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1.
Ann Intern Med ; 176(6): JC67, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37276601

RESUMO

SOURCE CITATION: Sorajja P, Whisenant B, Hamid N, et al; TRILUMINATE Pivotal Investigators. Transcatheter repair for patients with tricuspid regurgitation. N Engl J Med. 4 Mar 2023. [Epub ahead of print]. 36876753.


Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Tricúspide , Humanos , Insuficiência da Valva Tricúspide/cirurgia , Resultado do Tratamento , Qualidade de Vida , Cateterismo Cardíaco
2.
N Engl J Med ; 382(9): 799-809, 2020 02 27.
Artigo em Inglês | MEDLINE | ID: mdl-31995682

RESUMO

BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).


Assuntos
Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estudos de Coortes , Ecocardiografia , Feminino , Nível de Saúde , Humanos , Incidência , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Masculino , Análise Multivariada , Complicações Pós-Operatórias/mortalidade , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento
3.
Catheter Cardiovasc Interv ; 100(5): 890-900, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35971750

RESUMO

OBJECTIVE: To describe outcomes of patients who underwent transcatheter aortic valve replacement (TAVR) in a native valve or failed bioprosthetic valve or transcatheter heart valve (THV) and a transcatheter mitral valve replacement procedure (TMVR; valve-in-valve [mViV], valve-in-ring [mViR], and valve in mitral annulus calcification [ViMAC]) either concomitantly (same procedure) or staged (different procedures). BACKGROUND: Patient characteristics, procedural details, and outcomes of concomitant or staged TAVR and TMVR procedures are largely unknown. METHODS: Data were extracted from the STS/ACC TVT Registry™ for patients undergoing concomitant or staged TAVR and TMVR with SAPIEN XT, SAPIEN 3, or SAPIEN 3 Ultra (Edwards Lifesciences) THVs. Descriptive results were reported for procedural, index hospitalization, 30-day, and 1-year outcomes. RESULTS: A total of 257 patients underwent TAVR and TMVR in concomitant (n = 135) or staged (n = 122) procedures. Device success was 82.9% and 83.9% for concomitant TAVR and TMVR procedures and 83.8% and 82.5% for staged TAVR and TMVR procedures. Significant improvements in aortic and mitral valve function remained stable through 1 year. All-cause mortality for concomitant and staged groups was 14.7% and 10.5% at 30 days, and 32.8% and 24.6% at 1 year, respectively. Stroke rate for concomitant and staged groups was 0.8% and 3.6% at 30 days and 3.9% and 5.6% at 1 year, respectively. Improvements from baseline to 1 year in NYHA class and KCCQ overall summary scores were observed for all patients. CONCLUSIONS: Concomitant or staged transcatheter treatment of patients with aortic and mitral valve disease can be performed in select high-risk patients in experienced centers.


Assuntos
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 , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Desenho de Prótese , Resultado do Tratamento , Fatores de Tempo , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia
4.
N Engl J Med ; 374(17): 1609-20, 2016 04 28.
Artigo em Inglês | MEDLINE | ID: mdl-27040324

RESUMO

BACKGROUND: Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. METHODS: We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. RESULTS: The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. CONCLUSIONS: In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).


Assuntos
Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Feminino , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Estimativa de Kaplan-Meier , Masculino , Análise Multivariada , Complicações Pós-Operatórias/mortalidade , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Ultrassonografia
5.
J Cardiothorac Vasc Anesth ; 33(3): 796-807, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30064851

RESUMO

The development of transcatheter interventions to provide a minimally invasive alternative to open surgical repair has revolutionized the care of patients with valvular heart disease. Recently, this technology has been expanded to allow for the treatment of pathology of the mitral valve. This review discusses the anesthetic considerations for patients presenting for transcatheter management of mitral valve disease, including transcatheter mitral valve replacement (TMVR) and transcatheter mitral valve repair (TMVRep). The initial focus is on the current literature on transcatheter interventions for mitral valve pathologies as well as current and developing technology for TMVR and TMVRep. The authors' institutional experience with anesthetic management for the TMVR and TMVRep procedures is described, including potential pitfalls and complications, concluding with a discussion of the role of transesophageal echocardiography in the care of this patient population.


