Five-year follow-up of patients who underwent everolimus-eluting bioresorbable scaffold implantation.

OBJECTIVES: The aim of this study was to evaluate very long-term results after unrestricted everolimus-eluting bioresorbable scaffolds (BRS) implantation. BACKGROUND: Previous randomized studies mainly included selected patients differing from those seen during daily routine and long-term data from all-comers registries are sparse. METHODS: Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 5 years. Endpoint of interest was the composite of target lesion failure (TLF), including target-vessel myocardial infarction and target lesion revascularization and cardiac death. Furthermore, ARC-defined scaffold thrombosis (ScT) were assessed. RESULTS: A total of 176 patients with a median age of 64 (55 - 72) years were analyzed, of which 59.6% presented an acute coronary syndrome. A total of 183 mainly complex lesions (55.8%) were treated. At 5 years, the rate for TLF was 21.6%. Definite or probable ScT rate was 4.1%. The rate of ScT within the first year was 2.8% and afterwards 1.2%. Notably, no ScT was seen later than 2 years. CONCLUSIONS: Although this real-world registry displays high rates of clinical events during long-term follow-up, no ScT was seen after 2 years.

Latest Developments in Robotic Percutaneous Coronary Intervention.

Interventional cardiovascular medicine has seen constant progress over the last few decades. Since the first angiograms and percutaneous transluminal coronary angioplasty were carried out, this progress has been tremendous and has led to a substantial decline in cardiovascular morbidity and mortality. The purpose of this article is to report and review the latest developments and evidence in robotics-assisted percutaneous coronary intervention (rPCI) and its potential future applications, opportunities, and limitations. Contemporary evidence shows that rPCI can lead to a significant reduction in radiation exposure as well as medical hazards for cardiologists. Rates of device and procedural success remain high and there is no evidence of a disadvantage for the patient. The accuracy of implantation with a reduced geographic mismatch is a further advantage that can result in a higher quality of treatment. Even in complex coronary lesions and procedures, rPCI seems to be safe and efficient. The latest developments include telestenting over hundreds of kilometers from a remote platform. Currently, the main limitations are the absence of large-scale randomized trials for the valid assessment of the benefits and disadvantages of rPCI as well as the technical limitations of the currently available rPCI systems. rPCI is a forward-looking innovation in cardiology that is applicable to a wide range of coronary interventions. Despite the present lack of knowledge and the limited data concerning the outcome for the patient, the available literature reveals promising results that should lead to improvements for physicians and patients.

Fractional flow reserve and frequency of PCI in patients with coronary artery disease.

BACKGROUND: Fractional flow reserve (FFR) guided percutaneous coronary intervention (PCI) has been validated in patients with stable coronary artery disease (CAD) but has not yet been verified under specific conditions such as heart failure or microvascular dysfunction. The aim of the present study was to examine the influence of specific patient comorbidities on FFR values and thus the frequency of PCI in patients with intermediate coronary stenosis. METHODS: A total of 652 patients with CAD and intermediate coronary stenosis who were assessed for FFR were included in this retrospective study. In a subgroup analysis, specific comorbidities such as heart failure with non-ST-segment-elevated acute coronary syndrome (NSTE-ACS), heart failure, diabetes mellitus, atrial fibrillation (AF), and left ventricular hypertrophy (LVH) were considered. RESULTS: In all lesions with an FFR ≤ 0.80 (n = 227/808, 28.1%), PCI was performed using drug-eluting stents. Pathological FFR values (FFR ≤ 0.80) before PCI were most frequently observed in the left anterior descending artery (LAD; n = 168/418, 39.9%) followed by the right coronary artery (RCA; n = 37/178, 20.7%) and the left circumflex artery (LCX; 22/223, 9.8%). The comorbidities NSTE-ACS (p = 0.28), heart failure with reduced ejection fraction (HFrEF; p = 0.63), heart failure with preserved ejection fraction (HFpEF; p = 0.3719), diabetes mellitus (p = 0.177), or LVH (p = 0.407) had no major impact on the occurrence of pathological FFR values; there was also no association between FFR and the occurrence of lesions in the different target vessels. CONCLUSION: The occurrence of pathological FFR values, most frequently documented in the LAD, was the same in patients with or without HFrEF, HFpEF, diabetes mellitus, AF, and LVH, demonstrating that these comorbidities did not influence FFR values and, thus, the indication for PCI.

