BACKGROUND:Body mass index (BMI) is an independent, predictor of adverse outcomes among patients with cardiovascular diseases. Our aim was to evaluate how BMI modifies the association of severe tricuspid regurgitation (TR) with poor survival. METHODS:Consecutive echocardiographic reports linked to clinical data from a tertiary medical center (2007-2021) were reviewed. BMI was stratified to underweight, normal weight, overweight, and obesity with cutoffs of 18.5, 25, and 30 Kg/m2. Multivariable Cox regression models were applied to calculate adjusted hazard ratios (aHR) for all-cause mortality. RESULTS:The study population included 111,830 patients with a median age of 65 (IQR 52-76) years (58% males), 3436 (3.1%) patients had severe TR. There were 2398 (2%), 40,393 (36%), 43,790 (39%), and 25,249 (24%) individuals with underweight, normal weight, overweight, and obesity, respectively. During a median follow-up of 6 (3-10) years, 29,921 (27%) patients died. There was an interaction between BMI and TR with the outcome (p < 0.01). Severe TR was associated with mortality for patients with normal weight, overweight, and obesity, with an HR of 1.29 (95% CI 1.20-1.39), 1.26 (1.16-1.37), and 1.28 (1.15-1.43), respectively. This association was not evident among patients with underweight with an HR of 0.88 (0.64-1.22). Sub-analysis of hospitalized patients, with adjustment of the model to baseline comorbidities, including frailty, yielded similar point estimates to the main analysis. CONCLUSIONS:The association of severe TR with mortality is modified by BMI group. Severe TR is associated with mortality among patients of all BMI groups, except for individuals with underweight.
Background:Aortic valve stenosis can be treated surgically or with transcatheter aortic valve implantation (TAVI). However, bicuspid aortic valve (BAV) anatomy presents unique challenges that may affect procedural outcomes. We aimed to compare outcomes between the two approaches. Methods:a retrospective cohort of 480 patients with BAV stenosis: 75 (16%) underwent TAVI and 405 (84%) underwent SAVR. Median age was 76 (Q1-Q3: 72-82) in the TAVI group and 61 (Q1-Q3: 52-70) in the SAVR group. Patients with isolated aortic insufficiency were excluded. Primary analyses were adjusted for age, sex, and comorbidities, followed by a sensitivity analysis using 1:1 age matching. Outcomes included overall survival, stroke/TIA, pacemaker implantation, paravalvular leak, and heart failure hospitalizations. Results:During a mean follow-up of 9 ± 5 years, 72 patients died (28 TAVI, 44 SAVR). TAVI was associated with higher mortality (adjusted HR = 5.9, 95% CI 2.6-12.9, p < 0.001), higher rates of pacemaker implantation (19% vs. 4%; HR = 2.6, 95% CI 1.1-6.7, p < 0.001), paravalvular leak (adjusted OR = 5.8, 95% CI 2.6-12.7, p < 0.001) and heart failure hospitalizations (IRR=7.7, 95% CI 2.7-22.2, p < 0.001). Stroke rates were similar. Age-matched analyses confirmed higher mortality (adjusted HR = 3.6, 95% CI 1.5-8.6, p = 0.004), increased pacemaker implantation (adjusted HR = 3.9, 95% CI 1.04-14.5, p = 0.002), and heart failure hospitalizations (IRR=7.7, 95% CI 3.9-15.1, p < 0.001). Conclusions:In BAV stenosis, SAVR was associated with better survival and fewer complications than TAVI, while stroke/TIA rates were similar. Randomized trials are needed to determine the optimal treatment approach.
Coronary artery obstruction is a potential life-threatening complication of transcatheter aortic valve replacement (TAVR) in all settings including native, valve-in-valve, and redo-TAVR. Risk of obstruction can be identified on preprocedural computed tomography. BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) effectively prevents TAVR-induced coronary obstruction. Perceived technical complexity, limited availability of purpose-built devices, and scarce training opportunities have hindered the adoption of BASILICA and related techniques. This document synthesizes international experience to provide contemporary best-practice guidance for BASILICA and related leaflet modification strategies. This state-of-the-art review details transcatheter electrosurgery principles; how to determine risk and computed tomographic risk analysis and plan the procedures; a step-by-step guide to electrosurgical BASILICA; tips and tricks for uncommon challenges; scenarios in which BASILICA is unlikely to succeed; and variant techniques such as intraleaflet valve deployment, alternative measures, and dedicated devices. These contemporary best practices can help operators gain or maintain proficiency.
