Efficacy and Safety of Transcarotid Transcatheter Aortic Valve Replacement: A Systematic Review

BackgroundIn patients who are not suitable for traditional access routes for transcatheter aortic valve replacement (TAVR) due to severe peripheral vascular disease (PVD) or prohibitive surgical risk, carotid artery (CA) access is an emerging route for TAVR. This study represents the most up to date on outcomes of carotid access TAVR.MethodsA systematic review was conducted as per the Preferred Reporting Instructions for Systematic Reviews and Meta-analysis (PRISMA). We performed a thorough electronic search through Pubmed, SCOPUS and Embase databases. Statistical analyses were performed using SPSS version 24 (IBM Corporation, Armonk, New York, USA).ResultsA total of 15 non-randomized studies were included in this systematic review comprising of patients that received TAVR via 4 vascular access sites, transcarotid (TC) (N = 1035), transfemoral (TF) (N = 1116), transapical (TAP) (N = 307), transaortic (TAO) (N = 176) and transaxillary (TAX) (N = 90). In the Transcarotid cases, device success was achieved in 95.6% of patients (n = 748). The 30-day and 1-yr mortality was 4.2% and 10.5% respectively. 15.3% of patients required new pacemaker implantation. In-hospital stroke or TIA occurred in 4% of cases. 30-day stroke or TIA occurred in 5% of cases. There were no hemorrhagic strokes. 30-day Mortality was significantly higher in the Transaortic group (12.1%) compared to the Transcarotid group (2.6%) [RR = 2.93 95% CI = 1.15–7.58; p = 0.027]. There were no differences in outcomes between the Transcarotid group and the Transapical or Transaxillary groups.ConclusionThe most contemporary data on Carotid access TAVR shows impressive device success, low rates of stroke and pacemaker implantation and an acceptable 30-day and 1-year mortality. 30-day mortality was significantly lower in TC compared to TAO patients.     

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.     

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.     

Clinical Outcomes of Sentinel Cerebral Protection System Use During Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

ObjectiveTo compare the clinical outcomes following transcatheter aortic valve replacement (TAVR) with and without the use of the Sentinel Cerebral Protection System (Sentinel CPS).BackgroundStroke occurs in 2–5% of patients at 30 days after TAVR and increases mortality >3 fold. The Sentinel CPS is the only FDA (Food and Drug Administration) approved cerebral embolic protection device.MethodsThe Cochrane Library, PubMed and Web of Science were searched for relevant studies for inclusion in the meta-analysis. Two authors independently screened and included studies comparing the clinical outcomes after TAVR with and without the Sentinel CPS. Risk of bias was assessed using the Cochrane tools (RoB2.0 and ROBINS-I).ResultsFour studies comparing 606 patients undergoing TAVR with Sentinel CPS to 724 without any embolic protection device were included. Sentinel CPS use was associated with lower rates of 30-day mortality [0.8% vs 2.7%; RR 0.34 (95% CI 0.12, 0.92) I² = 0%], 30-day symptomatic stroke [3.5% vs 6.1%; RR 0.51 (95% CI 0.29, 0.90) I² = 0] and major or life-threatening bleeding [3.3% vs 6.6%; RR 0.50 (0.26, 0.98) I² = 16%]. There was no significant difference between the two arms in the incidence of acute kidney injury [0.8% vs 1%; RR 0.85 (95% CI 0.22, 3.24) I² = 0%] and major vascular complications [5.1% vs 6%; RR 0.74 (0.33, 1.67) I² = 45%].ConclusionThe results suggest that Sentinel CPS use in TAVR is associated with a lower risk of stroke, mortality and major or life-threatening bleeding at 30 days.     

