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1.
Cardiovasc Revasc Med ; 21(8): 959-963, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32387217

RESUMO

BACKGROUND: The advent of transcatheter aortic valve replacement (TAVR) has changed which patients undergo surgical aortic valve replacement (SAVR). We sought to understand the impact of TAVR on the characteristics of SAVR patients in the United States. METHODS: A cohort of 2959 patients who underwent isolated SAVR at 11 US hospitals that perform both TAVR and SAVR from 2013 through 2017 were grouped by the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database version (v)2.73 (2011-2014), v2.81 (2014-2017), and v2.9 (2017) to assess temporal trends in patient characteristics. RESULTS: Over time, SAVR patients were younger with fewer preoperative comorbidities. There was a significant decrease in median STS predicted risk of mortality (PROM) score (2.0 vs. 1.8 vs. 1.3, p < 0.001, in v2.73 vs. v2.81 vs. v2.9). Specifically, there were fewer high-risk (STS PROM > 8%: 4.3% vs. 4.7% vs. 1.2%, p = 0.03) and intermediate-risk (STS PROM 4% to 8%: 16.3% vs. 11.7% vs. 4.3%, p < 0.001) patients. The proportion of patients with bicuspid aortic valve disease increased significantly (11.2% vs. 26.9% vs. 36.6%, p < 0.001). There were no differences in operative mortality (1.9% vs. 2.1% vs. 1.4%, p = 0.75). CONCLUSIONS: The introduction of TAVR has already impacted the demographics, clinical characteristics and risk profiles of patients undergoing SAVR in the US. Now that TAVR is approved for low-risk patients, SAVR is likely to be reserved for younger patients who are willing to receive a mechanical valve and for patients with aortopathy, coronary artery disease, or concomitant mitral or tricuspid pathology.


Assuntos
Valva Aórtica/cirurgia , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/tendências , Substituição da Valva Aórtica Transcateter/tendências , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Tomada de Decisão Clínica , Comorbidade , Bases de Dados Factuais , Feminino , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/mortalidade , Doenças das Valvas Cardíacas/fisiopatologia , Próteses Valvulares Cardíacas/tendências , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Estados Unidos
2.
JACC Cardiovasc Interv ; 12(10): 901-907, 2019 05 27.
Artigo em Inglês | MEDLINE | ID: mdl-30860059

RESUMO

OBJECTIVES: This study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients. BACKGROUND: Early results from the LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement. METHODS: The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year. RESULTS: The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%). At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two (1.0%) subjects underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53). CONCLUSIONS: TAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Estudos de Viabilidade , Feminino , Hemodinâmica , Humanos , Masculino , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Recuperação de Função Fisiológica , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Índices de Gravidade do Trauma , Resultado do Tratamento , Estados Unidos
3.
J Am Coll Cardiol ; 72(18): 2095-2105, 2018 10 30.
Artigo em Inglês | MEDLINE | ID: mdl-30170075

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is now the standard of care for patients with symptomatic severe aortic stenosis who are extreme, high, or intermediate risk for surgical aortic valve replacement (SAVR). OBJECTIVES: The authors sought to evaluate TAVR in a prospective multicenter trial involving low-risk patients. METHODS: The Low Risk TAVR (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis) trial was the first U.S. Food and Drug Administration-approved Investigational Device Exemption trial to enroll in the United States. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days. RESULTS: The authors enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The authors compared outcomes with an inverse probability weighting-adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke rate in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% vs. 4.5%). The rates of new-onset atrial fibrillation (3.0%) and length of stay (2.0 ± 1.1 days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days. CONCLUSIONS: TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days. (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis [Low Risk TAVR; NCT02628899).


