CICE2012NEWS
Transcrição
CICE2012NEWS
Canal de Informação Vascular CICE2012 NEWS 25-28 de Abril, 2012 BEM-VINDOS AO CICE 2012 Aprimorando a Cirurga Endovascular no Brasil Presidente: Armando C. Lobato • Codiretores do Programa Científico: Clifford J. Buckley, EUA & Ruth L. Bush, EUA Mudando a Face da Medicina Uma Homenagem as Mulheres Técnica Sanduíche para Aneurisma Toracoabdominal TEVAR O Panorama em 2012 Pág. 1 Pág. 3 a 13 Pág. 15 a 24 Com a Palavra o Presidente Caros Colegas, Ca É sempre um grande prazer poder aprepr sentar a vocês mais se uma nova edição do um evento CICE. ev A Anualmente o CICE é elaborado com base em fatos e ba processos pr atuais que mudam paqu drões vigentes e revolucionam conceitos, conceitos de forma f a oferecer a vocês, congressistas, o que há de mais moderno e atual em Cirurgia Endovascular, sempre em “embalagem” nova e instigante. Este ano, a palavra de ordem no CICE é CONSOLIDAÇÃO, ou seja, vamos apresentar as novidades e ao mesmo tempo firmar e solidificar conceitos, mostrando o que “fica e o que cai” através dos nossos Fóruns de Consenso. Presidente: Armando C. Lobato A transformação do CICE nesta “OFICINA DE CONSOLIDAÇÃO” permitirá aos participantes atualizar-se frente à profusão de novidades publicadas na literatura médica especializada de forma direcionada e, melhor, guiada pelos maiores especialistas do mundo no assunto. Codiretores do Programa Científico: Clifford J. Buckley, EUA Ruth L. Bush, EUA Os destaques da edição 2012 do CICE são a extensão do evento para 4 dias, os Fóruns de Consenso, o CICE SUMMIT, a Sessão Mulheres Salvando Vidas, a Sessão TAVI em parceria com a SBCCV, o Workshop Endovenoso e a interação com o Colégio Argentino de Cirurgia Cardiovascular e Endovascular. Realização: Inscreva-se já, submeta seus temas livres, faça sua reserva no WTC Hotel e participe. Não perca também a nossa festa de confraternização no Clube A! O CICE 2012 ESTÁ FANTÁSTICO!! Um grande abraço a todos, nos vemos no CICE 2012. Armando de Carvalho Lobato Mudando a Face da Medicina Uma Homenagem às Mulheres… Apoio: SBACV INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS 3 COLLABORATIVE, GLOBAL, RELEVANT. Este ano pela primeira vez no CICE e também no Brasil, teremos uma Sessão dedicada às mulheres cirurgiãs vasculares. A Sessão XXI - 17:00-18:36hs Perspectivas Internacionais em Terapia Endovascular: Mulheres Salvando Vidas (Ballroom 3&4) foi possível graças ao grande empenho da Dra Ruth L. Bush, que selecionou e convidou cirurgiãs de renome, provenientes de várias partes do mundo. A Trajetória das mulheres na Medicina teve in início em 1754, na Alemanha, com a graduação da Dra. Dorotea Cristina Erxleben, seguida em 1809 pela inauguração da primeira Faculdade de Medicina para Mulheres, em Filadélfia, EUA. No Brasil, o ingresso de mulheres na medicina ocorreu a partir de 1879 com a reforma Leôncio de Carvalho que autorizou a matrícula de mulheres nas Universidades. As três primeiras médicas a se formarem no Brasil eram gauchas e se graduaram na Faculdade de Medicina do Rio de Janeiro. A primeira delas, coincidência ou não, se chamava Rita Lobato. A despeito de crônicas maldosas com a “Machona” de Sílvio Romero, as mulheres médicas souberam encontrar o seu caminho e hoje já são OITO prêmios NOBEL em Fisiologia e Medicina concedidos a mulheres, além de DOIS concedidos a Maria Curie. (Física em 1903 e Química em 1911) 1 Centro de Estudos Com os Nossos Agradecimentos aos Patrocinadores pelo Apoio e Respeito às Normas Éticas A face da Medicina vem mudando no nosso país e hoje as médicas com idade inferior a 35 anos já correspondem a 50% do total de médicos nesta faixa etária. Estes valores, no entanto, não refletem a participação das mulheres na Cirurgia e segundo o Colégio Brasileiro de Cirurgiões, em 2008 apenas 11,9% dos cirurgiões em nosso país eram mulheres. Canal de Informação Vascular CICE2012 NEWS Canal de Informação Vascular CICE2012 NEWS 4 5 2 3 Festa de Confraternização Dia: 27/04/12 Horário: 20:30hs Local: Club A Pegue o seu convite no stand 18, de acordo com a disponibilidade* * Serão disponibilizado APENAS 700 convites. O convite da festa de confraternização não está incluído no preço da inscrição, portanto, não haverá qualquer reembolso ou indenização para os inscritos que não quiseram ou não conseguiram pegar um convite. Canal de Informação Vascular CICE2012 NEWS Festa de Confraternização - Clube A Festa de Confraternização - Clube A Canal de Informação Vascular CICE2012 NEWS Festa de Confraternização - Clube A THE NEW, MORE NATURAL APPROACH TO OPTIMAL FIT Conformability without Compromise Pre-Intervention Post-Intervention 7 Introducing the New Standard in Conformability and Radial Fit. The Conformable GORE® TAG® Thoracic Endoprosthesis. The new Conformable GORE® TAG® Thoracic Endoprosthesis offers a unique 6–33% oversizing window: • Allows physicians to choose lower radial force at the low end or higher radial force at the high end of the device sizing window, depending on patient anatomy. • A single straight device can be used to treat tapered aortas. 