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BACKGROUND: The optimal medical treatment strategy after transcatheter aortic valve replacement (TAVR) has not been established, and may be impacted by the extent of extra-valvular cardiac damage. We aimed to investigate the prognostic effect of renin-angiotensin system (RAS) inhibitors in TAVR patients stratified by the extent of extra-valvular cardiac damage. METHODS: In a prospective TAVR registry, patients were retrospectively evaluated for baseline cardiac damage and classified into five stages of cardiac damage (0-4) according to established criteria. Clinical outcomes at 1 year were compared according to RAS inhibitor prescription at discharge. RESULTS: Among 2,247 eligible patients undergoing TAVR between August 2007 and June 2021, 1,634 (72.7%) were prescribed RAS inhibitors at discharge. Eighty-three patients (3.7%) were classified as Stage 0, 276 (12.3%) as Stage 1, 889 (39.6%) as Stage 2, 489 (21.8%) as Stage 3, and 510 (22.7%) as Stage 4. RAS inhibitor prescription after TAVR was associated with a reduced risk of 1-year mortality (HRadjusted 0.59, 95% CI 0.45-0.77). The protective effect was accentuated among patients with cardiac stage 3 and 4 (HRadjusted 0.54, 95% CI 0.32-0.92 and HRadjusted 0.58, 95% CI 0.36-0.92, respectively), but not statistically significant in stages 2 (HRadjusted 0.70, 95% CI 0.43-1.14). CONCLUSIONS: In patients undergoing TAVR, we found a strong association of RAS inhibitor prescription and improved clinical outcome in the overall population, and there were no signs of heterogeneity across stages of cardiac damage.
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BACKGROUND: Cardiac damage caused by aortic stenosis (AS) can be categorized into stages, which are associated with a progressively increasing risk of death after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The authors investigated sex-related differences in cardiac damage among patients with symptomatic AS and the prognostic value of cardiac damage classification in women and men undergoing TAVR. METHODS: In a prospective registry, pre-TAVR echocardiograms were used to categorize patients into 5 stages of cardiac damage caused by AS. Differences in the extent of cardiac damage were compared according to sex, and its implications on clinical outcomes after TAVR were explored. RESULTS: Among 2,026 patients undergoing TAVR between August 2007 and June 2022 (995 [49.1%] women and 1,031 [50.9%] men), we observed sex-specific differences in the pattern of cardiac damage (women vs men; stage 0: 2.6% vs 3.1%, stage 1: 13.4% vs 10.1%, stage 2: 37.1% vs 39.5%, stage 3: 27.5% vs 15.6%, and stage 4: 19.4% vs 31.7%). There was a stepwise increase in 5-year all-cause mortality according to stage in women (HRadjusted: 1.43; 95% CI: 1.28-1.60, for linear trend) and men (HRadjusted: 1.26; 95% CI: 1.14-1.38, for linear trend). Female sex was associated with a lower 5-year mortality in early stages (stage 0, 1, or 2) but not in advanced stages (stage 3 or 4). CONCLUSIONS: The pattern of cardiac damage secondary to AS differed by sex. In early stages of cardiac damage, women had a lower 5-year mortality than men, whereas in more advanced stages, mortality was comparable between sexes. (SwissTAVI Registry; NCT01368250).
