Engineered heart muscle (EHM) is formulated as surgically transplantable, contractile "heart patches" for the remuscularization of the heart in advanced heart failure. We tested whether epicardial EHM allografts composed of induced pluripotent stem cell-derived cardiomyocytes and stromal cells can structurally and functionally support the failing heart in rhesus macaques without limiting side effects such as arrhythmia or tumor formation. After demonstration of the feasibility of rhesus EHM production, we observed a dose-dependent remuscularization of the rhesus macaque heart for up to 6 months after EHM transplantation. In a newly developed heart failure model EHM transplantation was associated with improved target heart wall contractility and signals of enhanced global function (ejection fraction). Histopathology and gadolinium-based perfusion magnetic resonance imaging (MRI) confirmed cell retention and functional vascularization. No EHM-related arrhythmia or tumor growth was observed. These feasibility, safety and efficacy data provided the basis for approval of a first-in-human clinical trial on tissue-engineered heart repair. Clinical data obtained from one patient confirmed the data on remuscularization after EHM implantation in advanced-stage heart failure.

Engineered heart muscle (EHM) wird als chirurgisch applizierbares, kontraktiles „Herzpflaster“ für die Therapie der fortgeschrittenen Herzinsuffizienz durch Remuskularisierung entwickelt. In der vorliegenden Arbeit wurde geprüft, ob epikardiale EHM-Allografts aus von induzierten pluripotenten Stammzellen (iPS) abgeleiteten Herzmuskelzellen und Stromazellen das nach einem Herzinfarkt geschädigte Herz des Rhesus-Makaken strukturell und funktionell unterstützen können, ohne schwerwiegende Nebenwirkungen wie Arrhythmien oder Tumorwachstum auszulösen. Nach der Entwicklung von EHM aus iPS des Rhesusaffen konnten wir das Überleben von Rhesus-EHM-Allografts für mindestens 6 Monate, eine dosisabhängige Stärkung der behandelten Herzwand sowie eine verbesserte lokale und globale Herz(wand)kontraktilität im Herzinsuffizienzmodell nachweisen. Mittels Histopathologie und Gadolinium-gestützter Perfusions-MRT (Magnetresonanztomographie) konnten wir neben Herzmuskelzellretention Herzmuskelzellreifung und funktionelle Vaskularisierung dokumentieren. Die gewonnenen Machbarkeits‑, Sicherheits- und Wirksamkeitsdaten bildeten die Grundlage für die Genehmigung der ersten klinischen Studie zur gewebebasierten Herzreparatur. Im ersten Patientenfall konnten die Daten zur Remuskularisierung aus dem Tiermodell bestätigt werden.

BACKGROUND:Biologic ventricular assist tissue (BioVAT) is formulated from engineered heart muscle composed of cardiomyocytes and stromal cells derived from allogeneic induced pluripotent stem cells for cardiac remuscularization in patients with heart failure and a reduced left ventricular ejection fraction. METHODS:We conducted an open-label, phase 1-2 study of tissue-engineered heart repair by means of BioVAT transplantation. Patients with heart failure and a left ventricular ejection fraction of 35% or less and at least one hypokinetic or dyskinetic left ventricular segment were treated with BioVAT allografts, which consisted of 5, 10, or 20 engineered-heart-muscle units. All the patients received immunosuppression. Safety was assessed as adverse events related to the procedure. The primary efficacy end points were the change from baseline in the target heart-wall thickness, the left ventricular ejection fraction, and the Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OSS). RESULTS:A total of 20 patients were treated in the study. Three patients died during the study (1 each from vasoplegia, coronavirus disease 2019, and aortic dissection). One patient underwent heart transplantation. Immunosuppression was discontinued in 4 patients because of implantation of a left ventricular assist device (in 2 patients), renal failure (in 1 patient), and urothelial carcinoma (in 1 patient). Of the 16 patients who were treated with the safe maximal dose (20 engineered-heart-muscle units), 12 patients completed the prespecified 3-month interim follow-up. The least-squares mean increase in the target-wall thickness was 4.5 mm (90% confidence interval [CI], 3.7 to 5.4; P<0.001), the increase in the left ventricular ejection fraction was 3.9 percentage points (90% CI, 0.9 to 6.8; P = 0.04), and the increase in the KCCQ-OSS was 6.7 points (90% CI, 1.0 to 12.5; P = 0.06). All the patients had at least one adverse event. CONCLUSIONS:In this interim analysis, cardiac remuscularization with BioVAT was associated with an increase in the target heart-wall thickness, left ventricular ejection fraction, and KCCQ-OSS at 3 months; all the patients had at least one adverse event. Longer-term follow-up and further clinical investigation are warranted. (Funded by the German Center for Cardiovascular Research and Repairon; BioVAT-HF ClinicalTrials.gov number, NCT04396899.).

