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Outcomes of Same-Day Discharge with Manual Compression and 5F Sheath Compatible Devices for Lower Extremity Arterial
Yann Gouëffic1, Jean-Luc Pin2, Jean Sabatier3
1Groupe Hospitalier Paris St Joseph, Service de Chirurgie Vasculaire et Endovasculaire, Paris, France.
Insights
Manual compression is a safe and effective option for same-day discharge in patients undergoing lower extremity arterial disease (LEAD) endovascular procedures using a 5F sheath. This approach avoids arterial closure devices and demonstrates good clinical outcomes.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Endovascular Procedures
Background:
- Lower extremity arterial disease (LEAD) management often involves endovascular revascularization.
- Same-day discharge protocols aim to improve patient flow and reduce healthcare costs.
- Arterial closure devices are commonly used for femoral access hemostasis.
Purpose of the Study:
- To evaluate the safety and efficacy of manual compression for same-day discharge after 5F sheath endovascular LEAD revascularization.
- To assess the in-hospital admission and 1-month rehospitalization rates.
- To compare clinical and hemodynamic status post-procedure to baseline.
Main Methods:
- Prospective, national, multicenter, single-arm study (FREEDOM OP).
- Inclusion of symptomatic LEAD patients (Rutherford 2-5) eligible for same-day discharge.
- Primary endpoint: total in-hospital admission rate (including overnight surveillance and 1-month rehospitalization).
Main Results:
- 114 patients included; mean age 66±10 years; 94% claudicants.
- 97% technical success for femoropopliteal lesions; 4.5% major access-related complications.
- 11% total in-hospital admission rate; no deaths or major cardiovascular events; significant clinical and hemodynamic improvement.
Conclusions:
- Manual compression is a feasible and safe hemostasis method for same-day discharge in LEAD endovascular procedures.
- This technique offers a viable alternative to arterial closure devices.
- Patients experience significant clinical and hemodynamic benefits post-procedure.
Background:
For same-day discharge lower extremity arterial disease (LEAD) endovascular procedures, femoral manual compression could be an alternative to arterial closure devices. The aim of this study was to assess the security and efficacy of same-day discharge after manual compression in patients treated for LEAD endovascular revascularization with 5F sheath.
Methods:
FREEDOM OP was a national multicenter, prospective, single arm study. Patients with symptomatic LEAD (Rutherford 2-5) and eligible for same-day discharge were included. The primary endpoint was the total in-hospital admission rate, which includes overnight surveillance and rehospitalization rate at 1 month.
Results:
Between September 2017 and August 2019, 114 patients were included. The mean age of the patients was 66 ± 10 years and most of them were claudicant (103; 94%). Mainly femoropopliteal lesions were treated (178; 70%) and the technical success was 97%. One hundred forty-two 5F stents and fifty one 5F drug coated balloon were delivered. The mean manual compression duration was 13 ± 4 min. Major access-related complications rate was 4.5%. Total in-hospital admission rate was 11%. Seven patients had overnight surveillance and 5 were rehospitalized (2 for the target lesion). No rehospitalisation was carried out within 24 hr after discharge. No major cardiovascular event, including death, was observed. The patients were significantly improved in term of clinical status (P < 0.0001) and hemodynamic (P < 0.0001) in comparison to baseline.
Conclusion:
FREEDOM OP showed that manual compression is feasible and safe for same-day discharge after LEAD revascularization with 5F sheath femoral approach.
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