Acute Mechanical Performance Research Articles

Acute Mechanical Performance of Magmaris vs. DESolve Bioresorbable Scaffolds in a Real-World Scenario.

Background: After the bioresorbable PLLA-based vascular scaffold (Absorb BVS) was taken from the market due to its high adverse event rates, a magnesium-based scaffold (Magmaris) was introduced.Objective: To compare the acute performance of the sirolimus-eluting magnesium alloy Magmaris scaffold with that of the novolimus-eluting PLLA-based DESolve scaffold in terms of appropriate scaffold deployment using optical coherence tomography (OCT).Methods and Results: Data from the final OCT pullback of 98 patients were included (19 Magmaris, 79 DESolve) and analyzed at 1-mm intervals. The following indices were calculated: mean and minimal area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection. OCT showed a minimum lumen area for Magmaris vs. DESolve of 6.6 ± 1.6 vs. 6.0 ± 1.9 (p = 0.06). Scaffolds with residual area stenosis >20% were predominantly seen in the DESolve group (15.8 vs. 46.8%; p = 0.01). The mean eccentricity index did differ significantly (0.74 ± 0.06 vs. 0.63 ± 0.09; p < 0.001). No fractures were observed for Magmaris scaffolds, but 15.2% were documented for DESolve BRS (p < 0.001). Incomplete scaffold apposition area was significantly higher in the DESolve group (0.01 ± 0.02 vs. 1.05 ± 2.32 mm2; p < 0.001).Conclusion: This is the first study to compare the acute mechanical performance between Magmaris and DESolve in a real-world setting. The acute mechanical performance of Magmaris BRS seems to be superior to that of DESolve BRS, whereas OCT showed a good acute mechanical performance for both BRS in terms of generally accepted imaging criteria.

Magnesium versus poly-L-lactic acid bioresorbable scaffolds: in vivo optical coherence tomography comparison of mechanical performance

Background Different mechanical properties have been suggested for metallic bioresorbable vascular scaffolds (BVS) in comparison to polymeric BVS. We aim to evaluate the acute mechanical performance of Magmaris® scaffold in comparison to Absorb®. Materials and Methods Two groups of 10 coronary lesions treated with Magmaris® and Absorb® 1.1 (20584 vs. 21016 struts) were compared. In all cases, optical coherence tomographic (OCT) images were acquired after scaffold deployment. Baseline clinical, angiographic, and procedural characteristics were compared, including OCT evaluations. Results No baseline clinical or angiographic significant differences were found between groups. The most common indication for revascularization was effort angina (60% vs. 70% p = 0.45) with no ST-elevation myocardial infarction (MI) cases. Main target artery was left anterior descending, with a mean vessel diameter of 3.46 ± 0.23 in Absorb® and 3.52 ± 0.19mm in Magmaris® groups (p = 0.56). All cases underwent pre- and post-dilatation with a procedural success rate of 100%. OCT analyses showed larger scaffold and vessel diameters in Magmaris® group: 3.11 ± 0.38 mm versus 3.07 ± 0.36 mm, p = 0.03 and 4.12 ± 0.51 mm versus 4.04 ± 0.46 mm, p = 0.04. Despite the application of slightly higher postdilatation pressures to Magmaris® devices (18.01 ± 2.15 vs. 17.20 ± 3.80 atm, p = 0.05), significantly lower percentages of disrupted and malapposed struts were identified within Magmaris® scaffolds (0.15% vs. 0.27%, p = 0.03 and 1.06% vs. 1.46% p = 0.01). No cardiac death, target vessel-related MI, or clinically driven target lesion revascularization was reported in a 30-day follow-up. Conclusion Mechanical properties of Magmaris® scaffold allow achieving larger vessel and scaffold diameters in a safe manner, with lower rates of malapposition and scaffold disruption.

