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Transcatheter aortic valve implantation (TAVI) has increasingly been utilized in patients with aortic insufficiency (AI) with insufficient data on its safety. The Nationwide Readmissions Database (NRD) was queried to identify patients undergoing TAVI for AI. Net clinical events (composite of in-hospital mortality, stroke, major bleeding) and procedural complications were assessed using a propensity-score matched (PSM) analysis to calculate adjusted odds ratios (OR). A total of 185,703 (AI 3873, aortic stenosis [AS] 181,830) patients were included in the analysis. Due to a significant difference in the baseline characteristics, a matched sample of 7929 patients (AI 3873, AS 4056) was selected. At index admission, the adjusted odds of in-hospital NACE (aOR 2.0, 95% CI 1.59-2.51), mortality (aOR 3.06, 95% CI 2.38-5.47), major bleeding (aOR 1.53, 95% CI 1.13-2.06) and valvular complications (aOR 9.48, 95% CI 6.73-13.38) were significantly higher in patients undergoing TAVI for AI compared with those undergoing TAVI for AS. However, there was no significant difference in the incidence of NACE, mortality, stroke, major bleeding, and need for permanent pacemaker implantation at 30- and 180-days follow-up. TAVI in AI was associated with a higher risk of periprocedural NACE, mortality, and major bleeding. The risk of these complications attenuated at 30- and 180-day readmission., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) is the standard of care for patients with severe aortic valve stenosis (AS). However, evidence on its safety in patients with end-stage renal disease (ESRD) is limited., Methods: The Nationwide Readmissions Database (NRD) from 2015 to 2019 was queried to identify patients undergoing TAVI in ESRD versus patients with no ESRD. The in-hospital, 30-day and 180-day outcomes were assessed using a propensity-score matched (PSM) analysis to calculate adjusted odds ratios (aOR)., Results: A total of 198,816 underwent TAVI, of which 34,546 patients (TAVI-ESRD 16,986 vs. non-ESRD 17,560) were selected using PSM analysis. The adjusted odds of net adverse cardiovascular events (NACE) (aOR 1.65, 95 % CI 1.49-1.82), in-hospital mortality (aOR 2.99, 95 % CI 2.52-3.55), major bleeding (aOR 1.21, 95 % CI 1.05-1.40), postprocedural cardiogenic shock (aOR 1.54, 95 % CI 1.11-2.13), and need for permanent pacemaker implantation (PPM) (aOR 1.24, 95 % CI 1.15-1.38) were significantly higher in TAVI-ESRD patients compared with non-ESRD patients at index admission. There was no significant difference in the odds of stroke (aOR 1.09, 95 % CI 0.86-1.34) and cardiac tamponade (aOR 1.06, 95 % CI 0.78-1.45) between the two groups. At 30- and 180-day follow-up, the odds of readmission, NACE, and mortality remained high in TAVI-ESRD patients., Conclusion: ESRD patients undergoing TAVI have a high risk of NACE, in-hospital mortality, and major bleeding compared with patients with no ESRD., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) has increasingly been utilized in patients with bicuspid aortic valve (BAV) related aortic stenosis (AS) with insufficient large-scale data on its safety., Methods: The Nationwide Inpatient Sample and Nationwide Readmission Database (2011-2018) were queried to identify patients undergoing TAVI for BAV versus trileaflet aortic valve (TAV) associated AS. The in-hospital, 30- and 180-day odds of outcomes were assessed using a propensity-matched analysis (PSM) to calculate adjusted odds ratios (aOR) with its 95% confidence interval (CI)., Results: A total of 216,723 TAVI (TAV: 214,050 and BAV: 2,673) crude and 5,347 matched population (TAV: 2,674 and BAV: 2,673) was included in the final analysis. At index admission, the adjusted odds of in-hospital mortality (aOR: 1.57, 95% CI: 0.67-3.66), stroke (aOR: 0.77, 95% CI: 0.38-1.57), cardiac tamponade (aOR: 0.75, 95% CI: 0.17-3.36), vascular complications (aOR: 