Intermediate Surgical Risk Research Articles

In-hospital outcomes of transcatheter aortic valve implantation procedure: data of single-center registry

Transcatheter aortic valve replacement is an appropriate alternative to open surgery in some patients with severe aortic stenosis who have significant comorbidities and high surgical risk.Aim. To evaluate the immediate results of transcatheter aortic valve replacement in patients with severe aortic stenosis.Material and Methods. This is a retrospective study, which included 350 patients who underwent transcatheter aortic valve replacement from 2015 to 2021. Mortality, complications, clinical data, and echocardiographic parameters were assessed in the early postoperative period after the procedure.Results. The patient mean age was 75.3 ± 7.2 years. The majority of patients had intermediate surgical risk: EuroScore II of 6.7 ± 5.4 and STS-PROM score of 3.3 ± 1.9. In most cases, there was severe hypertrophy of left ventricular (LV) myocardium with an average LV myocardial mass of 330.9 ± 88.4 g. The average postprocedural pressure gradient across the aortic valve was 8.9 ± 4.4 mm Hg. The most common procedural complication was complete heart block (10%). In-hospital mortality rate was 1.7%.Conclusion. Our register demonstrated the optimal immediate clinical and echocardiographic results of transcatheter aortic valve replacement in patients with severe aortic stenosis.

Economic Evaluation of Transcatheter Aortic Valve Replacement Compared to Surgical Aortic Valve Replacement in Chinese Intermediate-Risk Patients.

BackgroundAortic stenosis (AS) is a severe disease that causes heart failure and sudden death. Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are both recommended for patients with intermediate surgical risk, but the cost-effectiveness of TAVR compared to SAVR in China has not been investigated.MethodsA combined decision tree and Markov model were conducted to compare the cost-effectiveness of TAVR versus SAVR with a 5-year simulation. The primary outcome was the incremental cost-effectiveness ratio (ICER), a ratio of incremental costs to incremental quality-adjusted life-year (QALY). One-way sensitive analysis and probabilistic sensitivity analysis (PSA) were conducted to test the robustness of the model.ResultsAfter a simulation of 5 years, the costs of TAVR and SAVR were 54,573 and 35,002 USD, respectively, and the corresponding effectiveness was 2.826 versus 2.712 QALY, respectively. The ICER for the TAVR versus SAVR comparison was 170,056 USD/QALY, which was three times higher than the per capita gross domestic product (GDP) in China. One-way sensitive analysis showed that the cost of the TAVR device impacted the ICER. The TAVR could be cost-effective only in the case where its cost is lowered to 29,766 USD.ConclusionTAVR is currently not cost-effective in China, but it could be cost-effective with a reduction of costs to 29,766 USD, which is approximately 65% of the current price.

Latest Advances in Transcatheter Aortic Valve Implantation (2022)

Since the last decade, transcatheter aortic valve implantation (TAVI) has become the treatment of choice in patients with symptomatic severe aortic stenosis (AS) who are ineligible or at higher risk for surgery. Due to the high safety profile of current device generation, TAVI has emerged as a qualified alternative to surgical aortic valve replacement (SAVR) in patients with classic aortic stenosis and intermediate surgical risk, severe bicuspid aortic valve stenosis, and isolated pure aortic regurgitation. Moderate aortic stenosis, with and without concomitant heart failure with reduced ejection fraction, are under investigation in randomized controlled clinical trials from which we will gain exciting insights on the best timing of TAVI to protect the left ventricle from further functional deterioration due to increasing AS. In these cases, a meticulous diagnostic approach including advanced imaging is becoming more and more important. Current evidence on antithrombotic strategies after TAVI is weak, contributing to poor levels of standardization and high variability in daily clinical practice. This review will provide a short overview of recent clinical trials including best timing for TAVI with moderate AS and antithrombotic strategies after TAVI with current and future TAVI generations.

