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Avoiding the Learning Curve for Transcatheter Aortic Valve Replacement.

ABSTRACT: Objectives. To evaluate whether collaboration between existing and new transcatheter aortic valve replacement (TAVR) programs could help reduce the number of cases needed to achieve optimal efficiency. Background. There is a well-documented learning curve for achieving procedural efficiency and safety in TAVR procedures. Methods. A multidisciplinary collaboration was established between the Minneapolis VA Medical Center (new program) and the University of Minnesota (established program since 2012, n = 219) 1 year prior to launching the new program. Results. 269 patients treated with TAVR (50 treated in the first year at the new program). Mean age was 76 (±18) years and STS score was 6.8 (±6). Access included transfemoral (n = 35, 70%), transapical (n = 8, 16%), transaortic (n = 2, 4%), and subclavian (n = 5, 10%) types. Procedural efficiency (procedural time 158 ± 59 versus 148 ± 62, p = 0.27), device success (96% versus 87%, p = 0.08), length of stay (5 ± 3 versus 6 ± 7 days, p = 0.10), and safety (in hospital mortality 4% versus 6%, p = 0.75) were similar between programs. We found no difference in outcome measures between the first and last 25 patients treated during the first year of the new program. Conclusions. Establishing a partnership with an established program can help mitigate the learning curve associated with these complex procedures.

SUBMITTER: Gurevich S

PROVIDER: S-EPMC5299191 | biostudies-other | 2017

REPOSITORIES: biostudies-other

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Avoiding the Learning Curve for Transcatheter Aortic Valve Replacement.

Gurevich Sergey S John Ranjit R Kelly Rosemary F RF Raveendran Ganesh G Helmer Gregory G Yannopoulos Demetris D Biring Timinder T Oestreich Brett B Garcia Santiago S

Cardiology research and practice 20170126

Objectives. To evaluate whether collaboration between existing and new transcatheter aortic valve replacement (TAVR) programs could help reduce the number of cases needed to achieve optimal efficiency. Background. There is a well-documented learning curve for achieving procedural efficiency and safety in TAVR procedures. Methods. A multidisciplinary collaboration was established between the Minneapolis VA Medical Center (new program) and the University of Minnesota (establis ...[more]

PMID: 28246571

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Project description:BACKGROUND:Transcatheter aortic valve replacement (TAVR) is a fundamentally new procedure for the treatment of native aortic regurgitation (AR). The number of cases needed to gain proficiency with the procedure is unknown. HYPOTHESIS:This study aimed to evaluate the learning curve for TAVR for native AR. METHODS:This study retrospectively reviewed a prospective database from 134 consecutive native AR patients who underwent the J-valve TAVR system, which performed by a single team interventional cardiologist. The cumulative sum (CUSUM) method was used to analyze the learning curve. Patients were divided into two groups in chronological order, defined by the surgeon's early (group 1: the first 52 cases) and skilled (group 2: the next 82 cases) experience. Demographic data, intraoperative characteristics, and short-term surgical outcomes were compared between the two groups. RESULTS:CUSUM plots revealed decreasing procedure time and fluoroscopy time after patients 52 and 43, respectively. The patient date consistently demonstrated that high-risk scores and major perioperative parameters were comparable between the two groups. The use of contrast dye (group 1, 94.22?±?30.07?mL; group 2, 70.43?±?15.02?mL, P<.05), total procedure time (group 1, 84.96?± 17.76?minutes; group 2, 59.95?±?12.83?minutes, P<.05), and fluoroscopy time (group 1, 11.52?± 3.81?minutes; group 2, 6.47?±?1.53?minutes, P<.05) were significantly reduced in group 2. The overall device success rate in group 1 was 96.2% vs 96.3% in group 2 and remained high (P = 1.0). The overall 30-day mortality was 3.8% in group 2 (group 1, 0 to group 2, 3.8%; P = .16). The complications rate, such as pulmonary hypertension, chronic kidney disease, and coronary artery disease were higher in group 2. CONCLUSIONS:For a surgeon without previous TAVR experience, 52 cases of performance is the minimal requirement to gain the proficiency of TAVR for native AR. The skilled surgeons have been observed with reduced procedural time, fluoroscopy times, radiation exposure dose, and contrast volume usage. However, the overall prognosis was not significantly different between the two groups.

Project description:ImportanceThe Centers for Medicare & Medicaid Services national coverage determination for transcatheter aortic valve replacement (TAVR) includes volume requirements for surgical aortic valve replacement (SAVR) for hospitals seeking to initiate or continue TAVR programs. Evidence regarding the association between SAVR volume and TAVR outcomes is limited.ObjectiveTo examine the association of hospital SAVR and combined SAVR and TAVR volumes with patient outcomes of TAVR procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs.Design, setting, and participantsThis observational cohort study included 60 538 TAVR procedures performed in 438 hospitals between October 1, 2011, and December 31, 2015, among Medicare beneficiaries.Main outcomes and measuresThe associations between SAVR volume, SAVR and TAVR volumes, and risks of death, death or stroke, and readmissions within 30 days were determined using a hierarchical logistic regression model adjusting for patient and hospital characteristics. The association between SAVR and SAVR and TAVR volumes and 1-year and 2-year mortality after TAVR procedures was determined using a multivariable proportional hazard model with a robust variance estimator. The associations for procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs were examined.ResultsAmong the 60 538 patients, 29 173 were women and 31 365 were men, with a mean (SD) age of 82.3 (8.0) years. Hospitals with high SAVR volume (mean annual volume, ≥97 per year) were more likely to adopt TAVR early and had a higher growth in TAVR volumes over time (median TAVR volume by hospitals with high SAVR volume and low SAVR volume: year 1, 32 vs 19; year 2, 48 vs 28; year 3, 82 vs 38; year 4, 118 vs 54; P < .001). In adjusted analysis, high hospital SAVR volume alone was not associated with better patient outcomes after TAVR. When hospital TAVR and SAVR volumes were jointly analyzed, patients treated in hospitals with high TAVR volume had lower 30-day mortality after TAVR (high TAVR and low SAVR vs low TAVR and low SAVR: odds ratio, 0.85; 95% CI, 0.72-0.99; high TAVR and high SAVR vs low TAVR and high SAVR: odds ratio, 0.81; 95% CI, 0.69-0.95), the effect of which was more pronounced when hospitals also had high SAVR volume. Patients treated in hospitals with high SAVR volume and high TAVR volume had the lowest 30-day mortality (vs hospitals with low SAVR volume and TAVR volume: odds ratio, 0.77; 95% CI, 0.66-0.89).Conclusions and relevanceHospitals with high SAVR volume are most likely to be fast adopters of TAVR. Hospital SAVR volume alone is not associated with better TAVR outcomes. Accumulating high volumes of TAVR is associated with lower mortality after TAVR, particularly when hospitals have high SAVR volumes. Hospitals with high caseloads of both SAVR and TAVR are likely to achieve the best outcomes.

Dataset Information

Avoiding the Learning Curve for Transcatheter Aortic Valve Replacement.

Publications

Avoiding the Learning Curve for Transcatheter Aortic Valve Replacement.

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