RESUMO
Background: ModulHeart (Puzzle Medical Devices Inc) is a modular device providing hemodynamic support through 3 endovascular pumps inserted in series and assembled in parallel into a self-expandable anchor implanted in the descending aorta. The current study evaluates the feasibility and safety of cardiorenal support with ModulHeart among patients undergoing high-risk percutaneous coronary intervention (PCI). Methods: This study was a prospective, single-center, first-in-human study. The primary end point was procedural success, defined as successful delivery, function, and removal of the ModulHeart device. Secondary end points included pump hemodynamics, cardiac hemodynamics, and urine output. Results: On June 28 and 29, 2022, 4 patients were enrolled and underwent high-risk PCI with ModulHeart implanted via transfemoral approach. All 4 patients achieved procedural success. The mean delivery time was 8 minutes, the mean support time was 49 minutes, and the mean pump removal time was 7 minutes. The mean pressure gradient across the pump was 5 ± 2 mm Hg. Under ModulHeart support, cardiac index increased by 25%, central venous pressure decreased by 37%, and left ventricular end-diastolic pressure decreased by 78%. Urine output increased by â¼9-fold after 15 minutes of support. No device malfunction or procedural or device-related adverse events occurred. There was no evidence of pump thrombosis. All 4 patients were alive at 30 days. Conclusions: This first-in-human study demonstrated the feasibility and safety of cardiorenal support with ModulHeart among patients undergoing high-risk PCI. ModulHeart demonstrated significant improvement in cardiac output, left ventricular end-diastolic pressure, and urine output. Future studies are planned to assess outcomes associated with ModulHeart support in patients with heart failure.
RESUMO
Introdução: A regurgitação mitral não tratada resulta em aumento da mortalidade em pacientes com insuficiência cardíaca congestiva. O Sistema Mitralign de Anuloplastia Mitral Percutânea propicia uma opção de tratamento sem cirurgia em casos selecionados, com dilatação do anel mitral. Método: O procedimento é realizado por meio de uma única punção da artéria femoral com introdutor 14 F, sendo usados para visualização tanto a fluoroscopia como o ecocardiograma transesofágico. O cateter-guia é manobrado até o ventrículo esquerdo e posicionado sob o anel da valva mitral. Um sistema de cateteres implanta fios de sutura no anel mitral posterior, que são então aproximados mediante um sistema de tração, remodelando o anel valvar. Uma vez alcançado o resultado desejado as suturas são fixadas e cortadas. Resultados: O procedimento foi realizado em 6 pacientes e foi bem tolerado. A duração do procedimento foi, em média, inferior a duas horas e, na maioria dos casos (4/6), houve redução imediata da regurgitação mitral. Todos os pacientes foram acompanhados por até 12 meses. Não ocorreu nenhum óbito, estando 4 pacientes em classe I, 1 paciente em classe II e 1 paciente em classe III da New York Heart Association. Obteve-se redução significativa dos diâmetros ventriculares esquerdos e também do tamanho do átrio esquerdo após os primeiros 90 dias de acompanhamento. Conclusão: Essa técnica pode ser realizada com segurança e mostra benefício considerável para pacientes selecionados, nos quais a cirurgia não é uma boa opção. Maior número de pacientes tratados com esse novo procedimento nos permitirá compreender melhor os limites da anuloplastia mitral percutânea.
Background: Untreated mitral regurgitation results in increased mortality in patients with congestive heart failure (CHF). The Mitralign Percutaneous Annuloplasty System provides a treatment option without surgery in selected cases with mitral annulus dilation. Methods: The procedure is performed through a single 14 F femoral artery puncture; fluoroscopy and transesophageal echocardiography are both used for visualization. The guide catheter is maneuvered into the left ventricle and positioned at the posterior mitral annulus. A catheter system places sutured pledgets into the posterior mitral annulus and these implants are pulled together to remodel the mitral valve annulus. Once the desired effects are achieved, the suture is locked and cut. Results: The procedure was performed in 6 patients and was well tolerated. Procedure times were generally < 2 hours and in most cases (4/6) immediate mitral regurgitation reduction was achieved. All patients were followed up to 12 months. There were no deaths and 4 patients were New York Heart Association class I, one was class II and one class III. There was a significant reduction of the left ventricular diameters, and left atrium size after the first 90 days of follow up. Conclusions: Direct percutaneous mitral annuloplasty is achievable and reproducible. This is a technique that can be performed safely and shows a considerable benefit for selected patients in whom surgery is not a good option. A higher number of patients treated with this new procedure will provide us with a better understanding of the limitations of percutaneous mitral annuloplasty approach.