RESUMO
BACKGROUND: The TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) trial (NCT01700439) evaluated the performance of the INTUITY rapid deployment aortic valve replacement (RDAVR) system in patients with severe aortic stenosis. METHODS: TRANSFORM was a prospective, nonrandomized, multicenter (n = 29), single-arm trial. INTUITY is comprised of a cloth-covered balloon-expandable frame attached to a Carpentier-Edwards PERIMOUNT Magna Ease aortic valve. Primary and effectiveness endpoints were evaluated at 1 year. RESULTS: Between 2012 and 2015, 839 patients underwent RDAVR. Mean age was 73.5 ± 8.3 years. Full sternotomy (FS) was used in 59% and minimally invasive surgical incisions in 41%. Technical success rate was 95%. For isolated RDAVR, mean crossclamp and cardiopulmonary bypass times for FS were 49.3 ± 26.9 minutes and 69.2 ± 34.7 minutes, respectively, and for minimally invasive surgical 63.1 ± 25.4 minutes and 84.6 ± 33.5 minutes, respectively. These times were favorable compared with Society of Thoracic Surgeons database comparators for FS: 76.3 minutes and 104.2 minutes, respectively, and for minimally invasive surgical, 82.9 minutes and 111.4 minutes, respectively (P < .001). At 30 days, all-cause mortality was 0.8%; valve explant, 0.1%; thromboembolism, 3.5%; and major bleeding, 1.3%. In patients with isolated aortic valve replacement, the rate of permanent pacemaker implantation was 11.9%. At 1 year, mean effective orifice area was 1.7 cm2; mean gradient, 10.3 mm Hg; and moderate and severe paravalvular leak, 1.2% and 0.4%, respectively. CONCLUSIONS: INTUITY RDAVR performed effectively in this North American trial. It may lead to a relative reduction in aortic crossclamp time and cardiopulmonary bypass time and has excellent hemodynamic performance. Pacemaker implantation rate observed was somewhat greater than European trials and requires further investigation.
Assuntos
Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Desenho de Prótese , Procedimentos Cirúrgicos sem Sutura/métodos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Causas de Morte/tendências , Ecocardiografia , Feminino , Seguimentos , Humanos , Incidência , Masculino , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: Minimal access aortic valve replacement is associated with favorable clinical outcomes; however, several meta-analyses have reported significantly longer crossclamp times compared with a full sternotomy. We examined the procedural and early safety outcomes after isolated rapid deployment aortic valve replacement by surgical approach in patients enrolled in the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve trial. METHODS: The Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve trial was a prospective, multicenter, single-arm study, with successful implants in 287 patients with aortic valve stenosis who underwent rapid deployment aortic valve replacement using the EDWARDS INTUITY Valve System (Edwards Lifesciences, Irvine, Calif). Patients were evaluated perioperatively for procedural times and technical success rates; at discharge, for hospital length of stay; and, at 30 days, for early adverse events. RESULTS: A total of 158 patients underwent isolated aortic valve replacement through a full sternotomy (n = 71), upper hemisternotomy (n = 77), or right anterior thoracotomy (n = 10). Mean age at baseline was 75.7 ± 7.2 years. Mean aortic crossclamp and cardiopulmonary bypass times (minutes) were similar for full sternotomy and upper hemisternotomy, 43.5 ± 32.5/71.6 ± 41.8 and 43.1 ± 13.1/69.6 ± 19.1, respectively, and significantly longer for right anterior thoracotomy, 88.3 ± 18.6/122.2 ± 22.1 (P < .000). Early adverse event rates were similar, and in-hospital mortality rates were low regardless of surgical approach. CONCLUSIONS: These data suggest that isolated rapid deployment aortic valve replacement through an upper hemisternotomy can lead to shorter crossclamp times than has been reported historically in the literature. This may facilitate minimal access aortic valve replacement by eliminating the issue of prolonged crossclamp times. Further, low in-hospital mortality and new permanent pacemaker implant rates were observed regardless of surgical approach.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias/epidemiologia , Idoso , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico , Ecocardiografia , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Mortalidade Hospitalar , Humanos , Incidência , Masculino , Estudos Prospectivos , Desenho de Prótese , Taxa de Sobrevida/tendências , Resultado do TratamentoRESUMO
