Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 77
Filtrar
Mais filtros










Base de dados
Intervalo de ano de publicação
1.
JACC Cardiovasc Interv ; 13(2): 219-231, 2020 Jan 27.
Artigo em Inglês | MEDLINE | ID: mdl-31973795

RESUMO

OBJECTIVES: This study sought to evaluate the ability of individual markers of frailty to predict outcomes after transcatheter aortic valve replacement (TAVR) and of their discriminatory value in different age groups. BACKGROUND: Appropriate patient selection for TAVR remains a dilemma, especially among the most elderly and potentially frail. METHODS: The study evaluated patients ≥65 years of age in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry, linked to Centers for Medicare and Medicaid administrative claims data, receiving elective TAVR from November 2011 to June 2016 (n = 36,242). Indices of frailty included anemia, albumin level, and 5-m walk speed. We performed Cox proportional hazards regression for 30-day and 1-year mortality, adjusting for risk factors known to be predictive of 30-day mortality in the Transcatheter Valve Therapy registry, as well as survival analysis. RESULTS: These indices are independently associated with mortality at 30 days and 1 year and provide incremental value in risk stratification for mortality, with low albumin providing the largest value (hazard ratio: 1.52). Those with low albumin and slower walking speed had longer lengths of stay and higher rates of bleeding and readmission (p < 0.001). Those with anemia also had higher rates of bleeding, readmission, and subsequent myocardial infarction (p < 0.001). CONCLUSIONS: This represents the largest study to date of the role of frailty indices after TAVR, further facilitating robust modeling and adjusting for a large number of confounders. These simple indices are easily attainable, and clinically relevant markers of frailty that may meaningfully stratify patients at risk for mortality after TAVR.

2.
Circ Cardiovasc Interv ; 12(10): e008155, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31607151

RESUMO

BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (TAVR) is an option when a surgical valve demonstrates deterioration and dysfunction. This study reports 3-year results following valve-in-valve with self-expanding TAVR. METHODS: The CoreValve US Expanded Use Study is a prospective, nonrandomized, single-arm study that evaluates safety and effectiveness of TAVR in extreme risk patients with symptomatic failed surgical biologic aortic valves. Study end points include all-cause mortality, need for valve reintervention, hemodynamic changes over time, and quality of life through 3 years. Patients were stratified by presence of preexisting surgical valve prosthesis-patient mismatch. RESULTS: From March 2013 to May 2015, 226 patients deemed extreme risk (STS-PROM [Society of Thoracic Surgeons Predicted Risk of Mortality] 9.0±7%) had attempted valve-in-valve TAVR. Preexisting surgical valve prosthesis-patient mismatch was present in 47.2% of the cohort. At 3 years, all-cause mortality or major stroke was 28.6%, and 93% of patients were in New York Heart Association I or II heart failure. Valve performance was maintained over 3 years with low valve reintervention rates (4.4%), an improvement in effective orifice area over time and a 2.7% rate of severe structural valve deterioration. Preexisting severe prosthesis-patient mismatch was not associated with 3-year mortality but was associated with significantly less improvement in quality of life at 3-year follow-up (P=0.01). CONCLUSIONS: Self-expanding TAVR in patients with failed surgical bioprostheses at extreme risk for surgery was associated with durable hemodynamics and excellent clinical outcomes. Preexisting surgical valve prosthesis-patient mismatch was not associated with mortality but did limit patient improvement in quality of life over 3-year follow-up. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01675440.

3.
Am J Cardiol ; 124(7): 1091-1098, 2019 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-31362879

RESUMO

Transcatheter aortic valve implantation with a bioprosthetic valve of insufficient size is associated with a higher risk of aortic regurgitation (AR). The 31-mm CoreValve and the next generation 34-mm Evolut R bioprostheses were designed to address the need for larger diameter aortic annuli. This analysis examined the clinical and hemodynamic outcomes following commercial transcatheter aortic valve implantation with the 31-mm CoreValve and 34-mm Evolut R in the Society of Thoracic Surgeons/the American College of Cardiology Transcatheter Valve Therapy Registry. Patients receiving a 31-mm CoreValve or 34-mm Evolut R valve for symptomatic severe native aortic stenosis from January 2014 to September 2017 in the Transcatheter Valve Therapy Registry underwent propensity score matching using baseline demographics, clinical and frailty measures, and procedural variables. Procedural characteristics, in-hospital and 30-day clinical and echocardiographic outcomes were compared. Of 4545 patients implanted with a 31-mm CoreValve and 3036 patients with a 34-mm Evolut R valve, matching resulted in 1813 patient sets. Most patients were male (>92%), elderly (∼80 years) with the Society of Thoracic Surgeons score of 6.6%. Use of the 34-mm versus 31-mm valve resulted in shorter median procedural time (113.0 [85.0, 150.0] vs 93.0 [71.0, 126.0] min, p <0.001), higher device success (98.1% vs 93.9%, p <0.001), fewer pacemakers (16.7% vs 24.6%, p <0.001), less ≥moderate AR with the 34-mm (5.5% vs 13.7%), p <0.001) and shorter hospital stay (3.0 [2.0, 4.0] vs 4.0 [3.0, 6.0] days, p <0.001). In conclusion, this largest experience with the 34-mm Evolut R valve showed higher device success, reduced hospital stay, lower pacemaker rates and less ≥moderate AR compared with the 31-mm CoreValve bioprosthesis.