Transcatheter aortic valve replacement: A novel abdominal transaortic approach

Transcatheter aortic valve replacement (TAVR) via the transfemoral (TF), transapical (TA), or even the transaortic (TAO) approach in high‐risk or inoperable patients is quickly becoming a safe and effective modality for the treatment of symptomatic severe aortic stenosis (AS). However, in this selected group of patients, those with anatomical or physiologic constraints preventing TF, TA, and conventional TAO TAVR, alternative sites of access must be explored. Here, we report a successful TAVR in an inoperable patient with severe AS using a distal abdominal TAO approach via a synthetic graft‐conduit. © 2013 Wiley Periodicals, Inc.     

Racial/Ethnic Disparities in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights from the Healthcare Cost and Utilization Project's National Inpatient Sample

PurposeTo identify racial/ethnic disparities in utilization rates, in-hospital outcomes and health care resource use among Non-Hispanic Whites (NHW), African Americans (AA) and Hispanics undergoing transcatheter aortic valve replacement (TAVR) in the United States (US).Methods and resultsThe National Inpatient Sample database was queried for patients ≥18 years of age who underwent TAVR from 2012 to 2014. The primary outcome was all-cause in hospital mortality. A total of 36,270 individuals were included in the study. The number of TAVR performed per million population increased in all study groups over the three years [38.8 to 103.8 (NHW); 9.1 to 26.4 (AA) and 9.4 to 18.2 (Hispanics)]. The overall in-hospital mortality was 4.2% for the entire cohort. Race/ethnicity showed no association with in-hospital mortality (P > .05). Though no significant difference were found between AA and NHW in any secondary outcome, being Hispanic was associated with higher incidence of acute myocardial infarction (aOR = 2.02; 95% CI, 1.06–3.85; P = .03), stroke/transient ischemic attack (aOR = 1.81; 95% CI, 1.04–3.14; P = .04), acute kidney injury (aOR = 1.65; 95% CI, 1.23–2.21; P < .01), prolonged length of stay (aOR = 1.18; 95% CI, 1.08–1.29; P < .01) and higher hospital costs (aOR = 1.27; 95% CI, 1.18–1.36; P < .01).ConclusionThere are significant racial disparities in patients undergoing TAVR in the US. Though in-hospital mortality was not associated with race/ethnicity, Hispanic patients had less TAVR utilization, higher in-hospital complications, prolonged length of stay and increased hospital costs.     

In-Hospital Outcomes with Transfemoral Versus Transapical Access for Transcatheter Aortic Valve Replacement in Patients with Peripheral Arterial Disease

BackgroundThere is a paucity of data regarding outcomes with transfemoral (TF) versus transapical (TA) access for transcatheter aortic valve replacement (TAVR) in patients with peripheral artery disease (PAD).MethodsWe queried the national inpatient sample database (NIS) (2012−2013) to identify patients with PAD who underwent TAVR. We conducted a propensity matching analysis using 25 clinical variables to compare TF-TAVR versus TA-TAVR. The main outcome was in-hospital mortality.ResultsThe analysis included 22,349 patients who underwent TAVR, among those 6692 (29.9%) had PAD. In the matched cohort, in-hospital mortality was similar between TF-TAVR and TA-TAVR groups (4.8% vs. 5.1%, OR 0.95; 95%CI 0.74–1.21). TF-TAVR was associated with lower rates of cardiogenic shock (OR 0.64; 95%CI 0.50–0.82), use of mechanical circulatory support (OR 0.56; 95%CI 0.42–0.75), acute kidney injury (OR 0.76; 95%CI 0.67–0.86), hemodialysis (OR 0.51; 95%CI 0.36–0.71), major bleeding (OR 0.72; 95%CI 0.64–0.80), blood transfusion (OR 0.65; 95%CI 0.58–0.73), discharge to a skilled nursing facility (OR 0.61; 95%CI 0.54–0.68) as well as shorter length of hospital stay (8.13 ± 6.76 vs. 10.11 ± 7.80 days) compared with TA-TAVR. However, TF-TAVR was associated with higher rate of vascular complications (11.7% vs. 3.7%, OR 3.40; 95%CI 2.63–4.38), complete heart block (OR 1.52; 95%CI 1.23–1.87), and pacemaker insertion (OR = 1.58; 95%CI: 1.28–1.94). There was no difference between both groups in the rate of cerebrovascular accidents (OR 1.26; 95%CI 0.93–1.72).ConclusionIn this observational analysis from a large national database, there was no difference in in-hospital mortality between TF-TAVR and TA-TAVR among patients with PAD. Further studies are encouraged to identify the optimal access for TAVR in patients with PAD.     