AIMS:Closing the evidence-practice gap for the treatment of acute coronary syndrome (ACS) is central to improving quality of care. Under the European Society of Cardiology (ESC) framework, we aimed to develop updated quality indicators (QIs) for the evaluation of quality of care and outcomes for patients with ACS. METHODS AND RESULTS:A Working Group of experts including members of the ESC Clinical Practice Guidelines Task Force for ACS, Association for Acute Cardiovascular Care, and European Association of Percutaneous Cardiovascular Interventions followed the ESC methodology for QI development. This methodology involved (i) the identification of the domains of ACS care for the diagnosis and management of ACS; (ii) the construction of candidate QIs through a systematic review of the literature; and (iii) the selection of the final set of QIs (using a modified Delphi method). Five domains of care for the diagnosis and management of ACS were identified: (i) structural framework and logistics, (ii) in-hospital non-invasive care, (iii) invasive strategy and periprocedural management, (iv) secondary prevention interventions, and (v) outcomes. In total, 21 main QIs were selected, covering all five domains of care for the diagnosis and management of ACS. CONCLUSION:This document defines the five domains of ACS care and provides 21 QIs for the diagnosis and management of ACS. The updated ESC QIs for ACS may be used for quality improvement initiatives.
Background: Atrial fibrillation (AF) is the most common arrhythmia among patients undergoing transcatheter aortic valve replacement (TAVR). Post-TAVR permanent pacemaker implantation (PPI) predictors for patients in sinus rhythm were studied. However, scarce data is available about patients with AF. The aim of the study is to assess the prevalence of AF among patient undergoing TAVR, to identify predictors of PPI, and to study the association between PPI and long-term mortality. Methods: A historical cohort study of all patients who underwent TAVR between 2008-2022 in a large tertiary medical center. Patients with prior aortic valve bio-prosthesis or pacemakers were excluded. 30-days PPI and 3-year mortality were studied. Univariate and multivariable analyses were performed. Results: Of the 1,579 patients who met the inclusion criteria, 405 (25.6%) had a history of AF either paroxysmal (17.1%) or persistent (8.4%). Among them, 49.9% were male and the mean age was 82±6 years. The 30-days PPI rate was 21.7%. Right bundle branch block (RBBB, aOR 5.34, 95%CI 2.79-10.21) and CoreValve/Evolut valve (aOR 2.51, 95%CI 1.40-4.51) were significantly associated with 30-days PPI. PPI was not statistically significant associated with increased 3-year mortality. Conclusion: AF is prevalent among TAVR patients and PPI rates among this population are high. Predictors for PPI among patients with AF are similar to prior known predictors in patients with sinus rhythm and include baseline RBBB and transcatheter heart valve type. Despite the high PPI rates, there is no association between PPI and long-term mortality among Patients with AF.
Background Closing the evidence-practice gap for the treatment of acute coronary syndrome (ACS) is central to improving quality of care. Under the European Society of Cardiology (ESC) framework, we aimed to develop updated quality indicators (QIs) for the evaluation of quality of care and outcomes for patients with ACS. Methods A Working Group of experts including members of the ESC Clinical Practice Guidelines Task Force for ACS, Acute CardioVascular Care Association and European Association of Percutaneous Cardiovascular Interventions followed the ESC methodology for QI development. This methodology involved (i) the identification of the domains of ACS care for the diagnosis and management of ACS; (ii) the construction of candidate QIs through a systematic review of the literature; and (iii) the selection of the final set of QIs (using a modified Delphi method). Results Five domains of care for the diagnosis and management of ACS were identified: (1) structural framework and logistics, (2) in-hospital non-invasive care, (3) invasive strategy and periprocedural management, (4) secondary prevention interventions, and (5) outcomes. In total, 21 main QIs were selected, covering all five domains of care for the diagnosis and management of ACS. Conclusions This document defines five domains of ACS care, and provides 21 QIs for the diagnosis and management of ACS. The updated ESC QIs for ACS may be used for quality improvement initiatives.
