Very Late Scaffold Thrombosis Research Articles

Long-term results of a prospective, single-arm evaluation of everolimus-eluting bioresorbable vascular scaffolds in infrapopliteal arteries.

The aim of this study was to perform a long-term evaluation of an everolimus eluting, bioresorbable vascular scaffold (BVS) in the treatment of de novo atherosclerotic disease within crural arteries. A prospective, single-arm study was performed enrolling patients with chronic lower limb ischemia between 2013 and 2018. Fifty-five limbs in 48 patients (56% male; mean age 82.1 ± 8.0 years, range 65-97) were treated for critical limb ischemia (72.7%) or severe claudication (27.3%). Seventy-one scaffolds were used to treat 61 lesions with a mean length of 20.1 ± 10.8 mm. During a mean follow-up period of 35.2 ± 20.4 months, 22 (45.8%) patients had died. No late or very-late scaffold thrombosis was observed. Overall, clinical improvement was observed in 90.9% and a limb-salvage rate of 100% was observed. Binary restenosis was detected in 11/71(15.5%) scaffolds. Primary patency and freedom from clinically driven target lesion revascularization rates at 12, 24, 36, 48, and 60 months were 90.8% (95% confidence interval 80.7-95.8), 90.8% (80.7-95.8), 79.7% (65.8-88.4), 76.3% (61.1-86.2), 72.3% (55.5-83.4) and 97.2% (89.2-99.3), 97.2% (89.2-99.3), 90.7% (78.7-96.1), 90.7% (78.7-96.1), and 90.7% (78.7-96.1), respectively. This long-term study shows excellent rates of patency and freedom from target lesion revascularization using the absorb BVS below-the-knee. This proof of concept study lays the foundation for the next generation of BVS to be evaluated in infrapopliteal arteries.

Long-term follow-up of BVS from a prospective multicenter registry: Impact of a dedicated implantation technique on clinical outcomes

ObjectivesThe aim of this study was to evaluate the impact of a consistent and dedicated implantation strategy on long-term outcomes after implantation of bioresorbable vascular scaffold (BVS) in a real-world cohort of patients with a high prevalence of complex lesions. BackgroundBioresorbable vascular scaffolds may result in a reduced incidence of late and very-late scaffold thrombosis (ScT) after the complete reabsorption of the scaffold, but this hypothesis is hampered by data from RCTs that showed a higher than expected incidence of late events. However, these studies did not adopt a dedicated implantation technique, that proved to be fundamental in reducing the incidence of adverse events. Methods573 consecutive patients (912 lesions) treated with bioresorbable scaffolds between May 2012 and December 2014 were enrolled in 3 high-volume centers that used a dedicated implantation strategy from the beginning. Primary endpoints were target-lesion failure (TLF) and definite and probable ScT. Secondary endpoints included myocardial infarction, target-lesion and target-vessel revascularization. ResultsThe registry enrolled a high complexity subset of lesions (69.4% of type B2 or C lesions; 10.3% of severe calcific lesions; 26.1% of bifurcations). Predilatation was performed in almost all cases (99.2%); intracoronary imaging was liberally adopted (37.3%). Mean scaffold length was 42.9 ± 27.4 mm per patient, and post-dilation with a 1:1 high-pressure (22 ± 3.5 atm) balloon was performed in 99.9% of lesions. Median follow-up (available for 98.6% of patients) was 981 days (IQR 802–1133). Overall incidence of ScT was reassuringly low: three thrombotic events occurred during the first year (0.5%), while only one event ensued in the second year of follow-up, and ScT rate remained stable thereafter up to the fourth year (0.7%). Cumulative TLF rates at 1, 2, 3 and 4 years were 3.0%, 6.0%, 7.8% and 12.2%. ConclusionsThese long-term results from a complex “real-world” population appear to be reassuring as regards to the incidence of ScT and TLF when BVS are implanted by experienced operators with a dedicated implantation technique.

