Use Of Bioresorbable Scaffolds Research Articles

Outcomes of the novolimus-eluting bioresorbable vascular scaffold in real world clinical practice.

BACKGROUND Most of the current data regarding the use of bioresorbable scaffolds (BRS) come from everolimus-eluting stent platforms. Adverse events with the everolimus-eluting BRSs which are the most comprehensively characterized BRS, hampered the clinical use of other BRS. There is paucity of published data regarding long term use of novolimus-eluting BRS. METHODS This study sought to evaluate the performance of novolimus-eluting BRS device at midterm follow-up in real world clinical practice. One hundred and forty-four patients (mean age 57.5±9.7 years, 78.5% male) treated with 206 scaffolds between October 2015 and December 2017 were enrolled. A device-oriented composite endpoint (DOCE) comprising cardiac death, target vessel myocardial infarction (TV-MI), clinically driven target lesion revascularization (TLR) and rate of scaffold thrombosis were investigated. RESULTS During a mean follow-up of 33±9 months, DOCE occurred in 9 patients (6.3%) of which cardiac death occurred in 2 patients (1.4%), and clinically driven TLR in 7 patients (4.9%), TV-MI in one patient. Target vessel revascularization (TVR) was observed in nine patients. None of the patients experienced scaffold thrombosis. CONCLUSIONS The use of novolimus-eluting BRS in this real-world population achieved good clinical outcomes.

Outcomes of the novolimus-eluting bioresorbable vascular scaffold in real world clinical practice.

Most of the current data regarding the use of bioresorbable scaffolds (BRS) come from everolimus-eluting stent platforms. Adverse events with the everolimus-eluting BRSs which are the most comprehensively characterized BRS, hampered the clinical use of other BRS. There is paucity of published data regarding long term use of novolimus-eluting BRS. This study sought to evaluate the performance of novolimus-eluting BRS device at midterm follow-up in real world clinical practice. One hundred and forty-four patients (mean age 57.5±9.7 years, 78.5% male) treated with 206 scaffolds between October 2015 and December 2017 were enrolled. A device-oriented composite endpoint (DOCE) comprising cardiac death, target vessel myocardial infarction (TV-MI), clinically driven target lesion revascularization (TLR) and rate of scaffold thrombosis were investigated. During a mean follow-up of 33±9 months, DOCE occurred in 9 patients (6.3%) of which cardiac death occurred in 2 patients (1.4%), and clinically driven TLR in 7 patients (4.9%), TV-MI in one patient. Target vessel revascularization (TVR) was observed in nine patients. None of the patients experienced scaffold thrombosis. The use of novolimus-eluting BRS in this real-world population achieved good clinical outcomes.

Eriyebilen Stentlerin Prosedür Üzerine Olan Etkilerinin İlaç Kaplı Stentlerle Karşılaştırılması

Eriyebilen Stentlerin Prosedür Üzerine Olan Etkilerinin İlaç Kaplı Stentlerle Karşılaştırılması

Tendon Fascicle-Inspired Nanofibrous Scaffold of Polylactic acid/Collagen with Enhanced 3D-Structure and Biomechanical Properties

Surgical treatment of tendon lesions still yields unsatisfactory clinical outcomes. The use of bioresorbable scaffolds represents a way forward to improve tissue repair. Scaffolds for tendon reconstruction should have a structure mimicking that of the natural tendon, while providing adequate mechanical strength and stiffness. In this paper, electrospun nanofibers of two crosslinked PLLA/Collagen blends (PLLA/Coll-75/25, PLLA/Coll-50/50) were developed and then wrapped in bundles, where the nanofibers are predominantly aligned along the bundles. Bundle morphology was assessed via SEM and high-resolution x-ray computed tomography (XCT). The 0.4-micron resolution in XCT demonstrated a biomimetic morphology of the bundles for all compositions, with a predominant nanofiber alignment and some scatter (50–60% were within 12° from the axis of the bundle), similar to the tendon microstructure. Human fibroblasts seeded on the bundles had increased metabolic activity from day 7 to day 21 of culture. The stiffness, strength and toughness of the bundles are comparable to tendon fascicles, both in the as-spun condition and after crosslinking, with moderate loss of mechanical properties after ageing in PBS (7 and 14 days). PLLA/Coll-75/25 has more desirable mechanical properties such as stiffness and ductility, compared to the PLLA/Coll-50/50. This study confirms the potential to bioengineer tendon fascicles with enhanced 3D structure and biomechanical properties.

