TOP-AS: Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis
Study Details
Study Description
Brief Summary
As for today, transcatheter aortic valve implantation (TAVI) is indicated only in symptomatic patients with severe aortic stenosis (AS) at high surgical risk. As cancer therapy improves, some AS patients suffering active malignancy (including advanced metastatic diseases) may be more endangered by their untreated valvular disease than their oncological disease. Among these patients, TAVI may be indicated before cancer related surgery or cardiotoxic anti-cancer therapy in order to achieve better anti-cancer therapy outcomes. Individualized life expectancy assumptions should be evaluated by the heart team in the clinical decision-making process as an essential factor in weighing the risk-benefit ratio for oncologic patients undergoing TAVI. A multicenter, international TAVI in Oncology Patients with AS (TOP-AS) registry was designed to collect data on patients with an active malignancy and severe AS undergoing TAVI. The aim of the study is to evaluate the outcomes, benefits and risks of oncology patients undergoing TAVI, mainly the patients' survival and cause of death and also the interactions between the valvular and the oncologic conditions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The TAVI program was initiated in Rabin Medical Center in 2008 and the institutional review board approved the prospective collection of our TAVI Database (i.e. RECORD TAVI). During these years, several oncology patients were treated with TAVI. Also, in daily practice a few asymptomatic AS patients in whom TAVI was indicated before cancer related surgery / cardiotoxic anti-cancer therapy underwent TAVI.
This study will initiate a multicenter, international registry designed to collect data on TAVI in cancer patients in correspondence to medical records within each center. Data will be collected retrospectively for cases performed before registry initiation and prospectively thereafter. All inconsistencies regarding data collection will be resolved directly with local investigators and on-site data monitoring. Patients' inclusion approval is by a local ethics committee in each center.
Saving Data: Data will be recorded in Excel table; each center and patient will receive a unique code so the data file will be anonymous.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| TAVI Patients with active cancer Patients with active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves. |
Device: Native aortic valve
Native valve, with any transcatheter heart valve type
Procedure: Transcatheter aortic valve implantation (TAVI)
Percutaneous aortic valve implantation preformed in one of these methods: transfemoral, transapical,subclavian or other.
|
| TAVI patients without cancer Patients with no active cancer undergoing transcatheter aortic valve implantation (TAVI) with native aortic valves. |
Device: Native aortic valve
Native valve, with any transcatheter heart valve type
Procedure: Transcatheter aortic valve implantation (TAVI)
Percutaneous aortic valve implantation preformed in one of these methods: transfemoral, transapical,subclavian or other.
|
Outcome Measures
Primary Outcome Measures
- Patients survival [2 years]
Patients survival in days
Secondary Outcome Measures
- New York Heart Association Functional Classification (NYHA FC) [2 years]
Provides information regarding patients functional status on scale of 1-4.
- Cause of death [2 years]
Whether the cause of death is cardiovascular or non-cardiovascular.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with active malignancy (all types excluding non-melanoma skin Ca)
-
Severe aortic stenosis undergoing native valve TAVI (any transcatheter heart valve type).
Exclusion Criteria:
-
TAVI for conditions other than severe AS.
-
Valve in valve TAVI patient.
-
Patients cured /in remission from cancer during the index TAVI.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rabin Medical Center, | Petaẖ Tiqwa | Israel |
Sponsors and Collaborators
- Rabin Medical Center
Investigators
- Study Chair: Ran Kornowski, Prof,MD, Chairman, Dept. of Cardiology, Rabin Medical Center, Israel
- Study Director: Ran Kornowski, Prof,MD, Chairman, Dept. of Cardiology, Rabin Medical Center, Israel
- Principal Investigator: Uri Landes, MD, Dept. of Cardiology, Rabin Medical Center, Israel
Study Documents (Full-Text)
None provided.More Information
Publications
- Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15.
- Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Epub 2014 Mar 3. Erratum in: J Am Coll Cardiol. 2014 Jun 10;63(22):2489. Dosage error in article text.
- Swain SM, Kim SB, Cortés J, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Knott A, Clark E, Ross G, Benyunes MC, Baselga J. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2013 May;14(6):461-71. doi: 10.1016/S1470-2045(13)70130-X. Epub 2013 Apr 18.
- 0136-17-RMC