Biovascular Scaffold Research Articles

Enhancement of Poly-L-lactic acid stents through polydopamine coating: Boosting endothelialization and suppressing inflammation

The utilization of Poly-L-lactic acid (PLLA) as a biodegradable material for biovascular scaffolds (BVS) stems from its superior mechanical attributes, biodegradability, and biocompatibility. However, PLLA's challenges, such as its lack of active surface functional groups and high hydrophobicity, impede endothelial cells' (ECs) attachment and growth. These factors subsequently amplify the risk of thrombosis and restenosis in PLLA implants. To counteract this problem, we've adapted the polydopamine (PDA) coating technique, a technique commonly used for metal stents. This method has demonstrated potential for promoting EC adhesion and proliferation on PLLA surfaces. Our study involved the application of PDA coating to PLLA, which resulted in improved EC attachment and proliferation while simultaneously inhibiting macrophage activation and the release of the inflammatory factor TNF-α. Additionally, the reactive functional groups on the PDA-coated surface provide a reactive platform for immobilizing therapeutic molecules onto PLLA, thereby further enhancing the biocompatibility of PLLA cardiovascular stents.

Thirty-Day Outcomes After Unrestricted Implantation of Bioresorbable Vascular Scaffold (from the Prospective RAI Registry)

The Absorb biovascular scaffold (BVS) is a bioresorbable, everolimus-eluting scaffold whose data on real-world patients with complex lesions are limited. Short-term follow-up from recent studies point to a higher rate of 30-day thrombosis than observed with drug-eluting stents. We aimed to understand the short-term safety and efficacy of BVS. Registro Absorb Italiano (RAI, ClinicalTrials.gov:NCT02298413) is an Italian, prospective, multicenter registry not funded, whose aim is to investigate BVS performance through a 5-year follow-up of all consecutive patients who have undergone successful implantation of ≥1 BVS in different clinical/lesion subsets. Co-primary end points were target lesion revascularization and definite/probable thrombosis. Secondary end point was the occurrence of device-oriented cardiac events. The registry involved 23 centers, with patient enrollment from October 2012 to December 2015. We here report the 30-day outcomes of the whole population of the registry. We enrolled 1,505 consecutive patients, of which 82% were men and 22.4% diabetic. At presentation, 59.6% of the patients had an acute coronary syndrome, including 21% ST-elevation myocardial infarction. All lesions were pre-dilated and in 96.8% of the cases BVS was post-dilated. At 30days, the co-primary study end point target lesion revascularization occurred in 0.6% of patients and definite/probable BVS thrombosis in 0.8%. There were 2 cases of cardiac and overall death (0.13%). Device-oriented cardiac events occurred in 1% of the patients. In conclusion, our data of consecutive patients suggest that current use of BVS in a wide spectrum of coronary narrowings and clinical settings is associated with good outcome at 30days.

Final shape of biovascular scaffolds and clinical outcome. Results from a multicenter all-comers study with intravascular imaging

AimsRadial strength of bioresorbable vascular scaffolds (BVS) implanted in coronary arteries is still under debate. Moreover, their final shape patterns, when implanted in an all-comer, unselected population, have not yet been completely correlated with clinical outcome and should be better investigated. Methods and resultsA multicenter collaborative analysis was performed on all consecutive patients with native coronary artery disease undergoing PCI with intravascular imaging-guided BVS implantation. The BVS was arbitrarily categorized as having a final “oval shape” through intravascular imaging, if maximal lumen diameter was longer than 150% of minimal lumen diameter at the target lesion. Primary study-endpoint was device-oriented major adverse events (DOCE) at mid-term follow-up. Sixty-seven consecutive patients were evaluated at 6 European centers. Mean patient age was 58±11years, and 12 patients (18%) had diabetes. Mean percent diameter stenosis was 79±12.5%. Average lesion length was 24.4±13.8mm and 66% of lesions were AHA/ACC type B2/C. Postdilation rate was 91% and all BVS resulted well apposed to the vessel wall. Procedural success was achieved in all patients and 10 (14.9%) had an “oval shape” at intravascular imaging. This occurrence was not associated with an increase in periprocedural myocardial infarction (p=0.37) or DOCE during hospitalization (p=0.65). Seven-month DOCE occurred in 3 patients (5.6%) of the oval shape group, they were target-vessel revascularization and did not differ significantly between patients with vs. without final “oval shape” (p=0.34). We did not register episodes of scaffold thromboses. ConclusionsIn an all-comer population with complex coronary lesions treated with BVS, a final oval shape after postdilation was not rare and not associated with immediate and medium term adverse events.

