Pulmonary Hypertension
Conditions
Keywords
Distal Lesions, Post-embolic HTP, Angioplasty
Brief summary
Currently, the standard treatment for proximal thromboses lesions responsible for post-embolic pulmonary hypertension, is the surgical thromboendarterectomy. When the ravages are judged too distal or the patient is judged inoperable for a curative surgical gesture, there is no evidence of any therapeutic option, exept for K anti-vitamins for recurrent embolism. Prognosis is then pejorative with a 60% mortality at 5 years. This study propose an alternative treatment for these patients in therapeutic dead end. This is about applying arterial thrombosis technique to the pulmonary circulation.
Interventions
PROCEDURERight heart catheterization
PROCEDUREEchocardiography
OTHERA six-minute walking test
PROCEDUREFunctional respiratory investigations
PROCEDUREPulmonary tomography or pulmonary angiography
PROCEDUREPercutaneous angioplasty
PROCEDUREBalloon angioplasty
Sponsors
University Hospital, Grenoble
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years * Patients with a pulmonary hypertension diagnosed by right catheterisation, with a mean arterial pressure \>30 mmHg and arterial pulmonary resistance \> 3 UW. * Patients with group 4 (Dana point) pulmonary hypertension, thromboembolic. * Chronic thrombosis visible to scanner, pulmonary IRM angiogram or to pulmonary angiogram. * Patient's file refused by the reference center multidisciplinary coordination meetings for surgical thromboendartériectomy or refusal from the patient to be operate. * Absence of counter-argument to the femoral venous or jugular way. * Normal kidney function or moderatly degraded (clearance\>30 mL) or dialysed renal failure * Persons affiliated to national social security * Signed free consent by patients
Exclusion criteria
* Pulmonary hypertension pos-embolic operated by thromboendarteriectomy * Pulmonary hypertension Group 1 of Dana Point, meaning idiopathic, familial, post-anorectics, associate with a congenital heart disease associated to a scleroderma, associated to a chronic hemolytic disease * Pulmonary hypertension Group 2 of Dana Point, associated with a left cardiovascular disease * Pulmonary hypertension Group 3 of Dana Point, associated to a respiratory disease * Pulmonary hypertension Group 5 of Dana Point, of unclear or multifactorial mechanism * Hypersensitivity to HEXABRIX, to iodinated contrast product or one of its components * Obvious thyrotoxicosis * Protected major persons * Pregnant or breastfeeding women * Persons deprived of liberty * Persons in emergency situations. * No consent signed or approoved * Persons no affiliated to national social security
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Balloon angioplasty | About 90 minutes | Same mode than valscular or coronal angioplasty. |
| Percutaneous angioplasty | About 90 minutes | International Normalized Ratio wil be measure and need to be between 2 and 3. |
| Right heart catheterization | Few minutes | Right auricular pressure auriculaire droite moyenne ou POD (mmHg) * Blood pressure : systolic, diastolic, and average(mmHg) * pression artérielle pulmonaire d'occlusion (PAPO) moyenne (mmHg) |
| Echocardiography | Few minutes | Right ventricular heart function with evaluation of : \- The maximum pressure gradient (mmHg) |
| Walking test | 6 minutes | Start heart rate (T0) and at the end (T6) of the test (bpm) |
| Functional respiratory investigations | About an hour | * Forced expiratory volume (FEV) ml/kg * Forced vital capacity (FVC) ml/kg * Total lung capacity ml/kg * Alveolar capillarytransfer of Carbon monoxide (CO) ml/kg * Transfer coefficient of CO (KCO) ml/kg All volumes in ml/kg |
| Pulmonary tomography or pulmonary angiography | About 30 minutes | tomography (CT) or angiography |
| Heart rate | Few minutes | Heart rate (bpm) during right heart catheterization. |
| Cardiac output (L/min) | Few minutes | Cardiac output (L/min) during right heart catheterization. |
| Venous oxygen saturation (%) | Few minutes | Venous oxygen saturation (%) during right heart catheterization. |
Countries
France
Outcome results
None listed