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Estenose da Valva Aórtica , Disparidades nos Níveis de Saúde , Sistema de Registros , Substituição da Valva Aórtica Transcateter , Humanos , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Feminino , Masculino , Fatores Sexuais , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso , Fatores de Risco , Idoso de 80 Anos ou mais , Medição de Risco , Fatores de Tempo , Resultado do Tratamento , Estudos Prospectivos , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Índice de Gravidade de DoençaRESUMO
Background: Transcatheter aortic valve replacement (TAVR) is a treatment option for severe aortic valve stenosis. Pre-TAVR assessments, extending beyond anatomy, include evaluating frailty. Potential frailty parameters in pre-TAVR computed tomography (CT) scans are not fully explored but could contribute to a comprehensive frailty assessment. The primary objective was to investigate the impact of total muscle area (TMA) and visceral adipose tissue (VAT) as frailty parameters on 5-year all-cause mortality in patients undergoing TAVR. Methods: Between 01/2017 and 12/2018, consecutive TAVR patients undergoing CT scans enabling TMA and VAT measurements were included. Results: A total of 500 patients qualified for combined TMA and VAT analysis. Age was not associated with a higher risk of 5-year mortality (HR 1.02, 95% CI: 0.998-1.049; p = 0.069). Body surface area normalized TMA (nTMA) was significantly associated with 5-year, all-cause mortality (HR 0.927, 95% CI: 0.927-0.997; p = 0.033), while VAT had no effect (HR 1.002, 95% CI: 0.99-1.015; p = 0.7). The effect of nTMA on 5-year, all-cause mortality was gender dependent: the protective effect of higher nTMA was found in male patients (pinteraction: sex × nTMA = 0.007). Conclusions: Normalized total muscle area derived from a routine CT scan before transcatheter aortic valve replacement complements frailty assessment in patients undergoing TAVR.
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BACKGROUND: Extravalvular cardiac damage caused by aortic stenosis affects prognosis after transcatheter aortic valve replacement (TAVR). The long-term impact of changes in cardiac damage in response to relief from mechanical obstruction has not been fully investigated. OBJECTIVES: The authors aimed to investigate changes in cardiac damage early after TAVR and the prognostic impact of the cardiac damage classification after TAVR. METHODS: In this single-center observational study, patients undergoing transfemoral TAVR were retrospectively evaluated for cardiac damage before and after TAVR and classified into 5 stages of cardiac damage (0-4). RESULTS: Among 1,863 patients undergoing TAVR between January 2007 and June 2022, 56 patients (3.0%) were classified as stage 0, 225 (12.1%) as stage 1, 729 (39.1%) as stage 2, 388 (20.8%) as stage 3, and 465 (25.0%) as stage 4. Cardiac stage changed in 47.7% of patients (improved: 30.1% in stages 1-4 and deteriorated: 24.7% in stages 0-3) early after TAVR. Five-year all-cause mortality was associated with cardiac damage both at baseline (HRadjusted: 1.34; 95% CI: 1.24-1.44; P < 0.001 for linear trend) and after TAVR (HRadjusted: 1.40; 95% CI: 1.30-1.51; P < 0.001 for linear trend). Five-year all-cause mortality was stratified by changes in cardiac damage (improved, unchanged, or worsened) in patients with cardiac stage 2, 3, and 4 (log-rank P < 0.001 for stage 2, 0.005 for stage 3, and <0.001 for stage 4). CONCLUSIONS: The extent of extra-aortic valve cardiac damage before and after TAVR and changes in cardiac stage early after TAVR have important prognostic implications during long-term follow-up. (SwissTAVI Registry; NCT01368250).
