Use and Outcomes of Acute Treatment Strategies in Patients with Severe Aortic Valve Stenosis

Background:This study aimed to evaluate the acute treatment of patients with severe aortic valve stenosis in Germany.Methods and Results:Three treatment strategies in 11,027 patients acutely admitted due to aortic valve stenosis were compared from 2014 until 2018 using German nationwide records: The annual number of transcatheter aortic valve replacement (TAVR) procedures (1,294 to 1,827) and balloon valvuloplasty (BV only) procedures (170 to 233) in patients acutely admitted increased, but surgical aortic valve replacement (SAVR) procedures decreased (426 to 316). In comparison to BV only patients (mean age 81.3; EuroSCORE 23.2) SAVR patients were younger and at lower logistic EuroSCORE (mean age 66.9; EuroSCORE 9.4). Patients treated with TAVR were at comparable age and operative risk (mean age 81.3; EuroSCORE 24.4) as those patients treated with BV only. Primary outcome was in-hospital mortality. Reimbursement was considered secondary outcome. After risk adjustment using multivariable logistic and linear regression analyses, SAVR (OR 0.26 [96%CI 0.16;0.45], p < 0.001) and TAVR (OR 0.38 [0.29;0.49], p < 0.001) were associated with lower risk for mortality compared to BV only. Compared to BV only, hospitalization costs of patients undergoing SAVR were reduced by €5,578 ([95%CI €8,023; €3,133], p < 0.001). TAVR procedures were associated with higher hospitalization costs than BV only (risk-adjusted difference €4,143 [€2,330; €5,926], p < 0.001).Conclusions:BV only was associated with a substantially increased risk of in-hospital mortality in acute patients. We conclude that a definitive aortic valve replacement should be preferred as primary treatment in patients with severe aortic valve stenosis causing an acute admission.     

The impact of mitral stenosis on outcomes of aortic valve stenosis patient undergoing surgical aortic valve replacement or transcatheter aortic valve replacement

Background

The concomitant presence of mitral stenosis (MS) in the setting of symptomatic aortic stenosis represent a clinical challenge. Little is known regarding the outcome of mitral stenosis (MS) patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Therefore, we sought to study the outcome of MS patients undergoing aortic valve replacement (AVR).

Method

Using weighted data from the National Inpatient Sample (NIS) database between 2011 and 2014, we identified patients who were diagnosed with MS. Patients who had undergone TAVR as a primary procedure were identified and compared to patients who had SAVR. Univariate and multivariate logistic regression analysis were performed for the outcomes of in‐hospital mortality, length of stay (LOS), blood transfusion, postprocedural hemorrhage, vascular, cardiac and respiratory complications, permanent pacemaker placement (PPM), postprocedural stroke, acute kidney injury (AKI), and discharge to an outside facility.

Results

A total of 4524 patients were diagnosed with MS, of which 552 (12.2%) had TAVR and 3972 (87.8%) had SAVR. TAVR patients were older (79.9 vs 70.0) with more females (67.4% vs 60.0%) and African American patients (7.7% vs 7.1%) (P < 0.001). In addition, the TAVR group had more comorbidities compared to SAVR in term of coronary artery disease (CAD), congestive heart failure (CHF), chronic lung disease, hypertension (HTN), chronic kidney disease (CKD), and peripheral vascular disease (PVD) (P < 0.001 for all). Using Multivariate logistic regression, and after adjusting for potential risk factors, TAVR patients had lower in‐hospital mortality (7.9% vs 8.1% adjusted Odds Ratio [aOR], 0.615; 95% confidence interval [CI], 0.392–0.964, P = 0.034), shorter LOS. Also, TAVR patients had lower rates of cardiac and respiratory complications, PPM, AKI, and discharge to an outside facility compared with the SAVR group.

Conclusion

In patients with severe aortic stenosis and concomitant mitral stenosis, TAVR is a safe and attractive option for patients undergoing AVR with less complications compared with SAVR.

     

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Prior Cardiac Surgery in the Randomized PARTNER 2A Trial

Objectives

The aim of this study was to further evaluate clinical outcomes in patients with and without PCS.

Transcatheter Aortic Valve Replacement: 2015 in Review

Transcatheter aortic valve replacement (TAVR) has emerged as an attractive option for patients with severe symptomatic aortic stenosis (AS) who are either at high risk or extreme risk for surgical aortic valve replacement (SAVR). This article summarizes the major advances in TAVR that were published or reported in 2015. (J Interven Cardiol 2016;29:27–46)

     

Outcomes of Transcatheter and Surgical Aortic Valve Replacement in Patients on Maintenance Dialysis

Background

The introduction of transcatheter aortic valve replacement (TAVR) expanded definitive therapy of aortic stenosis to many high-risk patients, but it has not been fully evaluated in the dialysis population. We aimed to evaluate the current trend and in-hospital outcome of surgical aortic valve replacement (SAVR) and TAVR in the dialysis population.

Effect of SAPIEN 3 Transcatheter Valve Implantation on Health Status in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER S3i Trial

Objectives

The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR).

Implementation of Transcatheter Aortic Valve Replacement in France

Background

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic valve replacement (SAVR), but unbiased data regarding evolution of the treatment of patients with aortic stenosis at the nationwide level are scarce.

Vascular complications post-transcatheter aortic valve procedures

Transcatheter aortic valve replacement (TAVR) has rapidly emerged as the standard of care for severe symptomatic aortic stenosis in patients whose comorbidities put them at prohibitive risk for surgical aortic valve replacement (SAVR). Several trials have demonstrated superior outcomes with TAVR compared to medical management alone. TAVR has also shown favorable outcomes in patients at high risk for SAVR. TAVR can be associated with significant vascular complications, which adversely impact outcomes, and operators should be cognizant of their early recognition and appropriate management. In this article, we review the major vascular complications associated with TAVR, along with optimal prevention and management strategies.     

