Peripheral Arterial Disease Clinical Trial
Official title:
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
Over the past years, arterial closure systems have tended to replace manual compression to
ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce
hemostasis and patient immobilization times, thus enabling early resumption of walking. These
devices have contributed extensively to the development of outpatient stays for cardiology,
vascular and neuro-radiology procedures.
According to certain studies however, it would appear that arterial closure devices do not
present any greater benefits than manual compression in terms of hemostasis and
complications. Moreover, the use of increasingly small diameter instruments would tend to
render manual compression sufficient. Finally, the use of these devices generates additional
costs.
The purpose of our prospective study is to evaluate the feasibility and safety of same-day
discharge after manual compression in patients treated for peripheral artery disease by
endovascular technique with 5F sheath.
The reference management strategies for patients treated for peripheral arterial disease by
endovascular technique are conventional hospitalization with manual compression and discharge
after at least one over-night observation and outpatient hospitalization with the use of an
arterial closure device. There are currently no official guidelines for guiding the patient
towards one or other of these types of care. Indeed, outpatient management of artery disease
is implemented in only a few centers in France. Several studies have shown that outpatient
care is perfectly safe for patients. Our experiment at the Nantes University Hospital
demonstrates also the reliability and safety of this care through the use of closure systems
as shown by Albert. Now, it seems judicious to develop and improve this care since the use of
smaller diameter devices would tend to render manual compression sufficient.
The method used is based on our previous protocols, routine practice and evaluation. First of
all, patients eligible for same-day discharge are first selected according to SFAR (Société
Française d'Anesthésie Réanimation - French Society for Anesthesia and Resuscitation)
criteria for outpatients. Patients failing to meet these criteria are directed towards
conventional hospitalization.
For outpatients, the patients are hospitalized in a specific unit hosting outpatients of
different medico-surgical specialties. The paramedical team checks the prerequisites and the
preoperative assessment. The use of a common femoral approach with 5F sheath is required.
According to patients' needs, femoral anterograde or retrograde puncture are performed under
duplex scan guidance. Aortoiliac and infrainguinal occlusive lesions are indifferently
treated but the endovascular treatment must be compatible with the use of a stent or a drug
coating balloon 5F sheath and 0.035 compatible..
The procedure should be finished 5h prior the outpatients unit closing to allow 5h follow-up.
The intervention proceeded after an intravenous bolus of heparin. Anesthesia, antiplatelet
regimen were let at the discretion of the interventionnalist. End-of-procedure hemostasis
shall be implemented by the operator by manual compression for at least 10 minutes,
potentially extended until complete hemostasis is achieved. A pressure pad shall be applied
just after the end of manual compression.
The patient's general and local condition shall be monitored in the recovery room. If there
are no local or general complications, the patient shall return to the ambulatory unit. In
the unit, at H4, the compressive dressing is removed, patient is place in half-sitting
position and without any complications, the ability to be discharged will be evaluated. The
day after the operation, the patient is contacted by the ambulatory unit according with HAS
and SFAR recommandations for a medical checkpoint. All of this will be conducted under
medical and paramedical supervision. In the event of femoral puncture site active bleeding at
any stage during care, the patient's surgeon will be notified and an additional manual
compression will be applied if necessary. There are no specific guidelines concerning
treatment with platelet aggregation inhibitors, whose choice will be left to the operator's
discretion. In all cases, the treatments will be recorded.
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