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Estenose da Valva Aórtica , Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/mortalidade , Masculino , Feminino , Estudos Retrospectivos , Fatores de Tempo , Idoso de 80 Anos ou mais , Idoso , Fatores de Risco , Resultado do Tratamento , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Medição de RiscoRESUMO
BACKGROUND: Coronary obstruction (CO) is a potentially life-threatening complication of transcatheter aortic valve replacement (TAVR). Chimney stenting or leaflet laceration with transcatheter electrosurgery (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) are 2 techniques developed to prevent CO. OBJECTIVES: The aim of the present study was to compare periprocedural and 1-year outcomes of chimney and BASILICA in TAVR patients at high risk of CO. METHODS: This multicenter observational registry enrolled consecutive TAVR patients at high risk of CO, undergoing either preventive chimney stenting or BASILICA. Clinical success was defined as successful performance of the chimney or BASILICA technique without clinically relevant ostial CO. The primary endpoint was major adverse cardiovascular events, a composite of death, myocardial infarction, stroke, or unplanned target lesion coronary revascularization at 1 year. RESULTS: A total of 168 patients were included: 71 (42.3%) received chimney stenting, and 97 (57.7%) underwent BASILICA. Patients undergoing BASILICA had higher preprocedural risk of CO, as indicated by lower sinotubular junction height (18.2 ± 4.8 mm vs 14.8 ± 3.4 mm; P < 0.001) and diameter (28.2 ± 4.5 vs 26.8 ± 3.4; P = 0.029). Rates of periprocedural complications were similar between the 2 groups. Clinical success was 97.2% and 96.9% in chimney and BASILICA, respectively (P = 0.92). At 1-year follow-up, the cumulative incidence of major adverse cardiovascular events was 18.7% (95% CI: 11%-30.6%) in the chimney group and 19.9% (95% CI: 12.1%-31.5%) in the BASILICA group (log-rank P = 0.848), whereas chimney was associated with a numerically higher cardiovascular mortality than BASILICA (6.7% vs 1.3%; log-rank P = 0.168). CONCLUSIONS: Chimney stenting and BASILICA effectively prevent TAVR-induced acute CO. Both techniques seem to have comparable acceptable periprocedural and 1-year outcomes.
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Estenose da Valva Aórtica , Oclusão Coronária , Próteses Valvulares Cardíacas , Lacerações , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Lacerações/complicações , Lacerações/cirurgia , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Oclusão Coronária/etiologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Desenho de PróteseRESUMO
PURPOSE: Our study aimed to determine whether 4D cardiac computed tomography (4DCCT) based quantitative myocardial analysis may improve risk stratification and can predict reverse remodeling (RRM) and mortality after transcatheter aortic valve implantation (TAVI). METHODS: Consecutive patients undergoing clinically indicated 4DCCT prior to TAVI were prospectively enrolled. 4DCCT-derived left- (LV) and right ventricular (RV), and left atrial (LA) dimensions, mass, ejection fraction (EF) and myocardial strain were evaluated to predict RRM and survival. RRM was defined by either relative increase in LVEF by 5% or relative decline in LV end diastolic diameter (LVEDD) by 5% assessed by transthoracic echocardiography prior TAVI, at discharge, and at 12-month follow-up compared to baseline prior to TAVI. RESULTS: Among 608 patients included in this study (55 % males, age 81 ± 6.6 years), RRM was observed in 279 (54 %) of 519 patients at discharge and in 218 (48 %) of 453 patients at 12-month echocardiography. While no CCT based measurements predicted RRM at discharge, CCT based LV mass index and LVEF independently predicted RRM at 12-month (ORadj = 1.012; 95 %CI:1.001-1.024; p = 0.046 and ORadj = 0.969; 95 %CI:0.943-0.996; p = 0.024, respectively). The most pronounced changes in LVEF and LVEDD were observed in patients with impaired LV function at baseline. In multivariable analysis age (HRadj = 1.037; 95 %CI:1.005-1.070; p = 0.022) and CCT-based LVEF (HRadj = 0.972; 95 %CI:0.945-0.999; p = 0.048) and LAEF (HRadj = 0.982; 95 %CI:0.968-0.996; p = 0.011) independently predicted survival. CONCLUSION: Comprehensive myocardial functional information derived from routine 4DCCT in patients with severe aortic stenosis undergoing TAVI could predict reverse remodeling and clinical outcomes at 12-month following TAVI.
