Publications by authors named "Sreekanth Vemulapalli"

144 Publications

A Composite Metric for Benchmarking Site Performance in TAVR: Results from the STS/ACC TVT Registry.

Circulation 2021 May 5. Epub 2021 May 5.

Division of Cardiovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA; Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, Leonard Davis Institute of Health Economics, Philadelphia, PA.

Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine if there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure. We performed a retrospective cohort study using data from the STS/ACC TVT Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites whose risk-adjusted outcomes were significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected. The development cohort consisted of 52,561 patients who underwent TAVR between January 1, 2015 and December 31, 2017. Based on the associations with 1-year risk-adjusted mortality and health status, we identified four periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe peri-valvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) of sites; performance as expected was observed in 242/301 sites (80%); and worse than expected performance was observed in 34/301 (11%) of sites. Thirty-day mortality, stroke, major, life-threatening or disabling bleeding, and moderate or severe peri-valvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model. There are substantial variations in the quality of TAVR care received in the United States, and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.051456DOI Listing
May 2021

Sex disparities in patients with symptomatic severe aortic stenosis.

Am Heart J 2021 Mar 17;237:116-126. Epub 2021 Mar 17.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address:

Background: We evaluated whether there is equitable distribution across sexes of treatment and outcomes for aortic valve replacement (AVR), via surgical (SAVR) or transcatheter (TAVR) methods, in symptomatic severe aortic stenosis (ssAS) patients.

Methods: Using de-identified data, we identified 43,822 patients with ssAS (2008-2016). Multivariate competing risk models were used to determine the likelihood of any AVR, while accounting for the competing risk of death. Association between sex and 1-year mortality, stratified by AVR status, was evaluated using multivariate Cox regression models with AVR as a time-dependent variable.

Results: Among patients with ssAS, 20,986 (47.9%) were female. Females were older (median age 81 vs. 78, P<0.001), more likely to have body mass index <20 (8.5% vs. 3.5%), and home oxygen use (4.4% vs. 3.4%, P<0001 for all). Overall, 12,129 (27.7%) patients underwent AVR for ssAS. Females were less likely to undergo AVR compared with males (24.1% vs. 31.0%, adjusted hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.77-0.83), but when treated, were more likely to undergo TAVR (37.9% vs. 30.9%, adjusted HR 1.21, 95% CI 1.15-1.27). Untreated females and males had similarly high rates of mortality at 1 year (31.1% vs. 31.3%, adjusted HR 0.98, 95% CI 0.94-1.03). Among those undergoing AVR, females had significantly higher mortality (10.2% vs. 9.4%, adjusted HR 1.24, 95% CI 1.10-1.41), driven by increased SAVR-associated mortality (9.0% vs. 7.6%, adjusted HR 1.43, 95% CI 1.21-1.69).

Conclusions: Treatment rates for ssAS patients remain suboptimal with disparities in female treatment.
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http://dx.doi.org/10.1016/j.ahj.2021.01.021DOI Listing
March 2021

Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results from the TVT Registry.

Circulation 2021 Feb 23. Epub 2021 Feb 23.

Cardiovascular Research Foundation, New York, NY; St. Francis Hospital, Roslyn, NY.

Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited. We performed an observational study using data from the STS/ACC-TVT Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable (IV) analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights. Our analytic sample included 123,186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing zero procedures with an EPD in the last quarter of 2019. In our primary analysis using the IV model, there was no association between EPD use and in-hospital stroke (adjusted relative risk (0.90 [95% CI: 0.68, 1.13], absolute risk difference -0.15% [95% CI: -0.49, 0.20]). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted OR 0.82 [95% CI 0.69, 0.97], absolute risk difference -0.28% [95% CI: -0.52, -0.03]). Results were generally consistent across the secondary endpoints as well as subgroup analyses. In this nationally-representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary IV analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale RCTs to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.052874DOI Listing
February 2021

Practical Application of Patient-Reported Health Status Measures for Transcatheter Valve Therapies: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry.

Circ Cardiovasc Qual Outcomes 2021 Mar 18;14(3):e007187. Epub 2021 Feb 18.

Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, Kansas City, MO (V.H., A.O.M., J.A.S., S.V.A.).

Background: Health status assessment is essential for documenting the benefit of transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve repair on patients' symptoms, function, and quality of life. Health status can also be a powerful marker for subsequent clinical outcomes, but its prognostic importance around the time of both TAVR and transcatheter mitral valve repair has not been fully defined.

Methods: Among 73 699 patients who underwent transfemoral TAVR or transcatheter mitral valve repair between 2011 and 2018 (mean age, 81.9±7.0 years, 53% men, 92% TAVR), we constructed sequential models examining the association of health status (as assessed with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Score; KCCQ-OS) at baseline, 30 days, change from baseline to 30 days, and combinations of these assessments with death and heart failure (HF) hospitalization from 30 days to 1 year.

Results: Although higher baseline KCCQ-OS and 30-day KCCQ-OS scores were each associated with lower risk of death and HF hospitalization (in individual models and in a model including both measures), the 30-day KCCQ-OS was most predictive (death: hazard ratio, 0.89 per 5-point increase [95% CI, 0.89-0.90]; HF hospitalization: hazard ratio, 0.91 [95% CI, 0.90-0.91]). The 30-day KCCQ-OS also was most predictive when included in a separate model with change in KCCQ from baseline to 30 days. Similar findings were noted for the outcomes of death and of HF hospitalization, unadjusted and adjusted for patient factors. All interaction terms between procedure type and KCCQ were not significant, suggesting that health status provided similar prognostic information in both procedures.