4 • 16–42 mm vessel diameters can be treated with as few as five device sizes. Refer to page xx of this journal for prescribing information. W. L. Gore & Associates, Inc. • Flagstaff, AZ 86004 • goremedical.com Products listed may not be available in all markets. GORE®, C3, EXCLUDER®, PERFORMANCE BY DESIGN, TAG®, and designs are trademarks of W. L. Gore & Associates. ©2011 W. L. Gore & Associates, Inc. AQ4750-EN1 SEPTEMBER 2011 GORE® Tri-Lobe Balloon Catheter GORE® DrySeal Sheath GORE® EXCLUDER® Endoprosthesis featuring C3 Delivery System Canal de Informação Vascular CICE2012 NEWS Learn more about conformability and radial fit at www.conformabletag.com 24 a 27 de Abril, 2013 Sheraton São Paulo WTC Hotel www.cice.com.br Canal de Informação Vascular CICE2012 NEWS 8 9 6 5 Livro Aprovado como Referência Bibliográfica Livro Aprovado como Referência Bibliográfica Pela SBACV para: Pela SBACV para: Informações - Prova de Título de Especialista em Cirurgia Vascular - Prova de Área de Atuação em Angiorradiologia e Cir. Endovascular Pela SBCCV para: - Prova de Título de Especialista para Cirurgia Cardiovascular Sinopse A segunda edição do livro CIRURGIA ENDOVASCULAR, com 70 Capítulos, nove Secções e mais de 2500 ilustrações, distribuídas ao longo de suas 1236 páginas, contempla revisão ampla e atualizada da literatura nacional e internacional no que tange aos mais diversos aspectos desta área de atuação. Canal de Informação Vascular CICE2012 NEWS Editora: ICVE Especialidade: Cirurgia Vascular ISBN: 978-85-99777-03-9 Páginas: 1236 Ano de Publicação: 2010 Edição: 2ª Encadernação: Capa Dura Informações - Prova de Área de Atuação em Angiorradiologia e Cir. Endovascular Sinopse O livro intitulado “Tratamento Endovascular das Complicações Aorto-Ilíacas” foi especialmente idealizado para fornecer ao médico intervencionista e demais profissionais da área médica interessados na terapêutica intervencionista vascular, os conhecimentos teóricos necessários à resolução das complicações advindas de sua prática clínica no segmento aorto-ilíaco. Editora: ICVE Especialidade: Cirurgia Vascular ISBN: 978-85-99777-02-2 Páginas: 364 Ano de Publicação: 2008 Edição: 1ª Encadernação: Capa Dura Canal de Informação Vascular CICE2012 NEWS 10 7 CICE MOBILE A Qualquer Momento, em Qualquer Lugar... Faça o Download e Acompanhe o Programa Científico no seu Celular www.cice.com.br/mobile Canal de Informação Vascular CICE2012 NEWS Canal de Informação Vascular CICE2012 NEWS 12 13 8 Caso ao Vivo Sessão Plenária Canal de Informação Vascular CICE2012 NEWS Exposição Canal de Informação Vascular CICE2012 NEWS 9 Curso Avançado DISSECÇÃO AÓRTICA E ANEURISMAS COMPLEXOS 25-27 de outubro, 2012 08:00-18:00hs Direção: Dr. Armando de Carvalho Lobato o DEMONSTRAÇÃO DE TÉCNICAS INOVADORAS: • Técnica de SANDUÍCHE para Correção de Aneurisma Tóracoabdominal (Tipos I, II e III) e/ou Aneurisma Aortoilíaco Englobando a Artéria Hipogástrica COVER STORY The TEVAR Landscape in 2012 A status report on thoracic endovascular aortic repair. • Técnica de CHAMINÉ para Aneurisma Tóracoabdominal (Tipos IV e V) e/ou Justarrenal (Colo < 10mm) BY FRANK J. CRIADO, MD, FACS, FSVM • Técnica de LIBERAÇÃO CONTROLADA de Endoprótese Bifurcada para Aneurisma com Bifurcação Aórtica Estreita (< 18mm) • Correção de Aneurismas Viscerais CURSO B NO LIVR ASEADO O CIRU RG ENDOV ASCULA IA R, 2010 E DESTAQUES: • Procedimentos Endovasculares ao Vivo e/ou Editados, Amplamente Comentados e Debatidos • Participação do Inscrito nos Procedimentos como Auxiliar • Aulas Teóricas Abordando o Passo a Passo desde a Mensuração do Aneurisma e Seleção das Endopróteses Apropriadas para a Aorta e Art. Viscerais até o Tratamento Endovascular Propriamente Dito e o Seguimento Pós-Operatório • Workshop Hands-On com Materiais Endovasculares Disponíveis no Mercado • Sessão de Debates dos Casos de Aneurisma da Aorta Trazidos pelos Participantes GARAN TA SUA VA JÁ GA ! • REFEIÇÕES INCLUÍDAS (ALMOÇO E JANTAR) • VAGAS LIMITADAS • TRAGA SEUS CASOS PARA SEREM DEBATIDOS!!! INSCRIÇÕES / INFORMAÇÕES: (11) 3285-0635/3251-3387/3263-0309 (c/ Ana Maria ou Sandra), e-mail: [email protected] - www.icve.com.br ndovascular developments have changed the entire field of thoracic aortic surgery in a profound and irreversible manner. The true beginnings can be traced back to the first stent graft procedure for repair of a descending thoracic aortic aneurysm (TAA) performed by Dake et al in 1992.1 Looking back, it was almost inevitable then that endovascular solutions for the thoracic aorta would emerge after the landmark procedure for treatment of an abdominal aortic aneurysm (AAA) by Parodi and associates in 1990 and Volodos’ first-ever endovascular aortic repair in 1986.2 When compared historically with their abdominal counterpart, thoracic devices and techniques have lagged behind in terms of caseload and refinement. But, to their advantage, thoracic endovascular approaches have been embraced with enormous enthusiasm and acceptance, almost from inception, because of the widely acknowledged unmet needs in the field where open surgical treatment puts patients through maximally invasive and technically difficult operations that have been mastered only by a select few centers of excellence around the world. The perception of a poorly served patient population has thus evolved, providing great impetus for the creation of less-invasive therapies. The new era in thoracic aortic surgery is upon us today: it can be defined with a single acronym, TEVAR (thoracic endovascular aortic repair), in which the “A” stands for aortic, reflecting the varied multiple pathologies encountered in the thoracic aorta. This is different from the “A” of EVAR (endovascular aneurysm repair), which signifies aneurysm, because AAA is the predominant and almost exclusive target pathology in the abdominal segment. 