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1.
Eur Heart J ; 2023 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-36660821

RESUMO

AIMS: Additional randomized clinical trial (RCT) data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) is available, including longer term follow-up. A meta-analysis comparing TAVI to SAVR was performed. A pragmatic risk classification was applied, partitioning lower-risk and higher-risk patients. METHODS AND RESULTS: The main endpoints were death, strokes, and the composite of death or disabling stroke, occurring at 1 year (early) or after 1 year (later). A random-effects meta-analysis was performed. Eight RCTs with 8698 patients were included. In lower-risk patients, at 1 year, the risk of death was lower after TAVI compared with SAVR [relative risk (RR) 0.67; 95% confidence interval (CI) 0.47 to 0.96, P = 0.031], as was death or disabling stroke (RR 0.68; 95% CI 0.50 to 0.92, P = 0.014). There were no differences in strokes. After 1 year, in lower-risk patients, there were no significant differences in all main outcomes. In higher-risk patients, there were no significant differences in main outcomes. New-onset atrial fibrillation, major bleeding, and acute kidney injury occurred less after TAVI; new pacemakers, vascular complications, and paravalvular leak occurred more after TAVI. CONCLUSION: In lower-risk patients, there was an early mortality reduction with TAVI, but no differences after later follow-up. There was also an early reduction in the composite of death or disabling stroke, with no difference at later follow-up. There were no significant differences for higher-risk patients. Informed therapy decisions may be more dependent on the temporality of events or secondary endpoints than the long-term occurrence of main clinical outcomes.

2.
JACC Cardiovasc Interv ; 16(1): 94-102, 2023 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-36599593

RESUMO

BACKGROUND: Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal. OBJECTIVES: The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow. METHODS: The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography-based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction. RESULTS: Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%. CONCLUSIONS: Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR.


Assuntos
Estenose da Valva Aórtica , Bioprótese , Oclusão Coronária , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Masculino , Humanos , Suínos , Animais , Idoso de 80 Anos ou mais , Próteses Valvulares Cardíacas/efeitos adversos , Fatores de Risco , Falha de Prótese , Resultado do Tratamento , Bioprótese/efeitos adversos , Desenho de Prótese , Oclusão Coronária/diagnóstico por imagem , Oclusão Coronária/etiologia , Oclusão Coronária/prevenção & controle , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações
4.
Circ Cardiovasc Interv ; 15(12): e012195, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36538580

RESUMO

BACKGROUND: Rehospitalization is a common end point in clinical trials of structural heart interventions, but whether rehospitalization is clinically and prognostically relevant in these patients is uncertain. The aim of this study was to evaluate the risk of rehospitalization events after aortic valve replacement (AVR) and their association with mortality and health status. METHODS: The study population included patients who underwent transcatheter or surgical AVR in the PARTNER I' II' and III trials (Placement of Aortic Transcatheter Valves). Health status was assessed with the Kansas City Cardiomyopathy Questionnaire-overall summary score. The primary analysis focused on heart failure hospitalization within 1 year after AVR and its association with mortality, poor outcome (death, Kansas City Cardiomyopathy Questionnaire-overall summary score <60 or decrease by ≥10), and health status at 1 year using adjusted models. Secondary analyses examined the prognostic associations of rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes. RESULTS: Among 3403 patients treated with AVR (2008 transcatheter AVR, 1395 surgical AVR), the 1-year incidence was 6.7% for heart failure hospitalization and 9.7% for rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes. Heart failure hospitalization after AVR was associated with increased risk of 1-year mortality (hazard ratio, 3.97 [2.48 to 6.36]; P<0.001), poor outcome (OR, 2.76 [1.73 to 4.40]; P<0.001), and worse health status (Kansas City Cardiomyopathy Questionnaire-overall summary mean difference -9.8 points [-13.8 to -5.8]; P<0.001). Rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes was similarly associated with increased 1-year mortality (hazard ratio, 4.64 [3.11 to 6.92]; P<0.001), poor outcome (OR, 2.06 [1.38 to 3.07]; P=0.0004), and worse health status (Kansas City Cardiomyopathy Questionnaire-overall summary mean difference -8.8 points [-11.8 to -5.7]; P<0.001). There was no effect modification by treatment type (transcatheter AVR versus surgical AVR) for these associations. CONCLUSIONS: Heart failure hospitalization and rehospitalization after AVR are associated with increased risk of mortality and worse 1-year health status. These findings confirm the clinical and prognostic relevance of rehospitalization end points for trials of AVR. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT00530894.


