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1.
JAMA ; 326(11): 1034-1044, 2021 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-34546301

RESUMO

Importance: There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Design, Setting, and Participants: Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159 661 patients (7058 bicuspid, 152 603 tricuspid), 37 660 patients (3243 bicuspid and 34 417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis. Exposures: TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures: Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Results: Among 159 661 patients (7058 bicuspid; 152 603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). Conclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Doença da Válvula Aórtica Bicúspide/cirurgia , Acidente Vascular Cerebral/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/mortalidade , Estudos de Coortes , Feminino , Humanos , Masculino , Pontuação de Propensão , Sistema de Registros , Fatores de Risco , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
2.
Ann Thorac Surg ; 2021 Aug 23.
Artigo em Inglês | MEDLINE | ID: mdl-34437853

RESUMO

BACKGROUND: Variation in degenerative mitral morphology may contribute to suboptimal repair rates. This study evaluates outcomes of a standardized mitral repair technique. METHODS: An institutional clinical registry was used to identify 1036 consecutive patients undergoing robotic mitral surgery between 2005-2020: 87% (n=902) had degenerative disease. Calcification, failed transcatheter repair, and endocarditis were excluded, leaving 582 (68%) patients with isolated posterior leaflet and 268 (32%) with anterior/bileaflet prolapse. Standardized repair comprised triangular resection and true-sized flexible band in posterior leaflet prolapse. Freedom from >2+ moderate mitral regurgitation stratified by prolapse location was assessed using competing risk analysis with death as a competing event. Median follow-up was 5.5 (range 0-15) years. RESULTS: Of patients with isolated posterior leaflet prolapse, 87% (n=506) had standardized repairs, and 13% (n=76) had additional or non-resectional techniques, versus 24% (n=65) and 76% (n=203) respectively for anterior/bileaflet prolapse (P<0.001). Adjunctive techniques in the isolated posterior leaflet group included chordal reconstruction (8.6%, n=50) and commissural sutures (3.4%, n=20). Overall, median clamp time was 80 (IQR 68-98) minutes, 17 patients required intra-operative re-repair, and 6 required mitral replacement. Freedom from >2+ regurgitation or reintervention at 10 years was 92% for posterior prolapse (versus 83% for anterior/bileaflet prolapse). Anterior/bileaflet prolapse was associated with late >2+ regurgitation (HR 3.0, 95% CI 1.3-7.0). CONCLUSIONS: Posterior leaflet prolapse may be repaired in > 99% of patients using triangular resection and band annuloplasty, with satisfactory long-term durability. Increased risk of complex repairs and inferior durability highlights the value of identifying anterior and bileaflet prolapse pre-operatively.

3.
J Heart Lung Transplant ; 40(9): 970-980, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34272125

RESUMO

BACKGROUND: Primary graft dysfunction (PGD) is a major cause of early mortality following heart transplant (HT). The International Society for Heart and Lung Transplantation (ISHLT) subdivides PGD into 3 grades of increasing severity. Most studies have assessed risk factors for PGD without distinguishing between PGD severity grade. We sought to identify recipient, donor and surgical risk factors specifically associated with mild/moderate or severe PGD. METHODS: We identified 734 heart transplant recipients at our institution transplanted between January 1, 2012 and December 31, 2018. PGD was defined according to modified ISHLT criteria. Recipient, donor and surgical variables were analyzed by multinomial logistic regression with mild/moderate or severe PGD as the response. Variables significant in single variable modeling were subject to multivariable analysis via penalized logistic regression. RESULTS: PGD occurred in 24% of the cohort (n = 178) of whom 6% (n = 44) had severe PGD. One-year survival was reduced in recipients with severe PGD but not in those with mild or moderate PGD. Multivariable analysis identified 3 recipient factors: prior cardiac surgery, recipient treatment with ACEI/ARB/ARNI plus MRA, recipient treatment with amiodarone plus beta-blocker, and 3 surgical factors: longer ischemic time, more red blood cell transfusions, and more platelet transfusions, that were associated with severe PGD. We developed a clinical risk score, ABCE, which provided acceptable discrimination and calibration for severe PGD. CONCLUSIONS: Risk factors for mild/moderate PGD were largely distinct from those for severe PGD, suggesting a differing pathophysiology involving several biological pathways. Further research into mechanisms underlying the development of PGD is urgently needed.

