OCT enables the detection of CAV-associated plaque compositions and allows early detection and differentiation of vessel wall disease not visible on angiography. LFP was the most prevalent plaque component, was strongly associated with NFCP, and may be associated with stepwise CAV progression caused by organizing mural thrombi. (The GRAFT Study: Evaluation of Graft Function, Rejection and Cardiac Allograft Vasculopathy in First Heart Transplant Recipients; NCT02077764).
Objectives: To compare on the bench the physical and mechanical properties of Magmaris, a magnesium bioresorbable scaffold (BRS), with Absorb and DESolve polymeric BRS and a permanent metallic stent. Background: Understanding the mechanical and physical properties of BRS is crucial for appropriate implantation and postdilatation. Methods: Testing was performed in fluid at 37 C and in silicone bifurcation phantoms with a 30 angle between main branch (MB) and side branch. Results: The 3.0-mm Magmaris BRS did not fracture after MB postdilatation up to 4.4 mm in contrast to the Absorb where the safe postdilatation diameter was 3.7 mm. For dilatation through stent cells, there were no Magmaris fractures with 3.0-mm noncompliant (NC) balloons inflated to nominal pressure. Mini-kissing balloon postdilatation with two 3.0-mm NC balloons up to 17 atm was without fracture except for an outlier. Longitudinal and radial strengths were similar for Magmaris and Absorb BRS. The crossing profile for the Magmaris was larger than other devices. Recoil 120 min after deployment was the greatest for Magmaris but 120 min after 3.5 mm postdilatation all devices had similar diameters. Conclusions: The Magmaris BRS was more resistant to strut fracture than Absorb. It had a larger crossing profile than other devices and similar radial and longitudinal strengths to Absorb. While recoil after deployment was greater with Magmaris, 120 min after 3.5 mm postdilatation all devices had similar diameters.
ObjectivesTo confirm clinically that coronary balloon catheter tips may be damaged during bifurcation treatment with side‐branch access through the side of a stent. On the bench, we aimed to assess the susceptibility of different balloon designs to damage. We compared catheter tip widths. We tested whether balloon tip flaring can cause stent distortion.BackgroundWe had observed that balloon catheters that failed to cross to a side‐branch frequently exhibited tip damage.Methods and ResultsWe examined microscopically for damage 82 balloon tips after clinical side‐branch access. In a bench study, the forces required to compress catheter tips 0.5 mm were compared to assess susceptibility to damage. We compared tip widths of balloons of different nominal inflation diameters. We examined stents after side‐branch access for distortion. In 42 of 48 (88%) of balloon tips from patients with resistance to or failure to cross through the side of a stent there was tip damage. Even when the balloon crossed without perceptible resistance, tip damage occurred in over half of balloons 18/34 (53%). Some balloon designs were more resistant to damage than others. Tips from balloons of different nominal diameters from the same manufacturer had the same width. Stent distortion caused by damaged balloon tips is improved by kissing balloon post‐dilatation.ConclusionsBalloon tip damage is common with crossing between stent struts. This is one cause of failure of a balloon to access a side‐branch and a new balloon should be used. If stent distortion is suspected, it should be corrected with kissing balloon post‐dilatation.
OCT can visualize thrombus formation in young ACS patients with non-obstructive thrombus or following thrombus reduction by aspiration and balloon dilatation. These patients seems safely treated with a conservative medical approach rather than with stent implantation.
Background
Primary percutaneous coronary intervention with implantation of a metallic drug-eluting stent (DES) is the standard treatment for patients presenting with ST-elevation myocardial infarction (STEMI). Implantation of a bioresorbable scaffold (BRS) during STEMI represents a novel strategy without intravascular metal.
Objective
The aim of the study was to investigate 12-month healing response in an STEMI population after implantation of either the Absorb BRS or Xience DES (Abbott Vascular, USA).
Methods
The present trial was a prospective, randomized, controlled, nonblinded, noninferiority study with planned inclusion of 120 patients with STEMI. Patients were randomly assigned 1:1 to treatment with Absorb BRS or Xience DES. Implantation result and healing response were evaluated by angiography and optical coherence tomography (OCT) at baseline and 12-month follow-up. The primary endpoint was minimum flow area (MFA) assessed at 12 months. Coronary stent healing index (CSHI) was calculated from OCT images.
Results
Out of 66 included patients, 58 had follow-up OCT after 12 months, and 49 entered matched analysis. One death occurred in each group; none were stent-related. MFA was 5.13 ± 1.70 mm2 (95% CI, 4.44–5.82) in the BRS group compared with 6.30 ± 2.49 mm2 (95% CI, 5.22–7.37) (P = 0.06) in the DES group. Noninferiority could not be evaluated. CSHI for both groups had a median score of 3.
Conclusion
The DES group performed numerically better in primary and secondary endpoints, but the CSHI showed good stent healing in both groups.
Objectives: To evaluate the feasibility, safety, and healing response of a magnesiumbased bioresorbable scaffold (BRS) in the treatment of simple bifurcation lesions using the single stent provisional technique.Background: BRS may hold potential advantages in the treatment of coronary bifurcation lesions, however low radial strength and expansion capacity has been an issue with polymer-based scaffolds. The magnesium BRS may prove suitable for bifurcation treatment as its mechanical properties are closer to those of permanent metallic drug-eluting stents.
Methods:The study was a proof-of-concept study with planned inclusion of 20 patients with stable angina pectoris and a bifurcation lesion involving a large side branch (SB) > 2.5 mm with less than 50% diameter stenosis. Procedure and healing response were evaluated by optical coherence tomography (OCT). The main endpoints were a composite clinical safety endpoint and an OCT healing index at 1 month (range: 0-98).Results: Eleven patients were included in the study. The study was prematurely terminated due to scaffold fractures and embolization of scaffold fragments in three cases requiring bailout stenting with drug-eluting stents. One patient underwent bypass surgery at 3 months due to stenosis proximal to the study segment. All SB were patent for 1 month. One-month OCT evaluation showed strut coverage of 96.9% and no malapposition. Scaffold fractures and uncovered jailing struts resulted in a less favorable mean OCT healing index score of 10.4 ± 9.0.Conclusions: Implanting a magnesium scaffold by the provisional technique in nontrue bifurcation lesions was associated with scaffold fracture, embolization of scaffold fragments, and a high need for bailout stenting.
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