BACKGROUND:While clinical practice guidelines advocate for multidisciplinary heart team (MDHT) discussions in coronary revascularization, variability in implementation across health care settings remains a challenge. This variability could potentially be addressed by language learning models like ChatGPT, offering decision-making support in diverse health care environments. Our study aims to critically evaluate the concordance between recommendations made by MDHT and those generated by language learning models in coronary revascularization decision-making. METHODS:From March 2023 to July 2023, consecutive coronary angiography cases (n=86) that were referred for revascularization (either percutaneous or surgical) were analyzed using both ChatGPT-3.5 and ChatGPT-4. Case presentation formats included demographics, medical background, detailed description of angiographic findings, and SYNTAX score (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery; I and II), which were presented in 3 different formats. The recommendations of the models were compared with those of an MDHT. RESULTS:ChatGPT-4 showed high concordance with decisions made by the MDHT (accuracy 0.82, sensitivity 0.8, specificity 0.83, and kappa 0.59), while ChatGPT-3.5 (0.67, 0.27, 0.84, and 0.12, respectively) showed lower concordance. Entropy and Fleiss kappa of ChatGPT-4 were 0.09 and 0.9, respectively, indicating high reliability and repeatability. The best correlation between ChatGPT-4 and MDHT was achieved when clinical cases were presented in a detailed context. Specific subgroups of patients yielded high accuracy (>0.9) of ChatGPT-4, including those with left main disease, 3 vessel disease, and diabetic patients. CONCLUSIONS:The present study demonstrates that advanced language learning models like ChatGPT-4 may be able to predict clinical recommendations for coronary artery disease revascularization with reasonable accuracy, especially in specific patient groups, underscoring their potential role as a supportive tool in clinical decision-making.
Background/Objective: Transcatheter aortic valve replacement (TAVR) is indicated for severe aortic stenosis patients with a prohibitive surgical risk. However, its use has been expanding in recent years to include intermediate- and low-risk patients. Thus, registry data describing changes in patient characteristics and outcomes are needed. The aim of this study was to analyse the temporal changes in patient profiles and clinical outcomes of all-comer TAVR. Methods: Baseline characteristics and VARC-3 outcomes of 1632 consecutive patients undergoing TAVR between 2008 and 2021 were analysed. Results: The annual rate of TAVR increased from 30 procedures in 2008–2009 to 398 in 2020–2021. Over the follow-up period, patient age decreased from 85 ± 4 to 80 ± 6.8 (p < 0.001) and the STS score decreased from 5.9% to 2.8% (p < 0.001). Procedural characteristics significantly changed, representing a shift into a minimally invasive approach: adoption of local anaesthesia (none to 48%, p < 0.001) and preference of transfemoral access (74% in 2011–2012 vs. 94.5% in 2020–2021, p < 0.001). The rates of almost all procedural complications decreased, including major vascular and bleeding complications, acute kidney injury (AKI) and in-hospital heart failure. There was a striking decline in rates of complete atrioventricular block (CAVB) and the need for a permanent pacemaker (PPM). PPM rates, however, remain high (17.8%). Thirty-day and one-year mortality significantly declined to 1.8% and 8.3%, respectively. Multivariable analysis shows that AKI, bleeding and stroke are strong predictors of one-year mortality (p < 0.001). Conclusions: The TAVR procedure has changed dramatically during the last 14 years in terms of patient characteristics, procedural aspects and device maturity. These shifts have led to improved procedural safety, contributing to improved short- and long-term patient outcomes.