Effect of non-compliant balloon postdilatation on magnesium-based bioresorbable vascular scaffolds.

BACKGROUND: Optimal implantation results of bioresorbable scaffolds (BRS) are typically assumed to require postdilatation with non-compliant (NC) balloons to achieve full scaffold apposition and minimize event rates. We systematically evaluated the mechanical effect of NC balloon postdilatation on magnesium-based BRS (Magmaris®, Biotronik AG, Bülach, Switzerland) in vivo. METHODS: In 35 patients, 40 Magmaris® BRS were implanted to treat 37 de novo coronary artery stenoses. A systematic implantation protocol was followed. After appropriately sized NC balloon predilatation (1:1:1 vessel:balloon:scaffold ratio), Magmaris® BRS were implanted with a pressure of 10 atm, followed by NC balloon postdilatation at nominal BRS size (standardized at 16 atm). OCT was performed before and after postdilatation and OCT images were analyzed at a spacing of 0.2 mm to measure BRS dimensions and determine apposition as well as to detect strut fractures. RESULTS: PCI with Magmaris® BRS (mean diameter: 3.21 ± 0.32 mm; mean length: 20 ± 4 mm) was successful in all cases, in one case a non-flow-limiting distal edge dissection occurred after implantation and before postdilatation. NC balloon postdilatation led to significantly larger mean scaffold diameter (3.21 ± 0.32 mm vs. 2.80 ± 0.39 mm, P < 0.001), abluminal scaffold area (7.92 ± 1.43 mm2 vs. 6.72 ± 1.28 mm2 , P < 0.001) and lumen area (7.58 ± 1.1 mm2 vs. 6.83 ± 1.12 mm2 , P < 0.001). Incomplete scaffold apposition area was significantly lower if postdilatation was performed (0.01 ± 0.04 mm2 vs. 0.17 ± 0.11 mm2 , P < 0.001). Strut fractures could neither be observed before nor after postdilatation. CONCLUSION: NC balloon postdilatation of Magmaris® BRS is required to achieve optimal expansion. It significantly reduces malapposition and can safely be performed without relevant rates of strut fracture.

OCT-assessment of scaffold resorption: Analysis of strut intensity by a new resorption index for poly-l-lactic acid bioresorbable vascular scaffolds.

BACKGROUND: The aim of this study was to analyze individual differences in resorption of bioresorbable vascular scaffolds (BRS) through optical coherence tomography (OCT) analysis and to identify factors potentially influencing the resorption process. METHODS: Between April 2016 and July 2017 clinically driven invasive coronary angiography and OCT examinations were performed in 36 patients who had previously been treated with a total of 48 BRS (ABSORB BVS, Abbott Vascular, Santa Clara, CA). For each scaffold, a new BRS-RESORB-INDEX (BRI) was calculated. RESULTS: The mean time interval since implantation was 789 ± 321 days. In OCT, BRS struts remained detectable in all 48 BRS. Normalized light intensity as a marker for the resorption of BRS struts increased with time in a linear fashion (Spearman Rho: p < .001, correlation coefficient = .90; R2 [linear] = .91). Multivariable analysis identified diabetes (BRI of patients with diabetes vs. patients without diabetes: 0.34 ± 0.13 vs. 0.58 ± 0.22; p = .002) and presence of Peri-strut low intensity areas (PSLIA, BRI of 10 patients with PSLIA vs. 26 patients without PSLIA: 0.44 ± 0.21 vs. 0.61 ± 18; p = .027) as independent predictors for a prolonged BRS resorption, whereas the resorption rate in ACS patients (STEMI, NSTEMI, and unstable angina; n = 13) was significantly higher as compared to patients without ACS (0.62 ± 0.17 vs. 0.43 ± 0.24; p = .012). CONCLUSION: In humans, BRS resorption rate is significantly influenced by numerous factors. Our data suggest that diabetes and PSLIA are associated with a prolonged resorption process, whereas in ACS patients, BRS resorption appears to be significantly faster.

