Safety and Feasibility of Early Discharge Using the Portico Self-Expanding Prosthesis for Transfemoral Transcatheter Aortic Valve Replacement: The SAFE TAVR Study

Nickname: SAFE 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

Abbott Laboratories

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 rigorous assessment of the efficacy, feasibility, and safety of the Vancouver Clinical Pathway in patients undergoing elective transfemoral TAVR with the self-expanding PORTICO valve (Abbott Laboratories, Lake Bluff, Illinois).
  2. To evaluate the effect of the Vancouver Clinical Pathway on patient-reported outcomes and quality of life compared to contemporary TAVR.

Methodology

This is a prospective, multi-centre, case-series study under an Investigation Testing Authorization (ITA) with Health Canada. Patients will be selected to undergo TAVR using the Vancouver Clinical Pathway (315 patients who meet all inclusion criteria).

Significance

The SAFE TAVR Study is similar to the previous 3M  (The Multidisciplinary, Multimodality, but Minimalist) TAVR Study, which used a balloon expandable valve. In contrast, the SAFE TAVR Study will employ a self-expanding valve. These studies have critical implications for improving outcomes in patients with severe symptomatic aortic stenosis with opportunities for reduced length of stay and improved quality of life, and better use of health care resources globally.