An upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation

Costa, Giuliano; Valvo, Roberto; Picci, Andrea; Criscione, Enrico; Reddavid, Claudia; Motta, S.; Strazzieri, Orazio; Deste, Wanda; Giuffrida, Angelo; Garretto, Valeria; Cannizzaro, Maria Teresa; Inserra, Maria Cristina; Veroux, Pierfrancesco; Giaquinta, Alessia; Sgroi, Carmelo; Tamburino, Corrado; Barbanti, Marco

doi:10.4244/eij-d-20-01125

Cited by 13 publications

(2 citation statements)

References 22 publications

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“…Furthermore, the sutures of the crossing Perclose Pro-Glide might interfere with those of the first one, thereby increasing the likelihood of ineffective closure. 23 Similarly, although described as safe and effective, 26 adjunctive or bailout VCD such as Angioseal 6F or 8F is often used. Additionally, the need to use an additional VCD such as Angioseal 6F or 8F might, although rare, increase the risk of vascular complications.…”

Section: Discussionmentioning

confidence: 99%

Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System

Krishnan,

Farhan,

Zidar

et al. 2024

Circ: Cardiovascular Interventions

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BACKGROUND: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. METHODS: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. RESULTS: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). CONCLUSIONS: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03756558.

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Section: Discussionmentioning

confidence: 99%

Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System

Krishnan,

Farhan,

Zidar

et al. 2024

Circ: Cardiovascular Interventions

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“…When a failure of VCD is recognized and wire is still left through the arteriotomy, either a third ProGlide device or an Angio-Seal (Abbott Vascular, Redwood City, CA, United States) can be utilized with great effectiveness and safety[ 32 , 33 ]. Yet, if a wire is no longer available, only prolonged manual compression or endovascular techniques through other arterial accesses can be practiced.…”

Section: Discussionmentioning

confidence: 99%

Pledget-assisted hemostasis to fix residual access-site bleedings after double pre-closure technique

Burzotta¹,

Aurigemma²,

Kovacevic³

et al. 2022

WJC

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BACKGROUND The use of pre-closure suture-based devices represents a widely access-site hemostasis technique in percutaneous transfemoral transcatheter-aortic-valve-replacement (TF-TAVR); yet this technique is associated with the risk of a device failure that may result in clinically relevant residual bleeding. Thus, a bailout intervention is needed. So far, the best management of pre-closure device failure has not been recognized. AIM To report the first clinical results obtained using a novel bailout hemostasis technique for patients with double suture-based vascular closure device failure in the setting of TF-TAVR. METHODS We developed a “pledget-assisted hemostasis” technique to manage residual access-site bleeding. This consists of the insertion of a surgical, non-absorbable, polytetrafluoroethylene pledget over the sutures of the two ProGlide (Abbott Vascular, CA, United States). The ProGlide’s knot-pushers are used to push down the pledget and the hand-made slipknot to seal the femoral artery leak. This technique was used as a bailout strategy in patients undergoing TF-TAVR with a systematic double pre-closure technique. Post-procedural access-site angiography was systematically performed. In-hospital complications were systematically detected and classified according to Valve Academic Research Consortium-2 criteria. RESULTS Out of 136 consecutive patients who underwent TF-TAVR, 15 patients (mean age 80.0 ± 7.2 years, 66.7% female) with access-site bleeding after double pre-closure technique failure were treated by pledget-assisted hemostasis. In the majority of patients, 16F sheath was used ( n = 12; 80%). In 2 cases (13%), a peripheral balloon was also inflated in the iliac artery to limit blood loss during pledget preparation. Angiography-confirmed hemostasis (primary efficacy endpoint) was achieved in all patients. After the procedure, 1 patient required blood transfusion (2 units), and no other bleeding or major ischemic complication was noticed. CONCLUSION The “pledget assisted hemostasis” might be considered as a possible bailout technique to treat patients with residual access site bleeding. Further studies are needed to compare this approach with other bail-out techniques.

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Dual Suture Versus Suture and Plug Closure Devices for Large Bore Access Haemostasis During Percutaneous Access Endovascular Aneurysm Repair

Xu,

Zhang,

et al. 2023

Cardiovasc Intervent Radiol

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An upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation

Cited by 13 publications

References 22 publications

Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System

Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System

Pledget-assisted hemostasis to fix residual access-site bleedings after double pre-closure technique

Dual Suture Versus Suture and Plug Closure Devices for Large Bore Access Haemostasis During Percutaneous Access Endovascular Aneurysm Repair

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