Serum C-peptide level correlates with the course of muscle tissue healing in the rabbit model of critical limb ischemia.

Aim: The therapeutic potential of adipose-derived stem cell conditioned medium (ASC-CM) was studied in the rabbit model of critical limb ischemia (CLI).

Methods: Rabbits received treatment with ASC-CM or placebo. Gastrocnemius muscle tissue was collected 35 days after ischemia induction.

Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial.

Background: We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens.

Methods: GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months.

Comparison of the Absorb bioresorbable vascular scaffold to the Xience durable polymer everolimus-eluting metallic stent in routine clinical practice: a propensity score-matched analysis from a multicenter registry.

Introduction: Most clinical trials related to bioresorbable vascular scaffold (BVS) technology are limited to a highly selected patient population.

Aim: To evaluate early and long-term clinical outcomes of the Absorb everolimus-eluting BVS compared to the everolimus-eluting metallic XIENCE V stent in routine clinical practice.

Material And Methods: This is a multicenter, retrospective propensity score-matched comparative study, comprising 76 patients treated with a bare metal stents (BMS) and 501 with a XIENCE stent.

A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial.

Background: MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population.

State-of-the-art of transcatheter treatment of aortic valve stenosis and the overview of the InFlow project aiming at developing the first Polish TAVI system.

Initial experience of transcatheter aortic valve implantation (TAVI) or replacement (TAVR) has ap-peared as a promising minimally invasive technology for patients disqualified from surgical treatment (SAVR). Safety and efficacy of TAVI has been analyzed and assessed through numerous registries and trials. Furthermore, results obtained from comparative TAVI vs.

Assessment of vascular response to BiOSS LIM C stents vs Orsiro stents in the porcine coronary artery model.

Aims: The optimal treatment strategy for coronary bifurcation lesions is still unknown. The aim of the study was to assess applicability of the new cobalt-chromium version of the sirolimus-eluting dedicated bifurcation BiOSS LIM C stent in comparison with regular sirolimus-eluting Orsiro  stent in a porcine coronary model.

Methods: A total of 13 BiOSS LIM C stents and 6 Orsiro stents were implanted in normal nonatherosclerotic porcine straight coronary arteries of six animals using 1.

BiOSS LIM C: thin-strut cobalt-chromium version of the dedicated bifurcation stent.

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).

MynxGrip for Closure of Antegrade Puncture After Peripheral Interventions With Same-Day Discharge.

Background: This was the first prospective study to assess the safety and efficiency of MynxGrip vascular closure device (VCD) in peripheral interventions with antegrade access.

Methods And Results: We enrolled 66 consecutive patients from 1 center. All patients were discharged home on the day of procedure and were observed for adverse events at 1 and 30 days of follow-up.

REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study.

The number of patients with heart failure implantable cardiac electronic devices (CIEDs) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow-up is crucial.

Comparable vascular response of a new generation sirolimus eluting stents when compared to fluoropolymer everolimus eluting stents in the porcine coronary restenosis model.

Background: Novel sirolimus eluting stents (SES) have shown non-inferior clinical outcomes when compared to everolimus eluting stents (EES), however only limited preclinical data have been published. Therefore, we evaluate vascular response of a new generation biodegradable polymer SES (BP-SES: Alex Plus, Balton) and fluoropolymer EES (EES: Xience Pro, Abbott) in the porcine coronary restenosis model.

Methods: A total of 40 stents were implanted with 120% overstretch in coronaries of 17 domestic swine: 16 BP-SES, 16 EES and 8 bare metal controls (BMS).

Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry.

Objectives: The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease.

Background: TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance.

Methods: The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers.

Evaluation of safety and efficacy of NexGen - an ultrathin strut and hybrid cell design cobalt-chromium bare metal stent implanted in a real life patient population - the Polish NexGen Registry.

Introduction: Despite the dominance of drug-eluting stents in modern interventional cardiology, there is still a niche for bare metal stents.

Aim: The aim of the Polish NexGen registry was to evaluate the safety and efficacy of a new generation cobalt-chromium NexGen stent in a real life patient population.

Material And Methods: A prospective multi-center registry was conducted in five clinical sites of American Heart of Poland.

Left Main Stenting in Comparison With Surgical Revascularization: 10-Year Outcomes of the (Left Main Coronary Artery Stenting) LE MANS Trial.

Objectives: This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial.

Background: The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown.

Methods: In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53).

A Nuclear Magnetic Resonance Spectroscopy as a Method for Evaluation of In Vivo Poly-l-Lactide Biodegradation Kinetics From Stent-Polymer Matrices: An Experimental Study Utilizing Porcine Model of In-Stent Restenosis.

Objectives: We aimed to comprehensively evaluate poly-lactide polymer degradation and sirolimus release kinetics from a drug-eluting stent matrix in the in vivo setting using a nuclear magnetic resonance (NMR) method.

Methods: In 22 domestic swine, 18 biodegradable polymer-only coated stents (BPSs) and 36 biodegradable polymer-coated sirolimus-eluting stents (BP-SES) were implanted in coronary arteries with 115% overstretch. The animals were sacrificed at 1, 3, 7, 14, 28, and 56 days following baseline procedures.

Nutrition management of the post-bariatric surgery patient.