Conclusions: The patient's assessment of their health status immediately before and 30 days after TAVR and transcatheter mitral valve repair is associated with subsequent risk of death and HF hospitalization, with the 30-day assessment being most strongly associated with outcomes. Our findings support the routine use of KCCQ data as a prognostic tool.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007187DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982132PMC
March 2021

Evaluating Out-of-Hospital 30-Day Mortality After Transfemoral Transcatheter Aortic Valve Replacement: An STS/ACC TVT Analysis.

JACC Cardiovasc Interv 2021 02;14(3):261-274

Division of Cardiac Surgery, Methodist DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas, USA.

Objectives: This study sought to better understand out-of-hospital 30-day mortality following transfemoral transcatheter aortic valve replacement (TAVR) and identify factors associated with poor outcomes.

Background: Despite improvements in outcomes with TAVR for severe aortic stenosis, out-of-hospital 30-day mortality has not been evaluated.

Methods: This study examined patients in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry undergoing TAVR for severe aortic stenosis from January 2015 to March 2018. Primary and secondary endpoints were 30-day out-of-hospital all-cause mortality and out-of-hospital cardiovascular mortality, respectively. Logistic regression models were used to assess association between pre-specified factors and endpoints.

Results: A total of 106,749 patients underwent TAVR and were eligible for analysis. Transfemoral TAVR was performed in 92.3% of patients. A total of 2,137 (2.2%) transfemoral patients died within 30 days of the procedure, and 623 (29%) patients of these patients experienced out-of-hospital 30-day mortality. Cardiovascular and pulmonary etiologies accounted for the majority of observed mortality. Multivariable regression analysis identified older age, gender, lower body surface area, lower left ventricular ejection fraction, lower hemoglobin, atrial fibrillation or flutter, severe lung disease, home oxygen use, lack of moderate-to-severe aortic insufficiency, urgent TAVR, lower Kansas City Cardiomyopathy Questionnaire score, longer hospital length of stay, and in-hospital complications as being independently associated with the primary endpoint. New onset or pre-existent atrial fibrillation or flutter was also independently associated with 30-day out-of-hospital cardiovascular mortality in the transfemoral population.

Conclusions: We identified 30-day all-cause mortality rate for TAVR of 2.2%. Approximately one-third of patients experienced out-of-hospital mortality at 30 days. Several factors were identified as being independently associated with 30-day out-of-hospital all-cause and cardiovascular mortality. Further work is needed to understand how best to improve out-of-hospital mortality following TAVR.
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http://dx.doi.org/10.1016/j.jcin.2020.10.027DOI Listing
February 2021

African American-Caucasian American differences in aortic valve replacement in patients with severe aortic stenosis.

Am Heart J 2021 04 13;234:111-121. Epub 2021 Jan 13.

Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Durham, NC. Electronic address:

Background: Among patients with severe aortic stenosis (AS), there are limited data on aortic valve replacement (AVR), reasons for nonreceipt and mortality by race.

Methods: Utilizing the Duke Echocardiography Laboratory Database, we analyzed data from 110,711 patients who underwent echocardiography at Duke University Medical Center between 1999 and 2013. We identified 1,111 patients with severe AS who met ≥1 of 3 criteria for AVR: ejection fraction ≤50%, diagnosis of heart failure, or need for coronary artery bypass surgery. Logistic regression models were used to assess the association between race, AVR and 1-year mortality. χ2 testing was used to assess potential racial differences in reasons for AVR nonreceipt.

Results: Among the 1,111 patients (143 AA and 968 CA) eligible for AVR, AA were more often women, had more diabetes, renal insufficiency, aortic regurgitation and left ventricular hypertrophy. CA were more often smokers, had more ischemic heart disease, hyperlipidemia and higher median income levels. There were no racial differences in surgical risk utilizing logistic euroSCORES. Relative to CA, AA had lower rates of AVR (adjusted odds ratio 0.46, 95% CI 0.3-0.71, P < .001) yet similar 1-year mortality (aHR 0.81, 95% CI 0.57-1.17, P = .262). There were no significant differences in reasons for AVR nonreceipt.

Conclusions: We identified 143 African Americans (AA) and 968 Caucasian Americans(CA) with severe AS who met prespecified criteria for AVR.. AA relative to CA were more often women, had more diabetes, renal insufficiency, and left ventricular hypertrophy, however had less tobacco use, ischemic heart disease, hyperlipidemia and lower median income levels. Among patients with severe AS, AA relative to CA had lower rates of AVR (adjusted odds ratio 0.46, 95% CI 0.3-0.71, P < .001) without significant differences in reasons for AVR nonreceipt and similar 1-year mortality.
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http://dx.doi.org/10.1016/j.ahj.2021.01.005DOI Listing
April 2021

Transcatheter aortic valve replacement and surgical aortic valve replacement volume-outcome relationships: a Pandora's box.

Ann Cardiothorac Surg 2020 Nov;9(6):493-495

Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.

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http://dx.doi.org/10.21037/acs-2020-av-16DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724065PMC
November 2020

Site-Level Variability in 30-Day Patient Outcomes After Transcatheter Mitral Valve Repair in the United States.