Two-Stent Strategy? Which One to Choose? First Case Example

Optimal treatment of bifurcation lesions is still a major challenge for coronary intervention. A planned two-stent approach may be more appropriate when both the parent vessel and side branch (SB) are large, and when there is significant disease distal to the ostium of a SB that arises from the main vessel at a shallow angle. A simple, provisional stenting approach that is associated with shorter fluoroscopy time, lower incidence of periprocedural myocardial infarction, and similar rates of target-vessel revascularisation compared with a routine two-stent strategy is needed. The combination of a biovascular scaffold and drug-eluting stent implantation as a two-stent technique using a ‘mini-crush’ technique is a safe, feasible, effective, and durable treatment option for patients with true bifurcation disease. Patient selection for complex stenting requires accurate lesion evaluation. Our current institutional recommendations are to use provisional stenting in the majority of cases, but if a planned two-stent approach is required, we recommend the use of imaging methods, plaque modification before stent implantation, final kissing balloon, and proximal optimisation inflation technique to achieve good final results.

Biovascular resorbable scaffold for spontaneous coronary artery dissection: RAIders on the storm of a debatable therapy.

Biovascular resorbable scaffold for spontaneous coronary artery dissection: RAIders on the storm of a debatable therapy.

CRT-200.60 Multi-analysis With Oct and Vasomotion in Everolimus-eluting Synergy Coronary Stents - The Moves Trial

To compare endothelium-dependent and -independent vasomotor function and vascular healing 15 months after implantation of 2 new-generation drug eluting stents and biovascular scaffolds (BVS). A total of 28 patients previously treated with a SYNERGY stent (BP-EES), a PROMUS stent (PP-EES) or an

Spontaneous coronary artery dissection treated with biovascular scaffolds: Old riddle, novel approach

Introduction: Spontaneous coronary artery dissection (SCAD) is a rare, poorly understood disease (incidence 0.1–1.1%). Management modalities vary and are mostly based on consensus from relatively some study results. Percutaneous intervention (PCI) with conventional drug eluting stents (DES), though acceptable treatment for complicated cases, has a widely variable rate of success (65–90%), hence the search for alternative solutions. Case Report: We present the case of a premenopausal female with no known cardiac risk factor, admitted with a non-ST elevation myocardial infarction (NSTEMI), who, on cardiac angiogram, was found to have had a spontaneous coronary artery dissection (SCAD). Conservative management is the consensus treatment for uncomplicated cases, but failed in this case. Biovascular scaffolds were then deployed and 12 months post procedure, have proven to be a successful treatment option for this rare disease. Conclusion: This case highlights the difficulties posed by this rare disease and the potential for better results for PCI in complicated cases when biovascular scaffolds are employed. Failure

0505: Bioresorbable vascular scaffold: preliminary experience of 200 patients and follow up at 18 months of the first 100

Between February 2013 and May 2015, of 2,700 coronary angioplasty procedures realized in our institution, 200 patients aged 65.6 (23-94) underwent coronary stenting with Absorb Biovascular Scaffold. exercise angina in 30% of the patients, acute coronary syndroms in 61%, silent ischaemia in 7% and heart failure in 2%. all stents have been implanted under angiographic control, only 2 beeing imaged by IVUS, in de novo lesions, through a radial approach with 6 French guiding catheters, following mandatory predilatation. 67% of patents had single vessel desease, 33% multivessel desease. Left anterior descending artery was the target vessel in 64%, the left circumflex in 19% and the right coronary artery in 26%. 212 stents have neen sdelivered with only one failure. 25 patients underwent metallic stenting of other arteries. Side branch angioplasty had to be performed in 4 cases. No death. One complication withe non Q wave myocardial infraction secondary to side branch occlusion (diagonal branch). One transient ischaemic attack. at 22 months (12-27) no stent thrombosis occured. One patient died of cranial traumatism; two patients (1%) had restenosis at the margin of the BVS requiring repeated angioplasty. at nearly two years follow up, our data confirm the safety of the device and the low rate of reintervention.

Late coronary BVS malapposition and aneurysm: A Time for Appraisal.

Late strut malapposition of currently available stents is a major issue, associated with an increased risk of stent thrombosis. To this day, biovascular scaffolds showed an increased immediate risk of struts malapposition, that however resulted reduced after a few months. Little is known about late acquired struts malapposition of biovascular scaffolds. We here describe two cases that recently occurred in our patients, and we speculate on possible mechanisms for this unexpected and potentially lethal complication.