Assuntos
Anestesia/métodos , Anestésicos/administração & dosagem , Estenose da Valva Aórtica/diagnóstico por imagem , Cateterismo Cardíaco/métodos , Insuficiência da Valva Mitral/diagnóstico por imagem , Anestesia/normas , Anestésicos/normas , Estenose da Valva Aórtica/tratamento farmacológico , Estenose da Valva Aórtica/cirurgia , Cateterismo Cardíaco/normas , Próteses Valvulares Cardíacas/normas , Humanos , Insuficiência da Valva Mitral/tratamento farmacológico , Insuficiência da Valva Mitral/cirurgia
6.
Eur Heart J ; 39(28): 2659-2667, 2018 07 21.
Artigo em Inglês | MEDLINE | ID: mdl-29741615

RESUMO

Aims: In patients randomized to transcatheter or surgical aortic valve replacement (TAVR, SAVR), we sought to determine whether SAVR is associated with worsening right ventricular (RV) function and whether RV deterioration is associated with mortality. Methods and results: In 1376 patients from PARTNERIIA with paired baseline and 30-day core lab echocardiograms, worsening RV function was defined as decline by at least one grade from baseline to 30 days. Our primary outcome was all-cause mortality from 30 days to 2 years. Among 744 patients with TAVR, 62 (8.3%) had worsening RV function, compared with 156 of 632 patients with SAVR (24.7%) (P < 0.0001). In a multivariable model, SAVR [odds ratio (OR) 4.05, 95% confidence interval (CI) 2.55-6.44], a dilated RV (OR 2.38, 95% CI 1.37-4.14), and more than mild tricuspid regurgitation (TR) (OR 2.58, 95% CI 1.25-5.33) were associated with worsening RV function. There were 169 deaths, and patients with worsening RV function had higher all-cause mortality [hazard ratio (HR) 1.98, 95% CI 1.40-2.79]. This association remained robust after adjusting for clinical and echocardiographic variables. Among patients with worsening RV function, there was no mortality difference between TAVR and SAVR (HR 1.16, 95% CI 0.61-2.18). The development of moderate or severe RV dysfunction from baseline normal RV function conferred the worst prognosis (HR 2.87, 95% CI 1.40-5.89). Conclusion: After aortic valve replacement, worsening RV function is more common in patients with baseline RV dilation, more than mild TR, and in patients treated with SAVR. Worsening RV function and the magnitude of deterioration have important prognostic implications.


Assuntos
Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Complicações Pós-Operatórias/epidemiologia , Disfunção Ventricular Direita/epidemiologia , Idoso de 80 Anos ou mais , Progressão da Doença , Feminino , Humanos , Incidência , Masculino , Complicações Pós-Operatórias/mortalidade , Prognóstico , Estudos Prospectivos , Substituição da Valva Aórtica Transcateter , Disfunção Ventricular Direita/mortalidade
7.
Catheter Cardiovasc Interv ; 88(1): E28-33, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26945801

RESUMO

Pulmonary valve replacement (PVR) is indicated in patients with significant pulmonary regurgitation (PR), stenosis (PS), or mixed pulmonary valve disease. While once an exclusively surgical procedure, many patients can undergo transcatheter PVR (TPVR) with excellent early outcomes (Haas et al. 2013, Clin. Res. Cardiol. Off. J. German Cardiac Soc. 102:119-128; Kenny et al. 2011, J. Am. Coll. Cardiol. 58:2248-2256; Cheatham et al. Circulation 2015, 131:1960-1970). The available transcatheter options continue to expand, but the majority of cases performed in the United States involve the use of FDA approved Melody valve (Medtronic; Minneapolis, MN) or the SAPIEN (Edwards Lifesciences; Irvine, CA) family of valves. The SAPIEN 3 valve (S3) recently received FDA approval for transcatheter aortic valve replacement. We report the first S3 implantation in the pulmonary position for treatment of chronic pulmonary regurgitation and progressive right ventricular dilation in an 18 year old male with repaired Tetralogy of Fallot. © 2016 Wiley Periodicals, Inc.


