Nauman Khalid, MD
,
MedStar Heart and Vascular Institute, Washington, DC
Hasan Javed
,
MedStar Heart and Vascular Institute, Washington, DC
Toby Rogers, MD
,
MedStar Heart and Vascular Institute, Washington, DC
Hayder D. Hashim, M.D.
,
MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC
Evan Shlofmitz, D.O.
,
MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC
Yuefeng Chen, MD, PhD
,
MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC
Jaffar Khan, M.D.
,
MedStar Heart and Vascular Institute, Washington, DC
Anees Musallam, MD
,
MedStar Heart and Vascular Institute, Washington, DC
Micaela Iantorno, M.D.
,
Medstar Institute, Washington Hospital Center, Potomac, MD
Deepakraj Gajanana, M.D.
,
Medstar Institute, Washington Hospital Center
Rebecca Torguson
,
MedStar Heart and Vascular Institute, Washington, DC
Nelson L. Bernardo, M.D., FSCAI
,
MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC
Ron Waksman, M.D., FSCAI
,
MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC
Background:
Robust data on the most commonly reported complications and modes of failure associated with the Orbital atherectomy (OA) (Diamondback 360 Cardiovascular Systems, Inc., St. Paul, MN, USA) and Rotational atherectomy (RA) (Rotablatorâ„¢ Boston Scientific, Marlborough, MA, USA) devices is limited. We analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess these endpoints.
Methods:
The MAUDE registry was queried from September 1, 2016, through September 31, 2018, for OA and RA devices yielding 520 and 298 reports respectively. After excluding reports for peripheral interventions, incomplete and duplicate reports, 317 reports for OA and 282 reports for RA devices were included in the final analysis.
Results:
The most commonly reported patient complications for both OA and RA included vascular complications (perforation and dissection), arrhythmias, and death – Table 1. Of the reported device-related adverse events, mortality occurred with OA and RA 21.8% and 6.4% of the times respectively. The most commonly reported modes of failure for OA and RA included detachment and/or structural damage of the device component in 24.3% of OA and 39.7% of RA reports and entrapment of the device or its component in 5.4% of OA and 35.5% of RA reports respectively. Adverse events stratified by the target vessel for OA and RA are depicted in Figure 1.
Conclusions:
Our analysis highlights important complications associated with OA and RA devices. Judicious use, appropriate patient selection, and operator experience can help mitigate these potential complications.
