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Outcomes After Transcatheter Mitral Valve Repair in Patients With Renal Disease.

ABSTRACT: 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.

SUBMITTER: Shah B

PROVIDER: S-EPMC6839891 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Outcomes After Transcatheter Mitral Valve Repair in Patients With Renal Disease.

Shah Binita B Villablanca Pedro A PA Vemulapalli Sreekanth S Manandhar Pratik P Amoroso Nicholas S NS Saric Muhamed M Staniloae Cezar C Williams Mathew R MR

Circulation. Cardiovascular interventions 20190201 2

<h4>Background</h4>Renal disease is associated with poor prognosis despite guideline-directed cardiovascular therapy, and outcomes by sex in this population remain uncertain.<h4>Methods and results</h4>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 Medi ...[more]

PMID: 30704286

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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.

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.

Dataset Information

Outcomes After Transcatheter Mitral Valve Repair in Patients With Renal Disease.

Publications

Outcomes After Transcatheter Mitral Valve Repair in Patients With Renal Disease.

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