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BACKGROUND: Whether the two drug-eluting stents approved by the US Food and Drug Administration-a sirolimus-eluting stent and a paclitaxel-eluting stent-are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with bare-metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. METHODS: We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with bare-metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18,023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. FINDINGS: Mortality was similar in the three groups: hazard ratios (HR) were 1.00 (95% credibility interval 0.82-1.25) for sirolimus-eluting versus bare-metal stents, 1.03 (0.84-1.22) for paclitaxel-eluting versus bare-metal stents, and 0.96 (0.83-1.24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0.81, 95% credibility interval 0.66-0.97, p=0.030 vs bare-metal stents; 0.83, 0.71-1.00, p=0.045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2.11, 95% credibility interval 1.19-4.23, p=0.017 vs bare-metal stents; 1.85, 1.02-3.85, p=0.041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with bare-metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0.70, 0.56-0.84; p=0.0021). INTERPRETATION: The risks of mortality associated with drug-eluting and bare-metal stents are similar. Sirolimus-eluting stents seem to be clinically better than bare-metal and paclitaxel-eluting stents. [ABSTRACT FROM AUTHOR]

Background: Periprocedural electrophysiological (EP) testing may be useful to predict high degree atrioventricular block (HAVB) risk in patients undergoing transcatheter aortic valve replacement (TAVR)., Objective: To determine whether pre- and immediate post-TAVR ECG and HV interval findings are predictive of HAVB., Methods: Consecutive TAVR patients without prior pacemaker (PM) implantation underwent ECG and standardized HV interval measurements pre- and post-TAVR using the quadripolar catheter for rapid pacing. The primary outcome was HAVB >24 h after TAVR or ventricular pacing need RESULTS: Out of 97 included patients, 8 experienced the primary outcome (7 with HAVB and 1 with PM need). On univariate analysis, pre- and post-TAVR PR, post-TAVR HV, and Delta-HV intervals were predictors of the primary outcome. A Delta-HV interval ≥18 ms predicted HAVB with sensitivity = 50% and specificity = 90% (AUC = 0.708, PPV = 31%), while an HV interval ≥60 ms after TAVR had sensitivity = 63% and specificity = 79% (AUC = 0.681, PPV = 21%). None of the patients with a PR interval ≤180 ms post-TAVR experienced the primary outcome. Among patients with new-onset LBBB, an HV interval post-TAVR >65 ms was the only predictor of HAVB (AUC = 0.776, PPV = 33%, and NPV = 97%)., Conclusion: The yield of periprocedural EP assessment during TAVR is limited considering that about half of the at-risk patients fail to be identified. However, early periprocedural risk stratification may be more useful in the subset of patients with new-onset LBBB. Among ECG findings, a post-TAVR PR interval ≤180 ms identifies a subgroup at very low risk, independently of QRS interval and morphology., (© 2025 Wiley Periodicals LLC.)

Telemetry monitoring (conventional cardiac monitoring system [CCMS]) is a universal method for postoperative arrhythmia detection; however, the clinical challenge of alarm fatigue, primarily associated with noise or cable disconnections, persists. The introduction of wireless continuous cardiac monitoring (WCCM) represents a potential solution to enhance recording fidelity. Patients were simultaneously outfitted with both a monitoring device considered the standard of care and a novel adhesive wireless patch. A 48-h cardiac monitoring session with the two devices occurred after cardiac surgery in a unit equipped with a telemetry system. A total of 53 patients with a mean age of 60 ± 17 years were included in the trial. The number of events detected by the two systems was significantly different at 190 versus 174 for the CCMS and the WCCM system, respectively ( P < .05). However, the percentage of agreement was not significantly different at 91% versus 88% ( P = .37). Events were classified as follows: pause (2 events, 1%), atrial or premature ventricular contractions (18 events, 11%), atrial flutter or fibrillation (76 events, 45%), bradycardia (12 events, 7%), and tachycardia (61 events, 36%). False alarms were significantly more frequent with the CCMS (n = 21) than with the WCCM system (n = 5; P = .002). The study successfully demonstrated the feasibility and usability of wireless monitoring for patients requiring telemetry. The overall results are compelling, as the WCCM system performed satisfactorily, achieving results comparable to those obtained with the CCMS, even with significantly fewer false alarms., Competing Interests: The authors report no conflicts of interest for the published content. No funding information was provided., (Copyright: © 2024 Innovations in Cardiac Rhythm Management.)

Background: Various scoring systems have been developed to assess the risk of bleeding in medical settings. HAS-BLED and HEMORR2HAGES risk scores are commonly used to estimate bleeding risk in patients receiving anticoagulation for atrial fibrillation, but data on their predictive value in patients undergoing percutaneous coronary intervention (PCI) are limited., Methods: This study evaluated and compared the predictive abilities of the HAS-BLED and HEMORR2HAGES bleeding risk scores in all-comer patients undergoing PCI. The PARIS score, specifically designed for patients undergoing PCI, was used as a comparator. The scores were calculated at baseline and compared with the occurrence of events during a 2-year clinical follow-up period. Between 2015 and 2017, all consecutive patients undergoing PCI we re prospectively enrolled and divided into risk tertiles based on bleeding risk scores. The primary end points were hierarchical major bleeding events, defined by Bleeding Academic Research Consortium types 3 through 5, and patient-oriented composite end points according to Bleeding Academic Research Consortium classification, which were assessed during the 2-year follow-up period., Results: A total of 1,080 patients completed the follow-up period. Two years after index, 189 patients (17.5%) had experienced any bleeding, with 48 events (4.4%) classified as Bleeding Academic Research Consortium types 3 to 5. All bleeding risk scores showed statistically significant predictive ability for bleeding events. The HEMORR2HAGES score (C statistic, 0.73) was more effective than the HAS-BLED score (C statistic, 0.66; P = .07) and the PARIS score (C statistic, 0.66; P = .06) in predicting risk of major bleeding. Patients in high-risk bleeding groups also experienced a higher incidence of patient-oriented composite end points., Conclusions: The HEMORR2HAGES, HAS-BLED, and PARIS risk scores exhibited good predictive abilities for bleeding events following PCI. Patients at high risk of bleeding also demonstrated increased ischemic risk and higher mortality during the 2-year follow-up period., (© 2024 The Authors. Published by The Texas Heart Institute®.)

