Bioresorbable polymer Sirolimus-Eluting stent in native coronary artery stenosis: results of the prospective, multicenter inspirion and latitude trials

INTRODUCTION: Inspiron® (Scitech, Brazil) is a 3rd generation drug eluting stent designed to create a fast and homogeneous endothelialization, possibly improving clinical outcomes. OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of a sirolimus-eluting coronary stent, composed of a metallic chromium-cobalt platform with thin struts (75 µm), which releases sirolimus from a bioresorbable polymer applied only to the abluminal surface, in a real-world scenario, as a post-marketing clinical follow-up evaluation. METHODS: We pooled patient-level databases derived from the INSPIRION and LATITUDE prospective trials. Between June 2017 and January 2022, a total of 25 Brazilian centers included 2,803 patients that underwent percutaneous coronary intervention (PCI) in native coronary arteries lesions with Inspiron® (Scitech, Brazil) stent implantation. Exclusion criteria included target lesion located in saphenous vein or arterial graft, and use of coronary stent other than Inspiron® in the index procedure. The primary endpoint was a composite outcome of major adverse cardiovascular events (MACE) defined by the composite of cardiovascular death, myocardial infarction (MI) or target-lesion revascularization (TLR) at 12 months. The secondary outcomes included all-cause death, cardiovascular death, any MI, TLR, target-vessel revascularization (TVR), and probable and definite stent thrombosis at 12 months. RESULTS: The mean age was 62.0 ± 10.8 years, 36.5% had diabetes (12.7% on insulin), 17.6% had previous PCI and 54.9% presented with an acute coronary syndrome (ACS). At a median follow-up of 410 days, MACE occurred in 58 (2.1%) patients, all-cause death in 102 (3.6%), MI in 14 (0.5%), and target vessel revascularization in 2 (0.1%) patients. Definite or probable stent thrombosis occurred in 20 (0.7%) patients. CONCLUSIONS: The 1-year MACE rate, as well as the individual endpoint components, were low and consistent with previous results available for 3rd generation drug eluting stent. The result of this study demonstrates the safety and efficacy of this stent in a real-world population.

Partial left ventriculectomy in elderly patients not suitable for heart transplantation.

BACKGROUND: Although donor scarcity and intolerance to immunosuppression tend to exclude elderly patients from transplantation, partial left ventriculectomy (PLV) has been performed without bias against advanced age. METHODS: Among 392 patients undergoing PLV, 61 elderly patients aged 65 or older (> or =65) were compared with the rest of the patients in terms of underlying disease, postoperative course, and survival time. RESULTS: The aged patients (> or =65) compared to younger patients (<65), had ischemic disease (37.7% vs. 19.3%, p < 0.05) more frequently than cardiomyopathy (34.4% vs. 43.2%) or valvular disease (23.9% vs. 16.4%) and underwent lateral PLV (74% vs. 79%) more frequently than extended PLV (26% vs. 21%). Although the elderly patients required coronary bypass grafting more frequently (39.3% vs.17.2%, p < 0.05), surgical complexity was similar in terms of bypass time (63 minutes vs. 63 minutes) and percentage requiring cardiac arrest (31% vs. 44%). Despite advanced age, they required comparable ICU care (6.6 days vs. 5.4 days) and postoperative hospital stay (12 days vs. 11 days), resulting in a low but similar hospital survival (57% vs. 62%) and functional capacity after discharge (NYHA class 1.5 vs. 1.4). CONCLUSION: The results suggest that PLV can be performed in elderly patients (> or =65 years) with comparable risks and benefits with the younger patients, promoting its application in patients disqualified for heart transplantation because of age criteria.

Angiographic and hemodynamic follow-up of patients after partial left ventriculectomy.