Importance Patients with obstructive hypertrophic cardiomyopathy (oHCM) endure life-altering exercise limitations. Current treatment guidelines recommend β-blockers as first-line therapy primarily based on expert opinion. The Metoprolol vs Aficamten in Patients with Left Ventricular Outflow Tract Obstruction on Exercise Capacity in HCM (MAPLE-HCM) trial characterizes comprehensive exercise response to aficamten monotherapy vs β-blockade (metoprolol). Objective To determine the effect of aficamten compared with metoprolol across all stages of exercise using 16 quantitative measures in individuals with oHCM. Design, Setting, and Participants This was a prespecified secondary analysis of the MAPLE-HCM study, a phase 3, randomized, active-control trial conducted from June 2023 to March 2025 with data analyzed between May and July 2025 at 71 sites in North America, South America, Europe, Israel, and China. Patients with symptomatic oHCM with objective evidence of exercise intolerance (peak oxygen uptake [pVO 2 ] <100% of predicted) were included. Those with a history of atrial fibrillation (paroxysmal or persistent), medical indication for β-blockers or calcium channel blockers prohibiting drug discontinuation, or intolerance or medical contraindication to β-blockers were excluded. Intervention Randomized 1:1 to titrated aficamten (5-20 mg daily) or matching titrated metoprolol (50-200 mg daily) for 24 weeks. Main Outcomes and Measures The main outcomes were submaximal exercise minute ventilation (VE)/carbon dioxide output (VCO 2 ) slope and anaerobic threshold; peak exercise duration, workload, heart rate and heart rate reserve; and postexercise oxygen recovery rates; and composite variables, such as circulatory power. Results Of 175 randomized participants (mean [SD] age, 57.7 [13.2] years; 102 [58.3%] male), 165 (94%) had core laboratory–validated exercise tests at baseline and week 24. Compared with metoprolol, aficamten treatment improved multiple stages of exercise; including submaximal exercise VE/VCO 2 slope (−2.8; 95% CI, −4.0 to −1.5; P < .001) and anaerobic threshold (76 mL/min; 95% CI, 41 to 111; P < .001); peak workload (8 watts; 95% CI, 3 to 13; P = .003); the time required for VO 2 to recover by 12.5% postexercise (−11 seconds; 95% CI, −16 to −5; P < .001); and circulatory power (819 mm Hg × mL/min per kg; 95% CI, 569 to 1070; P < .001). Large improvements (≥3.0 mL/kg/min) in peak VO 2 were more common with aficamten compared with metoprolol (17 [20.5%] vs 3 [3.7%], respectively; odds ratio, 6.8; 95% CI, 2.0 to 22.5; P < .001). In contrast, large reductions in peak VO 2 (≥3.0 mL/kg/min) were significantly more common with metoprolol than aficamten (17 [20.7%] vs 2 [2.4%], respectively; odds ratio, 10.6; 95% CI, 2.6 to ∞; P < .001). Conclusions and Relevance This prespecified analysis of MAPLE-HCM demonstrated monotherapy with aficamten was superior to metoprolol in promoting adaptation to multiple phases of exercise in patients with symptomatic oHCM and supports aficamten as first-line therapy for oHCM. Trial Registration ClinicalTrials.gov Identifier: NCT05767346