Background: Studies suggest that performing an electrophysiological study (EPS) may be useful to identify patients with new-onset left bundle branch block (LBBB) post-TAVR at risk of atrioventricular block. However, tools to optimize the yield of such strategy are needed. We therefore aimed to investigate whether 12-lead ECG changes post-TAVR may help identify patients with abnormal EPS findings., Materials and Methods: Consecutive patients with new-onset LBBB post-TAVR who underwent EPS were included. PR and QRS intervals were measured on 12-lead ECG pre-TAVR and during EPS. Abnormal EPS was defined as an HV interval > 55 ms., Results: Among 61 patients, 28 (46%) had an HV interval > 55 ms after TAVR. Post-TAVR PR interval and ΔPR (PR-post-pre-TAVR) were significantly longer in patients with prolonged HV (PR: 188 ± 38 vs. 228 ± 34 ms, p < 0.001, ΔPR: 10 ± 30 vs. 34 ± 23 ms, p = 0.001), while no difference was found in QRS duration. PR and ΔPR intervals both effectively discriminated patients with HV > 55 ms (AUC = 0.804 and 0.769, respectively; p < 0.001). A PR > 200 ms identified patients with abnormal EPS results with a sensitivity of 89% and a negative predictive value (NPV) of 88%. ΔPR ≥ 20 ms alone provided a somewhat lower sensitivity (64%) but combining both criteria (i.e., PR > 200 ms or ΔPR ≥ 20 ms) identified almost every patients with abnormal HV (sensitivity = 96%, NPV = 95%). Selecting EPS candidate based on both criteria would avoid 1/3 of exams., Conclusion: PR interval assessment may be useful to select patients with new-onset LBBB after TAVR who may benefit most from an EPS. In patients with PR ≤ 200 ms and ΔPR < 20 ms the likelihood of abnormal EPS is very low independently of QRS changes., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Pagnoni, Meier, Luca, Fournier, Aminfar, Gentil, Haddad, Domenichini, Lebloa, Herrera-Siklody, Cook, Goy, Roguelov, Girod, Rubimbura, Dupré, Eeckhout, Pruvot, Muller and Pascale.)

Background: Our goal was to evaluate the performance of a new wearable arm located pulse oximeter., Methods: Twelve volunteers were monitored with three pulse oximeters and underwent desaturation to 70% SaO 2 . We compared the accuracy of SpO 2 reading from the SmartCardia system with SpO 2 using two well established devices (Masimo and Nellcor) as reference. Oximetry was performed at different level of oxygen saturation varying from 70 to 100%. Bias, ARMS and precision were evaluated using Bland-Altman plots., Results: The mean (SD) differences between SaO 2 compared to SpO 2 and the devices were as follows: SaO 2 versus Masimo 2,12 ± 1,01% (95% CI 1,45 to 2,79), SaO 2 versus Nellcor 0,78 ± 0,58% (95% CI - 0,29 to 1,65) and SaO 2 versus SmartCardia 0,42 ± 0,24% (95% CI - 0,64 to 1,46). The bias between SmartCardia, Masimo, Nellcor devices and SaO 2 was 0.16 (95% CI 0.05 to 0.33) and LoA (level of agreements) 2.96 (95% CI - 2,68 to 2,89) for SmartCardia, 2,02 (95% CI 1,49 to 2,54) and LoA - 6 to 11 for Masimo, and 0,76 (95% CI 0,5 to - 1) and LoA - 3,5 to 5,0 for Nellcor. ARMS for the 70-100% SaO 2 range was 1,4 for SmartCardia, 5,0 for Masimo and 2,31 for Nellcor., Conclusions: The new wireless SmartCardia SpO 2 measurement system demonstrated in-line results, bias, ARMS and precision in healthy volunteers, when compared with the gold standard SaO2 and with two well established systems, Masimo and Nellcor., Trial Registration: The present trial was prospectively registered at UCSF record (registration number:10-00437), on March 8, 2021., (© 2022. The Author(s).)

