Author + information
- Received May 29, 2018
- Revision received December 12, 2018
- Accepted December 18, 2018
- Published online March 4, 2019.
- David A. Wood, MDa,∗ (, )
- Sandra B. Lauck, PhDa,
- John A. Cairns, MDa,
- Karin H. Humphries, DScb,
- Richard Cook, MDa,
- Robert Welsh, MDc,
- Jonathon Leipsic, MDa,
- Philippe Genereux, MDd,
- Robert Moss, MBBSa,
- John Jue, MDa,
- Philipp Blanke, MDa,
- Anson Cheung, MDa,
- Jian Ye, MDa,
- Danny Dvir, MDe,
- Hamed Umedaly, MDa,
- Rael Klein, MDa,
- Kevin Rondi, MDa,
- Rohan Poulter, MDa,
- Dion Stub, MD, PhDa,
- Marco Barbanti, MDa,
- Peter Fahmy, MBBSa,
- Nay Htun, MBBSa,
- Dale Murdoch, MBBSa,
- Roshan Prakash, MBBSa,
- Madeleine Barker, MDa,
- Kevin Nickel, MDa,
- Jay Thakkar, MBBSa,
- Janarthanan Sathananthan, MBChB, MPHa,
- Ben Tyrell, MDf,
- Faisal Al-Qoofi, MDg,
- James L. Velianou, MDh,
- Madhu K. Natarajan, MDh,
- Harindra C. Wijeysundera, MDi,
- Sam Radhakrishnan, MDi,
- Eric Horlick, MDj,
- Mark Osten, MDj,
- Christopher Buller, MDk,
- Mark Peterson, MDk,
- Anita Asgar, MDl,
- Donald Palisaitis, MDa,
- Jean-Bernard Masson, MDm,
- Susheel Kodali, MDn,
- Tamim Nazif, MDn,
- Vinod Thourani, MDo,
- Vasilis C. Babaliaros, MDp,
- David J. Cohen, MDq,
- Julie E. Park, MMathb,
- Martin B. Leon, MDn and
- John G. Webb, MDa
- aCentre for Heart Valve Innovation, University of British Columbia, Vancouver, British Columbia, Canada
- bBC Centre for Improved Cardiovascular Health, Vancouver, Canada
- cMazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada
- dGagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey
- eDepartment of Cardiology, University of Washington, Seattle, Washington
- fCK Hui Heart Centre, Royal Alexandra Hospital, Edmonton, Canada
- gLibin Cardiovascular Institute of Alberta, Foothills Medical Centre, Calgary, Canada
- hDivision of Cardiology, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada
- iSchulich Heart Center, Sunnybrook Health Sciences Center, University of Toronto, Toronto, Canada
- jPeter Munk Cardiac Centre, University of Toronto, Toronto, Canada
- kSt. Michael’s Hospital, University of Toronto, Toronto, Canada
- lMontreal Heart Institute, Montreal, Quebec, Canada
- mCentre Hospitalier de l’Université de Montréal, Montreal, Canada
- nColumbia University Medical Center, New York, New York
- oMedStar Heart and Vascular Institute and Georgetown University School of Medicine, Washington, DC
- pEmory University, Atlanta, Georgia
- qSaint Luke’s Hospital, St. Luke’s Mid America Heart Institute, Kansas City, Missouri
- ↵∗Address for correspondence:
Dr. David A. Wood, Centre for Heart Valve Innovation, St. Paul’s and Vancouver General Hospitals, University of British Columbia, 2775 Laurel Street (9th Floor), Vancouver, V5Z 1M9 British Columbia, Canada.
Objectives The authors sought to prospectively determine the safety and efficacy of next-day discharge using the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway.
Background Transfemoral transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high- and intermediate-risk patients; however, hospital stays average at least 6 days in most trials. The Vancouver 3M Clinical Pathway is focused on next-day discharge, made possible by the use of objective screening criteria as well as streamlined peri- and post-procedural management guidelines.
Methods Patients were enrolled from 6 low-volume (<100 TAVR/year), 4 medium-volume, and 3 high-volume (>200 TAVR/year) centers in Canada and the United States. The primary outcomes were a composite of all-cause death or stroke by 30 days and the proportion of patients successfully discharged home the day following TAVR.
Results Of 1,400 screened patients, 411 were enrolled at 13 centers and received a SAPIEN XT (58.2%) or SAPIEN 3 (41.8%) valve (Edwards Lifesciences, Irvine, California). In centers enrolling exclusively in the study, 55% of screened patients were enrolled. The median age was 84 years (interquartile range: 78 to 87 years) with a median STS score of 4.9% (interquartile range: 3.3% to 6.8%). Next-day discharge home was achieved in 80.1% of patients, and within 48 h in 89.5%. The composite of all-cause mortality or stroke by 30 days occurred in 2.9% (95% confidence interval: 1.7% to 5.1%), with neither component of the primary outcome affected by hospital TAVR volume (p = 0.51). Secondary outcomes at 30 days included major vascular complication 2.4% (n = 10), readmission 9.2% (n = 36), cardiac readmission 5.7% (n = 22), new permanent pacemaker 5.7% (n = 23), and >mild paravalvular regurgitation 3.8% (n = 15).
Conclusions Adherence to the Vancouver 3M Clinical Pathway at low-, medium-, and high-volume TAVR centers allows next-day discharge home with excellent safety and efficacy outcomes.
- clinical pathway
- hospital volume
- length of stay
- next-day discharge
- permanent pacemaker
- procedural sedation
- transcatheter aortic valve replacement
The 3M TAVR study was funded by an unrestricted grant from Edwards Lifesciences. Dr. Wood has received grant support from Edwards Lifesciences. Drs. Lauck, Moss, Blanke, Ye, Dvir, Buller, and Babaliaros have been consultants for Edwards Lifesciences. Dr. Cairns has received research support from Edwards Lifesciences, Boston Scientific, and Medtronic Canada. Dr. Welsh has received research grants from Edwards Lifesciences, Bayer, and AstraZeneca; and honoraria from Pfizer/Bristol-Myers Squibb and Amgen. Dr. Leipsic has been a consultant for Edwards Lifesciences; and his institution has served as the core lab for Edwards Lifesciences, Medtronic, Abbott, and Neovasc. Dr. Genereux has received consultant and speaker fees from Edwards Lifesciences. Dr. Cheung is a consultant for Abbott and Medtronic. Dr. Barbanti has been a consultant for Edwards Lifesciences; and served on advisory boards for Biotronik and Medtronic. Drs. Velianou and Peterson have served as proctors for Edwards Lifesciences. Dr. Natarajan has served as a speaker and proctor for Edwards Lifesciences. Dr. Horlick has served as a consultant for Edwards Lifesciences and Medtronic; and has received research and program support from Medtronic and Abbott Vascular. Dr. Kodali has been a consultant for and received honoraria from Abbott Vascular, Claret Medical, and Merrill Lifesciences; has served on advisory boards for Dura Biotech, Thubrikar Aortic Valve, and Biotrace Medical; and holds equity in Thubrikar Aortic Valve, Dura Biotech, and Biotrace Medical. Dr. Nazif has been a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Cohen has received research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; and has received consulting fees from Edwards Lifesciences and Medtronic. Dr. Webb has been a consultant for Edwards Lifesciences and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 29, 2018.
- Revision received December 12, 2018.
- Accepted December 18, 2018.
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