Transcatheter aortic valve implantation (TAVI) serves a growing range of patients with severe aortic stenosis (AS). TAVI has evolved to a streamlined procedure minimizing length of hospital stay. To evaluate the safety and efficacy of an early discharge (ED) strategy after TAVI. We performed an international, multi-center, prospective observational single-arm study in AS patients undergoing TAVI with the ACURATE valve platform. Eligibility for ED was assessed prior to TAVI and based on prespecified selection criteria. Discharge ≤ 48 h was defined as ED. Primary Valve Academic Research Consortium (VARC)-3-defined 30-day safety and efficacy composite endpoints were landmarked at 48 h and compared between ED and non-ED groups. A total of 252 patients were included. The median age was 82 [25th–75th percentile, 78–85] years and the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.2
Sex-related differences in left ventricular (LV) remodeling in response to severe aortic stenosis (AS) and post-transcatheter aortic valve implantation (TAVI) remain unclear. Previous studies have demonstrated inconsistent and discordant findings regarding the relationships between LV remodeling and clinical endpoints across sexes following TAVI. More importantly, it has been shown that females with severe AS are often diagnosed later and less likely to be referred for TAVI. We sought to evaluate sex-based differences in LV remodeling prior to and after TAVI, and to assess whether these differences were associated with long-term clinical outcomes. We conducted a retrospective study of 977 patients with severe AS undergoing TAVI (2013–2020). Serial echocardiograms were performed at baseline (before TAVI) and at various timepoints post-TAVI. Echocardiographic parameters related to LV remodeling were extracted. Clinical outcomes (myocardial infarction [MI], heart failure hospitalization [HFH], stroke, and survival) were tracked over 10 years. Compared with males, females had larger baseline indexed LV end-diastolic dimension (26.5 ± 4.0 mm/m2 vs. 25.3 ± 3.5; p < 0.001), lower LV mass index[LVMI] (101.5 ± 28.0 vs. 111.5 ± 30.1 g/m2; p < 0.001), higher left ventricular ejection fraction (59.5 ± 11.13 vs. 53.8 ± 13.5
BACKGROUND:Complete revascularization is superior to culprit lesion-only percutaneous coronary intervention (PCI) in reducing ischemic events in patients with ST-segment-elevation myocardial infarction and multivessel disease. However, the relationship between the extent of revascularization and the benefits of a complete revascularization strategy remains unclear. The aim of this substudy of the COMPLETE trial was to evaluate how the degree of anatomic completeness of revascularization, measured by the core laboratory-derived modified residual SYNTAX score (R'SS), relates to major cardiovascular events. METHODS:We conducted an exploratory post hoc analysis of the COMPLETE trial (n=3738), stratifying patients randomized in the complete revascularization group based on the R'SS assessed after staged nonculprit lesion-PCI. Complete revascularization was defined by an R'SS=0, whereas incomplete revascularization was defined by an R'SS>0. A stratified Cox proportional hazards model was used, with the culprit-only PCI arm designated as the reference group for comparison. The first coprimary outcome was a composite of cardiovascular death or new myocardial infarction. The second coprimary outcome was a composite of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. RESULTS:Among patients randomized to a complete revascularization strategy, 90% achieved complete revascularization (R'SS=0), whereas 10% did not (R'SS>0). In patients with R'SS=0, the first coprimary outcome occurred less frequently (6.6%) compared with those randomized to the culprit lesion-only PCI strategy (10.7%; adjusted hazard ratio, 0.61 [95% CI, 0.47-0.78]). Among patients with an R'SS>0, the first coprimary outcome was similar (10.7%) to those in the culprit lesion-only PCI group (10.7%; adjusted hazard ratio, 1.01 [95% CI, 0.61-1.67]). A similar result was observed for the second coprimary outcome. CONCLUSIONS:This exploratory analysis of the COMPLETE trial suggests that the benefit of a complete revascularization strategy in patients with ST-segment-elevation myocardial infarction and multivessel disease may be related to the extent of anatomic completeness of revascularization. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01740479.
