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Association of Smoking Status With Long-Term Mortality and Health Status After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

ABSTRACT: Background Smoking is a significant risk factor for aortic stenosis but its impact on clinical and health status outcomes after transcatheter aortic valve replacement (TAVR) has not been described. Methods and Results Patients (n=72 165) undergoing TAVR at 457 US sites in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between November 2011 and June 2016 were categorized at the time of TAVR as current/recent smokers versus prior/nonsmokers. A series of multivariable models examined the association between smoking status and outcomes, including 1-year mortality, rehospitalization, mean gradient, and health status (measured by the 12-item Kansas City Cardiomyopathy Questionnaire-Overall Summary Score [KCCQ-OS]) and in-hospital outcomes. A total of 4063 patients (5.6%) were smokers. Smokers presented for TAVR at a younger age (75 [68-81] years versus 83 [77-88] years) but with a greater burden of cardiovascular and lung disease. In adjusted models, smoking was associated with lower in-hospital mortality (relative risk, 0.74; 95% CI, 0.62-0.89 [P=0.001]) but not with in-hospital stroke/transient ischemic attack or myocardial infarction. Smoking status had no association with postdischarge mortality, stroke, myocardial infarction, or heart failure (HF) but was associated with slightly lower 1-year KCCQ-OS scores (2.4-point lower KCCQ-OS; 95% CI, -4.6 to -0.2 [P=0.031]) and higher mean aortic valve gradients (11.1 versus 10.2 mm Hg, P<0.001) in adjusted models. Conclusions The current/recent smoking rate in US patients with TAVR is 5.6% and smokers present at a younger age for TAVR. Smoking was associated with lower in-hospital but similar long-term survival after TAVR, slightly worse long-term health status, and marginally higher mean aortic valve gradients. Further research is needed to understand the effect of smoking cessation on outcomes.

SUBMITTER: Qintar M

PROVIDER: S-EPMC6759891 | biostudies-other | 2019 Aug

REPOSITORIES: biostudies-other

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Association of Smoking Status With Long-Term Mortality and Health Status After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Qintar Mohammed M Li Zhuokai Z Vemulapalli Sreekanth S Chhatriwalla Adnan K AK Baron Suzanne J SJ Kosinski Andrzej S AS Saxon John T JT Spertus John A JA Cohen David J DJ Arnold Suzanne V SV

Journal of the American Heart Association 20190819 16

Background Smoking is a significant risk factor for aortic stenosis but its impact on clinical and health status outcomes after transcatheter aortic valve replacement (TAVR) has not been described. Methods and Results Patients (n=72 165) undergoing TAVR at 457 US sites in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between November 2011 and June 2016 were categorized at the time of TAVR as current/recent smokers versus prior/ ...[more]

PMID: 31423877

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Project description:ImportanceGeographic access to transcatheter aortic replacement (TAVR) centers varies in the United States as a result of controlled expansion through minimum volume requirements.ObjectiveTo describe the current geographic access to TAVR centers in the United States.Design, setting, and participantsObservational 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 measuresMedian driving distance to a TAVR center.ResultsAmong 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 relevanceMost 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.

Project description:OBJECTIVES:The aim of this study was to develop and validate a risk adjustment model for 30-day mortality after transcatheter aortic valve replacement (TAVR) that accounted for both standard clinical factors and pre-procedural health status and frailty. BACKGROUND:Assessment of risk for TAVR is important both for patient selection and provider comparisons. Prior efforts for risk adjustment have focused on in-hospital mortality, which is easily obtainable but can be biased because of early discharge of ill patients. METHODS:Using data from patients who underwent TAVR as part of the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry (June 2013 to May 2016), a hierarchical logistic regression model to estimate risk for 30-day mortality after TAVR based only on pre-procedural factors and access site was developed and internally validated. The model included factors from the original TVT Registry in-hospital mortality model but added the Kansas City Cardiomyopathy Questionnaire (health status) and gait speed (5-m walk test). RESULTS:Among 21,661 TAVR patients at 188 sites, 1,025 (4.7%) died within 30 days. Independent predictors of 30-day death included older age, low body weight, worse renal function, peripheral artery disease, home oxygen, prior myocardial infarction, left main coronary artery disease, tricuspid regurgitation, nonfemoral access, worse baseline health status, and inability to walk. The predicted 30-day mortality risk ranged from 1.1% (lowest decile of risk) to 13.8% (highest decile of risk). The model was able to stratify risk on the basis of patient factors with good discrimination (C = 0.71 [derivation], C = 0.70 [split-sample validation]) and excellent calibration, both overall and in key patient subgroups. CONCLUSIONS:A clinical risk model was developed for 30-day death after TAVR that included clinical data as well as health status and frailty. This model will facilitate tracking outcomes over time as TAVR expands to lower risk patients and to less experienced sites and will allow an objective comparison of short-term mortality rates across centers.

