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Competing Interests: Declaration of competing interest Authors report the following disclosures of conflicts of interest.

Background: Conventional drug-eluting stents achieve good safety and performance outcomes, but the stents permanently cage the vessel, leading to a non-plateauing rate of clinical events. The DynamX Bioadaptor is designed to reduce these long-term events through unique design features that permit restoring vessel function and physiology through the disengagement of uncaging elements after the resorption of a biodegradable polymer over six months. Promising initial results have been obtained in the DynamX mechanistic study, with excellent safety and effectiveness, positive arterial remodeling, improved vasomotion, compliance, and cyclic pulsatility. We now aim to confirm these findings randomizing the DynamX Bioadaptor against the Resolute Onyx stent., Methods: This multi-center, international, randomized single-blinded study is conducted in 34 sites across Europe, Japan, and New Zealand and is divided into the European/New Zealand cohort and the Japanese cohort (which includes an imaging subset). It is designed to randomly assign 444 patients (222 per region) in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus after implantation of the DynamX Bioadaptor. Study follow-up is scheduled at one, six, and 12 months, and annually thereafter for five years; imaging follow-up includes angiographic, intravascular ultrasound, and optical coherence tomography assessments at 12 months in a subset of patients. The primary endpoint is 12-month target lesion failure., Conclusions: This trial will provide valuable insights into the safety and efficacy of this novel bioadaptor when compared to a contemporary drug-eluting stent., Condensed Abstract: The DynamX Sirolimus-Eluting Bioadaptor has unique design features aiming to reduce long-term events after percutaneous coronary intervention by permitting the restoration of vessel function through the freeing of uncaging elements. Promising initial results have been obtained in the DynamX mechanistic study. This trial aims to confirm these findings in a randomized setting. The European/ New Zealand and Japanese cohorts were designed to randomly assign 444 subjects in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus., Competing Interests: Declaration of competing interest Shigeru Saito receives consulting fees from Elixir Medical which are paid to the NPO International TRI network, Holger Nef reports honoraria, payments for expert testimony, and support for attending meeting from Elixir Medical, Mark Webster reports research support from Elixir Medical to its institution, Stefan Verheye reports research support from Elixir Medical to its institution, consulting fees from Elixir and Neovasc, and honoraria for lecturers etc. from Elixir and Neovasc., (Copyright © 2023. Published by Elsevier Inc.)

Background: In addition to the edge-to-edge MitraClip repair system, the edge-to-spacer PASCAL repair system was approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data are lacking., Objectives: The aim of this study was to compare procedural and short-term safety and efficacy of 2 leaflet-based transcatheter mitral valve repair systems., Methods: Procedural and 30-day outcomes were investigated in a propensity score-matched cohort of 307 PASCAL and 307 MitraClip patients at 10 sites. Matching criteria included sex, age, left ventricular ejection fraction, New York Heart Association functional class, MR etiology, left ventricular end-diastolic diameter, left atrial volume index, and vena contracta width. The primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE)., Results: Technical success was 97.0% in the PASCAL group and 98.0% in the MitraClip group (P = 0.624). MR ≤2+ at discharge was comparable in both groups (PASCAL: 93.8% vs MitraClip: 92.4%; P = 0.527), with more patients exhibiting MR ≤1+ in the PASCAL group (70.5% vs 56.6%; P < 0.001). The postprocedural mean gradient was significantly higher in the MitraClip group (3.3 ± 1.5 mm Hg vs 3.9 ± 1.7 mm Hg; P < 0.001). At 30 days, all-cause mortality and MAE rates were similar (mortality: 1.7% vs 3.3%; P = 0.299; MAE: 3.9% vs 5.2%; P = 0.562)., Conclusions: In this first large propensity score-matched comparison, procedural success rates and MAE did not differ significantly between patients treated with the PASCAL or MitraClip valve repair system. Procedural results with less than moderate MR and no elevated transmitral gradient were more common in the PASCAL group, which might have an impact on long-term outcome., Competing Interests: Funding Support and Author Disclosures Dr Iliadis has received travel support