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 ± 2.97 mm2 vs. no overlap: 7.70 ± 2.55 mm2; p = 0.71; minimal lumen area overlap: 6.83 ± 2.71 mm2 vs. no overlap: 6.17 ± 2.58 mm2; 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.

Optical coherence tomography: influence of contrast concentration on image quality and diagnostic confidence.

OCT requires intracoronary injection of contrast agent to remove blood from the coronary lumen during data acquisition, which is a possible limitation of this method. Aim of this study was to analyze the influence of iodine concentration on image quality and diagnostic certainty of optical coherence tomography (OCT). OCT sequences acquired using contrast agent with a reduced concentration of 150 mg iodine/ml and a standard concentration of 350 mg iodine/ml were analyzed. Cross-sectional images with a spacing of 10 mm were evaluated regarding image quality and diagnostic confidence. A total of 67 OCT sequences acquired in 24 patients were analyzed. 31 sequences were acquired using contrast agent with a concentration of 150 mg iodine/ml and 36 sequences with a concentration of 350 mg iodine/ml. The percentage of remaining blood streaks in the cross sections was significantly lower for 350 mg iodine/ml compared to 150 mg iodine/ml (19 ± 21 vs. 34 ± 26%, p = 0.013). Contrast with 350 mg iodine/ml showed a significantly higher percentage of completely flushed pullback length as compared to 150 mg iodine/ml (78 ± 24 vs. 58 ± 27%, p = 0.004). Diagnostic certainty was significantly higher for 350 mg iodine/ml than for 150 mg iodine/ml (Likert scale average 1.4 ± 0.7 vs. 2.1 ± 1.2, p < 0.001; Likert scale: 1 = absolutely confident, 2 = confident with slight doubts, 3 = doubtful/not confident, 4 = non-diagnostic). Regarding image quality and diagnostic certainty, contrast agent with a concentration of 350 mg iodine/ml is superior to 150 mg iodine/ml.

Comparison of interventional treatment options for coronary calcified nodules: A sub-analysis of the ROTA.shock trial.

BACKGROUND: The optimal treatment for coronary calcified nodules (CNs) is still unclear. The aim of this study was to compare the modification of these lesions by coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA) using optical coherence tomography (OCT). METHODS: ROTA.shock was a 1:1 randomized, prospective, double-arm multi-center non-inferiority trial that compared the use of IVL and RA with percutaneous coronary intervention (PCI) in severely calcified lesions. In 19 of the patients out of this study CNs were detected by OCT in the target lesion and were treated by either IVL or RA. RESULTS: The mean angle of CNs was significantly larger in final OCT scans than before RA (92 ± 17° vs. 68 ± 7°; p = 0.01) and IVL (89 ± 18° vs. 60 ± 10°; p = 0.03). The CNs were thinner upon final scans than in initial native scans (RA: 17.8 ± 7.8 mm vs. 38.6 ± 13.1 mm; p = 0.02; IVL: 16.5 ± 9.0 mm vs. 37.2 ± 14.3 mm; p = 0.02). Nodule volume did not differ significantly between native and final OCT scans (RA: 0.66 ± 0.12 mm3 vs. 0.61 ± 0.33 mm3; p = 0.68; IVL: 0.64 ± 0.19 mm3 vs. 0.68 ± 0.22 mm3; p = 0.74). Final stent eccentricity was high with 0.62 ± 0.10 after RA and 0.61 ± 0.09 after IVL. CONCLUSION: RA or IVL are unable to reduce the volume of the calcified plaque. CN modulation seems to be mainly induced by the stent implantation and not by RA or IVL.