Aims: To compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES)., Methods: The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years., Results: Five-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup., Conclusion: Five-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up., (© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: The Academic Research Consortium have identified a set of major and minor risk factors in order to standardize the definition of a High Bleeding Risk (ACR-HBR). Aims: The aim of this study is to stratify the bleeding risk in patients included in the Cardio-Fribourg registry, according to the Academic Research Consortium for High Bleeding Risk (ACR-HBR) definition, and to report ischemic and hemorrhagic events at 2-year of clinical follow-up. Methods: Between 2015 and 2017, consecutive patients undergoing percutaneous coronary intervention were prospectively included in the Cardio-Fribourg registry. Patients were considered high (HBR) or low (LBR) bleeding risk depending on the ARC-HBR definition. Primary endpoints were hierarchical major bleeding events as defined by the Bleeding Academic Research Consortium (BARC) grade 3-5, and ARC patient-oriented major adverse cardiac events (POCE) at 2-year follow-up. Results: Follow-up was complete in 1,080 patients. There were 354 patients in the HBR group (32.7%) and 726 patients in the low-bleeding risk (LBR) group (67.2%). At 2-year follow-up, cumulative BARC 3-5 bleedings were higher in HBR (10.5%) compared to LBR patients (1.5%, p < 0.01) and the impact of HBR risk factors was incremental. At 2-year follow-up, POCE were more frequent in HBR (27.4%) compared to LBR group (18.2%, <0.01). Overall mortality was higher in HBR (14.0%) vs. LBR (2.9%, p < 0.01). Conclusions: ARC-HBR criteria appropriately identified a population at a higher risk of bleeding after percutaneous coronary intervention. An increased risk of bleeding is also associated with an increased risk of ischemic events at 2-year follow-up., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Doomun, Doomun, Schukraft, Arroyo, Cook, Huwyler, Wenaweser, Stauffer, Goy, Togni, Puricel and Cook.)

Background: The Academic Research Consortium has identified a set of major and minor risk factors in order to standardize the definition of a high bleeding risk (ACR-HBR). Oral anticoagulation is a major criterion frequently observed. Aims: The objective of this study is to quantify the risk of bleeding in patients on oral anticoagulation with at least one additional major ACR-HBR criteria in the Cardio-Fribourg Registry. Methods: Between 2015 and 2017, consecutive patients undergoing percutaneous coronary intervention were prospectively included in the Cardio-Fribourg registry. The study population included patients with ongoing long-term oral anticoagulation (OAC) and planned to receive triple antithrombotic therapy. Patients were divided in two groups: patients on OAC with at least one additional major ACR-HBR criteria vs. patients on OAC without additional major ACR-HBR criteria. The primary endpoint was any bleeding during the 24-month follow-up. Secondary bleeding endpoint was defined as Bleeding Academic Research Classification (BARC) ≥3. Results: Follow-up was completed in 142 patients at high bleeding risk on OAC, of which 33 (23%) had at least one additional major ACR-HBR criteria. The rate of the primary endpoint was 55% in patients on OAC with at least one additional ACR-HBR criteria compared with 14% in patients on OAC without additional ACR-HBR criteria (hazard ratio, 3.88; 95%CI, 1.85-8.14; p < 0.01). Patients with additional major ACR-HBR criteria also experienced significantly higher rates of BARC ≥ 3 bleedings (39% at 24 months). Conclusion: The presence of at least one additional ACR-HBR criterion identifies patients on OAC who are at very high risk of bleeding after percutaneous coronary intervention., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Schukraft, Huwyler, Ottiger-Mankaka, Lehmann, Cook, Doomun, Doomun, Goy, Stauffer, Togni, Arroyo, Puricel and Cook.)

We report the case of an 18-year-old female admitted to the hospital for severe hemodynamic instability and fatal outcome within 6 hours following admission. Significant electrocardiographic modifications were noted and are presented with diagnostic options. ( Level of Difficulty: Intermediate. )., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2021 The Authors.)

Objectives: Bioprosthetic valve deterioration remains a major limitation following aortic valve replacement. Favorable results have been reported with an autologous pericardium aortic valve neocuspidization., Methods: Seventy patients (31 women and 39 men) (mean age, 62 ± 12 years) with aortic stenosis (n = 52 [74%]) or aortic regurgitation (n = 18 [26%]) underwent the aortic valve neocuspidization procedure. Thirty-four patients (49%) had a tricuspid valve, 35 (50%) had a bicuspid valve, and 1 (1%) had a monocuspid valve. European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons scores were, respectively, 2.2% ± 2% and 2.0% ± 1.8%. Four patients (6%) had active endocarditis and 2 (3%) had endocarditis sequelae. One patient (1%) had fibroelastoma. A combined procedure was performed in 33 patients (46%)., Results: The follow-up period was 24 ± 12 months. One patient (1%) died in hospital and 1 patient (1%) underwent conventional valve replacement for significant aortic regurgitation. Postoperative peak and mean pressure gradients were respectively 14 ± 5 and 8 ± 3 mm Hg. Aortic valve area was 2.5 ± 0.6 cm 2 . During follow-up, no patients died. Reintervention occurred in 2 patients (3%). At last follow-up, peak pressure gradient was 13 ± 7 mm Hg, mean pressure gradient was 7 ± 4 mm Hg, and aortic valve area was 2.3 ± 0.7 cm 2 . There was 1 recurrence of moderate aortic stenosis (1%). All patients were in New York Heart Association functional class I (90%) or II (10%). Freedom from major valve-related events was 92.1%, (98.5% for death, 95.2% for reintervention, and 95.2% for endocarditis)., Conclusions: In our experience, the midterm outcomes of the aortic valve neocuspidization procedure with autologous glutaraldehyde fixed pericardium were acceptable for survival, operative risk and valve-related complications, for our all-comer patient population with various aortic valve diseases., (© 2021 The Author(s).)