Assuntos
Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco
4.
Ann Thorac Surg ; 105(5): 1322-1329, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29253463

RESUMO

BACKGROUND: The Placement of Aortic Transcatheter Valves 2A (PARTNER-2A) randomized trial compared outcomes of transfemoral transcatheter and surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe aortic stenosis. The purpose of the present study was to perform an in-depth analysis of outcomes after SAVR in the PARTNER-2A trial. METHODS: From January 2012 to January 2014, 937 patients underwent SAVR at 57 centers. Mean age was 82 ± 6.7 years and 55% were men. Less-invasive operations were performed in 140 patients (15%) and concomitant procedures in 198 patients (21%). Major outcomes and echocardiograms were adjudicated by an independent events committee. Follow-up was 94% complete to 2 years. RESULTS: Operative mortality was 4.1% (n = 38, Society of Thoracic Surgeons predicted risk of mortality: 5.2% ± 2.3%), observed to expected ratio (O/E) was 0.8, and in-hospital stroke was 5.4% (n = 51), twice expected. Aortic clamp and bypass times were 75 ± 30 minutes and 104 ± 46 minutes, respectively. Patients having severe prosthesis-patient mismatch (n = 260, 33%) had similar survival to patients without (p > 0.9), as did patients undergoing less-invasive SAVR (p = 0.3). Risk factors for death included cachexia (p = 0.004), tricuspid regurgitation (p = 0.01), coronary artery disease (p = 0.02), preoperative atrial fibrillation (p = 0.001), higher white blood cell count (p < 0.0001), and lower hemoglobin (p = 0.0002). CONCLUSIONS: In this adjudicated prospective study, SAVR in intermediate-risk patients had excellent results at 2 years. However, there were more in-hospital strokes than expected, most likely attributable to mandatory neurologic assessment after the procedure. No pronounced structural valve deterioration was found during 2-year follow-up. Continued long-term surveillance remains important.


Assuntos
Estenose da Valva Aórtica/cirurgia , Complicações Pós-Operatórias/epidemiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Estudos de Coortes , Feminino , Mortalidade Hospitalar , Humanos , Tempo de Internação , Masculino , Fatores de Risco , Taxa de Sobrevida , Resultado do Tratamento
5.
Am Heart J ; 189: 103-109, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28625366

RESUMO

BACKGROUND: Safety and effectiveness of transcatheter aortic valve replacement (TAVR) in low-risk patients with symptomatic severe aortic stenosis have not yet been established. HYPOTHESIS: Transcatheter aortic valve replacement is feasible in patients with symptomatic severe aortic stenosis and low risk for surgical aortic valve replacement. DESIGN: The LRT study is the first US Food and Drug Administration-approved Investigational Device Exemption prospective multicenter feasibility trial of TAVR in low-risk patients. Patients determined to be low risk by the Heart Team will be enrolled to undergo TAVR with a commercially available balloon-expandable or self-expandable device. A propensity score-matched, site-specific cohort of historical surgical aortic valve replacement patients will serve as a control group treated during the site's enrollment period or within the prior 3 years. Low-risk patients with symptomatic bicuspid aortic stenosis undergoing TAVR will be enrolled into a separate registry arm. All TAVR patients will undergo 4-dimensional contrast-enhanced cardiac computed tomography 4-6 weeks after implantation to assess for subclinical leaflet thrombosis and will be followed up clinically for 5 years with yearly echocardiography to monitor prosthesis function. SUMMARY: The LRT study will test feasibility of TAVR in low-risk patients with symptomatic severe aortic stenosis in the United States with either tricuspid or bicuspid native aortic valves. Enrollment commenced in 2016 and results are expected in 2018.


Assuntos
Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Estenose da Valva Aórtica/diagnóstico , Ecocardiografia , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Masculino , Estudos Prospectivos , Fatores de Risco , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X , Resultado do Tratamento
6.
J Spec Oper Med ; 17(2): 74-81, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28599037

RESUMO

The combat focus of the US Military over the past 15 years has primarily centered on the Iraq and Afghanistan areas of operation (AOs). Thus, much human and financial capital has been dedicated to the creation of a robust medical infrastructure to support those operations. However, Special Operation Forces (SOF) are often called upon to deploy in much more medically austere AOs. SOF medical providers operating in such environments face significant challenges due to the diversity of medical threats, extremely limited access to medical resupply, a material shortage of casualty evacuation platforms, lack of medical facilities, and limited access to higher-level care providers. This article highlights the challenges faced during a recent Special Forces deployment to such an austere environment. Many of these challenges can be mitigated with a specific approach to premission training and preparation.