Purpose Federated training is often challenging on heterogeneous datasets due to divergent data storage options, inconsistent naming schemes, varied annotation procedures, and disparities in label quality. This is particularly evident in the emerging multi-modal learning paradigms, where dataset harmonization including a uniform data representation and filtering options are of paramount importance.Methods DICOM-structured reports enable the standardized linkage of arbitrary information beyond the imaging domain and can be used within Python deep learning pipelines with highdicom. Building on this, we developed an open platform for data integration with interactive filtering capabilities, thereby simplifying the process of creation of patient cohorts over several sites with consistent multi-modal data.Results In this study, we extend our prior work by showing its applicability to more and divergent data types, as well as streamlining datasets for federated training within an established consortium of eight university hospitals in Germany. We prove its concurrent filtering ability by creating harmonized multi-modal datasets across all locations for predicting the outcome after minimally invasive heart valve replacement. The data include imaging and waveform data (i.e., computed tomography images, electrocardiography scans) as well as annotations (i.e., calcification segmentations, and pointsets), and metadata (i.e., prostheses and pacemaker dependency).Conclusion Structured reports bridge the traditional gap between imaging systems and information systems. Utilizing the inherent DICOM reference system arbitrary data types can be queried concurrently to create meaningful cohorts for multi-centric data analysis. The graphical interface as well as example structured report templates are available at https://github.com/Cardio-AI/fl-multi-modal-dataset-creation .

Introduction: Interim analyses from MAVA-LTE (NCT03723655) demonstrated that mavacamten is efficacious and well tolerated in patients with obstructive hypertrophic cardiomyopathy (oHCM). The relationship between the duration of oHCM diagnosis at mavacamten initiation and the effects of mavacamten are unknown. Research Questions: To assess the effects of mavacamten in patients from the EXPLORER cohort of MAVA-LTE by duration of oHCM diagnosis. Methods: All patients in MAVA-LTE received mavacamten. The effects of mavacamten on echocardiographic parameters and disease biomarker levels by duration of oHCM diagnosis were assessed (data cut-off: April 5, 2024). Results: In total, 231 patients were categorized into 4 subgroups based on duration of oHCM diagnosis at mavacamten initiation: 0–2.5 years (n=61), 2.5–5 years (n=49), 5–10 years (n=64) and >10 years (n=57) ( Table 1 ). At MAVA-LTE baseline, patients in the 0–2.5 years group had lower resting and Valsalva left ventricular outflow tract (LVOT) gradients, left atrial volume index (LAVI), interventricular septum (IVS) thickness, ratio of early diastolic mitral inflow velocity to mitral annular velocity (E/e’), and N-terminal pro B-type natriuretic peptide (NT-proBNP) levels than patients in other subgroups, while a higher proportion were New York Heart Association Class I ( Table 1 and 2 ). By week 204, improvements in LAVI ( Figure 1 ) were observed in all groups with abnormal baseline values ( Table 2 ). For resting and Valsalva LVOT gradients, E/e’, LVMI, and NT-proBNP levels, values improved from baseline in all subgroups by week 204 ( Table 2 ). IVS thickness improved from baseline in all subgroups by week 204 but remained elevated. Exposure adjusted incidence rates for serious treatment emergent adverse events per 100 patient-years of exposure were generally similar across subgroups (0–2.5 yrs: 9.30; 2.5–5 yrs: 7.04; 5–10 yrs: 12.33; >10 yrs: 11.53). Conclusion: Patients in MAVA-LTE who had a shorter duration from diagnosis of oHCM to mavacamten initiation had lower values for key echocardiographic parameters and disease biomarker levels at baseline than those with a longer duration. Mavacamten treatment trended towards improvement in echocardiographic parameters and disease biomarker levels regardless of the duration of oHCM diagnosis.