4.
Ann Thorac Surg ; 2021 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-34197828

RESUMO

Mitral valve repair is infrequently performed in patients undergoing corrective surgery for failed mitral transcatheter edge-to-edge repair (TEER) in current US practice. This article describes surgical techniques for reconstructive surgery following failed TEER. A total of nine patients underwent robotic-assisted mitral surgery following failed TEER between 2010 and 2020 at a single center. Repair was completed in 88.9% (n=8) patients and freedom from >2+ mitral regurgitation was 87.5% (n=7) at a median follow up of 1.9 years.

5.
J Am Coll Cardiol ; 78(1): 1-9, 2021 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-33945832

RESUMO

BACKGROUND: Transcatheter edge-to-edge (TEER) mitral repair may be complicated by residual or recurrent mitral regurgitation. An increasing need for surgical reintervention has been reported, but operative outcomes are ill defined. OBJECTIVES: This study evaluated national outcomes of mitral surgery after TEER. METHODS: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was used to identify 524 adults who underwent mitral surgery after TEER between July 2014 and June 2020. Emergencies (5.0%; n = 26), previous mitral surgery (5.3%; n = 28), or open implantation of transcatheter prostheses (1.5%; n = 8) were excluded. The primary outcome was 30-day or in-hospital mortality. RESULTS: In the study cohort of 463 patients, the median age was 76 years (interquartile range [IQR]: 67 to 81 years), median left ventricular ejection fraction was 57% (IQR: 48% to 62%), and 177 (38.2%) patients had degenerative disease. Major concomitant cardiac surgery was performed in 137 (29.4%) patients: in patients undergoing isolated mitral surgery, the median STS-predicted mortality was 6.5% (IQR: 3.9% to 10.5%), the observed mortality was 10.2% (n = 23 of 225), and the ratio of observed to expected mortality was 1.2 (95% confidence interval [CI]: 0.8 to 1.9). Predictors of mortality included urgent surgery (odds ratio [OR]: 2.4; 95% CI: 1.3 to 4.6), nondegenerative/unknown etiology (OR: 2.2; 95% CI: 1.1 to 4.5), creatinine of >2.0 mg/dl (OR: 3.8; 95% CI: 1.9 to 7.9) and age of >80 years (OR: 2.1; 95% CI: 1.1 to 4.4). In a volume outcomes analysis in an expanded cohort of 591 patients at 227 hospitals, operative mortality was 2.6% (n = 2 of 76) in 4 centers that performed >10 cases versus 12.4% (n = 64 of 515) in centers performing fewer (p = 0.01). The surgical repair rate after failed TEER was 4.8% (n = 22) and was 6.8% (n = 12) in degenerative disease. CONCLUSIONS: This study indicates that mitral repair is infrequently achieved after failed TEER, which may have implications for treatment choice in lower-risk and younger patients with degenerative disease. These findings should inform patient consent for TEER, clinical trial design, and clinical performance measures.


Assuntos
Cateterismo Cardíaco , Implante de Prótese de Valva Cardíaca , Anuloplastia da Valva Mitral/efeitos adversos , Insuficiência da Valva Mitral , Valva Mitral , Complicações Pós-Operatórias , Reoperação , Fatores Etários , Idoso , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Feminino , Doenças das Valvas Cardíacas/patologia , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Mortalidade Hospitalar , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/patologia , Valva Mitral/cirurgia , Anuloplastia da Valva Mitral/métodos , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/cirurgia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/cirurgia , Prognóstico , Recidiva , Reoperação/efeitos adversos , Reoperação/métodos , Reoperação/estatística & dados numéricos , Fatores de Risco , Estados Unidos
6.
J Invasive Cardiol ; 33(4): E236-E243, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33794477