BACKGROUND:Degeneration is an inevitable outcome for bioprosthetic heart valves. In the setting of transcatheter aortic valve (TAV) replacement (TAVR), calcifications and leaflet thickening have implications for feasibility and outcomes of repeat interventions, including leaflet modification techniques. In this study, we aimed to investigate the frequency and pattern of leaflet calcification and thickening in explanted TAVs to inform repeat interventions. METHODS:TAV explants were obtained from the Explanted THV registry and clinical institutions. Micro-computed tomography imaging and histology were used to evaluated TAV calcium volume, distribution, and leaflet thickening. RESULTS:Twenty TAV explants were analyzed: 11 self-expanding CoreValve/Evolut (Medtronic, Dublin, Ireland) TAVs, 8 balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA) TAVs, and 1 mechanically-expandable Lotus (Boston Scientific, Marlborough, MA) TAV. Median patient age at explant was 73.0 (interquartile range [IQR], 63.0-81.0) years, with a median time to explant of 3 years and 3 months (IQR, 1 year and 10 months to 4 years and 10 months). Eleven TAVs (55%) had leaflet calcification (median, 77.9; IQR, 24.7-336.1) mm3, and 9 TAVs (45%) had no calcium according to micro-computed tomography. Calcified TAVs had an increased leaflet thickness compared with noncalcific samples (median, 1.02 [IQR, 0.81-1.59] mm vs 0.64 [IQR, 0.47-0.89 mm]; P = 0.006). Leaflet thickness had a positive correlation with implant duration. Calcium distribution was heterogenous within each individual leaflet but also among leaflets of an individual TAV. Calcium pattern appeared to differ between TAV models. CONCLUSIONS:Calcified TAVs tend to have thicker leaflets and calcium distribution appears to vary according to TAV type. These findings might have important clinical implications when considering redo-TAV replacement and leaflet modification techniques.
Background:Early discharge home is the standard of care after transcatheter aortic valve implantation (TAVI). Transition home can be challenging for this population. We lack evidence of patients' experiences during their immediate recovery to develop targeted and effective interventions. We aimed to describe patients' self-reported readiness; supports for early discharge; and very early experience of physical health status, activities of daily living, and procedure-related events after TAVI. Methods:We conducted a prospective observational study at five Canadian hospitals; registered nurses and nurse practitioners conducted telephone assessments three and 10 days after TAVI to document patients' self-reports. Results:We recruited 188 patients (81.6 years, SD = 7.0, 41.5% female) treated with local anesthesia or conscious sedation (n = 171, 91.0%) and balloon-expandable device (77.7%). All patients reported feeling "totally ready" (88.1%) or "somewhat ready" (11.9%) for discharge, and 95.5% returned home with social support. On day 3, most participants completed all activities of daily living (n = 165, 93.2%) and at least six instrumental activities of daily living (n = 105, 59.3%). Their self-reported level of energy was moderate (n = 89, 51.7%), high, or very high (n = 34, 19.8%) and increased by 88.4% by day 10 (n = 49). On day 3, most patients (n = 139, 80.3%) restricted their mobilization to their home, with a 77% increase in daily walking by day 10. Conclusions:Most patients report high level of self-efficacy, self-care behavior, and improved physical status in the first week after TAVI. Research is needed to identify, monitor, and intervene in patients who do not follow this trajectory.