4.
Am J Cardiol ; 124(5): 781-788, 2019 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-31311661

RESUMO

Transcatheter aortic valve implantation (TAVI) is approved for treatment of symptomatic aortic stenosis in patients at increased risk for surgical valve replacement, but outcomes data in patients with severe native aortic regurgitation (AR) treated with TAVI remain limited. The objective of this analysis was to evaluate outcomes among patients identified in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent TAVI for native AR with a commercially available self-expanding valve system. From January 2014 to December 2017, 230 patients in the TVT Registry underwent TAVI for primary severe native AR using a commercially available self-expanding valve (n = 81, CoreValve; n = 149, Evolut R). For inclusion, AR was either pure or mixed with predominantly moderate/severe AR and mean aortic valve gradient ≤20 mm Hg. Thirty-day outcomes were evaluated using time-to-event methods. Device success was reported in 81.7% of patients (CoreValve, 72.2%; Evolut R, 86.9%; p = 0.0.01). Thirty-day all-cause mortality was 13.3%. All patients presented with moderate/severe AR at baseline; at 30 days, 9.1% of implanted patients with data continued to have moderate and 1.4% severe AR. There was a significant reduction in residual moderate/severe AR from the CoreValve to Evolut R device (19.1% vs 6.3%, p = 0.02). Multivariable analysis revealed factors associated with 30-day all-cause mortality include number of valves used (hazard ratio [HR] 2.361, 1.643 to 3.391, p <0.001), albumin < 3.3 mg/dL (HR 3.358, 1.551 to 7.273, p=0.002), and left ventricular ejection fraction (HR 0.978, 0.957 to 1.000, p = 0.047). Despite higher 30-day all-cause mortality, self-expanding TAVI may be an option in selected patients with AR who have no surgical options.


Assuntos
Insuficiência da Valva Aórtica/mortalidade , Insuficiência da Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Sistema de Registros , Substituição da Valva Aórtica Transcateter/mortalidade , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/diagnóstico por imagem , Causas de Morte , Feminino , Mortalidade Hospitalar/tendências , Humanos , Masculino , Análise Multivariada , Prognóstico , Modelos de Riscos Proporcionais , Desenho de Prótese , Estudos Retrospectivos , Medição de Risco , Taxa de Sobrevida , Resultado do Tratamento
5.
Artigo em Inglês | MEDLINE | ID: mdl-31255552

RESUMO

BACKGROUND: Predictors of hospital readmissions and tools to predict readmissions after TAVR are scarce. Our objective was to identify predictors of early hospital readmission following TAVR in contemporary clinical practice and develop a risk calculator. METHODS: Patients with a contemporary self-expanding TAVR between 2015 and 2017 in the STS/ACC/TVT Registry™ database were included. Patients were divided into a derivation and validation cohort (2:1). A risk score was calculated using the derivation cohort based on multivariable predictors of 30-day unplanned readmissions and applied to the validation cohort. RESULTS: A total of 10,345 TAVR patients at 350 centers were included. Unplanned 30-day hospital readmission was 9.2%. Patients with an early readmission had higher 30-day rates for mortality (2.3% vs. 0.8%, p ≪ 0.001), stroke (4.1% vs. 2.7% p = 0.009), major vascular complications (2.0% vs. 1.0%, p = 0.003) and new pacemaker implantation (25.7% vs. 18.6%, p ≪ 0.001). Multivariable predictors of 30-day readmission included diabetes, atrial fibrillation, advanced heart failure symptoms, home oxygen, decreased 5-m gait speed or the inability to walk, serum creatinine ≫1.6 mg/dL, index hospitalization length of stay ≫5 days, major vascular complication and ≥ moderate post-procedure aortic or mitral valve regurgitation. Based on these predictors, we stratified 30-day readmission risk into low-, moderate- and high-risk subsets. There was a 2.5× difference in readmission rates between the low- (5.8%) and high-risk subsets (14.6%). CONCLUSION: We stratified the risk of early hospital readmission after TAVR based on a simple scoring system. This score may improve discharge planning centered on the individual's readmission risk. SUMMARY: Unplanned readmissions in the United States are prevalent and costly accounting for $41.3 billion in annual hospital payments and are associated with adverse clinical outcomes. We found that diabetes, atrial fibrillation, advanced heart failure symptoms, home oxygen, frailty, acute kidney injury, prolonged hospitalization, major vascular complications, and moderate or worse post-procedure aortic or mitral valve regurgitation predicted of 30-day readmission following self-expanding TAVR. This information may improve discharge planning centered on each patient's readmission risk.