30,000 ■ Estimated number of TAA patients diagnosed anew in the United States each year ■ Number of thoracic aneurysm repairs performed annually Figure 1. Estimated number of TAA patients diagnosed in the United States each year compared to the number of thoracic aneurysm repairs performed annually. left untreated).3,4 The incidence of TAA is said to be 10.4 per 100,000 person-years5 or approximately 30,000 new cases annually (minimum) in the United States alone; the corresponding figure for AAA is approximately 200,000. The actual numbers are likely to be even higher, given the asymptomatic nature of TAA disease in 95% of cases. The true magnitude of the disease total in the United States (number of patients harboring a TAA) can be approximated from its known incidence and a comparison with the more reliable data available for abdominal aneurysms (Figure 1).3 THORACIC AORTIC ANEURYSM Although less frequent than AAA, TAA remains a serious problem because affected patients face a rather limited 20% to 54% 5-year survival expectation (due to rupture when 34 I ENDOVASCULAR TODAY I NOVEMBER 2011 Canal de Informação Vascular CICE2012 NEWS 10,000 Canal de Informação Vascular CICE2012 NEWS 15 COVER STORY mon pathogenesis and essentially the same risk factors: advanced age, male gender, cigarette smoking, atherosclerosis, hypertension, and genetic predisposition. Cigarette smoking is unequivocally the most important modifiable risk factor.11 Historically, most TAAs (and AAAs) were labeled to be atherosclerotic in nature, a misnomer that has been corrected at presFigure 2. Hinge points of aortic diameter. Reprinted from the Journal of the American ent with the more proper term College of Cardiology, 55/9, Elefteriades JA, Farkas EA, Thoracic aortic aneurysm: clinically degenerative. But it should be pertinent controversies and uncertainties, 841-857, Copyright 2010, with permission noted that both diseases—ath6 from Elsevier. erosclerosis and aortic aneurysm—often coexist and Thoracic aneurysms larger than 5.5 cm in diameter carry a tend to be aggravated by the same risk factors. Degradation yearly rupture risk of 15% and must be considered for elecand loss of collagen and elastin in the aortic wall are the 4,7,8 tive repair. Ruptured TAAs (rTAAs) occur at the rate of pathogenic hallmarks of aneurysm formation. For reasons 3.5 per 100,000 persons per year—far lower than the numthat are not yet clear, there is an apparent cross-link ber of ruptured AAAs (rAAAs). Intriguingly, the incidence of between TAA disease and intracranial aneurysms, with acute aortic dissection (AD) and rTAA are almost identical.9 some experts suggesting that thoracic aneurysm patients Overall mortality rates for rTAA approach 97% among should undergo cerebrovascular imaging to uncover occult those who reach the hospital alive,10 and most experts and potentially dangerous aneurysms in the head. would agree that a thoracic aneurysm is a more efficient The Yale database, with more than 3,000 patients, has killer than AAA because rupture tends to cause rapid exsan- produced much valuable information on the nature of TAA guination with little, if any, anatomical opportunity for the disease.12 Noteworthy facts include: TAA disease is largely kind of tamponade and temporary containment often seen genetic in nature, with a predominantly autosomal-domiin rAAA cases. nant inheritance; matrix metalloproteinase enzymes are TAAs are designated by their anatomic location and activated in the pathogenesis of TAA; wall tension extent: ascending, arch, descending, and thoracoabdominal approaches the tensile limits of aortic tissue at a diameter of aortic aneurysms (TAAAs). The descending thoracic aorta 6 cm; by the time a TAA reaches 6 cm in diameter, 34% of is the most common location (30%–40%). Anatomic segpatients have suffered dissection or rupture; and, extreme ment notwithstanding, all aortic aneurysms share a comphysical exertion and severe emotion can and do precipi(Permission for use granted by Cook Medical Incorporated, Bloomington, Indiana; Medtronic, Inc.; and W. L. Gore & Associates.) 16 March 2005 May 2008 April 2011 June 2008 August 2011 Gore Cook Medtronic Medtronic Gore TAG Zenith TX2 Talent Captivia Valiant Captivia Conformable TAG COVER STORY tate acute aortic dissection. The incidence of TAA seems to be on the rise, although this could be related to enhanced detection amid the everincreasing use of diagnostic imaging. However, some evidence appears to suggest an actual bona fide increase in the true incidence.8,13,14 TAA growth tends to be slow and indolent: approximately 0.3 cm per year in the descending thoracic aorta and 0.1 cm per year for the ascending thoracic aorta. Rapid enlargement is usually associated with an intercurrent aortic dissection.6 Lifetime analysis of the TAA’s risk of rupture and dissection11 has uncovered clear-cut “hinge points” in the aortic diameter at which rupture or dissection are likely to occur (Figure 2): 6 cm in the ascending and 7 cm in the descending thoracic aorta. These are the sizes (presumably) where the wall tension approaches (or exceeds) the elastic limits of the aortic wall;6 it is not at all clear why the descending Figure 4. Relay thoracic stent graft (Bolton Medical, Inc., Sunrise, FL). aorta tends to rupture at a larger size. It is therefore possible, at least conceptually, to prevent death from thoracic aortic TABLE 1. KEY FEATURES OF THORACIC STENT GRAFTS Stent Graft Stent Graft Length Diameters Material Material Expansion (cm) (mm) Company Name Product Name Bolton Medical Relay Thoracic Nitinol Stent Grafta Cook Medical TX2 With Pro-Form Gore & Associates Gore TAG Nitinol Thoracic Endoprosthesis Introducer Sheath Required Woven Self-expanding Straight: 10, 15, Straight: 22–46; No polyester 20, 25; tapered tapered: 15, 20, proximal: 28–46; 25 distal 24–42 Stainless Woven Self-expanding Proximal: steel polyester 12–21.6; tapered proximal: 15.2–20.8; distal: 13.6–20.7 ePTFE Self-expanding 10, 15, 20 Gore Conformable TAG Thoracic Endoprosthesis Medtronic, Talent Inc. Thoracic Captivia Nitinol Dacron Self-expanding 11, 16, 20 polyester Straight No proximal: 28–42; tapered proximal: 32–42; distal: 28–42 23, 25 (OD) 26, 28, 31, 34, 37, Yes 40, 45 20, 22, 24 (ID) Straight proximal: 21, 26, 28, 31, 34; tapered proximal: 31, 26; distal: 26, 21 18, 20, 22, 24 (ID) 22, 24, 26, 28, 30, No 32, 34, 36, 38, 40, 42, 44, 46 22, 24, 25 (OD) Valiant Thoracic Captivia Abbreviations: ePTFE, expanded polytetrafluoroethylene; OD, outer diameter; ID, inner diameter. a The Relay Thoracic Stent Graft is not currently FDA approved, but approval is expected in 2012. Figure 3. A timeline of FDA approvals for TEVAR stent grafts. NOVEMBER 2011 I