Assuntos
Doenças Transmissíveis/terapia , Meio Ambiente , Recursos em Saúde , Hospitais Militares , Medicina Militar , Unidades Móveis de Saúde , Ferimentos e Lesões/terapia , África , Transfusão de Sangue , Técnicas de Laboratório Clínico , Humanos , Refugiados , Sudão , Medicina Tropical/educação
7.
J Am Coll Cardiol ; 69(4): 381-391, 2017 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-28040318

RESUMO

BACKGROUND: Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR. OBJECTIVES: This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery. METHODS: Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes. RESULTS: Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m2 at baseline vs. 72.1 ± 19.3 ml/m2 at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m2 vs. 43.1 ± 16.2 ml/m2; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%. CONCLUSIONS: TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514).


Assuntos
Implante de Prótese de Valva Cardíaca/métodos , Insuficiência da Valva Mitral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Cateterismo , Ecocardiografia , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tomografia Computadorizada por Raios X , Resultado do Tratamento
9.
Cardiovasc Revasc Med ; 17(5): 318-21, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27394178

RESUMO

OBJECTIVE: To compare early and late mortality of transfemoral (TF) and transapical (TA) transcatheter aortic valve replacement (TAVR) patients and assess predictors for mortality. BACKGROUND: Studies have shown conflicting results regarding impact of access on outcome in severe aortic stenosis (AS) patients undergoing TAVR. METHODS: AS patients undergoing TAVR between May 2007-December 2014 were included. Baseline demographic, clinical, and imaging parameters were compared according to access, and landmark analysis models were generated to assess outcomes and associated factors. RESULTS: Among 648 severe AS patients undergoing TAVR, TF was used in 516 and TA in 132. Baseline characteristics between groups demonstrated lower body mass index, higher STS score, and rate of peripheral vascular disease among TA patients. Procedural complications were more common in the TA group, especially major bleeding (15% vs. 6%, p<0.001) and acute kidney injury >1 (8% vs. 1.4%, p<0.001). Landmark analysis demonstrated higher cumulative mortality rates at 30days among TA than TF patients (log-rank p<0.001), with similar mortality after 30days and up to 1-year (13% in both log-rank p=0.64). In a multivariate model, TA was an independent predictor of early mortality (HR=4.55 95% CI [12.5-1.6], p=0.003) along with pulmonary artery systolic pressure>60mmHg (HR=3.08 95% CI [7.37-1.29], p=0.01) and residual aortic regurgitation severity above mild (HR=3.99 95% CI [10.2-1.56], p=0.004). CONCLUSIONS: Patients undergoing TAVR via TA have higher adjusted early mortality and similar late mortality rates compared to TF, despite higher risk profile.


Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica , Cateterismo Cardíaco/métodos , Cateterismo Periférico/métodos , Artéria Femoral , Implante de Prótese de Valva Cardíaca/métodos , Artéria Radial , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/mortalidade , Distribuição de Qui-Quadrado , District of Columbia , Feminino , Artéria Femoral/diagnóstico por imagem , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Hospitais com Alto Volume de Atendimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Análise Multivariada , Modelos de Riscos Proporcionais , Punções , Artéria Radial/diagnóstico por imagem , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
11.
Am J Cardiol ; 117(5): 839-46, 2016 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-26873331

RESUMO

The impact of the specific etiology of mitral regurgitation (MR) on outcomes in the transcatheter aortic valve replacement (TAVR) population is unknown. This study aimed to evaluate the longitudinal changes in functional versus organic MR after TAVR in addition to their impact on survival. Consecutive patients who underwent TAVR from May 2007 to May 2015 who had baseline significant (moderate or greater) MR were included. Transthoracic echocardiography was used to evaluate the cohort at baseline, post-procedure, 30-day, 6-month, and 1-year follow-up. The primary outcomes included mortality at 30 days and 1 year. Longitudinal, mixed-model regression analyses were performed to assess the differences in the magnitude of longitudinal changes of MR, left ventricular (LV) ejection fraction, and New York Heart Association functional class. Seventy patients (44% men, mean 83 years) with moderate or greater MR at baseline (30 functional vs 40 organic) were included, with the functional group having a statistically significant mean younger age and higher rates of previous coronary artery bypass grafting. Kaplan-Meier cumulative mortality rates were similar: 30 days (10% vs 17.5%, unadjusted log-ranked p = 0.413) and 1 year (29.4% vs 23.2%, unadjusted log-ranked p = 0.746) in the functional versus organic MR groups, respectively. There were greater degrees of short- and long-term improvement in MR severity (slope difference p = 0.0008), LV ejection fraction (slope difference p = 0.0009), and New York Heart Association class (slope difference p = 0.0054) in the functional versus organic group. In conclusion, patients with significant functional versus organic MR who underwent TAVR have similar short- and long-term survival; nevertheless, those with a functional origin are more likely to have significant improvements in MR severity, LV-positive remodeling, and functional class. These findings may help strategize therapies for MR in patients with combined aortic and mitral valve disease who are undergoing TAVR.