First case report of fully robotically assisted lithotripsy in heavily calcified left main stenosis.

Background: Percutaneous coronary intervention (PCI) is the standard-of-care treatment for left main stenosis as an alternative to bypass surgery. In addition, severe coronary lesion calcification can be modified by intravascular lithotripsy (IVL). However, with PCI and debulking treatment options, there are inherent limitations. PCI poses an increased health burden for the treating physician that is associated with wearing a heavy, lead-lined apron and being exposed to radiation. To overcome these issues, a robotically assisted angioplasty system (rPCI) was established that enables the operator to perform PCI remotely in routine clinical procedures. Furthermore, IVL have not been used remotely. Case summary: Here, we report the use of this technique for treating a heavily calcified left main stenosis in an 82-year-old male with previously diagnosed two-vessel coronary artery disease, progressive symptoms of dyspnoea at high cardio-vascular risk profile. The decision of the local heart team declined surgery. To the best of our knowledge, this is the first report of successful rPCI combined with IVL. Discussion: In the case presented, rPCI was feasible and safe even in a complex lesion of the left main coronary artery requiring IVL. rPCI is a revolutionary new technique that may be applied to various types of coronary artery lesions.

Second-generation robotic angioplasty system use for the treatment of ST-elevation myocardial infarction: a first-in-man proof of concept case report.

Background: Robotically assisted remote-controlled PCI (rPCI) was introduced in the past decade as one of the latest enhancements in this rapidly evolving field. The use of a second-generation rPCI system in ST-elevation myocardial infarction (STEMI) is an effort to couple immediate revascularization with the accuracy of newer robotic assistance and software support. Case summary: Here we report on the safety and efficacy of rPCI applied to a 74-year-old female STEMI patient with persistent acute chest pain as well as regional wall motion abnormalities in the echocardiogram. The first medical contact-to-device time was 76 min, and door-to-balloon time was 33 min. The impatient course was uneventful, so the patient was discharged from hospital after 5 days. To the best of our knowledge, this is the first report of the successful application of second-generation rPCI in STEMI. Discussion: In the case presented, rPCI was feasible and safe even in acute coronary syndrome based on a single-centre experience. rPCI is a revolutionary new technique that may be applied to various types of clinical presentations.

Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses.

Debulking techniques are often necessary for successful lesion preparation in percutaneous coronary intervention. The aim of this study was to compare plaque modification of severely calcified lesions by coronary intravascular lithotripsy (IVL) with that of rotational atherectomy (RA) using optical coherence tomography (OCT). ROTA.shock was a 1:1 randomized, prospective, double-arm, multicenter noninferiority trial designed to compare final minimal stent area after IVL with RA for lesion preparation in percutaneous coronary interventional treatment of severely calcified lesions. On the basis of OCT acquired before and immediately after IVL or RA in 21 of the 70 patients included, we performed a detailed analysis of the modification of the calcified plaque. After RA and IVL, calcified plaque fractures were present in 14 of the patients (67%), with a significantly greater number of fractures after IVL (3.23 ± 0.49) than after RA (1.67 ± 0.52; p < 0.001). Plaque fractures after IVL were longer than after RA (IVL: 1.67 ± 0.43 mm vs RA: 0.57 ± 0.55 mm; p = 0.01), resulting in a greater total volume of the fractures (IVL: 1.47 ± 0.40 mm3 vs RA: 0.48 ± 0.27 mm3; p = 0.003). Use of RA was associated with a greater acute lumen gain than was use of IVL (RA: 0.46 ± 0.16 mm2 vs IVL: 0.17 ± 0.14 mm2; p = 0.03). In conclusion, we were able to show differences in plaque modification of calcified coronary lesions by OCT: although RA leads to a greater acute lumen gain, IVL induces more and longer fractures of the calcified plaque.