Background:Transcatheter heart valve (THV) underexpansion following transcatheter aortic valve implantation (TAVI) is associated with elevated gradients, paravalvular leak, and/or risk of hypoattenuating leaflet thickening. We aimed to simulate TAVI using pre-TAVI computed tomography (CT) images to predict the extent of THV underexpansion and the effect of staged balloon postdilatation on THV expansion. Methods:Patients who underwent balloon postdilatation as a staged procedure for symptomatic THV dysfunction following native or valve-in-valve TAVI with available pre-TAVI, post-TAVI, and post-balloon aortic valvuloplasty CT between 2016 and 2023 were analyzed. TAVI and postdilatation were simulated computationally in patient-specific models using finite element analysis. Simulations were performed in blinded fashion without information of index procedure. THV expansion was defined as the percentage of THV area achieved by THV in CT or modeling when compared to nominal area defined by THV manufacturer. Results:Among patients with balloon-expandable THVs following TAVI, the differences in expansion between CT and simulation measurements were -0.88% ± 3.27% (p = 0.75), -3.11% ± 4.65% (p = 0.26), and -3.27% ± 4.67% (p = 0.03) at the inflow, mid, and outflow regions, respectively. Following postdilatation, the differences in expansion between CT and simulation measurements were -0.60% ± 4.7% (p = 0.71), -1.64% ± 6.0% (p = 0.99), and -1.13% ± 4.2% (p = 0.55), respectively. Among patients with self-expandable THVs following TAVI, the percentage difference between CT and simulation measurements were 6.2% ± 4.2% (p = 0.99) and 9.3% ± 2.7% (p = 0.99) at the inflow and mid regions, respectively. Following postdilatation, the differences in expansion between CT and simulation measurements were 9.0% ± 3.2% and 8.9% ± 3.4%, respectively. Conclusions:Patient-specific computational modeling can predict THV underexpansion during the index procedure and the effect of postdilatation on THV expansion.
Introduction: Transcatheter aortic valve replacement (TAVR) has become the predominant treatment for severe aortic stenosis across all surgical risk categories. However, its role in patients aged 65 years and younger remains uncertain, and current guideline recommendations continue to favor surgical aortic valve replacement (SAVR) in this population. Despite this, contemporary real-world data demonstrate a marked increase in TAVR utilization among younger patients, creating an important gap between guidelines and clinical practice. Methods: This review synthesizes contemporary observational evidence evaluating TAVR in patients ≤65 years, with a focus on patient selection, clinical outcomes, and lifetime management considerations. Results: Available studies demonstrate that younger patients undergoing TAVR often represent a highly selected and clinically complex population with greater comorbidity burden, higher surgical risk, and shorter life expectancy than age-matched SAVR recipients, yet substantial hospital-level variation in TAVR utilization exists even after risk adjustment. Mid-term observational data suggest higher mortality and heart failure readmission rates following TAVR compared with SAVR, although these findings are likely influenced by substantial baseline differences between treatment groups. No randomized controlled trial has specifically compared TAVR and SAVR in patients ≤65 years. Furthermore, long-term issues including valve durability, coronary access, redo-TAVR feasibility, and THV optimization remain incompletely understood. Conclusions: TAVR recipients ≤65 are often a clinically distinct group characterized by significantly heavier comorbidity burdens than SAVR recipients of the same age with standard surgical risk models possibly underestimating the true clinical risk. Despite this, significant hospital-level variation in TAVR utilization persists even after risk adjustment, suggesting that institutional practice patterns and other non-clinical factors continue to influence treatment selection.
Background: The advantage of employing multidisciplinary heart teams (MDHT) for the selection process of minimally invasive (MIS) mitral valve repair (MVr) and mitral valve replacement (MVR) has been previously substantiated. Here, we outline the contributions each member of the MDHT at our institution made during the intra-operative and peri-operative periods and describe their impacts on short-term outcomes. Patients and Methods: This is a single-center retrospective review of all 278 adult patients who underwent MIS MVR or MVr by a single surgeon at our institution between 2006 and 2023. The repair's efficacy was assessed intraoperatively and at 1 year post-operation. The surgical technique involved a mini-thoracotomy and valve repair or replacement. Outcomes included post-operative mortality, complications, operative time, repair success rate, hospital length of stay (LOS), and post-operative ejection fraction. There was no control group, as all patients undergoing MIS MVR/MVr were treated within an MDHT model. Results: Delivery of regional anesthesia via paravertebral catheter (PVC) was associated with a statistically significant shorter hospital LOS (6.52 vs. 7.81 days, p = 0.028). Enhanced Recovery After Surgery (ERAS) implementation by nurses was associated with a potentially clinically important, although not statistically significant, reduction in LOS (6.7 vs. 10.1 days, p = 0.168). Introduction of the COR-KNOT® DEVICE for securing annuloplasty sutures was associated with a statistically significant reduction in operative time (288 vs. 326 min, p < 0.001). Percutaneous cannulation, proctored by interventional cardiology in 2019, was associated with a decrease in lymphocele rate from 6.2% before 2019 to 0% after 2019. Conclusions: Initiatives implemented by our MDHT were associated with reduced post-operative LOS, shorter operative times, and lower incidence of post-operative complications.
