Impact of PSP Technique on Clinical Outcomes Following Bioresorbable Scaffolds Implantation.
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SUBMITTER: Ortega-Paz L
PROVIDER: S-EPMC5852443 | biostudies-literature | 2018 Feb
REPOSITORIES: biostudies-literature
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Impact of PSP Technique on Clinical Outcomes Following Bioresorbable Scaffolds Implantation.
Ortega-Paz Luis L Brugaletta Salvatore S Sabaté Manel M
Journal of clinical medicine 20180206 2
Bioresorbable scaffolds (BRS) were introduced in clinical practice to overcome the long-term limitations of newer-generation drug-eluting stents. Despite some initial promising results of the Absorb BRS, safety concerns have led to the discontinuation of the commercialization of this device. Several retrospective studies have assessed the impact of the so-called Pre-dilation, Sizing and Post-dilation (PSP) technique concluding that an optimal PSP technique can improve clinical outcomes following ...[more]
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Project description:BackgroundThe magnesium-based sirolimus-eluting bioresorbable scaffold (Mg-BRS) Magmaris™ showed promising clinical outcomes, including low rates of both the target lesion failure (TLF) and scaffold thrombosis (ScT), in selected study patients. However, insights regarding long-term outcomes (>2 years) in all-comer populations remain scarce.MethodsWe analyzed data from a single-center registry, including patients with acute coronary syndrome (ACS) and chronic coronary syndrome (CCS), who had undergone percutaneous coronary intervention (PCI) using the Mg-BRS. The primary outcome comprised the device-oriented composite endpoint (DoCE) representing a hierarchical composite of cardiac death, ScT, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) up to 5 years.ResultsIn total, 84 patients [mean age 62 ± 11 years and 63 (75%) men] were treated with the Mg-BRS devices between June 2016 and March 2017. Overall, 101 lesions had successfully been treated with the Mg-BRS devices using 1.2 ± 0.4 devices per lesion. Pre- and postdilatation using dedicated devices had been performed in 101 (100%) and 98 (97%) of all the cases, respectively. After a median follow-up time of 62 (61-64) months, 14 (18%) patients had experienced DoCEs, whereas ScT was encountered in 4 (4.9%) patients [early ScTs (<30 days) in three cases and two fatal cases]. In 4 (29%) of DoCE cases, optical coherence tomography confirmed the Mg-BRS collapse and uncontrolled dismantling.ConclusionIn contradiction to earlier studies, we encountered a relatively high rate of DoCEs in an all-comer cohort treated with the Mg-BRS. We even observed scaffold collapse and uncontrolled dismantling. This implicates that this metal-based BRS requires further investigation and may only be used in highly selected cases.
| S-EPMC9046914 | biostudies-literature
Project description:The technique used at the time of implantation has a central role in determining the risk of thrombosis in bioresorbable vascular scaffolds (BRS). Different definitions of the "optimal" implantation technique exist, however. The impact of individual procedural characteristics on the risk of scaffold thrombosis (ScT) was evaluated in a single-center observational study that enrolled 657 patients (79% males, mean age 63 ± 12 years) with 763 lesions who received a total of 925 BRS for de novo lesions. During a median 1076 (762?1206) days' follow-up there were 28 cases of thrombosis. Independent predictors of ScT included the use of predilatation balloons bigger than the nominal BRS diameter (hazard ratio (HR) = 0.4 (0.16?0.98), p = 0.04), sizing (implantation in vessels with reference vessel diameter >3.5 mm or <2.5 mm: HR = 5.71 (2.32?14.05), p = 0.0002) and the degree of vessel expansion (ratio of minimum lumen to reference vessel diameter, HR: 0.005 (0.0001?0.23), p = 0.007). In addition, a mild BRS oversizing (final BRS diameter to vessel diameter 1.14?1.28) was associated with a lower thrombosis risk, whereas undersizing and more severe oversizing (final BRS diameter to vessel diameter <1.04 and >1.35, respectively) were associated with an increased risk of ScT (HR = 0.13 (0.02?0.59), p = 0.0007). In conclusion, different components of the "optimal" technique have different impacts on the risk of BRS thrombosis. Besides predilatation with a balloon larger than the BRS diameter, correct vessel size selection and a mild to moderate oversizing appear to be protective.