Transcatheter aortic valve replacement in the developing world: Lessons learnt and its implications for practice

BackrgroundTranscatheter aortic valve replacement (TAVR) has become an accepted modality of treatment in intermediate and high surgical risk patients of symptomatic severe calcific aortic stenosis (AS). We herein report Indian data of 84 intermediate and high-risk patients who underwent TAVR at two Armed Forces cardiac centres. MethodsMost of the patients underwent TAVR in cardiac catheterization lab by percutaneous transfemoral approach, under conscious sedation. Patients were followed up and echocardiographic parameters were assessed after six months of procedure. ResultsTotal of 84 intermediate and high-risk patients underwent TAVR between Jan 2017 and June 2021. Mean age of population was 71.5 ± 8.4 years; 28.5% of patients had bicuspid aortic valve and Mean STS score was 6.34 ± 2.08. Majority (92.8%) patients underwent the procedure under conscious sedation. Self-expanding valves were used in 72.6% and balloon expandable in 27.4% of patients. Predilatation was done in 64% patients while 13% cases underwent post dilatation. Procedural mortality was 2.3%. Rate of permanent pacemaker implantation was 4.9%. Ischemic stroke occurred in 1.1% of patents. There was no case of severe paravalvular leak. Emergency surgical aortic valve replacement was done in 2.4% patients. Procedural success in this study was 97.6%. All-cause mortality was 9.5% at 6 months. ConclusionsTAVR is an effective treatment modality in intermediate and high-risk Indian patients with severe aortic stenosis. Patients with bicuspid or previous bio prosthetic aortic valves also have a good outcome post TAVR.

Short-Term Outcomes After Transcatheter Aortic Valve Replacement in Predominant Aortic Regurgitation with Left Ventricular Dysfunction.

Patients with aortic stenosis and low left ventricular ejection fraction (LVEF) would benefit from transcatheter aortic valve replacement. However, the safety and efficacy of transcatheter aortic valve replacement in patients with aortic regurgitation and left ventricular dysfunction remains unknown.We defined LVEF < 50% as left ventricular dysfunction. A total of 27 symptomatic patients with aortic regurgitation and ejection fraction < 50% underwent transcatheter aortic valve replacement using the J-Valve™ system (JieCheng Medical Technology Co, Ltd, Suzhou, China) in Zhongshan Hospital, Fudan University, from May 2014 to June 2019. Procedural and postoperative clinical outcomes were analyzed according to Valve Academic Research Consortium-2 (VARC-2) criteria.All patients (eight females; 70.6 ± 7.1 years) were considered to be at least intermediate surgical risk and/or severe comorbidity precluding for surgical aortic valve replacement (logistic European System for Cardiac Operative Risk Evaluation, 16.8 ± 9.5%, range 4.6% to 37.9%) by a multidisciplinary heart team. Transapical implantations were successful in 26 (96.3%) patients. All-cause mortality was 3.7% in the latest follow-up (25-590 days, median 369 days). Significant improvements in LVEF, left ventricular end-diastolic, and systolic dimensions were observed after procedure (from 40.3 ± 6.7% to 50.8 ± 10.5%, P < 0.001; from 65.1 ± 8.9 mm to 56.0 ± 9.6 mm, P = 0.002; from 52.2 ± 9.8 mm to 35.9 ± 13.4 mm, P < 0.001, respectively). No patient had aortic stenosis and paravalvular leak more than moderate and heart function improvement was obtained in the majority of patients at 1-year follow-up.Transcatheter aortic valve replacement using the J-Valve™ system is a reasonable alternative for patients with aortic regurgitation and left ventricular dysfunction regarding promising short-term outcomes.

Evolution of right ventricular dysfunction and tricuspid regurgitation after TAVI: A prospective study