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.     

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.     

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.     

Frailty Predicts Adverse Outcomes in Older Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR): From the National Inpatient Sample

ObjectiveWe aimed to study the impact of frailty on the outcome of transcatheter aortic valve replacement (TAVR) procedures.MethodsThe National Inpatient Sample (NIS) database was queried for all patients aged ≥65 years who underwent a TAVR procedure during the years 2016–2017. Frailty was measured using a previously validated Hospital Frailty Risk Score (HFRS) scoring system. The score is ICD-10 code based; thus, it can be calculated from an administrative database. Study outcomes were in-hospital all-cause mortality, peri-procedural complications, length of stay, and total cost. Outcomes were modeled using logistic regression for binary outcomes and generalized linear regression for continuous outcomes.ResultsThere were 84,750 patients included in the study. These patients were divided into low-risk (61,050), intermediate-risk (22,955), and high-risk (744), based on average frailty index scores of 2, 7, and 16.8, respectively. On multivariable analysis, the HFRS correlated with increased odds for mortality with an adjusted odd ratio (a-OR) of 1.25 (95% CI: 1.22–1.29, p < 0.001), myocardial infarction [a-OR 1.10 (95% CI: 1.07–1.13, p < 0.001)], pericardiocentesis [a-OR 1.16 (95% CI: 1.12–1.20, p < 0.001)], pacemaker insertion [a-OR 1.06 (95% CI: 1.04–1.08, p < 0.001)], blood transfusion [a-OR 1.14 (95% CI: 1.11–1.16, p < 0.001)], vascular complications [a-OR 1.05 (95% CI: 1.00–1.09, p = 0.03)], longer length of stay [a-MR 1.10 (95% CI: 1.10–1.11, p < 0.001)] and higher cost [a-MR: 1.04 (95% CI: 1.03–1.04, p < 0.001)].ConclusionThe HFRS can be utilized in the risk stratification of older patients undergoing TAVR.     

Complications and Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement With Edwards SAPIEN & SAPIEN XT Valves: A Meta‐Analysis of World‐Wide Studies and Registries Comparing the Transapical and Transfemoral Accesses

Introduction

Both transfemoral (TF) and transapical (TA) routes are utilized for Transcatheter Aortic Valve Replacement (TAVR) using Edwards SAPIEN & SAPIEN XT valves. We intended to perform a meta‐analysis comparing the complication rates between these two approaches in studies published before and after the standardized Valve Academic Research Consortium (VARC) definitions.

Methods

We performed a comprehensive electronic database search for studies published until January 2014 comparing TF and TA approaches using the Edwards SAPIEN/SAPIEN XT aortic valve. Studies were analyzed based on the following endpoints: 1‐year mortality, 30‐day mortality, stroke, new pacemaker implantation, bleeding, and acute kidney injury.

Results

Seventeen studies were included in the meta‐analysis. Patients undergoing TA TAVR had a significantly higher logistic EuroSCORE (24.6 ± 12.9 vs. 21.3 ± 12.0; P < 0.001). The cumulative risks for 30‐day mortality (RR 0.61; 95%CI 0.46–0.81; P = 0.001), 1‐year mortality (RR 0.68; 95%CI 0.55–0.84; P < 0.001), and acute kidney injury (RR 0.53; 95%CI 0.38–0.73; P < 0.001) were significantly lower for patients undergoing TF as compared to TA approach. Both approaches had a similar incidence of 30‐day stroke, pacemaker implantation, and major or life‐threatening bleeding. Studies utilizing the VARC definitions and those pre‐dating VARC yielded similar results.

