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Coronary Intra-orbital Atherectomy Complications and Procedural Failure: Insight From the Manufacturer and User
Rashid Alhusain1, Dhruvil Patel2, Heba Osman3
1Internal Medicine, Detroit Medical Center, Detroit, USA.
Insights
Real-world data reveal device part separation as the most common failure mode for the Diamondback 360® Coronary Orbital Atherectomy System. Perforation, often leading to cardiac tamponade and death, was the most frequent complication.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Safety
Background:
- The Diamondback 360® Coronary Orbital Atherectomy System is FDA-approved for treating severely calcified lesions.
- While clinical trials indicate safety, real-world data on this device are limited.
Purpose of the Study:
- To analyze real-world adverse events and failure modes of the Diamondback 360® Coronary Orbital Atherectomy System.
- To identify common complications and their outcomes using post-market surveillance data.
Main Methods:
- A retrospective analysis of adverse event reports from the Manufacturer and User Facility Device Experience (MAUDE) database.
- Data from January 2019 to January 2022 were queried for reports concerning the Diamondback 360® Coronary Orbital Atherectomy System.
Main Results:
- 547 unique reports were analyzed, with device part separation (40.4%) being the most common failure mode, primarily involving the ViperWire tip.
- Coronary perforation (33.0%) was the most frequent adverse outcome, leading to cardiac tamponade in 23.7% of cases and death in 16.3% of events.
- The left anterior descending artery was the most commonly affected vessel.
Conclusions:
- Real-world data indicate that device part separation and perforation are significant concerns with orbital atherectomy.
- Understanding these failure modes and complications is crucial for physicians to anticipate and manage adverse events effectively.
- This analysis provides valuable insights for improving patient safety and procedural outcomes.
Background:
The Diamondback 360® Coronary Orbital Atherectomy System (Cardiovascular Systems Inc., St. Paul, MN) is the first and only orbital atherectomy system approved by the US FDA for the treatment of severely calcified lesions. While the device has proven to be safe in clinical trials, real-world data are minimal.
Methods:
The Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports on the Diamondback 360® Coronary from January 2019 to January 2022.
Results:
A total of 566 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 547 reports. The most common mode of failure was break or separation of a device part (40.4%, n = 221) mainly due to breaking in the tip of the ViperWire (66.1%), driveshaft (22.7%), or crown (12.2%). The most common vessel associated with events was the left anterior descending artery (31.4%), followed by the right coronary artery (26.9%), left circumflex (21.6%), and left main coronary artery (6.4%). The most common clinical adverse outcome was perforation (33.0%, n = 181) with 23.7% resulting in cardiac tamponade. Most perforation cases were treated by covered stent (44.2%), surgery (30.5%), stent (98%), and balloon angioplasty (9%). There were 89 (16.3%) events of death with 67% due to perforation (p < 0.001).
Conclusion:
Our study provided a glimpse of real-world adverse outcomes and common modes of failure due to orbital atherectomy. The most common mode of failure was the break or separation of a device part and the most common complication was perforation according to the MAUDE database. It will help physicians to anticipate complications and escalate care appropriately.