BACKGROUND:Leaflet modification (LM) techniques, including electrosurgical and mechanical BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) and intraleaflet deployment, are important in the lifetime management of aortic valve disease. However, benchtop assessment is limited. OBJECTIVES:The aim of this study was to provide a benchtop assessment of LM in native valves and bioprosthetic surgical aortic valves (SAVs). METHODS:Features of calcific native aortic valves (n = 100) and naive SAVs (7 types) were assessed. Calcific native cusps (n = 13) and SAV leaflets (n = 14) stratified by calcific load were modified by electrosurgical or mechanical BASILICA or intraleaflet deployment with assessment of splay, laceration patterns, and embolic debris. The impact of leaflet length and valve-in-valve implantation on splay area was analyzed. RESULTS:In native cusps, calcification in traversal and laceration zones was common (89% and 97%, respectively). LM was feasible across calcification severities, although increasing calcification was associated with laceration difficulty (P = 0.028), leaflet tears (P = 0.02), and increased embolic debris (P < 0.05). Leaflet splay decreased with shortening of leaflet length (68.9% ± 10.7% at 5 mm; R2 = 0.72) and increased with simulated valve expansion in a limited analysis. In SAVs, neoskirt heights and features varied. LM was feasible across SAV leaflet calcification levels. No overall association between calcification and debris was observed; however, in a restricted subset, higher calcification was associated with increased debris (P = 0.035). SAV leaflet splay decreased with leaflet length (80.2% ± 8.8% at 5 mm; R2 = 0.84) and generally increased with simulated valve expansion, but this varied by SAV type. CONCLUSIONS:Features of native aortic valves and SAVs impact the efficacy of LM. LM is feasible across a spectrum of calcific disease. Further study is required.
BACKGROUND:Leaflet modification (LM) techniques are of interest in redo transcatheter aortic valve replacement (TAVR). However, factors impacting the efficacy of LM are poorly understood. OBJECTIVES:The aim of this study was to investigate the effects of valve constraint, redo-TAVR sizing, flow, and valve pathology on LM efficacy. METHODS:Naive and degenerated transcatheter heart valves (THVs) were used to evaluate BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction), balloon-assisted BASILICA (BA-BASILICA), and balloon laceration. Conditions included: 1) degree of annular constraint of the index THV (modeled using different annular sizes); 2) flow conditions during deployment of the second THV (pulsatile vs continuous flow in a simulated deployment system); 3) leaflet modification pattern; 4) degree of oversizing of the second THV; and 5) extent and type of leaflet degeneration in the index THV. Quantitative outcomes included splay area, functional splay area, and variability in splay geometry across repeated deployments. RESULTS:When unconstrained, BASILICA created a splay in SAPIEN, Evolut, and ACURATE valves but not in Navitor valves, with BA-BASILICA improving splay for ACURATE and Evolut valves. Annular constraint at the minimum diameter per the THV instructions for use reduced splay in all THVs, with the greatest effect in Evolut valves. Nonbasal and angled leaflet splits impacted leaflet splay. Simulated redo-TAVR under flow conditions caused variability of leaflet splay for all THVs. Balloon laceration resulted in highly variable splay patterns ranging from complete clearance to obstruction. Oversizing of the second THV resulted in larger splay areas. Leaflet fibrosis diminished functional splay area. Increasing calcification resulted in irregular cuts and decreased splay. CONCLUSIONS:Leaflet splay following LM for redo-TAVR is highly dependent on THV type and constraint, implantation of the second THV, laceration pattern, and the nature of index THV degeneration.