6.
Am Heart J ; 211: 45-53, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30831333

RESUMO

The Amulet IDE Trial is an ongoing, prospective, randomized, multi-national trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder for stroke prevention in comparison to the WATCHMAN Left Atrial Appendage Closure Device in patients with non-valvular atrial fibrillation. METHODS: Non-valvular atrial fibrillation patients at high risk of stroke (CHADS2 score ≥2 or a CHA2DS2-VASc score of ≥3) who are suitable candidates for left atrial appendage occlusion (LAAO) will be fully informed and requested to participate in the trial. A total of 1878 patients at up to 150 sites worldwide will be randomized in a 1:1 ratio between the AMPLATZER Amulet device (investigational) and the Boston Scientific WATCHMAN device (control). Each patient will be followed for 5 years, with follow-up assessments at discharge, 45 days, 3, 6, 9, 12, 18, and 24 months and then annually. The trial has three primary endpoints: A composite of procedure-related complications, or all-cause death, or major bleeding through 12 months (safety); a composite of ischemic stroke or systemic embolism through 18 months (effectiveness); and effective device LAAO, defined as residual jet around the device ≤5 mm at the 45-day visit (mechanism of action). SUMMARY: The Amulet IDE Trial is the first randomized head-to-head LAAO device trial and will provide data for the AMPLATZER Amulet occluder in a population with a high risk of stroke and bleeding.


Assuntos
Fibrilação Atrial/cirurgia , Procedimentos Cirúrgicos Cardíacos/instrumentação , Dispositivo para Oclusão Septal , Anticoagulantes/efeitos adversos , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Cateterismo Cardíaco , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Causas de Morte , Fibrinolíticos/efeitos adversos , Fibrinolíticos/uso terapêutico , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Complicações Pós-Operatórias , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Dispositivo para Oclusão Septal/efeitos adversos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
7.
Heart ; 105(21): 1622-1628, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30077993

RESUMO

OBJECTIVES: This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS). METHODS: Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up. RESULTS: At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 mL; 95% CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95% CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years. CONCLUSIONS: The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up. TRIAL REGISTRATION NUMBER: NCT01940120.

8.
JAMA Cardiol ; 3(12): 1151-1159, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-30476950

RESUMO

Importance: Improvements in symptoms, functional capacity, and quality of life are among the key goals of edge-to-edge transcatheter mitral valve repair (TMVR) for mitral regurgitation. Objective: To examine health status outcomes among patients undergoing TMVR in clinical practice and the factors associated with improvement. Design, Setting, and Participants: This cohort study used the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, which contains data on patients with severe mitral regurgitation treated with TMVR from 2013 through 2017 in 217 US hospitals. Main Outcomes and Measures: Change in disease-specific health status (Kansas City Cardiomyopathy Questionnaire-Overall Summary score [KCCQ-OS]; range 0-100 points, with higher scores indicating better health status) at 30 days and 1 year after TMVR. We also examined factors associated with health status at 30 days after TMVR, by means of multivariable linear regression using a generalized estimating equations approach to account for clustering of patients within sites. Results: The KCCQ data were available in 81.2% at baseline, 69.3% of survivors at 30 days, and 47.4% of survivors at 1 year. Among 4226 patients who underwent TMVR, survived 30 days, and completed the KCCQ at baseline and follow-up, the KCCQ-OS increased from 41.9 before TMVR to 66.7 at 30 days (mean change 24.8 [95% CI, 24.0-25.6] points; P < .001), representing a large clinical improvement. The KCCQ scores remained stable from 30 days to 1 year after TMVR, with no further significant increase or decline. On multivariable analysis, atrial fibrillation (-2.2 [95% CI, -3.7 to -0.6] points; P = .01), permanent pacemaker (-2.1 [95% CI, -3.7 to -0.4] points; P = .01), severe lung disease (-3.9 [95% CI, -6.2 to -1.5] points; P = .001), home oxygen (-2.7 [95% CI, -4.9 to -0.4] points; P = .02), and lower KCCQ scores at baseline (3.9 points for each 10-point increase [95% CI, 3.6-4.2]; P < .001) were independently associated with lower 30-day KCCQ-OS scores. In-hospital renal failure was uncommon but was also associated with significant reductions in 30-day KCCQ-OS scores (-7.3 [95% CI -13.3 to -1.2] points). In estimates calculated with inverse probability weighting, after 1 year after TMVR, 54.2% (95% CI 52.2%-56.1%) of patients were alive and well; 23.0% had died, 21.9% had persistently poor health status (KCCQ-OS <60 points), 5.5% had a health status decline from baseline, and 4.6% had both poor health status and health status decline. Conclusions and Relevance: In a national cohort of US patients undergoing edge-to-edge TMVR in clinical practice, health status was impaired prior to the procedure, improved within 30 days, and remained stable through 1 year among surviving patients with available data. While long-term mortality remains high, most surviving patients demonstrate improvements in symptoms, functional status, and quality of life, with only modest differences by patient-level factors.