Assuntos
Estenose da Valva Aórtica , Cardiomiopatias , Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , 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 , Estenose da Valva Aórtica/complicações , Cardiomiopatias/complicações , Cardiomiopatias/cirurgia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/epidemiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Readmissão do Paciente , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
5.
J Am Heart Assoc ; 11(24): e025275, 2022 12 20.
Artigo em Inglês | MEDLINE | ID: mdl-36515253

RESUMO

Background Use of the modified American College of Cardiology (ACC)/American Heart Association (AHA) lesion classification as a prognostic tool to predict short- and long-term clinical outcomes after percutaneous coronary intervention in the modern drug-eluting stent era is uncertain. Methods and Results Patient-level data from 7 prospective, randomized trials were pooled. Clinical outcomes of patients undergoing single lesion percutaneous coronary intervention with second-generation drug-eluting stent were analyzed according to modified ACC/AHA lesion class. The primary end point was target lesion failure (TLF: composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization). Clinical outcomes to 5 years were compared between patients treated for noncomplex (class A/B1) versus complex (class B2/C) lesions. Eight thousand five hundred sixteen patients (age 63.1±10.8 years, 70.5% male) were analyzed. Lesions were classified as A, B1, B2, and C in 7.9%, 28.5%, 33.7%, and 30.0% of cases, respectively. Target lesion failure was higher in patients undergoing percutaneous coronary intervention of complex versus noncomplex lesions at 30 days (2.0% versus 1.1%, P=0.004), at 1 year (4.6% versus 3.0%, P=0.0005), and at 5 years (12.4% versus 9.2%, P=0.0001). By multivariable analysis, treatment of ACC/AHA class B2/C lesions was significantly associated with higher rate of 5-year target lesion failure (adjusted hazard ratio, 1.39 [95% CI, 1.17-1.64], P=0.0001) driven by significantly higher rates of target vessel myocardial infarction and ischemia-driven target lesion revascularization. Conclusions In this pooled large-scale analysis, treating complex compared with noncomplex lesions according to the modified ACC/AHA classification with second-generation drug-eluting stent was associated with worse 5-year clinical outcomes. This historical classification system may be useful in the contemporary era for predicting early and late outcomes following percutaneous coronary intervention.


Assuntos
Cardiologia , Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Resultado do Tratamento , Estudos Prospectivos , Fatores de Risco , Ensaios Clínicos Controlados Aleatórios como Assunto , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Doença da Artéria Coronariana/cirurgia , Doença da Artéria Coronariana/etiologia
6.
JACC Cardiovasc Interv ; 15(21): 2206-2217, 2022 11 14.
Artigo em Inglês | MEDLINE | ID: mdl-36357025

RESUMO

BACKGROUND: Although the presence of severe stenosis in the left main coronary artery (LMCA) is a well-established predictor of mortality, whether this extends to nonobstructive atherosclerosis in the LMCA is unknown. OBJECTIVES: The aim of this study was to evaluate the association between LMCA disease by intravascular ultrasound (IVUS) and long-term mortality. METHODS: Between 2005 and 2013, 3,239 patients with LMCA IVUS imaging without LMCA revascularization (either before angiography or scheduled based on index angiography or IVUS) were included. The primary and secondary endpoints were all-cause and cardiac mortality at a minimum of 5 years obtained from the National Death Index. RESULTS: The IVUS-measured LMCA minimum lumen area (MLA) and plaque burden were 13.1 ± 5.0 mm2 and 41.7% ± 15.6%, respectively. The median follow-up was 8.2 years. The Kaplan-Meier estimated 12-year all-cause and cardiac death rates were 37.5% and 17.0%, respectively. Greater plaque burden (unadjusted HR per 10%: 1.17; 95% CI: 1.12-1.22; P < 0.0001) and smaller IVUS MLA (unadjusted HR per 1 mm2: 0.98; 95% CI: 0.96-0.99; P = 0.0008) were associated with all-cause death. After adjusting for clinical, angiographic, and IVUS factors, plaque burden (adjusted HR per 10%: 1.12; 95% CI: 1.04-1.21; P = 0.003) but not MLA (adjusted HR per 1 mm2: 1.02; 95% CI: 0.99-1.04; P = 0.18) was associated with long-term all-cause death. These findings were also consistent for long-term cardiac mortality. CONCLUSIONS: In the present large-scale study with a 12-year follow-up, increasing LMCA plaque burden was associated with long-term all-cause and cardiac mortality in patients not undergoing LMCA revascularization, even when the lumen area was preserved.