from Abbott; and has received consultant honoraria from Abbott and Edwards Lifesciences. Dr Hausleiter has received research grants and speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr Lurz has received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifesciences, and Medtronic. Dr Möllmann has received speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr Rudolph has received research grants and consulting honoraria from Edwards Lifesciences. Dr von Bardeleben has received consulting and lecture honoraria from Abbott Cardiovascular, Boehringer Ingelheim, Edwards Lifesciences, NeoChord, and Medtronic. Dr Nef has received speaker and consulting honoraria from Abbott Vascular and Edwards Lifesciences. Dr Luedike has received consulting and lecture honoraria from Edwards Lifesciences. Drs Pfister and Baldus have received consulting honoraria from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Radial (RA) instead of femoral access (FA) for coronary interventions has become a European Society of Cardiology Class-IA guideline recommendation. But when the decision on the access site is left to the discretion of the operator, differences in adverse event rates mitigate., Methods: We compared the 30-day outcome for RA and FA in all patients recruited for the observational German Austrian ABSORB Registry (GABI-R) in regard to all-cause mortality, stroke, myocardial infarction (MI), TIMI major bleedings (TMB) and quality of life (QoL). All patients were treated with a bioresorbable vascular scaffold. Access site was left to the discretion of the operator., Results: In total, 3137 patients included by 92 centers received percutaneous coronary interventions (PCI) for acute MI in 51.5% and non-acute settings in 48.5%. RA was performed in 47.8% and had a higher median radiation exposure (3896 vs. 3082 cGycm 2 , p < 0.001). There was no difference in the amount of contrast used. There was also no difference in all-cause mortality (0.53% vs. 0.49%, p = 0.86), the combination of death, MI and stroke (1.87% vs. 1.83%, p = 0.94), but a trend towards more TMB (0.47% vs. 1.04%, p = 0.07) with FA. These outcomes were consistent across the subgroups of patients with ST-elevation MI, non-ST-elevation-ACS and stable coronary artery disease. Finally, QoL did not differ between RA and FA., Conclusions: In this contemporary GABI-R cohort, in which access site was left to the discretion of the operator, both access routes were safe and equal concerning QoL (ClinicalTrials.gov; NCT02066623)., Competing Interests: Declaration of competing interest, (Copyright © 2021 Elsevier Inc. All rights reserved.)

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., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objectives: The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system., Background: The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture., Methods: Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE)., Results: Among the 309 patients (mean age 77 ± 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 ± 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was ≤2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class ≤II (p < 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%)., Conclusions: Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status., Competing Interests: Author Disclosures Drs. Pfister and Baldus have received honoraria for consulting from Edwards Lifesciences. Dr. Luedike has received honoraria for consulting and lectures from Edwards Lifesciences. Dr. Rudolph has received research grants and honoraria for consulting from Edwards Lifesciences. Dr. Hausleiter has received research grants and speaking honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr. Lurz has received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifesciences, and Medtronic. Dr. Nef has received speaking and consulting honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Möllmann has received speaking honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr. von Bardeleben has received consulting and lecture honoraria from Abbott Cardiovascular, Boehringer Ingelheim, Cardiac Dimensions, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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., Competing Interests: Declaration of competing interest The authors have no conflict to declare., (Copyright © 2020 Elsevier Inc. All rights reserved.)

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 ± 1.9 mm 2 and a scaffold area of 11.5 ± 2.1 mm 2 . 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 mm 2 84.1% vs. SEI of 86.6% in group with CP area ≥0.52 mm 2 , 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., (Copyright © 2018 Elsevier Inc. All rights reserved.)