RESUMO

OBJECTIVE: To evaluate candidacy for surgical mitral valve (MV) repair of recurrent mitral regurgitation (MR) after failed MitraClip. BACKGROUND: Percutaneous mitral repair with MitraClip is safe and effective in patients with degenerative and functional MR with high surgical risk. However, some patients require subsequent mitral surgery for recurrence of significant MR. METHODS: This single-center, observational study includes consecutive patients who underwent mitral surgery after failed MitraClip. RESULTS: Twenty-five patients (age, 69 ± 15 years; 52% women) with severe symptomatic MR after failed MitraClip implantation underwent mitral surgery after a median interval of 5.1 months (interquartile range, 2.5-14 months). Ten patients underwent MV repair (8 with robotic minithoracotomy) and 15 underwent MV replacement (most with sternotomy). Two patients in whom MV repair was intended underwent MV replacement because MitraClip-related leaflet damage prohibited repair. Examples of relative contraindication for MV repair that led to pursuing MV replacement were advanced patient age in 4 patients (mean age, 85 ± 7.6 years), endocarditis in 1 patient, and severely calcified or rheumatic leaflets in 5 patients. Perioperative complications were rare and intermediate-term mortality was similar between groups (3 patients in the MV repair group [30%] vs 4 patients in the MV replacement group [27%]; P=.90). CONCLUSION: When performed by an experienced mitral surgeon and within 1 year of failed MitraClip implantation, surgical MV repair is feasible in most patients who were surgical repair candidates before the clip. Having the option for surgical MV repair after failed MitraClip is important to preserve optimal long-term outcomes for patients who undergo transcatheter mitral repair with MitraClip, especially as ongoing trials are shifting to study lower-risk patients who are also candidates for surgical repair.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Idoso , Idoso de 80 Anos ou mais , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico , Insuficiência da Valva Mitral/cirurgia , Resultado do Tratamento
7.
Transplant Proc ; 53(1): 329-334, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-32917391

RESUMO

BACKGROUND: Indications for heart transplantation are expanding to include amyloid light chain (AL) and transthyretin-related (TTR) amyloidosis. Previously, AL amyloid had been a contraindication to heart transplantation given inferior outcomes. These patients typically have biventricular failure requiring mechanical circulatory support (MCS). We report the outcomes of patients with end-stage cardiac amyloidosis who underwent cardiac transplantation, including some who were bridged to transplantation with a durable biventricular MCS METHODS: The records for patients with cardiac amyloidosis who underwent cardiac transplant between 2010 and 2018 were reviewed. Primary endpoint was post-transplant 1-year survival. Secondary endpoints included 1-year freedom from cardiac allograft vasculopathy (as defined by stenosis ≥ 30% by angiography), nonfatal major adverse cardiac events (myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, stroke), and any rejection. RESULTS: A total of 46 patients received heart transplantation with a diagnosis of either AL or TTR amyloidosis. Of these, 7 patients were bridged to transplantation with a durable biventricular MCS device (6 AL, 1 TTR) and 39 patients were transplanted without MCS bridging. The MCS group consisted of 5 total artificial hearts and 2 biventricular assist devices. The 1-year survival was 91% for the entire cohort, 83% for those with AL amyloidosis, 94% for those with TTR amyloidosis, and 86% for those who received MCS bridging. CONCLUSIONS: Cardiac transplantation can be safely performed in selected amyloidosis patients with reasonable short-term outcomes. Those bridged to transplantation with biventricular MCS appear to have short-term outcomes similar to those transplanted without MCS. Larger numbers and longer observation are required to confirm these findings.


Assuntos
Amiloidose/complicações , Cardiopatias/etiologia , Cardiopatias/cirurgia , Transplante de Coração , Resultado do Tratamento , Adulto , Idoso , Amiloidose/cirurgia , Estudos de Coortes , Feminino , Transplante de Coração/efeitos adversos , Coração Auxiliar , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos
8.
Transplant Proc ; 53(1): 353-357, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-32650992

RESUMO

BACKGROUND: Temporary mechanical circulatory support (MCS) devices are generally used short term to maintain adequate organ perfusion in patients with advanced heart failure and cardiogenic shock. Unacceptably high waitlist mortality in this cohort motivated changes to heart allocation policy, which recognized the severity of illness by prioritization for temporary MCS and broader sharing in the new U.S. donor heart allocation policy. We evaluated the post-heart transplant outcomes for patients bridged with temporary MCS, a control population not bridged with MCS, and a cohort bridged with durable MCS. METHODS: The heart transplant research database was queried to identify patients bridged with temporary MCS and bridged with durable MCS who went directly to heart transplant in our center. Temporary MCS included Impella, intra-aortic balloon pump, and extracorporeal membrane oxygenation. Post-transplant endpoints were assessed at 30 days, 6 months, and 1 year. RESULTS: From 2010 to 2017, a total of 23 patients were bridged to heart transplant with temporary MCS and 548 were transplanted without MCS bridge. Patients bridged with temporary MCS had younger age, lower body mass index, and higher frequencies of prior blood transfusion and Status 1 (1A/1B) listing at transplant compared to patients not bridged with MCS (all P < .001). Despite the severity of illness in patients bridged with temporary MCS, post-transplant outcomes were indistinguishable from those in patients transplanted without MCS bridge, with no difference in 30-day, 6-month, or 1-year survival or 1-year freedom from cardiac allograft vasculopathy, nonfatal major adverse cardiac events, any-treated rejection, acute cellular rejection, or antibody-mediated rejection (P = .23-.97). Similarly, compared to 157 patients bridged with durable MCS, no differences in post-transplant outcomes were identified for the temporary MCS cohort (P = .15-.94). CONCLUSION: Temporary MCS as a bridge to transplant achieves similar post-transplant outcomes at 1 year compared to no MCS and durable MCS. These encouraging findings support recent changes in the Organ Procurement and Transplantation Network | United Network Organ Sharing (OPTN|UNOS) adult heart allocation policy.