Assuntos
Estenose da Valva Aórtica/cirurgia , Insuficiência da Valva Mitral/fisiopatologia , Complicações Pós-Operatórias , Substituição da Valva Aórtica Transcateter/efeitos adversos , Função Ventricular Esquerda/fisiologia , Remodelação Ventricular/fisiologia , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , District of Columbia/epidemiologia , Ecocardiografia , Feminino , Seguimentos , Humanos , Masculino , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/mortalidade , Prognóstico , Estudos Retrospectivos , Índice de Gravidade de Doença , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
12.
Am J Cardiol ; 117(2): 305-9, 2016 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-26684518

RESUMO

This analysis was designed to (1) examine the impact of heparin-induced thrombocytopenia (HIT) on contemporary cardiac surgical practice and (2) describe the results of a protocol designed for early identification of the presence of the immune mechanisms involved. Consecutive patients who underwent cardiac surgery were screened postoperatively for thrombocytopenia. Patients with thrombocytopenia were tested for antiplatelet factor 4 (PF4)/heparin antibodies by ELISA and clinical evidence of thrombosis sought. Demographics, co-morbidities, operative details, and outcomes were abstracted from the departmental registry. Of 14,415 consecutive patients undergoing cardiac surgery, 1,849 patients (13%) had thrombocytopenia. Of them, 277 patients (15%) had PF4/heparin antibodies and 76 patients (4%) had both antibodies and clinical thrombosis. Antibodies were more frequent: (1) in women (p = 0.01), (2) in patients with an increased body mass index (p <0.01), and (3) in patients with clinical heart failure before surgery (p <0.01). Thirty-day mortality was greatest among the 76 patients with the triad of thrombocytopenia, antibodies, and clinical thrombosis (30%). Of the 1,849 patients with thrombocytopenia, the presence of PF4/heparin antibodies was an independent predictor of 30-day mortality (odds ratio 2.09, 95% CI 1.46 to 2.49; p <0.001). HIT remains an infrequent but very serious complication of heparin therapy in contemporary cardiac surgical practice. The possibility that the presence of HIT antibodies in patients with thrombocytopenia independently increases operative mortality deserves further study.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Diagnóstico Precoce , Heparina/efeitos adversos , Trombocitopenia/induzido quimicamente , Trombocitopenia/diagnóstico , Anticoagulantes/efeitos adversos , Humanos , Complicações Pós-Operatórias , Fatores de Risco
13.
J Thorac Cardiovasc Surg ; 150(3): 557-68.e11, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26238287