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)., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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±1.6mm 2 , 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±9.8mm 2 ., 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., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

A 64-year old woman was referred to the division of cardiology due to recurrent angina pectoris (CCS III). The patient's symptoms and high cardiovascular risk profile were an indication for coronary angiography. Relevant coronary heart disease was hereby ruled out; however, angiography showed a direct drainage of coronary vessels into the chambers. These Thebesian veins are of venoluminal nature in most cases and have a clinical implication in selected cases only., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: To examine ischemic and bleeding outcomes in patients on triple antithrombotic therapy (TAT) compared with dual antiplatelet therapy (DAPT) after the implantation of bioresorbable scaffolds (BRS)., Background: The optimal antithrombotic regimen in patients undergoing percutaneous coronary intervention that have an indication for oral anticoagulation is unclear, in particular among those undergoing BRS implantation., Methods: Consecutive patients of a single-center, all-comers BRS registry were included. Patients were followed up after 30days, 6 and 12months, and thereafter yearly. Outcome parameters were target vessel failure (TVF), major adverse cardiac events (MACE) including target lesion revascularization (TLR), scaffold thrombosis (ST), death, myocardial infarction, and any bleeding as defined by BARC. Patients on TAT were matched to patients on DAPT., Results: A total of 607 patients were included. Fifty-five patients receiving TAT were matched with 165 patients treated with DAPT. Acute coronary syndrome was an indication for coronary angiography in 50.9% vs 50.4% groups (p=0.97). Major adverse cardiac events occurred in 16.4% of TAT patients vs. 8.9% DAPT patients (p=0.12), TLR in 5.5% vs. 1.9% (p=0.17), ST in 3.6% vs. 1.9% (p=0.46), and TVF in 3.6 vs. 1.9% (p=0.46). Patients died in 7.3% in the TAT group vs. 5.1% in the DAPT group (p=0.26). No severe bleeding was recorded in either of the groups., Conclusion: There was no difference in bleeding or ischemic events between the patients on TAT and those on DAPT after BRS implantation. The high rate of scaffold thrombosis in all of these patients, however, is not negligible., (Copyright © 2016. Published by Elsevier B.V.)

Objectives: The purpose of this study was to compare the 1-year outcome of everolimus-eluting bioresorbable scaffolds (eBRS) and Novolimus-eluting bioresorbable scaffolds (nBRS) in patients undergoing percutaneous coronary intervention in a real-life clinical practice scenario., Background: eBRS and nBRS are available and have been proved safe for coronary artery stenting in well-selected patients., Methods: Consecutive patients who underwent bioresorbable scaffold implantation were evaluated retrospectively via 2:1 propensity matching. Target lesion failure comprising cardiac death, target vessel myocardial infarction, and target lesion revascularization was examined after 12 months, along with its individual components as well as scaffold thrombosis., Results: A total 506 patients were available for matching. Of these, 212 eBRS patients (mean age = 62.9 years) and 106 nBRS patients (mean age = 63.1 years) were analyzed after matching. Baseline characteristics and clinical presentation were comparable in both groups. Acute coronary syndromes were present in 53.3% of the eBRS group and in 48.1% of the nBRS group (p = 0.383). Lesion characteristics were also similar. Pre-dilation (99.5% vs. 98.1%; p = 0.218) and post-dilation (84.4% vs. 86.8%; p = 0.576) were performed in the same proportion of matched eBRS and nBRS patients, respectively. The 1-year rates of target lesion failure (4.7% vs. 4.5%; p = 0.851), target lesion revascularization (2.6% vs. 3.5%; p = 0.768), cardiac death (1.5% vs. 2.0%; p = 0.752), and definite scaffold thrombosis (2.0% vs. 1.0%; p = 0.529) did not differ significantly between the eBRS and nBRS groups., Conclusions: The present study reveals comparable clinical results for the 2 types of bioresorbable scaffolds when used during routine practice, but further evidence from randomized controlled trials is needed., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The MitraClip procedure can be an alternative treatment option for patients with high surgical risk for whom surgical treatment is contraindicated. Patients with prosthetic material have an increased risk for infective endocarditis., Hypothesis: Incidence, treatment and outcome of patients with endocarditis after interventional mitral valve repair are not known., Methods: We searched for articles using PubMed using the terms "interventional mitral valve repair", "mitraclip" and "endocarditis". We have also searched for case reports in major congresses. Furthermore, we report two cases., Results: Four cases of IE after MitraClip were found in addition to our cases. The leading cause is a bacterial infection, typically with staphylococcal bacteria. Approximately two thirds of these patients underwent surgery. Short-term outcome seems to be reasonable for these patients. During the early postoperative period and if Staphylococcus aureus can be cultivated mortality seems to be significantly elevated., Conclusion: IE after MitraClip procedure is a dilemma. While surgical bail-out seems to be the favorable treatment option, patients were rejected conventional surgery in first place due to their high operative risk. Best treatment recommendation must be made on an individual basis. Predisposing factors should be conscientiously addressed prior to the procedure., (Copyright © 2016 Elsevier Inc. All rights reserved.)