BackgroundRight ventricular (RV) dysfunction and tricuspid regurgitation (TR) may impact prognosis of patients undergoing Transcatheter Aortic Valve Implantation (TAVI). We aimed to evaluate the evolution of previous RV dysfunction and/or significant TR after TAVI procedure. MethodsAll patients undergoing TAVI between January 2018 and January 2019 were enrolled in this prospective cohort. Patients with at least one right heart (RH) abnormality at baseline including RV dysfunction (TAPSE < 17 mm, S-wave < 9.5 cm/s, Fractional area change < 35%, Strain > −20%, Tei > 0.54) and/or significant TR (Effective Regurgitant Orifice Area ≥ 40 mm2 and/or Regurgitant Volume ≥ 45 mL) underwent transthoracic echocardiography at day 1 and 6-month after TAVI. The primary endpoint was the regression of pre-TAVI RV dysfunction and/or significant TR at 6-month follow-up. ResultsThe study enrolled 144 patients including 76 women (52.8%) with a mean age of 81.1 ± 6.8 yo, a mean EuroSCORE 2 of 5.2 ± 3.9%. At least one RH abnormality was observed in 53 patients (36.8%). At 6-month, at least one RV dysfunction parameter significantly improved in 26 patients (63.4%), TAPSE increasing from 13.0 ± 2.6 to 16.0 ± 9.8 mm, p < 0.0001 and S-wave from 7.7 ± 1.2 to 10.0 ± 2.6 cm/s, p = 0.004. Among 31 patients with baseline significant TR, TR decreased in 14 (45.2%); p = 0.003. Among patients with baseline RH abnormalities, 13 (24.5%) fully recovered. Baseline significant TR was predictive of 6-month clinical outcomes (OR = 3.1, 95%CI = [1.01–9.0], p = 0.03). ConclusionIn our recent intermediate surgical risk TAVI population, RV dysfunction and/or significant TR are frequent at baseline and fully or partially recover in most patients at 6-month follow-up.

Impact of Frailty and Prefrailty on Outcomes of Transcatheter or Surgical Aortic Valve Replacement.

Randomized trials have shown short- and mid-term benefits with transcatheter versus surgical aortic valve replacement (TAVR versus SAVR) for patients at intermediate or low-risk for surgery. Frailty and prefrailty could explain some of this benefit due to an impaired ability to recover fully from a major surgical procedure. We examined 2-year outcomes (survival and Kansas City Cardiomyopathy Questionnaire [KCCQ] scores) among patients at intermediate or low surgical risk treated with transfemoral-TAVR or SAVR within the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial, SAPIEN 3 intermediate-risk registry, and PARTNER 3 trial. Frailty was examined as a continuous variable based on grip strength, gait speed, serum albumin, and activities of daily living. We tested the interaction of frailty markers by treatment (TAVR versus SAVR) in proportional hazards regression models (survival) and piecewise linear regression models (KCCQ), adjusting for patient demographic and clinical factors. Among the 3025 patients in the analytic cohort (2003 TAVR, 1022 SAVR; mean age 79.3 years, 61.6% men), 799 (26.4%) were nonfrail, 2041 (67.5%) were prefrail (1-2 frailty markers), and 185 (6.1%) were frail (3-4 frailty markers). Increasing frailty (none versus prefrail versus frail) was associated with higher 2-year mortality (5.5% versus 11.1% versus 22.8%; log-rank P<0.001) and worse 2-year health status among survivors (KCCQ scores adjusted for baseline: 84.8 versus 79.6 versus 77.4, P<0.001). In multivariable models, there were no significant interactions between frailty markers and treatment group for either survival (interaction P=0.39) or health status (interaction P>0.47 for all time points). In a cohort of older patients with severe aortic stenosis who were at low or intermediate surgical risk, increasing frailty markers were associated with worse 2-year mortality and greater health status impairment after either TAVR or SAVR, but there were no significant interactions between type of valve replacement and frailty with respect to either outcome.

Antithrombotic therapy in patients undergoing transcatheter aortic valve replacement (TAVR): from current evidence to perspective

The use of transcatheter aortic valve replacement (TAVR) for care of symptomatic severe aortic stenosis has increased over the last years; after initially treating patients at prohibitive or high surgical risk, nowadays the procedure can be considered for intermediate or low surgical risk. Although thrombotic events (ischemic stroke, myocardial infarction, and leaflet thrombosis) decreased in patients at lower risk, antithrombotic therapy after TAVR is still recommended. However, the optimal antithrombotic regimen is a still matter of debate due to the lack of randomized data and the concomitant increased risk of bleeding events. In the present review, we analyze current data, recommendations of international guidelines and consensus documents, and potential future scenarios with a rational approach of separation of patients with or without a pre-procedural indication for long-term oral anticoagulant therapy.