Assuntos
Cateterismo Cardíaco/instrumentação , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Insuficiência da Valva Pulmonar/terapia , Tetralogia de Fallot/cirurgia , Obstrução do Fluxo Ventricular Externo/terapia , Adolescente , Cateterismo Cardíaco/métodos , Doença Crônica , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Masculino , Desenho de Prótese , Insuficiência da Valva Pulmonar/diagnóstico por imagem , Insuficiência da Valva Pulmonar/etiologia , Índice de Gravidade de Doença , Resultado do Tratamento , Obstrução do Fluxo Ventricular Externo/diagnóstico por imagem , Obstrução do Fluxo Ventricular Externo/etiologia
8.
Catheter Cardiovasc Interv ; 87(2): 232-40, 2016 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-23728924

RESUMO

OBJECTIVES: To evaluate the long-term outcomes of patients with ostial lesions who underwent percutaneous coronary intervention (PCI) with and without the use of intravascular ultrasound (IVUS). BACKGROUND: A higher rate of adverse cardiac events is associated with PCI of ostial lesions as compared with nonostial disease. METHODS: From 7/2002 to 8/2010, 225 patients with 233 coronary ostial lesions underwent PCI with (n = 82) and without (n = 143) IVUS guidance. Ostial lesions included both native aorto-ostial or major coronary vessel (left anterior descending, left circumflex, and ramus intermedius) lesions. Clinical outcomes [cardiovascular death, myocardial infarction (MI), and target lesion revascularization (TLR)] at a mean follow-up of 4.2 ± 2.5 years were compared between patients undergoing PCI of an ostial lesion with and without use of IVUS using univariate and propensity score adjusted analyses. RESULTS: Aorto-ostial lesions (n = 109) comprised 47% of lesions, whereas the remaining lesions (53%) involved major coronary vessels. After propensity score adjustment, IVUS use was associated with lower rates of the composite of cardiovascular death, MI, or TLR (HR 0.54, 95% CI 0.29-0.99; P = 0.04), composite MI or TLR (HR 0.39, 95% CI 0.18-0.83; P = 0.01), and MI (HR 0.31, 95% CI 0.11-0.85; P = 0.02) as compared with no IVUS. The use of IVUS was also associated with a trend towards a lower rate of TLR (HR 0.42, 95% CI 0.17-1.02; P = 0.06). CONCLUSIONS: PCI of coronary ostial lesions with the use of IVUS was associated with significantly lower rates of adverse cardiac events.


Assuntos
Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea/métodos , Ultrassonografia de Intervenção/métodos , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Feminino , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Pontuação de Propensão , Modelos de Riscos Proporcionais , Fatores de Proteção , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia de Intervenção/efeitos adversos , Ultrassonografia de Intervenção/mortalidade
9.
Eur Heart J ; 36(8): 509-15, 2015 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-25336221

RESUMO

AIMS: Although lesions deferred revascularization following fractional flow reserve (FFR) assessment have a low risk of adverse cardiac events, variability in risk for deferred lesion intervention (DLI) has not been previously evaluated. The aim of this study was to develop a prediction model to estimate 1-year risk of DLI for coronary lesions where revascularization was not performed following FFR assessment. METHODS AND RESULTS: A prediction model for DLI was developed from a cohort of 721 patients with 882 coronary lesions where revascularization was deferred based on FFR between 10/2002 and 7/2010. Deferred lesion intervention was defined as any revascularization of a lesion previously deferred following FFR. The final DLI model was developed using stepwise Cox regression and validated using bootstrapping techniques. An algorithm was constructed to predict the 1-year risk of DLI. During a mean (±SD) follow-up period of 4.0 ± 2.3 years, 18% of lesions deferred after FFR underwent DLI; the 1-year incidence of DLI was 5.3%, while the predicted risk of DLI varied from 1 to 40%. The final Cox model included the FFR value, age, current or former smoking, history of coronary artery disease (CAD) or prior percutaneous coronary intervention, multi-vessel CAD, and serum creatinine. The c statistic for the DLI prediction model was 0.66 (95% confidence interval, CI: 0.61-0.70). CONCLUSION: Patients deferred revascularization based on FFR have variation in their risk for DLI. A clinical prediction model consisting of five clinical variables and the FFR value can help predict the risk of DLI in the first year following FFR assessment.