ENDOVASCULAR TODAY I 35 Canal de Informação Vascular CICE2012 NEWS 36 I ENDOVASCULAR TODAY I NOVEMBER 2011 Canal de Informação Vascular CICE2012 NEWS Delivery System (F) 22–25 (OD) 17 2500 500 0 Q3 2010 Q4 2010 ■ Surgery Q1 2011 Reposition Your Expectations for EVAR When facing a challenging infrarenal neck, don’t settle for one ‘controlled’ deployment. Put yourself in the best position to succeed — put the confidence of the GORE® C3 Delivery System in your hands. And you will have not one, not two, but three opportunities to go beyond control — and reposition the future of EVAR. ExcluderC3.com W. L. Gore & Associates, Inc. • Flagstaff, AZ 86004 • goremedical.com Products listed may not be available in all markets. GORE®, C3, EXCLUDER®, PERFORMANCE BY DESIGN, and designs are trademarks of W. L. Gore & Associates. ©2010 W. L. Gore & Associates, Inc. AP0791-EN1 DECEMBER 2010 10 Anos de Tradição Mais de 500 Cirurgiões Endovasculares Formados 864 Horas de Treinamento Teórico-Prático e Experimental Participação dos Inscritos nos Procedimentos Endovasculares Transmissão ao Vivo dos Procedimentos Endovasculares para a Sala de Aula Workshop Hands-on com os Dispositivos/Materiais Endovasculares Disponíveis no Brasil Realizado no Hospital Santa Catarina de São Paulo 1x/mês (Quinta-Domingo) por 1 ano Baseado nos Livros de Nossa Autoria e que são Referência Bibliográfica para Título de Especialista em Cirurgia Vascular e Prova de Área de Atuação em Angiorradiologia e Cirurgia Endovascular: Cirurgia Endovascular, 2ª Edição, 2010 Tratamento Endovascular das Complicações Aortoilíacas, 1ª Edição, 2008 Benefícios Adicionais: Taxas de Inscrição Reduzidas no Evento CICE (para ex-alunos do CECE) A Projeção Internacional do Curso tem Facilitado o Acesso a Estágios Internacionais e Vantagens em Congressos no Exterior. INSCRIÇÕES ABERTAS! Realização: Instituto de Cirurgia Vascular e Endovascular de São Paulo ICVE-SP Canal de Informação Vascular CICE2012 NEWS 1,788 Figure 5. Current estimate of repair procedures performed for TAA repair. Reproduced from the United States Vascular and Endovascular Monitor Panel Report, 2nd Quarter, September 2011. Liderança e Pioneirismo no Treinamento Endovascular no Brasil 3 controlled deployments of the proven GORE® EXCLUDER® Device. 3 chances to maximize seal in the infrarenal aortic neck. 3 opportunities to rotate the stent-graft for precise orientation. Q2 2011 ■ Endovascular Direção: Armando C. Lobato 3 2,188 1,873 1000 1,454 1500 2,279 2000 CECE - CURSO DE ESPECIALIZAÇÃO EM CIRURGIA ENDOVASCULAR PERFORMANCE by design Repositioning = Control 3000 2,370 rupture by undertaking repair before the aorta reaches such a dangerous diameter. The 5.5-cm-diameter threshold for intervention emerges as the most reasonable for the majority of patients. Available evidence on mechanical forces and wall behavior supports the notion that the aorta becomes quite literally “a rigid tube” as it reaches 6 cm in diameter in which the systolic expansion ceases, and the full force of ventricular contraction translates into wall stress, leading to rupture (or dissection). Certain clinical conditions might warrant an even more aggressive attitude, such as patients with Marfan syndrome, bicuspid aortic valve, and those with a family history of aortic dissection. Symptomatic aneurysms (5% of the TAA population), on the other hand, should be repaired regardless of size. Surgical treatment of TAA was reported as early as 1951.15 Operative techniques and perioperative care have improved enormously over the past several years, allowing skilled surgeons to perform extensive and complex thoracic aortic surgery with relative safety and excellent outcomes. But, remarkably, such excellence is confined to a few centers worldwide.16 Furthermore, many patients are deemed noncandidates for such highly invasive operations because of 1,423 the future of EVAR 2,441 Repositioning COVER STORY Informações Detalhadas por e-mail ([email protected]) ou por Tel (11) 3285-0635/3262-1158 com Ana Maria Canal de Informação Vascular CICE2012 NEWS 19 COVER STORY COVER STORY otal trial enrollment and awaits regulatory approval (anticipated for 2012). The various devices differ in several important aspects (Table 1). They have been approved for endovascular treatment of fusiform and saccular aneurysms of the descending thoracic aorta, as well as penetrating aortic ulcers (PAUs), with the exception of Gore TAG, which received a TAA indication only. FDA approval was based on the 1-year results achieved in the various trials that were designed and conducted to test each device in the clinical arena.17-20 TEVAR developments have transformed the thoracic aortic surgery landscape (Figure 5). Advances in aortic imaging have contributed significantly as well. An important retrospective review of rates of TAA repair in the United States from 2000 to 2007 published by Walker et al in 2010 was illuminating in this regard:21 the open repair rate was observed to increase from 3.3 per million in the 2000 to 2002 time period, up to 5.6 per million in 2003 (when multislice computed tomographic scanners were introduced). The TEVAR repair rate changed dramatically from a low of 1.2 per million in 2005, moving sharply upward to 6.1 repairs per million in 2006 after the first FDA approval of a thoracic stent graft (Gore TAG). From a technology standpoint, thoracic devices got through the “infancy” phase in the 1990s and early 2000s and are now beginning to reach “early adulthood.” Although the list of TEVAR accomplishments is robust and impressive, several important issues remain to be conquered, chiefly: • Conformability to the bend, or knuckle, of the distal arch to make it possible for endografts to hug the lesser curve without bird-beaking (Figure 6). Such a prob- Figure 6. Bird-beaking occurs from malapposition to the lesser curve when a stent graft is placed at or across the knuckle of the aortic arch. 20 serious medical comorbidities and the fear of complications and death. This explains better than anything else the rapid rise of TEVAR and its transformational influence. There are currently four FDA-approved thoracic stent graft devices: Gore TAG (Gore & Associates, Flagstaff, AZ), Zenith TX2 (Cook Medical, Bloomington, IN), Talent (Medtronic, Inc., Minneapolis, MN), and Valiant (Medtronic, Inc.) (Figure 3). Formal commercial launch of the latter is expected in the near future. A fifth thoracic device, the Relay stent graft (Figure 4), has completed pivA B Figure 7. Branched thoracic stent graft development. Gore’s branched thoracic stent graft prototype (A). Medtronic’s branched thoracic stent graft prototype (B). 