Bariatric surgery is considered one of the most effective methods of achieving long-term weight loss when all other medical treatments have failed. The number of bariatric procedures increases each year. Nevertheless, bariatric procedures are associated with a number of complications that require careful multidisciplinary management.

Safety and biocompatibility of a novel self-expanding nitinol carotid stent with hybrid cell design in a porcine model of neointimal hyperplasia.

Background: Stent design may influence the outcomes, suggesting that adverse event rates vary according to free cell area and cell design. Open cell design technology of self-expandable stents, dedicated for carotid revascularisation has better deliverability, although closed cell technology is expected to cause fewer thromboembolic events.

Aim: To evaluate the feasibility and vascular response of novel, hybrid cell, self-expandable nitinol stents (MER®, Balton, Poland) implanted into porcine carotid arteries.

Comparison of stenting and surgical revascularization strategy in non-ST elevation acute coronary syndromes and complex coronary artery disease (from the Milestone Registry).

The optimal revascularization strategy in patients with complex coronary artery disease and non-ST-segment elevation acute coronary syndromes is undetermined. In this multicenter, prospective registry, 4,566 patients with non-ST-segment elevation myocardial infarctions, unstable angina, and multivessel coronary disease, including left main disease, were enrolled. After angiography, 3,033 patients were selected for stenting (10.

Long-term clinical outcomes after percutaneous coronary intervention versus coronary artery bypass grafting for ostial/midshaft lesions in unprotected left main coronary artery from the DELTA registry: a multicenter registry evaluating percutaneous coronary intervention versus coronary artery bypass grafting for left main treatment.

Objectives: The aim of this study was to report the long-term clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) for ostial/midshaft lesions in an unprotected left main coronary artery (ULMCA).

Background: Data regarding outcomes in these patients are limited.

Methods: Of a total of 2,775 patients enrolled in the DELTA multinational registry, 856 patients with isolated ostial/midshaft lesions in an ULMCA treated by PCI with DES (n = 482) or CABG (n = 374) were analyzed.

Differences in vessel healing following delivery of everolimus or paclitaxel: a comparative experimental study using identical stent and biodegradable polymer platforms.

We aimed to compare the vascular effects exclusive to antiproliferative agents by using identical stent and biodegradable polymeric matrices eluting everolimus (BP-EES) (Carlo; Balton) and paclitaxel (BP-PES) (Luc-Chopin2; Balton) in the porcine model of coronary injury. A total of 37 stents were implanted with 110% overstretch in the coronary arteries of 14 domestic pigs: 13 BP-PES, 16 BP-EES and eight bare metal stents (BMS) (Chopin2; Balton). Coronary angiography was performed after 28 and 90 days, the animals were sacrificed and the stented segments harvested for histopathological evaluation.

Long-term clinical outcomes after percutaneous coronary intervention for ostial/mid-shaft lesions versus distal bifurcation lesions in unprotected left main coronary artery: the DELTA Registry (drug-eluting stent for left main coronary artery disease): a multicenter registry evaluating percutaneous coronary intervention versus coronary artery bypass grafting for left main treatment.

Objectives: The aim of this study was to compare, in a large all-comer registry, the long-term clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for ostial/mid-shaft lesions versus distal bifurcation lesions in unprotected left main coronary artery (ULMCA) stenosis.

Background: Limited data are available regarding clinical outcomes following DES implantation at the different ULMCA sites.

Methods: Patients with ULMCA stenosis treated by PCI with DES were analyzed in this multinational registry.

Experimental evaluation of pharmacokinetic profile and biological effect of a novel paclitaxel microcrystalline balloon coating in the iliofemoral territory of swine.

Background: New paclitaxel coated balloons (PCB) developments have been proposed to maintain therapeutic levels of drug in the tissue while decreasing particle release. In this series of studies, we evaluated the pharmacokinetic profile and biological effects after paclitaxel delivery via novel microcrystalline PCB coating (mcPCB, Pax®, Balton) in porcine iliofemoral arteries.

Methods: Ten domestic swine were enrolled yielding 24 iliofemoral segments for evaluation.

Vascular response and mechanical integrity of the new biodegradable polymer coated sirolimus-eluting PROLIM stent implanted in porcine coronary arteries.

Background: Although durable polymer coated drug-eluting stents (DES) are standard care in percutaneous coronary interventions, new stent platforms employing biodegradable polymer based drug delivery are increasingly being used in clinical practice.

Aim: To evaluate the short- (28 days) and medium-term (90 days) vascular effects of the new biodegradable polymer coated sirolimus-eluting stent - the PROLIM stent.

Methods: The objectives of the study were evaluated using standard angiographic and histological methods.

Controlled reperfusion with intravenous bivalirudin and intracoronary abciximab combination therapy in the porcine myocardial infarction model.

Introduction: The reperfusion injury (RI) remains a significant limitation of primary PCI, therefore we evaluated the role of intracoronary abciximab and bivalirudin for anticoagulation on myocardial salvage and RI in the porcine model of ischemia/reperfusion.

Materials And Methods: Myocardial infarction was induced in 23 pigs by 60-minute over-the-wire (OTW) balloon occlusion of the LAD. Animals received intravenous bivalirudin and then five minutes prior to reperfusion, either a coronary downstream infusion of abciximab (n=11) or saline (n=12) through the central lumen of an OTW catheter.