Transcatheter Aortic Valve Implantation in Low and Intermediate Surgical Risk Patients: a Critical Appraisal of Seminal Studies

Transcatheter Aortic Valve Implantation in Low and Intermediate Surgical Risk Patients: a Critical Appraisal of Seminal Studies

The Alfred, Cabrini and Epworth Transcatheter Aortic Valve Implantation (ACE-TAVI) Registry: Description and Short-Term Clinical Outcomes

Aortic valve stenosis is the most common valvular disease in developed countries. Transcatheter aortic valve implantation (TAVI) has evolved to be the new standard of care for inoperable, high and intermediate surgical risk patients with aortic stenosis.

Budget impact analysis of transcatheter aortic valve replacement in low, intermediate, and high-risk patients with severe aortic stenosis in Saudi Arabia

Aims A budget impact analysis (BIA) comparing transcatheter aortic valve replacement (TAVR) with SAPIEN 3 and surgical aortic valve replacement (SAVR) for severe, symptomatic aortic stenosis among patients of low, intermediate, and high surgical risk from the perspective of the public and private sectors in Saudi Arabia. Materials and methods A Markov model was developed with six states to calculate the budget impact from time of either TAVR or SAVR intervention up to 5 years. We compared the budget effects of new permanent pacemaker implantation (PPI), new onset atrial fibrillation (AF), major/disabling stroke (MDS), and surgical site infections (SSI). One-way sensitivity analyses (OWSA) were performed on cost and probability inputs. Results Analysis of the base case parameters suggests TAVR vs. SAVR is budget saving among intermediate- and high-risk patients at 5 years. TAVR vs. SAVR for low surgical risk reaches budget neutrality at 5 years. TAVR is associated with higher costs for PPI and budget savings for MDS, AF, and SSI. TAVR also results in savings for non-device costs due to fewer human resource uses and shorter procedure durations. Similarly, TAVR is associated with cost savings due to shorter hospital intensive care unit (ICU) and non-ICU stays. The OWSA consistently revealed that SAVR non-device theater costs were the leading cost driver across all surgical risk levels. Limitations This is the first budget impact analysis of its kind in Saudi Arabia and future research is needed on costing TAVR and SAVR procedures, the economic impact of SSI, and corroborating estimates for the public and private sectors. Conclusions Payers, providers, and policymakers increasingly turn to results of BIA to inform technologies affordability decisions. TAVR with SAPIEN 3 appears to generate savings vs. SAVR from a budget impact perspective across various surgical risk levels in Saudi Arabia.

Thrombose et TAVI : beaucoup de questions restent sans réponses

Over the past decade, TAVI has become the standard technique for treatment of severe symptomatic aortic stenosis in patients at high or intermediate surgical risk and more recently in low-surgical-risk patients. Like any technique, TAVI is associated with certain complications such as post-TAVI thrombosis. This complication can have clinical manifestations with recurrence of symptoms and/or increase in trans-prosthetic gradients. It can also be infraclinical, i.e asymptomatic without trans-prosthetic gradient elevation as revealed by cardiac CT scan showing a thickening of the valvular leaflets or cusp thrombosis, with potential impairment of the valve opening. This greatly underestimated complication has a 10% to 15% incidence. Biomechanical factors, intrinsic patient-related predisposition as well as post-TAVI anti-thrombotic treatment have all been incriminated in the occurrence of TAVI thrombosis. The use of anticoagulation treatment by AVK or DOAC in the presence of post TAVI prosthetic thrombosis seems obvious. However, their benefit in the treatment of infraclinical thrombosis has not been clearly established.

Life Expectancy After Surgical Aortic Valve Replacement

BackgroundSurgical risk, age, perceived life expectancy, and valve durability influence the choice between surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation. The contemporaneous life expectancy after SAVR, in relation to surgical risk and age, is unknown. ObjectivesThe purpose of this study was to determine median survival time in relation to surgical risk and chronological age in SAVR patients. MethodsPatients ≥60 years with aortic stenosis who underwent isolated SAVR with a bioprosthesis (n = 8,353) were risk-stratified before surgery into low, intermediate, or high surgical risk using the logistic EuroSCORE (2001-2011) or EuroSCORE II (2012-2017) and divided into age groups. Median survival time and cumulative 5-year mortality were estimated with Kaplan-Meier curves. Cox regression analysis was used to further determine the importance of age. ResultsThere were 7,123 (85.1%) low-risk patients, 942 (11.3%) intermediate-risk patients, and 288 (3.5%) high-risk patients. Median survival time was 10.9 years (95% confidence interval: 10.6-11.2 years) in low-risk, 7.3 years (7.0-7.9 years) in intermediate-risk, and 5.8 years (5.4-6.5 years) in high-risk patients. The 5-year cumulative mortality was 16.5% (15.5%-17.4%), 30.7% (27.5%-33.7%), and 43.0% (36.8%-48.7%), respectively. In low-risk patients, median survival time ranged from 16.2 years in patients aged 60 to 64 years to 6.1 years in patients aged ≥85 years. Age was associated with 5-year mortality only in low-risk patients (interaction P < 0.001). ConclusionsEighty-five percent of SAVR patients receiving bioprostheses have low surgical risk. Estimated survival is substantial following SAVR, especially in younger, low-risk patients, which should be considered in Heart Team discussions.

