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.

Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry.

BACKGROUND: Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation. METHODS: All consecutive patients treated with the custom-made TRICENTO implant at the participating centers were included in this retrospective multicentre registry. RESULTS: A total of 21 high-risk patients (mean age 76±7 years; 67% female) with severe or higher grade tricuspid regurgitation were analyzed. The majority of the patients were in New York Heart Association class III/IV (95%), had peripheral edema (95%), and previous hospitalization for right heart failure (67%). Technical success was 100%, and there was no case of in-hospital mortality. During follow-up (median 61 days), symptomatic improvement was observed (65% in New York Heart Association class I/II; P<0.001). Computed tomography revealed asymptomatic fractures of the TRICENTO prosthesis in 3 patients. Cardiac magnetic resonance imaging obtained in 7 patients showed a significant decrease (252±65 mm3 at baseline versus 216±58 mm3 at follow-up, P=0.006) of right ventricular end-diastolic volume. The overall-survival rate was 76% at 1 year. CONCLUSIONS: The present data indicate the feasibility of transfemoral bicaval valved stent implantation for the treatment of severe tricuspid regurgitation. Functional improvement and signs of right ventricular reverse remodeling were observed. Stent fractures did not impair valve function, but require refinement of prosthesis design and careful assessment of eligibility criteria.

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.

Age and Phenotype of Patients With Plaque Erosion.

Background A recent study reported that the outcome of patients with plaque erosion treated with stenting is poor when the underlying plaque is lipid rich. However, the detailed phenotype of patients with plaque erosion, particularly as related to different age groups, has not been systematically studied. Methods and Results Patients with acute coronary syndromes caused by plaque erosion were selected from 2 data sets. Demographic, clinical, angiographic, and optical coherence tomography findings of the culprit lesion were compared between 5 age groups. Among 579 erosion patients, male sex and current smoking were less frequent, and hypertension, diabetes, and chronic kidney disease were more frequent in older patients. ST-segment-elevation myocardial infarction was more frequent in younger patients. Percentage of diameter stenosis on angiogram was greater in older patients. The prevalence of lipid-rich plaque (27.3% in age <45 years and 49.4% in age ≥75 years, P<0.001), cholesterol crystal (3.9% in age <45 years and 21.8% in age ≥75 years, P=0.027), and calcification (5.5% in age <45 years and 54.0% in age ≥75 years, P<0.001) increased with age. After adjusting risk factors, younger patients were associated with the presence of thrombus, and older patients were associated with greater percentage of diameter stenosis and the presence of lipid-rich plaque and calcification. Conclusions The demographic, clinical, angiographic, and plaque phenotypes of patients with plaque erosion distinctly vary depending on age. This may affect the clinical outcome in these patients. Registration URL: https://www.clinicaltrials.gov. Unique identifiers: NCT03479723, NCT02041650.

Coronary plaque and clinical characteristics of South Asian (Indian) patients with acute coronary syndromes: An optical coherence tomography study.

BACKGROUND: South Asians, and Indians in particular, are known to have a higher incidence of premature atherosclerosis and acute coronary syndromes (ACS) with worse clinical outcomes, compared to populations with different ethnic backgrounds. However, the underlying pathobiology accounting for these differences has not been fully elucidated. METHODS: ACS patients who had culprit lesion optical coherence tomography (OCT) imaging were enrolled. Culprit plaque characteristics were evaluated using OCT. RESULTS: Among 1315 patients, 100 were South Asian, 1009 were East Asian, and 206 were White. South Asian patients were younger (South Asians vs. East Asians vs. Whites: 51.6 ± 13.4 vs. 65.4 ± 11.9 vs. 62.7 ± 11.7; p < 0.001) and more frequently presented with ST-segment elevation myocardial infarction (STEMI) (77.0% vs. 56.4% vs. 35.4%; p < 0.001). On OCT analysis after propensity group matching, plaque erosion was more frequent (57.0% vs. 38.0% vs. 50.0%; p = 0.003), the lipid index was significantly greater (2281.6 [1570.8-3160.6] vs. 1624.3 [940.9-2352.4] vs. 1303.8 [1090.0-1757.7]; p < 0.001), and the prevalence of layered plaque was significantly higher in the South Asian group than in the other two groups (52.0% vs. 30.0% vs. 34.0%; p = 0.003). CONCLUSIONS: Compared to East Asians and Whites, South Asians with ACS were younger and more frequently presented with STEMI. Plaque erosion was the predominant pathology for ACS in South Asians and their culprit lesions had more features of plaque vulnerability. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov, NCT03479723.