Assuntos
Doença da Artéria Coronariana/terapia , Revascularização Miocárdica , Estudos de Coortes , Ponte de Artéria Coronária , Doença da Artéria Coronariana/fisiopatologia , Reserva Fracionada de Fluxo Miocárdico/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Medição de Risco , Fatores de Tempo , Resultado do Tratamento
10.
Eur Heart J ; 36(7): 449-56, 2015 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-25273886

RESUMO

AIM: The impact of paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) remains uncertain. In this analysis, we sought to evaluate the impact of varying degrees of PVR on both mortality and changes in ventricular geometry and function. METHODS AND RESULTS: Clinical and echocardiographic outcomes of patients who underwent TAVR from the randomized cohorts and continued access registries in the PARTNER trial were analysed after stratifying by severity of post-implant PVR, which was graded as none/trace in 52.9% (n = 1288), mild in 38.0% (n = 925), and moderate/severe in 9.1% (n = 221). There were significant differences in baseline clinical and echocardiographic characteristics. After TAVR, all the patients demonstrated increase in left ventricular (LV) function and reduction in the LV mass index, although the magnitude of mass regression was lower in the moderate/severe PVR group. The 30-day mortality (3.1 vs. 3.4 vs. 4.5%, P = 0.56) and stroke (3.4 vs. 3.7 vs. 2.3%, P = 0.59) were similar in all groups (none/trace, mild, and moderate/severe). At 1 year, there was increased all-cause mortality (15.9 vs. 22.2 vs. 35.1%, P < 0.0001), cardiac mortality (6.1 vs. 7.4% vs. 16.3%, P < 0.0001) and re-hospitalization (14.4 vs. 23.0 vs. 31.3%, P < 0.0001) with worsening PVR. A multivariable analysis indicated that the presence of moderate/severe PVR (HR: 2.18, 95% CI: 1.57-3.02, P < 0.0001) or mild PVR (HR: 1.37, 95% CI: 1.14-1.90, P = 0.012) was associated with higher late mortality. CONCLUSION: Differences in baseline characteristics in patients with increasing severities of PVR may increase the risk of this complication. Despite these differences, multivariable analysis demonstrated that both mild and moderate/severe PVR predicted higher 1-year mortality.


Assuntos
Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/mortalidade , Insuficiência da Valva Aórtica/patologia , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/patologia , Ecocardiografia , Feminino , Prolapso das Valvas Cardíacas , Humanos , Masculino , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/patologia , Tamanho do Órgão , Reoperação/estatística & dados numéricos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
11.
Circulation ; 129(25): 2682-90, 2014 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-24958751