40 I ENDOVASCULAR TODAY I NOVEMBER 2011 A B 30% 1/3 2/3 70% ■ Complicated ■ Uncomplicated ■ Type A ■ Type B Figure 8. There are an estimated 10,000 total new cases of aortic dissection in the United States each year, two-thirds being type A and one-third being type B (A). There are an estimated 3,000 cases each year of acute type B dissection, 30% of which are complicated, and 70% of which are uncomplicated (B). lem can result in malapposition and proximal seal failure and type I endoleak, poor fixation, and even graft collapse in some cases. More recent device developments may have already addressed such issues: Medtronic’s Valiant Captivia, Cook’s Zenith TX2 Pro-Form, and Gore’s Conformable TAG devices represent the latest-available design enhancements that would appear to have largely resolved such shortcomings. • Lower-profile delivery systems with an outer diameter of < 22 F are eagerly awaited. This will be most helpful to minimize access-related complications and expand the applicability of TEVAR as women (who have notoriously small and fragile access arteries) make up > 20% of patients overall. • Aortic branch management has long been recognized as a critically important next frontier and represents a significant research and development project for every major company in the field. Multiple iterations and designs will likely be developed and become available in the years to come (Figure 7). Meanwhile, the use of adjunctive techniques (chimney technique, etc.) and hybrid combinations (debranching included) continue to gain momentum at the present time. resulting in more deaths annually than ruptured AAAs. The incidence in the United States is estimated to be relatively low at 10 to 15 cases per 100,000 adults annually, amounting perhaps to 10,000 new cases each year (Figure 8).22 AD’s frequently malignant clinical course justifies its status as a major cause of cardiovascular morbidity and mortality. An intimomedial tear, or entry tear, allowing the powerful aortic blood flow to rip into the wall is the initiating event, resulting in the creation of a secondary flow channel, or false lumen (FL), that propagates distally in a spiraled (more commonly) or straight fashion to involve various extents of the aorta. This frequently occurs all the way down to the bifurcation and into one or both iliac arteries. The FL can also propagate proximally. The pressurized FL tends to compress the true lumen (TL) in the chest (and beyond), sometimes to the point of near-collapse with impediment of distal blood flow to the viscera, the spinal cord, and the lower extremities below. The entry tear is almost always located in the thoracic aorta—ascending aorta in type A and descending aorta distal to the origin COMPONENTS OF ACUTE AORTIC SYNDROME AORTIC DISSECTION Acute AD is the most common fatal aortic catastrophe, • Aortic dissection • Penetrating aortic ulcer • Intramural hematoma • rTAA 42 I ENDOVASCULAR TODAY I NOVEMBER 2011 Canal de Informação Vascular CICE2012 NEWS Canal de Informação Vascular CICE2012 NEWS 21 (Permission for use granted by Cook Medical Incorporated, Bloomington, Indiana.) COVER STORY 22 COVER STORY of the left subclavian artery in type B. Secondary, or reentry tears (fenestrations), on the other hand, can occur in the distal thoracic and/or the abdominal aorta. Medial degeneration of the aortic wall is the underlying anatomic defect that sets the stage for AD to occur. Inherited connective tissue disorders such as Marfan syndrome (and Ehlers-Danlos or Loeys-Dietz syndromes) and other TAA and AD familFigure 9. Zenith TX2 TAA stent graft. ial syndromes can serve as the root cause in some cases.23 But it seems that the majority of AD patients develop dissection from severe, often uncontrolled or poorly treated arterial hypertension that induces severe degenerative changes in the aortic wall over time. It is not certain whether hypertension alone can cause AD without a predisposed aorta. The likelihood of dissection occurring is also influenced by diameter because dilatation of the aorta results in increasing wall tension and mechanical stress.12 Data from the International Registry of Acute Aortic Dissection24 point with clarity to the most important risk factors for the development of acute AD. The following stand out: male gender (2:1 male-to-female ratio), age (sixth and seventh decade), a history of hypertension, previous cardiac surgery (including aortic valve replacement or repair), bicuspid aortic valve, Marfan syndrome, and crack cocaine use. Intramural hematoma (IMH) and PAU are two other conditions that often present with similar symptoms as those of acute AD and may be linked etiologically and pathogenically. IMH results from hemorrhage within the aortic wall but without an intimomedial flap or tear. It is thought of as a precursor to dissection in many cases and has been documented to evolve into a classic AD (with a double-barrel lumen) in nearly 20% of afflicted patients.25 Unlike AD, however, the majority (2/3) are classified as type B because they involve the descending thoracic aorta. Similarly, most