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.

Predictors of scaffold failure and impact of optimized scaffold implantation technique on outcome: Results from the German-Austrian ABSORB RegIstRy.

AIMS: We aimed to investigate predictors of scaffold failure and the potential impact of an optimized scaffold implantation technique by means of a learning curve on long-term clinical outcome after bioresorbable scaffold (BRS) implantation and to evaluate predictors of scaffold failure. METHODS AND RESULTS: A total of 3326 patients were included in this prospective, observational, multi-center study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BRS implantation between November 2013 and January 2016. The 3144 patients completed follow-up after 24 months, 3265 patients were eligible for time-to-event-analysis. Clinical endpoints were major adverse cardiac events-a composite endpoint of death, target vessel revascularization and myocardial infarction, and scaffold thrombosis (ScT). Patients were grouped according to treatment before or since 2015. During follow-up MACE rate improved from 2.52% after 30 days, 5.45% after 6 months and 12.67% after 24 months to 1.52%, 3.44%, and 10.52%, respectively. A total of 75 ScT occurred. In multiple regression analysis, treatment of bifurcations, long lesions, and procedures performed earlier than 2014 were identified as predictors for the occurrence of ScT. CONCLUSION: Treatment of bifurcation lesions is the strongest predictor of ScT following BRS implantation. A significantly lower incidence of ScT and 24-month target lesion revascularization in patients recruited after 2014 into our observational registry suggests the influence of a learning curve.

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.

Fusion imaging guided implantation of a Tricento transcatheter heart valve for severe tricuspid regurgitation.

We report the case of a 64-year-old patient with history of chronic kidney disease on dialysis who was repeatedly hospitalized due to hydropic decompensation. Right heart failure with secondary severe tricuspid regurgitation was diagnosed. An interventional approach was recommended due to the heavy calcification of the sinus venosus and the perioperative risk (EuroScore II 3.2%) and taking into account the explicit request of the patient. After analysis of a full-cycle computed tomography, the patient was eligible for the implantation of the Tricento transcatheter heart valve. The custom-made prosthesis was implanted successfully using periprocedural transoesophageal guidance supported by fusion imaging that integrates live co-registration. After implantation of the valve prosthesis, the primary result was excellent. The patient was discharged without further complications shortly after the procedure and her status is being closely monitored.

Determinants of ST-segment elevation myocardial infarction as clinical presentation of acute coronary syndrome.

Antiplatelet agents and statin therapies are widely used in patients with known cardiovascular disease. Plaque rupture (PR) and plaque erosion (PE) are the most frequent underlying mechanisms of acute coronary syndromes (ACS). The conditions and medications that are associated with ST-segment elevation myocardial infarction (STEMI) following PR or PE have not been systematically studied. A total of 838 ACS patients (494 with STEMI, 344 with NSTE-ACS) who were diagnosed with PR or PE by optical coherence tomography were included. The patients were categorized into two groups based on underlying pathology, and the baseline characteristics and culprit plaque morphology associated with STEMI were investigated within each group. Among 838 patients, 467 (55.7%) had PR, and 371 (44.3%) were diagnosed with PE. Among patients with PR, older age, hyperlipidemia, no antiplatelet therapy, higher level of low-density lipoprotein cholesterol, and greater lipid burden and macrophage infiltration were associated with increased probability of STEMI. Among patients with PE, no dual antiplatelet therapy and no statin therapy were associated with increased probability of STEMI. The incidence of STEMI caused by PR was significantly lower on antiplatelet therapy (P < 0.001), and the incidence of STEMI caused by PE was significantly lower on antiplatelet therapy (P < 0.001) or on statin therapy (P < 0.001). Antiplatelet therapy is associated with lower probability of STEMI, regardless of underlying pathology, and statin therapy is associated with lower probability of STEMI in PE as clinical presentation of ACS. Statin therapy prior to the onset of acute coronary syndromes (ACS) may reduce the probability of plaque rupture. Antiplatelet therapy prior to the onset of ACS is associated with reduced probability of ST-segment elevation myocardial infarction (STEMI) following both plaque rupture and plaque erosion, and dual antiplatelet therapy offers additional protection compared to a single antiplatelet agent in plaque erosion. The combination of statin and antiplatelet therapy may have an additive effect on reducing the probability of STEMI caused by plaque erosion. Yellow: lipid pool(necrotic core); red: fibrin-rich thrombus; gray; platelet-rich thrombus.

