Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis (TOP-AS)

TOP-AS Registry: Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Malignancy
• Intervention / Treatment: Device: Native aortic valve; Procedure: Transcatheter aortic valve implantation (TAVI)

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 Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• Israel
  • Petaẖ Tiqwa, Israel
    • Rabin Medical Center,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will be selected from several international transcatheter aortic valve implantation centers.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients survival	Patients survival in days	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New York Heart Association Functional Classification (NYHA FC)	Provides information regarding patients functional status on scale of 1-4.	2 years
Cause of death	Whether the cause of death is cardiovascular or non-cardiovascular.	2 years

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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. No abstract available. Erratum In: J Am Coll Cardiol. 2014 Jun 10;63(22):2489. Dosage error in article text.
• Swain SM, Kim SB, Cortes 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.
• 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. No abstract available.
• Landes U, Iakobishvili Z, Vronsky D, Zusman O, Barsheshet A, Jaffe R, Jubran A, Yoon SH, Makkar RR, Taramasso M, Russo M, Maisano F, Sinning JM, Shamekhi J, Biasco L, Pedrazzini G, Moccetti M, Latib A, Pagnesi M, Colombo A, Tamburino C, D' Arrigo P, Windecker S, Pilgrim T, Tchetche D, De Biase C, Guerrero M, Iftikhar O, Bosmans J, Bedzra E, Dvir D, Mylotte D, Sievert H, Watanabe Y, Sondergaard L, Dagnegard H, Codner P, Kodali S, Leon M, Kornowski R. Transcatheter Aortic Valve Replacement in Oncology Patients With Severe Aortic Stenosis. JACC Cardiovasc Interv. 2019 Jan 14;12(1):78-86. doi: 10.1016/j.jcin.2018.10.026.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Aortic Valve Stenosis; Malignancy; Transcatheter Aortic Valve Implantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Neoplasms; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 0136-17-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No