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Cardiac arrhythmias are very common but underdiagnosed due to their transient and asymptomatic nature. An optimization of arrhythmia detection would permit to better treat patients and could substantially reduce morbidity and mortality. The SmartCardia ScaAI wireless patch is a novel CE IIa approved, single-lead electrocardiographic (ECG) ambulatory monitor designed for cardiac arrhythmias detection. Hypothesis: The accuracy of the new SmartCardia wireless patch to detect arrhythmias is comparable to the conventional Holter monitoring. Methods: Patients referred for a suspicion of arrhythmia between February and March 2020 were included in the trial. Simultaneous ambulatory ECG were recorded using a conventional 24-h Holter and the SmartCardia. The primary endpoint was the detection of cardiac arrhythmias over the total wear time of the devices, defined as premature atrial contraction (PAC), supraventricular tachycardia ≥3 beats, premature ventricular contraction (PVC), and ventricular tachycardia ≥3 beats. Conduction abnormalities, pause ≥2 s and atrioventricular block (AVB), were also tracked. McNemar's test was used to compare the matched pairs of data from both devices. Results: A total of 40 patients were included in the trial. Over the total wear time, there was no significant difference between the devices for ventricular and supraventricular arrhythmias detection. Pauses and AVB were equally identified by the two devices in three patients. Conclusion: Over the total wear time, the SmartCardia device showed an accuracy to detect arrhythmia similar to the 24-h Holter monitoring: single-lead, adhesive-patch monitoring might become an interesting alternative to the conventional Holter monitoring., Competing Interests: SM, FR, and MM are members of the board of SmartCardia. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2020 Murali, Brugger, Rincon, Mashru, Cook and Goy.)

Increased age impacts the first medical contact to revascularisation delay in patients with STEMI. Patients with shorter treatment delays (&lt;90 minutes after first medical contact) have significantly lower major adverse cardiac events rates at 3 years.

Background: Interventional cardiologists are exposed to radiation-induced diseases, partly due to patient's scatter radiation., Objectives: We sought to compare the radiation exposure (RE) of the cardiac catheterization room staff using SEPARPROCATH®, a novel radio-protective drape versus standard shielding equipment., Methods: This was a two-step prospective, randomized pilot trial: first, in experimental conditions using a phantom model, and second, during cardiac catheterization. Primary end-point was operator RE corresponding to the ratio between operator cumulative dose (CD) and dose area product (DAP). Secondary end-points were nurse RE, operator and nurse CD, DAP, and fluoroscopy time., Results: A total of 51 patients were included. SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] μSv/Gy.cm 2 without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] μSv/Gy.cm 2 , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively. Similar reductions were observed for operator and nurse CDs. No difference was found in DAP (19 [11-29] vs. 14 [10-32] Gy.cm 2 without SEPARPROCATH®, p value 0.81)., Conclusion: SEPARPROCATH® offers significant additional radioprotection to the operator and nurse during cardiac catheterization without affecting patient safety., (© 2019 Wiley Periodicals, Inc.)

Aortic pseudo-aneurysm following the Bentall procedure is a rare but potentially severe complication. Surgical reintervention represents a high risk. We report on two cases with different pseudo-aneurysm types which were successfully treated using two different percutaneous techniques. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Aims: To compare endothelium-dependent vasomotor function and vascular healing 15 months after implantation of two new-generation drug-eluting stents and biovascular scaffolds (BVS)., Methods and Results: A total of 28 patients previously treated with a SYNERGY stent (bioabsorbable polymer everolimus-eluting stents (BP-EES)), a PROMUS stent (persistent polymer everolimus-eluting stents (PP-EES)) or an ABSORB (BVS) underwent control coronary angiography, 15 months after implantation, coupled with optical coherence tomography imaging and supine bicycle exercise. Intracoronary nitroglycerin was administered after exercise testing. Coronary vasomotor response was assessed using quantitative coronary angiography at rest, during supine bicycle exercise and after nitroglycerin. The primary end point was the percent change in mean lumen diameter compared with baseline. Secondary end points were strut coverage and apposition.There were no significant differences in vasomotor response between the three treatment groups. Patients with PP-EES showed significant vasoconstriction of the proximal peristent segment at maximum exercise (P=0.02). BP-EES (2.7%, 95% CI 0 to 5.5) and BVS (3.2%, 95% CI 0 to 6.7) showed less uncovered struts than PP-EES (12.1%, 95% CI 2.9 to 21.3, P=0.02 and 0.09, respectively). Complete strut apposition was more frequently seen with BP-EES (99.6%, 95% CI 99.2 to 100) than with BVS (98.9%, 95% CI 98.2 to 99.6, P=0.04) or PP-EES (95.0%, 95% CI 91.6 to 98.5, P=0.001)., Conclusion: BVS and thin strut BP-EES have a reassuring vasomotion profile, suggesting minimal endothelial dysfunction 15 months after implantation., Competing Interests: Competing interests: SC has received speaker fees/honoraria from Abbott Vascular, Biosensors International, and Boston Scientific.

