Schreiber, Theodore

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.

AbstractHealth care practices are influenced by variety of factors. These factors that include social determinants, race and ethnicity, and gender not only affect access to health care but can also affect quality of care and patient outcomes. These are a source of health care disparities. This article acknowledges that these disparities exist in getting optimal care in structural heart disease, reviews the literature and proposes steps that can help reduce these disparities on personal and committee levels.

AbstractObjectivesTo assess the in‐hospital mortality and complications in female between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).BackgroundFemale is one of the risk factors for increased adverse events in cardiac surgery.Methods and resultsNationwide Inpatient Sample database was queried from 2011 to 2014 for patients who underwent TAVR or SAVR in female patients. The primary endpoint was in‐hospital all‐cause mortality and second endpoints were perioperative complications. We performed a propensity score analysis to calculate the adjusted odds ratio (OR) for each outcome. Patients who had concomitant cardiac surgery and those who had TAVR or SAVR mainly for aortic regurgitation were excluded. Our query from 2011 to 2014 resulted in a total of 3,067 TAVR and 18,594 SAVR in female patients. TAVR patients were in general elder and had a higher burden of comorbidities. The primary endpoint was similar between TAVR and SAVR (4.2% vs. 3.9%, OR 1.0, P = 0.89). Compared to SAVR, female TAVR patients had less hemorrhage requiring transfusion (12% vs. 21%, OR 0.41, P < 0.001), perioperative cardiac arrest and nonfatal myocardial infarction (9.8% vs. 17%, OR 0.38, P < 0.001), respiratory complication (1.6% vs. 4.4%, OR 0.28, P < 0.001), post‐op sepsis (1.7% vs. 2.9%, OR 0.65, P = 0.03), acute myocardial infarction (3.0% vs. 4.9%, OR 0.60, P < 0.001), and acute kidney injury (15% vs. 18%, OR 0.62, P < 0.001). Conversely, female TAVR patients had significantly increased risk of new pacemaker implantation (11% vs. 5.9%, OR 1.7, P < 0.001) and use of extracorporeal membrane oxygenation (0.66% vs. 0.24%, OR 2.8, P < 0.001). TAVR patients had less nonroutine discharge. The median hospital cost was significantly higher in TAVR than SAVR (median $51,274 vs. $43,677, P < 0.001) but the length of stay was shorter (mean 7.8 days vs. 10.5 days).ConclusionsTAVR may be a better option for those patients with underlying comorbidities that predispose them at higher risk for complications that was less observed in TAVR group. However, higher cost and increased risk of need for extracorporeal membrane oxygenation, although rare, should be taken into consideration upon deciding the optimal mode for aortic valve replacement.

AbstractObjectivesTo summarize the published data of combined transcatheter aortic and mitral valve intervention (CTAMVI).BackgroundCTAMVI, a combination of either transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve‐in‐valve (TAViV) and transcatheter mitral valve replacement (TMVR), transcatheter mitral valve‐in‐valve/valve‐in‐ring (TMViV/ViR), or percutaneous mitral valve repair (PMVR) is an attractive alternative in high‐surgical risk patients with combined aortic and mitral valve disease. However, its procedural details and clinical outcomes have not been well described.MethodsWe performed a systematic review of all the published articles from PUBMED and EMBASE.ResultsA total of 37 studies with 60 patients were included. The indication for CTAMVI was high or inoperable surgical risk and symptomatic severe aortic stenosis (92%) or severe aortic regurgitation (8%) combined with moderate to severe/severe mitral stenosis (30%) or moderate/severe mitral regurgitation (65%) or both (5%). In majority of the cases, aortic valve intervention was performed prior to the mitral valve. Mortality rate were 25% for TAVR + TMVR (range 42 days to 10 months), 17% for TAVR + TMViV/ViR (range 13 days to 6 months), 0% for TAViV + TMViV/ViR (range 6–365 days), and 15% for TAVR/ViV + PMVR (range 17 days to 419 days). Significant (more than moderate) paravalvular regurgitation post‐procedure was rare.ConclusionsCTAMVI appears to confer reasonable clinical outcome. Further large study is warranted to clarify the optimal strategy, procedural details and clinical outcomes in the future.

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.

ObjectiveThe aim of the study was to assess the utilization of catheter‐directed thrombolysis (CDT) and its comparative effectiveness against systemic thrombolysis in acute pulmonary embolism (PE).BackgroundContemporary real world data regarding utilization and outcomes comparing systemic thrombolysis with CDT for PE is sparse.MethodsWe queried the Nationwide Inpatient Sample from 2010 to 2012 using the ICD‐9‐CM diagnosis code 415.11, 415.13, and 415.19 for acute PE. We used propensity score analysis to compare outcomes between systemic thrombolysis and CDT. Primary outcome was in‐hospital mortality. Secondary outcome was combined in‐hospital mortality and intracranial hemorrhage (ICH).ResultsOut of 110,731 patients hospitalized with PE, we identified 1,521 patients treated with thrombolysis, of which 1,169 patients received systemic thrombolysis and 352 patients received CDT. After propensity‐matched comparison, primary and secondary outcomes were significantly lower in the CDT group compared to systemic thrombolysis (21.81% vs. 13.36%, OR 0.55, 95% CI 0.36–0.85, P value = 0.007) and (22.89% vs. 13.36%, OR 0.52, 95% CI 0.34–0.80, P value = 0.003), respectively. The median length of stay [7 days, interquartile range (IQR) (5–9 days) vs. 7 days, IQR (5–10 days), P = 0.17] was not significant between the two groups. The CDT group had higher cost of hospitalization [$17,218, IQR ($12,272–$23,906) vs. $23,799, IQR ($17,892–$35,338), P < 0.001]. Multivariate analysis identified increasing age, saddle PE, cardiopulmonary arrest, and Medicaid insurance as independent predictors of in‐hospital mortality.ConclusionsCDT was associated with lower in‐hospital mortality and combined in‐hospital mortality and ICH. © 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.

Abstract Objectives To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre‐PCI) versus those who received it after PCI (post‐PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI). Background Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized. Methods Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end‐point was survival to discharge. Secondary end‐points included assessment of patients' hemodynamics and in‐hospital complications. A multivariate regression model was used to identify independent predictors for mortality. Results Both groups were comparable except for diabetes (P = 0.02), peripheral vascular disease (P = 0.008), chronic obstructive pulmonary disease (P = 0.05), and prior stroke (P = 0.04), all of which were more prevalent in the pre‐PCI group. Patients in the pre‐PCI group had more lesions (P = 0.006) and vessels (P = 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post‐PCI group (65.1% vs.40.7%, P = 0.003). Survival remained favorable for the pre‐PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in‐hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17–0.79, P = 0.01) in multivariate analysis. The incidence of in‐hospital complications included in the secondary end‐point was similar between the 2 groups. Conclusions The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI. (J Interven Cardiol 2014;27:1–11)