Circadian variations in pathogenesis of ST-segment elevation myocardial infarction: an optical coherence tomography study.

Previous studies have reported a circadian variation in the onset of ST-segment elevation myocardial infarction (STEMI). However, underlying mechanisms for the circadian variation have not been fully elucidated. We investigated the relationship between onset of STEMI and the underlying pathology using optical coherence tomography (OCT). Patients with a diagnosis of STEMI were selected from a multicenter OCT registry. Patients were divided into 4 groups based on the estimated time of onset (00:00-05:59, 06:00-11:59, 12:00-17:59, or 18:00-23:59). Underlying pathologies of MI (plaque rupture, plaque erosion, and calcified plaque) were compared among the 4 groups. Among 648 patients, plaque rupture was diagnosed in 386 patients (59.6%), plaque erosion in 197 patients (30.4%), and calcified plaque in 65 patients (10.0%). A marked circadian variation was detected in the incidence of plaque rupture with a peak at 09:00, whereas it was not evident in plaque erosion or calcified plaque. The probability of plaque rupture significantly increased in the periods of 06:00-11:59 [odds ratio (OR) 2.13, 95% confidence interval (CI) 1.30-3.49, p = 0.002] and 12:00-17:59 (OR 2.10, 95% CI 1.23-3.58, p = 0.005), compared to the period of 00:00-05:59. This circadian pattern was observed only during weekdays (p = 0.010) and it was not evident during the weekend (p = 0.742). Plaque rupture occurred most frequently in the morning and this circadian variation was evident only during weekdays. Acute MI caused by plaque rupture may be related to catecholamine surge.

Seasonal Variations in the Pathogenesis of Acute Coronary Syndromes.

Background Seasonal variations in acute coronary syndromes (ACS) have been reported, with incidence and mortality peaking in the winter. However, the underlying pathophysiology for these variations remain speculative. Methods and Results Patients with ACS who underwent optical coherence tomography were recruited from 6 countries. The prevalence of the 3 most common pathologies (plaque rupture, plaque erosion, and calcified plaque) were compared between the 4 seasons. In 1113 patients with ACS (885 male; mean age, 65.8±11.6 years), the rates of plaque rupture, plaque erosion, and calcified plaque were 50%, 39%, and 11% in spring; 44%, 43%, and 13% in summer; 49%, 39%, and 12% in autumn; and 57%, 30%, and 13% in winter (P=0.039). After adjusting for age, sex, and other coronary risk factors, winter was significantly associated with increased risk of plaque rupture (odds ratio [OR], 1.652; 95% CI, 1.157-2.359; P=0.006) and decreased risk of plaque erosion (OR, 0.623; 95% CI, 0.429-0.905; P=0.013), compared with summer as a reference. Among patients with rupture, the prevalence of hypertension was significantly higher in winter (P=0.010), whereas no significant difference was observed in the other 2 groups. Conclusions Seasonal variations in the incidence of ACS reflect differences in the underlying pathobiology. The proportion of plaque rupture is highest in winter, whereas that of plaque erosion is highest in summer. A different approach may be needed for the prevention and treatment of ACS depending on the season of its occurrence. Registration URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT03479723.