Angiographic, Doppler-echocardiographic and hemodynamic studies early (+6 days) and late (+180 days) after partial left ventriculectomy (PLV) on 24 patients revealed that PLV decreased end-systolic volume (or dimension) more than the end-diastolic volume (or dimension), improving stroke volumes (or contractile excursion), and doubling ejection fraction (or fractional shortening). Results of PLV appeared to depend on a balance between improved systolic contractility and reduced diastolic performance. All these survivors had improved diastolic relaxation, suggesting myocardial viability is a prerequisite for PLV to be successful.

Successful reversal of pulmonary hypertension in Eisenmenger complex / Reversão com Sucesso da Hipertensão Pulmonar no Complexo de Eisenmenge

We present a case of a 19-year old female with systemic pulmonary artery (PA) pressure due to a congenital ventricular septal defect (VSD) and atrial septal defect (ASD). She was pink at rest and cyanotic on exercise. Lung biopsy revealed grade IV pulmonary vascular changes. As a preliminary step PA was banded to increase right-to-left shunt and decrease aortic (Ao) saturation with consequent decrease in PA saturation. After one year, when she was no longer cyanotic, even on exercise, lung biopsy revealed total regression of pulmonary vascular changes. As a definitive procedure VSD and ASD were closed and PA was debanded. Cardiac catheterization one week postoperatively showed PA pressure to be 50of systemic pressure. We postulate that reversal of pulmonary vascular changes were due to lowered PA saturation. We further believe that lower PA pressure could have contributed to this regression of pulmonary vascular changes. We performed the same procedure in six more patients with similar positive clinical response. This new concept brings renewed hope to many children who otherwise are candidates for heart lung transplantation.

Bioprótese de pericárdio bovino Bioval: 5 anos de evoluçäo / Bioval pericardium bioprosthesis: 5 years' follow-up

De setembro de 1982 a dezembro de 1987, foram estudados 73 pacientes submetidos a cirurgia de substituiçäo valvar com implante de prótese biológica Bioval. A idade variou de 8 a 67 anos (média de 41 anos), sendo 36 do sexo feminino. Destes, 39 (53,42%) foram submetidos a cirurgia para implante de prótese mitral, 25 (34,2%) aórtica 5 (8,2%) pacientes eram mitro-aórticos 2 (3,5%) aórtico-coronarianos e 1 (1,8%) mitro-coronariano. Doença reumática foi a etiologia mais comum (72,6%), seguida da degeneraçäo mixomatosa (16,4%). Quatro pacientes foram operados na vigência de endocardite infecciosa. A mortalidade hospitalar foi de 5,4% e a análise atuarial revelou 2,7 óbitos/100 pacientes/ano. Um paciente com fibrilaçäo atrial (FA) crônica e átrio esquerdo (AE) muito volumoso apresentou trombose de AE envolvendo a prótese e 1 paciente do sexo feminino, jovem, apresentou calcificaçäo leve da prótese. Conclui-se que os resultados clínicos com a utilizaçäo dessa prótese foram absolutamento satisfatórios

Autotransplante cardíaco: um novo método no tratamento de problemas cardíacos complexos / Heart autotransplantation: a new method for treatment of complex cardiac problems