0.33, 95% CI: 0.09-1.22), cardiogenic shock (aOR: 1.77, 95% CI: 0.93-3.38), paravalvular leak (aOR: 0.55, 95% CI: 0.26-1.14), need for mechanical circulatory support device, and permanent pacemaker implantation (PPM) (aOR: 1.02, 95% CI: 0.69-1.52) were not significantly different between TAVI for BAV versus TAV. At 30- and 180-day follow-up duration, the risk of stroke and major postprocedural complications remained similar, except that TAVI in BAV had a higher incidence of PPM implantation compared with TAV. The yearly trend showed an increase in the utilization of TAVI for both TAV and BAV and a steady decline in the overall annual rate of in-hospital complications., Conclusion: TAVI utilization in patients with BAV has increased over the recent years. The relative odds of in-hospital mortality, and all other major complications, were similar between patients undergoing TAVI for BAV- and TAV-related AS., (© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: With advancements in cancer treatment, the life expectancy of oncology patients has improved. Thus, transcatheter aortic valve replacement (TAVR) may be considered as a feasible option for oncology patients with severe symptomatic aortic stenosis (AS). We aim to evaluate the difference in short- and long-term all-cause mortality in cancer and non-cancer patients treated with TAVR for severe AS., Methods: Medline, PubMed, and Cochrane Central Register of Controlled Trials were searched for relevant studies. Patients with cancer who underwent treatment with TAVR for severe AS were included and compared to an identical population without cancer. The primary endpoints were short- and long-term all-cause mortality., Results: Of 899 studies included, 8 met inclusion criteria. Cancer patients had significantly higher long-term all-cause mortality after TAVR when compared to patients without cancer (risk ratio [RR] 1.43; 95% confidence interval (CI) 1.26-1.62; P < 0.01). Four studies evaluated short-term mortality after TAVR and demonstrated no difference in it in patients with and without cancer (RR 0.72; 95% CI 0.47-1.08; P = 0.11)., Conclusion: Patients with cancer and severe AS have higher long-term all-cause mortality after TAVR. However, we found no difference in short-term all-cause mortality when comparing patients with and without cancer. The decision to perform TAVR in cancer patients should be individualized based on life expectancy and existing co-morbidities., (© 2022. The Author(s).)

Background: Patients with end-stage renal disease (ESRD) were excluded from all major trials on the safety of transcatheter aortic valve replacement (TAVR). This study aims to identify the predictors of mortality due to the rising rate of TAVR utilization and subsequent mortality in patients with ESRD., Methods: The National Inpatient Sample (NIS) (2002-2017) was queried to identify all patients with ESRD undergoing TAVR. The trend of all-cause mortality and its predictors were determined using a binary logistic regression model to obtain adjusted odds ratios (aOR)., Results: A total of 6836 patients (6341 survived, 495 died) were included in the analysis. The proportion of demographic and baseline comorbidities for survived vs. non-survived was nearly identical between the two groups. A rising trend in the utilization and mortality of TAVR in ESRD was noted. The adjusted odds of mortality was significantly higher for hypertension (6.92, 95% CI 3.78-12.66, p ≤ 0.0001), liver disease (4.51, 955 CI 3.30-6.17, p ≤ 0.0001), drug abuse (aOR 34.88, 95% CI 12.79-95.13, p ≤ 0.0001), periprocedural pneumonia (aOR 2.80, 95% CI 1.98-3.96, p ≤ 0.0001), cardiogenic shock (aOR, 5.97, 95% CI 4.63-7.70, p ≤ 0.0001), ST-elevation myocardial infarction (aOR 5.13, 95% CI 2.29-11.49, p ≤ 0.0001) and third-degree heart block (aOR 1.47, 955 CI 1.10-1.97, p0.01) in patients with ESRD undergoing TAVR. The mean length of stay and mean number of diagnoses recorded