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a less invasive option for treatment of high-risk patients with severe aortic stenosis. We sought to identify patients at high risk for poor outcome after TAVR using a novel definition of outcome that integrates quality of life with mortality. METHODS AND RESULTS: Among 2137 patients who underwent TAVR in the PARTNER (Placement of Aortic Transcatheter Valve) trial or its associated continued access registry, quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Scale (KCCQ-OS; range 0-100, where a higher score equates to a better quality of life) at baseline and at 1, 6, and 12 months after TAVR. A poor 6-month outcome (defined as death, KCCQ-OS score <45, or ≥10-point decrease in KCCQ-OS score compared with baseline) occurred in 704 patients (33%). Using a split-sample design, we developed a multivariable model to identify a parsimonious set of covariates to identify patients at high risk for poor outcome. The model demonstrated moderate discrimination (c-index=0.66) and good calibration with the observed data, performed similarly in the separate validation cohort (c-index=0.64), and identified 211 patients (10% of the population) with a ≥50% likelihood of a poor outcome after TAVR. A second model that explored predictors of poor outcome at 1 year identified 1102 patients (52%) with ≥50% likelihood and 178 (8%) with ≥70% likelihood of a poor 1-year outcome after TAVR. CONCLUSIONS: Using a large, multicenter cohort, we have developed and validated predictive models that can identify patients at high risk for a poor outcome after TAVR. Although model discrimination was moderate, these models may help guide treatment choices and offer patients realistic expectations of outcomes based on their presenting characteristics. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.


Assuntos
Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca , Modelos Estatísticos , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Análise Multivariada , Prognóstico , Qualidade de Vida , Estudos Retrospectivos , Índice de Gravidade de Doença , Inquéritos e Questionários , Resultado do Tratamento
12.
N Engl J Med ; 366(18): 1686-95, 2012 May 03.
Artigo em Inglês | MEDLINE | ID: mdl-22443479

RESUMO

BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. RESULTS: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). CONCLUSIONS: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca/métodos , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/classificação , Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/terapia , Cateterismo Cardíaco/efeitos adversos , Feminino , Seguimentos , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemorragia/etiologia , Heparina/efeitos adversos , Heparina/uso terapêutico , Humanos , Estimativa de Kaplan-Meier , Masculino , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Complicações Pós-Operatórias , Falha de Prótese , Acidente Vascular Cerebral/etiologia , Taxa de Sobrevida , Resultado do Tratamento , Ultrassonografia
13.
Circulation ; 128(25): 2776-84, 2013 Dec 24.
Artigo em Inglês | MEDLINE | ID: mdl-24152861

RESUMO

BACKGROUND: The effect of preoperative mitral regurgitation (MR) on clinical outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) is controversial. This study sought to examine the impact of moderate and severe MR on outcomes after TAVR and surgical aortic valve replacement (SAVR). METHODS AND RESULTS: Data were drawn from the randomized Placement of Aortic Transcatheter Valve (PARTNER) Trial cohort A patients with severe, symptomatic aortic stenosis undergoing either TAVR (n=331) or SAVR (n=299). Both TAVR and SAVR patients were dichotomized according to the degree of preoperative MR (moderate/severe versus none/mild). At baseline, moderate or severe MR was reported in 65 TAVR patients (19.6%) and 63 SAVR patients (21.2%). At 30 days, among survivors who had isolated SAVR/TAVR, moderate/severe MR had improved in 25 SAVR patients (69.4%) and 30 TAVR patients (57.7%), was unchanged in 10 SAVR patients (27.8%) and 19 TAVR patients (36.5%), and worsened in 1 SAVR patient (2.8%) and 4 TAVR patients (5.8%; all P=NS). Mortality at 2 years was higher in SAVR patients with moderate or severe MR than in those with mild or less MR (49.8% versus 28.1%; adjusted hazard ratio, 1.73; 95% confidence interval, 1.01-2.96; P=0.04). In contrast, MR severity at baseline did not affect mortality in TAVR patients (37.0% versus 32.7%, moderate/severe versus none/mild; hazard ratio, 1.14; 95% confidence interval, 0.72-1.78; P=0.58; P for interaction=0.05). CONCLUSIONS: Both TAVR and SAVR were associated with a significant early improvement in MR in survivors. However, moderate or severe MR at baseline was associated with increased 2-year mortality after SAVR but not after TAVR. TAVR may be a reasonable option in selected patients with combined aortic and mitral valve disease. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.


Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica , Cateterismo Cardíaco/métodos , Procedimentos Cirúrgicos Cardíacos/métodos , Implante de Prótese de Valva Cardíaca/métodos , Insuficiência da Valva Mitral/complicações , Índice de Gravidade de Doença , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estudos de Coortes , Ecocardiografia , Feminino , Seguimentos , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Estimativa de Kaplan-Meier , Masculino , Taxa de Sobrevida , Resultado do Tratamento
14.
Circ Cardiovasc Interv ; 17(2): e013298, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38235547

RESUMO

BACKGROUND: Frailty associates with worse outcomes after transcatheter aortic valve replacement (TAVR). Sarcopenia underlies frailty, but the association between a comprehensive assessment of sarcopenia-muscle mass, strength, and performance-and outcomes after TAVR has not been examined. METHODS: From a multicenter prospective registry of patients with symptomatic severe aortic stenosis undergoing TAVR, 445 who had a preprocedure computed tomography and clinical assessment of frailty were included. Cross-sectional muscle (psoas and paraspinal) areas were measured on computed tomography and indexed to height. Gait speed and handgrip strength were obtained, and patients were dichotomized into fast versus slow; strong versus weak; and normal versus low muscle mass. As measures of body composition, cross-sectional fat (subcutaneous and visceral) was measured and indexed to height. RESULTS: The frequency of patients who were slow, weak, and had low muscle mass was 56%, 59%, and 42%, respectively. Among the 3 components of sarcopenia, only slower gait speed (muscle performance) was independently associated with increased post-TAVR mortality (adjusted hazard ratio, 1.12 per 0.1 m/s decrease [95% CI, 1.04-1.21]; P=0.004; adjusted hazard ratio, 1.38 per 1 SD decrease [95% CI, 1.11-1.72]; P=0.004). Meeting multiple sarcopenia criteria was not associated with higher mortality risk than fewer. Lower indexed visceral fat area (adjusted hazard ratio, 1.48 per 1 SD decrease [95% CI, 1.15-1.89]; P=0.002) was associated with mortality but indexed subcutaneous fat was not. Death occurred in 169 (38%) patients. CONCLUSIONS: Among patients with symptomatic severe aortic stenosis and comprehensive sarcopenia and body composition phenotyping, gait speed was the only sarcopenia measure associated with post-TAVR mortality. Lower visceral fat was also associated with increased risk pointing to an obesity paradox also observed in other patient populations. These findings reinforce the clinical utility of gait speed as a measure of risk and a potential target for adjunctive interventions alongside TAVR to optimize clinical outcomes.


Assuntos
Estenose da Valva Aórtica , Fragilidade , Sarcopenia , Substituição da Valva Aórtica Transcateter , Humanos , Sarcopenia/diagnóstico por imagem , Sarcopenia/complicações , Fragilidade/diagnóstico , Fragilidade/complicações , Resultado do Tratamento , Força da Mão , Estudos Transversais , Medição de Risco , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Composição Corporal , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Fatores de Risco
15.
Circulation ; 125(19): 2353-62, 2012 May 15.
Artigo em Inglês | MEDLINE | ID: mdl-22447809

RESUMO

BACKGROUND: Pressure overload resulting from aortic stenosis causes maladaptive ventricular and vascular remodeling that can lead to pulmonary hypertension, heart failure symptoms, and adverse outcomes. Retarding or reversing this maladaptive remodeling and its unfavorable hemodynamic consequences has the potential to improve morbidity and mortality. Preclinical models of pressure overload have shown that phosphodiesterase type 5 inhibition is beneficial; however, the use of phosphodiesterase type 5 inhibitors in patients with aortic stenosis is controversial because of concerns about vasodilation and hypotension. METHODS AND RESULTS: We evaluated the safety and hemodynamic response of 20 subjects with severe symptomatic aortic stenosis (mean aortic valve area, 0.7 ± 0.2 cm(2); ejection fraction, 60 ± 14%) who received a single oral dose of sildenafil (40 or 80 mg). Compared with baseline, after 60 minutes, sildenafil reduced systemic (-12%; P<0.001) and pulmonary (-29%; P=0.002) vascular resistance, mean pulmonary artery (-25%; P<0.001) and wedge (-17%; P<0.001) pressures, and increased systemic (13%; P<0.001) and pulmonary (45%; P<0.001) vascular compliance and stroke volume index (8%; P=0.01). These changes were not dose dependent. Sildenafil caused a modest decrease in mean systemic arterial pressure (-11%; P<0.001) but was well tolerated with no episodes of symptomatic hypotension. CONCLUSIONS: This study shows for the first time that a single dose of a phosphodiesterase type 5 inhibitor is safe and well tolerated in patients with severe aortic stenosis and is associated with improvements in pulmonary and systemic hemodynamics resulting in biventricular unloading. These findings support the need for longer-term studies to evaluate the role of phosphodiesterase type 5 inhibition as adjunctive medical therapy in patients with aortic stenosis.