No período de janeiro de 1990 a maio de 1995 foram operados com a técnica do auto transplante cardíaco 92 pacientes com cardiopatias complexas e arritmias supraventriculares, principalmente fibrilaçao atrial (n=89), reentrada(n=2),QT longo(n=l). O sexo feminino predominou (n=63). A idade variou de l8 a 76 anos (m=43). Os defeitos concomitantes foram: átrio esquerdo gigante (medido pelo ecocardiograma > 6 cm) (n=65); átrio direito gigante (n=9); átrio esquerdo aumentado (< 6 cm/>4 cm) (n=23); estenose mitral (n=46); insuficiência mitral (n=28); dupla lesao mitral (n=l6); estenose aórtica (n=l2); insuficiência aórtica (n=5); insuficiência tricúspide (n=78); trombose atrial (n=23); calcificaçao atrial (n=l2); hipertensao pulmonar (n=86); flbroelastose biventricular (n=3); rotura atrioventricular (pós-troca de valva mitral) (n=l); aneurisma da raiz aórtica (n=l); ventriculectomia parcial (n=8); 88 pacientes saíram do centro cirúrgico em ritmo sinusal e assim permaneceram; 6 precisaram de drogas inotrópicas e 3 de drogas antiarrítmicas. Todos os pacientes que apresentavam átrio esquerdo ou direito gigante com fibrilaçao atrial tiveram seus átrios reduzidos ao tamanho normal. Nao houve mortalidade operatória e 6 evoluíram a óbito hospitalar. Na reavaliaçao aos seis meses de pós-operatório, os sobreviventes estavam bem, em ritmo sinusal. A técnica do autotransplante cardíaco facilita o reparo intracardíaco, proporciona a reduçao atrial e conseqüente retorno do paciente ao ritmo sinusal e abre novas perspectivas.

Ventriculectomia parcial: um novo conceito no tratamento cirúrgico de cardiopatias em fase final / Partial ventriculectomy: a new concept in the surgical treatment of end stage cardiopathies

A melhora clínica da funçao cardíaca pós aneurismectomia de ventrículo esquerdo e/ou cardiomioplastia com o músculo grande dorsal parece ser, ao menos parcialmente, devida ao remodelamento do ventrículo esquerdo. Através de pesquisa em nosso laboratório experimental com carneiros, demonstramos que o aumento do diâmetro do ventrículo é mais importante que a perda de massa muscular para a deterioraçao da funçao ventricular. Sabendo-se que em miocardiopatia dilatada nao ocorre aumento de massa muscular, reduzimos o diâmetro do ventrículo para o normal, em uma série consecutiva de pacientes com esta lesao. No período de 1984 a 1995, foram operados com esta nova técnica, denominada, entao, "Ventriculectomia Parcial", lO3 pacientes portadores de miocardiopatias complexas e insuficiência cardíaca congestiva (NYHA IV). A operaçao é baseada na lei de Laplace (T=P.1l.D) e consistiu na remoçao de uma fatia de músculo da parede lateral do ventrículo esquerdo, iniciando-se na ponta deste, estendendo-se entre os músculos papilares e terminando próximo ao anel mitral. A cirurgia é realizada sob circulaçao extracorpórea normotérmica e nao se utiliza cardioplegia. Todos os pacientes foram avaliados pré-operatoriamente com ecodopplercardiografia e ventriculografia digital, os quais revelaram fraçao de ejeçao < 20 por cento, confirmando estes pacientes como candidatos ao transplante cardíaco. A maioria era do sexo masculino (n=73) e a idade variou de l9 a 74 anos. As doenças foram: miocardite a virus (n=l2); pós miocardioplastia (n=l); doença de Chagas (n=l5); doença valvar (n=38); doença isquêmica (n=l6); idiopática (n=21). Obitos hospitalares (ocorridos nos primeiros 30 dias da cirurgia) (n=l3): embolia pulmonar (n=4); insuficiência renal (n=5); sangramento (n=4). Obitos tardios (ocorridos depois do 30( dia de cirurgia) (n=lO): arritmia (n=6); "insuficiência cardíaca" (n=2); causa desconhecida (n=2); 8 pacientes precisaram ser reoperados por sangramento. Nao houve infecçao e nenhum paciente precisou balao intra-aórtico. Todos saíram com nitroprussiato e 19 pacientes, com inotrópicos. A ventriculografia e a ecocardiografia pós-op mostraram melhora acentuada da FE (de 100 por cento a 300 por cento). Em conclusao, a nova técnica "Ventriculectomia Parcial", com o objetivo de reduzir o diâmetro do ventrículo esquerdo, pode beneficiar pacientes em estágio final de cardiopatia dilatada. Este novo conceito pode, na nossa experiência, proporcionar ao paciente melhora clínica significativa e prolongamento de sua vida.