First-in-Man Lithoplasty of a LIMA Bypass With ECMO Support in a Last-Remaining Vessel.

We report the case of a 70-year-old patient with history of chronic heart disease who underwent bypass surgery twice beforehand and was admitted due to non-ST segment elevation myocardial infarction. Angiography showed degeneration of all bypass grafts except the LIMA bypass, which showed significant ostial stenosis with severe calcification. Peri-operative risk was computed to be as high as 12.3% (STS Score). An interventional strategy was chosen: the very high-risk procedure was performed safely under the protection afforded by venoarterial ECMO and cardiac surgeons on standby using a coronary intravascular lithoplasty (IVL) balloon. After implantation of a drug eluting stent, the primary angiogram showed a satisfactory result. The patient was discharged without further complications short after the procedure and is closely followed-up.

Ethnic Differences in the Pathobiology of Acute Coronary Syndromes Between Asians and Whites.

Ethnic differences in the pathobiology of acute coronary syndromes (ACS) have not been systematically studied. We compared the underlying mechanisms of ACS between Asians and Whites. ACS patients with the culprit lesion imaged by optical coherence tomography were included. Patients were stratified into ST-elevation myocardial infarction (STEMI) and non-ST-elevation-ACS (NSTE-ACS), and baseline characteristics, underlying mechanisms of ACS, and culprit plaque characteristics were compared between Asians and Whites. Of 1,225 patients, 1,019 were Asian (567 STEMI and 452 NSTE-ACS) and 206 were White (71 STEMI and 135 NSTE-ACS). Asians had more diabetes and hypertension among STEMI patients; among NSTE-ACS patients, Asians had higher prevalence of diabetes and renal insufficiency, and lower prevalence of hyperlipidemia. There were no differences in the incidence of plaque rupture, plaque erosion and calcified plaque between Asians and Whites with STEMI (61.2%, 28.6%, 10.2% vs 46.5%, 38.0%, 15.5%, respectively, p = 0.055). Among NSTE-ACS patients, there was a significant difference between Asians and Whites (40.5%, 47.6%, 11.9% vs 27.4%, 48.9%, 23.7%, respectively, p = 0.001). After adjustment for clinical confounders, the risk of plaque rupture (p = 0.713), plaque erosion (p = 0.636), and calcified plaque (p = 0.986) was similar between the groups with STEMI. In NSTE-ACS patients, the only difference was an increased risk of calcified plaque in Whites (odds ratio: 2.125, 95% confidence interval: 1.213 to 3.723, p = 0.008). In conclusion, after adjustment for clinical confounders, Asian and White patients presenting with STEMI and NSTE-ACS showed similar underlying mechanisms of ACS, except for a higher risk of calcified plaque in Whites with NSTE-ACS.

Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience.

AIMS: To examine the clinical experience and practical use of the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, CA, USA) and to report some of the first clinical results. METHODS AND RESULTS: A total of 18 consecutive patients with severe, symptomatic mitral regurgitation (MR) were included in this German multicentre registry. All patients underwent clinical, echocardiographic, and laboratory assessment prior to the PASCAL procedure and before hospital discharge. MR was classified as functional in 6 patients, degenerative in 2, and combined in 10. All except one received a single PASCAL implant. The preprocedural severe MR present in all patients was reduced: grade 0 in 4 (22.2%), grade I in 11 (61.1%), grade II in 3 (16.7%). The v-wave was significantly reduced from 31.7 ± 9.5 to 18 ± 7.7 mmHg (p < 0.001). Independent leaflet capture, performed in 4 (22.2%) of the patients, wide clasps, and the 10-mm central spacer are features of the PASCAL device to optimize mitral leaflet repair. There were no periprocedural complications. CONCLUSION: PASCAL is a safe and effective mitral valve repair device for the treatment of severe MR. Device-specific features allow valve repair tailored to the individual anatomy of the underlying mitral pathology in each patient.

Clinical and Laboratory Predictors for Plaque Erosion in Patients With Acute Coronary Syndromes.