Background: Data from randomized controlled trials have shown that the ABSORB BVS is non-inferior to Cobalt Chromium everolimus-eluting stents at 2years., Methods & Results: The EVERBIO II trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) is a single-center, assessor-blind, randomized controlled trial enrolling 240 patients with an allocation ration of 1:1:1 conducted at University and Hospital Fribourg, Switzerland. The studied devices were an everolimus-eluting persistent polymer stent (EES), a biolimus-eluting stent with bioabsorbable polymer (BES) and a fully bioresorbable vascular scaffold (BVS). Clinical end points collected at 9months, 12months, and 2years, were academic research consortium defined composites, device thrombosis and target-vessel revascularization. Clinical follow-up at 2years was available in 96% (N=77) of patients in the EES group, in 100% (N=80) in the BES and 99% (N=77) in the BVS group. The device-oriented composite end point of cardiac death, target-vessel myocardial infarction and target-lesion revascularization occurred in 13 (16%) patients treated with EES, in 7 (9%) patients treated with BES and in 16 (21%) patients treated with BVS. There was no significant difference when the metallic stents were compared to the BVS (p=0.12). There was one late scaffold thrombosis throughout the trial in the BVS group, and no definite stent thrombosis in either EES or BES treated patients., Conclusions: The current analysis shows no significant differences with regard to clinical outcomes at 2years between BVS and the best-in-class metallic DES. Event rates were numerically higher in BVS-treated patients. However, when BVS were compared to BES alone, the occurrence of device related adverse events was significantly increased., (Copyright © 2017. Published by Elsevier B.V.)

Objectives: This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention., Background: Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce., Methods: The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization., Results: Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17)., Conclusions: The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcarotid access is an alternative route for transcutaneous aortic valve implantation (TAVI) in patients with impossible transfemoral access., Aims: We evaluated the safety, effectiveness and early and late clinical outcomes of CoreValve ® implantation via the common carotid artery., Methods: Eighteen patients (10 men, 8 women; mean age 84±5 years) at high surgical risk (mean EuroSCORE II 16±13%) with significant peripheral artery disease underwent TAVI via common carotid artery access under general anaesthesia. Mean aortic valve area was 0.64±0.13cm 2 (0.36±0.07cm 2 /m 2 )., Results: At a mean follow-up of 605±352 days, two patients (11%) had died in hospital, on days 6 and 20, as a result of sepsis with multiorgan failure (n=1) or pneumonia (n=1). There were no perioperative deaths, myocardial infarctions or strokes. Perioperative prosthesis embolization occurred in one patient (6%), requiring implantation of a second valve. In-hospital complications occurred in four patients (23%): blood transfusion for transient significant bleeding at the access site in one patient (6%); permanent pacemaker implantation in two patients (11%); and pericardial drainage in one patient (6%). The rate of event-free in-hospital stay was 66%. Post-procedural echocardiography showed very good haemodynamic performance, with a mean gradient of 8±3mmHg. Moderate paravalvular leak was present in one patient (6%). Mean intensive care unit stay was 48±31h; mean in-hospital stay was 7±3 days., Conclusion: TAVI performed by transcarotid access in this small series of severely ill patients was associated with a low incidence of complications, which were associated with the procedure itself rather than the access route., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

We sought to compare operator radiation exposure during procedures using right femoral access (RFA), right radial access (RRA), and left radial access (LRA) during coronary angiography (CA) and percutaneous coronary intervention (PCI). Because of an increased incidence of long-term malignancy in interventional cardiologists, operator radiation exposure is of rising concern. This prospective study included all consecutive patients who underwent elective or emergency CA ± PCI from September 2014 to March 2015. The primary end point was operator radiation exposure, quantified as the ratio of operator cumulative dose (CD) and patient radiation reported as dose-area product (DAP) (CD/DAP). Secondary end points included CD, DAP, and fluoroscopy time (FT). Overall 830 procedures (457 CA [55%] and 373 PCI [45%]) were performed, 455 (55%) through RFA, 272 (33%) through RRA, and 103 (12%) through LRA. The CD/DAP was lower in RFA (0.09 μSv/Gycm(2) [0.02 to 0.20]) compared with RRA (0.47 μSv/Gycm(2) [0.25 to 0.75], p <0.001). The LRA showed lower CD/DAP compared with RRA (p <0.001). CD was significantly lower in RFA (3 μSv [1 to 7]) compared with RRA (12 μSv [6 to 29], p <0.001). The LRA showed lower CD compared with RRA (p <0.001). There were no significant differences in DAP among the 3 access sites. FT was similar for the 3 groups (RFA 7 ± 7, RRA 5 ± 5, LRA 6 ± 5 minutes, RFA vs RRA: p = 1, RFA vs LRA: p = 0.16, RRA vs LRA: p = 0.52). In conclusion, the use of RFA during CA ± PCI is associated with significantly lower operator radiation exposure compared with RRA. LRA is associated with significantly lower operator radiation exposure compared with RRA., (Copyright © 2016 Elsevier Inc. All rights reserved.)