PAU lesions are located in the descending aorta. The condition tends to occur in elderly individuals with severe generalized atherosclerosis. PAU can also be a precursor to AD and be associated with IMH. All three conditions, together with rTAA, are often referred to as components of so-called acute aortic syndrome (see Components of Acute Aortic Syndrome sidebar).26 Clinically, AD is classified as acute when the symptoms are 14 days in duration or less. Beyond the first 2 weeks, AD is said to be chronic. Such designations evolved at a time (more than 30 years ago) when the vast majority of acute AD patients died within a few hours or days from onset, a fact that may perhaps explain the arbitrary and unhelpful use of the term chronic from the 15th day on.27 Anatomically, AD is classified according to the extent and location of the dissection process in the aorta: DeBakey’s types I and II (or Stanford type A) denote ascending aortic involvement (plus/minus more distal extension), and type IIIa and IIIb (Stanford type B) characterize an AD that begins beyond the origin of the left subclavian artery and propagates distally for various lengths.27 The mortality rate of untreated acute type A dissection is staggering: approximately one-third of patients die within the first 24 hours, and 50% die by the end of the second day. The 2-week mortality rate approaches 80%. It remains a true cardiac surgical emergency. The terms complicated and uncomplicated are used to further characterize acute type B (type III) dissection. Patients presenting with rupture (blood outside the aortic 8,000 1,000 ■ Annual total of thoracic aortic injuries ■ Number of patients making it to the hospital alive Figure 10. The annual total number of thoracic aortic injuries compared to the amount of patients arriving at the hospital alive. 44 I ENDOVASCULAR TODAY I NOVEMBER 2011 wall), malperfusion (visceral/renal, spinal cord, and/or the lower extremities), or acute diameter expansion in the distal arch or proximal descending aorta (> 45 mm total aortic diameter) are designated as having a complicated dissection. Unrelenting pain, uncontrolled hypertension, and “image worsening” are also considered components of this definition by some experts. Approximately 30% of acute type B patients are thus diagnosed as complicated and are known to be in great peril in the absence of urgent intervention. The rest (70%) present with uncomplicated AD and are generally managed medically, mainly through the use of pharmacologic anti-impulse and antihypertensive therapy as well as pain control. Patients with uncomplicated acute AD who are treated with present-day optimal medical therapy face a 30-day mortality rate of 10%. However, they are exposed to possible serious complications over time, including the development of a dissecting TAA (out of the enlarging FL in the chest) in 20% to 30% of cases.28 Thus, close monitoring and follow-up (with serial imaging) of medically managed patients is absolutely mandatory. AD complicated by overt ischemia (malperfusion) or rupture, on the other hand, requires prompt intervention, which results in a 20% or higher mortality rate within 30 days.29 In this realm, open surgical repair continues to disappoint because of excessive rates of morbidity and mortality.29 This is the same as with other clinical indications in the thoracic space. Dissatisfaction with standard surgical treatment has been the most powerful driving force propelling the development of less-invasive options. For AD, the endovascular revolution began precisely on May 20, 1999, with the publication of two landmark articles that appeared back-to-back in the same issue of the New England Journal of Medicine.30,31 The pioneering early work of Nienaber et al and Dake et al strongly suggested for the first time that endovascular treatment of acute AD using stent graft devices to reline the TL in the chest and cover the entry tear might offer a safer and more attractive alternative to traditional open surgery. Interest in such strategies peaked a few years later, and a rapidly growing clinical experience has largely substantiated their initial impression.32,33 Today, TEVAR is considered to be a first-line therapy for the majority of complicated AD patients presenting with an interventional imperative. This paradigm shift from open surgery to TEVAR has occurred gradually but unmistakably, fueled largely by the notoriously poor outcomes of traditional surgical treatment and the distinct appeal of the lessinvasive approach. However, on the downside, the evidence base is not strong, and thoracic devices have not been formally tested in the treatment of AD, and the use of stent grafts remains off label (as of the end of November 2011 when this writing was completed). It is hoped that ongoing and recently completed trials will provide the necessary clinical evidence to support regulatory approval of an on-label stent graft indication for AD in the near future.34,35 More daunting yet, scientific evidence in favor of TEVAR intervention in the setting of uncomplicated type B AD remains elusive, with the continuing recommendation at present to manage most of these patients medically. The development of dissection-specific devices is another important goal. Cook pursued such an endeavor before anyone else: the company’s TXD stent graft was recently approved for European commercialization. The device consists of a proximal standard endograft that can be extended distally using a variable number of interlinked bare-metal self-expanding stents to stabilize the dissected lamella and re-expand the TL throughout its extent (Figure 9). In truth, a similar strategy could be used with various combinations of currently available devices. The early clinical experience and patient outcomes have been encouraging.36 Other AD-specific endograft designs will no doubt follow