Project description:ImportanceClinical decisions are ideally based on evidence generated from multiple randomized controlled trials (RCTs) evaluating clinical outcomes, but historically, few clinical guideline recommendations have been based entirely on this type of evidence.ObjectiveTo determine the class and level of evidence (LOE) supporting current major cardiovascular society guideline recommendations, and changes in LOE over time.Data sourcesCurrent American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology (ESC) clinical guideline documents (2008-2018), as identified on cardiovascular society websites, and immediate predecessors to these guideline documents (1999-2014), as referenced in current guideline documents.Study selectionComprehensive guideline documents including recommendations organized by class and LOE.Data extraction and synthesisThe number of recommendations and the distribution of LOE (A [supported by data from multiple RCTs or a single, large RCT], B [supported by data from observational studies or a single RCT], and C [supported by expert opinion only]) were determined for each guideline document.Main outcomes and measuresThe proportion of guideline recommendations supported by evidence from multiple RCTs (LOE A).ResultsAcross 26 current ACC/AHA guidelines (2930 recommendations; median, 121 recommendations per guideline [25th-75th percentiles, 76-155]), 248 recommendations (8.5%) were classified as LOE A, 1465 (50.0%) as LOE B, and 1217 (41.5%) as LOE C. The median proportion of LOE A recommendations was 7.9% (25th-75th percentiles, 0.9%-15.2%). Across 25 current ESC guideline documents (3399 recommendations; median, 130 recommendations per guideline [25th-75th percentiles, 111-154]), 484 recommendations (14.2%) were classified as LOE A, 1053 (31.0%) as LOE B, and 1862 (54.8%) as LOE C. When comparing current guidelines with prior versions, the proportion of recommendations that were LOE A did not increase in either ACC/AHA (median, 9.0% [current] vs 11.7% [prior]) or ESC guidelines (median, 15.1% [current] vs 17.6% [prior]).Conclusions and relevanceAmong recommendations in major cardiovascular society guidelines, only a small percentage were supported by evidence from multiple RCTs or a single, large RCT. This pattern does not appear to have meaningfully improved from 2008 to 2018.

Project description:The American College of Cardiology (ACC) and European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) have recently published recommendations for the use of proprotein convertase subtilisin/kexin-9 (PCSK9) inhibitors in situations of very high risk. We aim to assess in the real world the suitability of PCSK9 inhibitors for acute coronary syndromes.We analyzed a prospective Swiss cohort of 2023 patients hospitalized for acute coronary syndromes between 2009 and 2014 with available data for low-density lipoprotein cholesterol and lipid-lowering therapy at 1 year. Clinical familial hypercholesterolemia was defined using the Dutch Lipid Clinic Network algorithm as unlikely, possible, probable, or definite. We simulated a fixed relative reduction of 24% in low-density lipoprotein cholesterol levels at 1 year in all patients not treated with ezetimibe, irrespective of the low-density lipoprotein cholesterol levels and statin regimen. At 1 year, 94.3% of patients were treated with statin, 5.8% with ezetimibe, and 35.8% of patients had on-target low-density lipoprotein cholesterol levels (<1.8 mmol/L); 25.6% met criteria for possible or probable/definite familial hypercholesterolemia. After a simulation of the lipid-lowering effect of ezetimibe, the proportion of patients who would be eligible for PCSK9 inhibitors at 1 year was 13.4% using American College of Cardiology criteria and 2.7% using European Society of Cardiology/European Atherosclerosis Society criteria. Patients with possible or probable/definite familial hypercholesterolemia were more eligible for PCSK9 inhibitors compared with their non-familial hypercholesterolemia counterparts: 27.6% versus 8.8% according to American College of Cardiology criteria and 6.6% versus 1.8% according to European Society of Cardiology/European Atherosclerosis Society criteria (P<0.001).Recommendations made by the American College of Cardiology guidelines would lead to 5-fold higher eligibility rates for PCSK9 inhibitors compared to the European Society of Cardiology/European Atherosclerosis Society consensus statement in acute coronary syndrome patients.

Dataset Information

Association of Smoking Status With Long-Term Mortality and Health Status After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Publications

Association of Smoking Status With Long-Term Mortality and Health Status After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

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