Assuntos
Aterosclerose , Doença da Artéria Coronariana , Placa Aterosclerótica , Humanos , Vasos Coronários/diagnóstico por imagem , Angiografia Coronária/métodos , Ultrassonografia de Intervenção/métodos , Resultado do Tratamento , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia
7.
Eur Heart J ; 2022 Nov 29.
Artigo em Inglês | MEDLINE | ID: mdl-36445158

RESUMO

BACKGROUND AND AIMS: The impact of sex in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI versus medical therapy alone. METHODS: The TriValve (Transcatheter Tricuspid Valve Therapies) registry collected patients with significant TR from 24 centers who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥ severe isolated TR diagnosed in 2015-2018. Primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). RESULTS: A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality (80.9% vs. 77.9%, p = 0.56, nor in HF hospitalization (p = 0.36), NYHA functional class III-IV (p = 0.17), and TR severity >2 + at last follow-up (p = 0.42). Multivariable Cox-regression weighted by IPTW showed an improved 1-year survival after TTVI compared to medical therapy alone in both women (adjusted hazard ratio [HR] 0.45, 95% confidence interval [CI] 0.23-0.83, p = 0.01) and men (adjusted HR 0.42, 95% CI 0.18-0.89, p = 0.03). CONCLUSIONS: After TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men.

9.
J Am Coll Cardiol ; 80(22): 2089-2101, 2022 11 29.
Artigo em Inglês | MEDLINE | ID: mdl-36424680

RESUMO

BACKGROUND: In the multicenter, randomized, sham-controlled FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial, quantitative flow ratio (QFR)-based lesion selection improved 1-year clinical outcomes compared with conventional angiographic guidance for percutaneous coronary intervention (PCI). OBJECTIVES: The purpose of this study was to determine whether the benefits of QFR guidance persist at 2 years, particularly for patients in whom QFR changed the revascularization strategy. METHODS: Eligible patients were randomized to a QFR-guided strategy (PCI performed only if QFR ≤0.80) or a standard angiography-guided strategy. Major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization occurring within 2 years were analyzed in the intention-to-treat population. RESULTS: Among 3,825 randomized participants, 2-year MACE occurred in 161 of 1,913 (8.5%) patients in the QFR-guided group and in 237 of 1,912 (12.5%) patients in the angiography-guided group (HR: 0.66; 95% CI: 0.54-0.81; P < 0.0001), driven by fewer MIs (4.0% vs 6.8%; HR: 0.58; 95% CI: 0.44-0.77; P = 0.0002) and ischemia-driven revascularizations (4.2% vs 5.8%; HR: 0.71; 95% CI: 0.53-0.95; P = 0.02) in the QFR-guided group. Landmark analysis showed consistent results within the first year and between 1-2 years (Pint = 0.99). Although the 2-year MACE rate was lower in the QFR-guided group in both patients with and without revascularization strategy changes, the extent of outcome improvement was greater (Pint = 0.009) among those patients in whom the preplanned PCI strategy was modified by QFR. CONCLUSIONS: QFR-guided lesion selection improved 2-year clinical outcomes compared with standard angiography guidance. The benefits were most pronounced among patients in whom QFR assessment altered the planned revascularization strategy. (FAVOR III China Study [The Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease] NCT03656848).


Assuntos
Doença da Artéria Coronariana , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Coração , Angiografia
10.
J Invasive Cardiol ; 34(10): E696-E700, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-36200995

RESUMO

OBJECTIVES: Orbital atherectomy (OA) has been shown to be safe and effective in patients with severe calcific coronary artery disease; however, there is a paucity of data on OA use in patients with concomitant severe aortic stenosis (AS). METHODS: A retrospective analysis of consecutive patients undergoing coronary OA treatment of severely calcified lesions, from January 2014 to September 2020 at the Mount Sinai Medical Center, Miami Beach, Florida (MSMCMB), was completed. Data were analyzed to assess rates of angiographic complications, successful stent placement, and in-hospital major adverse cardiovascular event (MACE; defined as the composite of cardiac death, myocardial infarction, ischemic cerebrovascular accident [CVA], and hemorrhagic CVA) in AS vs non-AS patients. RESULTS: A total of 609 patients underwent OA; of those, 32 (5.3%) had severe AS. The AS patient cohort was significantly older (80.3 years vs 73.7 years; P<.001), with a significantly higher percentage of Hispanic or Latino individuals (75% vs 56.5%; P=.04) and lower estimated glomerular filtration rate (64.6 mL/min/1.73 m² vs 76.6 mL/min/1.73 m²; P =.03) than the non-AS cohort. Angiographic complication rates were similar and both groups resulted in 100% successful stent placement. There was no difference in MACE rates between the AS and non-AS cohorts (3.1% vs 1.4%; P=.39). CONCLUSIONS: This study represents the largest real-world comparison of OA use in AS vs non-AS patients. OA appears feasible, safe, and effective prior to stent placement in patients with severe AS. Prospective randomized trials are needed to determine the ideal revascularization strategy for AS patients.