| S-EPMC6352132 | biostudies-literature
Project description:Percutaneous coronary intervention (PCI) has undergone major advances including the evolution in stent technology, from bare metal stents (BMS), to their drug eluting counterparts, to the development of bioresorbable scaffolds (BRS). The primary notion of BRS was to facilitate complete vascular healing and restore normal endothelial function following the resorption of stent scaffold while providing equivalent mechanical properties of a metallic drug eluting stents (DES) in the earlier stages. BRS provide attractive physiologic advancements over the existing DES and have shown promising results in initial clinical studies albeit with small sample sizes. Their use has been primarily restricted to patients recruited in clinical trials with limited real-world applicability. Thus, data from larger randomised control trials is awaited. The major objective of this article is to review the evidence on BRS and identify their clinical applicability in current interventional practice.
| S-EPMC5808659 | biostudies-other
Project description:BACKGROUND:Diabetes is among the strongest predictors of outcome after coronary artery stenting and the incidence of negative outcomes is still high in this specific group. Data of long-term outcomes comparing diabetic patients with non-diabetic patients treated with bioresorbable scaffolds are still incomplete. This work evaluates the long-term outcomes after implantation of a coronary bioresorbable scaffold (BRS) in diabetic patients compared to non-diabetics. METHODS:Patients who received at least one Absorb BRS in the time of May 2012 to December 2014 were enrolled into this single-center registry. Quantitative coronary angiography (QCA) was performed. RESULTS:Six hundred fifty seven patients including 138 patients (21%, mean age 65?±?11, 78% male) with diabetes were enrolled. Patients in the diabetic group were significantly older, were more likely to suffer from hypertension and hyperlipidemia and had more often a prior stroke or TIA as well as a reduced renal function (all P?<?0.05). The initial stenosis was less severe in the diabetic group (74.8% vs. 79.6%, P?=?0.036), but the residual stenosis after BRS implantation exceeded that of the control group (16.7% vs. 13.8%, P?=?0.006). History of diabetes had no impact on the incidence of events within one year after BRS implantation. Beyond 1 year, diabetic patients had a higher incidence of cardiovascular death (6.9 vs. 1.4%, HR:5.37 [1.33-21.71], P?=?0.001), scaffold restenosis (17.6 vs. 7.8%, HR:3.56 [1.40-9.05], P?<?0.0001) and target lesion revascularization (P?=?0.016). These results were confirmed in the propensity score analysis. In both diabetics and non-diabetics, there was a strong association (HR:18.6 [4.7-73.3]) between the risk of restenosis and the technique used at implantation; in contrast, the impact of vessel size was more manifest in non-diabetics than in diabetic patients, and an increased risk of restenosis was demonstrated for both large and small vessels. CONCLUSION:As for metal stents, beyond one year after implantation, diabetes was associated with an increased incidence of scaffold restenosis and related outcomes. This negative impact of diabetes was reset when an optimal implantation technique was used.