Uzun Segment Koroner Lezyonlarda Biyoeriyebilen Stentlerin Güvenlik ve Etkinlik Sonlanımları

Introduction: There is limited knowledge about the use of bioresorbable scaffolds (BRSs) in long segment coronary artery lesions. We aimed to evaluate the clinical outcomes of BRS-BRS and drug eluting stents (DESs)-BRS overlapping applications. Patients and Methods: Cross-sectional, single-center study between 2013 and 2016 enrolled 97 patients and 100 lesions scheduled for BRS placement in long segment lesions (> 28 mm). BRS-BRS overlap was performed in 30 patients and 30 lesions, DES-BRS overlap was performed in 67 patients and 70 lesions. Acute procedural success and major adverse cardiac events (MACE) (death, stent thrombosis, and target lesion reintervention) were assessed. Results: Acute procedural success was 97.1% in the overall group. MACE was observed in 6 patients (6.2%) in the entire group, 4 (5.9%) in the DES-BRS group, and 2 (6.6%) in the BRS-BRS group. Conclusion: BRS use might be a safe and effective option for the treatment of long segment lesions. Both BRS-BRS overlap and BRS-DES overlap may be performed with short overlap segment.

Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary.

A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device -the Absorb bioresorbable vascular scaffold- has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE- mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary.

A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device-the Absorb bioresorbable vascular scaffold-has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE-mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

CRT-100.60 Outcomes of Bioresorbable Scaffold Use for the Treatment of Bifurcating Lesions: A Global Study Analysis

Bioresorbable vascular scaffold (BVS) is demonstrated to be clinical equivalent to drug eluting stents (DES) for the treatment of de-novo coronary artery disease. One of his properties is the thicker struts being completed degraded by 24-36 months. Data reporting clinical outcomes is scarce. We

The use of Bioresorbable Scaffolds in Cardiovascular Surgery

The use of Bioresorbable Scaffolds in Cardiovascular Surgery

Bioresorbable Scaffolds for Coronary Artery Disease

The purpose of this review is to present an overview of the recent evidence regarding the use of bioresorbable scaffolds in percutaneous coronary intervention. Bioresorbable scaffolds represent a potentially unique engineering solution to the problems associated with metallic stents. The Absorb everolimus-eluting bioresorbable scaffold has been the most extensively tested of this class and is currently Food and Drug Administration-approved for use in the USA. While early studies suggested that it has comparable overall efficacy as compared to drug-eluting metallic stents, they also demonstrated a significantly increased risk of stent thrombosis. Bioresorbable scaffolds may be comparable to drug-eluting stents, though associated with an increased risk of stent thrombosis. They are a nascent technology with several competitive product designs in development and continued iterative technological improvements are expected over the next several years.

A Tri-Leaflet Nitinol Mesh Scaffold for Engineering Heart Valves.

The epidemiology of valvular heart disease has significantly changed in the past few decades with aging as one of the main contributing factors. The available options for replacement of diseased valves are currently limited to mechanical and bioprosthetic valves, while the tissue engineered ones that are under study are currently far from clinical approval. The main problem with the tissue engineered heart valves is their progressive deterioration that leads to regurgitation and/or leaflet thickening a few months after implantation. The use of bioresorbable scaffolds is speculated to be one factor affecting these valves' failure. We have previously developed a non-degradable superelastic nitinol mesh scaffold concept that can be used for heart valve tissue engineering applications. It is hypothesized that the use of a non-degradable superelastic nitinol mesh may increase the durability of tissue engineered heart valves, avoid their shrinkage, and accordingly prevent regurgitation. The current work aims to study the effects of the design features on mechanical characteristics of this valve scaffold to attain proper function prior to in vivo implantation.

Bioresorbable Scaffolds for theManagement of Coronary BifurcationLesions.

The use of bioresorbable scaffolds (BRS) may be associated with benefits including restoration of endothelial function, positive vessel remodeling, and reduced risk for very late (stent) thrombosis compared with metallic stents by virtue of their complete absorption within 3 to 4 years of implantation. When treating bifurcation lesions, these advantages may be even more pronounced. The aim of this review is to summarize current experiences and technical considerations of bifurcation treatment with BRS. Because of the physical properties of current-generation BRS, there are concerns with regard to the efficacy and safety of this novel technology for the treatment of bifurcations, with the potential for increased rates of scaffold thrombosis and side-branch occlusions, and as a consequence, bifurcations have been excluded from the major BRS trials. Nevertheless, BRS have been used for this indication in clinical practice, as evidenced by "real-world" registries. Considering the potential limitations, specific technical considerations and modified bifurcation strategies should be used in an attempt to attenuate problems and achieve optimal procedural and clinical outcomes.

Clinical Outcomes of Bioresorbable Scaffold in Coronary Artery Disease: A Systematic Literature Review.