Assuntos
Estenose da Valva Aórtica , Aterectomia Coronária , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Calcificação Vascular , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Aterectomia Coronária/efeitos adversos , Aterectomia Coronária/métodos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento , Calcificação Vascular/complicações , Calcificação Vascular/diagnóstico , Calcificação Vascular/cirurgia
11.
Am J Cardiol ; 185: 53-62, 2022 12 15.
Artigo em Inglês | MEDLINE | ID: mdl-36241571

RESUMO

The rate of aortic stenosis (AS) progression in patients with moderate AS is unclear. This study examined the risk factors of progression from moderate to severe AS and its impact on clinical outcomes. A total of 954 patients with moderate AS (valve area >1.0 and ≤1.5 cm²) and follow-up echocardiograms were included. AS progressed to severe (valve area <1.0 cm1) in 589 patients (61.7%) over a median follow-up of 2.46 (interquartile range [IQR] 1.29 to 3.91) years. Of those who progressed to severe AS, patients were subdivided into Slow (n = 294, over 3.91 [IQR 3.11 to 5.10] years) versus Fast (n = 295, over 1.29 [IQR 0.85 to 1.85] years) Progressors, according to the median time between the 2 echocardiograms. The correlates of fast AS progression and its impact on cumulative survival and freedom from valve intervention were evaluated. On multivariate analysis, age, thickened left ventricle posterior wall, severe renal impairment, and aortic valve area were significantly associated with fast AS progression. Over a median follow-up of 6.34 (IQR 4.05 to 9.55) years, 228 patients (38.7%) died. Despite similar aortic valve intervention rates, Fast Progressors had worse 5-year survival (61.2% vs 81.9%, log-rank p <0.001) and event-free (valve intervention and all-cause mortality) survival rates (16.2% vs 55.9%, log-rank p <0.001). On multivariable Cox analysis, shorter progression to severe AS (in years) was independently associated with increased risk of all-cause mortality (hazard ratio 1.26, 95% confidence interval 1.16 to 1.37, p <0.001), or combined aortic valve intervention and death (hazard ratio 1.46, 95% confidence interval 1.38 to 1.55, p <0.001). In conclusion, fast progression from moderate to severe AS is associated with worse outcomes.


Assuntos
Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Humanos , Estudos Retrospectivos , Índice de Gravidade de Doença , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Ecocardiografia , Fatores de Risco , Implante de Prótese de Valva Cardíaca/efeitos adversos
12.
JACC Cardiovasc Interv ; 15(18): 1823-1833, 2022 09 26.
Artigo em Inglês | MEDLINE | ID: mdl-36137685

RESUMO

BACKGROUND: Physiologic right ventricle-pulmonary artery (RV-PA) coupling may be impaired in patients with aortic stenosis (AS). OBJECTIVES: This study aimed to assess the incidence and prognostic significance of impaired RV-PA coupling in low-risk patients with symptomatic severe AS undergoing transcatheter aortic valve replacement or surgical aortic valve replacement. METHODS: RV-PA coupling was measured by transthoracic echocardiography as the ratio of tricuspid annular plane systolic excursion (TAPSE) to pulmonary artery systolic pressure (PASP) in patients in the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial. The primary endpoint was the composite of all-cause mortality, stroke, and rehospitalization at the 2-year follow-up. RESULTS: Among 570 low-risk patients included in the analysis, RV-PA uncoupling was defined by a TAPSE/PASP ratio ≤ 0.55 mm/mm Hg. At baseline, 222 of 570 (38.9%) patients had RV-PA uncoupling. At 2 years, patients with baseline RV-PA uncoupling had an increased incidence of the primary endpoint (19.1% vs 9.9%, P = 0.002), all-cause mortality (5.9% vs 0.6%, P < 0.001), cardiovascular mortality (4.1% vs 0.6%, P = 0.003), and rehospitalization (13.5% vs 7.3%, P = 0.018). On multivariable analysis, baseline RV-PA uncoupling remained an independent predictor of the primary endpoint at 2 years (HR: 1.92; 95% CI: 1.04-3.57; P = 0.038). CONCLUSIONS: In patients with symptomatic severe AS at low surgical risk undergoing transcatheter aortic valve replacement or surgical aortic valve replacement, baseline RV-PA uncoupling defined by TAPSE/PASP ≤ 0.55 mm Hg was associated with adverse clinical outcomes at 2 years, including all-cause mortality, cardiovascular mortality, and rehospitalization.


