Chronic Thromboembolic Pulmonary Hypertension
Conditions
Keywords
Pulmonary hypertension, Chronic thromboembolic pulmonary hypertension, Operability, Thromboendarteriectomy, Operative mortality rate, Technical failure, Pulmonary angiography, Computed tomography
Brief summary
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.
Detailed description
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 %.
Interventions
OTHERAngiography and Computed Tomography
Preoperative angiography and Computed Tomography
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| surgical effectiveness evaluated by the death or failure rate. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| surgical effectiveness evaluated by the death or failure rate. | 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. | 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. | before surgery |
| Determine the incidence of adverse events associated with each of these two exams or their combination. | 3 and 6 months after surgery |
| Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT | Before surgery |
Countries
France
Outcome results
None listed