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Tomografia Computadorizada Quadridimensional , Substituição da Valva Aórtica Transcateter , Remodelação Ventricular , Humanos , Masculino , Feminino , Idoso de 80 Anos ou mais , Tomografia Computadorizada Quadridimensional/métodos , Resultado do Tratamento , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estudos Prospectivos , Idoso , Ecocardiografia/métodosRESUMO
BACKGROUND: Evidence to support immediate P2Y12 inhibitor loading in ST-segment elevation myocardial infarction (STEMI) is limited. OBJECTIVES: This study sought to compare outcomes of STEMI patients receiving immediate or delayed P2Y12 inhibitor treatment. METHODS: Using data from the prospective Bern-PCI registry between 2016 and 2020, we stratified STEMI patients undergoing percutaneous coronary intervention according to time periods with different institutional recommendations regarding P2Y12 inhibitor pretreatment. In cohort 1 (October 2016-September 2018), immediate P2Y12 inhibitor treatment was recommended. In cohort 2 (October 2018-September 2020), P2Y12 inhibitor treatment was recommended after coronary anatomy was confirmed. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events (MACCEs) defined as all-cause death, recurrent myocardial infarction, stroke, or definite stent thrombosis at 30 days. Sensitivity analysis included only patients in whom these recommendations were followed. RESULTS: Cohort 1 included 1,116 patients; pretreatment was actually given in 708 (63.4%). Cohort 2 included 847 patients; pretreatment was withheld in 798 (94.2%). The mean age was 65 ± 13 years, and 24% were female. Baseline characteristics were well-balanced between groups. The median difference for P2Y12 loading to angiography was 52 minutes between cohort 1 and 2 and 100 minutes between patients receiving vs not receiving pretreatment. Rates of MACCEs were similar between cohort 1 and cohort 2 (10.1% vs 8.1%; adjusted HR: 0.91; 95% CI: 0.65-1.28; P = 0.59) and between patients receiving vs not receiving pretreatment (7.1% vs 8.4%; adjusted HR: 1.17; 95% CI: 0.78-1.74; P = 0.45). CONCLUSIONS: In this cohort study of patients with STEMI undergoing primary percutaneous coronary intervention, P2Y12 inhibitor pretreatment was not associated with improved MACCEs.
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Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Masculino , Estudos de Coortes , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Resultado do Tratamento , Sistema de RegistrosRESUMO
BACKGROUND: The optimal time point of staged percutaneous coronary intervention (PCI) among patients with acute coronary syndrome (ACS) remains a matter of debate. Quantitative flow ratio (QFR) is a novel noninvasive method to assess the hemodynamic significance of coronary stenoses. We aimed to investigate whether QFR could refine the timing of staged PCI of non-target vessels (non-TVs) on top of clinical judgment for patients with ACS. METHODS AND RESULTS: For this cohort study, patients with ACS from Bern University Hospital, Switzerland, scheduled to undergo out-of-hospital non-TV staged PCI were eligible. The primary end point was the composite of non-TV myocardial infarction and urgent unplanned non-TV PCI before planned staged PCI. The association between lowest QFR per patient measured in the non-TV (from index angiogram) and the primary end point was assessed using multivariable adjusted Cox proportional hazards regressions with QFR included as linear or penalized spline (nonlinear) term. QFR was measured in 1093 of 1432 patients with ACS scheduled to undergo non-TV staged PCI. Median time to staged PCI was 28 days. The primary end point occurred in 5% of the patients. In multivariable analysis (1018 patients), there was no independent association between non-TV QFR and the primary end point (hazard ratio, 0.87 [95% CI, 0.69-1.05] per 0.1 increase; P=0.125; nonlinear P=0.648). CONCLUSIONS: In selected patients with ACS scheduled to undergo staged PCI at a median of 4 weeks after index PCI, QFR did not emerge as an independent predictor of non-TV events before planned staged PCI. Thus, this study does not provide conceptual evidence that QFR is helpful to refine the timing of staged PCI on top of clinical judgment. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02241291.
