Characteristics and Prognosis of Patients With Critical Ischemia at High Risk of Amputation Managed by Endovascular Bypass: a Retrospective Study of 15 Patients (Pontage)

Obliterative arterial disease of the lower limbs (AOMI) is associated with a high risk of cardiovascular events, with a linear relationship between a fall in the systolic pressure index and a risk of cardiovascular morbidity and mortality. Critical ischemia is the most severe stage of AOMI, associated with decubitus pain and / or foot ulceration. The severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, as well as the patient's vital prognosis. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Consequently, the goal of management in a multidisciplinary setting is threefold: the treatment of pain, improvement of the functional prognosis and improvement of the patient's vital prognosis. Revascularization should be attempted as often as possible for the purpose of limb salvage and improvement of patient survival.

In the vascular medicine department, the indication and modalities of the revascularization procedure are discussed at a multidisciplinary consultation meeting. The medical-radiological-surgical expertise takes into consideration the patient's terrain and comorbidities and the technical possibilities according to the arterial damage. With the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. foot with a lower morbidity-mortality compared to surgery, especially in the most fragile patients. Since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with critical ischemia hospitalized in the vascular medicine department.

In patients with critical ischemia at high risk of major amputation and without the option of traditional endovascular or surgical revascularization, an endovascular revascularization technique for leg rescue is discussed as a last resort in multidisciplinary staff. This technique, performed by the interventional radiology team (MDP and GA), consists of an extra-anatomic endovascular femoro-popliteal bypass. We wish to describe the limb salvage rate and the preservation of autonomy in the 15 patients treated with this revascularization technique since 2013 in the vascular medicine department of the GHPSJ.

Study Overview

• Status: Completed
• Conditions: Limb Ischemia

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- Patient with critical ischemia at high risk of amputation without the option of "traditional" surgical or endovascular revascularization after multidisciplinary staff discussion, treated by the non-surgical technique called "endovascular bypass"

Description

Inclusion Criteria:

• Patient whose age ≥ 18 years
• Patient with critical ischemia at high risk of amputation without the option of "traditional" surgical or endovascular revascularization after multidisciplinary staff discussion
• Patient treated by the non-surgical technique called "endovascular bypass"
• Patient with preserved autonomy

Exclusion Criteria:

• Patient presenting a loss of autonomy, genu flessum analgesic
• Patient with a contraindication to antithrombotic therapy
• Patient with infectious complications of life-threatening ischemic wounds
• Patient under tutorship or curatorship
• Patient deprived of liberty
• Patient opposing the use of his data for this research

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Member rescue rate	This outcome measure the member rescue rate.	year 1

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: Alexandra P YANNOUTSOS, MD, Groupe hospitalier Paris saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: Pontage

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No