The DESolve® scaffold (Elixir Medical Corporation, Sunnyvale, California, USA) is manufactured from a poly-l-lactide based polymer and elutes an anti-proliferative, anti-inflammatory drug, Novolimus from a poly-l-lactide based topcoat mixture. The strut thickness is 150μm and the scaffold has platinum-iridium radiopaque markers at both ends. Radial support is available during the early time period to prevent recoil. The scaffold biodegrades within 1year (>90% reduction in molecular weight) and then completely bioresorbs within 2years. The DESolve® scaffold permits a wide range of expansion with a consequently reduced risk for strut fracture. Lumen and scaffold enlargement is observed within 3-6months in both preclinical and clinical studies potentially allowing for the scaffolded region to respond to vasoactive stimuli. The device has a unique property of self-correction observed in bench top studies, which in clinical practice has the potential to eliminate minor malapposition following deployment., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aims: To 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 Results: 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±4.2atm. OCT analysis showed a lumen area of 11.4±1.9mm(2) and a scaffold area of 11.5±2.1mm(2). 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., Conclusion: 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., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background/purpose: The clinical performance of bioresrobable scaffolds (BRSs) in bifurcation lesion is not well investigated so far and information can currently mostly be gleaned from the results of bench testing. The present analysis evaluates the technical feasibility of BRS use in this type of lesion and its mid-term clinical outcome., Methods/materials: Consecutive patients with bifurcation lesions treated with at least one everolimus-eluting BRS were enrolled. Procedural success was defined as successful delivery and deployment of at least one BRS and a residual diameter stenosis ≤30%. The primary endpoint (major adverse cardiac events, MACE) included death due to cardiac cause, clinically driven percutaneous or surgical target lesion revascularization (TLR), and any myocardial infarction at the 12-month follow-up., Results: A total of 28 patients were eligible for this evaluation. Median age was 67 (52-73) years and in 46.4% (13/28) an acute coronary syndrome was present. The procedural success rate was 97.1% (33/34). The 1-year Kaplan Meier event rates for MACE, target lesion revascularization, and scaffold thrombosis were 16.1%, 12.1%, and 8.1%, respectively. Half of these patients discontinued the antiplatelet therapy prematurely., Conclusions: The results for BRS use in bifurcation lesions are not in line with previous studies investigating primarily simple lesions. The impaired outcomes are most likely related to the early stage of BRS use and an exacerbated risk of scaffold thrombosis due to premature discontinuation of the antiplatelet therapy. Hypothesis generated from this investigation has to be proven in further studies., Summary: Technical feasibility of everolimus-eluting bioresorbable scaffold implantation in bifurcation lesion and the clinical mid-term outcomes were evaluated in a real world scenario. Technical success rate was high; however the clinical results were not in line with previous studies investigating primarily simple lesions. The impaired outcomes were mostly driven by an exacerbated risk of scaffold thrombosis due to premature discontinuation of the antiplatelet therapy., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background/purpose: The implantation of bioresorbable scaffolds (BVSs) is an emerging technique in the treatment of coronary lesions and implantation of BVSs is different than that of metallic drug-eluting stents, however, due to different mechanical properties. This investigation focused on procedural and mid-term results and was designed to evaluate whether there is evidence of a learning curve with BVSs and how it might influence the clinical outcome., Methods/materials: In an all-comers registry, the first 100 consecutive patients were compared with the second 100 patients. Target parameters were major adverse cardiac events (MACEs), including cardiac