Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with a pulmonary hypertension | Experimental | Pulmonary hypertension group 4 of Dana point, chronic thromboses lesions, thromboembolic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous angioplasty | Procedure |
| ||
| Balloon angioplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Percutaneous angioplasty | International Normalized Ratio wil be measure and need to be between 2 and 3. | About 90 minutes |
| Balloon angioplasty | Same mode than valscular or coronal angioplasty. | About 90 minutes |
| Right heart catheterization | Right auricular pressure auriculaire droite moyenne ou POD (mmHg)
| Few minutes |
| Echocardiography | Right ventricular heart function with evaluation of : - The maximum pressure gradient (mmHg) | Few minutes |
| Walking test | Start heart rate (T0) and at the end (T6) of the test (bpm) | 6 minutes |
| Functional respiratory investigations |
All volumes in ml/kg | About an hour |
| Pulmonary tomography or pulmonary angiography | tomography (CT) or angiography | About 30 minutes |
| Heart rate |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hélène Bouvaist, Doctor | Grenoble Hospital University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UniversityHospitalGrenoble | La Tronche | 38700 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23192917 | Background | Mizoguchi H, Ogawa A, Munemasa M, Mikouchi H, Ito H, Matsubara H. Refined balloon pulmonary angioplasty for inoperable patients with chronic thromboembolic pulmonary hypertension. Circ Cardiovasc Interv. 2012 Dec;5(6):748-55. doi: 10.1161/CIRCINTERVENTIONS.112.971077. Epub 2012 Nov 27. | |
| 22185711 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
|
| Right heart catheterization | Procedure |
|
| Echocardiography | Procedure |
|
| A six-minute walking test | Other |
|
| Functional respiratory investigations | Procedure |
|
| Pulmonary tomography or pulmonary angiography | Procedure |
|
| Biological parameters | Other |
|
Heart rate (bpm) during right heart catheterization. |
| Few minutes |
| Cardiac output (L/min) | Cardiac output (L/min) during right heart catheterization. | Few minutes |
| Venous oxygen saturation (%) | Venous oxygen saturation (%) during right heart catheterization. | Few minutes |
| Echocardiography | Right ventricular heart function with evaluation of : Surface area of the right ventricle (cm²) | Few minutes |
| Echocardiography | Right ventricular heart function with evaluation of : Cardiac output (L/min) and cardiac index (L/min/m²) | Few minutes |
| Walking test | Patient self evaluation of the dyspnea on a Borg scale from 0 (not breathless) to 10 (serious breathless) | 6 minutes |
| Walking test | Arterial blood saturation in oxygen measured by an oxymeter dat the beginning (T0) and at the end of the test (T6) (SO2) | 6 minutes |
| Sugimura K, Fukumoto Y, Satoh K, Nochioka K, Miura Y, Aoki T, Tatebe S, Miyamichi-Yamamoto S, Shimokawa H. Percutaneous transluminal pulmonary angioplasty markedly improves pulmonary hemodynamics and long-term prognosis in patients with chronic thromboembolic pulmonary hypertension. Circ J. 2012;76(2):485-8. doi: 10.1253/circj.cj-11-1217. Epub 2011 Dec 15. |
| 21747194 | Background | Fukumoto Y, Shimokawa H. Recent progress in the management of pulmonary hypertension. Circ J. 2011;75(8):1801-10. doi: 10.1253/circj.cj-11-0567. Epub 2011 Jul 11. |
| 11136677 | Background | Feinstein JA, Goldhaber SZ, Lock JE, Ferndandes SM, Landzberg MJ. Balloon pulmonary angioplasty for treatment of chronic thromboembolic pulmonary hypertension. Circulation. 2001 Jan 2;103(1):10-3. doi: 10.1161/01.cir.103.1.10. |
| 19095129 | Background | Jais X, D'Armini AM, Jansa P, Torbicki A, Delcroix M, Ghofrani HA, Hoeper MM, Lang IM, Mayer E, Pepke-Zaba J, Perchenet L, Morganti A, Simonneau G, Rubin LJ; Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension Study Group. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Dec 16;52(25):2127-34. doi: 10.1016/j.jacc.2008.08.059. |
| Background | Diggle PJ, Liang KY, Zeger SL. Analysis of longitudinal data. New York: Oxfiord University Press, 2000. |
| Background | Twisk JWR. Applied longitudinal analysis for epidemiology. Cambridge: Cambridge University Press, 2003. |
| 21335128 | Background | Mayer E, Jenkins D, Lindner J, D'Armini A, Kloek J, Meyns B, Ilkjaer LB, Klepetko W, Delcroix M, Lang I, Pepke-Zaba J, Simonneau G, Dartevelle P. Surgical management and outcome of patients with chronic thromboembolic pulmonary hypertension: results from an international prospective registry. J Thorac Cardiovasc Surg. 2011 Mar;141(3):702-10. doi: 10.1016/j.jtcvs.2010.11.024. |
| 23397304 | Background | Pepke-Zaba J, Jansa P, Kim NH, Naeije R, Simonneau G. Chronic thromboembolic pulmonary hypertension: role of medical therapy. Eur Respir J. 2013 Apr;41(4):985-90. doi: 10.1183/09031936.00201612. Epub 2013 Feb 8. |
| 22018451 | Background | de Perrot M, McRae K, Shargall Y, Pletsch L, Tan K, Slinger P, Ma M, Paul N, Moric J, Thenganatt J, Mak S, Granton JT. Pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension: the Toronto experience. Can J Cardiol. 2011 Nov-Dec;27(6):692-7. doi: 10.1016/j.cjca.2011.09.009. Epub 2011 Oct 21. |
| 23769649 | Background | Inami T, Kataoka M, Shimura N, Ishiguro H, Yanagisawa R, Taguchi H, Fukuda K, Yoshino H, Satoh T. Pulmonary edema predictive scoring index (PEPSI), a new index to predict risk of reperfusion pulmonary edema and improvement of hemodynamics in percutaneous transluminal pulmonary angioplasty. JACC Cardiovasc Interv. 2013 Jul;6(7):725-36. doi: 10.1016/j.jcin.2013.03.009. Epub 2013 Jun 14. |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
Not provided
Not provided