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Feasibility and clinical efficacy of double suture-mediated closure device technique for hemostasis during positioning of miniaturized wireless pacemaker

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Abstract

Purpose

The miniaturized transcatheter pacing system (TPS) implant is performed using a 27 Fr sheath. Achieving femoral vein access hemostasis after sheath removal is of utmost importance. Feasibility and clinical effectiveness of double device-based suture-mediated closure technique (DualPerclose) were evaluated.

Methods

Patients undergoing TPS positioning and treated with DualPerclose technique at our institution were considered. Feasibility of the DualPerclose technique included the rates of effective initial device suture fixation and effective hemostasis after sheath removal. Clinical efficacy considered intraprocedural and periprocedural bleeding events as well as midterm access site vascular injury assessed at 3 months using lower limb vascular ultrasonography. Data on all follow-up major adverse events were also collected.

Results

All patients (n = 83 patients; mean age 82.3 ± 7.1 years, 67.5% male gender, 85.5%, with structural heart disease, mean left ventricular ejection fraction 54.0 ± 9.6%, renal impairment in 31.3%) who underwent TPS positioning between November 2015 and February 2020 were considered. TPS positioning was successful in all patients. In 82 patients, the DualPerclose approach was utilized: 13 patients (15.8%) required > 2 devices to obtain effective fixing of 2 sutures; complete immediate hemostasis was achieved in 80 patients (97.6%). One (1.2%) severe groin-related bleeding event occurred. At midterm, 1 (1.2%) mildly symptomatic arteriovenous fistula was diagnosed (conservative treatment). Over a median follow-up of 22 (IQR 10–35.5) months, 14 (17.1%) major adverse events were recorded, including 1 loss of capture requiring TPS replacement and 5 deaths.

Conclusion

Femoral vein access closure using dual Perclose Proglide devices during TPS is feasible and clinically effective.

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Authors and Affiliations

  1. Cardiocentro Ticino Institute, Via Tesserete 48, 6900, Lugano, Switzerland

    François Regoli, Marco Roberto, Lorenzo Grazioli-Gauthier, Giacomo Cioffi, Elena Pasotti, Maria Luce Caputo, Giulio Conte & Tiziano Moccetti

  2. Ospedale San Giovanni, Bellinzona, Switzerland

    François Regoli

  3. Electrophysiology, Department of Cardiology, University Hospital Zurich, Zurich, Switzerland

    Alexander Breitenstein

Authors
  1. François Regoli
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  2. Marco Roberto
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  3. Lorenzo Grazioli-Gauthier
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  4. Giacomo Cioffi
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  5. Elena Pasotti
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  6. Maria Luce Caputo
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  7. Giulio Conte
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  8. Alexander Breitenstein
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  9. Tiziano Moccetti
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Correspondence to François Regoli.

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FR receives speaker fees from Medtronic and consultation fees from Daiichi Sankyo. Others: no disclosures.

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Supplementary Information

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10840_2021_1102_MOESM1_ESM.pptx

Supplementary file1. Closure of the femoral vein access site with the double suture-mediated closure device technique (DualPerclose) during TPS positioning (PPTX 8681 KB)

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Regoli, F., Roberto, M., Grazioli-Gauthier, L. et al. Feasibility and clinical efficacy of double suture-mediated closure device technique for hemostasis during positioning of miniaturized wireless pacemaker. J Interv Card Electrophysiol 64, 129–135 (2022). https://doi.org/10.1007/s10840-021-01102-y

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  • DOI: https://doi.org/10.1007/s10840-021-01102-y

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