were also significantly higher for non-surviving TAVR patients., Conclusion: Baseline hypertension, liver disease, third-degree heart block, periprocedural pneumonia, cardiogenic shock and STEMI can significantly increase the in-hospital mortality rate in ESRD patients undergoing TAVR., Competing Interests: Declaration of competing interest None., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Introduction: The comparative efficacy and safety of valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) and redo-surgical AVR (redo-SAVR) in patients with degenerated bioprosthetic aortic valves remain unknown., Method: Digital databases were searched to identify relevant articles. Unadjusted odds ratios for dichotomous outcomes were calculated using a random effect model. A total of 11 studies comprising 8326 patients (ViV-TAVR = 4083 and redo-SAVR = 4243) were included., Results: The mean age of patients undergoing ViV-TAVR was older, 76 years compared to 73 years for those undergoing SAVR. The baseline characteristics for patients in ViV-TAVR vs. redo-SAVR groups were comparable. At 30-days, the odds of all-cause mortality (OR 0.45, 95% CI 0.30-0.68, p = .0002), cardiovascular mortality (OR 0.44, 95% CI 0.26-0.73, p = .001) and major bleeding (OR 0.29, 95% CI 0.15-0.54, p = .0001) were significantly lower in patients undergoing ViV-TAVR compared to redo-SAVR. There were no significant differences in the odds of cerebrovascular accidents (OR 0.91, 95% CI 0.52-1.58, p = .74), myocardial infarction (OR 0.92, 95% CI 0.44-1.92, p = .83) and permanent pacemaker implantation (PPM) (OR 0.54, 95% CI 0.27-1.07, p = .08) between the two groups. During mid to long-term follow up (6-months to 5-years), there were no significant differences between ViV-TAVR and redo-SAVR for all-cause mortality, cardiovascular mortality and stroke. ViV-TAVR was, however, associated with higher risk of prosthesis-patient mismatch and greater transvalvular pressure gradient post-implantation., Conclusion: ViV-TAVR compared to redo-SAVR appears to be associated with significant improvement in short term mortality and major bleeding. For mid to long-term follow up, the outcomes were similar for both groups., (© 2021 Wiley Periodicals LLC.)

Background As transcatheter aortic valve replacement (TAVR) technology expands to healthy and lower-risk populations, the burden and predictors of procedure-related complications including the need for permanent pacemaker (PPM) implantation needs to be identified. Methods and Results Digital databases were systematically searched to identify studies reporting the incidence of PPM implantation after TAVR. A random- and fixed-effects model was used to calculate unadjusted odds ratios (OR) for all predictors. A total of 78 studies, recruiting 31 261 patients were included in the final analysis. Overall, 6212 patients required a PPM, with a mean of 18.9% PPM per study and net rate ranging from 0.16% to 51%. The pooled estimates on a random-effects model indicated significantly higher odds of post-TAVR PPM implantation for men (OR, 1.16; 95% CI, 1.04-1.28); for patients with baseline mobitz type-1 second-degree atrioventricular block (OR, 3.13; 95% CI, 1.64-5.93), left anterior hemiblock (OR, 1.43; 95% CI, 1.09-1.86), bifascicular block (OR, 2.59; 95% CI, 1.52-4.42), right bundle-branch block (OR, 2.48; 95% CI, 2.17-2.83), and for periprocedural atriorventricular block (OR, 4.17; 95% CI, 2.69-6.46). The mechanically expandable valves had 1.44 (95% CI, 1.18-1.76), while self-expandable valves had 1.93 (95% CI, 1.42-2.63) fold higher odds of PPM requirement compared with self-expandable and balloon-expandable valves, respectively. Conclusions Male sex, baseline atrioventricular conduction delays, intraprocedural atrioventricular block, and use of mechanically expandable and self-expanding prosthesis served as positive predictors of PPM implantation in patients undergoing TAVR.

Background: The risk of prosthetic valve endocarditis (PVE) in patients who underwent transcatheter aortic valve replacement (TAVR) is presumed to be high., Methods: Electronic databases were searched to identify articles comparing the rate of PVE in post-TAVR and post-surgical aortic valve replacement (SAVR) patients. Pooled adjusted odds ratio (OR) was computed using a random-effects model., Results: A total of 19 studies consisting of 84,288 patients, were identified. There was no significant difference in the odds of PVE between patients undergoing TAVR and SAVR, at 30-day (OR 0.62, 95% confidence interval (CI) 0.20-1.92, p = 0.41), 1-year (OR 0.99 95% CI 0.89-1.11, p = 0.84), 2-year (OR 1.02 95% CI 0.68-1.54, p = 0.92) and 5-year (OR 1.03 95% CI 0.80-1.33, p = 0.81). A subgroup sensitivity analysis also showed no significant inter-group differences in the rate of PVE at all time points, when stratified by the study design (clinical trial vs. observational), type of TAVR valves used (self-expanding bioprosthetic valves vs. balloon expanded bioprosthetic valves) and surgical risk of patients (high vs. intermediate vs. low). There was no heterogeneity (I2 = 0%) in the outcomes of the included studies at 30-day, 1-year and 2-year, while the heterogeneity in studies at 5-year was minimal (I2 = 22%)., Conclusions: In comparison to SAVR, both short and long-term risk of prosthetic valve endocarditis appears to be identical in patients undergoing TAVR. This risk is unaffected by the type of valve, duration of follow-up, study design and surgical risk of the patients., Competing Interests: Declaration of competing interest None., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The management of patients with severe but asymptomatic aortic stenosis is challenging. Evidence on early aortic valve replacement (AVR) versus symptom-driven intervention in these patients is unknown., Methods: Electronic databases were searched, articles comparing early-AVR with conservative management for severe aortic stenosis were identified. Pooled adjusted odds ratio (OR) was computed using a random-effect model to determine all-cause and cardiovascular mortality., Results: A total of eight studies consisting of 2201 patients were identified. Early-AVR was associated with lower all-cause mortality [OR 0.24, 95% confidence interval (CI) 0.13-0.45, P ≤ 0.00001] and cardiovascular mortality (OR 0.21, 95% CI 0.06-0.70, P = 0.01) compared with conservative management. The number needed to treat to prevent 1 all-cause and cardiovascular mortality was 4 and 9, respectively. The odds of all-cause mortality in a selected patient population undergoing surgical AVR (SAVR) (OR 0.16, 95% CI 0.09-0.29, P ≤ 0.00001) and SAVR or transcatheter AVR (TAVR) (OR 0.53, 95% CI 0.35-0.81, P = 0.003) were significantly lower compared with patients who are managed conservatively. A subgroup sensitivity analysis based on severe aortic stenosis (OR 0.24, 95% CI 0.11-0.52, P = 0.0004) versus very severe aortic stenosis (OR 0.20, 95% CI 0.08-0.51, P = 0.0008) also mirrored the findings of overall results., Conclusion: Patients with asymptomatic aortic valve stenosis have lower odds of all-cause and cardiovascular mortality when managed with early-AVR compared with conservative management. However, because of significant heterogeneity in the classification of asymptomatic patients, large scale studies are required.

Aim: TAVR in patients with bicuspid aortic valves (BAV) is more challenging compared to individuals with trileaflet aortic valves (TAV). BAV have been excluded from the large randomized clinical trials assessing transcatheter aortic valve replacements (TAVR) and has been considered as a relative contraindication to TAVR. To report the outcomes of TAVR in BAV and compare them to TAV in the National Inpatient Sample (NIS)., Methods and Results: TAVR procedures were identified between 2011 and 2014 in the NIS dataset. Endpoints assessed included in-hospital mortality, periprocedural complications, length of stay and cost. Of 40,604 identified TAVR procedures, 407 (1%) were BAV and the 40,197 (99%) were TAV. Patients with BAV were younger and had a lower comorbidity burden. In hospital mortality (4.89% vs 4.17%, OR: 1.71, 95%CI: 0.57-5.12, P = 0.21), AMI (3.49% vs 3.58%, OR: 1.12, 95%CI: 0.36-3.54, P = 0.85), stroke and TIA (2.49% vs 3.55%, OR: 0.75, 95%CI: 0.18-3.16, P = 0.70), vascular complications (2.39% vs 5.58%, OR:0.47, 95%CI: 0.11-1.93, P = 0.29), major bleeding (16.96% vs 23.50%, OR: 0.63, 95%CI: 0.34-1.17, P = 0.15) and rates of permanent pacemaker (PPM) (9.88% vs 10.88%, OR: 1.19, 95%CI: 0.57-2.51, P = 0.64) were similar in both cohorts., Conclusions: With multimodality imaging and further improvement in technology, our study demonstrates off-label TAVR should not be considered prohibitive and can be successfully performed for BAV with similar peri-procedural outcomes compared to those with TAV. However, there is a need for robust large prospective studies., (Copyright © 2018 Elsevier Inc. All rights reserved.)