BACKGROUND:Current clinical guidelines do not recommend mitral transcatheter edge-to-edge repair (M-TEER) for patients with moderate functional mitral regurgitation (FMR), and the implications of M-TEER in this population are not well documented. AIMS:We aimed to assess M-TEER outcomes in patients with symptomatic moderate FMR compared to those with FMR ≥3+ who were treated with the PASCAL system in the MiCLASP study. METHODS:Patients were stratified by baseline FMR grade (2+ or ≥3+). The echocardiographic core laboratory-assessed mitral regurgitation (MR) reduction, clinical events committee-adjudicated major adverse events (MAE) rate and functional and quality-of-life outcomes were evaluated up to 1 year after M-TEER. RESULTS:Of the 544 (FMR=322; degenerative MR=163; mixed/other=59) enrolled patients, 101 had baseline FMR 2+ and 197 FMR ≥3+. Both groups achieved significant MR reduction at discharge, which was sustained up to 1 year, with 89.8% of patients achieving MR ≤1+ in the FMR 2+ group and 77.8% in the FMR ≥3+ group (all p<0.001 vs baseline). At 1 year, significant improvements (all p<0.001 vs baseline) in functional capacity (New York Heart Association Class I/II: 67.1% FMR 2+; 70.1% FMR ≥3+) and quality of life (change in the Kansas City Cardiomyopathy Questionnaire overall score: +13.9 points FMR 2+; +13.9 points FMR ≥3+) were achieved in both groups, with high survival (90.0% FMR 2+; 84.2% FMR ≥3+; p=0.176) and low MAE rates (13.9% FMR 2+; 18.3% FMR ≥3+; p=0.413). CONCLUSIONS:In the MiCLASP study, patients with moderate FMR experienced significant MR reduction at 1 year, resulting in clinical and symptomatic benefits comparable to those with ≥moderate-severe FMR, suggesting that select patients with symptomatic moderate FMR can benefit from M-TEER.

Background: The diagnostic performance of preprocedural CT angiography in detecting coronary artery disease (CAD) in patients scheduled for transcatheter aortic valve implantation (TAVI) has been reported. However, data on predictors of diagnostic inaccuracy are sparse. We sought to investigate clinical characteristics and imaging criteria that predict the inaccurate assessment of coronary artery stenosis based on pre-TAVI-CT. Methods: The patient- and vessel-level analysis of all CT datasets from 192 patients (mean age 82.1 ± 4.8 years; 63.5% female) without known CAD or severe renal dysfunction was performed retrospectively in a blinded fashion. Significant CAD was defined as a CAD-RADS™ 2.0 category ≥ 4 by CT. Invasive coronary angiography (ICA) served as the reference standard for relevant CAD (≥70% luminal diameter stenosis or fractional flow reserve ≤ 0.80). Pertinent clinical characteristics and imaging criteria of all true-positive (n = 71), false-positive (n = 30), false-negative (n = 4), and true-negative patient-level CT diagnoses (n = 87) for relevant stenosis according to ICA were assessed. Results: In the univariate per-patient analysis, the following parameters yielded discriminative power (p < 0.10) regarding inaccurate CAD assessment by pre-TAVI-CT: age, atrial fibrillation, scanner generation, and image quality. Factors independently associated with CT diagnostic inaccuracy were determined using multivariable logistic regression analysis: a younger age (odds ratio [OR] 0.87; 95% confidence interval [CI] 0.80 to 0.94; p < 0.01) and insufficient CT image quality (OR 0.6; CI 0.41 to 0.89; p < 0.01). Conclusions: Our results demonstrate younger age and poor CT image quality to predict less accurate CAD assessments by pre-TAVI-CT in comparison with ICA. Knowledge of these predictors may aid in more efficient coronary artery interpretations based on pre-TAVI-CT.

The recent development and approval of a transcatheter tricuspid valve represent a significant breakthrough in the management of patients with tricuspid regurgitation who are not suitable for existing invasive or interventional therapies. Despite promising outcomes, pacemaker dependency is a common consequence of transcatheter tricuspid valve replacement (TTVR). In the pivotal TRISCEND II randomized trial, conduction disorders requiring pacemaker implantation were the most frequent major adverse event at 30 days. Managing bradycardia following valve implantation in the tricuspid position requires specialized knowledge and tailored approaches for both temporary and permanent pacing. This necessity is driven by the specific design features of the valves and the evolving choices of valve-sparing pacing strategies. Our aim is to summarize these unique challenges to support both heart team members and nonelectrophysiology health care professionals performing TTVR, as well as intensive care unit and bradycardia specialists who may be unfamiliar with the distinctive characteristics of TTVR. Bradycardia due to atrioventricular (AV) conduction delay, requiring new pacemaker implantation, affects approximately 1 in 4 patients receiving the bioprosthetic EVOQUE valve and is also common with other TTVR devices. This review summarizes current knowledge on TTVR-associated bradycardia and a management algorithm for both acute and long-term settings, highlighting specialized considerations for patients undergoing TTVR.