BACKGROUND:The management of Transcatheter Aortic Valve Implantation (TAVI) patients with a small aortic annulus (SAA) postures a substantial challenge, increasing the risk of patient- prosthesis mismatch (PPM) and overall mortality. AIMS:This study aimed to compare the hemodynamic and clinical outcomes of transcatheter balloon-expandable valve (BEV) versus transcatheter self-expandable valve (SEV) in SAA. METHODS:We conducted propensity score matching (PSM) of severe AS patients with SAA who underwent trans-femoral TAVR and enrolled to the Israeli TAVR registry between the years 2008 and 2023. SAA was defined as an aortic-valve annulus area ≤ 430 mm2. Since the BEV used have a smaller size cut-off, an additional analysis on very small aortic annulus (vSAA) as defined as aortic-valve annulus area ≤ 345 mm2 was performed. RESULTS:The study included 1364 consecutive patients with SAA of (BEV n = 485; SEV n = 879) at a mean age of 82 ± 7 years, of whom the vast majority were female (83%). Propensity-matched groups comprised of 329 and 122 paired for the SAA and vSAA patients, respectively. As compared to BEV in the SAA and vSAA analyses, SEV showed lower rates of postprocedural of LBBB (32% vs. 22% and 41% vs. 22%; both p < 0.01, respectively), however, higher rates of major vascular complications (2% vs. 7% and 2% vs. 12%; both p < 0.01, respectively) and major or life-threatening bleeding but only in vSAA group (17% vs. 9.1%, p = 0.009). One-month mortality was higher in the SEV versus BEV in both SAA and vSAA comparisons (2% vs. 0.6%, p = 0.048 and 3% vs. 0%, p = 0.018; respectively). A nonsignificant trend of higher 5-year mortality was observed in univariate models, noted mainly in vSAA patients (22% vs. 19%, p = 0.385; 24% vs. 15%, p = 0.073). CONCLUSIONS:The present analysis observed higher rates of major vascular complications and 1-month mortality in SAA and vSAA treated with SEV. A similar nonsignificant trend toward long-term mortality for the vSAA group was observed and should be evaluated in larger cohorts.
BACKGROUND:The ACURATE neo2 transcatheter aortic valve was developed to improve paravalvular leak (PVL) rates while maintaining low rates of conduction disturbances and permanent pacemaker implantation (PPMI) seen with its predecessor. We aimed to compare conduction disturbances rates of transcatheter aortic valve replacement (TAVR) using ACURATE Neo2 with other commonly used valves. METHODS:A retrospective analysis of the Israeli TAVR registry between the years 2014-2023 was performed to compare conduction disturbances and PVL rates, and procedural outcomes, among patients treated with ACURATE neo2, Edwards Sapien 3 (S3), and Evolut PRO valves. Propensity score matching was performed to compare groups with similar characteristics. RESULTS:Following exclusion of patients with non-femoral access, unknown valve type, older-generation valves, and less commonly used valves or (n = 4387), our analysis included 3208 patients undergoing TAVR using ACURATE neo2, Edwards S3, and Evolut PRO valves. Propensity matched groups comprised 169 patients each. Rates of any conduction disturbances [left bundle branch block (LBBB), atrioventricular block, or PPMI] were lower in the ACURATE neo2 group compared to both other valves [15.8 %, S3-37.5 % (p < 0.001), Evolut PRO-27.5 % (p = 0.02)] as were LBBB rates [9.0 %, S3-31.3 % (p < 0.001); Evolut PRO-20.1 % (p = 0.01). Atrioventricular block and PPMI rates were lower without statistical significance, as were rates of above-moderate PVL. CONCLUSIONS:In this analysis, TAVR using ACURATE neo2 was associated with a lower composite rate of conduction disturbances in comparison to the Evolut PRO and Edwards S3 valves, mainly due to lower left bundle branch block rates, with non-significantly lower rates of PPMI and PVL.
Background: Most patients after transcatheter aortic valve replacement (TAVR) are admitted directly to the cardiac intensive care unit (CICU) despite low complication rates. Reducing unnecessary CICU hospitalization reduces healthcare costs. This study aimed to compare the outcomes between patients admitted directly to the cardiology department (CD) and those admitted to CICU based on prespecified protocols. Methods: Historical cohort study of all patients who underwent TAVR and were admitted directly to the CD according to a prespecified protocol (uncomplicated procedure, hemodynamically stable, without new conduction abnormalities) in 2017 -2018, and the same number of patients meeting the same criteria who were admitted to the CICU in 2015-2016 before direct CD admission was initiated. Pacemaker implantation during the procedure was not considered a new conduction abnormality. In-hospital outcomes and 30-day post-discharge outcomes were compared. Results: Overall, 260 patients (130 CICU + 130 CD) were included in the study. There was no in-hospital mortality in either group, and the post-procedure length of stay was shorter for patients admitted to CD (median and IQR: 2, 2-4 vs. 4, 3-5 days, p <0.001). There was no significant difference in 30-day emergency department visits between groups (CICU:13.9% vs. CD:16.2%, p = 0.602), rehospitalization rate (9.3%) was the same in both groups, and one patient from the CICU group died. Similar results were observed in multivariable analysis and after matching. Conclusion: Direct admission to the CD after TAVR, according to the proposed criteria, may be considered as a safe and less expensive alternative for stable patients after an uncomplicated TAVR procedure.