Conclusion

This meta‐analysis demonstrates a decreased 30‐day and 1‐year mortality in TF TAVR as compared to TA TAVR. Post‐procedure acute kidney injury and the need for renal replacement therapy are also significantly lower in the TF group. These differences hold true even after utilizing the standardized Valve Academic Research Consortium criteria. (J Interven Cardiol 2015;28:266–278)

     

Non-Transfemoral Transcatheter Aortic Valve Replacement Approach is Associated with a Higher Risk of New-Onset Atrial Fibrillation: A Systematic Review and Meta-Analysis

BackgroundNew-onset atrial fibrillation (NOAF) is a frequent arrhythmic complication following transcatheter aortic valve replacement (TAVR). Choice of access routes for TAVR could be a factor that determines the risk of NOAF although the data is still not well-characterised. We aimed to assess the association between different access routes for TAVR (transfemoral versus non-transfemoral) and the risk of NOAF.MethodsA comprehensive literature review was performed through September 2018 using EMBASE and Medline. Eligible studies must compare the incidence of NOAF in patients without pre-existing atrial fibrillation who underwent TAVR. Relative risk (RR) and 95% confidence intervals (CI) were extracted from each study and combined together using the random-effects model, generic inverse variance method of DerSimonian and Laird.ResultsSeven (7) retrospective studies with 18,425 patients who underwent TAVR (12,744 with the transfemoral approach and 5,681 with the non-transfemoral approach) met the eligibility criteria. After the procedures, 2,205 (12.0%) patients developed NOAF (656 [5.1%] patients in the transfemoral group and 1,549 [27.3%] patients in the non-transfemoral group). There was a significant association between the non-transfemoral approach and an increased risk of NOAF with the pooled RR of 2.94 (95%CI, 2.53–3.41; p < 0.00001). Subgroup analysis showed the highest risk of NOAF in the transapical subgroup with the pooled RR of 3.20 (95% CI, 2.69–3.80; I² 33%).ConclusionsA significantly increased risk of NOAF following TAVR among those who underwent a non-transfemoral approach compared with transfemoral approach was observed in this meta-analysis.     

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.     

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.     

Impact of Pre-Existing and New-Onset Atrial Fibrillation on Outcomes After Transcatheter Aortic Valve Replacement

ObjectivesThis study sought to evaluate impact of new-onset and pre-existing atrial fibrillation (AF) on transcatheter aortic valve replacement (TAVR) long-term outcomes compared with patients without AF.BackgroundPre-existing and new-onset AF in patients undergoing TAVR are associated with poor outcomes.MethodsThe study identified 72,660 patients ≥65 years of age who underwent nonapical TAVR between 2014 and 2016 using Medicare inpatient claims. History of AF was defined by diagnoses on claims during the 3 years preceding the TAVR, and new-onset AF was defined as occurrence of AF during the TAVR admission or within 30 days after TAVR in a patient without prior history of AF. Outcomes included all-cause mortality, and readmission for bleeding, stroke, and heart failure (HF).ResultsOverall, 40.7% had pre-existing AF (n = 29,563) and 6.8% experienced new-onset AF (n = 2,948) after TAVR. Mean age was 81.3, 82.4, and 83.8 years in patients with no AF, pre-existing, and new-onset AF, respectively. Pre-existing AF patients had the highest burden of comorbidities. After follow-up of 73,732 person-years, mortality was higher with new-onset AF compared with pre-existing and no AF (29.7, 22.6, and 12.8 per 100 person-years, respectively; p < 0.001). After adjusting for patient characteristics and hospital TAVR volume, new-onset AF remained associated with higher mortality compared with no AF (adjusted hazard ratio: 2.068, 95% confidence interval [CI]: 1.92 to 2.20; p < 0.01) and pre-existing AF (adjusted hazard ratio: 1.35; 95% CI: 1.26 to 1.45; p < 0.01). In competing risk analysis, new-onset AF was associated with higher risk of bleeding (subdistribution hazard ratio [sHR]: 1.66; 95% CI: 1.48 to 1.86; p < 0.01), stroke (sHR: 1.92; 95% CI: 1.63 to 2.26; p < 0.01), and HF (sHR: 1.98; 95% CI: 1.81 to 2.16; p < 0.01) compared with pre-existing AF.ConclusionsIn patients undergoing TAVR, new-onset AF is associated with increased risk of mortality and bleeding, stroke, and HF hospitalizations compared with pre-existing AF or no AF.     