Circ Cardiovasc Qual Outcomes 2020 12 7;13(12):e006878. Epub 2020 Dec 7.

Saint Lukes' Mid America Heart Institute, Kansas City, MO (A.O.M., A.K.C., J.S., V.H., P.G.J., S.V.A., S.V.A., J.A.S.).

Background: Clinical trials have demonstrated health status benefit of transcatheter mitral valve repair (TMVr) with MitraClip in patients with mitral valve regurgitation. Real-world site-level variability in health status outcomes for TMVr, and factors associated with this variability, are unknown.

Methods: All patients undergoing TMVr procedure with MitraClip between November 2013 and March 2019 in the Transcatheter Valve Therapy Registry were included. Health status was measured at baseline and 30 days with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score. Site-level variability in 30-day change in KCCQ-OS was examined by calculating the median odds ratio from a hierarchical logistic regression model, with ≥20-point improvement as the dependent variable. To define the extent to which patient characteristics, procedural characteristics (residual mitral valve regurgitation, periprocedural bleeding), site volume, and patients' baseline health status accounted for variability in outcomes, the proportion of variability () explained by sequentially adding these variables to the model was quantified.

Results: Across 339 sites, 12 415 patients (mean age 79.0±9.5 years, 46.1%. females, 89.5% White) completed baseline and 30-day health status assessments. Mean KCCQ-OS score was 43.0±24.4 at baseline and 67.0±24.9 at 30-day follow-up. Across sites, the proportion of patients achieving a ≥20-point improvement in KCCQ-OS ranged from 12.5% to 100% and the adjusted median odds ratio was 1.58 (95% CI, 1.46-1.69). The greatest contribution to the variability in health status outcomes was from patients' baseline KCCQ-OS score (=25%) with <1% of the variability explained by patient and procedural characteristics, and annual site volume.

Conclusions: There is moderate variation across sites in their patients' achievement of health status benefits from TMVr, with patient's baseline health status accounting for the largest proportion of this variation. This underscores the importance of patient selection in supporting more consistent health status benefit from TMVr.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.006878DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7738373PMC
December 2020

STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement.

Ann Thorac Surg 2021 Feb 16;111(2):701-722. Epub 2020 Nov 16.

Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.

The STS-ACC TVT Registry (Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry) from 2011 to 2019 has collected data on 276,316 patients undergoing transcatheter aortic valve replacement (TAVR) at sites in all U.S. states. Volumes have increased every year, exceeding surgical aortic valve replacement in 2019 (72,991 vs. 57,626), and it is now performed in all U.S. states. TAVR now extends from extreme- to low-risk patients. This is the first presentation on 8,395 low-risk patients treated in 2019. In 2019, for the entire cohort, femoral access increased to 95.3%, hospital stay was 2 days, and 90.3% were discharged home. Since 2011, the 30-day mortality rate has decreased (7.2% to 2.5%), stroke has started to decrease (2.75% to 2.3%), but pacemaker need is unchanged (10.9% to 10.8%). Alive with acceptable patient-reported outcomes is achieved in 8 of 10 patients at 1 year. The Registry is a national resource to improve care and analyze TAVR's evolution. Real-world outcomes, site performance, and the impact of coronavirus disease 2019 will be subsequently studied. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528).
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http://dx.doi.org/10.1016/j.athoracsur.2020.09.002DOI Listing
February 2021

STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2020 11;76(21):2492-2516

Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.

The STS-ACC TVT Registry (Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry) from 2011 to 2019 has collected data on 276,316 patients undergoing transcatheter aortic valve replacement (TAVR) at sites in all U.S. states. Volumes have increased every year, exceeding surgical aortic valve replacement in 2019 (72,991 vs. 57,626), and it is now performed in all U.S. states. TAVR now extends from extreme- to low-risk patients. This is the first presentation on 8,395 low-risk patients treated in 2019. In 2019, for the entire cohort, femoral access increased to 95.3%, hospital stay was 2 days, and 90.3% were discharged home. Since 2011, the 30-day mortality rate has decreased (7.2% to 2.5%), stroke has started to decrease (2.75% to 2.3%), but pacemaker need is unchanged (10.9% to 10.8%). Alive with acceptable patient-reported outcomes is achieved in 8 of 10 patients at 1 year. The Registry is a national resource to improve care and analyze TAVR's evolution. Real-world outcomes, site performance, and the impact of coronavirus disease 2019 will be subsequently studied. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528).
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http://dx.doi.org/10.1016/j.jacc.2020.09.595DOI Listing
November 2020

Community Size and Lung Cancer Resection Outcomes: Studying the Society of Thoracic Surgery Database.

Ann Thorac Surg 2020 Nov 12. Epub 2020 Nov 12.

Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia.

Background: Socioeconomic factors play key roles in surgical outcomes. Socioeconomic data within the Society of Thoracic Surgery General Thoracic Surgery Database (STS GTSD) is limited. Therefore, we utilized community size as a surrogate to understand socioeconomic differences in lung cancer resection outcomes.

Methods: We retrospectively reviewed all lung cancer resections from January 2012 to January 2017 in the STS GTSD. This captured 68,722 patients from 286 centers nationwide. We then linked patient zip codes with 2013 Rural Urban Continuum Codes (RUCC) to understand the association between community size and postoperative outcomes. Demographic and clinical variables were evaluated for relationships with 30-day mortality, major morbidity, and readmission.