Assuntos
Estenose da Valva Aórtica/tratamento farmacológico , Estenose da Valva Aórtica/fisiopatologia , Nucleotídeo Cíclico Fosfodiesterase do Tipo 5/metabolismo , Inibidores da Fosfodiesterase 5/administração & dosagem , Piperazinas/administração & dosagem , Circulação Pulmonar/efeitos dos fármacos , Sulfonas/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Pressão Sanguínea/efeitos dos fármacos , Complacência (Medida de Distensibilidade)/efeitos dos fármacos , Feminino , Humanos , Masculino , Inibidores da Fosfodiesterase 5/efeitos adversos , Piperazinas/efeitos adversos , Purinas/administração & dosagem , Purinas/efeitos adversos , Índice de Gravidade de Doença , Citrato de Sildenafila , Volume Sistólico/efeitos dos fármacos , Sulfonas/efeitos adversos , Resultado do Tratamento , Ultrassonografia , Resistência Vascular/efeitos dos fármacos , Função Ventricular Esquerda/efeitos dos fármacos , Função Ventricular Direita/efeitos dos fármacos
16.
Catheter Cardiovasc Interv ; 82(5): E637-46, 2013 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-23420654

RESUMO

OBJECTIVES: To assess the long-term clinical outcomes associated with treatment of nonleft main coronary bifurcation lesions using a modified provisional jailed-balloon technique (JBT). BACKGROUND: Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with a higher risk of adverse events, including the risk of side branch (SB) loss during main branch (MB) stenting. METHODS: From 4/2003 to 8/2010, 406 patients with 424 nonleft main coronary bifurcation lesions underwent PCI with (n = 95) and without (n = 311) the use of JBT. Rates of SB loss and long term clinical outcomes [death, myocardial infarction (MI), and target lesion revascularization (TLR)] were compared between patients undergoing PCI with and without JBT using univariate and propensity score adjusted and matched analyses. RESULTS: The majority of patients presented with acute coronary syndrome (63%) and 90% of lesions were Medina class 1,1,1. Patients were followed for a mean of 2.7 ± 2.1 years. After propensity score matching (n = 81 in each group), JBT was associated with a significantly lower composite rate of death, MI, or TLR (HR 0.22, 95% CI 0.06-0.76; P = 0.02) and TLR (HR 0.20, 95% 0.04-0.92; P = 0.04) compared with no JBT. Permanent SB loss was significantly lower in the JBT group compared with no JBT group (OR 0.22, 95% CI 0.10-0.49; P = 0.0001). CONCLUSIONS: The use of JBT for the treatment of nonleft main coronary bifurcation lesions was associated with significantly lower rates of SB loss and major adverse cardiac events at late follow-up.


Assuntos
Síndrome Coronariana Aguda/terapia , Angioplastia Coronária com Balão/métodos , Doença da Artéria Coronariana/terapia , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/instrumentação , Angioplastia Coronária com Balão/mortalidade , Distribuição de Qui-Quadrado , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/etiologia , Reestenose Coronária/prevenção & controle , Feminino , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/prevenção & controle , Razão de Chances , Pontuação de Propensão , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento
17.
JACC Case Rep ; 8: 101654, 2023 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-36860562

RESUMO

A 38-year-old with Turner syndrome presented with acute myocardial infarction due to multivessel spontaneous coronary artery dissection (SCAD) complicated by left ventricular free wall rupture. Conservative management for SCAD was pursued. She underwent sutureless repair for an oozing-type left ventricular free wall rupture. SCAD has not been previously reported in Turner syndrome. (Level of Difficulty: Advanced.).

