Author + information
- Received March 13, 2019
- Revision received August 20, 2019
- Accepted August 22, 2019
- Published online January 20, 2020.
- Andrea Natale, MDa,b,c,d,
- Sanghamitra Mohanty, MD, MSa,b,
- P.Y. Liu, PhDe,
- Suneet Mittal, MDf,
- Amin Al-Ahmad, MDa,
- David B. De Lurgio, MDg,
- Rodney Horton, MDa,
- William Spear, MDh,
- Shane Bailey, MDa,
- Jared Bunch, MDi,
- Dan Musat, MDf,
- Padraig O’Neill, MDj,
- Steven Compton, MDk,
- Mintu P. Turakhia, MD, MASl,m,∗ (, )
- for the AMBULATE Trial Investigators
- aTexas Cardiac Arrhythmia Institute, St. David’s Medical Center, Austin, Texas
- bDell Medical School, University of Texas, Austin, Texas
- cCase Western Reserve University, Cleveland, Ohio
- dInterventional Electrophysiology, Scripps Clinic, San Diego, California
- eFred Hutchinson Cancer Research Center, Seattle, Washington
- fValley Health System and the Snyder Center for Comprehensive Atrial Fibrillation, Ridgewood, New Jersey
- gEmory Healthcare, Atlanta, Georgia
- hAdvocate Christ Medical Center, Oak Lawn, Illinois
- iIntermountain Medical Center, Salt Lake City, Utah
- jMercy Medical Group, Sacramento, California
- kAlaska Heart and Vascular Institute, Anchorage, Alaska
- lStanford University, Stanford, California
- mVA Palo Alto Health Care System, Palo Alto, California
- ↵∗Address for correspondence:
Dr. Mintu Turakhia, VA Palo Alto Health Care System, 3801 Miranda Avenue, 111C, Palo Alto California 94304.
Objectives This study compared the efficacy and safety of the VASCADE MVP Venous Vascular Closure System (VVCS) device (Cardiva Medical, Santa Clara, California) to manual compression (MC) for closing multiple access sites after catheter-based electrophysiology procedures.
Background The VASCADE MVP VVCS is designed to provide earlier ambulatory hemostasis than MC after catheter-based procedures.
Methods The AMBULATE (A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore [VASCADE MVP] VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 - 12 Fr Sheath Sizes) trial was a multicenter, randomized trial of device closure versus MC in patients who underwent ablation. Outcomes included time to ambulation (TTA), total post-procedure time (TPPT), time to discharge eligibility (TTDe), time to hemostasis (TTH), 30-day major and minor complications, pain medication usage, and patient-reported outcomes.
Results A total of 204 patients at 13 sites were randomized to the device arm (n = 100; 369 access sites) or the MC arm (n = 104; 382 access sites). Baseline characteristics were similar between groups. Mean TTA, TPPT, TTDe, and TTH were substantially lower in the device arm (respective decreases of 54%, 54%, 52%, and 55%; all p < 0.0001). Opioid use was reduced by 58% (p = 0.001). There were no major access site complications. Incidence of minor complications was 1.0% for the device arm and 2.4% for the MC arm (p = 0.45). Patient satisfaction scores with duration of and comfort during bedrest were 63% and 36% higher in device group (both p < 0.0001). Satisfaction with bedrest pain was 25% higher (p = 0.001) for the device overall, and 40% higher (p = 0.002) for patients with a previous ablation.
Conclusions Use of the closure device for multiple access ablation procedures resulted in significant reductions in TTA, TPPT, TTH, TTDe, and opioid use, with increased patient satisfaction and no increase in complications. (A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 - 12 Fr Sheath Sizes [AMBULATE]; NCT03193021).
This study was sponsored by Cardiva Medical, Inc. Dr. Natale has been a consultant for Biosense Webster, Boston Scientific, Medtronic, Biotronik, Abbott, and Baylis Medical. Dr. DeLurgio has been a consultant for BSCI, Medtronic, and Attricure. Dr. Spear has received fees from Cardiva Medical; and has been a member of the Speakers Bureau for Biosense Webster, Janssen Pharmaceuticals, Bristol-Myers Squibb, and Stereotaxis. Dr. Bunch has received research grants from Boston Scientific and Boehringer Ingelheim. Dr. O'Neill is a member of the Speakers Bureau for Pfizer; and has received research grants from Medtronic and St. Jude Medical. Dr. Turakhia has received compensation for services from Akebia, St. Jude Medical, Precision Health Economics, Cardiva Medical, and iRhythm Technologies; has received Speakers Bureau fees from Medscape; holds equity interest/stocks options (no-public) in AliveCor, Zipline Medical, and iBeat, Inc.; and has received research grants from AstraZeneca Pharmaceuticals, Janssen Pharmaceuticals, Medtronic, Inc., Veterans Administration, and Boehringer Ingelheim. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received March 13, 2019.
- Revision received August 20, 2019.
- Accepted August 22, 2019.