Stent Optimization Using Optical Coherence Tomography and Its Prognostic Implications After Percutaneous Coronary Intervention.

Background Stent underexpansion has been known to be associated with worse outcomes. We sought to define optical coherence tomography assessed optimal stent expansion index (SEI), which associates with lower incidence of follow-up major adverse cardiac events (MACEs). Methods and Results A total of 315 patients (involving 370 lesions) who underwent optical coherence tomography-aided coronary stenting were retrospectively included. SEI was calculated separately for equal halves of each stented segment using minimum stent area/mean reference lumen area ([proximal reference area+distal reference area]/2). The smaller of the 2 was considered to be the SEI of that case. Follow-up MACE was defined as a composite of all-cause death, myocardial infarction, stent thrombosis, and target lesion revascularization. Average minimum stent area was 6.02 (interquartile range, 4.65-7.92) mm2, while SEI was 0.79 (interquartile range, 0.71-0.86). Forty-seven (12.7%) incidences of MACE were recorded for 370 included lesions during a median follow-up duration of 557 (interquartile range, 323-1103) days. Receiver operating characteristic curve analysis identified 0.85 as the best SEI cutoff (<0.85) to predict follow-up MACE (area under the curve, 0.60; sensitivity, 0.85; specificity, 0.34). MACE was observed in 40 of 260 (15.4%) lesions with SEI <0.85 and in 7 of 110 (6.4%) lesions with SEI ≥0.85 (P=0.02). Least absolute shrinkage and selection operator regression identified SEI <0.85 (odds ratio, 3.55; 95% CI, 1.40-9.05; P<0.01) and coronary calcification (odds ratio, 2.47; 95% CI, 1.00-6.10; P=0.05) as independent predictors of follow-up MACE. Conclusions The present study identified SEI <0.85, associated with increased incidence of MACE, as the optimal cutoff in daily practice. Along with suboptimal SEI (<0.85), coronary calcification was also found to be a significant predictor of follow-up MACE.

Dual-axis rotational coronary angiography versus conventional coronary angiography: a randomized comparison.

BACKGROUND: Dual-axis of rotational coronary angiography (RA), with one single cine acquisition during continuous C-arm motion along a pre-described path, is an alternative to conventional coronary angiography (CA). We assessed the performance of RA versus CA in a modern, experienced cath lab setting. METHODS: Sixty-seven patients with suspected coronary artery disease undergoing invasive coronary angiography were randomized to CA (n = 35) or dual-axis RA (n = 32). CA was performed with four left and two right coronary artery acquisitions with manual contrast medium injection. In RA, one cine acquisition each was performed for the left (5 projections) and right coronary artery (3 projections) with a fixed amount of contrast medium applied by a power injector. In both groups, single cine acquisitions in additional angulations were performed to fully interpret the coronary system, if necessary. Procedural parameters and outcome were compared. RESULTS: Mean age was 63 ± 12 years (64% males). Six additional projections were required in the RA group compared to 13 in the CA group (p = 0.173). Fluoroscopy duration (CA: 3 ± 3 min, RA: 3 ± 2 min, p = 0.748) and dose area product (CA: 1291 ± 761 µGym2, RA: 1476 ± 679 µGym2, p = 0.235) did not differ significantly between both groups. For CA, the amount of contrast medium (42 ± 13 vs. 46 ± 8 ml, p = 0.022) and procedure time (8 ± 5 vs. 11 ± 3 min, p < 0.001) were significantly lower. No major adverse event occurred during hospital stay. CONCLUSIONS: Dual-axis RA represents a feasible and safe alternative method to CA for obtaining coronary angiograms. However, no superiority was observed when performed by an experienced interventionalist with a modern system.

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

INTRODUCTION: Initial 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. AIM: To 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 METHODS: The 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. RESULTS: OCT 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). CONCLUSIONS: This 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.

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.

