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IMPORTANCE: The effectiveness and safety of computed tomography (CT) and invasive coronary angiography (ICA) in different age groups is unknown. OBJECTIVE: To determine the association of age with outcomes of CT and ICA in patients with stable chest pain. DESIGN, SETTING, AND PARTICIPANTS: The assessor-blinded Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) randomized clinical trial was conducted between October 2015 and April 2019 in 26 European centers. Patients referred for ICA with stable chest pain and an intermediate probability of obstructive coronary artery disease were analyzed in an intention-to-treat analysis. Data were analyzed from July 2022 to January 2023. INTERVENTIONS: Patients were randomly assigned to a CT-first strategy or a direct-to-ICA strategy. MAIN OUTCOMES AND MEASURES: MACE (ie, cardiovascular death, nonfatal myocardial infarction, or stroke) and major procedure-related complications. The primary prespecified outcome of this secondary analysis of age was major adverse cardiovascular events (MACE) at a median follow-up of 3.5 years. RESULTS: Among 3561 patients (mean [SD] age, 60.1 [10.1] years; 2002 female [56.2%]), 2360 (66.3%) were younger than 65 years, 982 (27.6%) were between ages 65 to 75 years, and 219 (6.1%) were older than 75 years. The primary outcome was MACE at a median (IQR) follow-up of 3.5 (2.9-4.2) years for 3523 patients (99%). Modeling age as a continuous variable, age, and randomization group were not associated with MACE (hazard ratio, 1.02; 95% CI, 0.98-1.07; P for interaction = .31). Age and randomization group were associated with major procedure-related complications (odds ratio, 1.15; 95% CI, 1.05-1.27; P for interaction = .005), which were lower in younger patients. CONCLUSIONS AND RELEVANCE: Age did not modify the effect of randomization group on the primary outcome of MACE but did modify the effect on major procedure-related complications. Results suggest that CT was associated with a lower risk of major procedure-related complications in younger patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02400229

ABSTRACTBackgroundThis study sought to investigate the impact of extensive over-expansion of transcatheter heart valves (THVs) on leaflet structure. THVs may be over-expanded beyond recommended labeling in certain clinical scenarios. However, it is unknown whether over-expansion damages pericardial leaflets. Therefore, we assessed the effect of over-expansion on THV leaflets.MethodsSAPIEN 3 THVs (one of each a 23 mm, 26 mm, and 29 mm valve) were expanded to nominal dimensions and then over-expanded to larger than the recommended diameters. Leaflets from a nominally expanded THV were used as control. Structural changes to the leaflets were assessed by histology, scanning electron microscopy (SEM), and second-harmonic generation (SHG) microscopy.ResultsAnalysis of leaflets by SHG microscopy using texture analysis demonstrated that over-expansion of 23 mm, 26 mm, and 29 mm THVs resulted in significant disorganization of the fibrilar collagen on both aortic and ventricular surfaces (p< 0.05 for all). Histological analysis demonstrated significant thinning of leaflets in over-expanded THVs compared to control (p< 0.05 for over-expanded THVs) as well as a significant increase in pericardial tissue density within the leaflet (p< 0.05 for all over-expanded THVs) compared to control conditions. SEM analysis demonstrated breaks, stretching, and disorganization of collagen fibers within over-expanded THVs.ConclusionsSequential over-expansion by 1 mm increments up to 3 mm, which is not typically used in clinical practice, of SAPIEN 3 valves on the bench results in damage to the aortic and ventricular surfaces of pericardial leaflets. Whether a lesser degree of over-expansion or degree of over-expansion used clinically will cause similar leaflet injury will require further investigation.AbbreviationsAS: Aortic stenosis; A.U.: Arbitrary units; CT: Computed tomography; ECM: Extracellular matrix; GLCM: Gray level co-occurrence matrix (GLCM); H&E: Hematoxylin and eosin; ROI: Region of interest; S3: SAPIEN 3 transcatheter valve; SEM: Scanning electron microscopy; SHG: Second-harmonic generation; TAVR: Transcatheter aortic valve replacement; THV: Transcatheter heart valve

The coexistence of chronic kidney disease (CKD) and severe aortic stenosis (AS) is common, and the prevalence of both is rising. The 2 conditions are inherently linked in that significant CKD may accelerate the development of AS and severe AS may result in deteriorating kidney function. The volume of and indications for transcatheter aortic valve implantation (TAVI) procedures are ever-increasing, and there are many challenges that need to be considered in patients with concomitant severe AS and CKD being assessed for TAVI. Throughout the process of working these patients up for definitive management of their valvular heart disease, the presence of CKD impacts on diagnostic investigations, treatment decisions, and therapeutic interventions. Herein we review the current literature regarding TAVI in patients with CKD focusing on the decision-making process and specific risks involved in TAVI and CKD. We also provide specific practical strategies to best manage this challenging patient cohort.