Assuntos
Transplante de Coração , Seleção de Pacientes , Políticas , Obtenção de Tecidos e Órgãos , Adulto , Estudos de Coortes , Oxigenação por Membrana Extracorpórea/mortalidade , Feminino , Transplante de Coração/mortalidade , Coração Auxiliar , Humanos , Balão Intra-Aórtico/mortalidade , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Resultado do Tratamento , Listas de Espera/mortalidade
10.
Clin Transplant ; 34(10): e14029, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32633819

RESUMO

As the SARS-CoV-2-pandemic continues to unfold, the number of heart transplants completed in the United States has been declining steadily. The current case series examines the immediate short-term outcomes of seven heart transplant recipients transplanted during the SARS-CoV-2 pandemic. We hope to illustrate that with proper preparation, planning, and testing, heart transplantation can be continued during a pandemic. We assessed 7 patients transplanted from March 4, 2020, to April 15, 2020. The following endpoints were noted: in-hospital survival, in-hospital freedom from rejection, in-hospital nonfatal major cardiac adverse events (NF-MACE), severe primary graft dysfunction, hospital length of stay, and ICU length of stay. There were no expirations throughout the hospital admission. In addition, there were no patients with NF-MACE or treated rejection, and 1 patient developed severe primary graft dysfunction. Average length of stay was 17.2 days with a standard deviation of 5.9 days. ICU length of stay was 7.7 days with a standard deviation of 2.3 days. Despite the decreasing trend in completed heart transplants due to SARS-CoV-2, heart transplantation appears to be feasible in the immediate short term. Further follow-up is needed, however, to assess the impact of SARS-CoV-2 on post-heart transplant outcomes months after transplantation.


Assuntos
COVID-19/prevenção & controle , Transplante de Coração/métodos , Controle de Infecções/métodos , Adulto , Idoso , COVID-19/epidemiologia , COVID-19/etiologia , California/epidemiologia , Função Retardada do Enxerto/epidemiologia , Função Retardada do Enxerto/prevenção & controle , Estudos de Viabilidade , Feminino , Rejeição de Enxerto/epidemiologia , Rejeição de Enxerto/prevenção & controle , Transplante de Coração/mortalidade , Mortalidade Hospitalar , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Pandemias , Segurança do Paciente , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Estudos Retrospectivos , Análise de Sobrevida
11.
J Am Coll Cardiol ; 75(24): 3003-3015, 2020 06 23.
Artigo em Inglês | MEDLINE | ID: mdl-32553252

RESUMO

BACKGROUND: Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction. OBJECTIVES: The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes. METHODS: The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory. RESULTS: The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04). CONCLUSIONS: Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.


Assuntos
Estenose da Valva Aórtica/cirurgia , Bioprótese/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Trombose/epidemiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Canadá/epidemiologia , Feminino , Tomografia Computadorizada Quadridimensional , Humanos , Masculino , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/etiologia , Trombose/diagnóstico por imagem , Trombose/etiologia , Substituição da Valva Aórtica Transcateter/mortalidade , Estados Unidos/epidemiologia
13.
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
14.
Ann Thorac Surg ; 109(5): 1370-1377, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-31563492