As the number and complexity of fluoroscopically guided interventions increase, a serious effort has to be put on the optimisation of the X-ray dose delivered to the patient. In order to set up this optimisation process, the clinical practice for a given cardiology centre has to be analysed with relevant statistical power and compared with the data at local or national level. Data from 8 Swiss cardiology centres for 10 different vascular and heart rhythm procedures have been collected. The collected dose indicators were, when available, cumulated air kerma, cumulated dose-area product, fluoroscopy time and the number of images per procedure. Data analysis was performed using an in-house software solution in terms of the first, second and third quartiles. This kind of large-scale analysis could yield some onsets towards local practice optimisation based on anonymous dose indicator cross-comparison. Further effort should nevertheless be made in order to proceed towards an operator-based data analysis, thus allowing for an individual practice optimisation., (© The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background: Interventional cardiologists may be immune to stress, allowing them to perform complex percutaneous interventions under pressure., Objectives: To assess heart rate (HR) variations as a surrogate marker of stress of interventional cardiologists during percutaneous cardiac procedures and in every-day life., Design: This is a single-centre observational study including a total of six male interventional cardiologists performing coronary interventions and pacemaker implantations. Participants were asked to record their HR with the Apple Watch Device during procedures, every-day life and control activities such as outpatient consultations, sport, marital conflicts and sexual intercourse., Results: Average daily HR was 88±17 bpm. During work days, HR increased significantly during procedures (90±17 bpm) compared with days outside the cathlab (87±17 bpm, p=0.02). The average HR was higher during a regular week working (88±16 bpm) compared with weekends off (84±18 bpm, p=0.002). Complex cardiac procedures were associated with higher HR up to 122 bpm. Peak HR were higher during physical exertion. Of note, participants complained of hypersexuality and mania after night shifts., Conclusions: Work and especially percutaneous cardiac procedures increase HR independently of physical exertion suggesting that interventional cardiologists experience mental stress and emotions.

Background: Drug-eluting stents (DES) have been associated with local endothelial dysfunction in the segments proximal and distal to the stent (peristent segments) and increased thrombotic risk in long term follow-up. Little data exists on endothelial function post-implantation of new DES with biodegradable polymer. The aim of our study was to compare the local endothelial function assessed by exercise induced coronary vasomotion after implantation of a biolimus A9-eluting stent with biodegradable polymer (BES) with an everolimus-eluting stent with durable polymer (EES)., Methods: Coronary vasomotion was evaluated with quantitative coronary angiography at rest and during supine bicycle exercise in nine patients with EES and thirteen patients with BES, 16 months after stent implantation. Mean luminal diameter of the stent, peristent segments, and of a control vessel were determined at rest, during exercise, and after the administration of nitroglycerine., Results: The control vessel showed exercise-induced vasodilatation in both groups (EES: +6.4±5.5%, p=0.07; BES: +7.8±10.1%, p=0.07). Vasomotion in the stented vessel segment was abolished. There was exercise-induced vasoconstriction in both groups in the segments proximal (EES: -9.6±4.5%; p=0.03; BES: -4.3±5.4%, p=0.02) and distal to the stent (EES: -3.2±9.3%; p=0.41, BES -8.6±8.0%, p<0.01). Sublingual nitroglycerin was associated with maximal vasodilatation of the peristent segments in both groups., Conclusion: Alike DES with durable polymer, stents with a biodegradable polymer are associated with exercise-induced paradoxical coronary vasoconstriction of the peristent segments. This data suggests that endothelial dysfunction after DES implantation is not primarily caused by the durability of the polymer coating., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Aims: The aim of this analysis was to compare the long-term safety and efficacy of the biodegradable polymer biolimus-eluting stent (BES) with that of the durable polymer everolimus-eluting stent (EES)., Methods and Results: The COMPARE II study was a prospective, randomised, multicentre, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BES or EES. The pre-specified endpoint at three years was major adverse cardiac events (MACE), a composite of cardiac death, non-fatal myocardial infarction (MI), or target vessel revascularisation (TVR). Moreover, the combined endpoint all-cause death or MI was analysed as a safety, and TVR as an efficacy measure. Three-year follow-up was available in 2,683 patients (99.1%). At three years, MACE occurred in 213 patients (11.9%) in the BES group and in 101 patients (11.1 %) in the EES group (p=0.57). The rate of the combined safety endpoint all-cause death or MI was 9.3% in the BES group vs. 8.4% (p=0.52), while the efficacy measure TVR was 7.6% in BES vs. 6.5% (p=0.27). Interestingly, definite stent thrombosis rates did not differ between groups (1.2% for BES vs. 0.8%, p=0.33)., Conclusions: At three-year follow-up, MACE as well as safety and efficacy measures including stent thrombosis were not statistically different between the biodegradable polymer-coated BES and the durable polymer-coated EES. ClinicalTrials.gov Identifier: NCT01233453.

We perform subsurface ablation of atherosclerotic plaque using ultrafast pulses. Excised mouse aortas containing atherosclerotic plaque were ablated with ultrafast near-infrared (NIR) laser pulses. Optical coherence tomography (OCT) was used to observe the ablation result, while the physical damage was inspected in histological sections. We characterize the effects of incident pulse energy on surface damage, ablation hole size, and filament propagation. We find that it is possible to ablate plaque just below the surface without causing surface damage, which motivates further investigation of ultrafast ablation for subsurface atherosclerotic plaque removal.

Aims: To compare clinical outcome of Amplatzer PFO (APFO) to Cardia PFO (CPFO) occluder. Percutaneous patent foramen ovale (PFO) closure prevents stroke recurrence in stroke due to paradoxical embolism., Methods and Results: The primary endpoint was a composite of stroke, TIA, or peripheral embolism at follow-up. The secondary endpoint was residual shunt. Outcome was compared among 934 (APFO: 712; CPFO: 222) patients, and in 297 propensity score-matched patients. The primary endpoint occurred in 29 patients (0.71/100 patient-years): four (2%) with the CPFO (0.31/100 patient-years), and 25 (4%) with the APFO (0.89/100 patient-years) (p=0.20). Residual shunt at six months was more frequent with the CPFO (31% versus 9%, p<0.001). No differences in residual shunts were seen at the last available echocardiographic follow-up (9±18 months): APFO 11%, CPFO 14%, p=0.22., Conclusions: This study suggests that PFO closure with APFO or CPFO is equally effective for the prevention of recurrent events. Residual shunt was more frequent at six months with CPFO, but was similar to APFO at later follow-up.