Cardiomyocytes can be implanted to remuscularize the failing heart1-7. Challenges include sufficient cardiomyocyte retention for a sustainable therapeutic impact without intolerable side effects, such as arrhythmia and tumour growth. We investigated the hypothesis that epicardial engineered heart muscle (EHM) allografts from induced pluripotent stem cell-derived cardiomyocytes and stromal cells structurally and functionally remuscularize the chronically failing heart without limiting side effects in rhesus macaques. After confirmation of in vitro and in vivo (nude rat model) equivalence of the newly developed rhesus macaque EHM model with a previously established Good Manufacturing Practice-compatible human EHM formulation8, long-term retention (up to 6 months) and dose-dependent enhancement of the target heart wall by EHM grafts constructed from 40 to 200 million cardiomyocytes/stromal cells were demonstrated in macaques with and without myocardial infarction-induced heart failure. In the heart failure model, evidence for EHM allograft-enhanced target heart wall contractility and ejection fraction, which are measures for local and global heart support, was obtained. Histopathological and gadolinium-based perfusion magnetic resonance imaging analyses confirmed cell retention and functional vascularization. Arrhythmia and tumour growth were not observed. The obtained feasibility, safety and efficacy data provided the pivotal underpinnings for the approval of a first-in-human clinical trial on tissue-engineered heart repair. Our clinical data confirmed remuscularization by EHM implantation in a patient with advanced heart failure.

Federated learning is a renowned technique for utilizing decentralized data while preserving privacy. However, real-world applications often face challenges like partially labeled datasets, where only a few locations have certain expert annotations, leaving large portions of unlabeled data unused. Leveraging these could enhance transformer architectures ability in regimes with small and diversely annotated sets. We conduct the largest federated cardiac CT analysis to date (n=8,104) in a real-world setting across eight hospitals. Our two-step semi-supervised strategy distills knowledge from task-specific CNNs into a transformer. First, CNNs predict on unlabeled data per label type and then the transformer learns from these predictions with label-specific heads. This improves predictive accuracy and enables simultaneous learning of all partial labels across the federation, and outperforms UNet-based models in generalizability on downstream tasks. Code and model weights are made openly available for leveraging future cardiac CT analysis.

BACKGROUND Mechanical circulatory support (MCS) devices are frequently used in patients with acute myocardial infarction complicated by cardiogenic shock. In clinical practice, escalation of MCS device therapy is performed in a significant proportion of patients aiming to improve hemodynamic status. OBJECTIVES The aim of this study was to analyze outcomes of different MCS device strategies in the ECLS-SHOCK (Extracorporeal Life Support in Cardiogenic Shock) trial. METHODS The present subanalysis from the ECLS-SHOCK trial analyzed outcomes of patients treated with upfront extracorporeal life support (ECLS) only, bailout MCS, and escalated MCS therapy. The primary outcome was 30-day all-cause mortality. RESULTS Upfront ECLS only, bailout MCS, and escalated MCS therapy were used in 165 (78.9%), 54 (26.0%), and 27 (12.9%) patients, respectively. Thirty-day all-cause mortality was 44.8% (95% CI: 37.1%-52.8%), 61.1% (95% CI: 46.9%-74.1%), and 55.6% (95% CI: 35.3%-74.5%) in the upfront ECLS, bailout MCS, and escalated MCS group (P = 0.09). Need for renal replacement therapy was higher in the bailout MCS (35.2%; 95% CI: 22.7%-49.4%) than in upfront ECLS (7.3%; 95% CI: 3.8%-12.4%) and escalated MCS (14.8%; 95% CI: 4.2%-33.8%) (P < 0.001). Moderate or severe bleeding complications were similar in the upfront ECLS (25.5%; 95% CI: 19.0%-32.8%), bailout MCS (22.2%; 95% CI: 12.0%-35.6%), and escalated MCS (22.2%; 95% CI: 8.6%-42.3%) group (P = 0.86). CONCLUSIONS Bailout and escalated MCS therapy is associated with numerically higher 30-day mortality compared with upfront ECLS use only. Bailout MCS use is also associated with higher need for renal replacement therapy. (Extracorporeal Life Support in Cardiogenic Shock [ECLS-SHOCK]; NCT03637205) (JACC Cardiovasc Interv. 2025;18:691-701) (c) 2025 by the American College of Cardiology Foundation.

