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Background: We aimed to perform a meta-analysis of randomized trials comparing long-term outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) for severe aortic stenosis. The short-term efficacy and safety of TAVR are proven, but long-term outcomes are unclear. Methods: We included randomized controlled trials comparing TAVR vs SAVR at the longest available follow-up. The primary end point was death or disabling stroke. Secondary end points were all-cause mortality, cardiac mortality, stroke, pacemaker implantation, valve thrombosis, valve gradients, and moderate-to-severe paravalvular leaks. The study is registered with PROSPERO (CRD42023481856). Results: Seven trials (N = 7785 patients) were included. Weighted mean trial follow-up was 5.76 ± 0.073 years. Overall, no significant difference in death or disabling stroke was observed with TAVR vs SAVR (HR, 1.02; 95% CI, 0.93-1.11; P = .70). Mortality risks were similar. TAVR resulted in higher pacemaker implantation and moderate-to-severe paravalvular leaks compared to SAVR. Results were consistent across different surgical risk profiles. As compared to SAVR, self-expanding TAVR had lower death or stroke risk (P interaction = .06), valve thrombosis (P interaction = .06), and valve gradients (P interaction < .01) but higher pacemaker implantation rates than balloon-expandable TAVR (P interaction < .01). Conclusions: In severe aortic stenosis, the long-term mortality or disabling stroke risk of TAVR is similar to SAVR, but with higher risk of pacemaker implantation, especially with self-expanding valves. As compared with SAVR, the relative reduction in death or stroke risk and valve thrombosis was greater with self-expanding than with balloon-expandable valves.
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Background: The permanent pacemaker (PPM) implantation and pacemaker dependency rates after transcatheter aortic valve replacement (TAVR) are highly variable as some of the conduction disturbances are reversible. It remains poorly investigated how to optimise temporary pacing in these patients. This study aimed to explore the potential reduction in the PPM implantation rate using temporary-permanent pacemaker (TPPM) as a 1-month bridge. Methods: This is a prospective, multicentre, single-arm, observational study. Consecutive patients undergoing TAVR from March 1, 2022 to March 1, 2023 in 13 tertiary hospitals in China were screened. Patients who developed high-degree atrioventricular block, complete heart block, or first-degree atrioventricular block plus new onset left bundle branch block during the TAVR procedure or within 1 month after TAVR were included to receive TPPM. Patients with pre-existing PPM implantation or indications for PPM implantation before the TAVR procedure were excluded. Patients with TPPM were monitored to determine whether the conduction disturbances persisted or recovered. The primary endpoint was the rate of freedom from indications for PPM implantation 1 month after TAVR. This study is registered with ChiCTR, ChiCTR2200057931. Findings: Of 688 patients who have undergone TAVR, 71 developed conduction disturbance and met the inclusion criteria, 1 patient withdrew due to noncompliance, 70 patients received TPPM and completed follow-up. There were 41 (58.6%) men and 29 (41.4%) women in the study, with a mean age of 74.3 ± 7.3 years. At 1 month follow-up, 75.7% (53/70) of the patients with TPPM did not require PPM implantation. For 688 patients who have undergone TAVR, the rate of PPM implantation at 1 month was 2.47% (17/688, 95% CI 1.55%-3.92%), representing a significant reduction in self-comparison with the rate at 48 h after TPPM (2.47% vs. 8.28% [95% CI 6.45%-10.58%], P < 0.0001). Similar results were obtained in the subgroup analysis of patients with HAVB/CHB. Multivariate analysis revealed the baseline PR interval, difference between the membranous septum length and implantation depth, and timing of postprocedural conduction disturbance occurrence were independent predictors of freedom from indications for PPM implantation at 1 month after TAVR. Interpretation: Using TPPM as a 1-month bridge allows for a buffer period to distinguish whether conduction disturbances are reversible or persistent, resulting in a significant reduction in the PPM implantation rate after TAVR when compared with the current strategy. However, this is an observational study, the results need to be confirmed in a randomized trial. Funding: Beijing Science and Technology Plan 2022 from Beijing Municipal Science & Technology Commission.