Background: The first CE-approved bioresorbable vascular scaffold (BVS) is effective at treating simple lesions and stable coronary artery disease, but it has yet to be assessed versus the best-in-class drug-eluting stents (DES)., Objectives: This study sought to compare the performance of a BVS with that of everolimus-eluting stents (EES) and biolimus-eluting stents (BES) in all-comer patients., Methods: The EVERBIO II (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II) trial was a single-center, assessor-blinded study of 240 patients randomly assigned in a 1:1:1 ratio to EES, BES, or BVS. The only exclusion criterion was a reference vessel diameter >4.0 mm, which precluded treatment with BVS. The primary endpoint was angiographic late lumen loss (LLL) at 9 months. Secondary endpoints included patient-oriented major acute coronary events (MACE) (death, myocardial infarction [MI], and any revascularization), device-oriented MACE (cardiac death, MI, and target lesion revascularization), and stent thrombosis at the 9-month clinical follow-up., Results: Follow-up angiography was performed in 216 patients (90.7%) at 9 months. In-stent LLL was similar between patients treated with BVS (0.28 ± 0.39 mm) and those treated with EES/BES (0.25 ± 0.36 mm; p = 0.30). Clinical outcomes were similar at 9 months: the patient-oriented MACE rate was 27% in BVS and 26% in the EES/BES group (p = 0.83) and the device-oriented MACE rate was 12% in BVS and 9% in the EES/BES group (p = 0.6)., Conclusions: New-generation metallic DES (EES/BES) were not superior to BVS in terms of angiographic LLL and clinical outcomes. (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents [EVERBIO II]; NCT01711931)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Little is known on the "very" long-term incidence of major adverse cardiac events (MACE), target-lesion revascularization (TLR), target-vessel revascularization and stent thrombosis after sirolimus-eluting stent (SES) implantation. We present the first study to provide a 10-year clinical follow-up in an unselected patient population who underwent SES implantation., Methods and Results: We ran a systematic 10-year clinical follow-up in a series of 200 consecutive patients treated with unrestricted SES implantation between April 2002 and April 2003 in two Swiss hospitals. Outcomes and follow-up were obtained in all 200 patients. The cumulative 10-year MACE rate was 47% with all-cause death of 20%, cardiac death of 9%, myocardial infarction of 7%, TLR and target-vessel revascularization of 8% and 11% respectively. Academic Research Consortium-defined "definite and probable" stent thrombosis-rate was 2.5%. TLR risk was maximal between 3 to 6 years. New lesion revascularization increased throughout the study period., Conclusion: Incidence of TLR was maximal 3 to 6 years after SES implantation and decreased thereafter. MACE and non-TLR revascularization rates steadily increased during the complete follow-up underlining the progression of coronary artery disease., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Background: Second-generation everolimus-eluting stents (EES) and third generation biolimus-eluting stents (BES) have been shown to be superior to first-generation paclitaxel-eluting stents (PES) and second-generation sirolimus-eluting stents (SES). However, neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent (DES) implantation overall. The Absorb™ (Abbott Vascular, Abbott Park, IL, USA) is the first CE approved DES with a bioresorbable vascular scaffold (BVS) thought to reduce long-term complication rates. The EVERBIO II trial was set up to compare the BVS safety and efficacy with both EES and BES in all patients viable for inclusion., Methods/design: The EVERBIO II trial is a single-center, assessor-blinded, randomized trial. The study population consists of all patients aged≥18 years old undergoing percutaneous coronary intervention. Exclusion criterion is where the lesion cannot be treated with BVS (reference vessel diameter>4.0 mm). A total of 240 patients will be enrolled and randomly assigned into 3 groups of 80 with either BVS, EES or BES implantation. All patients will undergo a follow-up angiography study at 9 months. Clinical follow-up for up to 5 years will be conducted by telephone. The primary endpoint is in-segment late lumen loss at 9 months measured by quantitative coronary angiography. Secondary endpoints are patient-oriented major adverse cardiac event (MACE) (death, myocardial infarction and target-vessel revascularization), device-oriented MACE (cardiac death, myocardial infarction and target-lesion revascularization), stent thrombosis according to ARC and binary restenosis at follow-up 12 months angiography., Discussion: EVERBIO II is an independent, randomized study, aiming to compare the clinical efficacy, angiographic outcomes and safety of BVS, EES and BES in all comer patients., Trial Registration: The trial listed in clinicaltrials.gov as NCT01711931.

