Clinical Experience of the PK Papyrus Covered Stent in Patients With Coronary Artery Perforations: Results From a Multi-Center Humanitarian Device Exemption Survey.

Background/purpose: The PK Papyrus covered coronary stent system (Biotronik AG, Bülach, Switzerland) is intended for treatment of coronary artery perforation (CAP) and is approved for use under a Humanitarian Device Exemption (HDE) in the United States (US).

Methods/materials: The retrospective data analysis includes cases reported from the US PK Papyrus HDE post-market surveillance clinical dataset with CAP cited as the reason for PK Papyrus stent use.

Results: From April 2019 to July 2021, PK Papyrus device registration forms citing CAP as the reason for use were received for 1094 cases from 335 US hospital programs. Ellis classification was assessed as: type III cavity spilling/IV, 11.0%; type III, 57.9%; type II, 23.8%; type I, 7.3%. Mechanisms of perforation included: balloon angioplasty (42.3%), stent placement (31.3%), atherectomy (13.9%), and guidewire (10.9%). The majority (72.6%) of cases involved single covered stent placement. Successful PK Papyrus delivery was reported in 97.7% of cases with successful perforation sealing in 92.1%. Emergency cardiac surgery and in-hospital death occurred in 6.3% and 12.4% of cases, respectively. Pericardiocentesis was performed in 30.2% of patients. Acute/subacute stent thrombosis occurred in 10 patients (1.1%).

Conclusion: As the largest dataset of patients treated with a covered stent for CAP, these data provide significant insight into patient characteristics, procedural outcome, and in-hospital clinical events associated with this life-threatening complication. These results demonstrate that the PK Papyrus stent is a safe and effective method to seal CAP and with the potential to reduce high morbidity and mortality associated with this event.