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1.
Catheter Cardiovasc Interv ; 93(6): 1116-1123, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30773838

RESUMO

AIMS: Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post-market registry. METHODS AND RESULTS: The prospective, open-label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve-in-valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30-day follow-up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge (P < 0.001); mean effective orifice area (EOA) was increased from 0.6 ± 0.2 cm2 to 1.7 ± 0.4 cm2 (P < 0.001). There were no cases of moderate or severe paravalvular leak (PVL) adjudicated by the core laboratory; four subjects (13.8%) had mild PVL, 5 (17.2%) had trace PVL. The rate of pacemaker (PM) implantation for PM-naïve patients was 22.2% (6/27). CONCLUSIONS: Data from the RESPOND registry demonstrate good clinical and echocardiographic outcomes up to 1 year postimplantation in patients with bicuspid aortic valves using the repositionable Lotus Valve.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/anormalidades , Doenças das Valvas Cardíacas/complicações , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Idoso , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/etiologia , Estenose da Valva Aórtica/fisiopatologia , Doença da Válvula Aórtica Bicúspide , Europa (Continente) , Feminino , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemodinâmica , Humanos , América Latina , Masculino , Nova Zelândia , Vigilância de Produtos Comercializados , Estudos Prospectivos , Desenho de Prótese , Recuperação de Função Fisiológica , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento
2.
JAMA ; 312(2): 162-70, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25005653

RESUMO

IMPORTANCE: Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed. OBJECTIVE: To determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves. DESIGN, SETTING, AND PARTICIPANTS: Correlates for survival were evaluated using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 [SD, 9.8] years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8% [interquartile range, 7.7%-16%]). Surgical valves were classified as small (≤21 mm; 29.7%), intermediate (>21 and <25 mm; 39.3%), and large (≥25 mm; 31%). Implanted devices included both balloon- and self-expandable valves. MAIN OUTCOMES AND MEASURES: Survival, stroke, and New York Heart Association functional class. RESULTS: Modes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation and combined groups, respectively; P = .005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83.2% (95% CI, 80.8%-84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%-83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%-96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%-91%; 18 deaths; 66 survivors) (P = .01). Similarly, patients with small valves had worse 1-year survival (74.8% [95% CI, 66.2%-83.4%]; 27 deaths; 57 survivors) vs with intermediate-sized valves (81.8%; 95% CI, 75.3%-88.3%; 26 deaths; 92 survivors) and with large valves (93.3%; 95% CI, 85.7%-96.7%; 7 deaths; 73 survivors) (P = .001). Factors associated with mortality within 1 year included having small surgical bioprosthesis (≤21 mm; hazard ratio, 2.04; 95% CI, 1.14-3.67; P = .02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33-7.08; P = .008). CONCLUSIONS AND RELEVANCE: In this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis.


Assuntos
Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Implante de Prótese de Valva Cardíaca/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Falha de Prótese , Sistema de Registros , Análise de Sobrevida , Resultado do Tratamento
3.
Circulation ; 126(19): 2335-44, 2012 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-23052028

RESUMO

BACKGROUND: Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry. METHODS AND RESULTS: The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients. CONCLUSIONS: The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.


Assuntos
Valva Aórtica/cirurgia , Bioprótese/efeitos adversos , Falha de Equipamento/estatística & dados numéricos , Saúde Global/estatística & dados numéricos , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas/efeitos adversos , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/epidemiologia , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Feminino , Seguimentos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Incidência , Masculino , Reoperação , Estudos Retrospectivos , Resultado do Tratamento
4.
Catheter Cardiovasc Interv ; 82(2): E124-7, 2013 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-22744753

RESUMO

Transcatheter aortic valve implantation is a possible, although off-label, alternative to conventional aortic valve replacement for high-surgical-risk patients with severe, non-calcified aortic regurgitation (AR). To date, feasibility has only been demonstrated with the Medtronic CoreValve prosthesis (MCV). This prosthesis needs the aortic sinuses to have enough width to avoid coronary obstruction. We report a case of MCV implantation for severe AR where the narrow aortic root theoretically precluded the technique. Good procedural outcome was achieved thanks to a strategy of implantation with planned positioning of the prosthesis leaflets away from the coronary arteries.


Assuntos
Insuficiência da Valva Aórtica/terapia , Cateterismo Cardíaco , Doença da Artéria Coronariana/prevenção & controle , Implante de Prótese de Valva Cardíaca/métodos , Idoso , Insuficiência da Valva Aórtica/diagnóstico , Aortografia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Ensaios de Uso Compassivo , Doença da Artéria Coronariana/etiologia , Ecocardiografia Doppler em Cores , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Desenho de Prótese , Tomografia Computadorizada por Raios X , Resultado do Tratamento
6.
Catheter Cardiovasc Interv ; 76(7): 1059-64, 2010 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-20549689

RESUMO

OBJECTIVE: This study evaluated the feasibility of percutaneous endovascular treatment of infra-renal abdominal aortic aneurysm (AAA) using the novel low profile modular Tripelay system (Tripelay, France). BACKGROUND: Endovascular aortic aneurysm treatment (EVAR) has become more widely used as early mortality has been significantly reduced. Also, percutaneous access has become possible with the introduction of vascular closure devices and with the initial reduction in size of delivery catheters. However, percutaneous access is not commonly used and anatomical considerations, such as access vessel size and tortuousities, preclude a number of patients from being efficiently treated with EVAR. METHODS: The novel Tripelay system enables two semicircular preshaped self-expandable stentgrafts to be positioned side by side on the aneurysm neck extending into the iliac arteries. Each stentgraft being smaller than the target vessel diameter, the delivery catheter is reduced in size (14F) and accommodates with smaller and more tortuous access vessels than conventional devices. This device was used to treat a 57-year-old male patient with significant comorbidities (previous coronary artery bypass grafting (CABG) and abdominal surgeries, smoking, hypertension, obesity, hyperlipidemia). Percutaneous access was made on both femoral arteries. The device was inserted, positioned, and deployed as planned. Iliac extensions were used bilaterally. RESULTS: The EVAR procedure was performed successfully, and the patient was discharged on day 6. Follow-up computed tomography scans at 1, 6, and 12 months revealed perfect exclusion of the aneurysm sac, patent stentgraft, and vessels, and no prosthesis migration, endoleaks or stent fracture were observed. The patient remained asymptomatic and reported no adverse events during that period. CONCLUSION: The Tripelay system seemed as an effective and user friendly tool for treatment of AAAs. Of course, this procedure still needs further clinical evaluation with more cases and longer follow-up to confirm long-term efficacy and safety of this device.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Aneurisma Ilíaco/cirurgia , Stents , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aortografia/métodos , Humanos , Aneurisma Ilíaco/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Tomografia Computadorizada por Raios X , Resultado do Tratamento
7.
Catheter Cardiovasc Interv ; 76(5): 751-6, 2010 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-20927783

RESUMO

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a new treatment strategy for patients with symptomatic aortic stenosis who are high risk for traditional surgical aortic valve replacement. The incidence of conduction system abnormalities after the procedure is significant. We examine our experience with CoreValve TAVI focusing on electrocardiographic changes found pre-, peri-, and postintervention. METHODS: During 2007-08 we undertook 33 cases utilizing the CoreValve revalving system (CoreValve, Paris, France). Assessment of ECGs, with particular reference to the PR and QRS duration, was made daily during each patient's hospital stay. RESULTS: Patients were aged 81.7 ± 6.7 years and the majority were male (57%). Baseline cardiac rhythm was sinus (n = 28, 80%); atrial fibrillation (n = 6, 18%) or ventricular paced (n = 1, 3%). Following CoreValve implantation, prolongation of both the PR interval and QRS duration was seen. Preprocedural PR interval was 193.5 ± 38.7 ms and QRS interval preprocedure was 115.3 ± 24.8 ms. PR interval increased after the procedure by 23.5 ± 23.9 ms and peaked at day 4 with a mean increase of 66.1 ± 72.7 ms. QRS duration increased by a mean of 30.6 ± 26.1 ms postprocedure and remained stable thereafter during the remaining hospital stay. The need for PPM insertion was partially predicted by pre-procedural QRS morphology: patients with pre-existing right bundle branch block had an 83% chance of requiring a permanent pacemaker (P < 0.01 OR 28 95%CI 2.4-326.7); those with LBBB had a 33% chance of requiring a pacemaker (P = ns OR 2.3 95%CI 0.2-34.9). Patients undergoing the procedure later in our experience showed a decreased incidence of pacing (P = 0.046 OR 0.36 95% CI 0.07-1.82). Pre-procedural annulus measurements also predicted the requirement for pacing with larger annulus sizes more likely to require a pacemaker (P = 0.044 OR 3.3 95% CI 0.63-17.6). The requirement for pacing was not predicted by age, baseline PR interval or gender. Requirement for pacing overall was 32% with an additional 13% having had a pacemaker inserted prior to the TAVI. CONCLUSION: CoreValve insertion was associated with an increase in PR interval and QRS duration. PR interval continued to rise during admission, peaking on Day 4 post procedure, making a prolonged period of monitoring highly desirable. There was a significant requirement for permanent pacing, which was predicted by pre-procedural QRS morphology, annulus measurement, and the learning curve. © 2010 Wiley-Liss, Inc.


Assuntos
Estenose da Valva Aórtica/terapia , Arritmias Cardíacas/terapia , Cateterismo Cardíaco/efeitos adversos , Estimulação Cardíaca Artificial , Implante de Prótese de Valva Cardíaca/efeitos adversos , Marca-Passo Artificial , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Arritmias Cardíacas/etiologia , Bloqueio de Ramo/complicações , Cateterismo Cardíaco/instrumentação , Competência Clínica , Eletrocardiografia , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Masculino , Razão de Chances , Desenho de Prótese , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
8.
Circ Cardiovasc Imaging ; 12(10): e009178, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31594409

RESUMO

BACKGROUND: A patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) in tricuspid aortic valve has been developed, which can predict paravalvular regurgitation and conduction disturbance. We wished to validate a patient-specific computer simulation of TAVR in bicuspid aortic valve and to determine whether patient-specific transcatheter heart valve (THV) sizing and positioning might improve clinical outcomes. METHODS: A retrospective study was performed on TAVR in bicuspid aortic valve patients that had both pre- and postprocedural computed tomography imaging. Preprocedural computed tomography imaging was used to create finite element models of the aortic root. Finite element analysis and computational fluid dynamics was performed. The simulation output was compared with postprocedural computed tomography imaging, cineangiography, echocardiography, and electrocardiograms. For each patient, multiple simulations were performed, to identify an optimal THV size and position for the patient's specific anatomic characteristics. RESULTS: A total of 37 patients were included in the study. The simulations accurately predicted the THV frame deformation (minimum-diameter intraclass correlation coefficient, 0.84; maximum-diameter intraclass correlation coefficient, 0.88; perimeter intraclass correlation coefficient, 0.91; area intraclass correlation coefficient, 0.91), more than mild paravalvular regurgitation (area under the receiver operating characteristic curve, 0.86) and major conduction abnormalities (new left bundle branch block or high-degree atrioventricular block; area under the receiver operating characteristic curve, 0.88). When compared with the implanted THV size and implant depth, optimal patient-specific THV sizing and positioning reduced simulation-predicted paravalvular regurgitation and markers of conduction disturbance. CONCLUSIONS: Patient-specific computer simulation of TAVR in bicuspid aortic valve may predict the development of important clinical outcomes, such as paravalvular regurgitation and conduction abnormalities. Patient-specific THV sizing and positioning may improve clinical outcomes of TAVR in bicuspid aortic valve.


Assuntos
Valva Aórtica/anormalidades , Simulação por Computador , Diagnóstico por Imagem , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/cirurgia , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Doença da Válvula Aórtica Bicúspide , Feminino , Humanos , Masculino , Estudos Retrospectivos
9.
Catheter Cardiovasc Interv ; 72(6): 885-90, 2008 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-18798235

RESUMO

Percutaneous aortic valve replacement (PAVR) offers considerable promise in treating high risk patients with aortic valve disease. Two devices are currently clinically available for transfemoral delivery: the Edwards-Sapien balloon-expandable bioprosthesis and the Corevalve self-expanding bioprosthesis, both of which require careful sizing of the peripheral vasculature. Through a case based discussion, we illustrate that these limits of PAVR technology can be stretched in cases of extraordinary clinical need. We demonstrate that, following a learning curve of "optimal cases," successful PAVR is also possible in diffusely diseased peripheries of borderline small size or with focal aortoiliofemoral disease amenable to a separate intervention beforehand.


Assuntos
Estenose da Valva Aórtica/cirurgia , Bioprótese , Cateterismo Cardíaco , Cateterismo Periférico , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Doenças Vasculares Periféricas/complicações , Idoso , Idoso de 80 Anos ou mais , Aorta/patologia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/patologia , Cateterismo Cardíaco/efeitos adversos , Cateterismo Periférico/efeitos adversos , Competência Clínica , Constrição Patológica , Ecocardiografia Doppler em Cores , Feminino , Artéria Femoral/patologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Artéria Ilíaca/patologia , Masculino , Seleção de Pacientes , Doenças Vasculares Periféricas/patologia , Doenças Vasculares Periféricas/cirurgia , Desenho de Prótese , Radiografia Intervencionista , Medição de Risco , Resultado do Tratamento , Ultrassonografia de Intervenção
10.
Catheter Cardiovasc Interv ; 72(7): 1012-5, 2008 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-19021273

RESUMO

OBJECTIVES: We have developed an approach where percutaneous aortic valve (PAVI) procedures are done under remifentanil-based sedation administered by an anesthetist. We report here our initial experience. BACKGROUND: Percutaneous aortic valve implantation is proving to be an effective treatment for aortic stenosis in patients with significant comorbidity precluding surgical aortic valve replacement. Most PAVIs have been done under general anesthetic with transoesophageal echocardiography (TOE). General anesthesia in this patient group is hazardous and associated with significant complications. METHODS AND RESULTS: CoreValve implantation was performed via the retrograde approach in 12 patients at our cardiothoracic center between December 2007 and May 2008. Three had the procedure under general anesthetic and nine under sedation. There were no differences between the groups in terms of comorbidities and clinical characteristics. The procedure was visualized using fluoroscopic aortic calcification coupled with multiple small volume aortograms. One patient converted from sedation to general anesthetic during the procedure. One patient in the general anesthetic group died from respiratory complications. There were no significant differences in procedural success, procedure time, or hospital stay between the two groups. CONCLUSION: Percutaneous aortic valve implantation can, in the majority of cases, be performed under remifentanil-based sedation. Our initial experience suggests that this should result in a shorter implant procedure time, reduced stay in high dependency areas, and shorter time to hospital discharge.


Assuntos
Anestesia Geral , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca , Hipnóticos e Sedativos/uso terapêutico , Piperidinas/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Anestesia Geral/efeitos adversos , Valva Aórtica/patologia , Estenose da Valva Aórtica/patologia , Cateterismo , Feminino , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Hipnóticos e Sedativos/efeitos adversos , Tempo de Internação , Masculino , Piperidinas/efeitos adversos , Desenho de Prótese , Remifentanil , Fatores de Tempo , Resultado do Tratamento
11.
Echocardiography ; 25(8): 840-8, 2008 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-18476979

RESUMO

Percutaneous aortic valve replacement (PAVR) is an emerging therapy for nonsurgical patients with severe aortic stenosis (AS). We examined the role of transesophageal echocardiography (TEE) in PAVR. TEE was used initially to assess the native valve and aortic root, and served as a guide during PAVR. Following prosthetic valve deployment, TEE was used to assess valve function. Eleven patients aged 82 +/- 10 years with NYHA III-IV underwent PAVR. Periprocedural TEE gave immediate information on prosthetic position and function, LV function, mitral regurgitation, pericardium, and thoracic aorta anatomy. There was excellent visual agreement between fluoroscopic and TEE images of prosthetic positioning and deployment. TEE facilitated the detection and management of procedure-related complications. Compared with pre-PAVR, AV area (0.56 +/- 0.19 cm(2) vs. 1.3 +/- 0.4 cm(2); P < 0.001) and LVEF (49 +/- 17% vs. 56 +/- 11%; P < 0.001) increased. TEE provides key anatomical and functional information, and serves as a diagnostic guide for complications, which may arise during PAVR.


Assuntos
Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Ecocardiografia Transesofagiana/métodos , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Cirurgia Assistida por Computador/métodos , Idoso , Idoso de 80 Anos ou mais , Desenho de Equipamento , Análise de Falha de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
12.
Heart Surg Forum ; 11(5): E323-4, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18948247

RESUMO

We successfully implanted a bioprosthetic aortic valve via the right subclavian artery within the framework of the CoreValve transapical aortic valve replacement (TAVR) ReValving (CoreValve, Irvine, CA, USA) clinical trial on November 20, 2007, at the Clinic for Cardiovascular Surgery at the German Heart Center Munich, Technical University Munich. The self-expanding aortic valve prosthesis is primarily designed for retrograde delivery across the aortic valve. The described approach via the right subclavian artery was performed because of severe peripheral vascular disease of the femoral and iliac arteries, as well as the left subclavian artery, and because a transapical delivery system was not available at the time of surgery.


Assuntos
Insuficiência da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Artéria Subclávia/cirurgia , Idoso , Análise de Falha de Equipamento , Feminino , Humanos , Desenho de Prótese , Resultado do Tratamento
13.
Interact Cardiovasc Thorac Surg ; 27(6): 850-855, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-29917088

RESUMO

OBJECTIVES: To assess the feasibility and results of 'valve-in-valve' implantation using the 23-mm CoreValve for the treatment of degenerated 19-mm and 21-mm Mitroflow bioprostheses. METHODS: We retrospectively analysed all consecutive patients who underwent transcatheter aortic valve implantation for 19-mm and 21-mm Mitroflow bioprostheses. The height of implantation with respect to the ring of the Mitroflow prosthesis was targeted at -6 mm for the first 3 cases. In the following cases, the target was higher to promote free supra-annular movement of the leaflets. RESULTS: The procedure was successful in 17 of 18 patients (94%). For implantations above the limit of -6 mm, the mean gradient was 10.4 ± 2.6 mmHg compared with 28.1 ± 11.6 mmHg for implantations below the limit of -6 mm (P < 0.01). For patients with severe stenosis as main mechanism of failure of the bioprosthesis, the mean post-procedural gradient was 31.2 ± 11.8 mmHg compared with 12.7 ± 6 mmHg in the absence of severe stenosis (P < 0.01). Patient-prosthesis mismatch (indexed effective orifice area ≤ 0.85 cm2/m2) and severe mismatch (indexed effective orifice area ≤ 0.65 cm2/m2) were present in 83% (15 of 18) and 27% (5 of 18) of patients, respectively. We did not notice any complications following the procedures. Six months after the procedure, functional status was improved in all patients. CONCLUSIONS: Our short series demonstrates the ability to perform transcatheter 'valve-in-valve' implantation in 19-mm and 21-mm Mitroflow prostheses with satisfactory results, but high post-procedural gradients and patient-prosthesis mismatch remain a relatively frequent problem mostly when severe stenosis is the main mechanism of failure. Implantation in a high position is critical to decrease the rate of high postimplantation gradients.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese/efeitos adversos , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estudos de Viabilidade , Feminino , Fluoroscopia , Humanos , Masculino , Desenho de Prótese , Falha de Prótese , Reoperação , Estudos Retrospectivos
14.
Heart Surg Forum ; 10(6): E478-9, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-18187382

RESUMO

On June 26, 2007, the Clinic for Cardiovascular Surgery at the German Heart Center Technical University in Munich successfully implanted a bioprosthetic valve via the apex of the heart within the framework of the CoreValve TAVR ReValving (Corevalve Inc., Irvine, CA, USA) clinical trial. The self-expanding aortic valve prosthesis is primarily designed for retrograde delivery across the aortic valve. The described transapical approach, however, now allows for treatment in those patients who have, for instance, no adequate "access" in the groin vessels due to peripheral vascular disease. Therefore, its feasibility must be considered as a major step in treating high-risk patients.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/instrumentação , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Ecocardiografia , Desenho de Equipamento , Feminino , Seguimentos , Humanos
15.
JACC Cardiovasc Interv ; 10(3): 276-282, 2017 02 13.
Artigo em Inglês | MEDLINE | ID: mdl-28183467

RESUMO

OBJECTIVES: The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve. BACKGROUND: The Evolut R is a self-expanding, repositionable, and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications. METHODS: Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland. RESULTS: A total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%. CONCLUSIONS: This registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.


Assuntos
Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , 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/mortalidade , Insuficiência da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Competência Clínica , Feminino , Humanos , Irlanda , Curva de Aprendizado , Masculino , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Reino Unido
16.
Circ Cardiovasc Interv ; 10(4)2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28400461

RESUMO

BACKGROUND: Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV). METHODS AND RESULTS: Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm2; P=0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; P=0.02), and lower core laboratory-adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; P=0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; P=0.03). CONCLUSIONS: In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Bioprótese/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Sistema de Registros , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Estenose da Valva Aórtica/fisiopatologia , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Hemodinâmica , Humanos , Masculino , Oriente Médio/epidemiologia , Nova Zelândia/epidemiologia , Pontuação de Propensão , Estudos Prospectivos , Desenho de Prótese , Reoperação/métodos , Taxa de Sobrevida/tendências , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Estados Unidos/epidemiologia
19.
Circ Cardiovasc Interv ; 8(4)2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25873727

RESUMO

BACKGROUND: Valve thrombosis has yet to be fully evaluated after transcatheter aortic valve implantation. This study aimed to report the prevalence, timing, and treatment of transcatheter heart valve (THV) thrombosis. METHODS AND RESULTS: THV thrombosis was defined as follows (1) THV dysfunction secondary to thrombosis diagnosed based on response to anticoagulation therapy, imaging modality or histopathology findings, or (2) mobile mass detected on THV suspicious of thrombus, irrespective of dysfunction and in absence of infection. Between January 2008 and September 2013, 26 (0.61%) THV thromboses were reported out of 4266 patients undergoing transcatheter aortic valve implantation in 12 centers. Of the 26 cases detected, 20 were detected in the Edwards Sapien/Sapien XT cohort and 6 in the Medtronic CoreValve cohort. In patients diagnosed with THV thrombosis, the median time to THV thrombosis post-transcatheter aortic valve implantation was 181 days (interquartile range, 45-313). The most common clinical presentation was exertional dyspnea (n=17; 65%), whereas 8 (31%) patients had no worsening symptoms. Echocardiographic findings included a markedly elevated mean aortic valve pressure gradient (40.5±14.0 mm Hg), presence of thickened leaflets or thrombotic apposition of leaflets in 20 (77%) and a thrombotic mass on the leaflets in the remaining 6 (23%) patients. In 23 (88%) patients, anticoagulation resulted in a significant decrease of the aortic valve pressure gradient within 2 months. CONCLUSIONS: THV thrombosis is a rare phenomenon that was detected within the first 2 years after transcatheter aortic valve implantation and usually presented with dyspnea and increased gradients. Anticoagulation seems to have been effective and should be considered even in patients without visible thrombus on echocardiography.


Assuntos
Complicações Pós-Operatórias/epidemiologia , Trombose/epidemiologia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Estudos de Coortes , Eletrocardiografia , Feminino , Humanos , Itália , Masculino , Complicações Pós-Operatórias/tratamento farmacológico , Prevalência , Trombose/tratamento farmacológico , Trombose/etiologia , Fatores de Tempo , Resultado do Tratamento
20.
J Invasive Cardiol ; 15(7): 390-2, 2003 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-12840236

RESUMO

Coronary subclavian steal syndrome arises when a stenosis of the subclavian artery results in reduced antegrade or retrograde flow in an internal mammary artery with resultant coronary ischemia. This occurs in patients who have previously undergone surgical coronary revascularization utilizing an internal mammary artery graft. This syndrome can be successfully treated percutaneously with excellent immediate and long-term results.


Assuntos
Angioplastia com Balão/métodos , Arteriopatias Oclusivas/terapia , Anastomose de Artéria Torácica Interna-Coronária/efeitos adversos , Artéria Torácica Interna , Isquemia Miocárdica/etiologia , Isquemia Miocárdica/terapia , Artéria Subclávia , Idoso , Angiografia , Arteriopatias Oclusivas/complicações , Ponte de Artéria Coronária/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Resultado do Tratamento
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