Development and validation of explainable machine learning models for risk of mortality in transcatheter aortic valve implantation: TAVI risk machine scores.

AIMS Identification of high-risk patients and individualized decision support based on objective criteria for rapid discharge after transcatheter aortic valve implantation (TAVI) are key requirements in the context of contemporary TAVI treatment. This study aimed to predict 30-day mortality following TAVI based on machine learning (ML) using data from the German Aortic Valve Registry. METHODS AND RESULTS Mortality risk was determined using a random forest ML model that was condensed in the newly developed TAVI Risk Machine (TRIM) scores, designed to represent clinically meaningful risk modelling before (TRIMpre) and in particular after (TRIMpost) TAVI. Algorithm was trained and cross-validated on data of 22 283 patients (729 died within 30 days post-TAVI) and generalisation was examined on data of 5864 patients (146 died). TRIMpost demonstrated significantly better performance than traditional scores [C-statistics value, 0.79; 95% confidence interval (CI)] [0.74; 0.83] compared to Society of Thoracic Surgeons (STS) with C-statistics value 0.69; 95%-CI [0.65; 0.74]). An abridged (aTRIMpost) score comprising 25 features (calculated using a web interface) exhibited significantly higher performance than traditional scores (C-statistics value, 0.74; 95%-CI [0.70; 0.78]). Validation on external data of 6693 patients (205 died within 30 days post-TAVI) of the Swiss TAVI Registry confirmed significantly better performance for the TRIMpost (C-statistics value 0.75, 95%-CI [0.72; 0.79]) compared to STS (C-statistics value 0.67, CI [0.63; 0.70]). CONCLUSION TRIM scores demonstrate good performance for risk estimation before and after TAVI. Together with clinical judgement, they may support standardised and objective decision-making before and after TAVI

1-Year outcomes after transcatheter aortic valve replacement with balloon-expandable versus self-expandable valves

BACKGROUND The use of a balloon-expandable transcatheter heart valve previously resulted in a greater rate of device success compared with a self-expandable transcatheter heart valve. OBJECTIVES The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up. METHODS The investigator-initiated trial randomized 241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for treatment with both balloon- and self-expandable transcatheter heart valves to transfemoral transcatheter aortic valve replacement with either device. Patients were followed-up for 1 year, with assessment of clinical outcomes and echocardiographic evaluation of valve function. RESULTS At 1 year, the rates of death of any cause (17.4% vs. 12.8%; relative risk [RR]: 1.35; 95% confidence interval [CI]: 0.73 to 2.50; p ¼ 0.37) and of cardiovascular causes (12.4% vs. 9.4%; RR: 1.32; 95% CI: 0.63 to 2.75; p ¼ 0.54) were not statistically significantly different in the balloon- and self-expandable groups, respectively. The frequencies of all strokes (9.1% vs. 3.4%; RR: 2.66; 95% CI: 0.87 to 8.12; p ¼ 0.11) and repeat hospitalization for heart failure (7.4% vs. 12.8%; RR: 0.58; 95% CI: 0.26 to 1.27; p ¼ 0.19) did not statistically significantly differ between the 2 groups. Elevated transvalvular gradients during follow-up were observed in 4 patients in the balloon-expandable group (3.4% vs. 0%; p ¼ 0.12); all were resolved with anticoagulant therapy, suggesting a thrombotic etiology. More than mild paravalvular regurgitation was more frequent in the self-expandable group (1.1% vs. 12.1%; p ¼ 0.005). CONCLUSIONS Despite the higher device success rate with the balloon-expandable valve, 1-year follow-up of patients in CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT Trial), with limited statistical power, revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with both balloon- and self-expandable prostheses that were not statistically significantly different. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial; NCT01645202) (J Am Coll Cardiol 2015;66:791–800) © 2015 by the American College of Cardiology Foundation

Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study

Aim Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre ‘real-world' patient population in highly experienced centres. Methods and results Patients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively. Conclusion The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosi

Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study

Background Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking. Objectives This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice. Methods The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents. Results Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients. Conclusions TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369

Valvular heart disease 2019

The number of patients suffering from valvular heart diseases is steadily increasing due to the demographic changes and aging of the population. Interventional treatment modalities in particular have gained in importance in recent years. This is especially true for patients with aortic valve stenosis who can benefit from interventional treatment approaches. The number of catheter-based interventions (TAVI) performed in Germany in recent years is higher than the classical surgical aortic valve replacement (SAVR). This is driven not only by convincing results from randomized clinical trials and less invasive approaches but also due to excellent data derived from the mandatory quality assurance. These data could show that the in-hospital mortality was statistically significantly lower for TAVI in comparison to SAVR. The interventional approach has also gained in importance for patients suffering from mitral valve regurgitation secondary to heart failure. The recently presented results of the COAPT trial demonstrated clear superiority of interventional treatment when compared to optimal pharmacotherapy alone. Interventional treatment options for tricuspid valve regurgitation are relatively new. These offer valuable options for many patients for whom a meaningful treatment was so far unavailable, as isolated tricuspid valve surgery is associated with high mortality in this patient group where a high comorbidity is regularly present. This article summarizes the most important new aspects in the field of structural heart diseases

Current Status of Catheter-based Mitral Valve Replacement

Purpose of review!#!Transcatheter mitral valve replacement (TMVR) has been developed to address the need for an alternative therapeutic option to surgery in patients suffering from severe mitral regurgitation who are at high surgical risk. The present review illustrated the state-of-the-art of catheter-based mitral valve replacement evaluating technical characteristics and early clinical experience of different devices to outline prospects and challenges of TMVR.!##!Recent findings!#!Several devices are currently under clinical assessment. Early experience has demonstrated high procedural success of TMVR. However, TMVR faces several possible hurdles such as left ventricular outflow tract obstruction (LVOTO) after prosthesis deployment, access site complications, and thrombotic risk requiring anticoagulatory therapy. Future studies should assess long-term prosthesis stability, optimal anticoagulation regime, and occurrence of paravalvular leakage. The development of smaller TMVR prostheses suitable for transseptal implantation could overcome bleeding complications. In perspective, TMVR may emerge to a clinically relevant therapeutic approach for patients with severe MR at high surgical risk

Meta-Analysis of Stroke and Mortality Rates in Patients Undergoing Valve-in-Valve Transcatheter Aortic Valve Replacement

Background During the past decade, the use of transcatheter aortic valve replacement (TAVR) was extended beyond treatment-naive patients and implemented for treatment of degenerated surgical bioprosthetic valves. Selection criteria for either valve-in-valve (viv) TAVR or redo surgical aortic valve replacement are not well established, and decision making on the operative approach still remains challenging for the interdisciplinary heart team. Methods and Results This review was intended to analyze all studies on viv-TAVR focusing on short- and mid-term stroke and mortality rates compared with redo surgical aortic valve replacement or native TAVR procedures. A structured literature search and review process led to 1667 potentially relevant studies on July 1, 2020. Finally, 23 studies fulfilled the inclusion criteria for qualitative analysis. All references were case series either with or without propensity score matching and registry analyses. Quantitative synthesis of data from 8509 patients revealed that viv-TAVR is associated with mean 30-day stroke and mortality rates of 2.2% and 4.2%, respectively. Pooled data analysis showed no significant differences in 30-day stroke rate, 30-day mortality, and 1-year mortality between viv-TAVR and comparator treatment (native TAVR [n=11 804 patients] or redo surgical aortic valve replacement [n=498 patients]). Conclusions This review is the first one comparing the risk for stroke and mortality rates in viv-TAVR procedures with native TAVR approach and contributes substantial data for the clinical routine. Moreover, this systematic review is the most comprehensive analysis on ischemic cerebrovascular events and early mortality in patients undergoing viv-TAVR. In this era with increasing numbers of bioprosthetic valves used in younger patients, viv-TAVR is a suitable option for the treatment of degenerated bioprostheses