Single-Center Experience Comparing the Application of Small-Caliber versus Large-Caliber Arterial Access Closure in a Consecutive Series of Patients

Baumann, Frederic; Yates, Timothy; Gandhi, Ripal; Benenati, James F.; Peña, Constantino; Katzen, Barry T.

doi:10.1016/j.jvir.2015.04.024

Cited by 6 publications

(3 citation statements)

References 13 publications

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“…7,16 Sarin et al 16 used 8-F Angio-Seals for 9-F to 12-F access sites, reporting a 4.1% complication rate for the puncture site, including the need for surgical repair in 2.0%. Baumann et al 17 reported a similar study that resulted in 9.8% minor complications. These suture-mediated closure devices involve a more complex deployment mechanism than ExoSeal.…”

Section: Discussionmentioning

confidence: 84%

Suitability of a 7-F ExoSeal Vascular Closure Device for Femoral Artery Punctures Made by 8-F or 9-F Introducer Sheaths

et al. 2017

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Section: Discussionmentioning

confidence: 84%

Suitability of a 7-F ExoSeal Vascular Closure Device for Femoral Artery Punctures Made by 8-F or 9-F Introducer Sheaths

et al. 2017

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“…For Angio-Seal TM -VIP complication rates of 0.5% [14], 1.1% [13], and 5.9% have been reported [16]. Retrospective studies by Sarin et al [28], Baumann et al [29], or Fallahi et al [30] who used Angio-Seal TM 8F off-label to close 9-12F access sites, reported complications in 4.1% (48 procedures) with need of surgical repair in 2% [28] or minor complications in 9.8% (61 procedures), respectively without the need for additional interventions [29]. These results are in line with our study, including access sheaths up to 14F, minor (2.1%) and major (6.3%) vascular complications occurrence only in non-obese patients with low or average CFA depth and moderately to severe calcified access vessels.…”

Section: Discussionmentioning

confidence: 98%

Single Angio-Seal vascular closure device for transfemoral access exceeding 8F

Frenzel

Fries

Shayesteh-Kheslat

et al. 2020

Journal of Cardiology

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Background: This was a retrospective single-center evaluation for off-label use of a single Angio-Seal-VIP 8F vascular closure device (VCD) (Terumo Interventional Systems, Somerset, NJ, USA) for retrograde transfemoral arterial access exceeding 8F. Methods: Between 2010 and 2018, in 32 consecutive patients (3 females; mean age 67 AE 9; range 46-86 years) retrograde femoral access was performed in 48 groins for aortoiliac stent or stent graft implantations using 9-14F sheaths. For vascular closure, one single Angio-Seal TM -VIP 8F was used. Procedural success, closure-related complications, and risk factors were retrospectively evaluated using patient characteristics, duplex-ultrasound, and contrast-enhanced computed tomography angiography (CTA). Receiver-operating-characteristics were used for statistical analysis. Results: Technical success for deployment of VCD was 100%. Visual inspection and duplex-ultrasound confirmed immediate hemostasis in 100%. Postinterventional CTA depicted major vascular access site complications in 6.3% (3/48 groins) requiring surgical treatment. A subgroup of 13 patients underwent surgical cut-down one day after VCD deployment as part of a two-staged complex endovascular aortic aneurysm repair procedure, allowing for visual assessment of prior used undersized Angio-Seal TM . Patient's height (p = 0.028) and severe access site calcifications (p = 0.028) proved as predictors for one vessel occlusion and two pseudoaneurysms. Low body-mass-index (BMI) showed a nonsignificant trend. Sheath-size, common femoral artery depth, or body weight were not indicative for occurrence of complications. Conclusions: In selected cases, without availability of appropriate VCDs, a single Angio-Seal TM -VIP 8F served as a feasible option to achieve sufficient hemostasis of transfemoral access exceeding 8F without relevant bleeding complications. Very low BMI, tall body-height, and severe atherosclerosis were identified to predispose to access site complications.

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“…Femoral bleeding complications have been shown to change with sheath size, duration of femoral arterial access, as well as intensity and duration of anticoagulation (Doyle et al, 2008; Cantor et al, 2007). However, the influence of sheath size on overall complication rates and morbidity following femoral arterial access is not well described and is of particular interest given the potential mitigation of these complications with arterial closure devices (Tzinieris et al, 2007; Das et al, 2011; Baumann et al, 2015).…”

Section: Introductionmentioning

confidence: 99%

Are complication rates lower with 4-Fr versus 6-Fr transfemoral arterial access – prospective audit at a single interventional radiology centre

et al. 2018

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BackgroundFemoral arterial access constitutes the first step in a significant proportion of interventional endovascular procedures. Whilst existing reports describe sheath size as an independent risk factor for bleeding complications in radial arterial access for coronary intervention, the influence of sheath size on overall complication rates and morbidity following femoral arterial access is not well described. This prospective single centre study reports our experience of vascular sheath size, patient and procedural factors in influencing complication rates following femoral arterial access. From April 2010 to May 2013, data was collected prospectively for all femoral arterial access procedures performed in the Interventional Radiology department of a tertiary hospital. For vascular sheath size <6-Fr, haemostasis was achieved by manual compression. For 6-Fr sheath size, a closure device was used in the absence of any contraindication.ResultsOf the 320 femoral access cases with eligible inclusion criteria, 52.5% had 4-Fr whilst 47.5% had 6-Fr vascular sheaths inserted. Overall post procedure complications rates were significantly higher following 6-Fr sheath (17/152 (11.2%)) versus 4-Fr systems (3/168 (1.8%)) (p=0.0007) mostly comprising self-limiting hematoma. There was no significant difference in major complications that required escalation of treatment.ConclusionNo significant difference has been demonstrated between the use of either sheath systems for major complications. The practical limitations of a smaller system, combined with existing body of evidence, may not justify the routine use of 4-Fr sheath systems as the primary sheath size for all endovascular procedures.

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Single-Center Experience Comparing the Application of Small-Caliber versus Large-Caliber Arterial Access Closure in a Consecutive Series of Patients

Cited by 6 publications

References 13 publications

Suitability of a 7-F ExoSeal Vascular Closure Device for Femoral Artery Punctures Made by 8-F or 9-F Introducer Sheaths

Suitability of a 7-F ExoSeal Vascular Closure Device for Femoral Artery Punctures Made by 8-F or 9-F Introducer Sheaths

Single Angio-Seal vascular closure device for transfemoral access exceeding 8F

Are complication rates lower with 4-Fr versus 6-Fr transfemoral arterial access – prospective audit at a single interventional radiology centre

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