| S-EPMC5944115 | biostudies-literature
Project description:BackgroundDM remains a risk factor for poor outcome after stent-implantation, but little is known if and how DM affects the vascular response to BVS.AimThe aim of our study was to examine coronary responses to bioresorbable vascular scaffolds (BVS) in swine with and without diabetes mellitus fed a 'fast-food' diet (FF-DM and FF-NDM, respectively) by sequential optical coherence tomography (OCT)-imaging and histology.MethodsFifteen male swine were evaluated. Eight received streptozotocin-injection to induce DM. After 9 months (M), 32 single BVS were implanted in epicardial arteries with a stent to artery (S/A)-ratio of 1.1:1 under quantitative coronary angiography (QCA) and OCT guidance. Lumen, scaffold, neointimal coverage and composition were assessed by QCA, OCT and near-infrared spectroscopy (NIRS) pre- and/or post-procedure, at 3M and 6M. Additionally, polarization-sensitive (PS)-OCT was performed in 7 swine at 6M. After sacrifice at 3M and 6M, histology and polymer degradation analysis were performed.ResultsLate lumen loss was high (~60%) within the first 3M after BVS-implantation (P<0.01 FF-DM vs. FF-NDM) and stabilized between 3M and 6M (<5% change in FF-DM, ~10% in FF-NDM; P>0.20). Neointimal coverage was highly heterogeneous in all swine (DM vs. NDM P>0.05), with focal lipid accumulation, irregular collagen distribution and neointimal calcification. Likewise, polymer mass loss was low (~2% at 3M, ~5% at 6M;P>0.20) and not associated with DM or inflammation.ConclusionScaffold coverage showed signs of neo-atherosclerosis in all FF-DM and FF-NDM swine, scaffold polymer was preserved and the vascular response to BVS was not influenced by diabetes.
| S-EPMC5595285 | biostudies-literature
Project description:Protrusion of scaffold struts is related with local coronary flow dynamics that can promote scaffold restenosis and thrombosis. That fact has prompted us to investigate in vivo the protrusion status of different types of scaffolds and their relationship with endothelial shear stress (ESS) distributions. Six Absorb everolimus-eluting Bioresorbable Vascular Scaffolds (Absorb, Abbott Vascular) and 11 Mirage sirolimus-eluting Bioresorbable Microfiber Scaffolds (Mirage, Manli Cardiology) were implanted in coronaries of eight mini pigs. Optical coherence tomography (OCT) was performed post-scaffold implantation and obtained images were fused with angiographic data to reconstruct the three dimensional coronary anatomy. Blood flow simulation was performed and ESS distribution was estimated for each scaffold. Protrusion distance was estimated using a dedicated software. Correlation between OCT-derived protrusion and ESS distribution was assessed for both scaffold groups. A significant difference was observed in the protrusion distances (156 ± 137 µm for Absorb, 139 ± 153 µm for Mirage; p = 0.035), whereas difference remained after adjusting the protrusion distances according to the luminal areas. Strut protrusion of Absorb is inversely correlated with ESS (r = -0.369, p < 0.0001), whereas in Mirage protrusion was positively correlated with EES (r = 0.192, p < 0.0001). Protrusion distance was higher in Absorb than in Mirage. The protrusion of the thick quadratic struts of Absorb has a tendency to lower shear stress in the close vicinity of struts. However, circular shape of the less thick struts of Mirage didn't show this trend in creating zone of recirculation around the struts. Strut geometry has different effect on the relationship between protrusion and shear stress in Absorb and Mirage scaffolds.
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Project description:Evaluation of recurrent angina after percutaneous coronary interventions is challenging. Since bioresorbable vascular scaffolds (BVS) cause no artefacts in magnetic resonance imaging (MRI) due to their polylactate-based backbone, evaluation of vascular patency by MRI might allow for non-invasive assessment and triage of patients with suspected BVS failure.Patients with polylactate-based ABSORB-BVS in proximal coronary segments were examined with 3 Tesla MRI directly (baseline) and one year after implantation. For assessment of coronary patency, a high-resolution 3D spoiled gradient echo pulse sequence with fat-saturation, T2-preparation (TE: 40 ms), respiratory and end-diastolic cardiac gating, and a spatial resolution of (1.08 mm)3 was positioned parallel to the course of the vessel for bright blood imaging. In addition, a 3D navigator-gated T2-weighted variable flip angle turbo spin echo (TSE) sequence with dual-inversion recovery black-blood preparation and elliptical k-space coverage was applied with a voxel size of (1.14 mm)3. For quantitative evaluation lumen diameters of the scaffolded areas were measured in reformatted bright and black blood MR angiography data.11 patients with implantation of 16 BVS in the proximal coronary segments were included, of which none suffered from major adverse cardiac events during the one year follow up. Vascular patency in all segments implanted with BVS could be reliably assessed by MRI at baseline and after one year, whereas segments with metal stents could not be evaluated due to artefacts. Luminal diameter within the BVS remained constant during the one year period. One patient with atypical angina after BVS implantation was noninvasively evaluated showing a patent vessel, also confirmed by coronary angiography.Coronary MRI allows contrast-agent free and non-invasive assessment of vascular patency after ABSORB-BVS implantation. This approach might be supportive in the triage and improvement of diagnostic workflows in patients with postinterventional angina and scaffold implantation.German Register of Clinical Studies DRKS00007456.