We aim to perform a systematic literature review on all studies reporting the clinical outcomes of the use of bioresorbable scaffolds (BRS) in different settings of coronary artery disease (CAD). BRS are designed to provide early support of the vessel wall postangioplasty, deliver antiproliferative agents to prevent excessive hyperplastic healing responses and finally "disappear" when no longer required. Emerging data have provided evidence of their use in specific clinical scenarios. A comprehensive literature search was performed by 2 independent reviewers utilizing MEDLINE, EMBASE, and Cochrane Library databases. The only 2 CE marked BRS: everolimus-eluting Bioresorbable vascular scaffold ABSORB BVS and the myolimus-eluting DESolve Bioresorbable Coronary Scaffold (BCS) System were included. The studies were categorized into: ST elevation myocardial infarction (STEMI), stable CAD, and "all-comers" group. Thirty-one studies were included; 8 in STEMI patients (all ABSORB), 15 in stable CAD patients. In the STEMI group (n = 606), acute procedural success ranged from 96% to 100%, cardiac mortality 0-9.1%, recurrent MI and stent thrombosis rates were 0-4.3%. In the stable CAD group, the 13 ABSORB studies (n = 3259) demonstrated cardiac mortality rate of 0-0.6%, recurrent MI rate 0-4.5%, and stent thrombosis rate 0-4.3% Current clinical data suggest the BRS, especially the ABSORB BVS, may represent a reasonable alternative to DES in uncomplicated coronary anatomy.

Use of bioresorbable scaffold for neopulmonary artery in simple transposition of great arteries: Tissue engineering moves steps in pediatric cardiac surgery

BackgroundSupravalvular pulmonary stenosis (SPS) remains a worrisome complication in the long term of simple transposition of the great arteries. Issues of scar formation and inability to grow are considered at the base of this phenomenon. We pioneered the use of a tissue engineering approach to guide the maturation and the growth of pulmonary autograft in the Ross procedure with encouraging results. We therefore sought to investigate the use of a similar approach in the reconstruction of neopulmonary trunk (NPT) with the aim to recreate a vascular conduit that retains the structural architecture and the same biological potential of native pulmonary artery and prevents long-term SPS. MethodsA model of NPT reconstruction in growing lambs was used. NPT was constructed with autologous pericardium and reinforced with a four-layered knitted polydioxanone mesh (PDS n=10) or left unreinforced (control n=10). Animals were left growing for 6months and angiographic and transesophageal echocardiographic measurements were performed at day 1 and at the end of the study together with histological analysis. ResultsControl group developed SPS while PDS reinforcement allowed a progressive increase in diameter with an optimal size to match the pulmonary artery of healthy growing controls. Histological analysis showed in the control group disruption of endothelial lining with fibrosis, while demonstrated in the PDS group a trilaminar vessel-like structure. ConclusionsThe bioresorbable reinforcement induced the formation over time of a neopulmonary conduit able to both face the hemodynamic load of the pulmonary system and guarantee a harmonious increase in size during the somatic growth.

Simplifying the double kissing (DK) crush with the use of bioresorbable scaffolds

Simplifying the double kissing (DK) crush with the use of bioresorbable scaffolds

Medium-term outcomes after the use of bioresorbable scaffolds for treatment of coronary stenosis in real-world clinical practice: The Christchurch experience

Background: Bioresorbable Scaffolds (BRS) are a novel approach to treat coronary stenoses using a temporary polymeric scaffold to maintain normal arterial curvature, allow return of vasomotion and enable positive remodelling. We aimed to determine the medium-term outcomes of patients undergoing percutaneous coronary intervention (PCI) with BRS. Methods: 83 consecutive patients treated with ABSORB BRS at Christchurch and St George's Hospitals between 18/08/2011-31/12/2014 were followed for Major Adverse Cardiac Events (MACE - death, non-fatal myocardial infarction (MI) and revascularisation). Results: Mean age: 53.6 years, 82% males, 22% STEMI and 25% NSTEMI. 85.5% had single vessel PCI. 110 BRS were deployed to treat 92 lesions (53% LAD), including 52% type-B and 45% type-C lesions. 3 were ostial lesions, 7 in-stent restenosis, and 5 bifurcation lesions. Overlap stenting to treat 18 lesions: 10=BVS/BVS, 8=BVS/drug eluting stent. Median overlap stent/scaffold length was 46mm (20-88mm). Device/procedural success rates were 100%. During a median follow-up of 15 months (2-42 months), MACE rate was 4.8%: two cases of sub-acute stent thrombosis (ST) and two cases of late ST including one death. Subgroup analysis of lesion types found MACE of 0% in type-AB lesions and 9.7% in type-C lesions. Conclusions: BRS implantation appears feasible in daily clinical practice with good device and procedural success. Early and late ST are seen following treatment of complicated type-C lesions. Larger randomised studies using multimodality imaging may help to understand role of BRS in such lesions.