RESUMO

OBJECTIVES: The study objectives were to (1) compare the safety of high-risk surgical aortic valve replacement in the Placement of Aortic Transcatheter Valves (PARTNER) I trial with Society of Thoracic Surgeons national benchmarks; (2) reference intermediate-term survival to that of the US population; and (3) identify subsets of patients for whom aortic valve replacement may be futile, with no survival benefit compared with therapy without aortic valve replacement. METHODS: From May 2007 to October 2009, 699 patients with high surgical risk, aged 84 ± 6.3 years, were randomized in PARTNER-IA; 313 patients underwent surgical aortic valve replacement. Median follow-up was 2.8 years. Survival for therapy without aortic valve replacement used 181 PARTNER-IB patients. RESULTS: Operative mortality was 10.5% (expected 9.3%), stroke 2.6% (expected 3.5%), renal failure 5.8% (expected 12%), sternal wound infection 0.64% (expected 0.33%), and prolonged length of stay 26% (expected 18%). However, calibration of observed events in this relatively small sample was poor. Survival at 1, 2, 3, and 4 years was 75%, 68%, 57%, and 44%, respectively, lower than 90%, 81%, 73%, and 65%, respectively, in the US population, but higher than 53%, 32%, 21%, and 14%, respectively, in patients without aortic valve replacement. Risk factors for death included smaller body mass index, lower albumin, history of cancer, and prosthesis-patient mismatch. Within this high-risk aortic valve replacement group, only the 8% of patients with the poorest risk profiles had estimated 1-year survival less than that of similar patients treated without aortic valve replacement. CONCLUSIONS: PARTNER selection criteria for surgical aortic valve replacement, with a few caveats, may be more appropriate, realistic indications for surgery than those of the past, reflecting contemporary surgical management of severe aortic stenosis in high-risk patients at experienced sites.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Alocação de Recursos para a Atenção à Saúde , Implante de Prótese de Valva Cardíaca , Seleção de Pacientes , Avaliação de Processos em Cuidados de Saúde , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Benchmarking , Feminino , Alocação de Recursos para a Atenção à Saúde/normas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Implante de Prótese de Valva Cardíaca/normas , Mortalidade Hospitalar , Humanos , Estimativa de Kaplan-Meier , Masculino , Futilidade Médica , Complicações Pós-Operatórias/mortalidade , Avaliação de Processos em Cuidados de Saúde/normas , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
14.
Am J Cardiol ; 116(2): 256-63, 2015 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-25978977

RESUMO

Mortality after transcatheter aortic valve implantation (TAVI) has been reported to range up to 3 years. However, long-term mortality remains underexplored. The aims of this study were to determine long-term mortality in patients who undergo TAVI and to identify correlates of long-term death. From a single institution's prospectively collected TAVI database, all patients who underwent TAVI with a maximum follow-up duration of 5 years were analyzed. The population was analyzed on the basis of access route (transapical TAVI or transfemoral TAVI). Cox regression and Kaplan-Meier survival analysis were conducted. A total of 511 patients who underwent TAVI were included in the analysis (transapical TAVI n = 115, transfemoral TAVI n = 396). The mean Society of Thoracic Surgeons score was 9.6 ± 4. Mortality at 30 days (18% vs 6%, p <0.001) and 1 year (32% vs 21%, p <0.01) was significantly increased in the transapical TAVI group. Long-term survival probability was <50% for the 2 approaches (log-rank p = 0.33). Vascular complications (hazard ratio [HR] 2.14, 95% confidence interval [CI] 1.38 to 3.33, p = 0.001), more than mild aortic insufficiency (HR 1.81, 95% CI 1.15 to 2.83, p = 0.01), atrial fibrillation (HR 1.87, 95% CI 1.36 to 2.57, p <0.001), and in-hospital stroke (HR 2.35, 95% CI 1.39 to 4.00, p = 0.002) were independently associated with long-term death. The survival probability of patients at high surgical risk versus those who were inoperable was similar in the long term (log-rank p = 0.53). In conclusion, the overall long-term survival of patients with aortic stenosis who were approved to undergo TAVI was <50% irrespective of access method. Strategies geared toward reducing in-hospital stroke, vascular complications, and aortic regurgitation are still needed, as these variables are correlates of long-term mortality.


Assuntos
Estenose da Valva Aórtica/cirurgia , Hospitais com Alto Volume de Atendimentos/estatística & dados numéricos , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , District of Columbia/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Período Pós-Operatório , Prognóstico , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo
15.
Am J Cardiol ; 115(9): 1260-4, 2015 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-25759105