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Importance: Osteosarcopenia is an emerging geriatric syndrome characterized by age-related deterioration in muscle and bone. Despite the established relevance of frailty and sarcopenia among older adults undergoing transcatheter aortic valve replacement (TAVR), osteosarcopenia has yet to be investigated in this setting. Objective: To determine the association between osteosarcopenia and adverse outcomes following TAVR. Design, Setting, and Participants: This is a post hoc analysis of the Frailty in Aortic Valve Replacement (FRAILTY-AVR) prospective multicenter cohort study and McGill extension that enrolled patients aged 70 years or older undergoing TAVR from 2012 through 2022. FRAILTY-AVR was conducted at 14 centers in Canada, the United States, and France between 2012 and 2016, and patients at the McGill University-affiliated center in Montreal, Québec, Canada, were enrolled on an ongoing basis up to 2022. Exposure: Osteosarcopenia as measured on computed tomography (CT) scans prior to TAVR. Main Outcomes and Measures: Clinically indicated CT scans acquired prior to TAVR were analyzed to quantify psoas muscle area (PMA) and vertebral bone density (VBD). Osteosarcopenia was defined as a combination of low PMA and low VBD according to published cutoffs. The primary outcome was 1-year all-cause mortality. Secondary outcomes were 30-day mortality, hospital length of stay, disposition, and worsening disability. Multivariable logistic regression was used to adjust for potential confounders. Results: Of the 605 patients (271 [45%] female) in this study, 437 (72%) were octogenarian; the mean (SD) age was 82.6 (6.2) years. Mean (SD) PMA was 22.1 (4.5) cm2 in men and 15.4 (3.5) cm2 in women. Mean (SD) VBD was 104.8 (35.5) Hounsfield units (HU) in men and 98.8 (34.1) HU in women. Ninety-one patients (15%) met the criteria for osteosarcopenia and had higher rates of frailty, fractures, and malnutrition at baseline. One-year mortality was highest in patients with osteosarcopenia (29 patients [32%]) followed by those with low PMA alone (18 patients [14%]), low VBD alone (16 patients [11%]), and normal bone and muscle status (21 patients [9%]) (P < .001). Osteosarcopenia, but not low VBD or PMA alone, was independently associated with 1-year mortality (odds ratio [OR], 3.18; 95% CI, 1.54-6.57) and 1-year worsening disability (OR, 2.11; 95% CI, 1.19-3.74). The association persisted in sensitivity analyses adjusting for the Essential Frailty Toolset, Clinical Frailty Scale, and geriatric conditions such as malnutrition and disability. Conclusions and Relevance: The findings suggest that osteosarcopenia detected using clinical CT scans could be used to identify frail patients with a 3-fold increase in 1-year mortality following TAVR. This opportunistic method for osteosarcopenia assessment could be used to improve risk prediction, support decision-making, and trigger rehabilitation interventions in older adults.
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Estenose da Valva Aórtica , Sarcopenia , Substituição da Valva Aórtica Transcateter , Humanos , Masculino , Feminino , Sarcopenia/epidemiologia , Sarcopenia/complicações , Idoso de 80 Anos ou mais , Idoso , Estudos Prospectivos , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Fragilidade/complicações , Tomografia Computadorizada por Raios X , Densidade Óssea , Músculos Psoas/diagnóstico por imagem , Canadá/epidemiologia , França/epidemiologia , Idoso Fragilizado , Fatores de RiscoRESUMO
The identification and management of patients at high bleeding risk (HBR) undergoing transcatheter aortic valve implantation (TAVI) are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. VARC-HBR is an initiative of the CERC (Cardiovascular European Research Center), aiming to develop a consensus definition of TAVI patients at HBR, based on a systematic review of the available evidence, to provide consistency for future clinical trials, clinical decision-making, and regulatory review. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI..
