Identification of Criteria of the Success of the Endarterectomy in Chronic Pulmonary Post Embolic Hypertension

Assistance Publique - Hôpitaux de Paris249 enrolled

Overview

In order to improve effectiveness of the surgical operation thanks to a reduction in the rate of failure, this study will allow us to identify predictive angiographic and CT finding of surgical failure, starting from standardized reading grids, in order to have a better selection of the operable patients.

Chronic thromboembolic pulmonary hypertension(CTEPH) is caused by obstruction of the large pulmonary arteries by acute and recurrent pulmonary emboli, and organization of these blood clots. ANTOINE BECLERE respiratory unit, in partnership with the MARIE LANNELONGUE hospital thoracic and vascular surgery departments was designated recently as reference national centre for pulmonary hypertension and represents the only French structure for evaluation of CTEPH with 150 patients addressed each year.If the disease is proximately located, CTEPH can be cured surgically through a complex surgical procedure performed under Hypothermia and total circulatory arrest. In spite of multidisciplinary meeting deciding the operability of each case the rate of failure is approximately of 15% (9% of operative mortality rate and 6% of technical failure). The aim of this study is to identify predictive angiographic and CT findings of success, by allowing a better selection of operable patients. It would be possible to improve the effectiveness of the surgical treatment and reduce the rate failure from 15% to 7 % or even 5 %.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

249

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Interventions

Angiography and Computed TomographyOTHER

Preoperative angiography and Computed Tomography

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients addressed to the reference centre of pulmonary hypertension for a suspected CPC-PE * Achieving an assessment prior to the operation, including:1) Right cardiac catheterization confirming HTP with a mean pulmonary arterial pressure\> 25 mm Hg at rest; 2) Echography and Doppler of the lower limbs in search of phlebitis sequela; 3) Pulmonary scintigraphy with 6 views in ventilation and perfusion; 4) Digital pulmonary angiography; 5) A 64 detector pulmonary computed tomography; 6) Having read the briefing note and given their agreement. Exclusion criteria: * Refusal examinations . * Patient for which one method is contraindicated * Patient considered not operable by the staff * Life expectancy of less than 3 months * Geographical distance for the clinical follow-up at 3 months * Renal insufficiency (creatinine clearance \<30 mL / min) * Proven allergy to iodinated contrast agents * Pregnant woman.

Locations (2)

Hôpital Antoine Beclere

Clamart, France

Hospital Marie Lannelongue

Le Plessis-Robinson, France

Outcomes

Primary Outcomes

surgical effectiveness evaluated by the death or failure rate.

Time frame: 6 months

Secondary Outcomes

surgical effectiveness evaluated by the death or failure rate.

Time frame: 3 months

Check that none of the patients considered unresectable on data from staff was declared operable with the criteria predictive success of imaging examinations.

Time frame: before surgery

Determine the interest of pulmonary angiography in the operability decision compared first to Multi detector AngioCT alone with standardized analyze and then with the both exams.

Time frame: before surgery

Determine the incidence of adverse events associated with each of these two exams or their combination.

Time frame: 3 and 6 months after surgery

Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT

Time frame: Before surgery

Data from ClinicalTrials.gov

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