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Síndrome Coronariana Aguda , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Humanos , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/cirurgia , Estudos de Coortes , Angiografia Coronária , Intervenção Coronária Percutânea/métodos , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
Background Transthyretin amyloid cardiomyopathy (ATTR-CM) often coexists with severe aortic stenosis (AS). Although strain analysis from cardiac MRI and echocardiography was demonstrated to predict coexisting ATTR-CM, comparable data from four-dimensional (4D) cardiac CT are lacking despite wide availability. Purpose To evaluate the diagnostic performance of 4D cardiac CT-derived parameters in identifying ATTR-CM in older adults considered for transcatheter aortic valve implantation (TAVI). Materials and Methods This prospective single-center screening study for ATTR-CM included consecutive patients with severe AS considered for TAVI who underwent 4D cardiac CT between August 2019 and August 2021 approximately 1 day before technetium 99m (99mTc) 3,3-diphosphono-1,2-propanodicarboxylic-acid (DPD) scintigraphy. The diagnostic performance of CT-based left ventricular (LV), right ventricular, and left atrial dimensions, ejection fraction (EF), and myocardial strain were evaluated against 99mTc-DPD scintigraphy as the reference standard to identify ATTR-CM. Predictors and an unweighted cardiac CT score were validated with internal bootstrapping. The assignment of variables to the score was based on cutoff values achieving the highest Youden index J. Results Among 263 participants (mean age, 83 years ± 4.6 [SD]; 149 male and 114 female participants), 99mTc-DPD scintigraphy (Perugini grade 2 or 3) confirmed coexisting ATTR-CM in 27 (10.3%). CT-derived LV mass index, LV and LA global longitudinal strain (GLS), and relative apical longitudinal strain each predicted the presence of ATTR-CM with an area under the curve (AUC) of at least 0.70. Implementing these parameters with cutoff values of 81 g/m2 or higher, -14.9% or higher, less than 11.5%, and 1.7 or higher in the CT score, respectively, yielded high diagnostic performance (AUC = 0.89; 95% CI: 0.81, 0.94; P < .001) robust to internal bootstrapping validation (AUC = 0.88; 95% CI: 0.82, 0.94). If two criteria were fulfilled, the sensitivity and specificity in the detection of ATTR-CM were 96.3% (95% CI: 81.0, 99.9) and 58.9% (95% CI: 52.3, 65.2), respectively. Conclusion When compared against 99mTc-DPD scintigraphy as the reference standard, routine 4D cardiac CT in older adults considered for TAVI provided high diagnostic performance in the detection of concomitant ATTR-CM by assessing LV and left atrial GLS, relative apical longitudinal strain, and LV mass index. ClinicalTrials.gov registration no.: NCT04061213 © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Tavakoli and Onder in this issue.
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Neuropatias Amiloides Familiares , Amiloidose , Estenose da Valva Aórtica , Cardiomiopatias , Humanos , Masculino , Feminino , Idoso , Idoso de 80 Anos ou mais , Pré-Albumina , Estudos Prospectivos , Amiloidose/complicações , Tomografia Computadorizada por Raios X , Cardiomiopatias/complicações , Cardiomiopatias/diagnóstico por imagem , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Neuropatias Amiloides Familiares/complicações , Neuropatias Amiloides Familiares/diagnóstico por imagemRESUMO
BACKGROUND: The prognostic value of cardiac damage staging classifications across the haemodynamic spectrum of severe aortic stenosis (AS) remains unknown. AIMS: We aimed to investigate the prognostic impact of cardiac damage staging classifications in patients with high-gradient AS (HG-AS) and low-gradient AS (LG-AS) undergoing transcatheter aortic valve implantation (TAVI). METHODS: In a prospective TAVI registry, five-year mortality was evaluated for early stages of cardiac damage (stage 0, 1, or 2) and advanced stages of cardiac damage (stage 3 or 4) in patients with HG-AS, classical low-flow (LF) LG-AS, LF LG-AS with preserved ejection fraction (pEF), and normal-flow (NF) LG-AS. RESULTS: Among 2,090 patients undergoing TAVI, 1,045 patients had HG-AS, 337 patients had classical LF LG-AS, 394 patients had LF LG-AS with pEF, and 314 patients had NF LG-AS. The majority of patients with classical LF LG-AS exhibited advanced cardiac damage (73.6%), followed by LF LG-AS with pEF (55.6%), NF LG-AS (51.6%), and HG-AS (50.6%). Patients with advanced stage cardiac damage had significantly higher mortality after TAVI than those with early stage cardiac damage in all subtypes of AS (adjusted hazard ratio [HRadjusted] 1.66, 95% confidence interval [CI]: 1.34-2.06 for HG-AS; HRadjusted 1.49, 95% CI: 1.02-2.16 for classical LF LG-AS; HRadjusted 1.69, 95% CI: 1.22-2.35 for LF LG-AS with pEF; and HRadjusted 1.52, 95% CI: 1.04-2.32 for NF LG-AS). CONCLUSIONS: Cardiac damage staging classifications stratified mortality after TAVI irrespective of AS subtype.