Vascular access type and mortality in elderly incident hemodialysis patients

IntroductionThe ideal vascular access type for elderly hemodialysis (HD) patients remains debatable. The aim of this study was to analyze the association between patterns of vascular access use within the first year of HD and mortality in elderly patients.MethodsSingle-center retrospective study of 99 incident HD patients aged ≥ 80 years from January 2010 to May 2021. Patients were categorized according to their patterns of vascular access use within the first year of HD: central venous catheter (CVC) only, CVC to arteriovenous fistula (AVF), AVF to CVC, and AVF only. Baseline clinical data were compared among groups. Survival outcomes were analyzed using Kaplan–Meier survival curves and Cox's proportional hazards model.ResultsWhen compared with CVC to AVF, mortality risk was significantly higher among CVC only patients and similar to AVF only group [HR 0.93 (95% CI 0.32–2.51)]. Ischemic heart disease [HR 1.74 (95% CI 1.02–2.96)], lower levels of albumin [HR 2.16 (95% CI 1.28–3.64)] and hemoglobin [HR 4.10(95% CI 1.69–9.92)], and higher levels of c-reactive protein [HR 1.87(95% CI 1.11–3.14)] were also associated with increased mortality risk in our cohort, p < 0.05.ConclusionOur findings suggested that placement of an AVF during the early stages of dialysis was associated with lower mortality compared to persistent CVC use among elderly patients. AVF placement appears to have a positive impact on survival outcomes, even in those who started dialysis with a CVC.     

Screening for occult cancer in idiopathic venous thromboembolism — Systemic review and meta-analysis

BackgroundIdiopathic venous thromboembolism (VTE) may be associated with an occult malignancy. Early detection of cancer might be translated to a better prognosis for these patients. However, the efficacy of extensive screening for cancer in patients with idiopathic VTE is controversial.Materials and methodsSystemic review and meta-analysis of all available prospective trials comparing extensive to limited screening for occult malignancies in patients with idiopathic VTE.Primary outcome: all-cause mortality. Secondary outcomes: cancer related mortality, early cancer diagnosis, cancer diagnosis at the end of follow up and cancer diagnosis at an early stage. Risk ratios (RR) with 95% confidence intervals (CIs) were estimated and pooled.ResultsThe study included five trials and 2287 patients. Extensive screening did not affect all-cause mortality at the end of follow up [RR 0.86 (95% CI 0.58–1.27)] or cancer-related mortality [RR 0.93 (95% CI 0.54–1.58)]. Yet, it yielded more diagnoses of cancer [RR 2.17 (95% CI 1.42–3.32)]. Rates of cancer diagnosis at an early stage did not differ statistically between the two groups [RR 1.49 (95% CI 0.86–2.56)]. However, analysis of the randomized controlled trials alone showed a tendency towards early stage cancer at diagnosis in extensive screening group in, with results almost statistically significant [RR 2.14 (95% CI 0.98–4.67), p = 0.06].ConclusionsExtensive screening for malignancy after idiopathic VTE does not affect mortality rates. Yet, it yields more cancer diagnoses shortly after the VTE event. Further research is needed to determine whether extensive screening might be proper for specific high risk populations.     