Diagnostic Work-Up of the Aortic Patient: An Integrated Approach toward the Best Therapeutic Option.

Aortic stenosis (AS) is the most common valvular heart disease. In the last decade, transcatheter aortic valve implantation (TAVI) has become the standard of care for symptomatic patients at high surgical risk. Recently, indications to TAVI have also been extended to the low surgical risk and intermediate surgical risk populations. Consequently, in this setting, some aspects acquire greater relevance: surgical risk evaluation, clinical assessment, multimodality imaging of the valve, and management of coronary artery disease. Moreover, future issues such as coronary artery re-access and valve-in-valve interventions should be considered in the valve selection process. This review aims to summarize the principal aspects of a multidimensional (multidisciplinary) and comprehensive preprocedural work-up. The Heart Team is at the center of the decision-making process of the management of aortic valve disease and bears responsibility for offering each patient a tailored approach based on an individual evaluation of technical aspects together with the risks and benefits of each modality. Considering the progressive expansion in TAVI indication and technological progress, the role of a work-up and multidisciplinary Heart Team will be even more relevant.

Transcatheter aortic valve replacement for structural degeneration of previously implanted transcatheter valves (TAVR-in-TAVR): a systematic review

Abstract OBJECTIVES Transcatheter aortic valve replacement (TAVR) represents a valid treatment for patients with aortic valve stenosis and high or intermediate surgical risk. However, biological transcatheter valves can also experience a structural degeneration after years, and a redo-TAVR procedure (TAVR-in-TAVR) can be a valid option. We revised the current available literature for indications, procedural and technical details and outcome on TAVR-in-TAVR procedures for degenerated TAVR valves. METHODS A systematic search was conducted in the public medical database for scientific articles on TAVR-in-TAVR procedures for degenerated transcatheter valves. Data on demographics, indications, first and second transcatheter valve type and size, mortality, complications and follow-up were extracted and analysed. RESULTS A total of 13 studies (1 multicentre, 3 case series, 9 case reports) were included in this review, with a total amount of 160 patients treated with TAVR-in-TAVR procedures for transcatheter valve failure. The mean age was 74.8 ± 7.8 with 84 males (52.8%). The mean elapsed time from the first TAVR procedure was 58.1 ± 23.4 months. Main indication for TAVR-in-TAVR was pure stenosis (38.4%, with mean gradient of 44.5 ± 18.5 mmHg), regurgitation (31.4%), mixed stenosis and regurgitation (29.5%) and leaflet thrombosis (8.8%). Procedural success rate was 86.8%, with second TAVR valve malposition occurred in 4 cases (2.5%). The hospital mortality rate was 1.25% (2/160). Post-procedural echocardiographic control showed moderate regurgitation in 5.6% of patients (9/160) and residual transvalvular mean gradient ≥20 mmHg in 5% of cases. Postoperative complications included major vascular complications (8.7%), new pacemaker implantation (8.7%), acute kidney failure (3.7%), stroke (0.6%) and coronary obstruction (0.6%). The mean follow-up time was 6 ± 5.6 months with 1 non-cardiovascular death reported. CONCLUSIONS TAVR-in-TAVR represents a valid alternative to standard surgery for the treatment of degenerated transcatheter valves in high-risk patients. Despite these promising results, further studies are required to assess durability and haemodynamic performances of the second TAVR valve.