Acute mechanical performance of bioresorbable scaffolds compared with everolimus-eluting stents under optical coherence tomography guidance

Objective The aim was to compare the acute mechanical performance of the ABSORB bioresorbable scaffold (BRS) with the everolimus-eluted stents (EES) after optical coherence tomography (OCT)-guided deployment. Background The intrinsic differences in biomechanical properties between BRS and EES and the thicker BRS struts can affect the BRS acute mechanical performance in terms of scaffold expansion and struts apposition. Materials and methods The authors compared the acute mechanical performance of 245 scaffolds with that of 82 everolimus-eluted EES. All scaffolds/stents were deployed under OCT guidance. OCT was used to assess the following acute mechanical performance indices: residual area stenosis, device underexpansion, struts malapposition, edge dissection whether covered or uncovered, and strut fracture. Results Two hundred forty-five scaffolds implanted in 162 patients in the BRS arm were compared with 82 stents implanted in 61 patients in the EES arm. Final OCT acquisitions showed no statistically significant difference in the acute mechanical performance indices between both arms, in terms of residual area stenosis, device underexpansion, struts malapposition, and struts fracture. The only significant difference was noted in the higher rates of both covered and uncovered edge dissections in the BRS arm. Conclusion Under OCT guidance, there was no significant difference in the acute mechanical performance of BRS vs EES, apart from higher rates of both covered and uncovered edge dissections in the BRS arm.

Clinical presentation does not affect acute mechanical performance of the Novolimus-eluting bioresorbable vascular scaffold as assessed by optical coherence tomography.

IntroductionInitial trials of bioresorbable vascular scaffolds (BVS) have mostly excluded patients presenting with acute coronary syndrome (ACS). However, these patients might benefit from a BVS platform, in particular as they are often younger and have been less frequently treated than patients with chronic disease.AimTo compare the acute performance of a Novolimus eluting BVS in ACS and non-ACS patients using optical coherence tomography (OCT) in patients presenting with acute or chronic coronary syndrome.Material and methodsThe final OCT pullback of 79 patients (34 with ACS, 45 non-ACS) was analysed at 1-mm intervals. The following indices were calculated: mean and minimal area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection.ResultsOCT showed a minimum lumen area (non-ACS vs. ACS) of 6.2 ±2.1 vs. 5.6 ±1.5 mm2 (p = 0.21). Mean residual area stenosis was 14.5% vs. 19.5% (p = 0.39). The mean eccentricity index did not differ significantly (0.78 ±0.13 vs. 0.78 ±0.06; p = 0.42). There was a non-significant tendency for more fractures in the non-ACS group (22.2% vs. 5.9%; p = 0.07). Prolapse area was comparable (4.4 ±7.4 mm2 vs. 5.2 ±10.9 mm2; p = 0.62).ConclusionsThis is the first study to investigate the acute mechanical performance of a Novolimus-eluting BVS in patients with different clinical presentations using OCT. We found that clinical presentation did not determine acute mechanical performance as assessed by the final OCT pullback. There was evidence of more mechanical complications in terms of fractures and a higher percentage of incomplete strut apposition in the group of patients with chronic coronary syndrome.

Effect of Plaque Composition, Morphology, and Burden on DESolve Novolimus-Eluting Bioresorbable Vascular Scaffold Expansion and Eccentricity - An Optical Coherence Tomography Analysis.

This study of patients treated with novolimus-eluting bioresorbable scaffold (BRS) investigated the impact of plaque burden on the acute mechanical performance of the BRS and the short-term outcome. A total of 15 patients were enrolled. The following parameters were derived from optical coherence tomography (OCT) during the final pullback: mean and minimum area, residual area stenosis, incomplete strut apposition, tissue prolapse, scaffold expansion index (SEI), scaffold eccentricity index (SEC), symmetry index, strut fracture, and edge dissection. Fibrous plaque (FP) and calcific plaque (CP) characteristics were measured at each 200 μm longitudinal cross-section. The patients were divided into two groups based on their medians of the respective plaque characteristics. OCT analysis showed a lumen area of 11.4 ± 1.9 mm2 and a scaffold area of 11.5 ± 2.1 mm2. The mean eccentricity index overall was 0.65 ± 0.16 and mean symmetry index 0.39 ± 0.25. Statistically, scaffold expansion was not significantly influenced by a greater plaque burden as represented by greater CP area (SEI in group with CP area <0.52 mm2 84.1% vs. SEI of 86.6% in group with CP area ≥0.52 mm2, p = 0.06), thicker CP (85.7% vs. 85.1%, p = 0.06), greater CP arc angle (88.0% vs. 81.7%, p = 0.08), and CP being closer to the lumen (84.2% vs. 86.5%, p = 0.08). Scaffold expansion was also not significantly influenced by FP burden. The eccentricity of the implanted scaffolds was not dependent on the CP burden. On the other hand, a greater FP burden favoured a lower eccentricity index, indicating less circular expansion. Thus, greater FP area, FP thickness, and FP arc angle resulted in a more eccentric scaffold expansion. In contrast to previously studied BRS, the expansion and eccentricity characteristics of the novolimus-eluting scaffold did not show the strong dependency of plaque composition, morphology, and burden. As assessed by OCT, only eccentricity was significantly affected by the FP burden. A greater FP plaque arc in our cohort and device-specific properties, e.g. self-correction, may explain the lack of a relationship between plaque, expansion, and eccentricity.

