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1.
Kardiol Pol ; 81(11): 1103-1112, 2023.
Article in English | MEDLINE | ID: mdl-37937354

ABSTRACT

BACKGROUND: Impella is a percutaneous mechanical circulatory support device for treatment of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCIs). IMPELLA-PL is a national retrospective registry of Impella-treated CS and HR-PCI patients in 20 Polish interventional cardiological centers, conducted from January 2014 until December 2021. AIMS: We aimed to determine the efficacy and safety of Impella using real-world data from IMPELLA-PL and compare these with other registries. METHODS: IMPELLA-PL data were analyzed to determine primary endpoints: in-hospital mortality and rates of mortality and major adverse cardiovascular and cerebrovascular events (MACCE) at 12 months post-discharge. RESULTS: Of 308 patients, 18% had CS and 82% underwent HR-PCI. In-hospital mortality rates were 76.4% and 8.3% in the CS and HR-PCI groups, respectively. The 12-month mortality rates were 80.0% and 18.2%, and post-discharge MACCE rates were 9.1% and 22.5%, respectively. Any access site bleeding occurred in 30.9% of CS patients and 14.6% of HR-PCI patients, limb ischemia in 12.7% and 2.4%, and hemolysis in 10.9% and 1.6%, respectively. CONCLUSIONS: Impella is safe and effective during HR-PCIs, in accordance with previous registry analyses. The risk profile and mortality in CS patients were higher than in other registries, and the potential benefits of Impella in CS require investigation.


Subject(s)
Heart-Assist Devices , Percutaneous Coronary Intervention , Humans , Shock, Cardiogenic/therapy , Poland , Percutaneous Coronary Intervention/adverse effects , Retrospective Studies , Aftercare , Patient Discharge , Registries , Treatment Outcome
2.
Expert Rev Med Devices ; 14(4): 279-284, 2017 Apr.
Article in English | MEDLINE | ID: mdl-28394644

ABSTRACT

INTRODUCTION: Coronary bifurcation lesions pose therapeutic challenges during percutaneous coronary interventions. Dedicated bifurcation stents are one of the treatment options available. Areas covered: This paper will analyze the results of the BiOSS (Bifurcation Optimization Stent System) Clinical Program with a special focus on the cobalt-chromium BiOSS LIM C stent which has recently been introduced into the market (CE 2016). The stent is characterized by a strut thickness of 70 µm and sirolimus concentration of 1.4 µg/mm2. Expert commentary: The first BiOSS stent was a bare metal one, but shortly after a paclitaxel-eluting version was introduced - BiOSS Expert stent (CE 2010). After acceptable results of BiOSS Expert stent were obtained in registries as well as in the randomized clinical trial POLBOS I, a way for improvement was to change paclitaxel into the - olimus drug. Sirolimus has been chosen and the BiOSS LIM stent was developed (CE 2012). BiOSS LIM is the dedicated bifurcation stent with stainless steel platform that releases sirolimus (1.4 µg/mm2) from the surface of a biodegradable coating comprised of a copolymer of lactic and glycolic acids. Nevertheless, the idea to reduce late lumen loss and as a result TLR rate by using thinner struts appeared. Therefore, presently first-in-man registry with BiOSS LIM C is ongoing.


Subject(s)
Chromium , Cobalt , Coronary Disease/therapy , Drug-Eluting Stents , Coronary Disease/pathology , Equipment Design , Humans , Sirolimus/administration & dosage , Treatment Outcome
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