OBJECTIVES:Ostial CTOs can be challenging to revascularize. We aim to describe the outcomes of ostial chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS:We examined the clinical and angiographic characteristics and procedural outcomes of 8788 CTO PCIs performed at 35 US and non-US centers between 2012 and 2022. In-hospital major adverse cardiac events (MACE) included death, myocardial infarction, urgent repeat target-vessel revascularization, tamponade requiring pericardiocentesis or surgery, and stroke. RESULTS:Ostial CTOs constituted 12% of all CTOs. Patients with ostial CTOs had higher J-CTO score (2.9 ± 1.2 vs 2.3 ± 1.3; P less than .01). Ostial CTO PCI had lower technical (82% vs. 86%; P less than .01) and procedural (81% vs. 85%; P less than .01) success rates compared with non-ostial CTO PCI. Ostial location was not independently associated with technical success (OR 1.03, CI 95% 0.83-1.29 P =.73). Ostial CTO PCI had a trend towards higher incidence of MACE (2.6% vs. 1.8%; P =.06), driven by higher incidence of in-hospital death (0.9% vs 0.3% P less than.01) and stroke (0.5% vs 0.1% P less than .01). Ostial lesions required more often use of the retrograde approach (30% vs 9%; P less than .01). Ostial CTO PCI required longer procedure time (149 [103,204] vs 110 [72,160] min; P less than .01) and higher air kerma radiation dose (2.3 [1.3, 3.6] vs 2.0 [1.1, 3.5] Gray; P less than .01). CONCLUSIONS:Ostial CTOs are associated with higher lesion complexity and lower technical and procedural success rates. CTO PCI of ostial lesions is associated with frequent need for retrograde crossing, higher incidence of death and stroke, longer procedure time and higher radiation dose.
Abstract Background In recent decades, Transcatheter Aortic Valve Replacement (TAVR) has revolutionized the treatment landscape for aortic stenosis (AS). This study aimed to investigate the shifts in AS-related mortality rates before and after the introduction of TAVR in the United States (US). Methods Mortality data for all US adults (1999- 2020) were retrieved from the CDC WONDER dataset, encompassing all US death certificates and their associated causes. We analyzed AS-related age-adjusted mortality rates (AAMR) per 100,000 persons, contextualized with the FDA's TAVR approval for high-risk patients in 2012 and intermediate-risk patients in 2016. These rates were compared with mitral regurgitation (MR)-related mortality. Results We observed 306,376 AS- and 52,049 MR-related deaths. The average annual AAMR (95% CI) shifted from 4.21 (4.14, 4.28) in 1999-2012 to 4.31 (4.24, 4.38) in the years 2013-2016 and to 3.69 (3.63, 3.75) in the years 2017-2020 (FIGURE). Mitral valve AAMR also declined, however more moderately. While in pre-approval period, AS-related mortality was higher in rural compared with urban areas [4.42 (4.25, 4.59) and 4.16 (4.08, 4.24), respectively], the AAMR decline was comparable for both from the time of TAVR approval for high-risk patients to its approval for intermediate-risk patients, with a decrease of ~0.62 deaths per 100,000 persons annually for both demographics. Gender-specific analysis revealed that prior to approval, males exhibited higher mortality rates compared to females [4.59 (4.47, 4.72) vs. 3.94 (3.86, 4.03)]. However, the decline in mortality rates among males outpaced that among females (0.75 and 0.54 deaths per 100,000 persons annually, respectively. Conclusions Mortality rates associated with aortic stenosis have declined over the past two decades, with a clear temporal connection to the integration of TAVR into practice. Importantly, this decline was consistent across genders and geographical areas, suggesting that TAVR may play a pivotal role in mitigating health disparities within the US population.