Safety and effectiveness of coronary intravascular lithotripsy in eccentric calcified coronary lesions: a patient-level pooled analysis from the Disrupt CAD I and CAD II Studies.

BACKGROUND: The aim of this study was to assess the safety and effectiveness of intravascular lithotripsy (IVL) in treating eccentric calcified coronary lesions. METHODS: Between December 2015 and March 2019, 180 patients were enrolled in the Disrupt CAD I and CAD II studies across 19 sites in 10 countries. Patient-level data were pooled from these two studies (n = 180), within which 47 eccentric lesions (26%) and 133 concentric lesions were identified. RESULTS: Clinical success, defined as residual stenosis < 50% after stenting and no in-hospital MACE, was similar between the eccentric and concentric cohorts (93.6% vs. 93.2%, p = 1.0). There were no perforations, abrupt closure, slow flow or no reflow events observed in either group, and there were low rates of flow-limiting dissections (Grade D-F: 0% eccentric, 1.7% concentric; p = 0.54). Final acute gain and percent residual stenosis were similar between the two groups. Final residual stenosis of 8.6 ± 9.8% in eccentric and 10.0 ± 9.0% (p = 0.56) in concentric stenosis confirms the significant effect of IVL in calcified coronary lesions. CONCLUSION: In this first report from a pooled patient-level analysis of coronary IVL from the Disrupt CAD I and CAD II studies, IVL use was associated with consistent improvement in procedural and clinical outcomes in both eccentric and concentric calcified lesions.

Coronary Stent Strut Fractures: Classification, Prevalence and Clinical Associations.

INTRODUCTION: The frequency, characteristics and clinical implications of Strut fractures (SFs) remain incompletely understood. METHODS AND RESULTS: A total of 185 (160 patients) newer-generation drug-eluting stents (DES) were imaged. SFs were found in 21 DES (11.4%) and were classified in four patterns: one single stacked strut (41%); two or more stacked struts (23%); deformation without gap (27%); transection (9%). In multivariable analysis, calcific and bifurcation lesions were associated with SF in DES (OR: 3.5 [1.1-11] and 4.0 [2.2-7.2], p < 0.05). Device eccentricity and asymmetry as well as optical coherence tomography (OCT) features of impaired strut healing were also associated with SF. The prevalence of fractures was similar in a set of 289 bioresorbable scaffolds (BRS). In a separate series of 20 device thromboses and 36 device restenoses, the prevalence of SF was higher (61.2% of DES and 66.7% of BRS, p < 0.001 for both), with a higher frequency of complex SF patterns (p < 0.0001). In logistic regression analysis, fractures were a correlate of device complications (p < 0.0001, OR = 24.9 [5.6-111] for DES and OR = 6.0 [1.8-20] for BRS). DISCUSSION: The prevalence of OCT-diagnosed SF was unexpectedly high in the setting of elective controls and it increased by about three-fold in the setting of device failure. Fractures were associated with increased lesion complexity and device asymmetry/eccentricity and were more frequent in the setting of device failure such as restenosis and thrombosis.

Long-term follow-up and predictors of target lesion failure after implantation of everolimus-eluting bioresorbable scaffolds in real-world practice.

BACKGROUND: Bioresorbable scaffolds (BRS) have been shown to be inferior to drug-eluting stents in randomized trials. Nevertheless, patients treated during daily routine differ from those treated within randomized trials and thus need further long-term evaluation. The present investigation aims to address this lack. METHODS: Consecutive patients with coronary artery disease treated with implantation of everolimus-eluting BRS at 5 centers in Germany were included. Clinical follow-up was assessed up to 3 years. Analysis of clinical outcomes was performed by pooling of the individual patient data sets of each center. The major clinical endpoints of interest was target lesion failure (TLF) a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization. Furthermore occurrence of definite scaffold thrombosis was evaluated. A multivariable Cox regression analysis was applied to identify independent predictors of TLF. RESULTS: A total of 1614 patients treated with BRS were analyzed (mean age 64.0 ± 10.9 years, 75.8% male, 28.3% diabetics). A total 1817 lesions were treated with BRS and 56.0% were considered to be complex. At 3 years, the rate of TLF was 17.1% and definite scaffold thrombosis was noted in 2.6%. Independent predictors of TLF were a higher age, diabetes, bifurcation, complex lesions and the use of small BRS. CONCLUSIONS: In this large-scale analysis of patients undergoing BRS implantation in daily routine, event rates were high, but in line with randomized studies. Predictors of TLF were identified which may optimize patient and lesion selection for BRS.