Trends in Isolated Surgical Aortic Valve Replacement According to Hospital-Based Transcatheter Aortic Valve Replacement Volumes

Objectives

This study sought to evaluate the trends in isolated surgical aortic valve replacement (SAVR) procedures across hospitals with different transcatheter aortic valve replacement (TAVR) volumes among Medicare beneficiaries.

Trans-Catheter Aortic Valve Replacement and Surgical Aortic Valve Replacement Outcomes in Patients with Dialysis: Systematic Review and Meta-Analysis

BackgroundDialysis is associated with higher rate of aortic valve calcification and higher cardiovascular mortality. Transcatheter aortic valve replacement (TAVR) is an established alternative for surgical aortic valve replacement (SAVR) in patients with higher and intermediate co-morbidities including dialysis.MethodsTwo independent investigators systematically searched Medline, Cochrane, and Web of Science. The ROBINS-I tool was used to analyze and assess the bias from the selected studies.ResultsThe search resulted in 4 observational studies with a total of 966 patients. TAVR in dialysis patients was associated with no significant difference in in-hospital mortality [8.1% vs 10.3%; OR (95% CI) 0.74 (0.35, 1.60), I2 = 50%, P = 0.45], risk-of-strokes at 30 days [2% vs 4.4%; OR (95% CI) 0.49 (0.22, 1.09), I2 = 0%, P = 0.08], vascular complications [12.7% vs 13.2%; OR (95% CI) 0.96 (0.55, 1.67), I2 = 0%, P = 0.89], need of blood transfusion [43.1% vs 66.4%; OR (95% CI) 0.27 (0.05, 1.39), I2 = 89%, P = 0.12], or bleeding risk [5.6% vs 6.8%; OR (95% CI) 0.91 (0.18, 4.64), I2 = 5%, P = 0.91] when compared to SAVR. TAVR was associated with significantly shorter length of stay [8.5 days vs 14.2 days; mean difference (95% CI) ?5.89 (?9.13, ?2.64), I2 = 76%, P < 0.0001] and higher pacemaker implantation [11.4% vs 6.8%; OR (95% CI) 1.74 (1.07, 2.81), I2 = 5%, P = 0.02].ConclusionTAVR outcomes were comparable to SAVR but had a significantly shorter length of stay and a higher pacemaker implantation rate in dialysis patients.     

Intervention Versus Observation in Symptomatic Patients With Normal Flow Low Gradient Severe Aortic Stenosis

Objectives

The purpose of this study was to describe patients with severe symptomatic aortic stenosis with normal flow and low gradients and determine whether they benefit from intervention.

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.     

Durability of Transcatheter and Surgical Bioprosthetic Aortic Valves in Patients at Lower Surgical Risk

Background

Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk.

Outcomes of Surgical Aortic Valve Replacement: The Benchmark for Percutaneous Therapies

Historically, many patients with severe senile calcific aortic valve stenosis (AS) were not offered surgery, largely due to the perception that the risks of operation were prohibitive. Such patients have subsequently been formally designated as ‘high risk’ or ‘inoperable’ with respect to their suitability for surgical aortic valve replacement (SAVR) in the evolving lexicon of heart valve disease. The recent availability of transcatheter aortic valve replacement (TAVR) represents an alternative treatment option, and permits the opportunity to re-examine algorithms for assessing operative risk. As the experience with TAVR grows, expanded use in new patient populations can be anticipated. While TAVR in high risk AS patients has demonstrated benefits, the emerging indication in intermediate AS is less clear and conclusions will necessarily await the availability of results from ongoing clinical trials. This article will discuss current outcomes for SAVR among high- and intermediate-risk patients with AS as a barometer in assessing the results of nascent percutaneous therapies.     

Commissural Alignment of Bioprosthetic Aortic Valve and Native Aortic Valve Following Surgical and Transcatheter Aortic Valve Replacement and its Impact on Valvular Function and Coronary Filling

Objectives

The aim of this study was to assess the commissural alignment between bioprosthetic and native aortic valve leaflets following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) and to investigate its impact on valvular function and coronary filling.

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.     

Transcatheter versus surgical aortic valve replacement in severe, symptomatic aortic stenosis

Aortic stenosis (AS) is the most common type of valvular heart disease in the elderly. Surgical aortic valve replacement (SAVR) has been the standard practice for treating severe, symptomatic AS, but recently new treatment options have emerged. Transcatheter aortic valve replacement (TAVR) is now an established treatment option in patients at high surgical risk. In this review, we focus on recent developments and compare the two treatment methods in specific populations in terms of efficacy and safety (e.g., in patients with history of prior thoracic surgery, type of anesthesia employed, access site used or need for permanent pacing). The impact of comorbidities (pulmonary hypertension, arterial hypertension and obesity paradox), the cost-effectiveness of TAVR vs. SAVR and advances in transcatheter valve technology as well as issues that merit further investigation are further discussed. Moreover, outcomes and complications of TAVR in patients of different risk category (extremely high, high, intermediate and low risk) are analyzed. We strongly believe that during the following years, TAVR may evolve as the treatment of choice in a broader group of patients with symptomatic AS and beyond those with intermediate and high-risk features.     

Long-Term Risk of Infective Endocarditis After Transcatheter Aortic Valve Replacement

Background

Patients undergoing surgical aortic valve replacement (SAVR) are considered at high risk of infective endocarditis (IE). However, data on the risk of IE following transcatheter aortic valve replacement (TAVR) are sparse and limited by the lack of long-term follow-up as well as a direct comparison with patients undergoing SAVR.

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.     

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.