New-Onset Atrial Fibrillation After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

ObjectivesThe authors aimed to identify risk factors and outcomes associated with new-onset atrial fibrillation (NOAF) after transcatheter aortic valve replacement (TAVR).BackgroundNOAF is a common complication after TAVR, although estimates of the precise occurrence are variable. This study sought to quantify the occurrence of NOAF after TAVR and to explore the outcomes and predictors associated with this complication.MethodsWe searched Medline, EMBASE, and the Cochrane database from 2016 to 2020 for articles that reported NOAF after TAVR. We extracted data for studies published before 2016 from a previous systematic review. We pooled data using a random effects model.ResultsWe identified 179 studies with 241,712 total participants (55,271 participants with pre-existing atrial fibrillation (AF) were excluded) that reported NOAF from 2008 to 2020. The pooled occurrence of NOAF after TAVR was 9.9% (95% CI: 8.1%-12%). NOAF after TAVR was associated with a longer index hospitalization (mean difference = 2.66 days; 95% CI: 1.05-4.27), a higher risk of stroke in the first 30 days (risk ratio [RR]: 2.35; 95% CI: 2.12-2.61), 30-day mortality (RR: 1.76; 95% CI: 1.12-2.76), major or life-threatening bleeding (RR: 1.60; 95% CI: 1.39-1.84), and permanent pacemaker implantation (RR: 1.12; 95% CI: 1.05-1.18). Risk factors for the development of NOAF after TAVR included higher Society of Thoracic Surgeons score, transapical access, pulmonary hypertension, chronic kidney disease, peripheral vascular disease, and severe mitral regurgitation, suggesting that the risk for NOAF is highest in more comorbid TAVR patients.ConclusionsNOAF is common after TAVR. Whether AF after TAVR is a causal factor or a marker of sicker patients remains unclear.     

Comparison of postprocedural new-onset atrial fibrillation between transcatheter and surgical aortic valve replacement: A systematic review and meta-analysis based on 16 randomized controlled trials

Background:Presently, transcatheter aortic valve replacement (TAVR) as an effective and convenient intervention has been adopted extensively for patients with severe aortic disease. However, after surgical aortic valve replacement (SAVR) and TAVR, the incidence of new-onset atrial fibrillation (NOAF) is prevalently found. This meta-analysis was designed to comprehensively compare the incidence of NOAF at different times after TAVR and SAVR for patients with severe aortic disease.Methods:A systematic search of PubMed, Embase, Cochrane Library, and Web of Science up to October 1, 2020 was conducted for relevant studies that comparing TAVR and SAVR in the treatment of severe aortic disease. The primary outcomes were the incidence of NOAF with early, midterm and long term follow-up. The secondary outcomes included permanent pacemaker (PM) implantation, myocardial infarction (MI), cardiogenic shock, as well as mortality and other complications. Two reviewers assessed trial quality and extracted the data independently. All statistical analyses were performed using the standard statistical procedures provided in Review Manager 5.2.Results:A total of 16 studies including 13,310 patients were identified. The pooled results indicated that, compared with SAVR, TAVR experienced a significantly lower incidence of 30-day/in-hospital, 1-year, 2-year, and 5-year NOAF, with pooled risk ratios (RRs) of 0.31 (95% confidence interval [CI] 0.23–0.41; 5725 pts), 0.30 (95% CI 0.24–0.39; 6321 pts), 0.48 (95% CI 0.38–0.61; 3441 pts), and 0.45 (95% CI 0.37–0.55; 2268 pts) respectively. In addition, TAVR showed lower incidence of MI (RR 0.62; 95% CI 0.40–0.97) and cardiogenic shock (RR 0.34; 95% CI 0.19–0.59), but higher incidence of permanent PM (RR 3.16; 95% CI 1.61–6.21) and major vascular complications (RR 2.22; 95% CI 1.14–4.32) at 30-day/in-hospital. At 1- and 2-year after procedure, compared with SAVR, TAVR experienced a significantly higher incidence of neurological events, transient ischemic attacks (TIA), permanent PM, and major vascular complications, respectively. At 5-year after procedure, compared with SAVR, TAVR experienced a significantly higher incidence of TIA and re-intervention respectively. There was no difference in 30-day, 1-year, 2-year, and 5-year all-cause or cardiovascular mortality as well as stroke between TAVR and SAVR.Conclusions:Our analysis showed that TAVR was superior to SAVR in decreasing the both short and long term postprocedural NOAF. TAVR was equal to SAVR in early, midterm and long term mortality. In addition, TAVR showed lower incidence of 30-day/in-hospital MI and cardiogenic shock after procedure. However, pooled results showed that TAVR was inferior to SAVR in reducing permanent pacemaker implantation, neurological events, TIA, major vascular complications, and re-intervention.     