Results: Zip codes were included in 47.2% of patients. Zip coded patients were older, more comorbid, with less advanced disease, and more commonly treated with minimally invasive approaches than those without zip code classification. For geocoded patients, multivariable analyses demonstrated that sex, insurance payor, and hospital region were associated with all three major endpoints. Community size, based on RUCC coding, was not associated with any primary endpoint. Invasive mediastinal staging was related to morbidity, greater pathological stage predicted mortality, and worsened clinical stage was associated with readmission. More invasive surgery and greater extent of lung resection were associated with all primary endpoints.

Conclusions: Incomplete data capture can promote selection bias within the STS GTSD and skew outcomes reporting. Moreover, community size is an insufficient surrogate, compared to sex, insurance payor, hospital region, for understanding socioeconomic differences in lung cancer resection outcomes.
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http://dx.doi.org/10.1016/j.athoracsur.2020.08.076DOI Listing
November 2020

Geographic Access to Transcatheter Aortic Valve Replacement Centers in the United States: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

JAMA Cardiol 2020 09;5(9):1006-1010

Duke Clinical Research Institute, Durham, North Carolina.

Importance: Geographic access to transcatheter aortic replacement (TAVR) centers varies in the United States as a result of controlled expansion through minimum volume requirements.

Objective: To describe the current geographic access to TAVR centers in the United States.

Design, Setting, And Participants: Observational study from June 1, 2015, to June 30, 2017. United States census data were used to describe access to TAVR center. Google Maps and the Society of Thoracic Surgeons American College of Cardiology Transcatheter Valve Therapy Registry were used to describe characteristics of patients undergoing successful TAVR according to proximity to implanting center. The study analyzed 47 527 537 individuals 65 years and older in the United States and 31 098 patients who underwent successful transfemoral TAVR, were linked to fee-for-service Medicare, and had a measurable driving time.

Main Outcomes And Measures: Median driving distance to a TAVR center.

Results: Among 40 537 zip codes in the United States, 490 (1.2%) contained a TAVR center, and among 305 hospital referral regions (HRR), 234 (76.7%) contained a TAVR center. Of the 31 749 patients who underwent successful transfemoral TAVR and were linked to fee-for-service Medicare, 31 098 had a measurable driving time. Mean (SD) age was 82.4 (6.9) years, 14 697 patients (47.3%) were women, and 7422 (23.87%) lived in a rural area. This translated to 1 232 568 of 47 527 537 individuals (2.6%) 65 years and older living in a zip code with a TAVR center and 43 789 169 (92.1%) living in an HRR with a TAVR center. Among 31 749 patients who underwent successful transfemoral TAVR and were linked to fee-for-service Medicare, 31 098 had a measurable driving time. All of these patients (100.0%) underwent their procedure in a TAVR center within their HRR, with 1350 (4.3%) undergoing TAVR in a center within their home zip code. Median driving time to implanting TAVR center was 35.0 minutes (IQR, 20.0-70.0 minutes), ranging from 2.0 minutes to 18 hours and 48 minutes.

Conclusions And Relevance: Most US individuals 65 years and older live in an HRR with a TAVR center. Among patients undergoing successful transfemoral TAVR, median driving time to implanting center was 35.0 minutes. Within the context of the US health care system, where certain advanced procedures and specialized care are centralized, TAVR services have significant penetration. More studies are required to evaluate the effect of geographic location of TAVR sites on access to TAVR procedures among individuals with an indication for a TAVR within the US population.
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http://dx.doi.org/10.1001/jamacardio.2020.1725DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7287974PMC
September 2020

Outcomes of transcatheter aortic valve replacement for patients with severe aortic stenosis and concomitant aortic insufficiency: Insights from the TVT Registry.

Am Heart J 2020 10 17;228:57-64. Epub 2020 Jul 17.

University of Missouri-Kansas City, Kansas City, MO; Saint Luke's Mid-America Heart Institute, Kansas City, MO. Electronic address:

Aims: Data regarding outcomes for patients with severe aortic stenosis (AS) with concomitant aortic insufficiency (AI), undergoing transcatheter aortic valve replacement (TAVR) are limited. This study aimed to analyze the prevalence of severe AS with concomitant AI among patients undergoing TAVR and outcomes of TAVR in this patient group.

Methods And Results: Using data from the STS/ACC-TVT Registry, we identified patients with severe AS with or without concomitant AI who underwent TAVR between 2011 and 2016. Patients were categorized based on the severity of pre-procedural AI. Multivariable proportional hazards regression models were used to examine all-cause mortality and heart failure (HF) hospitalization at 1-year. Among 54,535 patients undergoing TAVR, 42,568 (78.1%) had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P < .001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P < .001).

Conclusions: Severe AS with concomitant AI is common among patients undergoing TAVR, and is associated with lower 1 year mortality and HF hospitalization. Future studies are warranted to better understand the mechanisms underlying this benefit.

Short Abstract: In this nationally representative analysis from the United States, 78.1% of patients undergoing TAVR had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P < .001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P < .001).
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http://dx.doi.org/10.1016/j.ahj.2020.07.010DOI Listing
October 2020

Identification of Undetected Monogenic Cardiovascular Disorders.

J Am Coll Cardiol 2020 08;76(7):797-808

Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, North Carolina; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina. Electronic address:

Background: Monogenic diseases are individually rare but collectively common, and are likely underdiagnosed.

