Clinical experience of the PK Papyrus covered stent in patients with coronary artery perforations: Results from a multi-center humanitarian device exemption survey.

MedStar author(s):
Citation: Cardiovascular Revascularization Medicine. 2022 Apr 25PMID: 35504818Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2022Local holdings: Available in print through MWHC library: 2002 - presentISSN:
  • 1878-0938
Name of journal: Cardiovascular revascularization medicine : including molecular interventionsAbstract: BACKGROUND/PURPOSE: The PK Papyrus covered coronary stent system (Biotronik AG, Bulach, 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).CONCLUSION: As the largest dataset of patients treated with a covered stent for CAP, these data provide significant insight to 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 potential to reduce high morbidity and mortality associated with this event. Copyright © 2022. Published by Elsevier Inc.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%).All authors: Kandzari DE, Sarao RC, Waksman RFiscal year: FY2022Digital Object Identifier: Date added to catalog: 2022-07-06
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 35504818 Available 35504818

Available in print through MWHC library: 2002 - present

BACKGROUND/PURPOSE: The PK Papyrus covered coronary stent system (Biotronik AG, Bulach, 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).

CONCLUSION: As the largest dataset of patients treated with a covered stent for CAP, these data provide significant insight to 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 potential to reduce high morbidity and mortality associated with this event. Copyright © 2022. Published by Elsevier Inc.

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%).

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