Major coronary evaginations following implantation of bioresorbable vascular scaffolds - Clinical and OCT characteristics.

BACKGROUND: Coronary evaginations can occur after implantation of bioresorbable vascular scaffolds (BRS) and may be associated with scaffold thrombosis. Aim of this study was to clarify the clinical manifestation, extent and time course of coronary artery remodeling in vessel segments that develop angiographically detectable evaginations following BRS implantation through optical coherence tomography (OCT) analysis. METHODS: In 8 patients, 10 BRS (Absorb, Abbott Vascular, Santa Clara, CA, USA) which displayed coronary evaginations in clinically driven late invasive coronary angiograms were identified and findings were compared to 10 BRS in 8 patients without coronary evaginations. Vessel and device geometry was analyzed in serial OCT cross-sections at a spacing of 200 µm. Measured BRS dimensions were normalized to the reference vessel size at implantation. RESULTS: In OCT, major evaginations on average affected 24 ±â€¯19% of the scaffold length. Scaffolds with major evaginations had a significantly larger lumen area than scaffolds without evaginations (mean normalized lumen area 1.19 ±â€¯0.58 vs. 0.77 ±â€¯0.38; p < 0.001), and also displayed a significantly larger scaffold area (mean normalized scaffold area: 1.36 ±â€¯0.6 vs. 1.13 ±â€¯0.43; p < 0.001), and scaffold diameter (mean normalized scaffold diameter: 1.17 ±â€¯0.33 vs.1.04 ±â€¯0.19; p < 0.001). Lumen area (r = 0.47; p < 0.001), scaffold area (r = 0.52; p < 0.001), and scaffold diameter (r = 0.74; p < 0.001) in the evagination group were positively correlated to the time since scaffold implantation. CONCLUSION: Coronary evaginations following BRS implantation are associated with an increased scaffold area, indicating that the scaffold follows the outward remodeling of the artery. The process affects the entire scaffold length and seems to be continuously progressing following implantation.

Incidental Finding of Strut Malapposition Is a Predictor of Late and Very Late Thrombosis in Coronary Bioresorbable Scaffolds.

Malapposition is a common finding in stent and scaffold thrombosis (ScT). Evidence from studies with prospective follow-up, however, is scarce. We hypothesized that incidental observations of strut malapposition might be predictive of late ScT during subsequent follow-up. One hundred ninety-seven patients were enrolled in a multicentre registry with prospective follow-up. Optical coherence tomography (OCT), performed in an elective setting, was available in all at 353 (0-376) days after bioresorbable scaffold (BRS) implantation. Forty-four patients showed evidence of malapposition that was deemed not worthy of intervention. Malapposition was not associated with any clinical or procedural parameter except for a higher implantation pressure (p = 0.0008). OCT revealed that malapposition was associated with larger vessel size, less eccentricity (all p < 0.01), and a tendency for more uncovered struts (p = 0.06). Late or very late ScT was recorded in seven of these patients 293 (38-579) days after OCT. OCT-diagnosed malapposition was a predictor of late and very late scaffold thrombosis (p < 0.001) that was independent of the timing of diagnosis. We provide evidence that an incidental finding of malapposition-regardless of the timing of diagnosis of the malapposition-during an elective exam is a predictor of late and very late ScT. Our data provide a rationale to consider prolonged dual antiplatelet therapy if strut malapposition is observed.