Electrocardiographic predictors of recovery from pacemaker dependency after transcatheter aortic valve implantation: a meta-analysis

Abstract Background Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgery for the treatment of patients with severe symptomatic aortic stenosis at high and intermediate surgical risk. The occurrence of electrical conduction disturbances with the need for permanent pacemaker (PPM) implantation remains one of the most frequent complications of the procedure. But PPM dependency after TAVI is often transient and conduction abnormalities may improve over time. Purpose We performed a meta-analysis to summarize available studies that reported the incidence of new PPM after TAVI and investigated the rate and possible predictors of recovery from PPM dependency during follow-up. Methods The authors conducted a literature search in PubMed and MEDLINE databases from January of 2012 until February of 2021. Eleven observational studies (n=6794) met inclusion criteria for the final analysis. The effect size was estimated using a random-effects model with 95% confidence interval (CI). Results PPM implantation was performed in 902 patients after TAVI (13.3%), mostly due to high degree atrioventricular (AV) block (81.3%). A follow-up of 683 patients was performed after a median period of 139 days. 322 of the patients examined during follow-up (48.6%) showed recovery from PPM dependency. Regarding secondary endpoints' analysis of relative risk (RR) and mean difference (MD) predictors of PPM recovery during follow-up were female sex (RR 1.37; 95% CI 1.10–1.71; p=0.006), preexisting coronary artery disease (RR 1.12; 95% CI 0.99–1.27; p=0.08) and reduced left ventricular ejection fraction (MD −2.08%; 95% CI 0.23–3.93%; p=0.03). ECG predictors for long-term PPM dependency after TAVI appeared to be preexisting right bundle branch block (RBBB) (RR 1.84; 95% CI 1.38–2.45; p&amp;lt;0.0001), bifascicular block (RR 4.41; 95% CI 1.64–11.86; p=0.003) and prolonged QRS duration (MD 8.69 ms; 95% CI 0.11–17.28 ms; p=0.05). While postprocedural complete heart block was highly predictive for long-term PPM dependency after TAVI (RR 1.35; 95% CI 0.97–1.89; p&amp;lt;0.0001), patients with recovery of PPM dependency showed more indications other than complete heart block for PPM implantation like lower degree AV block or sick sinus syndrome (RR 2.28; 95% CI 1.53–3.38; p&amp;lt;0.0001). Especially postprocedural AV block grade I (RR 1.73; 95% CI 0.96–3.14; p=0.07) and new left bundle branch block (LBBB) (RR 1.94; 95% CI 1.22–3.08; p=0.005) turned out to be predictors of PPM recovery during follow-up. Conclusion This structured meta-analysis proved new PPM implantation in 13.3% of patients following TAVI with half of the cases (48.6%) recovering from PPM dependency during follow-up. Therefore, it should be considered to carefully reassess the indication for PPM rather than to immediately implant PPM after TAVI, especially regarding postprocedural ECG predictors for early pacemaker recovery (lower degree AV block, postprocedural LBBB). Funding Acknowledgement Type of funding sources: None.

Transcatheter Aortic Valve Implantation for Patients with Severe Symptomatic Aortic Stenosis

&#x0D; The cost-effectiveness of transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement was examined in patients with severe symptomatic aortic stenosis at high, intermediate, and low surgical risk, and the findings were mixed. When compared to surgical aortic valve replacement, some studies suggest that TAVI is cost-effective (less costly and/or more effective) and some studies suggest that TAVI is not cost-effective.&#x0D; Factors such as the type of TAVI system used, the cost of treatment-associated expenses (such as post-operative follow-up costs and hospitalization costs), and the characteristics of patients selected for treatment likely impact the cost-effectiveness of TAVI for patients with severe symptomatic aortic stenosis.&#x0D;

Clinical Impact of Pre-Procedural Percutaneous Coronary Intervention in Low- and Intermediate-Risk Transcatheter Aortic Valve Replacement Recipients.