RESUMO

BACKGROUND: Acutely decompensated heart failure presents a complicated challenge. Established temporary support measures have significant adverse effects. A minimally invasive temporary left ventricular assist device (LVAD), the Impella 5.0 (Abiomed, Danvers, MA), has been developed to support these patients. METHODS: Patients with acutely decompensated heart failure in whom medical management had failed and who required additional support using an Impella 5.0 device were evaluated from January 2014 to September 2018 at a single center in a retrospective manner using a prospectively maintained database. Patients were treated with the device as a bridge to recovery (BTR; n = 30), bridge to durable device (BTDD; n = 23), or bridge to transplantation (BTT; n = 47). All devices were placed using an axillary artery approach. Demographic features and outcomes were evaluated for each group and compared. RESULTS: A total of 100 patients underwent insertion of an axillary Impella 5.0 LVAD. Patients had an average age of 56.7 ± 13.2 years, were predominantly male (84%), and had a severely depressed left ventricular ejection fraction (average 16%), and most had an Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 (57%) or 2 (33%) score. When divided into groups, there was no difference in age or INTERMACS score, but a statistical difference was noted in baseline left ventricular ejection fraction (20%, 14%, 15%) and creatinine level (1.0, 2.0, 1.6), in the BTR, BTDD, or BTT group, respectively (all P < .05). Survival was 64% overall, and it was 50%, 48%, and 81% for BTR, BTDD, and BTT, respectively (P = .007). Survival improved during this experience and was 90% overall in the most recent 30 patients. CONCLUSIONS: Use of this minimally invasive LVAD system is an attractive strategy to support patients with acute decompensated heart failure to recovery, durable LVAD, or heart transplantation.


Assuntos
Insuficiência Cardíaca/cirurgia , Coração Auxiliar , Sistema de Registros , Volume Sistólico/fisiologia , Função Ventricular Esquerda/fisiologia , Doença Aguda , Feminino , Seguimentos , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
17.
JAMA ; 321(22): 2193-2202, 2019 06 11.
Artigo em Inglês | MEDLINE | ID: mdl-31184741

RESUMO

Importance: Transcatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy. Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis. Design, Setting, and Participants: Registry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018. Exposures: TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures: Primary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment. Results: Of 81 822 consecutive patients with aortic stenosis (2726 bicuspid; 79 096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years [interquartile range {IQR}, 66-81 years]; 39.1%, women; mean [SD] STS-predicted risk of mortality, 4.9% [4.0%] and 5.1% [4.2%], respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio [HR], 1.04, [95% CI, 0.74-1.47]) and 1 year (10.5% vs 12.0%; HR, 0.90 [95% CI, 0.73-1.10]). The 30-day stroke rate was significantly higher for bicuspid vs tricuspid aortic stenosis (2.5% vs 1.6%; HR, 1.57 [95% CI, 1.06-2.33]). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid vs tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5% [95% CI, 0%-0.9%]). There were no significant differences in valve hemodynamics. There were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3% [95% CI, -1.3% to 0.7%]) and 1 year (3.2% vs 2.5%; absolute RD, 0.7% [95% CI, -1.3% to 2.7%]). At 1 year there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, -2.4 [95% CI, -5.1 to 0.3]; P = .08). Conclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients who had undergone transcatheter aortic valve replacement for aortic stenosis, patients with bicuspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30-day risk for stroke. Because of the potential for selection bias and the absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/anormalidades , Acidente Vascular Cerebral/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Pontuação de Propensão , Estudos Prospectivos , Sistema de Registros , Risco
18.
J Am Heart Assoc ; 8(4): e010570, 2019 02 19.
Artigo em Inglês | MEDLINE | ID: mdl-30741603

RESUMO

Background Combined heart and kidney transplantation ( HKT x) is performed in patients with severe heart failure and advanced renal insufficiency. We analyzed the long-term survival after HKT x, the influence of age and dialysis status, the rates of cardiac rejection, and the influence of sensitization. Methods and Results From June 1992 to December 2016, we performed 100 HKT x procedures. We compared older (≥60 years, n=53) with younger (<60 years, n=47) recipients, and recipients on preoperative dialysis (n=49) and not on dialysis (n=51). We analyzed actuarial freedom from any cardiac rejection, acute cellular rejection, and antibody-mediated rejection, and survival rates by sensitized status with panel-reactive antibody levels <10%, 10% to 50%, and >50%, and compared these survival rates with those from the United Network for Organ Sharing database. There was no difference in 15-year survival between the 2 age groups (35±12.4% and 49±17.3%, ≥60 versus <60 years; P=0.45). There was no difference in 15-year survival between the dialysis and nondialysis groups (44±13.4% and 37±15.2%, P=0.95). Actuarial freedom from any cardiac rejection ( acute cellular rejection >0 or antibody-mediated rejection >0) was 92±2.8% and 84±3.8%, acute cellular rejection (≥2R/3A) 98±1.5% and 94±2.5%, and antibody-mediated rejection (≥1) 96±2.1% and 93±2.6% at 30 days and 1 year after HKT x. There was no difference in the 5-year survival among recipients by sensitization status with panel-reactive antibody levels <10%, 10% to 50%, and >50% (82±5.9%, 83±10.8%, and 92±8.0%; P=0.55). There was no difference in 15-year survival after HKT x between the United Network for Organ Sharing database and our center (38±3.2% and 40±10.1%, respectively; P=0.45). Conclusions HKT x is safe to perform in patients 60 years and older or younger than 60 years and with or without dialysis dependence, with excellent outcomes. The degree of panel-reactive antibody sensitization did not appear to affect survival after HKT x.


