0-25.6] points; P < .001), representing a large clinical improvement. The KCCQ scores remained stable from 30 days to 1 year after TMVR, with no further significant increase or decline. On multivariable analysis, atrial fibrillation (-2.2 [95% CI, -3.7 to -0.6] points; P = .01), permanent pacemaker (-2.1 [95% CI, -3.7 to -0.4] points; P = .01), severe lung disease (-3.9 [95% CI, -6.2 to -1.5] points; P = .001), home oxygen (-2.7 [95% CI, -4.9 to -0.4] points; P = .02), and lower KCCQ scores at baseline (3.9 points for each 10-point increase [95% CI, 3.6-4.2]; P < .001) were independently associated with lower 30-day KCCQ-OS scores. In-hospital renal failure was uncommon but was also associated with significant reductions in 30-day KCCQ-OS scores (-7.3 [95% CI -13.3 to -1.2] points). In estimates calculated with inverse probability weighting, after 1 year after TMVR, 54.2% (95% CI 52.2%-56.1%) of patients were alive and well; 23.0% had died, 21.9% had persistently poor health status (KCCQ-OS <60 points), 5.5% had a health status decline from baseline, and 4.6% had both poor health status and health status decline.Conclusions and relevanceIn a national cohort of US patients undergoing edge-to-edge TMVR in clinical practice, health status was impaired prior to the procedure, improved within 30 days, and remained stable through 1 year among surviving patients with available data. While long-term mortality remains high, most surviving patients demonstrate improvements in symptoms, functional status, and quality of life, with only modest differences by patient-level factors.
| S-EPMC6583100 | biostudies-literature
Project description:BackgroundLimited data exist regarding the association between the quality of life (QoL) and clinical outcomes following transcatheter mitral valve repair (TMVr). We aimed to evaluate the prognostic significance of QoL assessment following TMVr and to characterize those who had procedural success, yet reported a low Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score.MethodsWe reported the experience of Cedars-Sinai Medical Center patients between 2013 and 2020. Patients were allocated into four groups according to the 30-day KCCQ: <25, 25-49, 50-74, and ≥75. Primary outcome included 1-year all-cause death or heart failure (HF) hospitalizations. We also examined the association between QoL and the primary outcome in those with procedural success.ResultsA total of 555 patients were included in our analysis, median follow-up of 650 days (IQR 243-1113). The lower KCCQ groups had a higher prevalence of functional mitral regurgitation (65%, 60%, 56%, and 43%, p = 0.001), as well as a higher Society of Thoracic Surgeon (STS) score. These groups had a significantly higher occurrence of 1-year all-cause death or HF hospitalizations in a stepwise fashion (40%, 22%, 16%, and 10%, p < 0.001). Multivariable Cox regression analysis revealed 30-day KCCQ as the strongest predictor of the 1-year primary outcome (HR 0.98, 95%CI (0.97-0.99), p = 0.006). Approximately a quarter of patients with procedural success had a low KCCQ score. These patients had a higher rate of the combined 1-year outcome regardless of procedural success or failure.ConclusionQoL following TMVr is a powerful prognostic factor. KCCQ assessment is an important indicator for identifying patients prone to adverse outcomes even after procedural success.
| S-EPMC10010880 | biostudies-literature