Patel, Samir

Introduction: The treatment options for high and extreme-risk patients with severe symptomatic aortic stenosis have changed significantly over the past decade because of advances in transcatheter aortic valve replacement (TAVR). However new permanent pacemaker implant (PPI) remains an impending concern after TAVR. Hypothesis: We sought to determine the frequency, predictors and outcomes of patients requiring PPI after TAVR. Methods: We queried the National Inpatient Sample (NIS) database using the ICD-9-CM procedure code of 35.05 for transfemoral/transaortic and 35.06 for transapical replacement of aortic valve .We identified TAVR procedures associated with new permanent pacemaker implants using appropriate validated ICD-9-CM codes. Using multivariate analysis we further identified predictors of PPM implants Results: An estimated 8828 TAVR procedures were performed in United States between 2011-2012. 773 (8.7%) TAVR procedures were associated with PPIs. PPI were higher in older (age>80 years), White race, diabetics, left bundle branch block (LBBB), right bundle branch block (RBBB), transfemoral approach. The inhospital mortality ( 5.2% vs.4.6% ) , mean length of stay ( 9.8 vs. 8.3 days ) disposition to short term nursing facility was higher (38.2% vs. 32.1%) and mean total costs (82217$ vs. 52283$) was higher in TAVR + PPI group . On multivariate analysis, Age in 5 year increment [Odds ratio (OR) 1.11; Confidence interval (CI) 1.05-1.17, p<0.001], diabetes [OR 1.26; CI 1.07-1.49, p<0.001], LBBB [OR 1.99; CI 1.55-2.56, p<0.001], RBBB [OR 5.36; CI 3.80-7.55, p<0.001] were independent predictors of PPI. Transfemoral approach was associated with more PPI implants [OR 1.41; CI 1.12 -1.78, p<0.001] Conclusion: Age, baseline conduction system disturbances, diabetes, transfemoral approach emerged as independent predictors of PPI after TAVR. This study provides useful tools to identify high-risk patients for PPI after TAVR.

Background: There is lack of data regarding impact of atherectomy on the length of stay (LOS) and cost of hospitalization in lower extremity arterial revascularization. Methods: HCUP’s Nationwide Inpatient Sample (NIS) 2012 was queried using the ICD-9- CM code for peripheral vascular disease and procedural codes 39.90 (bare metal stent - BMS), 00.55 (drug eluting stent - DES), 17.56 (peripheral atherectomy) and 39.50 for angioplasty. Only procedures performed in patients ≥18 years of age were included. Hierarchical mixed effects linear regression models were generated to evaluate multivariate predictors of LOS and hospitalization costs. Results: A total of 13,206 (weighted: 66,030) lower extremity arterial revascularizations were identified (43.8% female & 65.5% white). Out of these, atherectomy was utilized in 23.2%. Atherectomy utilization was associated with significant reduction in LOS (4.96 ± 0.11 days vs. 5.78 ± 0.07 days, p <0.001) but higher hospitalization cost ($ 25196 ± 359 vs. $ 23408 ± 185, p < 0.001). Multivariate analysis showed similar results with decrease in LOS (-0.71 days, -1.00 - - 0.43; p < 0.001) but higher hospitalization cost (+1875 $, +811 - +2940; p = 0.001) with atherectomy, which was matched by propensity score analysis. Additionally, emergent/urgent & weekend admissions and Charlson score ≥2 were further associated with increased LOS and hospitalization costs. (Figure) Conclusion: Our study demonstrates that atherectomy utilization is associated with significant reduction in length of stay, which was counterbalanced by a slight increase in hospitalization costs following lower extremity arterial revascularization.

Introduction: Use of transcatheter endovascular stenting has been increasing in the treatment of Coarctation of Aorta (CoA). The present study was undertaken on adults with CoA undergoing stent placement from the period of 2000 to 2011 to analyze the relationship of hospital volume to the outcomes of stenting in adults with CoA. Methods: We queried Healthcare Cost and Utilization Project (HCUP)’s Nationwide Inpatient Sample (NIS) database from 2000 to 2011. Patients with CoA were identified using ICD-9-CM diagnosis code of 747.10. Patients≥18 years of age undergoing endovascular stenting were identified using ICD-9-CM procedure code of 39.90. Hospital volume was divided into two groups with ≥3 and <3 procedures annually. The outcomes studied were procedure-related complications, length of stay (LOS), and cost in relation to the hospital volume. Complications were coded using specific patient safety indicator codes released by HCUP. Length of stay (≤1 and >1 days) and cost (≤ $13,830 and > $13,830) were divided at median and included in regression analysis. Results: No in-hospital death was reported in either group. Hospitals with ≥3 procedures annually had significantly lower incidence of complications (9.50% vs. 23.01%) compared to the hospitals with <3 procedures annually (p=0.002). After multivariate regression analysis, compared to hospitals with <3 procedures annually, the hospitals with ≥3 procedures annually had odds ratio (OR) of 0.40 (95% CI: 0.19-0.82, p=0.013) for having any complications, OR of 0.67 (95% CI: 0.39-1.17, p=0.15) for having LOS>1 day, and OR of 0.72 (95% CI: 0.45-1.13, p=0.15) for having cost>$13,830. Conclusion: Stenting in adults for aortic coarctation is remarkably safe and the outcomes of the procedure have improved in centers with annual hospital volume of ≥3 procedures, and there is also decreasing trend of procedure-related complications, shorter hospital stay, and lower costs compared to centers with annual volume <3 procedures.