Assuntos
Estenose da Valva Aórtica , Disfunção Ventricular Direita , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Ciclofosfamida/análogos & derivados , Ventrículos do Coração , Humanos , Artéria Pulmonar/diagnóstico por imagem , Resultado do Tratamento , Função Ventricular Direita
13.
Artigo em Inglês | MEDLINE | ID: mdl-36153166

RESUMO

OBJECTIVE: Implantation of a transcatheter valve-in-mitral annular calcification (ViMAC) has emerged as an alternative to traditional surgical mitral valve (MV) replacement. Previous studies evaluating ViMAC aggregated transseptal, transapical, and transatrial forms of the procedure, leaving uncertainty about each technique's advantages and disadvantages. Thus, we sought to evaluate clinical outcomes specifically for transatrial ViMAC from the largest multicenter registry to-date. METHODS: Patients with symptomatic MV dysfunction and severe MAC who underwent ViMAC were enrolled from 12 centers across the United States and Europe. Clinical characteristics, procedural details, and clinical outcomes were abstracted from the electronic record. The primary end point was all-cause mortality. RESULTS: We analyzed 126 patients who underwent ViMAC (median age 76 years [interquartile range {IQR}, 70-82 years], 28.6% female, median Society of Thoracic Surgeons score 6.8% [IQR, 4.0-11.4], and median follow-up 89 days [IQR, 16-383.5]). Sixty-one (48.4%) had isolated mitral stenosis, 25 (19.8%) had isolated mitral regurgitation (MR), and 40 (31.7%) had mixed MV disease. Technical success was achieved in 119 (94.4%) patients. Thirty (23.8%) patients underwent concurrent septal myectomy, and 8 (6.3%) patients experienced left ventricular outflow tract obstruction (7/8 did not undergo myectomy). Five (4.2%) patients of 118 with postprocedure echocardiograms had greater than mild paravalvular leak. Thirty-day and 1-year all-cause mortality occurred in 16 and 33 patients, respectively. In multivariable models, moderate or greater MR at baseline was associated with increased risk of 1-year mortality (hazard ratio, 2.31; 95% confidence interval, 1.07-4.99, P = .03). CONCLUSIONS: Transatrial ViMAC is safe and feasible in this selected, male-predominant cohort. Patients with significant MR may derive less benefit from ViMAC than patients with mitral stenosis only.