P575Magmaris vs. DESolve: a comparison study of acute mechanical performance using optical coherence tomography

P575Magmaris vs. DESolve: a comparison study of acute mechanical performance using optical coherence tomography

P5515Novolimus-eluting bioresorbable scaffold in acute coronary syndrome: an optical coherence tomography study of acute mechanical performance

P5515Novolimus-eluting bioresorbable scaffold in acute coronary syndrome: an optical coherence tomography study of acute mechanical performance

Impact of strut thickness on acute mechanical performance: A comparison study using optical coherence tomography between DESolve 150 and DESolve 100

ObjectiveTo evaluate the acute performance of a novolimus-eluting bioresorbable scaffold (BRS) with different strut thickness (DESolve system 150 and 100) using optical coherence tomography (OCT) in terms of appropriate scaffold deployment. BackgroundOutcome after BRS implantation seen in registries and meta-analyses continue to show a higher rate of scaffold thrombosis than those reported with DES. Thus, second scaffold generations with lower strut thickness might have potential advantages in terms of flow disturbance. However, whether mechanical properties are comparable has to be evaluated. Methods and resultsFifty-seven patients undergoing OCT-guided scaffold implantation were enrolled consecutively in this retrospective study. The final pullback after DESolve 150 (n=42) and DESolve 100 (n=15) were compared. The following indices were calculated: mean and minimum area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity and symmetry indexes, strut fracture, and edge dissection. Most patients suffered a multi vessel disease. Maximum pre-dilatation balloon inflation pressure was 13.5±3.2 vs 14.5±2.5atm. OCT analysis showed a minimal lumen area of 6.1±1.9 vs 5.2±1.6mm2, p=0.06. Mean residual area stenosis was 15.3% vs 21.3, p=0.22. Mean eccentricity index did not differ significantly (0.8±0.1 vs 0.6±0.1, p=0.61). Prolapse area was 4.5±8.8 vs 5.6±9.8mm2. ConclusionOCT showed similar post-procedural scaffold geometry and outcome indicating that both BRS may be implanted with good acute performance. However, the trend towards a smaller MLA and a higher percentage of RAS suggest a decreased radial strength for the 100μm BRS. The attempt to reduce strut thickness should not result in loss of radial strength. Condensed abstractRates of scaffold thrombosis after bioresorbable scaffold (BRS) implantation are reported to be higher than after metallic stent (DES) implantation. Thus, second scaffold generations with lower strut thickness might have potential advantages in terms of flow disturbance. We aimed to evaluate the acute performance of a novolimus-eluting BRS with different strut thickness (DESolve system 150 and 100) using optical coherence tomography (OCT) in terms of appropriate scaffold deployment. OCT showed similar post-procedural scaffold geometry and outcome indicating that both BRS may be implanted with good acute performance. However, the data suggest a decreased radial strength for the 100μm BRS.

Overlapping implantation of bioresorbable novolimus-eluting scaffolds: an observational optical coherence tomography study.