Transfemoral TAVR in Nonagenarians: From the CENTER Collaboration

ObjectivesThis study aimed to compare differences in patient characteristics and clinical outcomes of nonagenarians undergoing transcatheter aortic valve replacement (TAVR) versus patients younger than 90 years of age and to test the predictive accuracy of the logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), the EuroSCORE II, and the STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) for mortality after TAVR in nonagenarians.BackgroundThe prevalence of severe aortic valve stenosis is increasing due to the rising life expectancy. However, there are limited data evaluating outcomes in patients older than 90 years of age. Moreover, the predictive accuracy of risk scores for mortality has not been evaluated in nonagenarian patients undergoing transfemoral TAVR.MethodsThe CENTER (Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation) collaboration (N = 12,381) is an international collaboration consisting of 3 national registries, 6 local or multicenter registries, and 1 prospective clinical study, selected through a systematic online search. The primary endpoint of this study was the difference in 30-day all-cause mortality and stroke after TAVR in nonagenarians versus patients younger than 90 years of age. Secondary endpoints included differences in baseline characteristics, in-hospital outcomes, and the differences in predictive accuracy of the logistic EuroSCORE, the EuroSCORE II, and STS-PROM.ResultsA total of 882 nonagenarians and 11,499 patients younger than 90 years of age undergoing transfemoral TAVR between 2007 and 2018 were included. Nonagenarians had considerably fewer comorbidities than their counterparts. Nevertheless, rates of 30-day mortality (9.9% vs. 5.4%; relative risk [RR]: 1.8; 95% confidence interval [CI]: 1.4 to 2.3; p = 0.001), in-hospital stroke (3.0% vs. 1.9%; RR: 1.5; 95% CI: 1.0 to 2.3; p = 0.04), major or life-threatening bleeding (8.1% vs. 5.5%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.004), and new-onset atrial fibrillation (7.9% vs. 5.2%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.01) were higher in nonagenarians. The STS-PROM adequately estimated mortality in nonagenarians, with an observed-expected mortality ratio of 1.0.ConclusionsIn this large, global, patient-level analysis, mortality after transfemoral TAVR was 2-fold higher in nonagenarians compared with patients younger than 90 years of age, despite the lower prevalence of baseline comorbidities. Moreover, nonagenarians had a higher risk of in-hospital stroke, major or life-threatening bleeding, and new-onset atrial fibrillation. The STS-PROM was the only surgical risk score that accurately predicted the risk of mortality in nonagenarians.     

Incidence, 30-day readmission rates and predictors of readmission after new onset atrial fibrillation who underwent transcatheter aortic valve replacement

IntroductionNew onset Atrial Fibrillation (NOAF) is frequently seen post transcatheter aortic valve replacement (TAVR). NOAF in the setting of TAVR has also been recognized as predictor of worse outcomes, including higher readmission rates. Data assessing the effect and predictors of NOAF on 30-day readmission rates post TAVR is limited.ObjectiveTo assess the incidence, 30-day readmission rate and predictors of NOAF in patients who underwent TAVR.MethodsNationwide Readmissions Database was used to identify patients who developed NOAF post-TAVR between 2012 and 2015.ResultsA total of 24,076 patients were included in this study, of which 54% were males, and the mean age was 82.4 ± 7.2. NOAF was developed in 10,847 (45%) patients. Overall readmission rates with NOAF was 19.7% and trend in the readmissions reduced during the course of the study (21.9% to 18.7%, P_trend < 0.001). Thirty-day readmission rate in patients who developed NOAF post-TAVR was significantly higher compared to TAVR patients without NOAF (OR 1.39; 95% CI, 1.28–1.51; p < 0.001). Similarly, rate of ischemic stroke was significantly higher among patients who developed NOAF (OR 1.22; 95% CI, 1.07–1.4; p = 0.004). Predictors of readmissions in NOAF group were mostly non-cardiac, and included age, and comorbidities with chronic liver disease, renal failure and chronic lung disease been the most common comorbidities, in that order.ConclusionsIncidence of NOAF is associated with increased risk of readmissions and ischemic stroke. Future research should focus on interventions to prevent avoidable readmissions and associated morbidity and mortality.     