Assuntos
Cateterismo Cardíaco/métodos , Nível de Saúde , Implante de Prótese de Valva Cardíaca/métodos , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Qualidade de Vida , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Insuficiência da Valva Mitral/psicologia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
9.
Curr Cardiol Rep ; 20(10): 101, 2018 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-30173390

RESUMO

PURPOSE: This paper reviews the double-kiss crush (DK crush) technique in coronary artery bifurcation lesions. The technical aspects of the procedure and the clinical data supporting its use are summarized. RECENT FINDINGS: Randomized studies support the adoption of DK technique in complex bifurcation lesions for both left main and non-left-main lesions. For true bifurcation lesions, DK crush may become the default technique for lesions in which the side-branch disease is complex and long. Optimal technique is essential for obtaining the clinical outcomes noted in the DKCRUSH randomized studies.


Assuntos
Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea/métodos , Stents , Angioplastia Coronária com Balão/métodos , Angiografia Coronária , Reestenose Coronária/cirurgia , Estenose Coronária/cirurgia , Stents Farmacológicos , Humanos , Infarto do Miocárdio/cirurgia , Revascularização Miocárdica , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento
10.
J Am Coll Cardiol ; 72(22): 2687-2696, 2018 12 04.
Artigo em Inglês | MEDLINE | ID: mdl-30249462

RESUMO

BACKGROUND: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients. OBJECTIVES: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. METHODS: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. RESULTS: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. CONCLUSIONS: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).


Assuntos
Insuficiência da Valva Aórtica/mortalidade , Insuficiência da Valva Aórtica/cirurgia , Stents Metálicos Autoexpansíveis/tendências , Substituição da Valva Aórtica Transcateter/mortalidade , Substituição da Valva Aórtica Transcateter/tendências , Idoso , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/diagnóstico , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Mortalidade/tendências , Estudos Prospectivos , Fatores de Risco , Stents Metálicos Autoexpansíveis/efeitos adversos , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
11.
Am J Cardiol ; 121(11): 1358-1364, 2018 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-29680171

RESUMO

The impact of predilatation (Pre-Dil) on prosthesis hemodynamics and clinical outcomes of subjects who underwent transcatheter aortic valve implantation (TAVI) with a self-expanding prosthesis remains unclear. Two thousand seven hundred twenty-one subjects from the extreme- and high-risk CoreValve Continued Access Study (CAS) were included in the analysis. Subjects who underwent Pre-Dil before TAVI were compared with subjects who underwent TAVI without Pre-Dil. Clinical outcomes included death, stroke, myocardial infarction, acute kidney injury, and new permanent pacemaker implantation. Serial echocardiograms were analyzed to evaluate prosthesis hemodynamics, specifically paravalvular regurgitation, effective orifice area, and mean gradient. Two thousand one hundred eighteen and 603 subjects underwent TAVI with and without Pre-Dil, respectively. Subjects in the Pre-Dil cohort were more commonly male, while subjects in the no Pre-Dil cohort had higher rates of previous stroke and lower mean aortic valve gradients. Outcomes at 30 days were comparable between Pre-Dil and no Pre-Dil subjects, with no significant difference in mortality (5.5% vs 4.3%, p = 0.27), major stroke (2.6% vs 2.2%, p = 0.54), major vascular complications (6.9% vs 8.0%, p = 0.37), major bleeding (24.4% vs 26.1%, p = 0.40), and permanent pacemaker implantation (21.3% vs 23.4%, p = 0.36). There were no significant differences in the same outcomes at 12 months. Effective orifice area and mean gradient were comparable between Pre-Dil and no-Pre-Dil subjects at discharge, at 30 days, and at 12 months. In conclusion, when performing TAVI with the self-expanding CoreValve device, performing direct implantation without Pre-Dil maintains an acceptable safety profile and still achieves desired and consistent prosthesis hemodynamics.


