Cleman, Michael

Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

ObjectiveThe aim of our study was to study the impact of glycoprotein IIb/IIIa inhibitors (GPI) on in‐hospital outcomes.BackgroundThere is paucity of data regarding the impact of GPI on the outcomes following peripheral endovascular interventions.MethodsThe study cohort was derived from Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) database between the years 2006 and 2011. Peripheral endovascular interventions and GPI utilization were identified using appropriate ICD‐9 Diagnostic and procedural codes. Two‐level hierarchical multivariate mixed models were created. The study outcomes were: primary (in‐hospital mortality and amputation studied separately) and secondary (composite of in‐hospital mortality and postprocedural complications). Hospitalization costs were also assessed.ResultsGPI utilization (OR, 95% CI, P‐value) was independently predictive of lower amputation rates (0.36, 0.27–0.49, <0.001). There was no significant difference in terms of in‐hospital mortality (0.59, 0.31–1.14, P 0.117), although GPI use predicted worse secondary outcomes (1.23, 1.03–1.47, 0.023). Following propensity matching, the amputation rate was lower (3.2% vs. 8%, P < 0.001), while hospitalization costs were higher in the cohort that received GPI ($21,091 ± 404 vs. 19,407 ± 133, P < 0.001).ConclusionsMultivariate analysis revealed GPI use in peripheral endovascular interventions to be suggestive of an increase in composite end‐point of in‐hospital mortality and postprocedural complications, no impact on in‐hospital mortality alone, significantly lower rate of amputation, and increase in hospitalization costs. © 2016 Wiley Periodicals, Inc.

Purpose: To examine the impact of intravascular ultrasound (IVUS) utilization during lower limb endovascular interventions as regards postprocedural complications and amputation. Methods: The study cohort was derived from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample database between the years 2006 and 2011. Peripheral endovascular interventions were identified using appropriate ICD-9 procedure codes. Two-level hierarchical multivariate mixed models were created. The co-primary outcomes were in-hospital mortality and amputation; the secondary outcome was postprocedural complications. Model results are given as the odds ratio (OR) and 95% confidence interval (CI). Hospitalization costs were also assessed. Results: Overall, among the 92,714 patients extracted from the database during the observation period, IVUS was used in 1299 (1.4%) patients. IVUS utilization during lower extremity peripheral vascular procedures was independently predictive of a lower rate of postprocedural complications (OR 0.80, 95% CI 0.66 to 0.99, p=0.037) as well as lower amputation rates (OR 0.59, 95% CI 0.45 to 0.77, p<0.001) without any significant impact on in-hospital mortality. Multivariate analysis also revealed IVUS utilization to be predictive of a nonsignificant increase in hospitalization costs ($1333, 95% CI −$167 to +$2833, p=0.082). Conclusion: IVUS use during lower limb endovascular interventions is predictive of lower postprocedural complication and amputation rates with a nonsignificant increase in hospitalization costs.

ObjectivesTo compare the in‐hospital outcomes in cirrhosis patients undergoing transcatheter aortic valve replacement (TAVR) versus those undergoing surgical aortic valve replacement (SAVR).BackgroundOver the last 10 years, TAVR has emerged as a therapeutic option for treating severe aortic stenosis in high‐risk patients. Cirrhosis patients have a high risk of operative morbidity and mortality while undergoing cardiac surgery. This study's hypothesis was that TAVR is a safer alternative compared to SAVR in cirrhosis patients.MethodsThe study population was derived from the National Inpatient Sample (NIS) for the years 2011–2012 using ICD‐9‐CM procedure codes 35.21 and 35.22 for SAVR, and 35.05 and 35.06 for TAVR. Patients <50 years of age and those who concomitantly underwent other valvular procedures were excluded. ICD‐9‐CM diagnosis codes were used to identify patients with liver cirrhosis, portal hypertension, and esophageal varices. Using propensity score matching, two matched cohorts were derived in which the outcomes were compared using appropriate statistical tests.ResultsThere were 30 patients in the SAVR and TAVR group each. Compared to the TAVR group, the patients in SAVR group had significantly higher rate of transfusion of whole blood or blood products (p = 0.037), longer mean postprocedural length of stay (p = 0.006), and nonsignificantly higher mean cost of hospitalization (p = 0.2), any complications rate (p = 0.09), and liver complications rate (p = 0.4). In‐hospital mortality rate was same in the both the groups. No patients in the TAVR group required open‐heart surgery or cardiopulmonary bypass.ConclusionTAVR could be a viable option for aortic valve replacement in cirrhosis patients. © 2015 Wiley Periodicals, Inc.