Regional Differences in Outcomes for Patients Undergoing Transcatheter Aortic Valve Replacement in New York State and Ontario

BackgroundTranscatheter aortic valve replacement (TAVR) has become the standard of care for a wide spectrum of patients with severe aortic stenosis. However, there are wide variations in access to TAVR among jurisdictions. It is unknown if such variation is associated with differences in postprocedural outcomes. Our objective was to determine whether differences in health care delivery in jurisdictions with high vs low access of care to TAVR translate to differences in postprocedural outcomes.MethodsIn this observational, retrospective cohort study, we identified all Ontario and New York State residents greater than 18 years of age who received TAVR from January 1, 2012, to December 31, 2018. Our primary outcomes were post-TAVR 30 day in-hospital mortality and all-cause readmissions. Using indirect standardization, we calculated the observed vs expected outcomes for New York patients, had they been treated in Ontario.ResultsOur cohort consisted of 16,814 TAVR patients at 36 hospitals in New York State and 5007 TAVR patients at 11 hospitals in Ontario. In Ontario, TAVR access rates increased from ∼18.2 TAVR per million in 2012 to 87.4 TAVR per million in 2018, whereas for New York State, the rates increased from 31.9 to 220.4 TAVR per million. For 30-day mortality, 3.1% of Ontario TAVR patients had an in-hospital death, compared with 2.5% of New York patients. With adjustment, this translated to an observed-expected ratio of 0.70 (95% confidence interval [CI], 0.54-0.92) for New York patients.ConclusionsHaving greater access to TAVR may be associated with improved outcomes, potentially because of intervention earlier in the trajectory of the disease.     

One-Year Outcomes for Patients Undergoing Transcatheter Aortic Valve Replacement: The Gulf TAVR Registry

BackgroundThe use of transcatheter aortic valve replacement (TAVR) is steadily increasing with TAVR procedures offered to patients across the entire spectrum of surgical risks. The Gulf TAVR registry captures the demographics of patients undergoing TAVR in the Gulf region, comorbidities that drive outcomes, procedural success, complications, and one-year outcomes of death or rehospitalization.MethodsThis is a retrospective cohort study for adult patients aged at least 18 years undergoing TAVR at eight centers in the Gulf region. The primary outcome was a composite of death or re-hospitalization at one-year. Secondary outcomes included the individual components of the composite, stroke, and myocardial infarction (MI). We used multivariable Cox regression to determine factors associated with the composite endpoint.ResultsA total of 795 patients (56% male) were included in the final analysis with a mean age of 74.6 (standard deviation (SD) 8.9) years, Society of Thoracic Surgeons Score (STS) Score 4.9 (4.2), ejection fraction of 53% (12.7%). Transfemoral approach was employed in over 95% (762/795). The primary outcomes rate was 12.8% (95% confidence interval [CI]: 10.6–15.4); secondary endpoints were death 5.4% (95% CI 4.0–7.2); stroke 0.8% (95% CI 0.3, 1.7), MI 0.8% (95% CI 0.4–1.9), rehospitalization: 9.3% (95% CI 7.5–11.5) of whom 71.6% were related to cardiovascular causes. 77% of the cardiovascular admissions were attributable to heart failure or the need for pacemaker implantation. Stage IV or V chronic kidney disease was significantly associated with the primary composite endpoint (Hazard Ratio: 2.49, [95% CI: 1.31, 4.73], p = 0.005). Although not significant, paravalvular leak and severe left ventricular dysfunction showed a 2-fold and 3-fold increased risk for the composite endpoint, respectively.ConclusionsThe Gulf TAVR registry is the first of its kind in the region. It profiles an elderly population with a high procedural success rate and a low rate of complications. One-year outcomes were primarily driven by repeat hospitalization for heart failure and pacemaker implantation indicating a need to optimize heart failure management and improve algorithms for the detection of conduction abnormalities.