Assuntos
Previsões , Rejeição de Enxerto/epidemiologia , Insuficiência Cardíaca/cirurgia , Transplante de Coração , Transplante de Rim , Insuficiência Renal/terapia , Idoso , Feminino , Seguimentos , Insuficiência Cardíaca/complicações , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Prognóstico , Diálise Renal , Insuficiência Renal/complicações , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Estados Unidos/epidemiologia , Listas de Espera/mortalidade
19.
Eur Heart J Cardiovasc Imaging ; 20(4): 455-466, 2019 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-30107509

RESUMO

AIMS: Percutaneous edge-to-edge repair alters mitral valve (MV) geometry in functional mitral regurgitation (FMR). We sought to characterize MV morphology in patients with central and eccentric FMR, compare the geometrical effect of MitraClip therapy, and elucidate different mechanisms of MR improvement according to FMR subtypes. METHODS AND RESULTS: Seventy-six symptomatic patients with Grade 3 to 4+ FMR (central, n = 39; eccentric, n = 37) underwent three-dimensional transoesophageal echocardiography during MitraClip implantation. We defined procedural success as a reduction of MR by ≥1 grade with having a residual mitral regurgitation (MR) of ≤ grade 2+. Procedural success rate was similar between central and eccentric FMR (77% vs. 78%, P = 0.55). After MitraClip, the reduction in anterior-posterior diameter did not differ between FMR subtypes, but patients with eccentric FMR had a greater reduction in the averaged tethering angle difference (P < 0.001) with less reduction in tenting volume and height (both P < 0.001) than did patients with central FMR. On multivariable analysis, in central FMR, MR reduction post-clip was associated with shortening in anterior-posterior diameter [coefficient 0.388, 95% confidence interval (CI) 0.216-0.561; P < 0.001] and an increase in coaptation area (coefficient 0.117, 95% CI 0.039-0.194; P = 0.004), whereas in eccentric FMR MR reduction was mainly associated with a decrease in the averaged tethering angle difference (coefficient 0.050, 95% CI 0.021-0.078; P = 0.001). CONCLUSION: MV geometrical effect and its association with MR improvement after MitraClip therapy differ according to FMR subtypes. Our results indicate the MR jet direction and the leaflet tethering pattern may be considered in the strategy for percutaneous treatment for FMR.


Assuntos
Implante de Prótese Vascular , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Implante de Prótese Vascular/métodos , Ecocardiografia Transesofagiana , Feminino , Humanos , Imageamento Tridimensional , Masculino , Estudos Retrospectivos
20.
Circulation ; 139(1): 37-47, 2019 01 02.
Artigo em Inglês | MEDLINE | ID: mdl-30586701

RESUMO

BACKGROUND: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System). METHODS: Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality ≥12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated. RESULTS: A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3±10.5 years; Society of Thoracic Surgeons risk, 10.2±6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR ≤2+. At 1 year, there were 139 deaths, and the Kaplan-Meier estimate of freedom from mortality was 76.8%. The majority of surviving patients (84.7%) remained with MR ≤2+ and New York Heart Association class I/II (83.0%). Kaplan-Meier survival at 1 year was 74.1% in HR patients and 86.4% in non-HR patients ( P=0.0175). At 1 year, both groups achieved comparable MR reduction (MR ≤2+, 84.0% versus 87.0%) and improvement in left ventricular end-diastolic volume (-8.0 mL versus -12.7 mL), whereas New York Heart Association class I/II was found in 80.1% versus 91.8% ( P=0.008) of HR and non-HR patients, respectively. In HR patients, the annualized rate of heart failure hospitalizations decreased from 0.68 to 0.46 in the 12 months before to 12 months after the procedure ( P<0.0001). CONCLUSIONS: Transcatheter mitral valve repair with the MitraClip in patients with secondary MR is associated with acceptable safety, reduction of MR severity, symptom improvement, and positive ventricular remodeling. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov . Unique identifiers: NCT00209274, NCT01940120, and NCT01931956.


Assuntos
Cateterismo Cardíaco/instrumentação , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Ecocardiografia Transesofagiana , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Desenho de Prótese , Recuperação de Função Fisiológica , Sistema de Registros , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
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