Abstract Introduction Chronic kidney disease (CKD) patients are under-represented in clinical trials examining transcatheter interventions for tricuspid regurgitation (TR). The purpose of the current analysis was to investigate how CKD modifies the association of severe TR with overall survival. Methods Consecutive echocardiographic reports linked to clinical data from the largest medical center in Israel (2007-2022) were reviewed. Patients were dichotomized into four mutually exclusive TR groups (none/trivial, mild, moderate and severe), following by stratification according to CKD stage classification. The primary outcome was all-cause mortality. Kaplan Meier, Multivariate Cox regression and interaction analysis models were applied. Results Final study population included 78,147 patients with a median age of 67 (IQR: 55-78 years), 2,989 (4%) of whom had severe TR. There were 19,910 (25%) patients with estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m2, 14,359 (18%) with eGFR between 30-60 and 5,551 (7%) with eGFR <30. During a median follow-up period of 4 years (IQR: 1-7 years), 28,112 patients (36%) died. Kaplan-Meier survival analysis demonstrated an increased risk of death with both increasing severity of TR and/or CKD grade (log-rank p60 group severe TR was associated with 19% increased risk of death, whereas among patients with eGFR<60 the risk was significantly higher and reached 34% in the same multivariate model (p for interaction Conclusions While the association of severe TR with poor survival is consistent across all CKD groups, it is more pronounced among patients with advanced CKD. This association may be modulated through right ventricular function. When examining data and outcome of tricuspid clinical trials , special emphasis should be given to CKD status.Consort like figureHR modification by CKD
Background: Transcatheter edge-to-edge mitral valve repair (TEER) has been established as a therapy for severe symptomatic mitral regurgitation (MR) in stable patients, and it has recently emerged as a reasonable option for acutely ill patients. The aim of this study was to evaluate the safety and efficacy of TEER in hospitalized patients with acute decompensated heart failure (ADHF) and severe MR that was deemed to play a major role in their deterioration. Methods: We included 31 patients who underwent emergent TEER for MR ≥ 3+ from 2012 to 2022 at Sheba Medical Center. Outcomes included procedural safety, procedural success, all-cause mortality, heart failure readmission, and functional improvement. Outcomes were evaluated at 3 months and at 1 year. Data were obtained retrospectively by chart review. Results: Implantation of a TEER device was achieved in 97% of patients, and reduction in MR severity of at least two grades and final MR ≤ 2+ at discharge was achieved in 74%. No intra-procedural mortality or life-threatening complications were noted. Mortality at 30 days was 23%. No excess mortality occurred beyond 6 months, with a total mortality of 41%. At 1 year all survivors had MR ≤ 2+, all were free of heart failure hospitalizations, and 88% were at New York Heart Association class ≤ II. Conclusions: Mitral valve TEER for patients with ADHF and significant MR is safe, feasible, and achieves substantial reduction in MR severity. Despite high early mortality, procedural success is associated with good long-term clinical outcomes for patients surviving longer than 6 months.
BACKGROUND:New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD.AIM:To compare the safety and efficacy of suture-based Perclose Prostyle as compared to plug-based MANTA device.METHODS:A total of 408 consecutive TAVI patients from two high volume TAVI centers were included in the present study. Patients were grouped according to VCD: Prostyle versus MANTA. Propensity score matching (PSM) and multivariable analysis were utilized to compare clinical endpoints between the two groups. The primary endpoint was any vascular complication (VC) according to VARC-3 criteria.RESULTS:After PSM, a total of 264 patients were analyzed, of them 132 in each group. Overall baseline characteristics of the two groups were comparable. Primary end-point was similar between MANTA as compared to Prostyle (16.7% vs. 15.3% respectively, p = 0.888). The main driver for VC among MANTA group were minor vascular complications (15.2%). Conversely, minor and major VC contributed equally to the primary endpoint among Prostyle group (7.6%) (p = 0.013). No outcome predictors were identified in multivariate analysis.CONCLUSIONS:VCD for transfemoral TAVI using the new-generation Prostyle device or the MANTA device achieved comparable VARC-3 VC rates.