Background Plaque erosion is responsible for 25% to 40% of patients with acute coronary syndromes (ACS). Recent studies suggest that anti-thrombotic therapy without stenting may be an option for this subset of patients. Currently, however, an invasive procedure is required to make a diagnosis of plaque erosion. The aim of this study was to identify clinical or laboratory predictors of plaque erosion in patients with ACS to enable a diagnosis of erosion without additional invasive procedures. Methods and Results Patients with ACS who underwent optical coherence tomography imaging were selected from 11 institutions in 6 countries. The patients were classified into plaque rupture, plaque erosion, or calcified plaque, and predictors were identified using multivariable logistic modeling. Among 1241 patients with ACS, 477 (38.4%) patients were found to have plaque erosion. Plaque erosion was more frequent in non-ST-segment elevation-ACS than in ST-segment-elevation myocardial infarction (47.9% versus 29.8%, P=0.0002). Multivariable logistic regression models showed 5 independent parameters associated with plaque erosion: age <68 years, anterior ischemia, no diabetes mellitus, hemoglobin >15.0 g/dL, and normal renal function. When all 5 parameters are present in a patient with non-ST-segment elevation-ACS, the probability of plaque erosion increased to 73.1%. Conclusions Clinical and laboratory parameters associated with plaque erosion are explored in this retrospective registry study. These parameters may be useful to identify the subset of ACS patients with plaque erosion and guide them to conservative management without invasive procedures. The results of this exploratory analysis need to be confirmed in large scale prospective clinical studies. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03479723.

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.

Calcified Plaques in Patients With Acute Coronary Syndromes.

OBJECTIVES: This study conducted detailed analysis of calcified culprit plaques in patients with acute coronary syndromes (ACS). BACKGROUND: Calcified plaques as an underlying pathology in patients with ACS have not been systematically studied. METHODS: From 1,241 patients presenting with ACS who had undergone pre-intervention optical coherence tomography imaging, 157 (12.7%) patients were found to have a calcified plaque at the culprit lesion. Calcified plaque was defined as a plaque with superficial calcification at the culprit site without evidence of ruptured lipid plaque. RESULTS: Three distinct types were identified: eruptive calcified nodules, superficial calcific sheet, and calcified protrusion (prevalence of 25.5%, 67.4%, and 7.1%, respectively). Eruptive calcified nodules were frequently located in the right coronary arteries (44.4%), whereas superficial calcific sheet was most frequently found in the left anterior descending coronary arteries (68.4%) (p = 0.012). Calcification index (mean calcification arc × calcification length) was greatest in eruptive calcified nodules, followed by superficial calcific sheet, and smallest in calcified protrusion (median 3,284.9 [interquartile range (IQR): 2,113.3 to 5,385.3] vs. 1,644.3 [IQR: 1,012.4 to 3,058.7] vs. 472.5 [IQR: 176.7 to 865.2]; p < 0.001). The superficial calcific sheet group had the highest peak post-intervention creatine kinase values among the groups (eruptive calcified nodules vs. superficial calcific sheet vs. calcified protrusion: 241 [IQR: 116 to 612] IU/l vs. 834 [IQR: 141 to 3,394] IU/l vs. 745 [IQR: 69 to 1,984] IU/l; p = 0.032). CONCLUSIONS: Three distinct types of calcified culprit plaques are identified in patients with ACS. Superficial calcific sheet, which is frequently located in the left anterior descending coronary artery, is the most prevalent type and is also associated with greatest post-intervention myocardial damage. (Identification of Predictors for Coronary Plaque Erosion in Patients With Acute Coronary Syndrome; NCT03479723).

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

OBJECTIVE: 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. METHODS: 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. RESULTS: OCT analysis showed a lumen area of 11.4 ±â€¯1.9 mm2 and a scaffold area of 11.5 ±â€¯2.1 mm2. The mean eccentricity index overall was 0.65 ±â€¯0.16 and mean symmetry index 0.39 ±â€¯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. CONCLUSION: 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.

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

OBJECTIVE: To 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. BACKGROUND: Outcome 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 RESULTS: Fifty-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. CONCLUSION: OCT 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 ABSTRACT: Rates 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.