Background: Multivessel coronary artery disease carries significant mortality risk. Comprehensive data on inhospital outcomes following multivessel percutaneous coronary intervention (MVPCI) are sparse. Methods: We queried the Healthcare Cost and Utilization Project’s nationwide inpatient sample (NIS) between 2006 and 2011 using different International Classification of Diseases, 9th Revision, Clinical Modification procedure codes. The primary outcome was inhospital all-cause mortality, and the secondary outcome was a composite of inhospital mortality and periprocedural complications. Results: The overall mortality was low at 0.73% following MVPCI. Multivariate analysis revealed that (odds ratio, 95% confidence interval, P value) age (1.63, 1.48-1.79; <.001), female sex (1.19, 1.00-1.42; P = .05), acute myocardial infarction (AMI; 2.97, 2.35-3.74; <.001), shock (17.24, 13.61-21.85; <.001), a higher burden of comorbidities (2.09, 1.32-3.29; .002), and emergent/urgent procedure status (1.67, 1.30-2.16; <.001) are important predictors of primary and secondary outcomes. MVPCI was associated with higher mortality, length of stay (LOS), and cost of care as compared to single vessel single stent PCI. Conclusion: MVPCI is associated with higher inhospital mortality, LOS, and hospitalization costs compared to single vessel, single stent PCI. Higher volume hospitals had lower overall postprocedural mortality rate along with shorter LOS and lower hospitalization costs following MVPCI.

ObjectivesWe studied the trends and predictors of drug eluting stent (DES) utilization from 2006 to 2011 to further expound the inter‐hospital variability in their utilization.BackgroundWe queried the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample (NIS) between 2006 and 2011 using ICD‐9‐CM procedure code, 36.06 (bare metal stent) or 36.07 (drug eluting stents) for Percutaneous Coronary Intervention (PCI). Annual hospital volume was calculated using unique identification numbers and divided into quartiles for analysis.Methods and ResultsWe built a hierarchical two level model adjusted for multiple confounding factors, with hospital ID incorporated as random effects in the model. About 665,804 procedures (weighted n = 3,277,884) were analyzed. Safety concerns arising in 2006 reduced utilization DES from 90% of all PCIs performed in 2006 to a nadir of 69% in 2008 followed by increase (76% of all stents in 2009) and plateau (75% in 2011). Significant between‐hospital variation was noted in DES utilization irrespective of patient or hospital characteristics. Independent patient level predictors of DES were (OR, 95% CI, P‐value) age (0.99, 0.98–0.99, <0.001), female(1.12, 1.09–1.15, <0.001), acute myocardial infarction(0.75, 0.71–0.79, <0.001), shock (0.53, 0.49–0.58, <0.001), Charlson Co‐morbidity index (0.81,0.77–0.86, <0.001), private insurance/HMO (1.27, 1.20–1.34, <0.001), and elective admission (1.16, 1.05–1.29, <0.001). Highest quartile hospital (1.64, 1.25–2.16, <0.001) volume was associated with higher DES placement.ConclusionThere is significant between‐hospital variation in DES utilization and a higher annual hospital volume is associated with higher utilization rate of DES. © 2015 Wiley Periodicals, Inc.