BACKGROUND AND AIM OF THE STUDY: Structural valve deterioration (SVD) is the leading failure mode of bioprosthetic heart valves. The Edwards Integrity-Preservation (EIP™) technology was developed to permanently block tissue calcium-binding sites and allow for non-aqueous valve storage. The study aim was to evaluate the efficacy of tissue anti-calcification, valve performance, durability, and safety. METHODS: Bovine pericardial tissue with EIP technology was compared to industry-standard Carpentier-Edwards ThermaFix® and Xenologix® treatments. Anti-calcification efficacy was evaluated in the rabbit model at 60 days, and tissue calcium contents were quantified using atomic absorption spectrophotometry. Valve performance was assessed using an in-vivo 20-week chronic ovine model, and in-vitro hydrodynamic testing (effective orifice area and regurgitation). Valve durability was evaluated by accelerated wear testing at 200 million cycles (equivalent to five years). Valve safety was characterized by biocompatibility testing as per ISO requirements. RESULTS: Calcification results showed that the control and EIP technology tissues had a mean Ca content of 104.95 ± 102.69 and 21.20 ± 38.46 µg/mg dry tissue, respectively; the median Ca contents were 81.15 and 0.43 µg/mg dry tissue, respectively (p < 0.0001). The overall valve performance in the sheep was comparable between control and test. In-vitro hydrodynamics and durability were similar between groups, across all sizes, and met ISO requirements. EIP technology was shown to be biocompatible for use as an implantable device. CONCLUSION: Preclinical in-vitro and in-vivo evaluations showed that EIP technology significantly reduced tissue calcification and preserved valve performance and safety compared to current standards of care. Future studies will determine whether these findings can be replicated in humans.
Assuntos
Valva Aórtica/cirurgia , Bioprótese , Calcinose/prevenção & controle , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Pericárdio/transplante , Preservação de Tecido/métodos , Animais , Valva Aórtica/metabolismo , Valva Aórtica/patologia , Valva Aórtica/fisiopatologia , Calcinose/etiologia , Calcinose/metabolismo , Calcinose/patologia , Calcinose/fisiopatologia , Cálcio/metabolismo , Bovinos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemodinâmica , Xenoenxertos , Teste de Materiais , Modelos Animais , Pericárdio/metabolismo , Falha de Prótese , Coelhos , Ovinos , Estresse Mecânico , Fatores de TempoRESUMO
OBJECTIVE: Superior aortic valve hemodynamic performance can accelerate left ventricular mass regression and enhance survival and functional status after surgical aortic valve replacement. This can be achieved by rapid deployment aortic valve replacement using a subannular balloon-expandable stent frame, which functionally widens and reshapes the left ventricular outflow tract, to ensure a larger effective orifice area compared with conventional surgical valves. We report the intermediate-term follow-up data from a large series of patients enrolled in the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial. METHODS: In a prospective, multicenter (6 European hospitals), single-arm study, 287 patients with aortic stenosis underwent rapid deployment aortic valve replacement using a stented trileaflet bovine pericardial bioprosthesis. Core laboratory echocardiography was performed at baseline, discharge, and 3 months, 1 year, and 3 years after rapid deployment aortic valve replacement. RESULTS: The mean patient age was 75.7 ± 6.7 years (range, 45-93; 49.1% women). The mean aortic valve gradient significantly decreased from discharge to 3 years of follow-up. The mean effective orifice area remained stable from discharge to 3 years. At 1 year, the left ventricular mass index had decreased by 14% (P < .0001) and at 3 years by 16% (P < .0001) compared with at discharge. The prevalence of severe patient-prosthesis mismatch was 3% at discharge and remained stable during the follow-up period. CONCLUSIONS: In a large series of elderly patients with symptomatic severe aortic stenosis, rapid deployment aortic valve replacement using a subannular balloon-expandable stent frame demonstrated excellent hemodynamic performance and significant left ventricular mass regression. With continued follow-up, future studies will establish whether these favorable structural changes correlate with improvement in long-term survival and functional status.
Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Hemodinâmica , Hipertrofia Ventricular Esquerda/fisiopatologia , Função Ventricular Esquerda , Remodelação Ventricular , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Bioprótese , Europa (Continente) , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Hipertrofia Ventricular Esquerda/diagnóstico , Hipertrofia Ventricular Esquerda/etiologia , Hipertrofia Ventricular Esquerda/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Fatores de Tempo , Resultado do Tratamento , UltrassonografiaRESUMO
BACKGROUND: Since the first aortic valve replacement through a right thoracotomy was reported in 1993, upper hemisternotomy and right anterior thoracotomy have become the predominant approaches for minimally invasive aortic valve replacement. Clinical studies have documented equivalent operative mortality, less bleeding, and reduced intensive care/hospital stay compared with conventional sternotomy despite longer procedure times. However, comparative trials face challenges due to patient preference, surgeon bias, and the lack of a standardized minimally invasive surgical approach. METHODS: Twenty cardiothoracic surgeons from 19 institutions across the United States, with a combined experience of nearly 5000 minimally invasive aortic valve replacement operations, formed a working group to develop a basis for a standardized approach to patient evaluation, operative technique, and postoperative care. In addition, a stepwise learning program for surgeons was outlined. RESULTS: Improved cosmesis, less pain and narcotic use, and faster recovery have been reported and generally accepted by patients and by surgeons performing minimally invasive aortic valve replacement. These benefits are more likely to be verified with standardization of the procedure itself, which will greatly facilitate the design and implementation of future clinical studies. CONCLUSIONS: Surgeons interested in learning and performing minimally invasive aortic valve replacement must have expertise in conventional aortic valve replacement at centers with adequate case volumes. A team approach that coordinates efforts of the surgeon, anesthesiologist, perfusionist, and nurses is required to achieve the best clinical outcomes. By first developing fundamental minimally invasive skills using specialized cannulation techniques, neck lines, and long-shafted instruments in the setting of conventional full sternotomy, the safest operative environment is afforded to patients.
Assuntos
Valva Aórtica/cirurgia , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Esternotomia , Toracotomia , Valva Aórtica/diagnóstico por imagem , Competência Clínica , Educação de Pós-Graduação em Medicina , Doenças das Valvas Cardíacas/diagnóstico , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/educação , Humanos , Curva de Aprendizado , Radiografia , Esternotomia/efeitos adversos , Esternotomia/educação , Toracotomia/efeitos adversos , Toracotomia/educação , Resultado do Tratamento , UltrassonografiaRESUMO
BACKGROUND: Patients with severe, symptomatic aortic stenosis, who do not undergo valve replacement surgery have a poor long-term prognosis. Limited data exist on the medical resource utilization and costs during the final stages of the disease. METHODS AND RESULTS: We used data from the 2003 Medicare 5% standard analytic files to identify patients with aortic stenosis and a recent hospitalization for heart failure, who did not undergo valve replacement surgery within the ensuing 2 calendar quarters. These patients (n=2150) were considered to have medically managed severe aortic stenosis and were tracked over 5 years to measure clinical outcomes, medical resource use, and costs (from the perspective of the Medicare Program). The mean age of the cohort was 82 years, 64% were female, and the estimated logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (a measure of predicted mortality with cardiac surgery) was 17%. During 5 years of follow-up, overall mortality was 88.4% with a mean survival duration of 1.8 years. During this time period, patients experienced an average of 4.4 hospital admissions, 52% were admitted to skilled nursing care, and 28% were admitted to hospice care. The total 5-year costs were $63 844 per patient, whereas mean annual follow-up costs (excluding the index quarter) per year alive were $29 278. CONCLUSIONS: Elderly patients with severe aortic stenosis undergoing medical management have limited long-term survival and incur substantial costs to the Medicare Program. These results have important implications for policy makers interested in better understanding the cost-effectiveness of emerging treatment options such as transcatheter aortic valve replacement.