BACKGROUND AND AIMS:This observational study investigated whether patients with coronary heart disease (CHD) in Europe are achieving the standards set by prevention and rehabilitation guidelines. Variability was studied: (i) between countries; (ii) between geographical risk regions; and (iii) attendance at cardiac rehabilitation (CR) with outcomes. METHODS:Observational study between September 2024- February 2026 in 160 hospitals across 27 countries. Geographical risk regions were defined as high, moderate or low based on WHO cardiovascular mortality data. RESULTS:Among 8590 patients with CHD (23.7% female), 17.1% were current smokers, 32.0% were obese and 33.5% reported low physical activity. 59.8% were above blood pressure target (systolic ≥ 130 and/or diastolic ≥ 80 mmHg), 82.7% were above LDL-C target (≥ 1.4 mmol/l), 32.8% had known diabetes of whom 42.2% had HbA1c ≥ 7% and 30.6% had chronic kidney disease. Prevalences of these risk factors were all highest in countries from high risk regions. 29.1% of patients attended at least one CR session, with country variability ranging from 0% to 79%, and differing by risk region (55.9% low risk, 29.7% moderate risk and 10.2% high risk; p < 0.001). Attendance at CR programme was associated with significantly better lifestyles, risk factor control and use of cardioprotective drugs. CONCLUSIONS:Most European patients are not achieving targets set by prevention guidelines. There is marked variability in CR attendance, evidence of inverse care with lowest attendance in highest risk regions, despite better outcomes for CR. These results inform the challenges for implementation of the first ESC guideline on CR.
BACKGROUND:The SAPIEN 3 Ultra RESILIA (S3UR) transcatheter heart valve incorporates RESILIA-treated tissue and new commissural attachments in smaller valve sizes (20 and 23 mm). However, detailed performance data are lacking. OBJECTIVES:The aim of this study was to compare the S3UR with the SAPIEN 3 Ultra (S3U) transcatheter heart valve on the bench for transcatheter aortic valve replacement (TAVR), valve-in-valve (VIV), and redo-TAVR. METHODS:For index TAVR, 23- and 26-mm S3UR and S3U valves were compared at nominal size and during underexpansion. For VIV testing, 23-mm study valves were implanted in 25-mm Epic and 23-mm Mitroflow valves. Redo TAVR involved the implantation of 23-mm study valves in a 26-mm Evolut PRO valve. Hydrodynamic testing assessed mean gradient (MG), geometric orifice area, effective orifice area (EOA), opening index, pinwheeling, and leaflet motion. Histology, light transmission, micrometering, micro-computed tomography, and uniaxial tensile testing compared S3UR and S3U pericardium samples. Leaflet splay area was compared after leaflet modification. RESULTS:For index TAVR, 26-mm S3U and S3UR valves demonstrated comparable performance. In contrast, the 23-mm S3UR valve showed a lower MG (6.7 mm Hg vs 7.3 mm Hg) and larger EOA, geometric orifice area, and opening index than the 23-mm S3U valve, with MG differences increasing during underexpansion. In VIV, the 23-mm S3UR valve demonstrated systolic leaflet fluttering and hydrodynamics similar to those of S3U. In redo-TAVR, the S3UR showed a slightly lower MG and a marginally larger EOA. By micrometering, S3UR leaflet pericardium was thinner than S3U leaflet pericardium (0.28 ± 0.02 mm vs 0.36 ± 0.03 mm), but S3UR pericardium showed significantly higher tensile strength. S3UR leaflets splayed almost 40% less after modification with a central basal split. CONCLUSIONS:Commissural changes in smaller S3UR valves and thinner leaflets drive differences in hydrodynamics, leaflet motion, tensile strength, and leaflet splay after leaflet modification. This warrants further study.