Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair

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Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair

Tsilimparis, Nikolaos (author): University Hospital Munich

Gouveia e Melo, Ryan (author): University Hospital Munich

Schanzer, Andres (author): University of Massachusetts Medical School

Sobocinski, Jonathan (author): University of Lille

Austermann, Martin (author): University of Münster

Chiesa, Roberto (author): Vita-Salute San Raffaele University

Resch, Timothy (author): Copenhagen University Hospital,University of Copenhagen

Gargiulo, Mauro (author): St. Orsola-Malpighi University Hospital

Timaran, Carlos (author): University of Texas Southwestern Medical Center

Maurel, Blandine (author): Nantes University Hospital

Adam, Donald (author): University Hospitals Birmingham

Dias, Nuno (author): Lund University,Lunds universitet,Vaskulära sjukdomar - kliniska studier,Forskargrupper vid Lunds universitet,Vascular Diseases - Clinical Research,Lund University Research Groups,Skåne University Hospital

Oderich, Gustavo S. (author): Mayo Clinic Minnesota,University of Texas Health Science Center at Houston

Kölbel, Tilo (author): University Heart Center Hamburg

Gomez Palones, Francisco (author): Hospital Universitario Doctor Peset

Simonte, Gioele (author): Ospedale Santa Maria della Misericordia

Giudice, Rocco (author): San Giovanni Addolorata Hospital

Mesnard, Thomas (author): University of Lille

Loschi, Diletta (author): Vita-Salute San Raffaele University

Leone, Nicola (author): Copenhagen University Hospital,University of Copenhagen

Gallito, Enrico (author): St. Orsola-Malpighi University Hospital

Spath, Paolo (author): St. Orsola-Malpighi University Hospital,University Hospital Munich

Porras Cólon, Jesus (author): University of Texas Southwestern Medical Center

Elboushi, Amro (author): University Hospitals Birmingham

Wachtmeister, Melker (author): Skåne University Hospital

Sonesson, Bjorn (author): Lund University,Lunds universitet,Vaskulära sjukdomar - kliniska studier,Forskargrupper vid Lunds universitet,Vascular Diseases - Clinical Research,Lund University Research Groups,Skåne University Hospital

Tenorio, Emanuel (author): Mayo Clinic Minnesota,University of Texas Health Science Center at Houston

Panuccio, Giuseppe (author): University Heart Center Hamburg

Isernia, Giacomo (author): Ospedale Santa Maria della Misericordia

Bertoglio, Luca (author): Spedali Civili Di Brescia

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2023
2023
English.
In: Journal of Vascular Surgery. - 0741-5214. ; 78:4, s. 3-873

Related links:: http://dx.doi.org/10...; show more...; https://lup.lub.lu.s...; https://doi.org/10.1...; show less...

Journal article (peer-reviewed)

Abstract Subject headings

Objective: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. Methods: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. Results: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean, 3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. Conclusions: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)

Keyword

Aortic aneurysm
Fenestrated aortic repair
FEVAR
Modified delivery system
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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Surgery

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Cardiac and Card ...

Articles in the publication: Journal of Vascu ...

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