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Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Prognóstico , Estudos Prospectivos , Volume Sistólico , Resultado do Tratamento , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Índice de Gravidade de Doença , Função Ventricular EsquerdaRESUMO
Healthcare systems adopted various strategies to minimize the impact of the COVID-19 pandemic on clinical outcomes of patients with symptomatic severe aortic stenosis referred for transcatheter aortic valve implantation (TAVI). We aimed to compare baseline characteristics and procedural and clinical outcomes of patients who underwent TAVI during COVID-19 surge periods with those of patients who underwent TAVI during the nonsurge and prepandemic periods. In the prospective Bern TAVI registry, the pandemic period was divided into surge and nonsurge periods on the basis of the mean number of occupied beds in the intensive care unit in each month and matched with 11 months immediately preceding the pandemic. A total of 1,069 patients underwent TAVI between April 1, 2019 and December 31, 2021. Patients who underwent TAVI during surge periods had a higher surgical risk (Society of Thoracic Surgeons predicted risk of mortality) than that of patients who underwent TAVI during nonsurge and prepandemic periods. Diagnosis-to-procedure time (in days) was longer for patients who underwent TAVI during the surge period than during the nonsurge and prepandemic periods (95.20 ± 121.07 vs 70.99 ± 72.25 and 60.46 ± 75.43, both p <0.001). At 30 days, all-cause mortality was higher in the surge than in the nonsurge group (4.9 vs 1.1%, hazard ratio 4.68, 95% confidence interval 1.55 to 14.10, p = 0.006), and in the surge than in the prepandemic group (4.9 vs 1.3%, hazard ratio 3.67, 95% confidence interval 1.34 to 10.11, p = 0.012). In conclusion, TAVI during COVID-19 surge periods was associated with higher Society of Thoracic Surgeons predicted risk of mortality score, delayed procedure scheduling, and increased 30-day mortality than that of TAVI during nonsurge and prepandemic periods.
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Estenose da Valva Aórtica , COVID-19 , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/etiologia , Resultado do Tratamento , Estudos Prospectivos , Pandemias , Fatores de Risco , COVID-19/epidemiologia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodosRESUMO
BACKGROUND: Both measured and predicted effective orifice area (EOA) indexed to the body surface area (EOAi) have been suggested to define prosthesis-patient mismatch (PPM) in patients undergoing transcatheter aortic valve replacement (TAVR). The impact of PPM on clinical outcomes may accumulate with extended follow-up and vary according to the definition used. AIMS: We aimed to investigate the long-term clinical impact of PPM in patients undergoing TAVR. METHODS: Patients in a prospective TAVR registry were stratified by the presence of moderate (0.65-0.85 or 0.55-0.70 cm2/m2 if obese) or severe (≤0.65 or ≤0.55 cm2/m2 if obese) PPM according to echocardiographically measured EOAi (measured PPM), predicted EOAi based on published EOA reference values for each valve model and size (predicted PPMTHV), or predicted EOAi based on EOA reference values derived from computed tomography measurements of aortic annulus dimensions (predicted PPMCT). RESULTS: In an analysis of 2,463 patients, the frequency of measured PPM (moderate: 27.0%; severe: 8.7%) was higher than the frequency of predicted PPMTHV (moderate: 11.3%; severe: 1.2%) or predicted PPMCT (moderate: 12.0%; severe: 0.1%). During a median follow-up of 429 days, 10-year mortality was comparable in patients with versus without measured PPM or predicted PPMCT. In contrast, patients with moderate predicted PPMTHV had a lower risk of 10-year all-cause mortality compared with those without PPM (adjusted hazard ratio: 0.73, 95% confidence interval: 0.55-0.96). CONCLUSIONS: The use of predicted versus measured EOAi results in a lower estimate of PPM severity. We observed no increased risk of death in patients with PPM over a median follow-up time of 429 days. CLINICALTRIALS: gov: NCT01368250.