BACKGROUND:Epicardial adipose tissue (EAT) may play a role in the pathophysiology of heart failure (HF) with preserved ejection fraction (HFpEF). OBJECTIVES:This study examined associations between increased EAT, functional status, and invasive exercise hemodynamics in a large cohort of HFpEF patients. METHODS:All patients underwent echocardiography, 6-minute walk distance (MWD) test, Kansas City Cardiomyopathy Questionnaire, and invasive hemodynamic assessment at rest and during ergometry. EAT thickness was measured alongside the right ventricle on echocardiography, expressed in mm and patients were divided according to EAT tertiles. RESULTS:In total, 566 patients were examined with mean age 72 ± 8 years, 62% women, mean EAT thickness was 6.0 ± 2.4 mm and 11.5% had EAT ≥9 mm. With increasing EAT thickness tertiles, 6-MWD and Kansas City Cardiomyopathy Questionnaire overall summary score were significantly lower (320 [247-385] vs 315 [244-383] vs 287 [210-364] meters, P = 0.001; 51 [32-67] vs 45 [32-63] vs 41, [26-56], P = 0.003; respectively), whereas the latter was independent of body mass index (P = 0.004). At rest, invasive hemodynamics were not different across EAT tertiles. At peak exercise, patients in the highest EAT thickness tertile had higher pulmonary capillary wedge pressure and pulmonary capillary wedge pressure to right atrial pressure gradient, compared to patients in the first and second EAT thickness tertiles (36 ± 8 vs 34 ± 8 mm Hg, P = 0.009; 18 ± 7 vs 16 ± 7 mm Hg, P = 0.002, respectively). CONCLUSIONS:EAT thickness was associated with impaired quality of life, lower 6-MWD, and higher left-sided filling pressures at peak exercise. Excess EAT may therefore play an important role in functional status and exercise hemodynamics in patients with HFpEF.

Benchmark best practices have been shown to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI), but the impact in diverse health systems is unknown. We evaluated the impact of Benchmark best practices implementation in Germany, Austria, France, Spain, and Italy. International, multicentre registry of severe symptomatic aortic stenosis (AS) patients undergoing TAVI with a balloon-expandable valve, before and after Benchmark best practices implementation. Objectives were to reduce overall and intensive care unit (ICU) length of stay (LoS), and to document 30-day safety. A total of 890 patients were analysed in France, 454 in Spain, 362 in Germany, 300 in Italy, and 176 in Austria. Patients had the highest surgical risk in Germany (EuroSCORE II 6.8 ± 7.3

BACKGROUND Mitral transcatheter edge -to -edge repair (M-TEER) is a guideline -recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post -market setting have not been established. OBJECTIVES The authors report 30 -day and 1 -year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post -market clinical follow-up study. METHODS Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee -adjudicated 30 -day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory -assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality -of -life outcomes were assessed at 1 year. RESULTS A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30 -day composite major adverse event rate was 6.8%. MR reduction was signi ficant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR <= 2+ and 82.6% MR <= 1+ (all P < 0.001 vs baseline). One-year Kaplan -Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Signi ficant functional and quality -of -life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4 -point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6 -minute walk distance (all P < 0.001 vs baseline). CONCLUSIONS One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post -market setting. Results demonstrate high survival and freedom from heart failure hospitalization, signi ficant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life. (J Am Coll Cardiol Intv 2024;17:890 -903) (c) 2024 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Background and Aims There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. Methods This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. Results Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 +/- 7.0 to 5.8 +/- 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60 min; P < .001) and intervention times (85 vs. 95 min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). Conclusions Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.