Niamh Hynes1, Sherif Sultan2, Ala Elhelali3, Edward B Diethrich4, Edel P Kavanagh5, Mohamed Sultan5, Florian Stefanov3, Patrick Delassus6, Liam Morris6. 1. Western Vascular Institute, Department of Vascular and Endovascular Surgery, University Hospital Galway, National University of Ireland, Galway, Ireland Galway Clinic, Royal College of Surgeons of Ireland Affiliated Hospital, Doughiska, Galway, Ireland. 2. Western Vascular Institute, Department of Vascular and Endovascular Surgery, University Hospital Galway, National University of Ireland, Galway, Ireland Galway Clinic, Royal College of Surgeons of Ireland Affiliated Hospital, Doughiska, Galway, Ireland sherif.sultan@hse.ie. 3. Western Vascular Institute, Department of Vascular and Endovascular Surgery, University Hospital Galway, National University of Ireland, Galway, Ireland GMedTech, Department of Biomedical Engineering, Galway Mayo Institute of Technology, Galway, Ireland. 4. Arizona Heart Foundation, Phoenix, AZ, USA. 5. Western Vascular Institute, Department of Vascular and Endovascular Surgery, University Hospital Galway, National University of Ireland, Galway, Ireland. 6. GMedTech, Department of Biomedical Engineering, Galway Mayo Institute of Technology, Galway, Ireland.
Abstract
PURPOSE: To examine the safety and short-term efficacy of the Streamliner Multilayer Flow Modulator (SMFM) in the management of patients with complex thoracoabdominal aortic pathology who are unfit for alternative interventions. METHODS: Biomedical databases were systematically searched for articles published between 2008 and 2015 on the SMFM. A patient-level meta-analysis was used to evaluate aneurysm-related survival. Secondary outcomes were all-cause survival, stroke, spinal cord ischemia, renal impairment, and branch vessel patency. Other considerations were the impact of compliance with the instructions for use (IFU) on clinical outcome. Mean values and Kaplan-Meier estimates are presented with the 95% confidence interval (CI). RESULTS: Fifteen articles (3 multicenter cohort studies, 3 observational cohort studies, and 9 case reports) were included, presenting 171 patients (mean age 68.8±12.3 years; 139 men). The mean aneurysm diameter was 6.7±1.6 cm (95% CI 6.4 to 6.9 cm). Technical success reported in 15 studies was 77.2%. Aneurysm-related survival at 1 year was 78.7% (95% CI 71.7% to 84.4%). One-year all-cause survival was 53.7% (95% CI 46.0% to 61.3%). There were no reported cases of spinal cord ischemia, renal insult, or stroke. CONCLUSION: The SMFM can be safely utilized in some patients with complex thoracoabdominal pathologies provided operators adhere to the IFU. The SMFM is a novel technology with no long-term published data on its sustained effectiveness and a lack of comparative studies. Randomized clinical trials, registries, and continued assessment are essential before this flow-modulating technology can be widely disseminated.
PURPOSE: To examine the safety and short-term efficacy of the Streamliner Multilayer Flow Modulator (SMFM) in the management of patients with complex thoracoabdominal aortic pathology who are unfit for alternative interventions. METHODS: Biomedical databases were systematically searched for articles published between 2008 and 2015 on the SMFM. A patient-level meta-analysis was used to evaluate aneurysm-related survival. Secondary outcomes were all-cause survival, stroke, spinal cord ischemia, renal impairment, and branch vessel patency. Other considerations were the impact of compliance with the instructions for use (IFU) on clinical outcome. Mean values and Kaplan-Meier estimates are presented with the 95% confidence interval (CI). RESULTS: Fifteen articles (3 multicenter cohort studies, 3 observational cohort studies, and 9 case reports) were included, presenting 171 patients (mean age 68.8±12.3 years; 139 men). The mean aneurysm diameter was 6.7±1.6 cm (95% CI 6.4 to 6.9 cm). Technical success reported in 15 studies was 77.2%. Aneurysm-related survival at 1 year was 78.7% (95% CI 71.7% to 84.4%). One-year all-cause survival was 53.7% (95% CI 46.0% to 61.3%). There were no reported cases of spinal cord ischemia, renal insult, or stroke. CONCLUSION: The SMFM can be safely utilized in some patients with complex thoracoabdominal pathologies provided operators adhere to the IFU. The SMFM is a novel technology with no long-term published data on its sustained effectiveness and a lack of comparative studies. Randomized clinical trials, registries, and continued assessment are essential before this flow-modulating technology can be widely disseminated.
Authors: Anna Paula Weinhardt Baptista-Strazzi; Ricardo Aun; Igor Rafael Sincos; Allana M Tobita; Maria Fernanda Cassino Portugal; Vitória Penido de Paula; Oskar Kaufmann; Nelson Wolosker Journal: Clinics (Sao Paulo) Date: 2021-05-21 Impact factor: 2.365
Authors: Victor S Costache; Jorn P Meekel; Andreea Costache; Tatiana Melnic; Crina Solomon; Anca M Chitic; Cristian Bucurenciu; Horatiu Moldovan; Iulian Antoniac; Gabriela Candea; Kak K Yeung Journal: Materials (Basel) Date: 2020-05-15 Impact factor: 3.623