RESUMO

Risk assessment for transcatheter aortic valve replacement (TAVR) patients is challenging, and surgical scores do not optimally correlate with outcome. The aim of this study was to assess the correlation between serum albumin and survival of patients with symptomatic severe aortic stenosis undergoing TAVR. Patients with severe aortic stenosis who underwent TAVR were categorized into 2 groups according to low and normal preprocedural serum albumin (<3.5 and ≥3.5 g/dl, respectively). The all-cause mortality rates at hospital discharge, at 30-day and 1-year follow-up were compared across the groups. Additionally, a Cox proportional-hazards model was generated to assess the independent effect of serum albumin at 1-year follow-up. Among 567 consecutive patients who underwent TAVR, 476 (84%) had documented preprocedural serum albumin measurements. Of these, 50% had low serum albumin levels, and 50% had normal serum albumin levels. Baseline and procedural characteristics, including age, gender, and transapical access, were similar among the groups. Prevalence of left ventricular ejection fraction<40% was higher in patients with low albumin (29% vs 20%, p=0.02), and risk assessment according to Society of Thoracic Surgeons score tended to be higher in the low-albumin group (10±4.7 vs 9.4±4.4, p=0.09). Patients presenting with low albumin had higher in-hospital mortality (11% vs 5%), as well as at 30-day (12% vs 6%, p=0.01) and 1-year (29% vs 19%, p=0.02) follow-up. Serum albumin was independently associated with 1-year mortality (adjusted hazard ratio per 0.1 g/dl decrease 1.64, 95% confidence interval 2.50 to 1.75, p=0.02), along with body mass index<20 kg/m2 (hazard ratio 1.89, 95% confidence interval 3.33 to 1.75, p=0.03). In conclusion, preprocedural serum albumin level and low body mass index are independently associated with mortality in patients who undergo TAVR. Patients with severe aortic stenosis and low albumin levels should undergo careful evaluation before and after TAVR.


Assuntos
Estenose da Valva Aórtica/sangue , Estenose da Valva Aórtica/cirurgia , Albumina Sérica/metabolismo , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Índice de Massa Corporal , Feminino , Seguimentos , Humanos , Masculino , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Medição de Risco , Volume Sistólico , Taxa de Sobrevida , Resultado do Tratamento , Estados Unidos
16.
Ann Thorac Surg ; 98(1): 91-6, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24815908

RESUMO

BACKGROUND: An intraoperative decline in regional cerebral oxygen saturation (rSO2) has been associated with postoperative injury to the central nervous system. Wide individual variation in steady-state cerebral oxygen saturation limits the clinical use of rSO2 to monitoring during anesthesia and surgical procedures. Recently, low preoperative rSO2 has been proposed as a predictor of adverse postoperative outcomes in cardiovascular operations. We compared the sensitivity and specificity of preinduction rSO2 as a predictor of adverse operative events and compared this to the widely accepted risk index developed by the Society for Thoracic Surgeons. METHODS: 2,097 consecutive white patients who underwent cardiac operations from 2010 through 2012 were included. In 1,496 patients (group 1) the preinduction rSO2 was equal to or greater than 60%, whereas in the remaining 601 patients (group 2) it was below 60%. We compared the predictive accuracy of preinduction rSO2 with that of the STS mortality risk score by means of standard statistical techniques, including a receiver operating curve characteristic analysis. RESULTS: Patients with a preinduction rSO2 below 60% had significantly higher STS mortality risk scores than did patients with an rSO2 equal to or greater than 60% (2.0 vs 4.0, p<0.001). Those with an rSO2 below 60% experienced higher operative mortality (p<0.001) and after adjustment this determination emerged as an independent predictor of increased mortality (p<0.001). Receiver operating characteristic curve analysis demonstrated that the rSO2 was slightly less accurate as a mortality predictor (area under the curve: 0.71 vs 0.85). CONCLUSIONS: Measurement of rSO2 is considerably less complex than calculation of the STS score and is only slightly less accurate as a predictor of operative mortality. It may be useful when the STS mortality risk score cannot be calculated.


Assuntos
Química Encefálica , Encéfalo/irrigação sanguínea , Procedimentos Cirúrgicos Cardíacos , Oximetria/métodos , Consumo de Oxigênio/fisiologia , Oxigênio/análise , Complicações Pós-Operatórias/mortalidade , Idoso , Encéfalo/metabolismo , Feminino , Seguimentos , Humanos , Masculino , Complicações Pós-Operatórias/metabolismo , Período Pós-Operatório , Valor Preditivo dos Testes , Curva ROC , Estudos Retrospectivos , Espectroscopia de Luz Próxima ao Infravermelho , Taxa de Sobrevida , Estados Unidos/epidemiologia
17.
Interact Cardiovasc Thorac Surg ; 18(5): 562-7, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24497605

