Early and midterm outcome of Multilayer Flow Modulator stent for complex aortic aneurysm treatment in Germany

Walid Ibrahim; Konstantinos Spanos; Andreas Gussmann; Christoph A Nienaber; Joerg Tessarek; Heinrich Walter; Jörg Thalwitzer; Sebastian E Debus; Nikolaos Tsilimparis; Tilo Kölbel

doi:10.1016/j.jvs.2018.01.037

Early and midterm outcome of Multilayer Flow Modulator stent for complex aortic aneurysm treatment in Germany

Standard

Early and midterm outcome of Multilayer Flow Modulator stent for complex aortic aneurysm treatment in Germany. / Ibrahim, Walid; Spanos, Konstantinos; Gussmann, Andreas; Nienaber, Christoph A; Tessarek, Joerg; Walter, Heinrich; Thalwitzer, Jörg; Debus, Sebastian E; Tsilimparis, Nikolaos; Kölbel, Tilo.

in: J VASC SURG, Jahrgang 68, Nr. 4, 10.2018, S. 956-964.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Ibrahim, W, Spanos, K, Gussmann, A, Nienaber, CA, Tessarek, J, Walter, H, Thalwitzer, J, Debus, SE, Tsilimparis, N & Kölbel, T 2018, 'Early and midterm outcome of Multilayer Flow Modulator stent for complex aortic aneurysm treatment in Germany', J VASC SURG, Jg. 68, Nr. 4, S. 956-964. https://doi.org/10.1016/j.jvs.2018.01.037

APA

Ibrahim, W., Spanos, K., Gussmann, A., Nienaber, C. A., Tessarek, J., Walter, H., Thalwitzer, J., Debus, S. E., Tsilimparis, N., & Kölbel, T. (2018). Early and midterm outcome of Multilayer Flow Modulator stent for complex aortic aneurysm treatment in Germany. J VASC SURG, 68(4), 956-964. https://doi.org/10.1016/j.jvs.2018.01.037

Vancouver

Ibrahim W, Spanos K, Gussmann A, Nienaber CA, Tessarek J, Walter H et al. Early and midterm outcome of Multilayer Flow Modulator stent for complex aortic aneurysm treatment in Germany. J VASC SURG. 2018 Okt;68(4):956-964. https://doi.org/10.1016/j.jvs.2018.01.037

Bibtex

@article{500daedd91c64bd3b9bfc8872d4ea0ab,

title = "Early and midterm outcome of Multilayer Flow Modulator stent for complex aortic aneurysm treatment in Germany",

abstract = "OBJECTIVE: The objective of this study was to assess the early and midterm outcomes of endovascular repair of complex aortic aneurysm cases using the Multilayer Flow Modulator (MFM; Cardiatis, Isnes, Belgium) endograft in Germany.METHODS: A retrospective study including patients presenting with abdominal aortic aneurysm (AAA), thoracic aortic aneurysm, or thoracoabdominal aortic aneurysm treated with the MFM was conducted in Germany. Mortality and morbidity (in terms of spinal cord ischemia, visceral ischemia, and stroke) at 30 days postoperatively were evaluated. In addition, during follow-up, freedom from reintervention, rupture, and failure mode were also assessed.RESULTS: Between 2009 and 2014, a total of 61 patients with AAA, thoracoabdominal aortic aneurysm, or thoracic aortic aneurysm were treated with the MFM endograft in 29 hospitals around Germany. However, data of 40 patients with a mean age of 73.4 ± 11.2 years (72.5% male; 29/40) and mean aortic aneurysm diameter of 60.3 ± 16.6 mm from 14 hospitals were available for this retrospective study. Thirty-seven (93%) patients were treated urgently. In 12 cases (12/40 [30%]), patients were treated outside instructions for use because of aortic aneurysm diameter >65 mm. A total of 69 MFM stents were used (1.7/patient). The technical success rate was 95% (38/40). Postoperatively, no patient presented with spinal cord ischemia, renal function deterioration, stroke, or intestinal ischemia, except for one patient who developed multiorgan failure because of early stent migration. The intraoperative and 30-day mortality rate was 0% and 2.5%, respectively. The mean follow-up was 12.9 months (±14.9 months), with a survival rate at 1 month, 6 months, and 12 months of 97%, 78%, and 70%, respectively. Freedom from failure mode (type I or II) at 1 month, 6 months, and 12 months was 97.5%, 88%, and 86%, respectively, and visceral vessel patency was 99.3% (155/156 available). During follow-up, 4 patients (4/39 [10%]) had an aneurysm sac rupture and 10 (10/39 [25%]) underwent a reintervention. Freedom from rupture and freedom from reintervention at 1 month, 6 months, and 12 months were 97.5% and 100%, 96% and 84%, and 86% and 75%, respectively.CONCLUSIONS: The use of the MFM for endovascular treatment of complex aortic aneurysm in urgent cases appears to be technically feasible in terms of mortality and morbidity, with moderate 30-day and acceptable midterm outcomes. Reinterventions may be needed to expand the utility of outcomes.",