Overlapping implantation of bioresorbable vascular scaffolds is frequently necessary, but its influence on vessel and scaffold structure has not been thoroughly analyzed previously. The aim of this study was to analyze the acute effects of overlapping implantation on BRS as determined by optical coherence tomography (OCT). A total of 38 patients with de novo coronary artery stenoses who underwent OCT in the context of implantation of novolimus-eluting BRS (DESolve, Elixir Medical Corporation, Sunnyvale, California, USA) were investigated. In 15 patients, overlapping implantation of two BRS was performed, while 23 patients with implantation of one single BRS served as the control group. OCT data were retrospectively analyzed regarding acute scaffold implantation results. There were no significant differences between the overlap and control group in terms of residual in-scaffold area stenosis, scaffold area, mean or minimal lumen area, eccentricity index, incomplete scaffold apposition area or malapposition. While strut fracture was slightly more frequent in BRS with overlap its incidence was low overall. In patients with overlapping BRS, overlap segments did not display smaller lumen areas than segments without overlap (mean lumen area overlap: 8.16±2.97mm2 vs. no overlap: 7.70±2.55mm2; p=0.71; minimal lumen area overlap: 6.83±2.71mm2 vs. no overlap: 6.17±2.58mm2; p=0.37). Acute mechanical performance of novolimus-eluting BRS is not impaired by overlapping implantation. It can be assumed that vessel expansion compensates for the double scaffold layer in the overlap area resulting in a similar lumen area in overlap areas and in those with a single strut layer.

A new novolimus-eluting bioresorbable scaffold for large coronary arteries: an OCT study of acute mechanical performance

AimsTo evaluate the acute performance of a novolimus-eluting bioresorbable scaffold (BRS) with a nominal diameter of 4.0mm (DESolve® XL) using optical coherence tomography (OCT) in terms of appropriate scaffold deployment. Methods and resultsTen patients (55.6% male, mean age 60.0 y) undergoing OCT-guided scaffold implantation were enrolled consecutively in this retrospective study. Using data from the final pullback, the following indexes were calculated: mean and minimum area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity and symmetry indexes, strut fracture, and edge dissection. The clinical indication for the procedure was acute coronary syndrome in roughly half (55.5%) of the cases. All three main vessels were affected equally. The maximum post-dilatation balloon inflation pressure was 14.7±4.2atm. OCT analysis showed a lumen area of 11.4±1.9mm2 and a scaffold area of 11.5±2.1mm2. Mean residual area stenosis was 28.6%. No strut fractures or edge dissections were apparent. The mean eccentricity index was 0.65±0.16 and the mean symmetry index 0.39±0.25. ConclusionThe size of large vessels does not adversely influence acute mechanical performance as assessed by the eccentricity and symmetry indexes. No adverse cardiac event occurred during the hospital stay or the 30-day follow-up. It is feasible to treat large vessels with the DESolve® XL BRS.

The need to emphasize preventive medicine in future U.S. health care programs

To evaluate the acute performance of a novolimus-eluting bioresorbable scaffold (BRS) with a nominal diameter of 4.0 mm (DESolve® XL) using optical coherence tomography (OCT) in terms of appropriate scaffold deployment.Ten patients (55.6% male, mean age 60.0 y) undergoing OCT-guided scaffold implantation were enrolled consecutively in this retrospective study. Using data from the final pullback, the following indexes were calculated: mean and minimum area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity and symmetry indexes, strut fracture, and edge dissection. The clinical indication for the procedure was acute coronary syndrome in roughly half (55.5%) of the cases. All three main vessels were affected equally. The maximum post-dilatation balloon inflation pressure was 14.7 ± 4.2 atm. OCT analysis showed a lumen area of 11.4 ± 1.9 mm2 and a scaffold area of 11.5 ± 2.1 mm2. Mean residual area stenosis was 28.6%. No strut fractures or edge dissections were apparent. The mean eccentricity index was 0.65 ± 0.16 and the mean symmetry index 0.39 ± 0.25.The size of large vessels does not adversely influence acute mechanical performance as assessed by the eccentricity and symmetry indexes. No adverse cardiac event occurred during the hospital stay or the 30-day follow-up. It is feasible to treat large vessels with the DESolve® XL BRS.