Short-term outcomes following “full-plastic jacket” everolimus-eluting bioresorbable scaffold implantation

The advent of drug-eluting stents (DES) improved the rates ofrestenosis [1]. In cases of percutaneous coronary intervention (PCI) forlong-diffuse lesions, operators often face the dilemma of whether tofully cover most of the vessel length. Incomplete lesion coverage is anindependent risk factor of restenosis [2], while on the other hand,a “full-metal jacket (FMJ)” remains associated with higher rates of in-stent restenosis and stent thrombosis [3–5]. In addition, a FMJ oftenprecludes future surgical revascularization. The use of bioresorbablescaffolds (BRS) appears very attractive due to their full reabsorption 2to 3 years after implantation. However, very little is known about theperformanceofBRSwhenusedforthetreatmentoflong-diffuselesions.Onthisbasis,wesoughttoinvestigatethefeasibilityandtheshort-termclinical outcomes following BRS implantation for very long lesions(“full-plastic jacket”).A retrospective analysis in 2 high volume centers in Milan was per-formedonconsecutivepatientswhounderwentPCIwithBRS(ABSORB;Abbott Vascular, Santa Clara, California) between May 2012 and May2014. Exclusion criteria were PCI for ST-segment elevation myocardialinfarction, non-ST-segment elevation myocardial infarction and bypassgraft. During the study period, a total of 142 patients (191 lesions)underwent BRS implantation. Procedural “full-plastic jacket” (FPJ) was

Personal Experience with Bioresorbable Scaffolds in Bifurcations.

Bioresorbable scaffolds represent a promising new technology in the field of percutaneous coronary interventions. The concept of the eventual resorption of the scaffold pertains to multiple theoretical advantages that may hold true particularly in bifurcation lesions - no permanent caging of the coronary artery, avoidance of acquired device malapposition and delayed hypersensitivity reactions, no permanent metallic stent protrusion in the main branch, etc. The worldwide experience with the use of bioresorbable scaffolds is limited. In our experience of selected bifurcation lesions, a provisional approach using one-scaffold has excellent results. Two-scaffold techniques appeared feasible. Our data support the exploration of the use of bioresorbable scaffolds in more challenging coronary substrates like bifurcations. Prospective registries and ideally randomised trials should assess whether the theoretical benefits of bioresorbable vascular scaffolds (BVS) in bifurcation lesions can produce sustainable good clinical outcomes.

Fusion Performance of Low-Dose Recombinant Human Bone Morphogenetic Protein 2 and Bone Marrow-Derived Multipotent Stromal Cells in Biodegradable Scaffolds

A large animal study comparing interbody fusion of a bioresorbable scaffold loaded with either low-dose recombinant human bone morphogenetic protein 2 (rhBMP-2) or bone marrow-derived multipotent stromal cells (BMSCs). To compare the quality of fusion resulting from implantation of medical grade poly (ε-caprolactone)-20% tricalcium phosphate (mPCL/TCP) scaffolds and two different bone growth stimulating agents. Nondegradable cages have been used for interbody fusion with good results. However, the overall advantage of lifelong implantation of a nondegradable device remains a subject of ongoing debate. The use of bioresorbable scaffolds might offer superior alternatives. In this study, we evaluated the quality of fusion obtained with two potential bone graft substitutes. Eleven Yorkshire pigs underwent a bisegmental (L2/L3; L4/L5) anterior lumbar interbody fusion (ALIF) in four groups, namely: (1) mPCL/TCP + 0.6 mg rhBMP-2; (2) mPCL/TCP + BMSCs; (3) mPCL/TCP (negative control); and (4) autologous bone grafts (positive control). RESULTS. The mean radiographic scores at 9 months were 3.0, 1.7, 1.0, and 1.8 for groups 1 to 4, respectively. The bone volume fraction of group 1 was two-folds higher than group 2. Histology, micro-computed tomographic scanning and biomechanical evaluation demonstrated solid and comparable fusion between groups 1 and 4. However, group 2 showed inferior quality of fusion when compared with groups 1 and 4 while group 3 showed no fusion even at 9 months. In addition, there was no evidence of implant rejection, chronic inflammation or any other complications. mPCL/TCP scaffolds loaded with low-dose rhBMP-2 is comparable to autograft bone as a bone graft substitute in this large animal ALIF model. Although BMSCs lagged behind autograft bone and rhBMP-2, evidence of bone ingrowth in this group warrants further investigation. Our results suggest that mPCL/TCP scaffolds loaded with rhBMP-2 or BMSCs may be a viable alternative to conventional cages and autograft bone.