Clinical, Angiographic, and Procedural Correlates of Very Late Absorb Scaffold Thrombosis: Multistudy Registry Results

ObjectivesThe aim of this study was to identify independent correlates of very late scaffold thrombosis (VLST) from an analysis of consecutively treated patients from 15 multicenter studies. BackgroundRecent analyses suggest an increased risk for VLST with the Absorb Bioresorbable Vascular Scaffold compared with drug-eluting stents, but insights as to correlates of risk are limited. MethodsA total of 55 patients were identified with scaffold thrombosis. They were matched 2:1 with control subjects selected randomly from patients without thrombosis from the same study. Quantitative coronary angiography was available for 96.4% of patients. Multiple logistic and Cox regression analysis were used to identify significant independent outcome correlates from 6 pre-specified characteristics. ResultsPatients had scaffold thrombosis at a median of 20 months (interquartile range: 17 to 27 months). Control subjects were followed for 36 months (interquartile range: 24 to 38 months). For the combined groups, reference vessel diameter (RVD) was 2.84 ± 0.50 mm, scaffold length was 26 ± 16 mm, and post-dilatation was performed in 56%. Univariate correlates of thrombosis were smaller nominal scaffold/RVD ratio (linear p = 0.001; ratio <1.18:1; odds ratio: 7.5; p = 0.002) and larger RVD (linear p = 0.001; >2.72 mm; odds ratio: 3.4; p = 0.001). Post-dilatation at ≥16 atm, post-dilatation balloon/scaffold ratio, final percentage stenosis, and dual antiplatelet therapy were not correlated with VLST. Only scaffold/RVD ratio remained a significant independent correlate of VLST (p = 0.001), as smaller ratio was correlated with RVD (p < 0.001). Post hoc analysis of 8 other potential covariates revealed no other correlates of outcome. ConclusionsIn the present analysis, the largest to date of its type, relative scaffold undersizing was the strongest determinant of VLST. Given current understanding of “scaffold dismantling,” this finding likely has ramifications for all bioresorbable scaffolds.

TCT-10 Mechanisms of Very Late Bioresorbable Scaffold Thrombosis Assessed by Optical Coherence Tomography: Insights from the international INVEST registry

Very late scaffold thrombosis (VLScT) occurs more frequently following bioresorbable coronary scaffold (BRS: ABSORB BVS 1.1) implantation compared with metallic everolimus-eluting stents. The mechanisms underlying VLScT remain largely unclear. The INVEST (INdependent OCT registry on VEry late

TCT-12 Clinical, Angiographic and Procedural Correlates of Very Late Absorb Scaffold Thrombosis – Multi-Study Registry Results

Recent analyses suggest an increased risk of very late scaffold thrombosis (VLST) beyond 1 year after implantation of Absorb BVS compared to metallic DES, but insights as to correlates of risk emanate from a limited number of patients. We sought to identify and verify independent correlates of

New generation bioresorbable scaffold technologies: an update on novel devices and clinical results.

Bioresorbable scaffolds (BRS) represent a novel horizon in interventional cardiology and may lead to some potential long-term advantages including the restoration of vasomotion, positive remodeling and a reduced incidence of late and very-late scaffold thrombosis (ScT). This technology, introduced to overcome limitations of current metallic drug-eluting stents (DES), is constantly and rapidly evolving with many companies working on bioresorbable devices. The aim of this review is to present an update on the most promising scaffolds that are under development.

Very Late Scaffold Thrombosis: Intracoronary Imaging and Histopathological and Spectroscopic Findings