RESUMO

OBJECTIVES: Thrombocytopenia is very common after cardiac surgery, but rarely studied systematically. Heparin-induced thrombocytopenia has been studied extensively, but the diagnosis remains clouded by the lack of sensitivity and specificity of laboratory tests. It remains unknown whether a local initiative of screening program has been successful in the management of postoperative thrombocytopenia. METHODS: We have implemented a screening protocol since 2002. Cardiac surgery patients were postoperatively screened for thrombocytopenia. Thrombocytopenia was stratified by the anti-platelet factor 4/heparin antibody (enzyme-immune assay, Elisa) test. The presence of clinical embolithrombosis was sought in patients with antibodies. Preoperative and operative characteristics and outcomes were obtained from the departmental registry of cardiac surgical procedures. RESULTS: A total of 16 529 patients were screened for thrombocytopenia from January 2003 to 2012. One thousand two hundred and sixty-one patients undergoing isolated aortic valve replacement (AVR) were included in this study. The overall incidence of thrombocytopenia after AVR was 26.8%. Elisa (+) occurred in 43 of the 1261 patients (3.4%), Elisa (+) plus thrombosis occurred in 14 (1.1%) and in 32.6% of Elisa (+) patients. Age and preoperative lower platelet count were independent predictors of thrombocytopenia. Elisa (+) alone was associated with increased operative mortality, stroke and bleeding. Patients developed thrombocytopenia and Elisa (+) were more likely to receive bioprosthetic valves. CONCLUSIONS: Thrombocytopenia and Elisa (+) are more common after AVR than after other procedures, and both were associated with increased adverse clinical outcomes. Age and lower preoperative platelet count were associated with postoperative thrombocytopenia and Elisa (+).


Assuntos
Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Trombocitopenia/etiologia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anticorpos/sangue , Anticoagulantes/imunologia , Anticoagulantes/uso terapêutico , Biomarcadores/sangue , Bioprótese , Ensaio de Imunoadsorção Enzimática , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Heparina/imunologia , Heparina/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Contagem de Plaquetas , Fator Plaquetário 4/imunologia , Valor Preditivo dos Testes , Estudos Retrospectivos , Fatores de Risco , Trombocitopenia/sangue , Trombocitopenia/diagnóstico , Trombocitopenia/imunologia , Trombocitopenia/mortalidade , Fatores de Tempo , Resultado do Tratamento
18.
J Card Surg ; 28(6): 749-55, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-24224744

RESUMO

BACKGROUND: The diagnosis and the management of traumatic thoracic aortic injuries have undergone significant changes due to new technology and improved prehospital care. Most of the discussions have focused on descending aortic injuries. In this review, we discuss the recent management of ascending aortic injuries. METHODS: We found 5 cohort studies on traumatic aortic injuries and 11 case reports describing ascending aortic injuries between 1998 to the present through Medline research. RESULTS: Among case reports, 78.9% of cases were caused by motor vehicle accidents (MVA). 42.1% of patients underwent emergent open repair and the operative mortality was 12.5%. 36.8% underwent delayed repair. Associated injuries occurred in 84.2% of patients. Aortic valve injury was concurrent in 26.3% of patients. The incidence of ascending aortic injury ranged 1.9-20% in cohort studies. CONCLUSIONS: Traumatic injuries to the ascending aorta are relatively uncommon among survivors following blunt trauma. Aortography has been replaced by computed tomography and echocardiography as a diagnostic tool. Open repair, either emergent or delayed, remains the treatment of choice.


Assuntos
Aorta/lesões , Aorta/cirurgia , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Traumatismos Torácicos/complicações , Ferimentos não Penetrantes/complicações , Aorta/diagnóstico por imagem , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/lesões , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Aortografia , Estudos de Coortes , Ecocardiografia , Ecocardiografia Transesofagiana , Emergências , Implante de Prótese de Valva Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Assistência Perioperatória , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/métodos
19.
Heart Surg Forum ; 16(3): E170-6, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23803246