Objectives: The purpose of this study was to estimate the prevalence of monogenic cardiovascular diseases (MCVDs) and potentially missed diagnoses in a cardiovascular cohort.

Methods: Exomes from 8,574 individuals referred for cardiac catheterization were analyzed. Pathogenic/likely pathogenic (P/LP) variants associated with MCVD (cardiomyopathies, arrhythmias, connective tissue disorders, and familial hypercholesterolemia were identified. Electronic health records (EHRs) were reviewed for individuals harboring P/LP variants who were predicted to develop disease (G+). G+ individuals who did not have a documented relevant diagnosis were classified into groups of whether they may represent missed diagnoses (unknown, unlikely, possible, probable, or definite) based on relevant diagnostic criteria/features for that disease.

Results: In total, 159 P/LP variants were identified; 2,361 individuals harbored at least 1 P/LP variant, of whom 389 G+ individuals (4.5% of total cohort) were predicted to have at least 1 MCVD. EHR review of 342 G+ individuals predicted to have 1 MCVD with sufficient EHR data revealed that 52 had been given the relevant clinical diagnosis. The remaining 290 individuals were classified as potentially having an MCVD as follows: 193 unlikely (66.6%), 50 possible (17.2%), 30 probable (10.3%), and 17 definite (5.9%). Grouping possible, probable, definite, and known diagnoses, 149 were considered to have an MCVD. Novel MCVD pathogenic variants were identified in 16 individuals.

Conclusions: Overall, 149 individuals (1.7% of cohort) had MCVDs, but only 35% were diagnosed. These patients represents a "missed opportunity," which could be addressed by greater use of genetic testing of patients seen by cardiologists.
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http://dx.doi.org/10.1016/j.jacc.2020.06.037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7428466PMC
August 2020

Racial Differences in the Use of Aortic Valve Replacement for Treatment of Symptomatic Severe Aortic Valve Stenosis in the Transcatheter Aortic Valve Replacement Era.

J Am Heart Assoc 2020 08 11;9(16):e015879. Epub 2020 Aug 11.

Duke University School of Medicine Durham NC.

Background Aortic valve replacement (AVR) is a life-saving treatment for patients with symptomatic severe aortic valve stenosis. We sought to determine whether transcatheter AVR has resulted in a more equitable treatment rate by race in the United States. Methods and Results A total of 32 853 patients with symptomatic severe aortic valve stenosis were retrospectively identified via Optum's deidentified electronic health records database (2007-2017). AVR rates in non-Hispanic Black and White patients were assessed in the year after diagnosis. Multivariate Fine-Gray hazards models were used to evaluate the likelihood of AVR by race, with adjustment for patient factors and the managing cardiologist. Time-trend and 1-year symptomatic severe aortic valve stenosis survival analyses were also performed. From 2011 to 2016, the rate of AVR increased from 20.1% to 37.1%. Overall, Black individuals were less likely than Whites to receive AVR (22.9% versus 31.0%; unadjusted hazard ratio [HR], 0.70; 95% CI, 0.62-0.79; fully adjusted HR, 0.76; 95% CI, 0.67-0.85). Yet, during 2015 to 2016, AVR racial differences were attenuated (29.5% versus 35.2%; adjusted HR, 0.86; 95% CI, 0.74-1.02) because of greater uptake of transcatheter AVR in Blacks than Whites (53.4% of AVRs versus 47.3%; =0.128). Untreated patients had significantly higher 1-year mortality than those treated (adjusted HR, 0.57; 95% CI, 0.53-0.61), which was consistent by race (interaction value=0.52). Conclusions Although transcatheter AVR has increased the use of AVR in the United States, treatment rates remain low. Black patients with symptomatic severe aortic valve stenosis were less likely than White patients to receive AVR, yet these differences have recently narrowed.
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http://dx.doi.org/10.1161/JAHA.119.015879DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660794PMC
August 2020

Precision Medicine in TAVR: How to Select the Right Device for the Right Patient.

Can J Cardiol 2021 Jan 6;37(1):4-6. Epub 2020 Apr 6.

Sorbonne University, ACTION Group, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière, Paris, France.

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http://dx.doi.org/10.1016/j.cjca.2020.03.043DOI Listing
January 2021

Volume-Outcome Association of Mitral Valve Surgery in the United States.

JAMA Cardiol 2020 Oct;5(10):1092-1101

Division of Cardiac Surgery, Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston.

Importance: Early surgery for severe primary degenerative mitral regurgitation is recommended, provided optimal outcomes are achievable. Contemporary national data defining mitral valve surgery volume and outcomes are lacking.

Objective: To assess national 30-day and 1-year outcomes of mitral valve surgery and define the hospital- and surgeon-level volume-outcome association with mitral valve repair or replacement (MVRR) in patients with primary mitral regurgitation.

Design, Setting, And Participants: This multicenter cross-sectional observational study used the Society of Thoracic Surgeons Adult Cardiac Surgery Database to identify patients undergoing isolated MVRR for primary mitral regurgitation in the United States. Operative data were collected from July 1, 2011, to December 31, 2016, and analyzed from March 1 to July 1, 2019, with data linked to the Centers for Medicare and Medicaid Services.

