The Multidisciplinary, Multimodality, but Minimalist (3M) Approach to Transfemoral Transcatheter Aortic Valve Replacement (TAVR) Study

3M

Nickname: 3M TAVR

Principal Investigator

Dr. David Wood, UBC Clinical Associate Professor, Vancouver General Hospital

Co-Principal Investigator

Dr. John Webb, Medical Director, Centre for Heart Valve Innovation, St. Paul’s Hospital

Funding

Edwards Lifesciences

Background

When a patient’s aortic valve becomes narrowed, the heart’s ability to pump blood to reach the rest of the body becomes compromised. Patients develop chest pain and shortness of breath and often die within one to three years. The team at the Centre for Heart Valve Innovation at St. Paul’s Hospital have developed a new approach (the 3M Clinical Pathway), whereby carefully selected patients are awake when they undergo transcatheter aortic valve replacement (TAVR), typically walk 4 hours later, and are safely discharged the following day. The Vancouver 3M Clinical Pathway is an alternative to the more conventional, invasive open-heart surgery.

Objectives

  1. To provide a rigourous assessment of the efficacy, feasibility, and safety of the Vancouver 3M Clinical Pathway in patients undergoing elective transfemoral TAVR.
  2. To evaluate the effect of the Vancouver 3M Clinical Pathway on patient-reported outcomes and quality of life compared to standard contemporary care.
  3. To evaluate the economic impact of the Vancouver 3M Clinical Pathway compared to the standard contemporary care.

Methodology

This will be a prospective, multicentre, case-series study. Patients will be selected to undergo TAVR using either the Vancouver 3M Clinical Pathway (400 patients who meet all inclusion and exclusion criteria), or standard care.

Significance

The 3M TAVR Multicentre Study will document efficacy, feasibility, and safety of next-day discharge of 400 high-risk patients undergoing transfemoral TAVR for severe aortic stenosis using the Vancouver 3M Clinical Pathway. This study will have critical implications for improving outcomes in patients with severe symptomatic aortic stenosis, as well as for the deployment and optimal utilization of health care resources across North America.

For more information, please contact:

Shirley Wong
3M TAVR Project Manager
3M@ICVHealth.ubc.ca