Introduction: The data regarding use of different Mechanical Circulatory Support (MCS) devices in TAVR is limited. The present study was performed to analyze the complications and outcomes of different MCS in TAVR. Methods: The subjects under study were obtained from Nationwide Inpatient Sample (NIS) for the years 2011-12 using ICD-9-CM procedure codes for TAVR and MCS. The use of MCS was divided into Intra-aortic balloon pump (IABP), percutaneous ventricular assist devices (PVADs) including Impella and TandemHeart, Extracorporeal membrane oxygenation (ECMO) and percutaneous cardiopulmonary support and cardiopulmonary bypass (CBP) using ICD-9-CM codes. The incidence of in-hospital mortality and occurrence of procedure related complications were analyzed. Results: Out of total 1794 TAVR procedures, MCS was utilized in 190 (10.6%) procedures. CBP was the most commonly utilized 136 (71.6%) followed by IABP 36 (18.9%), ECMO 14 (7.4%) and 4 (2.1%). In-hospital mortality was highest with use of IABP (36.6%), followed by ECMO (14.3%), CBP (9.6%) and PVAD (0%) with p-value <0.01. The incidence of complications was similar in IABP and PVAD (100% each) followed by ECMO (85.7%) and CBP (59.4%) with p-value <0.01. Conclusion: Being retrospective in design, the present study has no information regarding indications and individual patient related variables in which each of the MCS devices used. Overall, CBP was observed as the most extensive used MCS modality with less mortality (9.6%) and least complications (59.4%).

Introduction: Over the past decade, Transcatheter Aortic Valve Replacement (TAVR) has emerged as a therapeutic option for treating severe aortic stenosis in high-risk patients. Patients with liver cirrhosis are at high risk for operative morbidity and mortality when they undergo cardiac surgery. In the present study, in-hospital outcomes are compared in cirrhotic patients undergoing TAVR vs. Surgical Aortic Valve Replacement (SAVR). Methods: The study population was derived from the National Inpatient Sample (NIS) for the years 2011 and 2012 using the International Classification of Diseases, 9th Revision, Clinical Modification (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 with concomitantly other valvular procedures were excluded. ICD-9-CM diagnosis codes were used to identify patients with liver cirrhosis including those with other manifestations of cirrhosis such as portal hypertension and esophageal varices. Using propensity score matching, two matched cohorts were derived in which the outcomes were compared using chi-square test, fisher’s exact test, and student’s t-test. Results: There were 30 cirrhotic patients in the SAVR and TAVR group each after propensity score matching. Compared to the TAVR group, the patients in the SAVR group had higher mean cost of hospitalization ($79,263 vs. $63,913, p=0.12), mean post-procedural length of stay (14.3 days vs. 6.2 days, p<0.01), any complications rate (80.0% vs. 60.0%, p=0.09), rate of transfusion of blood or blood products (56.7% vs. 30.0%, p=0.037) and liver complications rate (20.0% vs. 10.0%, p=0.4). The in-hospital mortality rate was same in both the groups (6.7%). Conclusions: In high-risk cirrhotic patients, TAVR is a viable option for aortic valve replacement compared to SAVR.

