PK Papyrus covered stent: Device description and early experience for the treatment of coronary artery perforations.

Background: Coronary artery perforation during percutaneous revascularization is associated with considerable morbidity and mortality. The PK Papyrus covered stent provides a physical barrier to seal perforated arteries and prevent associated complications including death.

Methods: In a survey of patients treated for coronary artery perforation with the PK Papyrus stent in 16 countries, procedural and in-hospital outcomes were ascertained. Procedural variables included device delivery, sealing of the perforation, and complications related to the covered stent.

Results: Among 80 patients with coronary perforation, Ellis classification was characterized as grade III or III-cavity spilling in 50.0% and 17.5% of events, respectively. The mean (±SD) number of stents attempted for use per patient was 1.25 ± 0.61. The PK Papyrus stent was successfully delivered to the site of perforation in 76 patients (95.0%), and successful sealing was reported in 73 patients (91.3%). Pericardiocentesis was performed in seven patients (8.8%), and in-hospital death occurred in eight patients (10.0%). Among patient deaths, Ellis grade III perforations were reported in all instances (data not reported in one patient), and two cases were associated with unsuccessful sealing of the perforation site.

Conclusions: The PK Papyrus covered stent is designed to overcome limitations of existing therapies and to facilitate device delivery and effectively treat coronary artery perforations. Initial experience demonstrates favorably high rates of successful delivery to and sealing of the perforation site. Despite treatment, in-hospital mortality remains high for patients experiencing Ellis grade III coronary perforations.