Main Outcomes And Measures: The primary outcome was 30-day in-hospital operative mortality after isolated MVRR for primary mitral regurgitation. Secondary outcomes were 30-day composite mortality plus morbidity (any occurrence of bleeding, stroke, prolonged ventilation, renal failure, or deep wound infection), rate of successful mitral valve repair of primary mitral regurgitation (residual mitral regurgitation of mild [1+] or better), and 1-year mortality, reoperation, and rehospitalization for heart failure.

Results: A total of 55 311 patients, 1094 hospitals, and 2410 surgeons were identified. Increasing hospital and surgeon volumes were associated with lower risk-adjusted 30-day mortality, lower 30-day composite mortality plus morbidity, and higher rate of successful repair. The lowest vs highest hospital volume quartile had higher 1-year risk-adjusted mortality (hazard ratio [HR], 1.61, 95% CI, 1.31-1.98), but not mitral reoperation (odds ratio [OR], 1.51; 95% CI, 0.81-2.78) or hospitalization for heart failure (HR, 1.25; 95% CI, 0.96-1.64). The surgeon-level 1-year volume-outcome associations were similar for mortality (HR, 1.60; 95% CI, 1.32-1.94) but not significant for mitral reoperation (HR, 1.14; 95% CI, 0.60-2.18) or hospitalization for heart failure (HR, 1.17; 95% CI, 0.91-1.50).

Conclusions And Relevance: National hospital- and surgeon-level inverse volume-outcome associations were observed for 30-day and 1-year mortality after mitral valve surgery for primary mitral regurgitation. These findings may help to define access to experienced centers and surgeons for the management of primary mitral regurgitation.
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http://dx.doi.org/10.1001/jamacardio.2020.2221DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7330833PMC
October 2020

Demographics, Procedural Characteristics, and Clinical Outcomes When Cardiogenic Shock Precedes TAVR in the United States.

JACC Cardiovasc Interv 2020 06;13(11):1314-1325

Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

Objectives: This paper details trends and outcomes in U.S. patients undergoing transcatheter aortic valve replacement (TAVR) who present pre-procedurally with cardiogenic shock.

Background: Demographic, procedural characteristics, and clinical outcomes in U.S. patients undergoing TAVR after presenting with cardiogenic shock are unknown.

Methods: The STS/ACC TVT (Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy) registry linked with Centers for Medicare & Medicaid Services claims data was used to identify patients between 2014 and 2017 who presented with cardiogenic shock before TAVR in comparison to a high-risk cohort that did not present with cardiogenic shock. The primary outcome of interest was 30-day mortality. Secondary outcomes included 30-day procedural complications.

Results: Presentations with cardiogenic shock currently represent 4.1% of the U.S. TAVR population. A total of 2,220 patients with acute cardiogenic shock undergoing TAVR (median STS 9.8) were compared with 12,851 high-risk patients (median STS 10.2). Cardiogenic shock was associated with higher 30-day mortality (19.1% vs. 4.9%) and higher rates of complications. The absence of 30-day major complications was not associated with a marked reduction in 30-day mortality, and overall procedural success rates were high. The risk of death from acute cardiogenic shock before TAVR was strongly related to the degree of shock pre-procedure.

Conclusions: TAVR appears to be a viable treatment option for patients presenting with aortic stenosis and acute cardiogenic shock. Although procedural success is high, this population remains at an elevated risk of death, which appears to be mostly driven by the degree of pre-procedural shock.
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http://dx.doi.org/10.1016/j.jcin.2020.02.033DOI Listing
June 2020

Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement: Variation in Practice and Outcomes.

JACC Cardiovasc Interv 2020 06;13(11):1277-1287

University of Missouri-Kansas City, Kansas City, Missouri. Electronic address:

Objectives: The aims of this study were to examine variation in the use of conscious sedation (CS) for transcatheter aortic valve replacement (TAVR) across hospitals and over time and to evaluate outcomes of CS compared with general anesthesia (GA) using instrumental variable analysis, a quasi-experimental method to control for unmeasured confounding.

Background: Despite increasing use of CS for TAVR, contemporary data on utilization patterns are lacking, and existing studies evaluating the impact of sedation choice on outcomes may suffer from unmeasured confounding.

Methods: Among 120,080 patients in the TVT (Transcatheter Valve Therapy) Registry who underwent transfemoral TAVR between January 2016 and March 2019, the relationship between anesthesia choice and TAVR outcomes was evaluated using hospital proportional use of CS as an instrumental variable.

Results: Over the study period, the proportion of TAVR performed using CS increased from 33% to 64%, and CS was used in a median of 0% and 91% of cases in the lowest and highest quartiles of hospital CS use, respectively. On the basis of instrumental variable analysis, CS was associated with decreases in in-hospital mortality (adjusted risk difference: 0.2%; p = 0.010) and 30-day mortality (adjusted risk difference: 0.5%; p < 0.001), shorter length of hospital stay (adjusted difference: 0.8 days; p < 0.001), and more frequent discharge to home (adjusted risk difference: 2.8%; p < 0.001) compared with GA. The magnitude of benefit for most endpoints was less than in a traditional propensity score-based approach, however.

Conclusions: In contemporary U.S. practice, the use of CS for TAVR continues to increase, although there remains wide variation across hospitals. The use of CS for TAVR is associated with improved outcomes (including reduced mortality) compared with GA, although the magnitude of benefit appears to be less than in previous studies.
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http://dx.doi.org/10.1016/j.jcin.2020.03.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7650030PMC
June 2020

Mitral Valve Surgical Volume and Transcatheter Mitral Valve Repair Outcomes: Impact of a Proposed Volume Requirement on Geographic Access.