Transcatheter versus surgical aortic valve replacement in low-risk surgical patients: A meta-analysis of randomized clinical trials

BackgroundTranscatheter aortic valve replacement (TAVR) is a valid option for patients with high or intermediate surgical risk. However, clinical outcomes of TAVR in low-risk patients are lacking. Our aim was to evaluate the efficacy and safety of TAVR versus surgical aortic valve replacement (SAVR) in low-surgical-risk patients.MethodsElectronic database review was conducted for all randomized clinical trials (RCTs) that compared TAVR versus SAVR in low-risk patients. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) using a random-effects model.ResultsWe included 3 RCTs totaling 604 patients (310 TAVR and 294 SAVR). Our results showed no significant difference in mortality between TAVR compared with SAVR (RR = 0.71; 95% CI = 0.22–2.30; P = 0.56), however, there was a significantly increased risk of pacemaker implantation (RR = 7.28; 95% CI = 3.94–13.42; P < 0.01) and moderate/severe paravalvular leakage (PVL) (RR = 6.74; 95% CI = 1.31–34.65; P = 0.02) with TAVR. Nevertheless, TAVR demonstrated a significantly reduced risk of post-procedural bleeding (RR = 0.40; 95% CI = 0.30–0.54; P < 0.01) and new-onset atrial fibrillation (RR = 0.36; 95% CI = 0.27–0.47; P < 0.01). Other clinical outcomes were not significantly different between the groups and included cardiovascular mortality, stroke, transient ischemic attack, and myocardial infarction.ConclusionsAmong low-risk patients, TAVR offered comparable efficacy outcomes and fewer bleeding events compared with SAVR. There were increased risks of pacemaker implantation and PVL associated with TAVR, though lower atrial fibrillation risks.     

Transcatheter vs surgical aortic valve replacement in low to intermediate surgical risk aortic stenosis patients: A systematic review and meta-analysis of randomized controlled trials

BackgroundTranscatheter aortic valve replacement (TAVR) is regarded as the most superior alternative treatment approach for patients with aortic stenosis (AS) who are associated with high surgical risk, whereas the effectiveness of TAVR vs surgical aortic valve replacement (SAVR) in low to intermediate surgical risk patients remained inconclusive. This study aimed to determine the best treatment strategies for AS with low to intermediate surgical risk based on published randomized controlled trials (RCTs).Hypothesis and MethodsRCTs that compared TAVR vs SAVR in AS patients with low to intermediate surgical risk were identified by PubMed, EmBase, and the Cochrane library from inception till April 2019. The pooled relative risks (RRs) with 95% confidence intervals (CIs) were calculated for the data collected using random‐effects models.ResultsSeven RCTs with a total of 6929 AS patients were enrolled. We noted that TAVR significantly increased the risk of transient ischemic attack (TIA) (RR: 1.43; 95%CI: 1.04‐1.96; P = .029), and permanent pacemaker implantation (RR: 3.00; 95%CI: 1.70‐5.30; P < .001). However, TAVR was associated with lower risk of post‐procedural bleeding (RR: 0.57; 95%CI: 0.33‐0.98; P = .042), new‐onset or worsening of atrial fibrillation (RR: 0.32; 95%CI: 0.23‐0.45; P < .001), acute kidney injury (RR: 0.40; 95%CI: 0.25‐0.63; P < .001), and cardiogenic shock (RR: 0.34; 95%CI: 0.19‐0.59; P < .001). The risk of aortic‐valve reintervention at 1‐ (RR: 2.63; 95%CI: 1.34‐5.15; P = .005), and 2 years (RR: 3.19; 95%CI: 1.63‐6.24; P = .001) in low to intermediate surgical risk patients who received TAVR was significantly increased than those who received SAVR.ConclusionsThese findings indicated that low to intermediate surgical risk patients who received TAVR had low risk of complications, whereas the risk of TIA, permanent pacemaker implantation, and aortic‐valve reintervention was increased.     

Network Meta-Analysis Comparing the Short- and Long-Term Outcomes of Alternative Access for Transcatheter Aortic Valve Replacement