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Consenso , Hemorragia , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Fatores de Risco , Hemorragia/etiologia , Medição de Risco , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgiaRESUMO
Background: Colchicine has shown potential cardioprotective effects owing to its broad anti-inflammatory properties. We performed a meta-analysis to assess its safety and efficacy in secondary prevention in patients with established coronary artery disease (CAD). Methods: We searched Ovid Healthstar, MEDLINE, and Embase (inception to May 2022) for randomized controlled trials (RCTs) evaluating the cardiovascular effects of colchicine compared with placebo or usual care in patients with CAD. Study-level data on efficacy and safety outcomes were pooled using the Peto method. The primary outcome was the composite of cardiovascular (CV) death, myocardial infarction (MI), or stroke. Results: A total of 8 RCTs were included with a follow-up duration of ≥1 month, comprising a total of 12,151 patients. Compared with placebo or usual care, colchicine was associated with a significant risk reduction in the primary outcome (odds ratio (OR) 0.70, 95% CI 0.60 to 0.83, P < 0.0001; I2 = 52%). Risks of MI (OR 0.75, 95% CI 0.62 to 0.91, P = 0.003; I2 = 33%), stroke (OR 0.47, 95% CI 0.30 to 0.74, P = 0.001; I2 = 0%), and unplanned coronary revascularization (OR 0.67, 95% CI 0.55 to 0.82, P = 0.0001; I2 = 58%) were all reduced in the colchicine group. Rates of CV and all-cause mortality did not differ between the two groups, but there was an increase in noncardiac deaths with colchicine (OR 1.54, 95% CI 1.10 to 2.15, P = 0.01; I2 = 51%). The occurrence of all other adverse events was similar between the two groups, including GI reactions (OR 1.06, 95% CI 0.94 to 1.20, P = 0.35; I2 = 42%) and infections (OR 1.04, 95% CI 0.84 to 1.28, P = 0.74; I2 = 53%). Conclusions: Colchicine therapy may reduce the risk of future cardiovascular events in patients with established CAD; however, there remains a concern about non-CV mortality. Further trials are underway that will shed light on non-CV mortality and colchicine NCT03048825, and NCT02898610.
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Doenças Cardiovasculares , Doença da Artéria Coronariana , Infarto do Miocárdio , Acidente Vascular Cerebral , Humanos , Doenças Cardiovasculares/prevenção & controle , Colchicina/efeitos adversos , Prevenção Secundária , Ensaios Clínicos Controlados Aleatórios como Assunto , Infarto do Miocárdio/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/epidemiologia , Doença da Artéria Coronariana/tratamento farmacológicoRESUMO
Human papillomavirus (HPV) is the most prevalent sexually transmitted virus globally and a primary cause of cervical cancer, which ranks fourth among tumors in both incidence and mortality. Despite the availability of effective vaccines worldwide, HPV vaccination rates vary, especially among migrant and refugee populations. Indeed, migrant status may act as a determinant against accessing vaccinations, among many other factors. The objective of this paper is to evaluate barriers to and facilitators for accessing HPV vaccination in migrant and refugee populations. A systematic review of the existing peer-reviewed academic literature was conducted according to the PRISMA 2020 guidelines in which we examined thirty-four studies to evaluate HPV vaccination rates in these populations and identify factors acting as barriers or facilitators. Key determinants include socio-economic status and health literacy. Communication barriers, including language and cultural factors, also impact access to information and trust in the health workforce. Understanding and considering these factors is crucial for developing proper and inclusive vaccination strategies to ensure that no population is overlooked.
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Background: Rates of major bleeding and intraprocedural thrombotic events (IPTE) in the setting of percutaneous coronary intervention (PCI) using weight-adjusted unfractionated heparin (UFH) without activated clotting time (ACT) monitoring are not known. Methods: We reviewed 2,748 consecutive patients who underwent coronary angiography at our tertiary care university hospital between January 2017 and December 2020. All patients who underwent PCI with weight-adjusted UFH without ACT guidance were considered for further analysis. Major bleeding complications occurring within 48 hours of PCI were collected from patients' medical records. IPTE were collected independently by two interventional cardiologists after review of coronary angiograms. Results: There were 718 patients included in the analysis (65.4 ± 12.2 years old; 81.3% male). In total, 45 patients (7.8%) experienced a major bleed or IPTE. The most common IPTE were slow/no reflow (1.5%) and coronary artery dissection with decreased flow (1.1%). Other IPTE occurred in <1% of cases. Major bleeding occurred in 11 patients (1.5%), of whom 8 required blood transfusion and 3 required vascular intervention. Bleeding complications were more common with femoral compared with radial access (6.6% vs. 0.2%, P < 0.001). Conclusion: Weight-adjusted UFH use during PCI without ACT monitoring was related to low rates of major bleeding or IPTE.