Aims: Second-generation everolimus-eluting stents (EES) are safer and more efficient than first-generation paclitaxel-eluting stents (PES). Third-generation biolimus-eluting stents (BES) have been found to be non-inferior to PES. To date, there is no available comparative study between EES and BES. We aimed to investigate the safety and efficacy of BES with biodegradable polymer compared to EES with durable polymer at a follow-up of two years in an unselected population of consecutively enrolled patients., Methods and Results: A group of 814 consecutive patients undergoing percutaneous coronary intervention (PCI) was enrolled between 2007 and 2010, of which 527 were treated with EES and 287 with BES implantation. Clinical outcome was compared in 200 pairs using propensity score matching. The primary endpoint was a composite of death, myocardial infarction (MI) and target vessel revascularisation (TVR) at two-year follow-up. Median follow-up was 22 months. The primary outcome occurred in 11.5% of EES and 10.5% of BES patients (HR 1.11, 95% CI: 0.61-2.00, p=0.74). At two years, there was no significant difference with regard to death (HR 0.49, 95% CI: 0.18-1.34, p=0.17), cardiac death (HR 0.14, 95% CI: 0.02-1.14, p=0.66) or MI (HR 6.10, 95% CI: 0.73-50.9, p=0.10). Stent thrombosis (ST) incidence was evenly distributed between EES (n=2) and BES (n=2) (p-value=1.0)., Conclusions: This first clinical study failed to demonstrate any significant difference regarding safety or efficacy between these two types and generations of drug-eluting stents (DES).

Background: Drug-eluting stents with durable biocompatible or biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation drug-eluting stents. We aimed to compare the safety and efficacy of a biodegradable polymer-coated biolimus-eluting stent with a thin-strut everolimus-eluting stent coated with a durable biocompatible polymer., Methods: This open-label, prospective, randomised, controlled, non-inferiority trial was undertaken at 12 sites across Europe. We used limited exclusion criteria (age >18 years, life expectancy >5 years, reference vessel diameter 2·0-4·0 mm) to enrol patients eligible for percutaneous coronary intervention. Patients were randomly allocated (2:1) by computer-generated random numbers to receive either a biodegradable polymer biolimus-eluting stent (Nobori, Terumo, Tokyo, Japan) or a durable fluoropolymer-based everolimus-eluting stent (Xience V or Prime, Abbott Vascular, Santa Clara, CA, USA, or Promus, Boston Scientific, Natick, MA, USA). The primary endpoint was a composite of safety (cardiac death and non-fatal myocardial infarction) and efficacy (clinically indicated target vessel revascularisation) at 12 months, analysed by intention to treat. Patients received dual antiplatelet therapy for 12 months after discharge. The trial is registered with ClinicalTrials.gov, number NCT01233453., Findings: From Jan 12, 2009, to Feb 7, 2011, we enrolled 2707 patients (4025 lesions), 1795 of whom were assigned to receive the biolimus-eluting stent (2638 lesions) and 912 to an everolimus-eluting stent (1387 lesions). 2688 (99·3%) patients completed 12 months' follow-up. Significantly more patients in the biolimus-eluting stent group received a non-assigned stent than did those in the everolimus-eluting stent group (105 [5·9%] vs 19 [2·1%]; p<0·0001). The primary endpoint occurred in 93 (5·2%) patients in the biolimus-eluting stent group and 44 (4·8%) patients in the everolimus-eluting stent group at 12 months (relative risk 1·07 [95% CI 0·75-1·52]; p(non-inferiority)<0·0001). Analysis per protocol did not change the outcome of this trial (p(non-inferiority)<0·0001)., Interpretation: Biodegradable polymer biolimus-eluting stents are as safe and efficacious as the current standard of a thin-strut everolimus-eluting stent with a durable biocompatible polymer. We need to follow-up patients for longer to show whether the biolimus-eluting stent reduces the risk of stent thrombosis after 1 year when compared with the everolimus-eluting stent., Funding: Terumo Europe (Leuven, Belgium) and the Research Foundation of the Cardiology Department, Maasstad Hospital (Rotterdam, Netherlands)., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Background: The salt linked to the clopidogrel molecule in generic preparations is suspected to affect its clinical efficacy. There is a lack of information about inhibition of platelet reactivity by generic preparations., Aims: To compare the effect of original clopidogrel (clopidogrel bisulphate [Plavix(®)]), generic clopidogrel preparations (clopidogrel hydrochloride [Clopidogrel-Mepha(®)]; clopidogrel besylate [Clopidogrel Sandoz(®)]) and prasugrel (Efient(®)) on platelet reactivity in patients with coronary artery disease., Methods: Patients with coronary artery disease treated with stents received, in a random sequence, original clopidogrel bisulphate, clopidogrel hydrochloride and clopidogrel besylate. Platelet function was assessed with the Multiplate analyser after an initial loading dose (600 mg) and at day 10 after each treatment period. Prasugrel was given for another 10 days. An adenosine diphosphate (ADP) test value<46 antiaggregation units (U) was defined as therapeutic platelet inhibition., Results: Sixty patients (mean age 69 ± 10 years; 50 men) were randomized. Original clopidogrel bisulphate, clopidogrel hydrochloride and clopidogrel besylate provided similar inhibition of platelet reactivity with values of 31 ± 25, 33 ± 28 and 28 ± 23 U, respectively (P not significant). Prasugrel provided better inhibition of platelet function (10 ± 11 vs. 31 ± 25 U for clopidogrel bisulphate; P<0.001). An ADP test value>46 U was measured in 11 patients (18%) with clopidogrel bisulphate, 13 (22%) with clopidogrel besylate and 13 (22%) with clopidogrel hydrochloride compared with only one (2%) with prasugrel., Conclusion: Generic clopidogrel preparations provided similar inhibition of platelet reactivity to original clopidogrel bisulphate, although prasugrel was more efficient., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)