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Use of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve Repair.

ABSTRACT: BACKGROUND:Clinical event committees are commonly employed for event validation in clinical studies, but little is known about the comparative performance of administrative claims data versus clinician-triggered event adjudication for ascertainment of adverse events in structural heart disease studies. METHODS AND RESULTS:Medicare claims were linked to 418 patients >65 years of age who underwent transcatheter mitral valve repair (MitraClip) for severe mitral regurgitation from 2007 to 2013 as part of the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study II) High-Risk Registry or the REALISM (Real World Expanded Multicenter Study of the MitraClip System) Continued-Access Registry. Each registry adjudicated mortality, heart failure hospitalization, renal failure, ventilation, and bleeding/transfusion within 1 year. Concordance of claims-based outcomes with events was assessed in 3 ways: 1-year occurrence, cumulative incidence, and synchrony of first events. For event occurrence, positive predictive value (PPV) of claims versus adjudication was the highest for mortality (PPV=97%) and heart failure hospitalization (PPV=69%) but lower for bleeding (PPV=40%) and renal failure (PPV=19%). Whereas claims-based cumulative incidence for mortality, heart failure hospitalization, and renal failure were consistent with clinician-triggered adjudication, incidence curves for bleeding events and ventilation diverged, with claims identifying a greater number of events. When events were detected by both methods, however, over 75% of event dates matched exactly. Mitral valve reinterventions were identified through claims with perfect sensitivity and specificity relative to physician adjudication. CONCLUSIONS:Ascertainment of mortality, heart failure hospitalization, and renal failure was highly concordant between physician adjudication and administrative claims. Further work is necessary to determine the role of administrative claims in event ascertainment in both prospective and retrospective studies of structural heart disease.

SUBMITTER: Lowenstern A

PROVIDER: S-EPMC6760250 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Use of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve Repair.

Lowenstern Angela A Lippmann Steven J SJ Brennan J Matthew JM Wang Tracy Y TY Curtis Lesley H LH Feldman Ted T Glower Donald D DD Hammill Bradley G BG Vemulapalli Sreekanth S

Circulation. Cardiovascular interventions 20190501 5

<h4>Background</h4>Clinical event committees are commonly employed for event validation in clinical studies, but little is known about the comparative performance of administrative claims data versus clinician-triggered event adjudication for ascertainment of adverse events in structural heart disease studies.<h4>Methods and results</h4>Medicare claims were linked to 418 patients >65 years of age who underwent transcatheter mitral valve repair (MitraClip) for severe mitral regurgitation from 200 ...[more]

PMID: 31084236

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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:IntroductionMitral valve repair has been established as the preferred treatment option in the management of degenerative mitral valve disease. Compared with other surgical treatment options, mitral valve repair is associated with increased survival and decreased rates of both complications and reoperations. However, among patients undergoing mitral valve repair, little is known about the predictors of postoperative outcomes. The purpose of this study is to identify preoperative patient risk factors associated with postoperative morbidity and mortality within 30 days of mitral valve repair.MethodsData was derived from the American College of Surgeons National Surgical Quality Improvement Program database to assess patients who underwent mitral valve repair from 2011 through 2017. Preoperative risk factors were analyzed to determine their association with a variety of postoperative 30-day outcome measures.ResultsOne thousand three hundred and sixty-six patients underwent mitral valve repair; 849 (62.2%) males and 517 (37.8%) females. Ages ranged from 18 to 90 years, with a mean age of 64 years. The overall 30-day mortality was 3.1% (43 patients). Among the 12 identified risk factors associated with increased mortality on univariate analysis, pre-operative hematocrit level was the only variable significantly correlated with mortality after undergoing multivariate analysis. 259 patients (19.1%) were discharged to a location other than home, an outcome associated with 22 identified risk factors. Among these risk factors, female gender, age, dialysis, pre-operative serum sodium, pre-operative serum albumin, and partial or full living dependency remained statistically significant following multivariate analysis. 126 patients (9.2%) experienced unplanned readmission. This outcome was associated with five risk factors, of which only dyspnea upon mild exertion was significant on multivariate analysis. Reoperation occurred in 105 patients (7.7%). Of the seven identified variables associated with reoperation, patient age, pre-operative platelet count, dyspnea upon mild exertion were independent predictors on multivariate analysis. 53 patients (3.9%) underwent reintubation, which was associated with 11 identified risk factors. Among them, patient age and pre-operative INR value were predictive of reintubation on multivariate analysis. 26 patients (1.9%) experienced stroke, of whom age was the only associated risk factor on both univariate and multivariate analysis. 31 patients (2.3%) experienced acute renal failure, which correlated with 11 risk factors on univariate analysis. Of these, only patient age and pre-operative hematocrit were identified as independent predictors on multivariate analysis.ConclusionsOutcomes are good following mitral valve repair. Although a substantial number of risk factors were found to be associated with adverse outcomes, only a small subset remained statistically significant following multivariate analysis. Identification of these risk factors may help guide clinical decision making with respect to which patients are the best candidates to undergo mitral valve repair.

Project description:ObjectiveIntraoperative predictors of functional mitral valve (MV) stenosis after surgical repair of mitral regurgitation (MR) caused by prolapse remain poorly characterised. This study evaluated the effect of annuloplasty size on postoperative MV haemodynamics during exercise and evaluated predictors of MV hemodynamics.Methods104 patients were randomly assigned to leaflet resection or preservation for surgical repair of MR in the Canadian Mitral Research Alliance CardioLink-2 study. In this post hoc analysis, we compared MV haemodynamics between the two surgical groups and examined the relationship between annuloplasty size and MV haemodynamics 1 year after repair in the combined groups. Echocardiograms were performed at baseline and intraoperatively. Exercise transthoracic echocardiography was performed 1 year postoperatively. Multivariable linear regression analysis was used to identify predictors of exercise MV gradients at follow-up.ResultsMean age of participants was 65±10 years, and 83% were male. Median annuloplasty size was 34 (IQR 32-36). Dividing by the median, 48 (46%) had annuloplasty size of <34 mm and 56 (54%) had ≥34 mm. Mean and peak exercise gradients at 1 year were 11±5 mm Hg and 22±9 mm Hg in <34, and 6±3 mm Hg and 14±5 mm Hg in ≥34 (p<0.001). Rate of residual MR was similar in both groups. In multivariable analyses, annuloplasty size of ≥34 mm was associated with lower mean and peak exercise gradients at 12 months, after adjustment for repair type, age, sex, heart rate and body surface area (β -4.1, 95% CI -6 to -3, p<0.001, and β -7 95% CI -10 to -4, p<0.001, respectively). Intraoperative mean and peak MV gradients by transesophageal echocardiography independently predicted mean and peak resting and exercise gradients at follow-up (p<0.001). Similar results were obtained in both leaflet resection and preservation.ConclusionAnnuloplasty size of ≥34 mm is associated with a 4 and 7 mm Hg reduction in mean and peak exercise MV gradients, respectively, 1 year post MV repair regardless of the repair strategy used. Intraoperative TEE MV gradients predict exercise MV gradients 1 year post repair.Trial registration numberNCT02552771.

Dataset Information

Use of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve Repair.

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Use of Medicare Claims to Identify Adverse Clinical Outcomes After Mitral Valve Repair.

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