ABSTRACTBackground:Valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) for failing bioprosthetic valves has been shown to be safe and effective in high-risk (HR) patients. Outcomes in intermediate-risk (IR) patients have not been reported.Methods:IR and HR patients that underwent VIV-TAVR between June 2015 and March 2018 were included. IR patients had a Society of Thoracic Surgeons’ (STS) score <8% without high-risk features. HR patients had STS ≥8% and/or high-risk features. IR and HR groups were compared with respect to baseline and procedural variables, and 30-day outcomes.Results:A total of 63 patients underwent VIV-TAVR: 39 IR and 24 HR (STS 3.74% [2.80] vs. 10.9% [6.71], p < 0.0001). Baseline and procedural variables were similar. Length of stay was shorter in the IR group (1.0 [2.0] vs. 3.0 [4.5] days, p = 0.0273). Post-procedure mean transaortic gradient was similar (12.0 [6.5] vs. 11.0 [7] mmHg, p = 0.53; aortic regurgitation ≤mild in all patients). New York Heart Association (NYHA) class improved between baseline and 30 days (IR 3.0 [1.0] vs. 1.0 [1.0], p < 0.0001, HR 4.0 [1.0] vs. 2.0 [1.0], p < 0.0001) and was better in the IR group at 30 days (1.0 vs. 2.0, p = 0.024). Rehospitalization occurred in 8.6% IR and 16.7% HR patients (p = 0.32). At 30-days, there were two deaths in the HR group and zero in the IR group (p = 0.14).Conclusion:VIV-TAVR in IR and HR patients show similar outcomes in terms of hemodynamics, rehospitalization and 30-day mortality. Length of stay and NYHA functional class at 30-days are superior in IR patients. VIV-TAVR is likely to continue to expand into intermediate-risk patients as experience and evidence accumulates.

ABSTRACTBackground:We assessed the safety and efficacy of a clinical pathway with transfemoral transcatheter aortic valve replacement (TAVR) performed in the catheterization laboratory, accelerated recovery on a general cardiology ward and early discharge.Methods:The Vancouver accelerated recovery clinical pathway is an initiative with aims to implement (1) multidisciplinary team selection of patients with lower TAVR procedural risk; (2) peri-procedural minimalist approach with minimal procedural sedation; (3) pre-specified criteria for accelerated transfer to a general cardiology ward; (4) rapid reconditioning post-procedural care; and (5) identification of patients suitable for early (<48 hours) discharge home.Results:A total of 100 prospective patients underwent TAVR with the Vancouver accelerated recovery pathway between September 2016 and August 2018 with a mean age of 79.4 ± 7.4 years and Society of Thoracic Surgeons (STS) score of 3.5 ± 1.7 (55% had STS≥3). Only one (1%) patient needed conversion to general anesthesia, two (2%) patients needed urgent pacemaker implantation for conduction disorder, one (1%) patient had a stroke and five (5%) patients had minor vascular complications. All patients were transferred to the ward but one (1%) patient subsequently needed escalation of care to the coronary care unit. Mean time to first mobilization was 267 ± 60 minutes. Overall, 87 (87%) patients achieved next day discharge and 97 (97%) patients were discharged ≤48 hours. The 30-day mortality was 1% and all-cause readmission rate was 5%.Conclusion:Use of the Vancouver accelerated recovery pathway in highly-selected patients allows TAVR to be performed in the catheterization laboratory followed by accelerated recovery to the ward, with minimal mortality, morbidity, and a high proportion of early discharge. As TAVR continues to expand, this has important implications for health care delivery.

Background:Currently there is no consensus regarding indications and timing of permanent pacemaker implantation (PPI) following transcatheter aortic valve replacement (TAVR). Despite all patients receiving a balloon-expandable valve platform with the same inclusion criteria and no baseline electrocardiographic exclusion criteria, the rates of new PPI ranged from 0% to 33.3% at 6 low (<100 TAVR/year), 4 medium (100 to 200 TAVR/year), and 3 high-volume (>200 TAVR/year) centers. We sought to understand this variability by comparing peri-procedural ECG characteristics and PPI rates at centres with different procedural volumes.Methods:As per protocol, patients could be discharged home with a new intraventricular conduction delay in the absence of a new high-grade AV block if the length of the QRS was stable or decreasing after 24 hrs. PPI indication and timing was at the discretion of the individual site. Of the total cohort, 61 patients had pre-existing pacemakers and were excluded, resulting in a final cohort of 350 patients.Results:The overall PPI rate was 6.6% (23) in pacemaker-na?ve patients. The rate of new PPI was similar at high (4.6%), medium (9.9%) and low (7.1%) volume centres (p=0.32). The baseline ECG characteristics of the total cohort were: 209 sinus rhythm (59.7%), 61 atrial fibrillation (17.4%), 35 LBBB (10%), and 45 RBBB (12.9%). In patients with no pre-existing BBB, the rate of new LBBB following TAVR was 28.1%, of which 48.7% had resolution of their LBBB prior to discharge. The rate of BBB was similar by site volume at both baseline (High: 25%, Medium: 22.5%, Low: 20.5%, P=0.67) and immediately post TAVR (High: 36.2%, Medium: 45%, Low: 47.2%, P=0.15). Of the total cohort, 16 (4.6%) had PPI during index admission, and 7 (2%) had PPI within 15 days post procedure with no associated harm. In patients that received PPI, the proportion of patients who achieved next day discharge was 39.1% versus 80.1% in the overall cohort (p<0.001).Conclusion:Although there was a heterogenous approach to new conduction disorders, the peri-procedural electrocardiographic characteristics and rates of PPI were similar when assessed by hospital volume. A consistent approach with adherence to the Vancouver 3M Clinical Pathway may further improve outcomes and reduce LOS.