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Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas/efeitos adversos , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estudos Prospectivos , Desenho de Prótese , Resultado do Tratamento , Obesidade , Fatores de RiscoRESUMO
Background The prevalence of calcific aortic stenosis and amyloid transthyretin cardiomyopathy (ATTR-CM) increase with age, and they often coexist. The objective was to determine the prevalence of ATTR-CM in patients with severe aortic stenosis and evaluate differences in presentations and outcomes of patients with concomitant ATTR-CM undergoing transcatheter aortic valve implantation. Methods and Results Prospective screening for ATTR-CM with Technetium99-3,3-diphosphono-1,2-propanodicarboxylic acid bone scintigraphy was performed in 315 patients referred with severe aortic stenosis between August 2019 and August 2021. Myocardial Technetium99-3,3-diphosphono-1,2-propanodicarboxylic acid tracer uptake was detected in 34 patients (10.8%), leading to a diagnosis of ATTR-CM in 30 patients (Perugini ≥2: 9.5%). Age (85.7±4.9 versus 82.8±4.5; P=0.001), male sex (82.4% versus 57.7%; P=0.005), and prior carpal tunnel surgery (17.6% versus 4.3%; P=0.007) were associated with coexisting ATTR-CM, as were ECG (discordant QRS voltage to left ventricular wall thickness [42% versus 12%; P<0.001]), echocardiographic (left ventricular ejection fraction 48.8±12.8 versus 58.4±10.8; P<0.001; left ventricular mass index, 144.4±45.8 versus 117.2±34.4g/m2; P<0.001), and hemodynamic parameters (mean aortic valve gradient, 23.4±12.6 versus 35.5±16.6; P<0.001; mean pulmonary artery pressure, 29.5±9.7 versus 25.8±9.5; P=0.037). Periprocedural (cardiovascular death: hazard ratio [HR], 0.71 [95% CI, 0.04-12.53]; stroke: HR, 0.46 [95% CI, 0.03-7.77]; pacemaker implantation: HR, 1.54 [95% CI, 0.69-3.43]) and 1-year clinical outcomes (cardiovascular death: HR, 1.04 [95% CI, 0.37-2.96]; stroke: HR, 0.34 [95% CI, 0.02-5.63]; pacemaker implantation: HR, 1.50 [95% CI, 0.67-3.34]) were similar between groups. Conclusions Coexisting ATTR-CM was observed in every 10th elderly patient with severe aortic stenosis referred for therapy. While patients with coexisting pathologies differ in clinical presentation and echocardiographic and hemodynamic parameters, peri-interventional risk and early clinical outcomes were comparable up to 1 year after transcatheter aortic valve implantation. REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT04061213.
