Cardiva Medical's Vascade MVP System Studied for Multivessel Closure After Electrophysiology Procedures
November 10, 2018—Cardiva Medical, Inc. announced that the Vascade MVP vascular closure system, which is designed specifically for multi-access venous closure after electrophysiology procedures such as arrhythmia ablation, met its endpoints compared with manual compression in the AMBULATE pivotal randomized clinical trial. Andrea Natale, MD, presented the findings at the American Heart Association (AHA) 2018 Scientific Sessions held November 10–12 in Chicago, Illinois.
The AMBULATE study of vessel closure was conducted exclusively by electrophysiology physicians.
The trial enrolled 204 patients who underwent arrhythmia ablation procedures by 28 physicians at 13 sites across the United States. All patients had multiple (three or four) midbore (6- to 12-F inner-diameter sheath) femoral venous access sites.
The patients were randomized into one of two groups, the treatment group had all sites closed with the Vascade MVP system versus the control group had all sites closed using manual compression, which is the current standard of care. Patients were enrolled with both radiofrequency and cryo energy sources used in their procedures.
According to the Cardiva Medical, the Vascade MVP system met all primary and key secondary endpoints compared with manual compression, including:
- In the primary endpoint of time to ambulation, the Vascade MVP arm showed a median reduction of 3.9 hours (2.2 hours vs 6.1 hours; P < .0001).
- The Vascade MVP arm showed a mean reduction of 3.7 hours in the total time from completion of the ablation procedure to the patient walking. This was inclusive of the time to achieve vessel closure (3.1 hours vs 6.8 hours; P < .0001).
- Vascade MVP reduced the mean time for patients to be deemed eligible for discharge by 3.4 hours (3.1 hours vs 6.5 hours; P < .0001).
- The patient-reported level of satisfaction with the duration of bed rest was 63% higher in the Vascade MVP arm (8.3 out of 10 vs 5.1 out of 10; P < .0001).
Additionally, an ad hoc analysis demonstrated that 58% fewer patients in the Vascade MVP arm used opioid-class pain medications after their procedure (15% vs 36% of patients; P = .001).
The Vascade MVP system has been submitted for premarket approval with the FDA, advised Cardiva Medical.
In the company's announcement, Dr. Natale commented, "The feedback from our patients and staff was extremely positive with Vascade MVP during the study. Patients with previous procedures noticed a significant improvement in their level of comfort due to the much shorter bed rest time, and the time saved overall enabled us to implement a new more efficient workflow in the hospital. Additionally, there was a substantial decrease in the use of post-procedural pain medications in patients receiving the Vascade device. This type of innovation will be particularly important as demand for these procedures continues to grow.” Dr. Natale is Executive Medical Director, Texas Cardiac Arrhythmia Institute in Austin, Texas.