in the next several years, and these are likely not to have proximal bare stents or redesigned bare stents that are short, soft, and with well-rounded smooth peaks. Lastly, ongoing disappointment with surgical outcomes and continued technological advances will almost inevitably result in the creation of endovascular solutions for type A dissection. Current developments with transcatheter valve devices make such a prediction all but certain. THORACIC AORTIC INJURY The term transection is misleading and largely inaccurate, because most thoracic aortic injuries (TAIs) do not involve a complete loss of continuity across the aorta. Nonetheless, the term has come to signify blunt traumatic aortic thoracic disruptions that often prove fatal. Most are related to deceleration injuries occurring during automobile accidents, falls from great heights, etc. It accounts for nearly 20% of deaths related to vehicular collisions,37 and it is the second most frequent cause of traumatic death overall.38 Eighty percent to 90% of victims die at the site, almost immediately. Among those who make it to the hospital alive, up to 50% will die within 24 hours. There may be as many as 8,000 such injuries occurring annually in the United States and approximately 1,000 victims arriving at the hospital alive (Figure 10).39 Historically, surgical treatment has produced less than stellar outcomes, with an average mortality rate of 28% and a 16% paraplegia rate. Endovascular repair is growing in acceptance and adoption, as the results appear to be clearly better than those of open surgery.39-41 In fact, in many centers, TEVAR has already replaced surgical treatment in the management of most such trauma victims,42 and it is antici- 46 I ENDOVASCULAR TODAY I NOVEMBER 2011 Canal de Informação Vascular CICE2012 NEWS Canal de Informação Vascular CICE2012 NEWS 23 COVER STORY pated to become the next FDA-approved indication for thoracic stent graft devices in the very near future. Approval of the Talent thoracic device in June 2008 represented an important enhancement of technical capabilities with the offer of relatively small-size grafts (22- and 24-mm diameter) that are particularly well suited for implantation in small (and healthy) aortas frequently encountered in these cases. That said, endovascular repair of TAI continues to be performed using all commercially available thoracic devices at this time. The current off-label nature of endovascular repair is likely to change soon, as TAI is set to become the next FDA-approved indication for TEVAR. A new classification that recognizes four different extents of aortic injuries (and their treatment implications) has been another helpful addition to our body of knowledge and is already having an impact at the time of making an informed decision on which lesions to select for prompt or immediate repair versus those that can safely be observed without intervention.43 But it must also be acknowledged that information on long-term outcomes following stent graft repair of thoracic aortic injury is essentially nonexistent, so proclamations of “total triumph” must be tempered accordingly. 24 CONCLUSION In the end, the TEVAR landscape can be described as one of profound transformation, paradigm shifts, and intense ongoing research and evolution. The pace of change will likely continue and almost inevitably accelerate in the foreseeable future. Although it is true that many challenges and unfulfilled promises remain, it is plain to see that we have (as a result) become inarguably better in our capacity to address a large number of complex life-threatening aortic pathologies, bringing enormous benefit to many patients. Stay tuned, for this is just the beginning! ■ Frank J. Criado, MD, FACS, FSVM, is a vascular surgeon and endovascular specialist at Union Memorial Hospital-MedStar Health in Baltimore, Maryland. He has disclosed that he receives honoraria from Medtronic, Inc., for consulting, speaking, and training. Dr. Criado may be reached at [email protected]. 1. Dake MD, Miller DC, Semba CP, et al. Transluminal placement of endovascular stent-grafts for the treatment of descending thoracic aortic aneurysms. N Engl J Med. 1994;331:1729-1734. 2. Criado FJ. EVAR at 20: the unfolding of a revolutionary new technique that changed everything. J Endovasc Ter. 2010;17:789-796. 3. Criado, FJ. The EVAR landscape in 2011: a status report on AAA therapy. Endovasc Today. 2011;10:40-44, 58. 4. Davies RR, Goldstein LJ, Coady MA, et al. Yearly rupture or dissection rates of for thoracic aortic aneurysms: simple prediction based on size. Ann Thorac Surg. 2002;73:17-27. 5. Ramanath VS, Oh JK, Sundt TM, et al. Acute aortic syndromes and thoracic aortic aneurysm. Mayo Clin Proc. 2009;84:465-481. 6. Elefteriades JA, Farkas EA. Thoracic aortic aneurysm: clinically pertinent controversies and uncertainties. J Am Coll Cardiol. 2010;55:841-857. 7. Svensson LG, Kouchoukos NT, Miller DC, et al. Society of Thoracic Surgeons Endovascular Surgery Task Force. Expert consensus document on the treatment of descending thoracic aortic disease using endovascular stent-grafts. Ann Thorac Surg. 2008;85(1 suppl):S1-41. 8. Elefteriades JA. Natural history of thoracic aortic aneurysms: indications for surgery, and surgical versus nonsurgical risks. Ann Thorac Surg. 2002;74:S1877-1880. 9. Clouse WD, Hallett JW, Schaff HV, et al. Acute aortic dissection: Population-based incidence compared with degenerative aortic aneurysm rupture. Mayo Clin Proc. 2004;79:176-180. 10. Jonker FH, Trimarchi S, Verhagen HJ, et al. Meta-analysis of open versus endovascular repair for ruptured descending thoracic aortic aneurysm. J Vasc Surg. 2010;51:1026-1032. 11. Lederle FA, Johnson GR, Wilson SE, et al. The aneurysm detection and management study screening process: validation cohort and final results. Aneurysm Detection and Management Veterans Affairs Cooperative Study Investigators. Arch Intern Med. 2000;160:1425-1430. 