Feasibility and safety of non-invasive ultrasound therapy (NIUT) on an porcine aortic valve.

Calcific aortic stenosis (CAS) is associated with advanced age and comorbidities, therefore a non-invasive therapy for it would be beneficial. We previously demonstrated that ultrasound therapy improved calcified bioprosthetic valve function in an open chest model. For translational applications, we tested non-invasive ultrasound therapy (NIUT) transthoracically on swine aortic valves and investigated the need for antithrombotic treatment as a follow-up.

One-Year Clinical Outcomes of Patients Presenting With ST-Segment Elevation Myocardial Infarction Caused by Bifurcation Culprit Lesions Treated With the Stentys Self-Apposing Coronary Stent: Results From the APPOSITION III Study.

Objective: To investigate outcomes in patients with ST-segment elevation myocardial infarction (STEMI) after treatment with the Stentys self-apposing stent (Stentys SAS; Stentys S.A.) for bifurcation culprit lesions.

Clinical outcomes with the STENTYS self-apposing coronary stent in patients presenting with ST-segment elevation myocardial infarction: two-year insights from the APPOSITION III (A Post-Market registry to assess the STENTYS self-exPanding COronary Stent In AcuTe MyocardIal InfarctiON) registry.

Aims: The APPOSITION III registry evaluated the feasibility and performance of the STENTYS self-apposing stent in an ST-segment elevation myocardial infarction (STEMI) population. This novel self-apposing stent device lowers stent strut malapposition rates and therefore carries the potential to prevent stent undersizing during primary percutaneous coronary intervention (PCI) in STEMI patients. To date, no long-term data are available using this device in the setting of STEMI.

STENTYS Self-Apposing sirolimus-eluting stent in ST-segment elevation myocardial infarction: results from the randomised APPOSITION IV trial.

Aims: We sought to investigate the impact of the self-apposing, sirolimus-eluting STENTYS stent on midterm and long-term stent apposition and strut coverage compared with a zotarolimus-eluting balloon-expandable stent in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI).

Methods And Results: In the APPOSITION IV trial, 152 STEMI patients were randomised (3:2) to the self-apposing, sirolimus-eluting STENTYS stent or a commercially available zotarolimus-eluting balloon-expandable stent at 12 sites in five countries with angiographic follow-up and optical coherence tomography at four or nine months. At four months, a lower percentage of malapposed stent struts was observed in the STENTYS group (N=21; Nstruts=501) compared with controls (N=26; Nstruts=326; 0.

Incidence and potential mechanism of resolved, persistent and newly acquired malapposition three days after implantation of self-expanding or balloon-expandable stents in a STEMI population: insights from optical coherence tomography in the APPOSITION II study.

Aims: The aim of the current study was to investigate the frequency and mechanisms of sequential incomplete stent apposition (ISA) changes such as persistent, resolved or newly acquired ISA during the first three days after primary PCI (pPCI) in a matched segment-level analysis, with the comparison between self-expanding and balloon-expandable stents assessed by optical coherence tomography (OCT).

Methods And Results: The current analysis is a substudy of the APPOSITION II study that included 69 patients (self-expanding: 35, balloon-expandable: 34) using serial optical coherence tomography (OCT) post procedure and three days after pPCI. In order to evaluate a temporal change in ISA, stented regions were segmented using fiduciary landmarks.

First-in-man evaluation of the novel balloon delivery system STENTYS Xposition S for the self-apposing coronary artery stent: impact on longitudinal geographic miss during stenting.

Aims: A novel balloon delivery system (BDS) for the self-apposing STENTYS sirolimus-eluting stent (SES) has been developed for highly precise longitudinal stent positioning and deployment. The aim of this first-in-man study is to report the quantitative coronary analysis (QCA) angiography and optical coherence tomography (OCT) results as well as the 30-day clinical outcomes of the STENTYS Xposition S SES.

Methods And Results: We included 25 patients (mean age 66.

One-year clinical outcomes of the STENTYS Self-Apposing¨ coronary stent in patients presenting with ST-segment elevation myocardial infarction: results from the APPOSITION III registry.

Aims: The aim of APPOSITION III was to evaluate the feasibility and performance of the STENTYS Self-Apposing¨ stent (STENTYS S.A., Paris, France) in the setting of primary percutaneous coronary intervention (PCI).

APPOSITION V: STENTYS coronary stent system clinical trial in subjects with ST-segment elevation myocardial infarction--rationale and design.

Background: Primary percutaneous coronary intervention (PCI) has considerably improved clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) when compared with thrombolytic therapy. Prognosis after primary PCI might be further improved by decreasing stent-related complications such as stent thrombosis. The STENTYS self-apposing stent has been shown to be superior compared with balloon-expandable stents with regard to stent apposition.

Self-expanding versus balloon-expandable stents in acute myocardial infarction: results from the APPOSITION II study: self-expanding stents in ST-segment elevation myocardial infarction.

Objectives: This study sought to investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 3 days after implantation in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Background: Acute myocardial infarction is associated with vasoconstriction and large thrombus burden. Resolution of vasoconstriction and thrombus load during the first hours to days after primary percutaneous coronary intervention may lead to stent undersizing and malapposition, which may subsequently lead to stent thrombosis or restenosis.

Six-month clinical and angiographic results of the STENTYS® self-apposing stent in bifurcation lesions.

Aims: We report the clinical and angiographic results of the OPEN I study, a multicentre prospective single-arm study evaluating both the drug-eluting and bare metal STENTYS® stents in the treatment of coronary bifurcation lesions.

Methods And Results: The STENTYS® stent is a provisional, self-expanding, nitinol stent with small interconnections that can be disconnected by balloon angioplasty in between the stent struts to provide access to the side branch (SB) and full ostium coverage. In nine European centres, 60 stents (33 BMS, 27 DES) were implanted in 63 patients (procedural success of 95.

Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study.

Aims: In the setting of ST-elevation myocardial infarction (STEMI), epicardial vasoconstriction and thrombus load may lead to stent undersizing and malapposition after primary percutaneous coronary intervention (PPCI), which can both be responsible for stent thrombosis or restenosis. Aggressive stent deployment can, on the other hand, cause distal embolisation and the no-reflow phenomenon. The purpose of our study was to evaluate the safety and feasibility of a novel self-expanding stent by assessing the clinical, angiographic and intravascular outcomes after stent deployment at three days and at six months follow-up.