BackgroundBioresorbable scaffolds provide transient lumen support followed by complete resorption. ObjectivesThis study examined whether very late scaffold thrombosis (VLScT) occurs when resorption is presumed to be nearly complete. MethodsPatients with VLScT at 3 tertiary care centers underwent thrombus aspiration followed by optical coherence tomography (OCT). Thrombus aspirates were analyzed by histopathological and spectroscopic examination. ResultsBetween March 2014 and February 2015, 4 patients presented with VLScT at 44 (case 1), 19 (cases 2 and 4), and 21 (case 3) months, respectively, after implantation of an Absorb Bioresorbable Vascular Scaffold 1.1 (Abbott Laboratories, Abbott Park, Illinois). At the time of VLScT, all patients were taking low-dose aspirin, and 2 patients were also taking prasugrel. OCT showed malapposed scaffold struts surrounded by thrombus in 7.1%, 9.0%, and 8.9% of struts in cases 1, 2, and 4, respectively. Scaffold discontinuity with struts in the lumen center was the cause of malapposition in cases 2 and 4. Uncovered scaffold struts with superimposed thrombus were the predominant findings in case 3. OCT percent area stenosis at the time of VLScT was high in case 1 (74.8%) and case 2 (70.9%) without evidence of excessive neointimal hyperplasia. Spectroscopic thrombus aspirate analysis showed persistence of intracoronary polymer fragments in case 1. ConclusionsVLScT may occur at advanced stages of scaffold resorption. Potential mechanisms specific for VLScT include scaffold discontinuity and restenosis during the resorption process, which appear delayed in humans; these findings suggest an extended period of vulnerability for thrombotic events.

Cardiology News / Recent Literature Review / Last Quarter 2015

Boston AF Symposium : Orlando, 14-16/1/2016 ACC 65 th Annual Session: Chicago, 2-4/4/2016 HRS 37 th Annual Meeting: San Francisco, 4-7/5/16 CardioStim/Europace : Nice, 8-11/6/2016 Euro PCR : Paris, 17-20/5/2016 ESC Meeting: Rome, 27-31/8/2016 Targeting Ablation to the Distal Segment of the Main Renal Artery and Post-Bifurcation Branches May Optimize Renal Denervation Insufficient procedural efficacy has been proposed to explain nonresponse to renal denervation (RDN). The impact of different patterns of lesion placements on the efficacy and consistency of catheter-based radiofrequency (RF) RDN was examined in pigs. Increasing the number of RF lesions (4, 8, and 12) in the main renal artery was not sufficient, but targeted treatment of the renal artery branches or distal segment of the main renal artery resulted in markedly less variability of response and significantly greater reduction of both norepinephrine (NE) and axon density than conventional treatment of only the main renal artery. Combination treatment (main artery plus branches) produced the greatest change in renal NE and axon density with the least heterogeneity. The changes lasted through 28 days post-treatment (Mahfoud F et al, J Am Coll Cardiol 2015;66:1766-1775). High Levels of Cardiorespiratory Fitness in Midlife Confer Lower Mortality, Use of Health Care Resources, and Health Care Costs Later in Life Among 19,571 healthy individuals who underwent cardiorespiratory fitness assessment at a mean age of 49 years, over 126,388 person-years of follow-up, average annual health care costs were significantly lower for participants aged > 65 years with high than low midlife fitness in both men and women. Average annual health care costs in later life were incrementally lower per MET achieved in midlife in men and women. The authors concluded that higher cardiorespiratory fitness in middle age is strongly associated with lower health care costs at an average of 22 years later in life, independent of cardiovascular risk factors (Bachmann JM et al, J Am Coll Cardiol 2015;66:1876-1885). Very Late Thrombosis of Bioresorbable Coronary Scaffolds Despite Antiplatelet Therapy, Possibly Related to Scaffold Discontinuity and Restenosis, Implies an Extended Period of Vulnerability to Ischemic Events Four patients presented with very late scaffold thrombosis (VLScT) at 44, 19 (2 cases), and 21 months, after implantation of an Absorb Bioresorbable Vascular Scaffold. At the time of VLScT, all patients were taking low-dose aspirin, and 2 patients were also taking prasugrel. Optical coherence tomography (OCT) showed malapposed scaffold struts surrounded by thrombus in 7.1%, 9.0%, and 8.9% of struts in 3 cases. Scaffold discontinuity with struts in the lumen center was the cause of malapposition in 2 cases. Uncovered scaffold struts with superimposed thrombus were the predominant findings in 1 case. OCT percent area stenosis at the time of VLScT was high in 2 cases (71-75%) without evidence of excessive neointimal hyperplasia. Thrombus aspirate analysis showed persistence of intracoronary polymer fragments in 1 case (Raber L et al, J Am Coll Cardiol 2015;66:1901-1914)... (excerpt)