Introduction: Short-term use of Mechanical Circulatory Support (MCS) has the potential to benefit the patients undergoing Transcatheter Aortic Valve Replacement (TAVR) who may be high-risk or suffer complications. The present study was conducted to address the contemporary use of MCS in TAVR procedures. Methods: The study included a total of 1794 TAVR procedures in the years 2011-2012 from Nationwide Inpatient Sample (NIS) database. Use of MCS was identified using ICD-9-CM codes. The patients were divided based on use of MCS devices. The primary outcome of the study was in-hospital mortality and the secondary outcomes were complications, length of stay (LOS) and cost. Multi-variate simple logistic regression models were used to identify independent predictors of the outcomes. Results: Out of total 1794 TAVR procedures, 190 (10.6 %) utilized a MCS device (MCS group) and 1,604 (89.4%) did not (non-MCS group). The use of MCS devices with TAVR was associated with increase in the in-hospital mortality (14.9% vs. 3.5%, p<0.01) with same results obtained in multi-variate models. The rates of complications were significantly higher in MCS group so as the mean length of stay (11.8±0.8 vs. 8.1±0.2 days, p<0.01) and cost ($68,997±3,656 vs. $55,878±653, p=0.03). Conclusion: Use of MCS in TAVR predicts increase in-hospital mortality, complications, LOS and cost of care.

Background: Contemporary outcome data regarding effects of atherectomy in lower extremity arterial revascularization is lacking. Methods: We queried HCUP’s Nationwide Inpatient Sample (NIS) for 2012 using the appropriate primary ICD 9-CM diagnostic code for peripheral vascular disease and procedural codes 39.90 (bare metal stent - BMS), 00.55 (drug eluting stent - DES), 17.56 (peripheral artherectomy) and 39.50 for angioplasty. Only procedures performed in patients >= 18 years were included. Hierarchical mixed effects logistic regression models were generated to evaluate multivariate predictors of outcomes. Results: In total 13,206 (weighted: 66,030) lower extremity arterial revascularization were analyzed (65.5% white, 56.2% Male & 97.4% angioplasty). Atherectomy utilization (23.2%) was associated with significant reduction in amputation (11.5% vs 13.4%), any complications (13.2% vs 16.3%) and in hospital morality (0.8% vs 1.4%) compared to no atherectomy group (p < 0.001). Multivariate analysis showed similar results with decrease amputation (OR, 95% CI; p - value) (0.83, 0.71 - 0.97, p = 0.02) and in hospital mortality/any complication (0.79, 0.69 - 0.90, p = 0.001) with atherectomy (similar results were observed with propensity score matching). “Atherectomy only” was utilized only in 2.3%. post-hoc analysis also shows better outcomes when atherectomy was used with either angioplasty or stenting (figure a & b). subgroup multivariate analysis shows significant reduction in amputation when atherectomy was utilized in chronic limb ischemia (0.74, 0.59 - 0.93, p = 0.01) and with angioplasty (0.72, 0.60 - 0.87, p = 0.001) and trend towards advantage while used along with stents but not reaching statistical significant. Conclusion: Lower extremity atherectomy utilization was associated with significant reduction in amputation and overall complication. We observed better outcomes when atherectomy was used in conjunction with angioplasty.

Introduction: With the technical advancements and expanding indications, utilization of TAVR is on the rise among various institutions in the United States .While appropriate patient selection and better techniques are essential to improving outcomes, the impact of institutional design (or hospital setting) on outcomes with TAVR has yet to be examined. Objective: The objective of our study is to compare TAVR complication rates among teaching vs non-teaching centers in the United States Methods: We used Healthcare Cost and Utilization Project - National Inpatient Sample (NIS) data , the largest all payer database of hospital inpatient stay available in United States, to identify patients (age ≥18 years) who underwent TAVR from Jan-Dec 2012. We constructed multivariable models to determine independent predictors (age, sex, race, Charlson’s comorbidity index, hospital size, hospital location and TAVR approach) of TAVR-associated complications. Statistical analysis was performed using Stata IC 11.0 (Stata-Corp, College Station, TX). Results: We identified 7,405 TAVR procedures performed in the United States in 2012. 88% of TAVR were performed in teaching centers. There was no difference in mortality following TAVR between teaching and non-teaching centers. The occurrence of any in-hospital complication was lower in teaching centers as compared to non-teaching centers (42% vs. 50%, p<0.001). Rates of individual complications in teaching vs. non-teaching centers are illustrated in the figure. In adjusted analysis, hemorrhage requiring transfusion (13.2% vs. 20.8%, p<0.001), renal complications requiring dialysis (1.2% vs. 2.3%, p=0.009), respiratory complications (7.5% vs. 11%, p<0.001) and complications requiring open-heart surgery (2% vs. 4.6%, p<0.001) were lower in teaching centers as compared to non-teaching centers. Vascular access site complications, pacemaker insertion, pericardial and neurological complications were similar between teaching and non-teaching centers (Figure). Conclusion: Institutional design impacts TAVR complication rates albeit no difference in mortality. In general, complication rates are lower in teaching centers compared to non-teaching centers.

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.