Assuntos
Estenose da Valva Aórtica/cirurgia , Dilatação/métodos , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/métodos , Lesão Renal Aguda/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Bloqueio de Ramo/epidemiologia , Bloqueio de Ramo/terapia , Estimulação Cardíaca Artificial , Ecocardiografia , Feminino , Hemodinâmica , Humanos , Masculino , Mortalidade , Infarto do Miocárdio/epidemiologia , Marca-Passo Artificial , Índice de Gravidade de Doença , Acidente Vascular Cerebral/epidemiologia , Resultado do Tratamento
12.
J Thorac Cardiovasc Surg ; 153(6): 1293-1301.e1, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-28249691

RESUMO

OBJECTIVE: Explore causes and timing of death from the CoreValve US Pivotal High-Risk Trial. METHODS: An independent clinical events committee adjudicated causes of death, followed by post hoc hierarchical classification. Baseline characteristics, early outcomes, and causes of death were evaluated for 3 time periods (selected based on threshold of surgical 30-day mortality and on the differences in the continuous hazard between the 2 groups): early (0-30 days), recovery (31-120 days), and late (121-365 days). RESULTS: Differences in the rate of death were evident only during the recovery period (31-120 days), whereas 15 patients undergoing transcatheter aortic valve replacement (TAVR) (4.0%) and 27 surgical aortic valve replacement (SAVR) patients (7.9%) died (P = .025). This mortality difference was largely driven by higher rates of technical failure, surgical complications, and lack of recovery following surgery. From 0 to 30 days, the causes of death were more technical failures in the TAVR group and lack of recovery in the SAVR group. Mortality in the late period (121-365 days) in both arms was most commonly ascribed to other circumstances, comprising death from medical complications from comorbid disease. CONCLUSIONS: Mortality at 1 year in the CoreValve US Pivotal High-Risk Trial favored TAVR over SAVR. The major contributor was that more SAVR patients died during the recovery period (31-121 days), likely affected by the overall influence of physical stress associated with surgery. Similar rates of technical failure and complications were observed between the 2 groups. This suggests that early TAVR results can improve with technical refinements and that high-risk surgical patients will benefit from reducing complications.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/mortalidade , Estudos Multicêntricos como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso , Idoso de 80 Anos ou mais , Animais , 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 , Causas de Morte , Comorbidade , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Masculino , Complicações Pós-Operatórias/mortalidade , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Sus scrofa , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Estados Unidos
14.
Coron Artery Dis ; 28(1): 77-89, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27561169

RESUMO

Although current everolimus-eluting coronary stents have shown improved event-free survival within the first year following implantation compared with bare-metal stents or earlier generation drug-eluting stents, they remain associated with an ongoing risk for adverse outcomes (thrombosis, myocardial infarction, and restenosis) beyond 1 year at rates similar to those observed following bare-metal stent deployment. This ongoing very late hazard has been attributed to the permanent presence of the metal frame and/or polymer in these stents. The Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) has been developed to provide mechanical support and drug-delivery functions similar to metallic drug-eluting stents, followed by complete resorption with recovery of more normal vascular structure and function, thus avoiding the limitations associated with permanent metallic endovascular prostheses. Absorb BVS has shown safety and efficacy in the dedicated clinical trial development program of Abbott Vascular and in an array of investigator-sponsored studies involving a broad spectrum of clinical (patient) as well as coronary anatomic complexity. Longer-term evidence, largely limited to single-arm studies, appears to reflect durable safety and efficacy and suggests Absorb BVS to be an attractive therapeutic option. Interim evidence from a series of randomized-clinical trials (RCTs) comparing Absorb BVS with the Xience cobalt-chromium metallic everolimus-eluting stent has shown noninferiority of Absorb BVS with respect to target lesion failure (composite occurrence of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target lesion revascularization) beyond the first year, with no statistically significant differences in other safety/efficacy measures. However, concerns do exist in terms of increased rates of scaffold thrombosis, the risk for which may be mitigated by improved patient and lesion selection, procedural technique, and device iteration. We provide an overview of the evolution of percutaneous coronary intervention, in-vivo characterization of Absorb BVS resorption, and a summary with a critical evaluation of available evidence from RCTs, pooled analyses, and meta-analyses of RCTs for the safety and efficacy of Absorb BVS obtained primarily following the treatment of noncomplex coronary lesions in patients with stable ischemic heart disease and/or stabilized acute coronary syndromes.


Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/terapia , Intervenção Coronária Percutânea/instrumentação , Ensaios Clínicos Controlados Aleatórios como Assunto , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/etiologia , Estenose Coronária/etiologia , Medicina Baseada em Evidências , Humanos , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
15.
EuroIntervention ; 12(12): 1534-1541, 2016 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-27998846

RESUMO

AIMS: Percutaneous structural heart therapies, such as mitral value repair, require site-specific transseptal access (TSA). This can be challenging for interventional cardiologists. We describe a TSA catheter (TSAC) that utilises suction for enhanced control and puncture accuracy. Here, we aim to evaluate the safety and efficacy of the device. METHODS AND RESULTS: Ex vivo interatrial septum preparations were dissected from swine (n=8) and diseased human hearts (n=6) to quantify TSAC suction and needle puncture force. TSAC suction was 6.5-fold greater than the opposing needle puncture force, and thus provides sufficient stabilisation for punctures. The safety and efficacy of TSAC was evaluated in a chronic mitral regurgitation swine model (n=10) and compared to a conventional TSA device. MR was induced by disrupting one to three mitral chordae tendineae, and the progression of heart disease was followed for three weeks. During device testing, procedure time and fluoroscopy exposure were not statistically different between devices. TSAC reduced septal displacement from 8.7±0.30 mm to 3.60±0.19 mm (p<0.05) and improved puncture accuracy 1.75-fold. CONCLUSIONS: TSAC provides controlled TSA and improves puncture accuracy, while maintaining procedure time and workflow. These findings provide a strong rationale for a first-in-man study to demonstrate the clinical utility of the device.


Assuntos
Septo Interatrial/cirurgia , Desenho de Equipamento , Septos Cardíacos/cirurgia , Punções , Sucção , Animais , Cateterismo Cardíaco/instrumentação , Ablação por Cateter/instrumentação , Feminino , Humanos , Masculino , Punções/métodos , Sucção/métodos , Suínos
16.
Catheter Cardiovasc Interv ; 88(S1): 21-30, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27797464

RESUMO

The permanent metal prosthesis common to bare metal stents (BMS) as well as both first- and second-generation drug-eluting stents (DES) following treatment of coronary artery disease represents a long-lasting substrate for late adverse coronary events including restenosis, thrombosis, and neoatherosclerosis. Following resorbtion, bioresorbable scaffolds (BRS) may eliminate this nidus and improve late outcomes through restoration of the vessel to more normal vascular structure and function. BRS represents a single platform which incorporates the mechanical features of metallic stents to provide safe and effective revascularization, suppression of restenosis and prevention of constrictive remodeling with long-term restoration of the treated vessel to a more natural state. The landscape of BRS is rapidly evolving with new materials which target various performance goals for the duration of vascular support and polymer resorption time. The Absorb bioresorbable vascular scaffold (Absorb BVS), recently approved by United States Food and Drug Administration, has extensive clinical evidence to date in support of its clinical efficacy and safety. Recently published data from well-executed randomized clinical trials (RCTs) as part of the ABSORB Clinical development program along with other investigator-initiated trials provide insights into the safety and performance of this device in patients with de novo coronary lesions as well in the setting of ST-segment elevation myocardial infarction (STEMI). This review provides a comprehensive, outcomes based understanding of the available evidence from RCTs that offer head-to-head comparisons of Absorb BVS with metallic everolimus-eluting stents (EES). © 2016 Wiley Periodicals, Inc.


Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Tecidos Suporte , Humanos , Desenho de Prótese
17.
JAMA Cardiol ; 1(8): 945-949, 2016 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-27541162