15.
Lancet ; 400(10361): 1405-1416, 2022 10 22.
Artigo em Inglês | MEDLINE | ID: mdl-36130612

RESUMO

BACKGROUND: The SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial showed the safety but not efficacy of the Symplicity system (Medtronic, Santa Rosa, CA, USA) at 6 months follow-up in patients with treatment-resistant hypertension. This final report presents the 36-month follow-up results. METHODS: SYMPLICITY HTN-3 was a single-blind, multicentre, sham-controlled, randomised clinical trial, done in 88 centres in the USA. Adults aged 18-80 years, with treatment-resistant hypertension on stable, maximally tolerated doses of three or more drugs including a diuretic, who had a seated office systolic blood pressure of 160 mm Hg or more and 24 h ambulatory systolic blood pressure of 135 mm Hg or more were randomly assigned (2:1) to receive renal artery denervation using the single electrode (Flex) catheter or a sham control. The original primary endpoint was the change in office systolic blood pressure from baseline to 6 months for the renal artery denervation group compared with the sham control group. Patients were unmasked after the primary endpoint assessment at 6 months, at which point eligible patients in the sham control group who met the inclusion criteria (office blood pressure ≥160 mm Hg, 24 h ambulatory systolic blood pressure ≥135 mm Hg, and still prescribed three or more antihypertensive medications) could cross over to receive renal artery denervation. Changes in blood pressure up to 36 months were analysed in patients in the original renal artery denervation group and sham control group, including those who underwent renal artery denervation after 6 months (crossover group) and those who did not (non-crossover group). For comparisons between the renal artery denervation and sham control groups, follow-up blood pressure values were imputed for patients in the crossover group using their most recent pre-crossover masked blood pressure value. We report long-term blood pressure changes in renal artery denervation and sham control groups, and investigate blood pressure control in both groups using time in therapeutic blood pressure range analysis. The primary safety endpoint was the incidence of all-cause mortality, end stage renal disease, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, hospitalisation for hypertensive crisis unrelated to non-adherence to medications, or new renal artery stenosis of more than 70% within 6 months. The trial is registered with ClinicalTrials.gov, NCT01418261. FINDINGS: From Sep 29, 2011, to May 6, 2013, 1442 patients were screened, of whom 535 (37%; 210 [39%] women and 325 [61%] men; mean age 57·9 years [SD 10·7]) were randomly assigned: 364 (68%) patients received renal artery denervation (mean age 57·9 years [10·4]) and 171 (32%) received the sham control (mean age 56·2 years [11·2]). 36-month follow-up data were available for 219 patients (original renal artery denervation group), 63 patients (crossover group), and 33 patients (non-crossover group). At 36 months, the change in office systolic blood pressure was -26·4 mm Hg (SD 25·9) in the renal artery denervation group and -5·7 mm Hg (24·4) in the sham control group (adjusted treatment difference -22·1 mm Hg [95% CI -27·2 to -17·0]; p≤0·0001). The change in 24 h ambulatory systolic blood pressure at 36 months was -15·6 mm Hg (SD 20·8) in the renal artery denervation group and -0·3 mm Hg (15·1) in the sham control group (adjusted treatment difference -16·5 mm Hg [95% CI -20·5 to -12·5]; p≤0·0001). Without imputation, the renal artery denervation group spent a significantly longer time in therapeutic blood pressure range (ie, better blood pressure control) than patients in the sham control group (18% [SD 25·0] for the renal artery denervation group vs 9% [SD 18·8] for the sham control group; p≤0·0001) despite a similar medication burden, with consistent and significant results with imputation. Rates of adverse events were similar across treatment groups, with no evidence of late-emerging complications from renal artery denervation. The rate of the composite safety endpoint to 48 months, including all-cause death, new-onset end-stage renal disease, significant embolic event resulting in end-organ damage, vascular complication, renal artery re-intervention, and hypertensive emergency was 15% (54 of 352 patients) for the renal artery denervation group, 14% (13 of 96 patients) for the crossover group, and 14% (10 of 69 patients) for the non-crossover group. INTERPRETATION: This final report of the SYMPLICITY HTN-3 trial adds to the totality of evidence supporting the safety of renal artery denervation to 36 months after the procedure. From 12 months to 36 months after the procedure, patients who were originally randomly assigned to receive renal artery denervation had larger reductions in blood pressure and better blood pressure control compared with patients who received sham control. FUNDING: Medtronic.


Assuntos
Hipertensão , Artéria Renal , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/fisiologia , Cateteres , Denervação/métodos , Diuréticos/uso terapêutico , Seguimentos , Hipertensão/cirurgia , Hipertensão/tratamento farmacológico , Rim/cirurgia , Rim/irrigação sanguínea , Artéria Renal/cirurgia , Método Simples-Cego , Simpatectomia/métodos , Resultado do Tratamento
16.
JACC Cardiovasc Interv ; 15(16): 1664-1674, 2022 08 22.
Artigo em Inglês | MEDLINE | ID: mdl-35981841

RESUMO

BACKGROUND: The clinical course of patients with moderate aortic stenosis (AS) remains incompletely defined. OBJECTIVES: This study sought to analyze the clinical course of moderate AS and compare it with other stages of the disease. METHODS: Multiple electronic databases were searched to identify studies on adult moderate AS. Random-effects models were used to derive pooled estimates. The primary endpoint was all-cause death. The secondary endpoints were cardiac death, heart failure, sudden death, and aortic valve replacement. RESULTS: Among a total of 25 studies (12,143 moderate AS patients, 3.7 years of follow-up), pooled rates per 100 person-years were 9.0 (95% CI: 6.9 to 11.7) for all-cause death, 4.9 (95% CI: 3.1 to 7.5) for cardiac death, 3.9 (95% CI: 1.9 to 8.2) for heart failure, 1.1 (95% CI: 0.8 to 1.5) for sudden death, and 7.2 (95% CI: 4.3 to 12.2) for aortic valve replacement. Meta-regression analyses detected that diabetes (P = 0.019), coronary artery disease (P = 0.017), presence of symptoms (P < 0.001), and left ventricle (LV) dysfunction (P = 0.009) were associated with a significant impact on the overall estimate of all-cause death. All-cause mortality was higher in patients with reduced LV ejection fraction (<50%) than with normal LV ejection fraction: 16.5 (95% CI: 5.2 to 52.3) and 4.2 (95% CI: 1.4 to 12.8) per 100 person-years, respectively. Compared with moderate AS, the incidence rate difference of all-cause mortality was -3.9 (95% CI: -6.7 to -1.1) for no or mild AS and +2.2 (95% CI: +0.8 to +3.5) for severe AS patients. CONCLUSIONS: Moderate AS appears to be associated with a mortality risk higher than no or mild AS but lower than severe AS, which increases in specific population subsets. The impact of early intervention in moderate AS patients having high-risk features deserves further investigation.