12. Elefteriades JA. Thoracic aortic aneurysm: reading the enemy’s playbook. Yale J Biol Med. 2008;81:175-186. 13. Elefteriades JA, Rizzo JA. Epidemiology, prevalence, incidence, trends. In: Elefteriades JA, editor. Acute Aortic Disease. New York, NY: Informa Healthcare; 2008:89-98. 14. Acosta S, Ogren M, Bengtsson H, et al. Increasing incidence of ruptured abdominal aortic aneurysm: a population-based study. J Vasc Surg. 2006;44:237-243. 15. Lam CR, Aram HH. Resection of the descending thoracic aorta for aneurysm; a report of the use of a homograft in a case and an experimental study. Ann Surg. 1951;134:743-752. 16. Conrad MF, Cambria RP. Contemporary management of descending thoracic and thoracoabdominal aortic aneurysms: endovascular versus open. Circulation. 2008;117:841-852. 17. Makaroun MS, Dillavou ED, Wheatley GH, et al; for the Gore TAG Investigators. Five-year results of endovascular treatment with the Gore TAG device compared with open repair of thoracic aortic aneurysms. J Vasc Surg. 2008;47:912-918. 18. Greenberg RK, O’Neill S, Walker E, et al. Endovascular repair of thoracic aortic lesions with the Zenith TX1 and TX2 thoracic grafts: intermediate-term results. J Vasc Surg. 2005;41:589-596. 19. Fairman RM, Criado F, Farber M, et al; for the VALOR Investigators. Pivotal results of the Medtronic Vascular Talent Thoracic Stent Graft System: the VALOR trial. J Vasc Surg. 2008;48:546-554. 20. Fairman RM. Results of the VALOR II trial of the Medtronic Valiant thoracic stent graft at 1 year. Presented at: 2011 SVS Vascular Annual Meeting; June 16-18, 2011; Chicago, IL. 21. Walker KL, Shuster JJ, Martin TD, et al. Practice patterns for thoracic aneurysms in the stent graft era: health care system implications. Ann Thorac Surg. 2010;90:1833-1839. 22. Svensson LG, Kouchoukos NT, Miller DC, et al. Society of Thoracic Surgeons Endovascular Surgery Task Force. Expert consensus document on the treatment of descending thoracic aortic disease using endovascular stent-grafts. Ann Thorac Surg. 2008;85:S1-S41. 23. Fattori R, Napoli G, Lovato L, et al. Descending thoracic aortic diseases: stent-graft repair. Radiology. 2003;229:176-183. 24. Hagan PG, Nienaber CA, Isselbacher EM, et al. The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease. JAMA. 2000;283:897-903. 25. Evangelista A, Mukherjee D, Mehta RH, et al. Acute intramural hematoma of the aorta: a mystery in evolution. Circulation. 2005;111:1063-1070. 26. Nienaber CA, Powell JT. Management of acute aortic syndromes. Eur Heart J. In press. 27. Criado FJ. The mystery of aortic dissection: a 250-year evolution. J Cardiovasc Surg. 2010;51:601-608. 28. Grabenwogen M, Fleck T, Czerny M, et al. Endovascular stent graft placement in patients with acute thoracic aortic syndromes. Eur J Cardiothorac Surg. 2003;23:788-793. 29. Bozinovski J, Coselli JS. Outcomes and survival in surgical treatment of descending thoracic aorta with acute dissection. Ann Thorac Surg. 2008;85:965-971. 30. Nienaber CA, Fattori R, Lund G, et al. Nonsurgical reconstruction of thoracic aortic dissection by stent-graft placement. N Engl J Med. 1999;340:1539-1545. 31. Dake MD, Kato N, Mitchell RS, et al. Endovascular stent-graft placement for the treatment of acute aortic dissection. N Engl J Med 1999;340:1546-1552. 32. Khoynezhad A, Donayre CE, Omari BO, et al. Midterm results of endovascular treatment of complicated acute type B aortic dissection. J Thorac Cardiovasc Surg. 2009;138:625-631. 33. White RA, Miller C, Criado FJ, et al. Report on the results of thoracic endovascular aortic repair for acute, complicated, type B aortic dissection at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee. J Vasc Surg. 2011;53:1082-1090. 34. Investigators for the Medtronic Valiant Captivia Trial. Clinical study to evaluate the performance of the Valiant thoracic stent graft with the Captivia delivery system (Valiant Captivia) for the treatment of acute, complicated type B aortic dissections. Study in progress. 35. Tang DG, Dake MD. TEVAR for acute uncomplicated aortic dissection: immediate repair versus medical therapy. Semin Vasc Surg. 2009;22:145-51. 36. Lombardi JV, Nienaber CA, Cambria R, et al. Endovascular treatment of complicated type B aortic dissection using a composite device design: initial results of a prospective multicenter clinical trial (STABLE). Presented at: the 2011 SVS Annual Vascular Meeting; June 16-18, 2011; Chicago, IL. 37. Rousseau H, Soula P, Perreault P, et al. Delayed treatment of traumatic rupture of the thoracic aorta with endoluminal covered stent. Circulation. 1999;99:498-504. 38. Plummer D, Petro K, Akbari C, O’Donnell S. Endovascular repair of traumatic thoracic aortic disruption. Perspect Vasc Surg Endovasc Ther. 2006;18:132-139. 39. Neschis DG, Moaine S, Gutta R, et al. Twenty consecutive cases of endograft repair of traumatic aortic disruption: lessons learned. J Vasc Surg. 2007;45:487-492. 40. Hong MS, Freezor RJ, Lee WA, Nelson PR. The advent of thoracic endovascular repair is associated with broadened treatment eligibility and decreased overall mortality in traumatic thoracic aortic injury. J Vasc Surg. 2011;53:36-43. 41. Estrera AL, Gochnour DC, Azizzadeh A, et al. Progress in the treatment of blunt thoracic aortic injury: 12-year single-institution experience. Ann Thorac Surg. 2010;90:64-71. 42. Lee WA, Matsumura JS, Mitchell RS, et al. Endovascular repair of traumatic thoracic aortic injury: clinical practice guidelines of the Society for Vascular Surgery. J Vasc Surg. 2011;53:187192. 43. Azizzadeh A, Keyhani K, Miller CC, et al. Blunt traumatic aortic injury: initial experience with endovascular repair. J Vasc Surg. 2009;49:1403-1408. NOVEMBER 2011 I ENDOVASCULAR TODAY I 47 Canal de Informação Vascular CICE2012 NEWS
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