RESUMO

Importance: Transcatheter aortic valve replacement (TAVR) is now a well-accepted alternative to surgical AVR (SAVR) for patients with symptomatic aortic stenosis at increased operative risk. There is interest in whether TAVR would benefit patients at lower risk. Objective: The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) has trended downward in US TAVR trials and the STS/American College of Cardiology Transcatheter Valve Therapy Registry. We hypothesized that if the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) alone is sufficient to define decreased risk, the contribution to survival based on the degree of invasiveness of the TAVR procedure will decrease, making it more difficult to show improved survival and benefit over SAVR. Design, Setting, and Participants: The CoreValve US Pivotal High Risk Trial was a multicenter, randomized, noninferiority trial. This retrospective analysis evaluated patients who underwent an attempted implant and had an STS PROM of 7% or less. The trial was performed at 45 US sites. Patients had severe aortic stenosis and were at increased surgical risk based on their STS PROM score and other risk factors. Interventions: Eligible patients were randomly assigned (1:1) to self-expanding TAVR or to SAVR. Main Outcomes and Measures: We retrospectively stratified patients by the overall median STS PROM score (7%) and analyzed clinical outcomes and quality of life using the Kansas City Cardiomyopathy Questionnaire in patients with an STS PROM score of 7% or less. Results: The mean (SD) ages were 81.5 (7.6) years for the TAVR group and 81.2 years (6.6) for the SAVR group. A little more than half were men (57.9% in the TAVR group and 55.8% in the SAVR group). Of 750 patients who underwent attempted implantation, 383 (202 TAVR and 181 SAVR) had an STS PROM of 7% or less (median [interquartile range]: TAVR, 5.3% [4.3%-6.1%]; SAVR, 5.3% [4.1%-5.9%]). Two-year all-cause mortality for TAVR vs SAVR was 15.0% (95% CI, 8.9-10.0) vs 26.3% (95% CI, 19.7-33.0) (log rank P = .01). The 2-year rate of stroke for TAVR vs SAVR was 11.3% vs 15.1% (log rank P = .50). Quality of life by the Kansas City Cardiomyopathy Questionnaire summary score showed significant and equivalent increases in both groups at 2 years (mean [SD] TAVR, 20.0 [25.0]; SAVR, 18.6 [23.6]; P = .71; both P < .001 compared with baseline). Medical benefit, defined as alive with a Kansas City Cardiomyopathy Questionnaire summary score of at least 60 and a less than 10-point decrease from baseline, was similar between groups at 2 years (TAVR, 51.0%; SAVR, 44.4%; P = .28). Conclusions and Relevance: Self-expanding TAVR compares favorably with SAVR in high-risk patients with STS PROM scores traditionally considered intermediate risk. Trial Registration: Clinicaltrials.gov Identifier: NCT01240902.


Assuntos
Estenose da Valva Aórtica/terapia , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Qualidade de Vida , Estudos Retrospectivos , Risco , Cirurgiões , Resultado do Tratamento
18.
JACC Cardiovasc Imaging ; 9(8): 973-81, 2016 08.
Artigo em Inglês | MEDLINE | ID: mdl-27491485

RESUMO

OBJECTIVES: The aim of this study was to determine the relationship between aortoventricular (AoV) angulation on clinical outcomes after self-expanding transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis who were deemed suboptimal for surgery. BACKGROUND: Multidetector computed tomographic (MDCT) imaging of the aortovalvular complex has become a prerequisite for case planning with self-expanding TAVR. The effect of aortic angulation, an index of an unfolded or "horizontal" aorta, on procedural outcome after self-expanding TAVR is not known. METHODS: The clinical course of 3,578 patients who received implants in the CoreValve US Clinical Trials and who had prospective MDCT estimation of the AoV angle before the procedure was reviewed. Clinical site echocardiogram assessments were used to determine the degree of residual aortic regurgitation 24 to 48 h after the procedure and at 30 days. On the basis of the measurement of the AoV angle on MDCT, patients were categorized into septiles, ranging from the lowest septile of an AoV angle <37.0° to the highest AoV angle septile of >55.0°. RESULTS: Patients were elderly (age 83.3 ± 7.8 years) and were at high risk for surgical valve replacement (Society of Thoracic Surgeons Predicted Risk of Mortality 8.8 ± 4.7). Greater degrees of AoV angulation were correlated with older age (p < 0.0001). Although procedure time was 6.9 min longer in the highest septile (59.4 ± 35.9 min vs. 52.5 ± 35.3 min in the lowest septile; p = 0.004), there were no linear trends (p > 0.05) in the frequencies of device success, procedural success, frequencies of moderate or greater aortic regurgitation at 30 days, number of valves implanted, or need for balloon post-dilation or new pacemakers among the AoV angle septiles. CONCLUSIONS: The degree of AoV angulation does not affect early clinical outcomes self-expanding transcatheter aortic valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve® U.S. Pivotal Trial]; NCT01240902).