Assuntos
Estenose da Valva Aórtica , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/cirurgia , Morte , Morte Súbita , Insuficiência Cardíaca , Humanos , Substituição da Valva Aórtica Transcateter , Resultado do Tratamento
17.
J Am Coll Cardiol ; 80(7): 666-676, 2022 08 16.
Artigo em Inglês | MEDLINE | ID: mdl-35953133

RESUMO

BACKGROUND: The prognostic implications of discordant grading in severe aortic stenosis (AS) are well known. However, the prevalence of different flow-gradient patterns and their prognostic implications in moderate AS are unknown. OBJECTIVES: The purpose of this study was to investigate the occurrence and prognostic implications of different flow-gradient patterns in patients with moderate AS. METHODS: Patients with moderate AS (aortic valve area >1.0 and ≤1.5 cm2) were identified and divided in 4 groups based on transvalvular mean gradient (MG), stroke volume index (SVi), and left ventricular ejection fraction (LVEF): concordant moderate AS (MG ≥20 mm Hg) and discordant moderate AS including 3 subgroups: normal-flow, low-gradient moderate AS (MG <20 mm Hg, SVi ≥35 mL/m2, and LVEF ≥50%); "paradoxical" low-flow, low-gradient moderate AS (MG <20 mm Hg, SVi <35 mL/m2, and LVEF ≥50%) and "classical" low-flow, low-gradient moderate AS (MG <20 mm Hg and LVEF <50%). The primary endpoint was all-cause mortality. RESULTS: Of 1,974 patients (age 73 ± 10 years, 51% men) with moderate AS, 788 (40%) had discordant grading, and these patients showed significantly higher mortality rates than patients with concordant moderate AS (P < 0.001). On multivariable analysis, "paradoxical" low-flow, low-gradient (HR: 1.458; 95% CI: 1.072-1.983; P = 0.014) and "classical" low-flow, low-gradient (HR: 1.710; 95% CI: 1.270-2.303; P < 0.001) patterns but not the normal-flow, low-gradient moderate AS pattern were independently associated with all-cause mortality. CONCLUSIONS: Discordant grading is frequently (40%) observed in patients with moderate AS. Low-flow, low-gradient patterns account for an important proportion of the discordant cases and are associated with increased mortality. These findings underline the need for better phenotyping patients with discordant moderate AS.


Assuntos
Estenose da Valva Aórtica , Valva Aórtica , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Prognóstico , Estudos Retrospectivos , Índice de Gravidade de Doença , Volume Sistólico , Resultado do Tratamento , Função Ventricular Esquerda
18.
J Am Coll Cardiol ; 80(6): 613-626, 2022 08 09.
Artigo em Inglês | MEDLINE | ID: mdl-35926935

RESUMO

BACKGROUND: Valvular heart disease is an important contributor to cardiovascular morbidity and mortality and remains underdiagnosed. Deep learning analysis of electrocardiography (ECG) may be useful in detecting aortic stenosis (AS), aortic regurgitation (AR), and mitral regurgitation (MR). OBJECTIVES: This study aimed to develop ECG deep learning algorithms to identify moderate or severe AS, AR, and MR alone and in combination. METHODS: A total of 77,163 patients undergoing ECG within 1 year before echocardiography from 2005-2021 were identified and split into train (n = 43,165), validation (n = 12,950), and test sets (n = 21,048; 7.8% with any of AS, AR, or MR). Model performance was assessed using area under the receiver-operating characteristic (AU-ROC) and precision-recall curves. Outside validation was conducted on an independent data set. Test accuracy was modeled using different disease prevalence levels to simulate screening efficacy using the deep learning model. RESULTS: The deep learning algorithm model accuracy was as follows: AS (AU-ROC: 0.88), AR (AU-ROC: 0.77), MR (AU-ROC: 0.83), and any of AS, AR, or MR (AU-ROC: 0.84; sensitivity 78%, specificity 73%) with similar accuracy in external validation. In screening program modeling, test characteristics were dependent on underlying prevalence and selected sensitivity levels. At a prevalence of 7.8%, the positive and negative predictive values were 20% and 97.6%, respectively. CONCLUSIONS: Deep learning analysis of the ECG can accurately detect AS, AR, and MR in this multicenter cohort and may serve as the basis for the development of a valvular heart disease screening program.