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Intervenção Coronária Percutânea , Trombose , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Heparina/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento , Hemorragia/induzido quimicamente , Anticoagulantes/efeitos adversosRESUMO
BACKGROUND: Transcatheter tricuspid valve replacement (TTVR) abolishes tricuspid regurgitation (TR) and has emerged as a definitive treatment for TR. OBJECTIVES: The purpose of this multicenter, observational study was to determine the clinical characteristics and short-term outcomes of patients with TR screened for TTVR. METHODS: Patients underwent TTVR screening at 7 centers on a compassionate-use basis. The primary endpoints were NYHA functional class and TR grade at 30-day follow-up. Secondary endpoints included all-cause mortality, heart failure hospitalization, technical success, and reasons for TTVR screening failure. RESULTS: A total of 149 patients (median age 79 years [Q1-Q3: 72-84 years], 54% women) underwent TTVR screening. The TTVR screening failure rate was 74%, mainly related to large tricuspid annular diameter. Patients undergoing TTVR (n = 38) had significant functional improvements (NYHA functional class I or II from 21% to 68%; P < 0.001), with TR ≤1+ in 97% at 30-day follow-up (P < 0.001 from baseline). Technical success was achieved in 91%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 8%, heart failure hospitalization 5%, major bleeding 18%, and reintervention 9%. Patients who failed screening for TTVR and subsequently underwent "bailout" transcatheter edge-to-edge repair (n = 26) had favorable outcomes (NYHA functional class I or II from 27% to 58%; P < 0.001), with TR ≤1+ in 43% at 30-day follow-up (P < 0.001 from baseline). CONCLUSIONS: This first real-world report of TTVR screening demonstrated a high screening failure rate, mainly related to large tricuspid annular diameter. Patients undergoing TTVR had superior TR reduction and symptom alleviation compared with bailout tricuspid transcatheter edge-to-edge repair, at the cost of greater procedural complications.
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Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Humanos , Feminino , Idoso , Masculino , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemodinâmica , Cateterismo Cardíaco/efeitos adversos , Resultado do Tratamento , Recuperação de Função Fisiológica , Fatores de Tempo , Índice de Gravidade de Doença , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/cirurgia , Sistema de RegistrosRESUMO
Tricuspid regurgitation (TR) is a highly prevalent and heterogeneous valvular disease, independently associated with excess mortality and high morbidity in all clinical contexts. TR is profoundly undertreated by surgery and is often discovered late in patients presenting with right-sided heart failure. To address the issue of undertreatment and poor clinical outcomes without intervention, numerous structural tricuspid interventional devices have been and are in development, a challenging process due to the unique anatomic and physiological characteristics of the tricuspid valve, and warranting well-designed clinical trials. The path from routine practice TR detection to appropriate TR evaluation, to conduction of clinical trials, to enriched therapeutic possibilities for improving TR access to treatment and outcomes in routine practice is complex. Therefore, this paper summarizes the key points and methods crucial to TR detection, quantitation, categorization, risk-scoring, intervention-monitoring, and outcomes evaluation, particularly of right-sided function, and to clinical trial development and conduct, for both interventional and surgical groups.
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Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Humanos , Diagnóstico por Imagem , Valor Preditivo dos Testes , Resultado do Tratamento , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/cirurgia , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/cirurgia , Ensaios Clínicos como AssuntoRESUMO
Murray law-based quantitative flow ratio (µQFR) assesses fractional flow reserve (FFR) in bifurcation lesions using a single angiographic view, enhancing the feasibility of analysis; however, accuracy may be compromised in suboptimal angiographic projections. FFRCT is a well-validated non-invasive method measuring FFR from coronary computed tomographic angiography (CCTA). We evaluated the feasibility of µQFR in left main (LM) bifurcations, the impact of the optimal/suboptimal fluoroscopic view with respect to CCTA, and its diagnostic concordance with FFRCT. In 300 patients with three-vessel disease, the values of FFRCT and µQFR were compared at distal LM, proximal left anterior descending artery (pLAD) and circumflex artery (pLCX). The optimal viewing angle of LM bifurcation was defined on CCTA by 3-dimensional coordinates and converted into a 2-dimensional fluoroscopic view. The best fluoroscopic projection was considered the closest angulation to the optimal viewing angle on CCTA. µQFR was successfully computed in 805 projections. In the best projections, µQFR sensitivity was 88.2% (95% CI 76.1-95.6) and 84.8% (71.1-93.7), and specificity was 96.8% (93.8-98.6) and 97.2% (94.4-98.9), in pLAD and pLCX, respectively, with regard to FFRCT. The AUC of µQFR for predicting FFRCT ≤ 0.80 tended to be improved using the best versus suboptimal projections (0.94 vs. 0.89 [p = 0.048] in pLAD; 0.94 vs. 0.88 [p = 0.075] in pLCX). Computation of µQFR in LM bifurcations using a single angiographic view showed high feasibility from post-hoc analysis of coronary angiograms obtained for clinical purposes. The fluoroscopic viewing angle influences the diagnostic performance of physiological assessment using a single angiographic view.