Assuntos
Amiloidose , Estenose da Valva Aórtica , Cardiomiopatias , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Idoso , Humanos , Masculino , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Cardiomiopatias/diagnóstico por imagem , Cardiomiopatias/epidemiologia , Cardiomiopatias/complicações , Pré-Albumina , Estudos Prospectivos , Acidente Vascular Cerebral/complicações , Volume Sistólico , Tecnécio , Tomografia Computadorizada por Raios X , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
AIMS: There is limited evidence on the prognostic significance of atrial fibrillation (AF) in patients with low flow, low gradient aortic stenosis with preserved ejection fraction (LFLG-pEF AS). We aimed to evaluate the recovery of stroke volume after transcatheter aortic valve implantation (TAVI) and clinical outcomes in patients with LFLG-pEF AS stratified by presence or absence of AF. METHODS AND RESULTS: In a prospective TAVI registry, patients with preserved left ventricular ejection fraction (LVEF ≥ 50%) were stratified according to flow-gradient status and presence of AF. Among 2 259 TAVI patients with preserved LVEF between August 2007 and June 2021, 765 had high-gradient AS (HG AS) and 444 had LFLG-pEF AS. AF was observed in 199 patients with HG AS (26.0%) and 190 patients with LFLG-pEF AS (42.8%). At 1 year, SVi was significantly improved in LFLG-pEF AS patients without AF, while SVi remained low in patients with AF (from 25.9 ± 8.5 mL/m2 to 37.2 ± 9.9 mL/m2 and from 26.8 ± 5.1 mL/m2 to 26.1 ± 9.1 mL/m2, respectively). LFLG-pEF AS patients with AF had an increased risk of 1-year all-cause mortality compared with those without AF (HRadjusted 2.57; 95% CI 1.44-4.59). LFLG-pEF AS patients without AF had similar mortality compared with HG AS patients without AF (HRadjusted 0.85; 95% CI 0.49-1.46). CONCLUSIONS: Patients with LFLG-pEF AS and AF experienced no relevant recovery of stroke volume after TAVI, but a more than two-fold increased risk of death compared to patients with HG AS or LFLG-pEF AS without AF. Clinical Trial Registration: https://www.clinicaltrials.gov. NCT01368250.
RESUMO
BACKGROUND: In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation. METHODS: Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort. RESULTS: Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 (25%) in the S3 group at 3 years. Comparing NEO with S3, the 3-year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73-1.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56-1.92]), and hospitalization for congestive heart failure (subhazard ratio, 0.74 [95% CI, 0.51-1.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [95% CI, 0.30-5.85]). New York Heart Association functional class ≤II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg; P<0.001). CONCLUSIONS: Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years. REGISTRATION: URL: https://clinicaltrials.gov, Unique identifier: NCT03011346.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Desenho de Prótese , Resultado do Tratamento , Substituição da Valva Aórtica Transcateter/efeitos adversosAssuntos
Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Sistema de Registros , Implante de Prótese de Valva Cardíaca/efeitos adversosRESUMO
AIMS: The interplay between pulmonary hypertension (PH) and right ventricular (RV) function is reflected in an index of RV function to pulmonary artery (PA) systolic pressure (PASP). The present study aimed to assess the importance of RV-PA coupling on clinical outcomes after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: In a prospective TAVI registry, clinical outcomes of TAVI patients with RV dysfunction or PH were stratified according to coupling or uncoupling of tricuspid annular plane systolic excursion (TAPSE) to PASP, and compared to those of patients with normal RV function and absence of PH. The median TAPSE/PASP ratio was used to differentiate uncoupling (>0.39) from coupling (<0.39). Among 404 TAVI patients, 201 patients (49.8 %) had RVD or PH at baseline: 174 patients had RV-PA uncoupling, and 27 had coupling at baseline. RV-PA hemodynamics normalized in 55.6 % of patients with RV-PA coupling and in 28.2 % of patients with RV-PA uncoupling, and deteriorated in 33.3 % of patients with RV-PA coupling and in 17.8 % of patients with no RVD, respectively, at discharge. Patients with RV-PA uncoupling after TAVI showed a trend towards an increased risk of cardiovascular death at 1 year as compared to patients with normal RV-function (HRadjusted 2.06, 95 % CI 0.97-4.37). CONCLUSION: After TAVI, RV-PA coupling changed in a significant proportion of patients and is a potentially important metric for risk stratification of TAVI patients with RVD or PH. TWEET: "Patients with right ventricular dysfunction and pulmonary hypertension are at increased risk of death after TAVI. Integrated right ventricular to pulmonary artery hemodynamics change after TAVI in a significant proportion of patients and is instrumental to refine risk stratification." CLINICAL TRIAL REGISTRATION: https://www. CLINICALTRIALS: gov: NCT01368250.