BackgroundSeveral studies have pair-wise compared access sites for transcatheter aortic valve replacement (TAVR) but pooled estimate of overall comparative efficacy and safety outcomes are not well known. We sought to compare short- and long-term outcomes following various alternative access routes for TAVR.MethodsThirty-four studies with a pooled sample size of 32,756 patients were selected by searching PubMed and Cochrane library databases from inception through 11th June 2021 for patients undergoing TAVR via 1 of 6 different access sites: Transfemoral (TF), Transaortic (TAO), Transapical (TA), Transcarotid (TC), Transaxillary/Subclavian (TSA), and Transcaval (TCV). Data were extracted to conduct a frequentist network meta-analysis with a random-effects model using TF access as a reference group.ResultsCompared with TF, both TAO [RR 1.91, 95% CI (1.46–2.50)] and TA access [RR 2.12, 95% CI (1.84–2.46)] were associated with an increased risk of 30-day mortality. No significant difference was observed for stroke, myocardial infarction, major bleeding, conversion to open surgery, and major adverse cardiovascular or cerebrovascular events at 30 days between different accesses. Major vascular complications were lower in TA [RR 0.43, (95% CI, 0.28–0.67)] and TC [RR 0.51, 95% CI (0.35–0.73)] access compared to TF. The 1-year mortality was higher in TAO [RR of 1.35, (95% CI, 1.01–1.81)] and TA [RR 1.44, (95% CI, 1.14–1.81)] groups.ConclusionNon-thoracic alternative access site utilization for TAVR implantation (TC, TSA and TCV) is associated with outcomes similar to conventional TF access. Thoracic TAVR access (TAO and TA) translates into increased short and long-term mortality.     

Evaluating Out-of-Hospital 30-Day Mortality After Transfemoral Transcatheter Aortic Valve Replacement: An STS/ACC TVT Analysis

ObjectivesThis study sought to better understand out-of-hospital 30-day mortality following transfemoral transcatheter aortic valve replacement (TAVR) and identify factors associated with poor outcomes.BackgroundDespite improvements in outcomes with TAVR for severe aortic stenosis, out-of-hospital 30-day mortality has not been evaluated.MethodsThis study examined patients in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry undergoing TAVR for severe aortic stenosis from January 2015 to March 2018. Primary and secondary endpoints were 30-day out-of-hospital all-cause mortality and out-of-hospital cardiovascular mortality, respectively. Logistic regression models were used to assess association between pre-specified factors and endpoints.ResultsA total of 106,749 patients underwent TAVR and were eligible for analysis. Transfemoral TAVR was performed in 92.3% of patients. A total of 2,137 (2.2%) transfemoral patients died within 30 days of the procedure, and 623 (29%) patients of these patients experienced out-of-hospital 30-day mortality. Cardiovascular and pulmonary etiologies accounted for the majority of observed mortality. Multivariable regression analysis identified older age, gender, lower body surface area, lower left ventricular ejection fraction, lower hemoglobin, atrial fibrillation or flutter, severe lung disease, home oxygen use, lack of moderate-to-severe aortic insufficiency, urgent TAVR, lower Kansas City Cardiomyopathy Questionnaire score, longer hospital length of stay, and in-hospital complications as being independently associated with the primary endpoint. New onset or pre-existent atrial fibrillation or flutter was also independently associated with 30-day out-of-hospital cardiovascular mortality in the transfemoral population.ConclusionsWe identified 30-day all-cause mortality rate for TAVR of 2.2%. Approximately one-third of patients experienced out-of-hospital mortality at 30 days. Several factors were identified as being independently associated with 30-day out-of-hospital all-cause and cardiovascular mortality. Further work is needed to understand how best to improve out-of-hospital mortality following TAVR.     

Cardiovascular Outcomes with Transcatheter vs. Surgical Aortic Valve Replacement in Low-Risk Patients: An Updated Meta-Analysis of Randomized Controlled Trials

BackgroundTAVR is an established treatment option in high and intermediate-risk patients with severe AS. There is less data regarding the efficacy of TAVR in low-risk patients. This meta-analysis evaluated efficacy and safety outcomes of transcatheter aortic valve replacement (TAVR) in comparison to surgical aortic valve replacement (SAVR) in low-risk patients with severe aortic stenosis (AS).MethodsDatabases were searched for randomized controlled trials (RCTs) that compared TAVR with SAVR for the treatment of low-risk patients with severe AS. We calculated pooled odds ratios (ORs) and 95% confidence intervals (CIs) using the random-effects model.ResultsThe final analysis included 2953 patients from 5 studies. Compared to SAVR, TAVR was associated with similar mid-term mortality [OR 0.67; 95% CI 0.37–1.21; p = 0.18], as well as similar short-term mortality [OR 0.51; 95% CI 0.24–1.11; p = 0.09]. Randomization to TAVR was associated with a reduced risk of developing acute kidney injury [OR 0.26; 95% CI 0.13–0.52; p < 0.001], short-term major bleeding [OR 0.27; 95% CI 0.12–0.60; p < 0.001] and new-onset atrial fibrillation [OR 0.17; 95% CI 0.14–0.21; p < 0.001]. However, TAVR was associated with a higher risk of requiring permanent pacemaker implantation [OR 4.25; 95% CI 1.86–9.73; p < 0.001]. There was no significant difference in the risk of myocardial infarction, stroke, endocarditis or aortic valve re-intervention between the two groups.ConclusionsOur meta-analysis showed that TAVR has similar clinical efficacy to SAVR, with a more favorable safety profile, in patients with severe AS who are at low-surgical risk.     