Assuntos
Aorta/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Aortografia/métodos , Valvuloplastia com Balão , Bioprótese , Angiografia por Tomografia Computadorizada , Próteses Valvulares Cardíacas , Tomografia Computadorizada Multidetectores , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Valvuloplastia com Balão/efeitos adversos , Valvuloplastia com Balão/mortalidade , Ecocardiografia , Feminino , Humanos , Masculino , Valor Preditivo dos Testes , Desenho de Prótese , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Estados Unidos
19.
J Am Coll Cardiol ; 68(4): 343-52, 2016 07 26.
Artigo em Inglês | MEDLINE | ID: mdl-27443429

RESUMO

BACKGROUND: Few studies have examined the impact of novel indices of comorbidity, frailty, and disability on outcomes after transcatheter aortic valve replacement (TAVR). OBJECTIVES: This study analyzed patients from the Medtronic CoreValve U.S. Pivotal Trial program to develop a simple scoring system that incorporates standard and novel predictor variables. METHODS: A multidisciplinary heart team used objective criteria, such as The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM), and subjective criteria to assess patients' eligibility for TAVR. The analysis included 3,687 patients randomly divided (2:1) into a derivation cohort (n = 2,482) and a validation cohort (n = 1,205). The study evaluated predictors of all-cause death, which were used to calculate a risk score for each patient. RESULTS: The overall mortality rate was 5.8% at 30 days and 22.8% at 1 year. Home oxygen use, assisted living, albumin levels <3.3 g/dl, and age >85 years predicted death at 30 days. Home oxygen use, albumin levels <3.3 g/dl, falls in the past 6 months, STS PROM score >7%, and severe (≥5) Charlson comorbidity score predicted death at 1 year. A simple scoring system created on the basis of these multivariable predictors effectively stratified risk at 30 days and 1 year into low-risk, moderate-risk, and high-risk subsets. This score showed a 3-fold difference in mortality rates for the low-risk and high-risk subsets at 30 days (3.6% and 10.9%, respectively) and 1 year (12.3% and 36.6%, respectively). The 1-year mortality model was more stable than the 30-day model (C-statistics: 0.79 vs. 0.75). CONCLUSIONS: A simple score dominated by novel predictors of outcome effectively stratified early and late mortality rates in extreme-risk and high-risk patients and may assist in selecting appropriate candidates for TAVR. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).


Assuntos
Estenose da Valva Aórtica/cirurgia , Bioprótese , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Animais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Causas de Morte/tendências , Ecocardiografia , Feminino , Seguimentos , Humanos , Masculino , Período Pós-Operatório , Prognóstico , Desenho de Prótese , Fatores de Risco , Índice de Gravidade de Doença , Taxa de Sobrevida/tendências , Suínos , Fatores de Tempo , Estados Unidos/epidemiologia
20.
Am J Cardiol ; 118(3): 396-402, 2016 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-27346591

RESUMO

Treatment for severe symptomatic aortic stenosis has changed significantly in recent years due to advances in transcatheter aortic valve replacement (TAVR). Recent studies with the CoreValve prosthesis have demonstrated superior results compared with surgical aortic valve replacement in patients at increased risk for surgery, but there are limited data on gender-related differences in patient characteristics and outcomes with this device. We compared baseline characteristics and clinical outcomes in women and men undergoing TAVR with the CoreValve prosthesis. A total of 3,687 patients (1,708 women and 1,979 men) were included. At baseline, women tended to be slightly older and to have increased frailty, but they had fewer cardiac co-morbidities, higher left ventricular systolic function, less coronary artery disease, and fewer previous strokes. All-cause mortality was 5.9% for women and 5.8% for men at 30 days (p = 0.87) and 24.1% and 21.3%, respectively, at 1 year (p = 0.08). The incidence of stroke was 5.7% in women and 4.0% in men at 30 days (p = 0.02) and 9.3% and 7.7%, respectively, at 1 year (p = 0.05). Women had a higher incidence of bleeding, including more life-threatening bleeds, and a greater incidence of major vascular complications than men at 30 days. Device success was achieved in 86.9% of women and 86.1% of men (p = 0.50). In conclusion, although there were significant baseline differences and procedure-related complications between women and men undergoing TAVR with the CoreValve prosthesis, this analysis found no significant difference in 30-day or 1-year mortality.


Assuntos
Estenose da Valva Aórtica/cirurgia , Complicações Pós-Operatórias/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/epidemiologia , Causas de Morte , Comorbidade , Feminino , Idoso Fragilizado , Humanos , Incidência , Masculino , Mortalidade , Hemorragia Pós-Operatória/epidemiologia , Índice de Gravidade de Doença , Fatores Sexuais , Resultado do Tratamento , Disfunção Ventricular Esquerda/epidemiologia
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA