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1.
N Engl J Med ; 382(13): 1208-1218, 2020 03 26.
Artigo em Inglês | MEDLINE | ID: mdl-32050061

RESUMO

BACKGROUND: Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited. METHODS: In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority. RESULTS: A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority). CONCLUSIONS: Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).


Assuntos
Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Imunossupressores/administração & dosagem , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/uso terapêutico , Polímeros , Sirolimo/análogos & derivados , Trombose Coronária/etiologia , Trombose Coronária/mortalidade , Quimioterapia Combinada , Stents Farmacológicos/efeitos adversos , Cardiopatias/mortalidade , Hemorragia/induzido quimicamente , Humanos , Estimativa de Kaplan-Meier , Inibidores da Agregação Plaquetária/efeitos adversos , Desenho de Prótese , Método Simples-Cego , Sirolimo/administração & dosagem
3.
Heart Lung Circ ; 24(3): 281-90, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25456213

RESUMO

BACKGROUND: Although numerous studies have reported the safety and effectiveness of transcatheter aortic valve implantation (TAVI), integration of this therapy into standard of care varies widely by region. We evaluated mid-term follow-up in 540 patients with severe symptomatic AS at high risk of surgical AV replacement, enrolled in the ongoing Medtronic CoreValve Australia-New Zealand Study. METHODS: Between August 2008 and July 2013, 10 centres in Australia/New Zealand enrolled 540 patients, which includes initial use of the CoreValve System for all investigators. Patients were deemed suitable for TAVI based on consensus of a multidisciplinary Heart Team. Primary endpoints were cardiovascular death and major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days. Data were fully monitored, and an independent Clinical Events Committee employed. RESULTS: Baseline characteristics include; 45% female, mean age 84 years, EuroSCORE 17.3±10.7%, and 74.9% had New York Heart Association III/IV symptoms. At 30 days, all deaths were cardiovascular (4.1%); MACCE was 11.5%. At one and two years, all-cause mortality was 11.9% and 21.2%; cardiovascular mortality, 9.9% and 15.2%; and stroke, 8.2% and 10.1%, respectively. CONCLUSIONS: Early experience with the CoreValve System in a large cohort of fully-monitored patients was associated with good early- and mid-term safety outcomes.


Assuntos
Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Austrália/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Nova Zelândia , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Substituição da Valva Aórtica Transcateter/efeitos adversos
4.
Heart Lung Circ ; 24(3): 219-23, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25488705

RESUMO

The Cardiac Society of Australia and New Zealand (CSANZ) and the Australia and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) have joined together to provide recommendations for institutions and individual operators to assess their ability to initiate and maintain a transcatheter valve program. Transcatheter aortic valve replacement has been developed as an alternative to traditional surgical replacement of the aortic valve in high risk patients, particularly the frail elderly. The position paper has endorsed the important role of a multi-disciplinary "Heart Team" in selecting patients for TAVI as fundamental to the establishment of a successful program. The paper outlines recommendations for the cardiologist to have a background in structural intervention and the surgeon to have experience in high-risk aortic valve replacement. It is further recommended that TAVI programs be established in high volume cardiac surgical centres where on site valve surgery is performed. The paper is intended to provide guidance to individual operators and prospective institutions considering the establishment of a successful TAVI program.


Assuntos
Sociedades Médicas , Cirurgia Torácica , Substituição da Valva Aórtica Transcateter/normas , Austrália , Humanos , Nova Zelândia , Guias de Prática Clínica como Assunto
5.
Am J Cardiol ; 207: 28-34, 2023 11 15.
Artigo em Inglês | MEDLINE | ID: mdl-37722198

RESUMO

Transcatheter aortic valve replacement (TAVR) generates significant debris, and strategies to mitigate cerebral embolization are needed. The novel Emboliner embolic protection catheter (Emboline, Inc., Santa Cruz, California) is designed to capture all particles generated during TAVR. This first-in-human study sought to assess the safety and feasibility of the device and to characterize the distribution and histopathology of the debris generated during TAVR. The SafePass 2 study was a prospective, nonrandomized, multicenter, single-arm investigation of the Emboliner device. Primary end points included 30-day major adverse cardiac and cerebrovascular events (MACCE) and technical performance. Computed tomography angiography was analyzed by an independent core laboratory, and filters were sent for histopathology of captured debris. Predictors of particle number were identified using >150 µm and >500 µm size thresholds. Of 31 subjects enrolled, technical success was 100%, and 30-day MACCE was 6.5% (2 cerebrovascular accidents, with 1 attributed to subtherapeutic dosing of rivaroxaban along with atrial fibrillation and the other to possible previous small ischemic strokes on magnetic resonance imaging; neither MACCE event had a causal relation to the Emboliner). All filters contained debris, with a median of 191.0 particles >150 µm and 14.0 particles >500 µm. Histopathology revealed mostly acute thrombus and valve or arterial tissue with lesser amounts of calcified tissue. A history of atrial fibrillation predicted a greater number of particles >500 µm (p = 0.0259) and its presence on admission was associated with 4.1 times more particles >150 µm (p = 0.0130) and 8.1 times more particles >500 µm (p = 0.0086). Self-expanding valves were associated with twice the number of particles >150 µm (p = 0.0281). TASK score was positively correlated with number of particles >500 µm (p = 0.0337). The Emboliner device was safe and feasible. Emboli after TAVR appear more numerous than previously documented. Atrial fibrillation, higher TASK score, and self-expanding valve use conferred higher embolic burden. Notably, none of the tested computed tomography angiography features were able to identify with higher embolic risk. Larger-scale studies are needed to identify high-risk patients for selective embolic protection device use.


Assuntos
Estenose da Valva Aórtica , Fibrilação Atrial , Dispositivos de Proteção Embólica , Embolia , Embolia Intracraniana , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Valva Aórtica/patologia , Estenose da Valva Aórtica/complicações , Estudos Prospectivos , Fibrilação Atrial/complicações , Fatores de Risco , Resultado do Tratamento , Embolia/epidemiologia , Embolia/etiologia , Embolia Intracraniana/epidemiologia , Embolia Intracraniana/etiologia , Embolia Intracraniana/prevenção & controle
6.
JACC Cardiovasc Interv ; 15(11): 1153-1163, 2022 06 13.
Artigo em Inglês | MEDLINE | ID: mdl-35680195

RESUMO

BACKGROUND: Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year. OBJECTIVES: This study reports the final 2-year results of the randomized Onyx ONE trial. METHODS: The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years. RESULTS: A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: -3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: -2.5% to 4.8%; P = 0.54). CONCLUSIONS: Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653).


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Stents Farmacológicos/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Polímeros , Desenho de Prótese , Stents/efeitos adversos , Resultado do Tratamento
7.
AsiaIntervention ; 7(2): 98-102, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34913013

RESUMO

AIMS: The requirement for a permanent pacemaker (PPM) is an important sequela after transcatheter aortic valve implantation (TAVI). The aim of this analysis was to identify predictive factors for pacemaker dependence in PPM-insertions post-TAVI. METHODS AND RESULTS: A retrospective analysis of all PPM insertions done between January 2009 and December 2018 (n=1,373) identified 33 patients who received a PPM within one month of TAVI. Thirty-two had completed a PPM check at one year and were included in the final analyses. Of those who had PPM insertions after TAVI, 41% (13/32) were not PPM-dependent at one year. This cohort was predominantly European (94%) and over half were octogenerians (56%). Statistically significant associations with being PPM-dependent at one year include intraoperative PPM dependence (OR 5.714 [95% CI: 1.163-28.070]; p=0.032), third-degree heart block being the indication for PPM insertion (OR 8.533 [95% CI: 1.616-45.063]; p=0.012) and mean valve depth over 6.0 mm (OR 6.222 [95% CI: 1.200-32.273]; p=0.030). CONCLUSIONS: A significant number of patients are not dependent on the PPMs inserted after TAVI. Although small, our study suggests that those who are pacing-dependent intraoperatively, have a third-degree heart block as their PPM indication or have a mean valve depth of over 6.0 mm, are more likely to be pacing-dependent in the long term. Larger studies are required to draw more definitive conclusions.

8.
Heart Lung Circ ; 19(10): 611-4, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20573545

RESUMO

The first percutaneous transcatheter aortic valve implantation (TAVI) was performed in 2002 by Alain Cribier with over 10,000 valve implants since. Despite this, as with all new technologies we remain on a learning curve and continue to encounter new challenges and complications. We report a case of acute structural valve failure treated successfully with a second valve in valve implantation of transcatheter aortic valve in a patient who had severe aortic stenosis (AS) complicated by a severely unfolded aorta.


Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica/patologia , Cateterismo Cardíaco/métodos , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico por imagem , Cateterismo Cardíaco/instrumentação , Feminino , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Fatores de Tempo , Ultrassonografia
9.
Circulation ; 116(7): 755-63, 2007 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-17646579

RESUMO

BACKGROUND: Percutaneous aortic valve replacement represents an endovascular alternative to conventional open heart surgery without the need for sternotomy, aortotomy, or cardiopulmonary bypass. METHODS AND RESULTS: Transcatheter implantation of a balloon-expandable stent valve using a femoral arterial approach was attempted in 50 symptomatic patients with severe aortic stenosis in whom there was a consensus that the risks of conventional open heart surgery were very high. Valve implantation was successful in 86% of patients. Intraprocedural mortality was 2%. Discharge home occurred at a median of 5 days (interquartile range, 4 to 13). Mortality at 30 days was 12% in patients in whom the logistic European System for Cardiac Operative Risk Evaluation risk score was 28%. With experience, procedural success increased from 76% in the first 25 patients to 96% in the second 25 (P=0.10), and 30-day mortality fell from 16% to 8% (P=0.67). Successful valve replacement was associated with an increase in echocardiographic valve area from 0.6+/-0.2 to 1.7+/-0.4 cm2. Mild paravalvular regurgitation was common but was well tolerated. After valve insertion, there was a significant improvement in left ventricular ejection fraction (P<0.0001), mitral regurgitation (P=0.01), and functional class (P<0.0001). Improvement was maintained at 1 year. Structural valve deterioration was not observed with a median follow-up of 359 days. CONCLUSIONS: Percutaneous valve replacement may be an alternative to conventional open heart surgery in selected high-risk patients with severe symptomatic aortic stenosis.


Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica , Cateterismo , Próteses Valvulares Cardíacas , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Ultrassonografia
10.
J Invasive Cardiol ; 30(5): 163-167, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29440625

RESUMO

OBJECTIVE: This first-in-human study evaluated the safety and technical feasibility of the Tempo temporary cardiac pacing lead (BioTrace Medical), which includes a novel fixation mechanism and soft tip. BACKGROUND: Complications of temporary pacing leads include dislodgment, arrhythmias, and ventricular perforation. Temporary pacing applications have increased with transcatheter aortic valve replacement (TAVR) growth, for rapid pacing during balloon valvuloplasty (BAV) and valve deployment, and for periprocedural bradyarrhythmia support. METHODS: Eligible patients required temporary pacing for TAVR, BAV, or electrophysiology (EP) procedures. Transthoracic echocardiograms were obtained at baseline and 24 hours after lead removal. Safety was defined as freedom from pericardial effusion requiring intervention or evidence of tamponade. Technical feasibility involved successful intracardiac delivery and pace capture. Additional evaluations included pacing threshold (PCT), rapid pacing, dislodgment, or sustained ventricular arrhythmias. Follow-up was to 30 days. RESULTS: Twenty-five patients (60% female; mean age, 64 ± 19 years) underwent 13 TAVRs (7 Sapien 3 valves [Edwards Lifesciences], 4 CoreValves [Medtronic], and 2 Lotus valves [Boston Scientific]), 11 EP procedures, and 1 BAV at two New Zealand centers from January 2016 to June 2016. Safety was met in all patients, with no device-related adverse events. Technical feasibility was achieved in 23 cases (92%); 2 patients had unsuitable anatomy. No patient had lead dislodgment or sustained ventricular arrhythmias, and the final procedural PCT was 0.7 ± 0.5 mA. Rapid pacing was successful in all cases. Five patients had successful postprocedural use up to 5 days. CONCLUSION: This first-in-human study demonstrates the safety and technical feasibility of the Tempo lead, providing stable periprocedural temporary pacing support.


Assuntos
Sistema de Condução Cardíaco/cirurgia , Magnetismo , Robótica/métodos , Cirurgia Assistida por Computador/métodos , Taquicardia Supraventricular/cirurgia , Idoso , Idoso de 80 Anos ou mais , Eletrocardiografia , Feminino , Sistema de Condução Cardíaco/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Taquicardia Supraventricular/diagnóstico , Taquicardia Supraventricular/fisiopatologia
11.
Circulation ; 114(6): 591-6, 2006 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-16880325

RESUMO

BACKGROUND: Aortic valve replacement with cardiopulmonary bypass is currently the treatment of choice for symptomatic aortic stenosis but carries a significant risk of morbidity and mortality, particularly in patients with comorbidities. Recently, percutaneous transfemoral aortic valve implantation has been proposed as a viable alternative in selected patients. We describe our experience with a new, minimally invasive, catheter-based approach to aortic valve implantation via left ventricular apical puncture without cardiopulmonary bypass or sternotomy. METHODS AND RESULTS: A left anterolateral intercostal incision is used to expose the left ventricular apex. Direct needle puncture of the apex allows introduction of a hemostatic sheath into the left ventricle. The valve prosthesis, constructed from a stainless steel stent with an attached trileaflet equine pericardial valve, is crimped onto a valvuloplasty balloon. The prosthetic valve and balloon catheter are passed over a wire into the left ventricle. Positioning within the aortic annulus is confirmed by fluoroscopy, aortography, and echocardiography. Rapid ventricular pacing is used to reduce cardiac output while the balloon is inflated, deploying the prosthesis within the annulus. Transapical aortic valve implantation was successfully performed in 7 patients in whom surgical risk was deemed excessive because of comorbidities. Echocardiographic median aortic valve area increased from 0.7 +/- 0.1 cm2 (interquartile range) to 1.8 +/- 0.8 cm2 (interquartile range). There were no intraprocedural deaths. At a follow up of 87 +/- 56 days, 6 of 7 patients remain alive and well. CONCLUSIONS: This initial experience suggests that transapical aortic valve implantation without cardiopulmonary bypass is feasible in selected patients with aortic stenosis.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Cateterismo/métodos , Implante de Prótese de Valva Cardíaca/métodos , Cirurgia Torácica/métodos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/fisiopatologia , Cateterismo/instrumentação , Ecocardiografia Transesofagiana , Feminino , Implante de Prótese de Valva Cardíaca/instrumentação , Ventrículos do Coração/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Prognóstico , Fatores de Risco , Cirurgia Torácica/instrumentação , Resultado do Tratamento
12.
Circulation ; 113(6): 842-50, 2006 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-16461813

RESUMO

BACKGROUND: Percutaneous aortic valve implantation by an antegrade transvenous approach has been described but is problematic. Retrograde prosthetic aortic valve implantation via the femoral artery has potential advantages. Percutaneous prosthetic aortic valve implantation via the femoral arterial approach is described and the initial experience reported. METHODS AND RESULTS: The valve prosthesis is constructed from a stainless steel stent with an attached trileaflet equine pericardial valve and a fabric cuff. After routine aortic balloon valvuloplasty, a 22F or 24F sheath is advanced from the femoral artery to the aorta. A steerable, deflectable catheter facilitates manipulation of the prosthesis around the aortic arch and through the stenotic valve. Rapid ventricular pacing is used to reduce cardiac output while the delivery balloon is inflated to deploy the prosthesis within the annulus. Percutaneous aortic prosthetic valve implantation was attempted in 18 patients (aged 81+/-6 years) in whom surgical risk was deemed excessive because of comorbidities. Iliac arterial injury, seen in the first 2 patients, did not recur after improvement in screening and access site management. Implantation was successful in 14 patients. After successful implantation, the aortic valve area increased from 0.6+/-0.2 to 1.6+/-0.4 cm2. There were no intraprocedural deaths. At follow-up of 75+/-55 days, 16 patients (89%) remained alive. CONCLUSIONS: This initial experience suggests that percutaneous transarterial aortic valve implantation is feasible in selected high-risk patients with satisfactory short-term outcomes.


Assuntos
Valva Aórtica , Implante de Prótese de Valva Cardíaca/métodos , Idoso , Idoso de 80 Anos ou mais , Animais , Bioprótese , Cateterismo/instrumentação , Desenho de Equipamento , Feminino , Artéria Femoral , Próteses Valvulares Cardíacas , Implante de Prótese de Valva Cardíaca/instrumentação , Cavalos , Humanos , Masculino , Resultado do Tratamento
13.
Eur J Cardiothorac Surg ; 31(1): 16-21, 2007 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-17126558

RESUMO

BACKGROUND: The current treatment of choice for symptomatic aortic stenosis is aortic valve replacement (AVR) with cardiopulmonary bypass (CPB), but AVR is associated with significant operative morbidity and mortality in elderly patients with multiple co-morbid conditions. We recently reported the first successful aortic valve implantation procedure (AVI) via a mini-thoracotomy and left ventricular apical puncture without cardiopulmonary bypass. We now report 6-month follow-up in our initial seven patients. METHODS: Seven patients (77+/-10 years old) with symptomatic aortic stenosis were deemed to be non-surgical candidates for AVR and not suitable for a transfemoral percutaneous heart valve implantation due to aorto-iliac disease. The predicted 30-day operative mortality was 31+/-23% according to logistic Euroscore. Patients underwent minimally invasive transapical AVI. With the guidance of fluoroscopy and transesophageal echocardiography, balloon predilation was followed by deployment of a 26mm Cribier-Edwardstrade mark valve (Edwards Lifesciences Inc., Irvine, CA) during rapid ventricular pacing to reduce forward flow and cardiac motion. RESULTS: Valve implantation was successful in all seven patients. There were no intra-procedural mortalities or complications. Thirty-day operative mortality was 14%. One patient died at day 12 due to pneumonia. Two patients died from non-cardiac diseases at day 51 and 85. The remaining four patients completed 6-month follow-up. The aortic valve area increased from 0.7+/-0.3 to 1.8+/-0.7 and 1.5+/-0.5cm(2) at 1 and 6 months, respectively. The mean transaortic gradient was reduced from 32+/-8 to 10+/-5 and 11+/-8mmHg at 1 and 6 months, respectively. Following AVI, none or trivial, mild, and moderate aortic regurgitation was observed in 4, 2, and 1 patients, respectively. There were no valve-related complications during the follow-up. CONCLUSION: Aortic valve implantation can successfully be performed via a minimally invasive apical approach without the need for cardiopulmonary bypass. The early results in this initial series are encouraging. This initial experience suggests that the minimally invasive transapical approach is a viable alternative for patients in whom open-heart surgery is not feasible or poses unacceptable risks.


Assuntos
Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Aortografia , Ponte Cardiopulmonar , Contraindicações , Ecocardiografia Transesofagiana , Feminino , Seguimentos , Próteses Valvulares Cardíacas , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Resultado do Tratamento
14.
JACC Cardiovasc Interv ; 8(10): 1359-1367, 2015 Aug 24.
Artigo em Inglês | MEDLINE | ID: mdl-26315740

RESUMO

OBJECTIVES: The purpose of this study was to prospectively evaluate the safety and clinical performance of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system (Medtronic, Inc., Minneapolis, Minnesota) in a single-arm, multicenter pivotal study in high- or extreme-risk patients with symptomatic aortic valve stenosis. BACKGROUND: Although outcomes following TAVR are improving, challenges still exist. The repositionable 14-F equivalent CoreValve Evolut R TAVR system was developed to mitigate some of these challenges. METHODS: Suitable patients (n = 60) underwent TAVR with a 26- or 29-mm Evolut R valve. Primary safety endpoints were mortality and stroke at 30 days. Primary clinical performance endpoints were device success per the VARC-2 (Valve Academic Research Consortium-2) and the percent of patients with mild or less aortic regurgitation 24 h to 7 days post-procedure. RESULTS: Patients (66.7% female; mean age 82.8 ± 6.1 years; Society of Thoracic Surgeons Score 7.0 ± 3.7%) underwent TAVR via the transfemoral route in 98.3%, using a 29-mm valve in 68.3% of patients. All attempts at repositioning were successful. No death or stroke was observed up to 30 days. The VARC-2 overall device success rate was 78.6%. Paravalvular regurgitation post TAVR was mild or less in 96.6%, moderate in 3.4%, and severe in 0% at 30 days. Major vascular complications occurred in 8.3%, and permanent pacemaker implantation was required in 11.7% of patients. CONCLUSIONS: The repositionable 14-F equivalent Evolut R TAVR system is safe and effective at treating high-risk symptomatic aortic stenosis patients. Repositioning was successful when required in all patients, with low rates of moderate or severe paravalvular aortic regurgitation and low permanent pacemaker implantation. (The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study; NCT01876420).


Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica , Cateterismo Cardíaco/instrumentação , Cateteres Cardíacos , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Arritmias Cardíacas/etiologia , Arritmias Cardíacas/terapia , Austrália , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Estimulação Cardíaca Artificial , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Masculino , Nova Zelândia , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Índice de Gravidade de Doença , Acidente Vascular Cerebral/etiologia , Fatores de Tempo , Resultado do Tratamento , Reino Unido
15.
J Invasive Cardiol ; 25(5): E110-3, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23645057

RESUMO

Attempted atrial transseptal puncture in a 63-year-old man undergoing an ablative procedure for atrial fibrillation was complicated by inadvertent delivery of an 8 Fr sheath across the aorta. Due to obesity-related perioperative risks, we opted for percutaneous repair rather than open-heart corrective surgery. Our case is unique for the novel percutaneous delivery of an Amplatzer atrial septal defect (ASD) closure device to the defect in the non-coronary aortic cusp through an 8 Fr left atrial multipurpose sheath not designed for this purpose. At 9-month follow-up, he had a mild residual internuclear ophthalmoplegia.


Assuntos
Ruptura Aórtica/etiologia , Cateterismo Cardíaco/instrumentação , Comunicação Interatrial/terapia , Erros Médicos/efeitos adversos , Dispositivo para Oclusão Septal/efeitos adversos , Angioplastia Coronária com Balão , Ruptura Aórtica/diagnóstico por imagem , Fibrilação Atrial/terapia , Cateterismo Cardíaco/métodos , Comunicação Interatrial/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Tomografia Computadorizada por Raios X , Resultado do Tratamento
16.
J Invasive Cardiol ; 24(4): 173-6, 2012 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-22477754

RESUMO

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been performed at Waikato Hospital for high-risk severe symptomatic aortic stenosis patients who are considered unsuitable for conventional cardiac surgery for the last 3 years. The Medtronic CoreValve (MCV) is a self-expandable device, while the Edwards SAPIEN valve (EV) requires the use of a balloon to expand the device. This observational study reports and compares the incidence of heart block in both Medtronic and Edwards transcatheter valves. METHODS: All patients who underwent TAVI between the periods of 28 August 2008 and 27 July 2011 were included in this study. Preprocedure and daily postprocedure until discharge electrocardiograms (ECG) were obtained prospectively. New onsets of significant atrioventricular (AV) and bundle branch blocks were recorded. Patients with existing pacemaker and those who did not survive the procedure were excluded. RESULTS: Sixty patients underwent TAVI during the study period, of whom 40 (67%) and 20 (33%) patients had MCV and EV implanted, respectively. Seven patients were excluded from the analysis; 38 MCV and 15 EV patients fulfilled the criteria for analysis. Mean age was 80 ± 7 years, 57% were male. Five patients (9%) required permanent pacemaker (PPM) implantation, which occurred exclusively post MCV TAVI (MCV vs EV: 13% vs 0%, respectively; P=.02). The indications of PPM were complete heart block in 3 patients (60%), Mobitz II second-degree heart block in 1 patient (20%), and symptomatic sick sinus syndrome in 1 patient (20%). The incidence of left bundle branch block (LBBB) was increased after the TAVI procedure and was more significant with MCV implants (MCV vs EV: 42% vs 8%, respectively; P<.01). Of note, 2 of the 5 patients (40%) with pre-existing right bundle branch block (RBBB) who underwent TAVI required PPM (P=.01). CONCLUSION: MCV implantation is associated with a higher incidence of significant AV block requiring PPM implantation and LBBB compared to EV. The overall rate of PPM requirement post MCV TAVI is, however, lower than previously published data. Pre-existing RBBB may help in predicting the likelihood of developing significant AV block.


Assuntos
Valva Aórtica , Cateterismo , Bloqueio Cardíaco/epidemiologia , Bloqueio Cardíaco/etiologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Próteses Valvulares Cardíacas/classificação , Idoso , Idoso de 80 Anos ou mais , Bloqueio de Ramo/epidemiologia , Bloqueio de Ramo/etiologia , Bloqueio de Ramo/terapia , Eletrocardiografia , Feminino , Bloqueio Cardíaco/terapia , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Incidência , Masculino , Marca-Passo Artificial , Desenho de Prótese , Estudos Retrospectivos , Resultado do Tratamento
17.
J Invasive Cardiol ; 23(9): E219-21, 2011 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-21891817

RESUMO

A 55-year-old female presented with 4-day history of fatigue and exertional shortness of breath. A late presentation inferior ST elevation myocardial infarction (STEMI) was diagnosed based on ST elevation in the inferior leads of electrocardiography and elevated cardiac troponin T (TnT). She developed complete heart block 1 day after admission to the hospital and remained hemodynamically stable. She was taken to the catheterization laboratory for a temporary pacing wire insertion. Coronary angiogram at the same time showed an occluded right coronary artery at the mid-section. The lesion was successfully opened. Within 24 hours, the patient's heart rhythm returned to sinus with first-degree atrioventricular block (AVB), thus avoiding the need for a permanent pacemaker. Current guidelines recommend medical management for late presentation hemodynamically stable STEMI of more than 72 H onset. Current ACC/AHA/HRS Pacemaker Guidelines recommend reperfusion strategy for acute presentation inferior STEMI associated with AVB. However, no clear strategy exists in the case of late presentation inferior STEMI with advanced AVB. Our case report suggests that late coronary intervention could be a management strategy in such a scenario in order to avoid a permanent pacemaker.


Assuntos
Angioplastia Coronária com Balão , Bloqueio Cardíaco/terapia , Infarto do Miocárdio/complicações , Nó Atrioventricular , Angiografia Coronária , Progressão da Doença , Dispneia/etiologia , Fadiga/etiologia , Feminino , Bloqueio Cardíaco/etiologia , Bloqueio Cardíaco/patologia , Humanos , Pessoa de Meia-Idade , Infarto do Miocárdio/patologia , Fatores de Tempo
18.
J Invasive Cardiol ; 23(8): 348-50, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21828402

RESUMO

A 52-year-old man was referred to the cardiology outpatient service with exertional angina and shortness of breath due to hypertrophic obstructive cardiomyopathy. He underwent transcoronary ethanol septal ablation (TESA) with successful procedural outcome. The patient returned to hospital with a 3-week history of intermittent fever and a positive blood culture showing Staphylococcus aureus, sensitive to flucloxacillin. Transoesophageal echocardiography on admission demonstrated vegetation on interventricular septum and a repeated scan 10 days later demonstrated Doppler flow across the interventricular septum, confirming the presence of a small ventricular septal defect. This patient was successfully managed with 6 weeks of intravenous antibiotics and remained well at 1-year follow-up.


Assuntos
Cardiomiopatia Hipertrófica/cirurgia , Ablação por Cateter/efeitos adversos , Endocardite/etiologia , Comunicação Interventricular/diagnóstico por imagem , Septos Cardíacos/cirurgia , Infecções Estafilocócicas/etiologia , Antibacterianos/uso terapêutico , Ablação por Cateter/métodos , Cefazolina/uso terapêutico , Endocardite/complicações , Endocardite/tratamento farmacológico , Endocárdio/microbiologia , Etanol , Humanos , Masculino , Pessoa de Meia-Idade , Infecções Estafilocócicas/complicações , Infecções Estafilocócicas/tratamento farmacológico , Staphylococcus aureus/isolamento & purificação , Resultado do Tratamento , Ultrassonografia
19.
N Z Med J ; 124(1345): 40-8, 2011 Nov 04.
Artigo em Inglês | MEDLINE | ID: mdl-22072165

RESUMO

BACKGROUND: Surgical aortic valve replacement remains the gold standard of the treatment of severe symptomatic aortic stenosis but is often not considered due to excessive risk factors and comorbidities especially in elderly patients. We describe the burden of untreated severe aortic stenosis at a tertiary care hospital in New Zealand. METHOD: Consecutive patients with severe aortic stenosis presented between January-December, 2005 were studied retrospectively. Outcome assessment included mortality, hospital stay and on going symptoms (angina >CCS class II, dyspnoea >NYHA class II and syncope). RESULTS: A total of 105 patients with severe aortic stenosis were identified (mean age 76 plus or minus 13 years, 51% men). Patients were divided into 3 groups according to the management strategy. (Group 1: Not referred for surgery as asymptomatic (n=25), Group 2: Declined for surgery (n=41), Group 3: Accepted for surgery (n=39)). Median follow-up was 34 months (interquartile range: 16-36 months). All-cause mortality in Group 1, Group 2 and Group 3 were 36%, 73% and 18% respectively while hospital days per 100 patient-years were 3.5, 10.1 and 6.4 and symptoms on last follow-up were 0%, 64% and 0% respectively. Almost half of symptomatic patients (Group 2 versus 3) were denied valve surgery due to comorbidities. Symptomatic patients had a significant mortality (p<0.0001) benefit with less hospitalisations (p<0.0001) post surgery. CONCLUSIONS: Untreated symptomatic severe aortic stenosis is associated with a poor prognosis and significant morbidity. For symptomatic patients with severe aortic stenosis who are denied surgery, alternative therapies such as transcatheter aortic valve implantation could be a viable option.


Assuntos
Estenose da Valva Aórtica/epidemiologia , Avaliação de Resultados em Cuidados de Saúde , Idoso , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Distribuição de Qui-Quadrado , Comorbidade , Ecocardiografia , Feminino , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Nova Zelândia/epidemiologia , Seleção de Pacientes , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de Doença , Análise de Sobrevida
20.
BMJ Case Rep ; 20092009.
Artigo em Inglês | MEDLINE | ID: mdl-21687005

RESUMO

A 70-year-old male presented to hospital with both anterior ST elevation myocardial infarction and spontaneous oesophageal rupture (Boerhaave's syndrome). He underwent primary angioplasty and stenting for a lesion of the left anterior descending in addition to cardiothoracic surgery for the oesophageal rupture. This combination of pathologies is a rare entity and often difficult to diagnose. To date, only a few cases have been reported.

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