Transcatheter aortic valve replacement outcomes in Japan: Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry

ObjectivesWe aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan.BackgroundData are limited concerning procedural safety and valve performance following TAVR in Japanese. A program by an on-site proctor and procedure screening system was applied during TAVR introduction.MethodsWe consecutively enrolled 1613 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese registry, which consists of 14 centers. Baseline characteristics and procedural outcomes including combined early 30-day non-safety, and mortality rates were assessed among 4 groups, divided into quartiles (Q1-Q4).ResultsMost patients were women (70.4%), elderly (84.4 ± 5.1 years), and had a median Society of Thoracic Surgeons score of 6.7(4.7–9.5). The overall 30-day mortality, combined early non-safety, and cumulative 1-year mortality rates were 1.7%, 15.1%, and 11.3%, respectively. Thirty-day mortality was not affected by center experience differences divided into quartiles (1.0%, 2.0%, 2.5%, 1.5%, p = 0.404), whereas 30-day early safety was significantly improved (19.1%, 17.9%, 14.6%, 8.9%, p < 0.001). Thirty-day mortality was 0% under transfemoral on-site proctor. Cox-regression multivariate analysis revealed that male sex, clinical frailty scale, New York Heart Association class, creatinine, albumin, hemoglobin, liver disease, and non-transfemoral approach were independent predictive factors of increased midterm mortality risk.ConclusionsOwning to the global supporting system in Japan, excellent early and midterm outcomes have been achieved to overcome the learning curve of the newly introduced TAVR procedure.     

Low-Risk Transcatheter Versus Surgical Aortic Valve Replacement – An Updated Meta-Analysis of Randomized Controlled Trials

ObjectivesTo perform a meta-analysis including all available randomized controlled trials (RCTs) to date comparing transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) and low surgical risk.BackgroundCurrent guidelines recommend SAVR for patients with severe symptomatic AS and low surgical risk. A few RCTs have evaluated TAVR in low surgical risk patients but equipoise exists related to TAVR valve durability, paravalvular leak (PVL) and role of TAVR in younger, low surgical risk patients.MethodsFive databases were analyzed from January-2000 to March-2019 for RCTs comparing SAVR to TAVR in low-risk severe AS patients.ResultsFour RCTs on low-risk TAVR patients with 2887 patients were included. Mean follow-up was ~24.1 ± 24 months. Early mortality was lower with TAVR compared to SAVR (RR: 0.44, 95% CI: 0.20–0.95, P = 0.038) whereas long-term mortality was similar (RR: 0.67, 95% CI: 0.39–1.14, P = 0.141). Both early and long-term stroke rates were similar. TAVR was associated with lower risk of atrial fibrillation, major bleeding, acute kidney injury (AKI) and rehospitalization, but higher rates of permanent pacemaker implantation (PPM) and moderate or severe PVL. There was no difference in major vascular complications, myocardial infarction, endocarditis, aortic valve gradients and valve area at follow-up.ConclusionsIn low-risk patients with severe AS, TAVR has a lower early mortality compared to SAVR with no difference in long-term mortality. Although complication rates varied between TAVR and SAVR, our study findings suggest that transfemoral-TAVR is an appropriate treatment option for severe symptomatic AS in patients with low surgical risk.     

Transcatheter Aortic Valve Replacement in Low-Risk Patients: A Meta-Analysis of Randomized Controlled Trials

IntroductionTranscatheter aortic valve replacement (TAVR) has become the standard treatment option for patients with symptomatic severe aortic stenosis (AS) with high surgical risk and a reasonable option for intermediate surgical risk as an alternative to surgical aortic valve replacement (SAVR). The role of TAVR in lower risk patients is less established but has been the focus of recent randomized controlled trials (RCTs). We performed a meta-analysis of RCTs to assess TAVR outcomes among low surgical risk patients.Methods and resultsSystematic search of RCTs was done using PubMed, EMBASE, and Cochrane Library databases. Statistical analysis was performed with RevMan v5.3 software using a random effects model to report risk ratio (RR) with 95% confidence interval (CI). A total of three RCTs including 2698 patients (1375 TAVR and 1323 SAVR) were analyzed. Compared to SAVR, TAVR was not associated with all-cause mortality [RR 0.86 (95% CI 0.61–1.19); P = 0.36; I² = 8%] or stroke [RR 0.82 (0.48–1.43); P = 0.49; I² = 42%]. However, TAVR was significantly associated with lower risk of acute kidney injury [RR 0.27 (0.13–0.54); P = 0.0002; I² = 0%], new-onset atrial fibrillation [RR 0.26 (0.18–0.39); P < 0.00001; I² = 80%], and life-threatening or disabling bleeding [RR 0.35 (0.22–0.55); P < 0.00001; I² = 57%], but a higher risk of moderate-severe paravalvular leak [RR 4.40 (1.22–15.86); P = 0.02; I² = 26%] and permanent pacemaker insertion [RR 2.73 (1.41–5.28); P = 0.003; I² = 83%].ConclusionsThere is no difference in all-cause mortality or stroke between TAVR and SAVR, but TAVR is associated with lower risk of other perioperative complications except for moderate-severe paravalvular leak and the need for permanent pacemaker implantation.     

The noninferiority of transcatheter aortic valve implantation compared to surgical aortic valve replacement for severe aortic disease: Evidence based on 16 randomized controlled trials

Background:Currently, transcatheter aortic valve implantation (TAVI) as an effective and convenient intervention has been adopted extensively for patients with severe aortic disease. However, the efficacy and safety of TAVI have not yet been well evaluated and its noninferiority compared with traditional surgical aortic valve replacement (sAVR) still lack sufficient evidence. This meta-analysis was designed to comprehensively compare the noninferiority of TAVI with sAVR for patients with severe aortic disease.Methods:A systematic search of PubMed, Embase, Cochrane Library, and Web of Science up to October 1, 2020 was conducted for relevant studies that comparing TAVI and sAVR in the treatment of severe aortic disease. The primary outcomes were early, midterm and long term mortality. The secondary outcomes included early complications and other late outcomes. Two reviewers assessed trial quality and extracted the data independently. All statistical analyzes were performed using the standard statistical procedures provided in Review Manager 5.2.Results:A total of 16 studies including 14394 patients were identified. There was no difference in 30-day, 1-year, 2-year, and 5-year all-cause or cardiovascular mortality as well as stroke between TAVI and sAVR. Regarding to the 30-day outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of myocardial infarction (risk ratio [RR] 0.62; 95% confidence interval [CI] 0.40–0.97; 5441 pts), cardiogenic shock (RR 0.34; 95% CI 0.19–0.59; 1936 pts), acute kidney injury (AKI) > stage 2 (RR 0.37; 95% CI 0.25–0.54; 5371 pts), and new-onset atrial fibrillation (NOAF) (RR 0.29; 95% CI 0.24–0.35; 5371 pts) respectively, but higher incidence of permanent pacemaker implantation (RR 3.16; 95% CI 1.61–6.21; 5441 pts) and major vascular complications (RR 2.22; 95% CI 1.14–4.32; 5371 pts). Regarding to the 1- and 2-year outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of NOAF, but higher incidence of neurological events, transient ischemic attacks (TIA), permanent pacemaker and major vascular complications respectively. Regarding to the 5-year outcomes, compared with sAVR, TAVI experienced a significantly lower incidence of NOAF, but higher incidence of TIA and reintervention respectively.Conclusions:Our analysis shows that TAVI was equal to sAVR in early, midterm and long term mortality for patients with severe aortic disease. In addition, TAVI may be favorable in reducing the incidence of both early, midterm and long term NOAF. However, pooled results showed superiority of sAVR in reducing permanent pacemaker implantation, neurological events, TIA, major vascular complications and reintervention.     