The clinical relevance of as well as the optimal treatment strategy for coronary artery disease (CAD) in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) are unclear. Current data are conflicting, and mainly derived from high-risk patients. We aimed to investigate the feasibility and safety of complete revascularization prior to TAVR for severe AS in low- and intermediate-risk patients. We enrolled 449 patients at low (STS score < 4%) and intermediate risk (STS score 4–8%) undergoing TAVR for severe AS and investigated the influence of recent (<3 months) and prior (>3 months) complete revascularization on clinical outcome. Primary study endpoint was all-cause mortality. Overall, 58% of patients had no or non-significant CAD; 18% had a history of complete revascularization prior to TAVR and 24% had complete revascularization shortly before TAVR. Two-year all-cause mortality was not different between patients with recent revascularization prior to TAVR and patients with no or non-significant CAD (13.7% vs. 14.2%, p = 0.905). Cox regression did not reveal an effect on all-cause mortality for recent revascularization. The present analysis reassures that percutaneous complete revascularization prior to TAVR procedures is neutral in terms of all-cause mortality in patients at low and intermediate surgical risk.

Doppler Velocity Index Outcomes Following Surgical or Transcatheter Aortic Valve Replacement in the PARTNER Trials.

The aim of this study was to assess the association between Doppler velocity index (DVI) and 2-year outcomes for balloon-expandable SAPIEN 3 transcatheter aortic valve replacement (TAVR) and for surgical aortic valve replacement (SAVR). DVI >0.35 is normal for a prosthetic valve, but recent studies suggest that DVI<0.50 is associated with poor outcomes following TAVR. Patients with severe aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valve) 2 (intermediate surgical risk) or PARTNER 3 (low surgical risk) trial undergoing TAVR (n=1,450) or SAVR (n=1,303) were included. Patients were divided into 3 DVI groups on the basis of core laboratory-assessed discharge or 30-day echocardiograms: DVILOW (≤0.35), DVIINTERMEDIATE (>0.35 to≤0.50), and DVIHIGH (>0.50). Two-year outcomes were assessed. Following TAVR, there were no differences among the 3 DVI groups in composite outcomes of death, stroke, or rehospitalization or in any individual components of 2-year outcomes (P > 0.70 for all). Following SAVR, there was no difference among DVI groups in the composite outcome (P=0.27), but there was a significant association with rehospitalization (P=0.02). Restricted cubic-spline analysis for combined outcomes showed an increased risk with post-SAVR DVI≤0.35 but no relationship post-TAVR. DVI≤0.35 was associated with increased 2-year composite outcome for SAVR (HR: 1.81; 95% CI: 1.29-2.54; P<0.001), with no adverse outcomes for TAVR (P=0.86). In intermediate- and low-risk cohorts of the PARTNER trials, DVI≤0.35 predicted worse 2-year outcomes following SAVR, driven primarily by rehospitalization, with no adverse outcomes associated with DVI following TAVR with the balloon-expandable SAPIEN 3 valve.

Right bundle branch block is not associated with worse short- and mid-term outcome after transcatheter aortic valve implantation.

BackgroundTranscatheter aortic valve implantation (TAVI) is the standard treatment option for patients with severe aortic stenosis (AS) at intermediate or high surgical risk. Preexisting right bundle branch block (RBBB) is a strong predictor of new pacemaker implantation (PPM) after TAVI, and previous data indicate a worse short- and long-term outcome of patients. The aim of this study was to investigate whether preexisting RBBB has an effect on the short- and mid-term outcome of patients undergoing TAVI in a German high-volume TAVI center.MethodsFor the present retrospective analysis, a total of 1,891 patients with native severe AS with successful TAVI without preexisting PPM were included. The primary endpoint was all-cause mortality after 30 days and 12 months. Baseline RBBB was present in 190 (10.1%) of cases.ResultsPatients with preexisting RBBB had a considerably higher rate of new PPM after TAVI compared with patients without RBBB (87/190 [45.8%] vs. 219/1,701 [12.9%]; p<0.001). RBBB had no impact on all-cause mortality at 30 days (2.1% vs. 2.7%; p = 0.625) and at 12 months (14.4% vs. 13.6%; p = 0.765). Further stratification according to the presence of new PPM showed a difference in mid-term survival rates between the four groups, with the worst outcome for patients without RBBB and new PPM (log rank p = 0.024). However, no difference in mid-term cardiovascular survival was found.ConclusionPreexisting RBBB is a common finding in patients with severe AS undergoing TAVI and is associated with considerably higher PPM rates but not with worse short- and mid-term outcome.