0146 : Bioresorbable everolimus eluting stents in acute coronary syndroms. Preliminary implantation data and follow up of 40 patients

Between February 20133 and October 2014, 105 patients aged 64.2 (25-94) underwent coronary artery stenting with at least one Absorb Biovascular Scaffold (BVS). Of these procédures 40 were realized in the setting of acute coronary syndroms (15 ST elevation myocardial Infarction – STEMI – and 25 non STEMI). 42 BVS have been implanted through a radial approach on the culprit lesion under angiographic control alone. Left anterior descending artery was involved in 19, the right coronary artery in 14 and the left circumflex in 7 patients.18 patients had multivesseldesease and underwent a second staged procedure before discharge with BVS or metallic drug eluting stents implantation In hospital stay was event free for all 40 patients. All were discharged under conventionnal dual antiplatellet therapy. Out hospital follow up (11.2 months –2-22): no clinical event occured. One patient experienced 70% restenosis proximal to the stent and underwent new stenting with metallic drug eluting stent (TLR: 2.5%). at that time our preliminary data confirm the safety at mid term of the BVS device in acute coronary syndroms.

Current-era biovascular scaffolds seen by experts: An experience-based survey

Current-era biovascular scaffolds seen by experts: An experience-based survey

Managing distorted ABSORB Scaffold in left main during anomalous LMCA stenting

The everolimus-eluting biovascular scaffold (BVS) does not contain any metal, therefore struts are not evident angiographically. Two adjacent platinum radio-opaque markers at each end facilitate precise location of stent ends. Here we report one case of anomalous left main stenting using BVS. The BVS got accidentally distorted in left main during the procedure, which was not visible on angiography but detected on OCT.

0182: Bioresorbable everolimus eluting stents in coronary arteries. Preliminary implantation data and follow up of 65 patients

Between february 2013 and april 2014, of 1450 coronary angioplaty procédures realized in our institution, 65 patients, aged 64.3 (40-94), underwent coronary artery stenting with Absorb Biovascular Scaffold (BVS) exercise angina 22 patients, acute coronary syndromes 37 (including acute myocardial infarction 5), silent ischemia 7, heart failure 2. Ten patients suffered diabètes (15%) and 14 experienced previous coronay interventions (20%). all stents have been implanted under angiographic control (except two cases including IVUS imaging) in de novo lésions through a radial approach with 6F guiding catheters following mandatory predilatation. 44 patients had single vessel desease (67%) and 21 multivessel desease. Target vessel was the left anterior descending artery in 35 cases, left circumflex in 10 and right artery in 14. 68 stents have been delivered; three patients had two BVS; 16 patients had also metallic drug eluting stents in other arteries. Side branch dilatation had to be performed in 4 patients. Implantation was successfull in all cases. No death Complications: side branch occlusion with non Q wave infarction in one case and transient ischaemic attack in one another. 58 patients left the institution the day after the procedure under conventionnal dual antiplatelet therapy. at 6.2 month (1-15) all patients were event free (100%) Three patients had angiographic control at one year and were free of restenosis; one another had 70% angiographic restenosis at the edges of the stent and underwent longer DES implantation (TLR: 1.5%). Three other patients had computed tomography scanner control at one year with no evidence of restenosis, including one case demonstrating restoration of systolic compression of the stented segment in a myocardal bridging whereas diastolic diameter was normal. at that time our preliminary data confirm the safety of the BVS device at implantation and at six months follow up.

Mechanical properties of compliant double layered poly(L-lactide-co-ɛ-caprolactone) vascular graft

We fabricated a tubular double-layered scaffold using two steps; poly(L-lactide-co-ɛ-caprolactone) (PLCL) gel spinning method and salt leaching. The objective of the present study was to characterize the mechanical properties of tubular double-layered PLCL scaffolds that had different wall thickness values. We evaluated the bio-vascular scaffold in terms of cardiovascular implants-tubular vascular prostheses in international standard; ANSI/AAMI/ISO 7198:1998/2001. According to the ISP 7198, PLCL had sufficient mechanical strength, burst strength, tensile strength to withstand blood pressure and had similar compliance to native vessels due to its elasticity. We applied the tubular vascular prostheses’ evaluation method using an existing surgical operation. The vascular scaffold, which had a similar compliance to native vessels, did not result in severe thrombosis in vivo for 4 weeks. Thus, this novel material holds great promise for use as a blood vessel substitute. Open image in new window