Outcomes Following Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: SWEDEHEART Observational Study

ObjectivesThis study was performed to investigate long-term, clinically important outcomes in patients who underwent permanent pacemaker implantation after transcatheter aortic valve replacement (TAVR).BackgroundThe impact of permanent pacemaker implantation after TAVR is unknown, and prior studies have produced conflicting results.MethodsIn this nationwide, population-based cohort study, the study included all patients who underwent transfemoral TAVR in Sweden from 2008 to 2018 from the SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) register. Additional baseline characteristics and information about outcomes were obtained by individual crosslinking with other national health data registers. Unadjusted and multivariable-adjusted analyses were performed using Cox proportional hazards regression.ResultsOf 3,420 patients, 481 (14.1%) underwent permanent pacemaker implantation within 30 days after TAVR. The survival rate at 1, 5, and 10 years was 90.0%, 52.7%, and 10.9% in the pacemaker group and 92.7%, 53.8%, and 15.3% in the nonpacemaker group, respectively (HR: 1.03; 95% CI: 0.88-1.22; P = 0.692). The median follow-up was 2.7 years (interquartile range: 2.5, and maximum 11.8 years). There was no difference in the risk of cardiovascular death (HR: 0.91; 95% CI: 0.71-1.18; P = 0.611), heart failure (HR: 1.23; 95% CI: 0.92-1.63; P = 0.157), or endocarditis (HR: 0.90; 95% CI: 0.47-1.69; P = 0.734) between the groups.ConclusionsThe study found no difference in long-term survival between patients who did and did not undergo permanent pacemaker implantation after TAVR. As the use of TAVR expands to include younger and low-risk patients with a long life expectancy, it will become increasingly important to understand the impact of permanent pacemaker implantation after TAVR.     

Outcomes of Veterans Undergoing TAVR Within Veterans Affairs Medical Centers: Insights From the Veterans Affairs Clinical Assessment,Reporting, and Tracking Program

ObjectivesThis study sought to describe clinical and procedural characteristics of veterans undergoing transcatheter aortic valve replacement (TAVR) within U.S. Department of Veterans Affairs (VA) centers and to examine their association with short- and long-term mortality, length of stay (LOS), and rehospitalization within 30 days.BackgroundVeterans with severe aortic stenosis frequently undergo TAVR at VA medical centers.MethodsConsecutive veterans undergoing TAVR between 2012 and 2017 were included. Patient and procedural characteristics were obtained from the VA Clinical Assessment, Reporting, and Tracking system. The primary outcomes were 30-day and 1-year survival, LOS >6 days, and rehospitalization within 30 days. Logistic regression and Cox proportional hazards analyses were performed to evaluate the associations between pre-procedural characteristics and LOS and rehospitalization.ResultsNine hundred fifty-nine veterans underwent TAVR at 8 VA centers during the study period, 860 (90%) by transfemoral access, 50 (5%) transapical, 36 (3.8%) transaxillary, and 3 (0.3%) transaortic. Men predominated (939 of 959 [98%]), with an average age of 78.1 years. There were 28 deaths within 30 days (2.9%) and 134 at 1 year (14.0%). Median LOS was 5 days, and 141 veterans were rehospitalized within 30 days (14.7%). Nonfemoral access (odds ratio: 1.74; 95% confidence interval [CI]: 1.10 to 2.74), heart failure (odds ratio: 2.51; 95% CI: 1.83 to 3.44), and atrial fibrillation (odds ratio: 1.40; 95% CI: 1.01 to 1.95) were associated with increased LOS. Atrial fibrillation was associated with 30-day rehospitalization (hazard ratio: 1.79; 95% CI: 1.22 to 2.63).ConclusionsVeterans undergoing TAVR at VA centers are predominantly elderly men with significant comorbidities. Clinical outcomes of mortality and rehospitalization at 30 days and 1-year mortality compare favorably with benchmark outcome data outside the VA.     

Routine Ultrasound or Fluoroscopy Use and Risk of Vascular/Bleeding Complications After Transfemoral TAVR

ObjectivesThis study aimed to examine the benefits of routine use of 2D-US in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR).BackgroundTwo-dimensional ultrasound (2D-US) reduces access-related vascular complications (VCs) and bleeding in patients undergoing percutaneous coronary intervention via transfemoral approach. Potential similar benefits in patients undergoing transfemoral TAVR have not been systemically investigated.MethodsRates of access-related VCs or bleeding were compared using 5-year retrospective observational data from 2 neighboring high-volume UK TAVR centers systemically using 2 different techniques (center 1: fluoroscopy and contralateral angiography [FCA], center 2: 2D-US) for femoral puncture at the time of transfemoral TAVR.ResultsOverall, 1,171 patients were included in the study (FCA, n = 624; 2D-US, n = 529). Baseline clinical and procedural characteristics were similar between the 2 groups. There was no difference in the risk of VCs, bleeding, or their composite according to femoral puncture technique (FCA vs. 2D-US: 6.7% [95% confidence interval (CI): 4.9% to 8.9%] vs. 6.8% [95% CI: 4.8% to 9.3%]; p = 0.63; 6.1% [95% CI: 4.4% to 8.2%] vs. 6.4% [95% CI: 4.8% to 9.3%]; p = 0.70; and 9.8% [95% CI: 7.6% to 12.4%] vs. 9.8% [95% CI: 7.4% to 12.7%]; p = 0.76, respectively) and no difference when analysis was restricted to a composite of major VCs or major and life-threatening bleeding.ConclusionsVascular and bleeding complications can be achieved using either FCA or 2D-US guidance. Further studies are required to identify and assess alternative strategies to reduce periprocedural VCs and bleeding in this patient population.     

