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

Kandzari, David E.; Birkemeyer, Ralf

doi:10.1002/ccd.28306

Cited by 28 publications

(20 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Amorphous SiC has recently been tested in various neural prosthetic applications not only as a conformal encapsulation material [36,58,63] but also as adhesion-promoting layer of a polymer coating [63,64] and as both substrate and an insulating material of neural interfaces, enabling all-SiC devices [65,66]. Additionally, a-SiC has been used in a recently regulatory approved cardiac stent [67].…”

Section: Inorganic Materialsmentioning

confidence: 99%

Emerging Encapsulation Technologies for Long-Term Reliability of Microfabricated Implantable Devices

2019

View full text Add to dashboard Cite

The development of reliable long-term encapsulation technologies for implantable biomedical devices is of paramount importance for the safe and stable operation of implants in the body over a period of several decades. Conventional technologies based on titanium or ceramic packaging, however, are not suitable for encapsulating microfabricated devices due to their limited scalability, incompatibility with microfabrication processes, and difficulties with miniaturization. A variety of emerging materials have been proposed for encapsulation of microfabricated implants, including thin-film inorganic coatings of Al2O3, HfO2, SiO2, SiC, and diamond, as well as organic polymers of polyimide, parylene, liquid crystal polymer, silicone elastomer, SU-8, and cyclic olefin copolymer. While none of these materials have yet been proven to be as hermetic as conventional metal packages nor widely used in regulatory approved devices for chronic implantation, a number of studies have demonstrated promising outcomes on their long-term encapsulation performance through a multitude of fabrication and testing methodologies. The present review article aims to provide a comprehensive, up-to-date overview of the long-term encapsulation performance of these emerging materials with a specific focus on publications that have quantitatively estimated the lifetime of encapsulation technologies in aqueous environments.

show abstract

Section: Inorganic Materialsmentioning

confidence: 99%

Emerging Encapsulation Technologies for Long-Term Reliability of Microfabricated Implantable Devices

2019

View full text Add to dashboard Cite

show abstract

“…The process of study selection is shown in Figure 1. From a total of 319 studies in our search, only 29 reports were included in the analysis 6,8–35 . The description of the included studies is shown in Table 1.…”

Section: Resultsmentioning

confidence: 99%

Outcomes of patients who undergo percutaneous coronary intervention with covered stents for coronary perforation: A systematic review and pooled analysis of data

Nagaraja

Schwarz

Moss

et al. 2019

Cathet Cardio Intervent

View full text Add to dashboard Cite

Objectives: This review aims to evaluate the adverse outcomes for patients after treatment with covered stents. Background: Coronary perforation is a potentially fatal complication of percutaneous coronary revascularization which may be treated using covered stents. Studies have evaluated long-term outcomes among patients who received these devices, but hitherto no literature review has taken place. Methods: We conducted a systematic review of adverse outcomes for patients after treatment with covered stents. Data from studies were pooled and outcomes were compared according to stent type. Results: A total of 29 studies were analyzed with data from 725 patients who received covered stents. The proportion of patients with chronic total occlusions, vein graft percutaneous coronary intervention (PCI), intracoronary imaging and rotational atherectomy were 16.9, 11.5, 9.2, and 6.6%, respectively. The stents used were primarily polytetrafluoroethylene (PTFE) (70%) and Papyrus (20.6%). Mortality, major adverse cardiovascular events, pericardiocentesis/tamponade and emergency surgery were 17.2, 35.3, 27.1, and 5.3%, respectively. Stratified analysis by use of PTFE, Papyrus and pericardial stents, suggested no difference in mortality (p = .323), or target lesion revascularization (p = .484). Stent thrombosis, pericardiocentesis/tamponade and emergency coronary artery bypass surgery (CABG) occurred more frequently in patients with PTFE stent use (p = .011, p = .005, p = .012, respectively). In-stent restenosis was more common with pericardial stent use (<.001, pooled analysis for first-and second-generation pericardial stents). Conclusions: Cases of coronary perforation which require implantation of a covered stent are associated with a high rate of adverse outcomes. The use of PTFE covered stents appears to be associated with more stent thrombosis, pericardiocentesis/ tamponade, and emergency CABG when compared to Papyrus or pericardial stents.

show abstract

“…Moreover, the performance in the long term was poor due to the high incidence of ISR (25%) and ST (from 3% to 16%) [ 16 – 18 ]. The PK Papyrus CS (Biotronik, USA) was a cobalt-chrome stent platform covered with a single-layer of PU material [ 19 ]. Hernandez-Enriquez et al came to an encouraging conclusion that delivery time of PK Papyrus stent was shorter and brought about reduced frequency of pericardial effusion and cardiac arrest in comparison with the Graftmaster [ 20 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical Outcomes of Self-Made Polyurethane-Covered Stent Implantation for the Treatment of Coronary Artery Perforations

Song

Qin

Chang

et al. 2021

Journal of Interventional Cardiology

View full text Add to dashboard Cite

Objectives. The present study aimed to investigate the short- and long-term clinical outcomes of self-made polyurethane-covered stents (PU-CS) in patients for the management of coronary artery perforation (CAP) during percutaneous coronary intervention (PCI). Background. Coronary artery perforation is reckoned as a serious complication in PCI and associated with considerable morbidity and mortality. Covered stents have been used for treating the life-threatening CAP during PCI. But in some catheterization laboratories, no commercial CS is immediately available when there is an urgent need for CS to rescue the coronary rupture site. Methods. We retrospectively identified 24 patients who underwent 31 self-made PU-CS implantations due to CAP in Zhongshan Hospital, Fudan University, from June 2015 to January 2020. Results. The total procedural success rate of CS to seal the perforation was 79.2%. Nine patients (37.5%) developed cardiac tamponade, of which 8 patients (33.3%) underwent pericardiocentesis and 4 patients (16.7%) underwent cardiac surgeries. Except for 4 cardiac death cases (16.7%), none of myocardial infarction (MI), target lesion revascularization (TLR), and stent thrombosis (ST) was reported during hospital stay. Data from 22 patients (91.7%) were available at 610.4 ± 420.9 days of follow-up. Major adverse cardiac events (MACE) occurred in 6 patients (27.3%), including 5 cases of cardiac death and one TLR case. Conclusions. Self-made PU-CS demonstrates high rates of successful delivery and sealing of severe CAP during PCI. Although the in-hospital mortality remains high after PU-CS implantation, the long-term follow-up shows favorable clinical outcomes, indicating the feasibility of PU-CS in treating CAP.

show abstract

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

Cited by 28 publications

References 15 publications

Emerging Encapsulation Technologies for Long-Term Reliability of Microfabricated Implantable Devices

Emerging Encapsulation Technologies for Long-Term Reliability of Microfabricated Implantable Devices

Outcomes of patients who undergo percutaneous coronary intervention with covered stents for coronary perforation: A systematic review and pooled analysis of data

Clinical Outcomes of Self-Made Polyurethane-Covered Stent Implantation for the Treatment of Coronary Artery Perforations

Contact Info

Product

Resources

About