18.
JACC Case Rep ; 27: 102045, 2023 Dec 06.
Artigo em Inglês | MEDLINE | ID: mdl-38094735

RESUMO

A 31-year-old woman with a mechanical aortic valve for congenital aortic stenosis presented to the cardiology clinic for preconception counseling. After experiencing an acute stroke 4 weeks prior, she was subsequently discovered to have prosthetic valve thrombosis requiring replacement of the aortic valve. We discuss her clinical course and preconception considerations.

19.
Ann Case Rep ; 8(5)2023.
Artigo em Inglês | MEDLINE | ID: mdl-37946711

RESUMO

Nontraumatic exertional syncope can be an ominous event reflecting profound arterial hypotension, cerebral hypoperfusion, and transient loss-of consciousness that occurs most commonly in patients with underlying cardiovascular disease. In contradistinction, transient loss-of-consciousness in "healthy adults" is typically vasovagal syncope related to exaggerated orthostatic cardiovascular responses attributed to a hyper-reactive autonomic nervous system. In the present report, a 34 yo male presents to the hospital emergency department (ED) for a sudden loss of consciousness and fall ultimately related to cardiac syncope ascribed to chronic recreational marijuana use complicated by coronary vasospasm.

20.
EuroIntervention ; 19(4): e352-e362, 2023 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-37334801

RESUMO

BACKGROUND: TAVI is a widely accepted treatment for patients with severe aortic stenosis (AS). Despite the adoption of diverse therapies, opportunities remain to develop technologies tailored to provide optimal acute and potential long-term benefits, particularly around haemodynamics, flow and durability. AIMS: We aimed to evaluate the safety and feasibility of the DurAVR transcatheter heart valve (THV), a first-in-class biomimetic valve, in the treatment of patients with symptomatic severe AS. METHODS: This was a first-in-human (FIH), prospective, non-randomised, single-arm, single-centre study. Patients with severe, symptomatic AS of any surgical risk and who were eligible for the DurAVR THV prosthesis were recruited; they were assessed at baseline, 30 days, 6 months, and 1 year post-procedure for implant success, haemodynamic performance, and safety. RESULTS: Thirteen patients (73.9±6.4 years old, 77% female) were enrolled. The DurAVR THV was successfully implanted in 100% of cases with no device-related complications. One access site complication, one permanent pacemaker implantation, and one case of moderate aortic regurgitation occurred. Otherwise, no deaths, stroke, bleeding, reinterventions, or myocardial infarction were reported during any of the follow-up visits. Despite a mean annulus size of 22.95±1.09 mm, favourable haemodynamic results were observed at 30 days (effective orifice area [EOA] 2.00±0.17 cm2, and mean pressure gradient [MPG] 9.02±2.68 mmHg) and were sustained at 1 year (EOA 1.96±0.11 cm2, MPG 8.82±1.38 mmHg), resulting in zero patients with any degree of prosthesis-patient mismatch. Additionally, new valve performance measures derived from cardiovascular magnetic resonance displayed restoration of laminar flow, consistent with a predisease state, in conjunction with a mean coaptation length of 8.3±1.7 mm. CONCLUSIONS: Preliminary results from the FIH study with DurAVR THV demonstrate a good safety profile with promising haemodynamic performance sustained at 1 year and restoration of near-normal flow dynamics. Further clinical investigation is warranted to evaluate how DurAVR THV may play a role in addressing the challenge of lifetime management in AS patients.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/cirurgia , Estudos Prospectivos , Estudos de Viabilidade , Biomimética , Resultado do Tratamento , Desenho de Prótese
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