Single-center experience of 105-minimalistc transfemoral transcatheter aortic valve replacement and its outcome

IntroductionTranscatheter aortic valve replacement (TAVR) increases worldwide, and indications expand from high-risk aortic stenosis patients to low-risk aortic stenosis. Studies have shown that minimalistic TAVR done under conscious sedation is safe and effective. We report single-operator, the single-center outcome of 105 minimalist transfemoral, conscious sedation TAVR patients, analyzed retrospectively.MethodsAll patients underwent TAVR in cardiac catheterization lab via percutaneous transfemoral, conscious sedation approach. A dedicated cardiac anesthetist team delivered the conscious sedation with a standard protocol described in the main text. The outcomes were analyzed as per VARC-2 criteria and compared with the latest low-risk TAVR trials.ResultsA total of 105 patients underwent transcatheter aortic valve replacement between July 2016 to February 2020. The mean age of the population was 73 years, and the mean STS score was 3.99 ± 2.59. All patients underwent a percutaneous transfemoral approach. Self-expanding valve was used in 40% of cases and balloon-expandable valve in 60% (Sapien3? in 31% and MyVal? in 29%) of cases. One patient required conversion to surgical aortic valve replacement. The success rate was 99 percent. The outcomes were: all-cause mortality: 0.9%, stroke rate 1.9%, New pacemaker rate 5.7%, 87.6% had no paravalvular leak. The mild and moderate paravalvular leak was seen in 2.8% and 1.9%, respectively. The mean gradient decreased from 47.5 mmHg to 9 mmHg. The average ICU stay was 26.4 h, and the average hospital stay was 5.4 days. Our outcomes are comparable with the latest published low-risk trial.ConclusionMinimalist, conscious sedation, transfemoral transcatheter aortic valve replacement when done following a standard protocol is safe and effective.     

Outcomes of Combined Transcatheter Aortic Valve Replacement and Peripheral Vascular Intervention in the United States

ObjectivesThe aim of this study was to compare the prevalence and real-world outcomes of patients who require peripheral vascular intervention during the same hospitalization as transcatheter aortic valve replacement (TAVR) compared with TAVR alone.BackgroundThere are limited data on the prevalence and outcomes of combined TAVR and percutaneous peripheral vascular intervention.MethodsAll patients who underwent TAVR in 2016 and 2017 were identified using the Nationwide Readmissions Database. Outcomes of patients undergoing TAVR alone were compared with those of patients undergoing combined TAVR and peripheral intervention, TAVR and peripheral intervention with and without a history of peripheral artery disease, and alternative-access TAVR with transfemoral TAVR in individuals undergoing peripheral intervention. The primary outcome was in-hospital mortality.ResultsA total of 99,654 hospitalizations were identified, among which 4,397 patients (4.42%) underwent peripheral intervention during the same admission as TAVR. Patients who required peripheral intervention had increased mortality (4.2% vs 1.5%; P < 0.001), stroke (3.5% vs 1.8%; P < 0.001), acute kidney injury (17.6% vs 10.8%; P < 0.001), blood transfusion (16.0% vs 11.3%; P < 0.001), 30-day readmission (16.3% vs 12.1%; P < 0.001), median length of stay (4 days [IQR: 2-8 days] vs 3 days [IQR: 2-5 days]; P < 0.001), and hospitalization charges. Compared with patients undergoing peripheral intervention to facilitate transfemoral TAVR, alternative-access TAVR was associated with increased mortality (4.6% vs 3.0%; P = 0.036), acute kidney injury (22.7% vs 14.3%; P < 0.001), median length of stay (5 days [IQR: 3-10 days] vs 4 days [IQR: 2-7 days]; P < 0.001), and 30-day readmission (18.1% vs 15.5%; P = 0.012).ConclusionsPeripheral vascular intervention may be used to facilitate transfemoral access or as a bailout for vascular complications during TAVR. Combined TAVR and peripheral intervention is associated with an increased risk for adverse events, though outcomes are better compared with alternative-access TAVR using a nonfemoral approach.