RESUMO

BACKGROUND: An impaired right ventricular function is associated with a poor survival rate in patients with heart failure. Few investigations have analyzed the prognostic value of right ventricular function on the outcomes of mitral valve (MV) surgery. The objectives of this study were to define the effect of right ventricular function on postoperative outcomes after MV repair (MVP) or replacement (MVR). METHODS: From September 2007 to February 2012, 335 consecutive patients underwent MVP or MVR at our institution. Preoperative transthoracic and transesophageal echocardiography (TEE) and postoperative TEE were used to define right ventricular function and MV performance. Preoperative right ventricular function was graded as normal to mild (grade 1-2) or as moderate to severe (grade 3-4). MV or tricuspid valve regurgitation was graded as non-trivial to mild (grade 0-2) or as moderate to severe (grade 3-4) preoperatively and postoperatively. Survival rate was evaluated at 1 year after surgery. RESULTS: Of the 334 patients in the study, 280 patients showed a normal to a mildly impaired right ventricular function preoperatively (group 1). Fifty-four patients presented with moderate to severe right ventricular dysfunction (group 2). Patients with a compromised right ventricular function were more likely to undergo MVR (28.6% versus 53.7%, P <.001). The mean pulmonary artery pressure was 23.6 mm Hg in group 1 and 34 mm Hg in group 2 (P <.001). The left atrial diameter was 4.6 cm in group 1 and 5.3 cm in group 2 (P <.001). The 2 groups were not different with respect to operative mortality, but the patients in group 2 experienced more transfusion of blood products (588.4 mL versus 1180.6 mL, P <.001), longer intensive care unit stays (83.9 versus 149.6 hours, P <.001), and hospital stays (8.9 versus 12.8 days, P = .005). The rate of postoperative MV regurgitation was significantly higher in group 2 (1.8 versus 14.8%, P <.001). The overall 1-year survival rate was 92.5% in group 1 and 94.5% in group 2 (P = .59). CONCLUSIONS: This study has shown that a dysfunctional preoperative right ventricular function uses more resources and is associated with postoperative MV regurgitation, but it is not associated short- and mid-term mortality after MV surgery.


Assuntos
Implante de Prótese de Valva Cardíaca/mortalidade , Anuloplastia da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/cirurgia , Disfunção Ventricular Direita/mortalidade , Disfunção Ventricular Direita/cirurgia , Comorbidade , District of Columbia/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Prognóstico , Estudos Retrospectivos , Medição de Risco , Análise de Sobrevida , Taxa de Sobrevida , Resultado do Tratamento
20.
Am J Cardiol ; 111(9): 1337-43, 2013 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-23415511

RESUMO

The incidence and prognostic implication of myocardial injury after transcatheter aortic valve replacement (TAVR) have not been consistently studied. We aimed to assess the incidence and extent of myocardial injury after TAVR performed using transfemoral and transapical approaches. The clinical data from patients with aortic stenosis who underwent TAVR were retrospectively analyzed. The myocardial necrosis markers cardiac troponin I and creatine kinase (CK)-MB were assessed during hospitalization. Of the 150 TAVR patients, 95% and 50% had an abnormally elevated cardiac troponin I and CK-MB level, respectively. The transapical patients had significantly greater elevations of both cardiac troponin I (13.8 ± 14.0 vs 2.5 ± 5.8 ng/ml, p <0.001) and CK-MB (28.4 ± 24.2 vs 7.4 ± 8.6 ng/ml, p ≤0.001). On receiver operating curve analysis, postprocedural CK-MB (twofold increase) had high predictive power for 30-day mortality (area under the curve 0.85, p <0.001). Patients with high CK-MB levels had greater rates of postprocedural kidney injury (22% vs 6%, p = 0.026), in-hospital (22% vs 0%, p <0.001), 30-day (27% vs 1.5%, p <0.001), and 1-year mortality (41% vs 18%, p = 0.01). Baseline renal failure and no ß-blocker treatment on admission were independent predictors of an elevated postprocedural CK-MB level. In conclusion, a cardiac biomarker increase after TAVR was common and more frequent among transapical access patients. A twofold increase (>7 ng/ml) in CK-MB after transfemoral TAVR was a surrogate for poor long-term outcomes.


Assuntos
Estenose da Valva Aórtica/cirurgia , Traumatismos Cardíacos/epidemiologia , Próteses Valvulares Cardíacas , Complicações Intraoperatórias , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/mortalidade , Biomarcadores/sangue , Creatina Quinase/sangue , Creatina Quinase Forma MB/sangue , District of Columbia/epidemiologia , Feminino , Seguimentos , Traumatismos Cardíacos/diagnóstico , Traumatismos Cardíacos/etiologia , Humanos , Masculino , Miocárdio/metabolismo , Prevalência , Prognóstico , Estudos Retrospectivos , Índice de Gravidade de Doença , Taxa de Sobrevida/tendências , Troponina/sangue
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