death, any myocardial infarction, and percutaneous or surgical target lesion revascularization (TLR). Target vessel failure (TVF) comprised cardiac death, target vessel myocardial infarction, and percutaneous or surgical target vessel revascularization (TVR)., Results: Baseline characteristics were not significantly different. Post-dilatation was used significantly more often in the second group (23.8% vs. 50.5%, p<0.05) as was intravascular imaging (9% vs. 19%, p<0.05). In-hospital MACEs (2.0% for both groups) and median duration of hospital stay (4 (2-6)days) did not differ significantly. During a follow-up of 210 (155-369) or 200 (176-286)days (p=n.s.) for the first and second groups, respectively, MACE (11.2% vs. 1.1%, p<0.01), TVF (10.1% vs. 1.1%, p<0.01), and TVR (9.9% vs. 1.1%, p<0.05) rates were significantly lower in the second group., Conclusion: There is evidence of a learning curve. Post-dilatation is most probably associated with an improved clinical result and intravascular imaging might be useful for further improvement., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: This study evaluates the feasibility of percutaneous coronary intervention with bioresorbable vascular scaffolds (BVSs) in chronic total occlusion (CTO) lesions., Background: Everolimus-eluting BVSs represent a new approach to treating coronary artery disease, but experience with CTO is limited., Methods: Patients with a previously diagnosed CTO who had been treated with BVS were included. Patients with unsuccessful CTO procedures and patients treated with drug-eluting stents were excluded. Difficulty of the CTO procedure was assessed by the J-score., Results: A total of 23 patients were included. Mean age was 60.4 ± 9.0 years, 17.4% were female, 91.3% suffered from hypertension and 34.8% from diabetes. Mean J-score was 1.7 ± 1.0. Median procedure time was 70 min (54-85), mean contrast volume was 213.5 mL (±94.2) and median fluoroscopy time was 19.1 min (13.1-30.0). A total of 64 BVSs were implanted with a mean number of 2.8 ± 1.0 BVSs per patient, a mean total BVS length of 64.8 ± 24.2 mm per lesion, and a mean BVS diameter of 3.1 ± 0.2 mm. Neither a scaffold-related dissection nor any other intra-procedural complication occurred. During a follow-up of 108 (79.5-214.5) days one in-scaffold thrombosis was noted 4 days after the CTO procedure due to a lack of dual antiplatelet therapy. No further major adverse cardiac events occurred., Conclusion: These results suggest that BVS implantation in CTO lesions can be performed with good procedural success and reasonable clinical short-term outcome in highly selected cases., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Background: The aim of the study was to characterize RV adaptation to varying loading conditions in patients with chronic thromboembolic hypertension (CTEPH) before and after pulmonary endarterectomy (PEA). Nearly 4% of patients with pulmonary embolism develop CTEPH. PEA offers a cure with excellent outcome. By use of cardiovascular magnetic resonance (CMR) combined with hemodynamic measurements pulmonary arterial elastance (Ea-pulm&#95;i), end-systolic right ventricular elastance (Ees-RV&#95;i) and ventriculo-arterial coupling (Ea-pulm&#95;i/Ees-RV&#95;i) can be studied before and after PEA., Methods: Sixty-five patients (mean age 41±12 years, 28 female) underwent CMR pre- and post-PEA. Ejection fraction (EF), end-diastolic (EDVi), end-systolic (ESVi), and stroke (SVi) volumes were indexed for body surface area. Ea-pulm&#95;i was calculated as pulmonary artery mean pressure (mPAP)/SVi, and Ees-RV&#95;i as mPAP/ESVi., Results: mPAP decreased from 47±12 to 25±9 mmHg, p=0.0001. Ea-pulm&#95;i was increased before PEA and normalized afterwards (2.8±2.1 vs. 0.85±0.4 mmHg/ml/m2, p=0.0001). Ees-RV&#95;i was depressed before and after PEA (0.72±0.27 vs. 0.66±0.3 mmHg/ml/m2, p=0.13). EF improved from 25±12% to 46±10%, p=0.0001, because ventriculo-arterial coupling was restored (4.2±3 vs. 1.4±0.6, p=0.0001). EDVi and ESVi mproved significantly (EDVi 92±32 to 72±23 ml, p=0.0001; ESVi 69±31 to 41±18 ml, p=0.0001)., Conclusion: RV function is largely determined by afterload and returns to normal once afterload is normalized. This is paralleled by a significant improvement of CMR indices of right ventricular remodelling.