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Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Humanos , Doença da Artéria Coronariana/diagnóstico por imagem , Constrição Patológica , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Valor Preditivo dos Testes , Angiografia Coronária/métodos , Angiografia por Tomografia Computadorizada/métodos , Vasos Coronários/diagnóstico por imagem , Estenose Coronária/diagnóstico por imagem , Índice de Gravidade de DoençaRESUMO
Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centred outcomes following TAVR. The PERFORM-TAVR trial is a multicentre parallel-group randomised clinical trial that is enrolling 200 frail older adults ≥ 70 years of age undergoing TAVR. Patients will be randomly allocated to 1 of 2 treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks before TAVR with the addition of home-based supervised exercise sessions for 12 weeks after TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL, as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety end point. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimise recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patients' frailty in parallel with their underlying heart valve disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03522454.
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Estenose da Valva Aórtica , Fragilidade , Substituição da Valva Aórtica Transcateter , Idoso , Feminino , Humanos , Masculino , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Fragilidade/complicações , Fragilidade/prevenção & controle , Qualidade de Vida , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
We report the case of a 64-year-old man with a history of chemotherapy-induced cardiomyopathy requiring heart transplant in 2022 who underwent successful endomyocardial biopsy using patient-specific computed tomographic fluoroscopic projections. (Level of Difficulty: Beginner.).
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BACKGROUND: A significant number of patients with severe mitral regurgitation (MR) are not suitable for either surgical or transcatheter edge-to-edge repair because of high surgical risk or inappropriate mitral valve anatomy. OBJECTIVES: The aim of this study was to evaluate the HighLife Trans-Septal Mitral Valve Replacement (TSMVR) system in patients with symptomatic MR and high surgical risk. METHODS: This prospective, multicenter, nonrandomized feasibility study evaluated the safety and performance of the HighLife TSMVR system in patients with moderate to severe or severe symptomatic MR during 1-year follow-up. Echocardiographic data were assessed at an independent core laboratory. RESULTS: A total of 30 patients (mean age 75.6 years, 27% women, median Society of Thoracic Surgeons score 5.5%) with severe MR (90% with secondary MR, median left ventricular ejection fraction 43%) were treated at 13 sites. In 27 of the 30 patients, the HighLife TSMVR system was implanted successfully (technical success rate 90%). Device success at 30 days was 83%. After 1 year, 5 patients (17%) had died. None of the patients who underwent implantation required mitral valve reintervention. All patients who underwent implantation had no or trace (78%) or mild (22%) MR, the mean gradient of the HighLife valve was 5.1 mm Hg, and there were no signs of left ventricular outflow tract obstruction (mean gradient 2.0 mm Hg). CONCLUSIONS: The 1-year results from the HighLife TSMVR feasibility study demonstrate a high technical success rate, excellent valve function, no left ventricular outflow tract obstruction, and no need for mitral valve reintervention. Additional patient outcomes and longer follow-up are needed to confirm these findings. (Expanded Study of the HighLife 28mm Trans-Septal Trans-Catheter Mitral Valve in Patients With Moderate-Severe or Severe Mitral Regurgitation and at High Surgical Risk; NCT04029363).