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Aprendizado Profundo , Doenças das Valvas Cardíacas , Insuficiência da Valva Mitral , Insuficiência da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/diagnóstico , Eletrocardiografia , Doenças das Valvas Cardíacas/diagnóstico , Doenças das Valvas Cardíacas/epidemiologia , Humanos , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/epidemiologia
19.
JAMA Cardiol ; 7(9): 934-944, 2022 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-35895046

RESUMO

Importance: In patients with severe aortic stenosis and left ventricular ejection fraction (LVEF) less than 50%, early LVEF improvement after transcatheter aortic valve replacement (TAVR) is associated with improved 1-year mortality; however, its association with long-term clinical outcomes is not known. Objective: To examine the association between early LVEF improvement after TAVR and 5-year outcomes. Design, Setting, and Participants: This cohort study analyzed patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1, 2, and S3 trials and registries between July 2007 and April 2015. High- and intermediate-risk patients with baseline LVEF less than 50% who underwent transfemoral TAVR were included in the current study. Data were analyzed from August 2020 to May 2021. Exposures: Early LVEF improvement, defined as increase of 10 percentage points or more at 30 days and also as a continuous variable (ΔLVEF between baseline and 30 days). Main Outcomes and Measures: All-cause death at 5 years. Results: Among 659 included patients with LVEF less than 50%, 468 (71.0%) were male, and the mean (SD) age was 82.4 (7.7) years. LVEF improvement within 30 days following transfemoral TAVR occurred in 216 patients (32.8%) (mean [SD] ΔLVEF, 16.4 [5.7%]). Prior myocardial infarction, diabetes, cancer, higher baseline LVEF, larger left ventricular end-diastolic diameter, and larger aortic valve area were independently associated with lower likelihood of LVEF improvement. Patients with vs without early LVEF improvement after TAVR had lower 5-year all-cause death (102 [50.0%; 95% CI, 43.3-57.1] vs 246 [58.4%; 95% CI, 53.6-63.2]; P = .04) and cardiac death (52 [29.5%; 95% CI, 23.2-37.1] vs 135 [38.1%; 95% CI, 33.1-43.6]; P = .05). In multivariable analyses, early improvement in LVEF (modeled as a continuous variable) was associated with lower 5-year all-cause death (adjusted hazard ratio per 5% increase in LVEF, 0.94 [95% CI, 0.88-1.00]; P = .04) and cardiac death (adjusted hazard ratio per 5% increase in LVEF, 0.90 [95% CI, 0.82-0.98]; P = .02) after TAVR. Restricted cubic spline analysis demonstrated a visual inflection point at ΔLVEF of 10% beyond which there was a steep decline in all-cause mortality with increasing degree of LVEF improvement. There were no statistically significant differences in rehospitalization, New York Heart Association functional class, or Kansas City Cardiomyopathy Questionnaire Overall Summary score at 5 years in patients with vs without early LVEF improvement. In subgroup analysis, the association between early LVEF improvement and 5-year all-cause death was consistent regardless of the presence or absence of coronary artery disease or prior myocardial infarction. Conclusions and Relevance: In patients with severe aortic stenosis and LVEF less than 50%, 1 in 3 experience LVEF improvement within 1 month after TAVR. Early LVEF improvement is associated with lower 5-year all-cause and cardiac death.


Assuntos
Estenose da Valva Aórtica , Infarto do Miocárdio , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Estudos de Coortes , Morte , Feminino , Humanos , Masculino , Infarto do Miocárdio/cirurgia , Volume Sistólico , Função Ventricular Esquerda
20.
J Am Coll Cardiol ; 80(5): 527-544, 2022 08 02.
Artigo em Inglês | MEDLINE | ID: mdl-35902177

RESUMO

A virtual workshop was organized by the Heart Valve Collaboratory to identify areas of expert consensus, areas of disagreement, and evidence gaps related to bioprosthetic aortic valve hemodynamics. Impaired functional performance of bioprosthetic aortic valve replacement is associated with adverse patient outcomes; however, this assessment is complicated by the lack of standardization for labelling, definitions, and measurement techniques, both after surgical and transcatheter valve replacement. Echocardiography remains the standard assessment methodology because of its ease of performance, widespread availability, ability to do serial measurements over time, and correlation with outcomes. Management of a high gradient after replacement requires integration of the patient's clinical status, physical examination, and multimodality imaging in addition to shared patient decisions regarding treatment options. Future priorities that are underway include efforts to standardize prosthesis sizing and labelling for both surgical and transcatheter valves as well as trials to characterize the consequences of adverse hemodynamics.


Assuntos
Estenose da Valva Aórtica , Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Ecocardiografia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemodinâmica , Humanos , Desenho de Prótese , Falha de Prótese , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
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