keywords = "Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal/diagnostic imaging, Aortic Aneurysm, Thoracic/diagnostic imaging, Aortography, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation/adverse effects, Disease-Free Survival, Endovascular Procedures/adverse effects, Feasibility Studies, Female, Germany, Hospital Mortality, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Postoperative Complications/etiology, Prosthesis Design, Regional Blood Flow, Retrospective Studies, Risk Factors, Stents, Time Factors, Treatment Outcome, Vascular Patency",

author = "Walid Ibrahim and Konstantinos Spanos and Andreas Gussmann and Nienaber, {Christoph A} and Joerg Tessarek and Heinrich Walter and J{\"o}rg Thalwitzer and Debus, {Sebastian E} and Nikolaos Tsilimparis and Tilo K{\"o}lbel",

year = "2018",

month = oct,

doi = "10.1016/j.jvs.2018.01.037",

language = "English",

volume = "68",

pages = "956--964",

journal = "J VASC SURG",

issn = "0741-5214",

publisher = "Mosby Inc.",

number = "4",

}

RIS

TY - JOUR

T1 - Early and midterm outcome of Multilayer Flow Modulator stent for complex aortic aneurysm treatment in Germany

AU - Ibrahim, Walid

AU - Spanos, Konstantinos

AU - Gussmann, Andreas

AU - Nienaber, Christoph A

AU - Tessarek, Joerg

AU - Walter, Heinrich

AU - Thalwitzer, Jörg

AU - Debus, Sebastian E

AU - Tsilimparis, Nikolaos

AU - Kölbel, Tilo

PY - 2018/10

Y1 - 2018/10

N2 - OBJECTIVE: The objective of this study was to assess the early and midterm outcomes of endovascular repair of complex aortic aneurysm cases using the Multilayer Flow Modulator (MFM; Cardiatis, Isnes, Belgium) endograft in Germany.METHODS: A retrospective study including patients presenting with abdominal aortic aneurysm (AAA), thoracic aortic aneurysm, or thoracoabdominal aortic aneurysm treated with the MFM was conducted in Germany. Mortality and morbidity (in terms of spinal cord ischemia, visceral ischemia, and stroke) at 30 days postoperatively were evaluated. In addition, during follow-up, freedom from reintervention, rupture, and failure mode were also assessed.RESULTS: Between 2009 and 2014, a total of 61 patients with AAA, thoracoabdominal aortic aneurysm, or thoracic aortic aneurysm were treated with the MFM endograft in 29 hospitals around Germany. However, data of 40 patients with a mean age of 73.4 ± 11.2 years (72.5% male; 29/40) and mean aortic aneurysm diameter of 60.3 ± 16.6 mm from 14 hospitals were available for this retrospective study. Thirty-seven (93%) patients were treated urgently. In 12 cases (12/40 [30%]), patients were treated outside instructions for use because of aortic aneurysm diameter >65 mm. A total of 69 MFM stents were used (1.7/patient). The technical success rate was 95% (38/40). Postoperatively, no patient presented with spinal cord ischemia, renal function deterioration, stroke, or intestinal ischemia, except for one patient who developed multiorgan failure because of early stent migration. The intraoperative and 30-day mortality rate was 0% and 2.5%, respectively. The mean follow-up was 12.9 months (±14.9 months), with a survival rate at 1 month, 6 months, and 12 months of 97%, 78%, and 70%, respectively. Freedom from failure mode (type I or II) at 1 month, 6 months, and 12 months was 97.5%, 88%, and 86%, respectively, and visceral vessel patency was 99.3% (155/156 available). During follow-up, 4 patients (4/39 [10%]) had an aneurysm sac rupture and 10 (10/39 [25%]) underwent a reintervention. Freedom from rupture and freedom from reintervention at 1 month, 6 months, and 12 months were 97.5% and 100%, 96% and 84%, and 86% and 75%, respectively.CONCLUSIONS: The use of the MFM for endovascular treatment of complex aortic aneurysm in urgent cases appears to be technically feasible in terms of mortality and morbidity, with moderate 30-day and acceptable midterm outcomes. Reinterventions may be needed to expand the utility of outcomes.