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Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral , Humanos , Feminino , Idoso , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Volume Sistólico , Estudos de Viabilidade , Estudos Prospectivos , Função Ventricular Esquerda , Resultado do Tratamento , Cateterismo CardíacoRESUMO
BACKGROUND: Data concerning the outcomes of transcatheter aortic valve replacement in type 0 bicuspid aortic stenosis (AS) are scarce. The study aims to compare the outcomes of transcatheter aortic valve replacement for AS in patients with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy. METHODS: We enrolled consecutive patients undergoing transcatheter aortic valve replacement for severe AS between 2012 and 2022 in this single-center retrospective cohort study. The primary outcome was mortality, while secondary outcomes included in-hospital complications such as stroke and pacemaker implantation and transcatheter heart valve hemodynamic performance. RESULTS: The number of patients with AS with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy was 328, 302, and 642, respectively. Self-expanding transcatheter heart valves were used in the majority of patients (n=1160; 91.4%). In the matched population, differences in mortality (30 days: 4.2% versus 1.7% versus 1.7%, Poverall=0.522; 1 year: 10% versus 2.3% versus 6.2%, Poverall=0.099) and all stroke (30 days: 1.0% versus 0.9% versus 0.0%, Poverall=0.765; 1 year: 1.4% versus 1.6% versus 1.3%, Poverall=NS) were nonsignificant, and the incidence of overall in-hospital complications was comparable among groups. Ascending aortic diameter was the single predictor of 1-year mortality in type 0 bicuspid patients (hazard ratio, 1.59 [95% CI, 1.03-2.44]; P=0.035). The proportion of patients with a mean residual gradient ≥20 mm Hg was the highest in those with type 0 bicuspid anatomy, although the need for permanent pacemaker implantation was the lowest in this group. CONCLUSIONS: Major clinical outcomes of transcatheter aortic valve replacement for AS in patients with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy are equivalent at short- and mid-term follow-up. These observations merit further exploration in prospective international registries and randomized controlled trials.
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Estenose da Valva Aórtica , Doenças das Valvas Cardíacas , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Estudos Prospectivos , Estudos Retrospectivos , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/cirurgia , Resultado do Tratamento , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/etiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/cirurgiaRESUMO
Paravalvular leak (PVL) is a shortcoming that can erode the clinical benefits of transcatheter valve replacement (TAVR) and therefore a readily applicable method (aortography) to quantitate PVL objectively and accurately in the interventional suite is appealing to all operators. The ratio between the areas of the time-density curves in the aorta and left ventricular outflow tract (LVOT-AR) defines the regurgitation fraction (RF). This technique has been validated in a mock circulation; a single injection in diastole was further tested in porcine and ovine models. In the clinical setting, LVOT-AR was compared with trans-thoracic and trans-oesophageal echocardiography and cardiac magnetic resonance imaging. LVOT-AR > 17% discriminates mild from moderate aortic regurgitation on echocardiography and confers a poor prognosis in multiple registries, and justifies balloon post-dilatation. The LVOT-AR differentiates the individual performances of many old and novel devices and is being used in ongoing randomized trials and registries.
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BACKGROUND: Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited. AIMS: We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry. METHODS: A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria. RESULTS: The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm2, and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies. CONCLUSIONS: BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.
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Estenose da Valva Aórtica , Doença da Válvula Aórtica Bicúspide , Doenças das Valvas Cardíacas , Próteses Valvulares Cardíacas , Estenose da Valva Mitral , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Doença da Válvula Aórtica Bicúspide/etiologia , Doença da Válvula Aórtica Bicúspide/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Constrição Patológica , Resultado do Tratamento , Desenho de Prótese , Estudos Prospectivos , Doenças das Valvas Cardíacas/cirurgia , Estenose da Valva Mitral/cirurgia , Sistema de Registros , MorteRESUMO
Coronary computed tomographic angiography (CCTA) is becoming the first-line investigation for establishing the presence of coronary artery disease and, with fractional flow reserve (FFRCT), its haemodynamic significance. In patients without significant epicardial obstruction, its role is either to rule out atherosclerosis or to detect subclinical plaque that should be monitored for plaque progression/regression following prevention therapy and provide risk classification. Ischaemic non-obstructive coronary arteries are also expected to be assessed by non-invasive imaging, including CCTA. In patients with significant epicardial obstruction, CCTA can assist in planning revascularisation by determining the disease complexity, vessel size, lesion length and tissue composition of the atherosclerotic plaque, as well as the best fluoroscopic viewing angle; it may also help in selecting adjunctive percutaneous devices (e.g., rotational atherectomy) and in determining the best landing zone for stents or bypass grafts.