Background: The role of adhoc multi-vessel percutaneous coronary intervention (MV-PCI) in patients with ST elevation myocardial infarction (STEMI) and non ST elevation acute coronary syndromes (NSTE-ACS) has not fully defined yet. Therefore, we sought to evaluate the impact of MV-PCI on in-hospital outcome of patients with MV disease presenting with ACS., Methods and Results: We evaluated 4, 457 haemodynamically stable patients with ACS and at least two major epicardial vessels with ≥70% stenosis of the contemporary Euro Heart Survey PCI registry. They were stratified into four categories: 419 STEMI and 734 NSTE-ACS patients undergoing MV-PCI and 2,118 STEMI and 1,186 NSTE-ACS patients undergoing culprit lesion (CL)-PCI only, respectively. In comparison to patients with CL-PCI hospital mortality was numerically lower among those undergoing MV-PCI for STEMI (1.4 versus 3.4%, P=0.03) and for NSTE-ACS (1.1 versus 2.1%, P=0.10). After adjustment for confounding variables no significant mortality difference was observed among patients treated with MV-PCI for STEMI (OR 0.48, 95%-CI 0.21-1.13) and for NSTE-ACS (OR 0.54, 95%-CI 0.24-1.22). However, the risk for non-fatal postprocedural myocardial infarction was markedly increased among patients undergoing MV-PCI for STEMI (8.8 versus 1.6%, P<0.0001) and for NSTE-ACS (5.3 versus 1.8%, P<0.0001)., Conclusions: In clinical practice MV-PCI in haemodynamically stable with ACS is used only in a minority of patients. There was no significant difference in hospital mortality between patients treated with MV- and CL-PCI, but MV-PCI was associated with a higher rate of postprocedural myocardial infarction., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Background: The percentage of elderly treated with percutaneous coronary intervention (PCI) has been increasing year by year. Little is known about predictors of hospital mortality in elderly undergoing PCI for acute coronary syndromes (ACS) and stable angina., Methods: Between 2005 and 2008 a total of 47,407 consecutive patients undergoing PCI were prospectively enrolled into the PCI-Registry of the EHS Programme. For the present analysis patients were divided into four categories: ACS patients ≥ 75 (n=4,943) and < 75 years (n=19,446), and patients with stable angina ≥ 75 (n=3,393) and < 75 years (n=19,625). A multiple logistic regression analysis was conducted to detect independent predictors of mortality in patients ≥ 75 years undergoing PCI. In addition, differences in clinical characteristics, procedural details and in-hospital outcomes between the subgroups were evaluated., Results: Patients ≥ 75 years had more co-morbidities, and more severe coronary pathology. The use of guideline-recommended adjunctive therapy and procedural success was high in all groups. The incidence of in-hospital death was highest in ACS patients ≥ 75 years (5.2%) and < 75 years (1.7%), followed by patients with stable angina ≥ 75 (0.5%) and < 75 years (0.2%). Haemodynamic instability and acute ST-elevation myocardial infarction were the strongest determinants of hospital mortality among patients ≥ 75 years with ACS, whereas interventional complications were the most meaningful predictors of death in older patients undergoing elective PCI., Conclusions: Patients ≥ 75 years undergoing PCI face a relatively low risk of hospital death. However, complication rates were significantly higher compared to younger patients, strongly influenced by clinical, angiographic and interventional variables., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Background: It is unknown whether the increased B-type natriuretic peptide (BNP) values found in ischemic heart disease are triggered directly by ischemia or whether they are caused indirectly by ischemia through diastolic contractures or regional wall motion abnormalities. Therefore, we investigated the BNP expression in isolated human muscle strips under conditions of ischemia with and without mechanical stress., Methods: Muscle strips (n=90) were isolated from human right atria (n=46). Contractures were induced by oxygen and glucose withdrawal. In 18 muscle strips contractures were prevented by means of butanedione monoxime (BDM). Sarcomere lengths were measured by electron microscopy (n=12). The gene expression and protein amount of BNP were determined and compared to control muscle strips contracting under physiological conditions., Results: Hypoxia significantly decreased systolic force and induced diastolic contractures. This mechanical stress could be prevented in the group treated with BDM as evidenced by electron microscopy. Ischemia significantly increased BNP expression in both groups as evidenced by Northern blot analysis and immunohistochemistry. This increase was independent from mechanical stress., Conclusion: Our results indicate that ischemia is a potent mechanism for the expression of BNP. The increase in BNP expression under ischemic conditions is independent from concomitant mechanical alterations., (Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.)