| S-EPMC5784929 | biostudies-literature
Project description:BackgroundBiomarkers of myocardial injury increase frequently during transcatheter aortic valve implantation (TAVI). The impact of postprocedural cardiac troponin (cTn) elevation on short-term outcomes remains controversial, and the association with long-term prognosis is unknown.Methods and resultsWe evaluated 577 consecutive patients with severe aortic stenosis treated with TAVI between 2007 and 2012. Myocardial injury, defined according to the Valve Academic Research Consortium (VARC)-2 as post-TAVI cardiac troponin T (cTnT) >15× the upper limit of normal, occurred in 338 patients (58.1%). In multivariate analyses, myocardial injury was associated with higher risk of all-cause mortality at 30 days (adjusted hazard ratio [HR], 8.77; 95% CI, 2.07-37.12; P=0.003) and remained a significant predictor at 2 years (adjusted HR, 1.98; 95% CI, 1.36-2.88; P<0.001). Higher cTnT cutoffs did not add incremental predictive value compared with the VARC-2-defined cutoff. Whereas myocardial injury occurred more frequently in patients with versus without coronary artery disease (CAD), the relative impact of cTnT elevation on 2-year mortality did not differ between patients without CAD (adjusted HR, 2.59; 95% CI, 1.27-5.26; P=0.009) and those with CAD (adjusted HR, 1.71; 95% CI, 1.10-2.65; P=0.018; P for interaction=0.24). Mortality rates at 2 years were lowest in patients without CAD and no myocardial injury (11.6%) and highest in patients with complex CAD (SYNTAX score >22) and myocardial injury (41.1%).ConclusionsVARC-2-defined cTnT elevation emerged as a strong, independent predictor of 30-day mortality and remained a modest, but significant, predictor throughout 2 years post-TAVI. The prognostic value of cTnT elevation was modified by the presence and complexity of underlying CAD with highest mortality risk observed in patients combining SYNTAX score >22 and evidence of myocardial injury.
| S-EPMC4802442 | biostudies-literature
Project description:Percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) is routine treatment for patients with acute coronary syndromes (ACS). However, permanent metallic caging of the vessel has several shortcomings, such as side branch jailing and impossibility of late lumen enlargement. Moreover, DES PCI is affected by vasomotion impairment. In ACS a high thrombus burden and vasospasm lead to a higher risk of acute and late acquired stent malapposition than in stable patients. This increases the risk of acute, late and very late stent thrombosis. In this challenging clinical setting, the implantation of bioresorbable vascular scaffolds (BVS) could represent an appealing therapeutic option. Temporary vessel scaffolding has proved to have several advantages over metallic stent delivery, such as framework reabsorption, late lumen enlargement, side branch patency, and recovery of physiological reactivity to vasoactive stimuli. In the thrombotic environment of ACS, BVS implantation has the benefit of capping the thrombus and the vulnerable plaque. Bioresorbable vascular scaffolds also seems to reduce the incidence of angina during follow-up. Acute coronary syndromes patients may therefore benefit more from temporary polymeric caging than from permanent stent platform implantation. The aim of this review is to update the available knowledge concerning the use of BVS in ACS patients, by analyzing the potential pitfalls in this challenging clinical setting and presenting tricks to overcome these limitations.
| S-EPMC4631727 | biostudies-literature