AB - OBJECTIVE: The objective of this study was to assess the early and midterm outcomes of endovascular repair of complex aortic aneurysm cases using the Multilayer Flow Modulator (MFM; Cardiatis, Isnes, Belgium) endograft in Germany.METHODS: A retrospective study including patients presenting with abdominal aortic aneurysm (AAA), thoracic aortic aneurysm, or thoracoabdominal aortic aneurysm treated with the MFM was conducted in Germany. Mortality and morbidity (in terms of spinal cord ischemia, visceral ischemia, and stroke) at 30 days postoperatively were evaluated. In addition, during follow-up, freedom from reintervention, rupture, and failure mode were also assessed.RESULTS: Between 2009 and 2014, a total of 61 patients with AAA, thoracoabdominal aortic aneurysm, or thoracic aortic aneurysm were treated with the MFM endograft in 29 hospitals around Germany. However, data of 40 patients with a mean age of 73.4 ± 11.2 years (72.5% male; 29/40) and mean aortic aneurysm diameter of 60.3 ± 16.6 mm from 14 hospitals were available for this retrospective study. Thirty-seven (93%) patients were treated urgently. In 12 cases (12/40 [30%]), patients were treated outside instructions for use because of aortic aneurysm diameter >65 mm. A total of 69 MFM stents were used (1.7/patient). The technical success rate was 95% (38/40). Postoperatively, no patient presented with spinal cord ischemia, renal function deterioration, stroke, or intestinal ischemia, except for one patient who developed multiorgan failure because of early stent migration. The intraoperative and 30-day mortality rate was 0% and 2.5%, respectively. The mean follow-up was 12.9 months (±14.9 months), with a survival rate at 1 month, 6 months, and 12 months of 97%, 78%, and 70%, respectively. Freedom from failure mode (type I or II) at 1 month, 6 months, and 12 months was 97.5%, 88%, and 86%, respectively, and visceral vessel patency was 99.3% (155/156 available). During follow-up, 4 patients (4/39 [10%]) had an aneurysm sac rupture and 10 (10/39 [25%]) underwent a reintervention. Freedom from rupture and freedom from reintervention at 1 month, 6 months, and 12 months were 97.5% and 100%, 96% and 84%, and 86% and 75%, respectively.CONCLUSIONS: The use of the MFM for endovascular treatment of complex aortic aneurysm in urgent cases appears to be technically feasible in terms of mortality and morbidity, with moderate 30-day and acceptable midterm outcomes. Reinterventions may be needed to expand the utility of outcomes.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Aneurysm, Abdominal/diagnostic imaging

KW - Aortic Aneurysm, Thoracic/diagnostic imaging

KW - Aortography

KW - Blood Vessel Prosthesis

KW - Blood Vessel Prosthesis Implantation/adverse effects

KW - Disease-Free Survival

KW - Endovascular Procedures/adverse effects

KW - Feasibility Studies

KW - Female

KW - Germany

KW - Hospital Mortality

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Postoperative Complications/etiology

KW - Prosthesis Design

KW - Regional Blood Flow

KW - Retrospective Studies

KW - Risk Factors

KW - Stents

KW - Time Factors

KW - Treatment Outcome

KW - Vascular Patency

U2 - 10.1016/j.jvs.2018.01.037

DO - 10.1016/j.jvs.2018.01.037

M3 - SCORING: Journal article

C2 - 29602471

VL - 68

SP - 956

EP - 964

JO - J VASC SURG

JF - J VASC SURG

SN - 0741-5214

IS - 4

ER -