J Am Heart Assoc 2020 06 27;9(11):e016140. Epub 2020 May 27.

Smith Center for Outcomes Research Institute Beth Israel Deaconess Medical Center Boston MA.

Background There is an open Centers for Medicare and Medicaid Services National Coverage Decision for Transcatheter Mitral Valve Repair (TMVr) and a recent multisociety consensus document suggesting that TMVr centers should achieve prespecified mitral valve replacement or repair (MVRr). Yet, little is known about the MVRr volume-TMVr outcome relationship. Methods and Results Using Centers for Medicare and Medicaid Services administrative claims from January 1, 2016 to December 31, 2018, we computed the Pearson correlation coefficient and performed multivariable hierarchical modeling to estimate the MVRr volume to TMVr outcome relationship for mortality and heart failure hospitalization. Additionally, we assessed the impact of the consensus recommendations on geographic access to care by hospital referral region. Total annualized MVRr volume was <11 to 1552 (median 96, interquartile range 53, 167). One-year survival, 1-year heart failure hospitalization after TMVr were not correlated with MVRr volume. After patient risk-adjustment for age, sex, and significant Elixhauser Comorbidities, there remained no significant correlation between institutional MVRr volume and 1-year mortality (estimate -0.010, SE 0.047, =0.834) or heart failure hospitalization (estimate -0.011, SE 0.045, =0.808) after TMVr. Raising the restriction on TMVr from 20 to 40 MVRr/y results in ≈30 million individuals having to travel outside of their hospital referral region to undergo TMVr, with a disproportionate impact in the Midwest and Southeast. Conclusions There is no relationship between MVRr volumes and TMVr outcomes. Additionally, adoption of an annual MVRr volume ≥40 for performance of TMVr disproportionately impacts geographic access in the Midwest and Southeast and their large black and Hispanic populations.
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http://dx.doi.org/10.1161/JAHA.119.016140DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7429011PMC
June 2020

Racial disparities and democratization of health care: A focus on TAVR in the United States.

Am Heart J 2020 06 13;224:166-170. Epub 2020 Mar 13.

Duke Clinical Research Institute and Duke University School of Medicine, Durham, NC, USA.

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http://dx.doi.org/10.1016/j.ahj.2020.03.008DOI Listing
June 2020

A care pathway for the cardiovascular complications of COVID-19: Insights from an institutional response.

Am Heart J 2020 07 3;225:3-9. Epub 2020 May 3.

Division of Cardiology and Duke Heart Center, Duke University Medical Center, Durham, NC.

The infection caused by severe acute respiratory syndrome coronavirus-2, or COVID-19, can result in myocardial injury, heart failure, and arrhythmias. In addition to the viral infection itself, investigational therapies for the infection can interact with the cardiovascular system. As cardiologists and cardiovascular service lines will be heavily involved in the care of patients with COVID-19, our division organized an approach to manage these complications, attempting to balance resource utilization and risk to personnel with optimal cardiovascular care. The model presented can provide a framework for other institutions to organize their own approaches and can be adapted to local constraints, resource availability, and emerging knowledge.
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http://dx.doi.org/10.1016/j.ahj.2020.04.024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7252188PMC
July 2020

Comparison of Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction With Versus Without Hyperuricemia or Gout.

Am J Cardiol 2020 07 22;127:64-72. Epub 2020 Apr 22.

Division of Cardiology, Department of Medicine, Duke University Hospital, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.

Hyperuricemia and gout are common in patients with heart failure (HF) and are associated with poor outcomes. Data describing hyperuricemia and gout in patients with HF with preserved ejection fraction (HFpEF) are limited. We used data from the Duke University Health System to describe characteristics of patients with HFpEF and hyperuricemia (serum uric acid >6 mg/dl) or gout (gout diagnosis or gout medication within the previous year) and to explore associations with 5-year outcomes (death and hospitalization). We identified 7,004 patients in the Duke University Health System with a known diagnosis of HFpEF who underwent transthoracic echocardiography between January 1, 2005 and December 31, 2017. A total of 1,136 (16.2%) patients with HFpEF also had hyperuricemia or gout. Patients with HFpEF and hyperuricemia or gout had a greater co-morbidity burden, more echocardiographic findings of cardiac remodeling, and higher unadjusted rates of all-cause death, all-cause hospitalization, and HF hospitalization compared with those with HFpEF without hyperuricemia or gout. After multivariable adjustment, patients with HFpEF and hyperuricemia or gout had a significantly higher rates of first all-cause hospitalization (adjusted hazard ratio 1.10 [95% confidence interval 1.02 to 1.19]; p = 0.020) and recurrent all-cause hospitalization (associated rate ratio 1.13 [95% confidence interval 1.01 to 1.25]; p = 0.026). After adjustment, no significant differences in death or HF hospitalization were observed. In conclusion, patients with HFpEF and hyperuricemia or gout were found to have a higher burden of co-morbidities and a higher rate of all-cause hospitalization, even after multivariable adjustment, compared to patients with HFpEF without hyperuricemia or gout.
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http://dx.doi.org/10.1016/j.amjcard.2020.04.026DOI Listing
July 2020

Lipoprotein (a): An Update on a Marker of Residual Risk and Associated Clinical Manifestations.

Am J Cardiol 2020 07 7;126:94-102. Epub 2020 Apr 7.

Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.

Lipoprotein (a) [Lp(a)] is a low-density, cholesterol-containing lipoprotein that differs from other low-density lipoproteins due to the presence of apolipoprotein(a) bound to its surface apolipoprotein B100. Multiple epidemiologic studies, including Mendelian Randomization studies, have demonstrated that increasing Lp(a) levels are associated with increased risk of heart disease, including atherosclerotic cardiovascular disease and calcific aortic stenosis. The risk associated with elevations in Lp(a) appears to be independent of other lipid markers. While the current treatment options for elevated Lp(a) are limited, promising new therapies are under development, leading to renewed interest in Lp(a). This review provides an overview of the biology and epidemiology of Lp(a), available outcome studies, and insights into future therapies.
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http://dx.doi.org/10.1016/j.amjcard.2020.03.043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376542PMC
July 2020

Appropriateness of Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry.

Circ Cardiovasc Qual Outcomes 2020 04 26;13(4):e006146. Epub 2020 Mar 26.

Department of Cardiology (T.I., S.K., F.Y., K.F., K.H.), Keio University School of Medicine, Tokyo, Japan.

Background: Transcatheter aortic valve replacement (TAVR) is widely used; however, its appropriateness is unknown. We sought to investigate the appropriateness of TAVR.

Methods And Results: We assigned appropriateness ratings to patients undergoing TAVR for severe aortic stenosis between October 2013 and May 2017 at 14 Japanese hospitals participating in the optimized transcatheter valvular intervention-transcatheter aortic valve implantation registry according to the US appropriate use criteria for treating severe aortic stenosis. To account for the influence of uncaptured variables on appropriate use criteria ratings, we initially assigned them to a best-case scenario where they were assumed to classify a case to the most appropriate clinical scenario and then to a worst-case scenario where assumed least appropriate. Overall proportion of TAVRs classified as appropriate, maybe appropriate, or rarely appropriate was assessed. In addition, extent of hospital-level variation in rarely appropriate procedures was evaluated. Of 2036 TAVRs (median age [25th, 75th]: 85.0 years [81.0-88.0]; 70.5% female the Society of Thoracic Surgeons Predicted Risk of Mortality score: 6.2% [4.4-8.9]), in the best-case scenario, 177 (8.7%) were not successfully mapped, and 1580 (77.6%) were classified as appropriate, 180 (8.8%) as maybe appropriate, 99 (4.9%) as rarely appropriate, respectively. In the worst-case scenario, the rate of rarely appropriate increased to 6.8%. The majority of rarely appropriate TAVRs was performed in patients with moderate to severe dementia (defined as mini-mental status examination of ≤17), bicuspid aortic valve, or anticipated life expectancy <1 year. There was substantial variation in the proportion of rarely appropriate TAVR across hospitals (median rate of rarely appropriate: 4.9% [3.8-6.6] in the best-case scenario, <0.001; 6.5% [5.6-8.6] in the worst-case scenario, <0.001).

Conclusions: In clinical practice, the proportion of rarely appropriate TAVRs ranged from 4.9% to 6.8% with substantial institutional variation. Our study elucidates common clinical scenarios deemed rarely appropriate and clarifies the potential targets of quality improvement. Registration: URL: https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000020423.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.006146DOI Listing
April 2020

Oral Anticoagulation and Cardiovascular Outcomes in Patients With Atrial Fibrillation and End-Stage Renal Disease.

J Am Coll Cardiol 2020 03;75(11):1299-1308

Duke Center for Atrial Fibrillation, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. Electronic address:

Background: Atrial fibrillation (AF) is common in patients with end-stage renal disease (ESRD). The impact of oral anticoagulation (OAC) in ESRD patients is uncertain.

Objectives: The purpose of this study was to describe patterns of OAC use in ESRD patients with AF and their associations with cardiovascular outcomes.

Methods: Using Medicare fee-for-service 5% claims data from 2007 to 2013, we analyzed treatment and outcomes in a cohort of patients with ESRD and AF. Prescription drug benefit information was used to determine the timing of OAC therapy. Cox proportional hazards modeling was used to compare outcomes including death, all-cause stroke, ischemic stroke, hemorrhagic stroke, and bleeding hospitalizations in ESRD patients treated with or without OAC.

Results: The cohort included 8,410 patients with AF and ESRD. A total of 3,043 (36.2%) patients were treated with OAC at some time during the study period. Propensity scores used to match 1,519 patients with AF and ESRD on OAC with 3,018 ESRD patients without OAC. Treatment with OAC was not associated with hospitalization for stroke (hazard ratio [HR]: 1.00; 95% confidence interval [CI]: 0.23 to 1.35; p = 0.97) or death (HR: 1.02; 95% CI: 0.94 to 1.10; p = 0.62). OAC was associated with an increased risk of hospitalization for bleeding (HR: 1.26; 95% CI: 1.09 to 1.46; p = 0.0017) and intracranial hemorrhage (HR: 1.30; 95% CI: 1.07 to 1.59; p = 0.0094).

Conclusions: OAC utilization was low in patients with AF and ESRD. We found no association between OAC use and reduced risk of stroke or death. OAC use was associated with increased risks of hospitalization for bleeding or intracranial hemorrhage. Alternative stroke prevention strategies are needed in patients with ESRD and AF.
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http://dx.doi.org/10.1016/j.jacc.2020.01.019DOI Listing
March 2020