Next-generation balloon-expandable Myval transcatheter heart valve in low-risk aortic stenosis patients.

OBJECTIVES: We aimed to describe hemodynamic performance and clinical outcomes at 30-day follow-up of the balloon-expandable (BE) Myval transcatheter heart valve (THV) in low-risk patients. BACKGROUND: The results of the next-generation BE Myval THV in low-risk aortic stenosis (AS) patients are still unknown. METHODS: Retrospective registry performed in nine European centers including patients with low predicted operative mortality risk according to Society of thoracic surgeons (STS) and European system for cardiac operative risk evaluation (EuroSCORE-II) scores. RESULTS: Between September 2019 and February 2021, a total of 100 patients (51% males, mean age 80 ± 6.5 years) were included. Mean STS score and EuroSCORE-II were 2.4 ± 0.8% and 2.2 ± 0.7%, respectively. Intermediate sizes were used in 39% (21.5 mm: 8%, 24.5 mm: 15%, 27.5 mm: 15%). There were no cases of valve embolization, coronary artery occlusion, annulus rupture, or procedural death. A definitive pacemaker implantation was needed in eight patients (8%). At 30-day follow-up aortic valve area (0.7 ± 0.2 vs. 2.1 ± 0.6 cm2 ) and mean aortic valve gradient (43.4 ± 11.1 vs. 9.0 ± 3.7 mmHg) improved significantly (p < 0.001). Moderate aortic regurgitation occurred in 4%. Endpoints of early safety and clinical efficacy were 3 and 1%, respectively. CONCLUSIONS: Hemodynamic performance and 30-day clinical outcomes of the BE Myval THV in low-risk AS patients were favorable. Longer-term follow-up is warranted.

Balloon-Expandable TAVR Bioprostheses: Area or Perimeter Sizing? A Prospective Pilot Study.

Objective: In TAVR, area sizing is used for balloon-expandable (BE) valves, whereas self-expanding valves are sized to annulus perimeter. For BE valves, this seems illogical: these frames force a circular shape even on an ellipsoid annulus. This can potentially lead to relative undersizing when area sizing is being applied. We developed a perimeter-based sizing algorithm to evaluate the safety and feasibility of perimeter sizing for the Myval BE valve. Methods: In this prospective single-center study, 60 patients with severe aortic stenosis treated with the Myval BE valve were included. Perimeter sizing was used with limited oversizing of 3.7% ± 1.3% compared to the annulus perimeter. After TAVR, clinical outcomes were evaluated at 30 days and 1 year. An echocardiographic follow-up took place at 30 days. Results: At 30 days, the need for PPI and stroke occurred in 2% and 3% of the patients, respectively. Moreover, cardiac death and moderate-severe PVL were absent. At 1-year, cardiac death and stroke were observed in 3% and 8% of the patients, respectively. In 33.3% of the patients, a larger valve size was implanted compared to the valve size calculated by area sizing. Conclusions: Perimeter sizing with the Myval BE valve leads to substantial use of larger valve sizes and favorable clinical outcomes, with low PPI and the absence of significant PVL. A randomized controlled trial is being planned to prove the superiority of this alternative sizing method.

Upper Extremity Function following Transradial Percutaneous Coronary Intervention: Results of the ARCUS Trial.

Objectives: To determine the incidence of upper extremity dysfunction (UED), after a transradial percutaneous coronary intervention (TR-PCI). Background: Transradial approach (TRA) is the preferred approach for coronary interventions. However, upper extremity complications may be underreported. Methods: The ARCUS was designed as a prospective cohort study, including 502 consecutive patients admitted for PCI. Patients treated with transfemoral PCI (TF-PCI) acted as a control group. A composite score of physical examinations and questionnaires was used for determining UED. Clinical outcomes were monitored during six months of follow-up, with its primary endpoint at two weeks. Results: A total of 440 TR-PCI and 62 control patients were included. Complete case analysis (n = 330) at 2 weeks of follow-up showed that UED in the TR-PCI group was significantly higher than that in the TF-PCI group: 32.7% versus 13.9%, respectively (p=0.04). The three impaired variables most contributing to UED were impaired elbow extension, wrist flexion, and extension. Multivariate logistic regression showed that smokers were almost three times more likely to develop UED. Conclusions: This study demonstrates that UED seems to occur two times more in TR-PCI than in TF-PCI at 2 weeks of follow-up. However, no significant long-term difference or difference between the intervention arm and the contralateral arm was found at all timepoints.

Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial.

AIMS: The aim of this study was to understand the impact of optical coherence tomography (OCT)-detected thin-cap fibroatheroma (TCFA) on clinical outcomes of diabetes mellitus (DM) patients with fractional flow reserve (FFR)-negative lesions. METHODS AND RESULTS: COMBINE OCT-FFR study was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with ≥1 FFR-negative lesions (target lesions) were classified in two groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint compared FFR-negative TCFA-positive patients with FFR-negative TCFA-negative patients for a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 months. Among 550 patients enrolled, 390 (81%) patients had ≥1 FFR-negative lesions. Among FFR-negative patients, 98 (25%) were TCFA positive and 292 (75%) were TCFA negative. The incidence of the primary endpoint was 13.3% and 3.1% in TCFA-positive vs. TCFA-negative groups, respectively (hazard ratio 4.65; 95% confidence interval, 1.99-10.89; P < 0.001). The Cox regression multivariable analysis identified TCFA as the strongest predictor of major adverse clinical events (MACE) (hazard ratio 5.12; 95% confidence interval 2.12-12.34; P < 0.001). CONCLUSIONS: Among DM patients with ≥1 FFR-negative lesions, TCFA-positive patients represented 25% of this population and were associated with a five-fold higher rate of MACE despite the absence of ischaemia. This discrepancy between the impact of vulnerable plaque and ischaemia on future adverse events may represent a paradigm shift for coronary artery disease risk stratification in DM patients.

Rationale and design of the ARCUS: Effects of trAnsRadial perCUtaneouS coronary intervention on upper extremity function.

OBJECTIVE: The aim of this study is to provide a complete insight in the access-site morbidity and upper extremity function after Transradial Percutaneous Coronary Intervention (TR-PCI). BACKGROUND: In percutaneous coronary intervention the Transradial Approach (TRA) is gaining popularity as a default technique. It is a very promising technique with respect to post-procedure complications, but the exact effects of TRA on upper extremity function are unknown. METHODS AND RESULTS: The effects of trAnsRadial perCUtaneouS coronary intervention on upper extremity function (ARCUS) trial is a multicenter prospective cohort study that will be conducted in all patients admitted for TR-PCI. Clinical outcomes will be monitored during a follow-up of 6 months, with its primary endpoint at two weeks of follow-up. To investigate the complete upper extremity function, a combination of physical examinations and validated questionnaires will be used to provide information on anatomical integrity, strength, range of motion (ROM), coordination, sensibility, pain, and functioning in everyday life. Procedural and material specifications will be registered in order to include all possible aspects influencing upper extremity function. CONCLUSIONS: Results from this study will elucidate the effect of TR-PCI on upper extremity function. This creates the opportunity to further optimize TR-PCI, to make improvements in functional outcome and to prevent morbidity regarding full upper extremity function. © 2016 Wiley Periodicals, Inc.

Impact of multisite artery disease on clinical outcomes after percutaneous coronary intervention: an analysis from the e-Ultimaster registry.

BACKGROUND: Multisite artery disease is considered a 'malignant' type of atherosclerotic disease associated with an increased cardiovascular risk, but the impact of multisite artery disease on clinical outcomes after percutaneous coronary intervention (PCI) is unknown. METHODS: Patients enrolled in the large, prospective e-Ultimaster study were grouped into (1) those without known prior vascular disease, (2) those with known single-territory vascular disease, and (3) those with known two to three territories (i.e coronary, cerebrovascular, or peripheral) vascular disease (multisite artery disease). The primary outcome was coronary target lesion failure (TLF), defined as the composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization at 1-year. Inverse propensity score weighted (IPSW) analysis was performed to address differences in baseline patient and lesion characteristics. RESULTS: Of the 37 198 patients included in the study, 62.3% had no prior known vascular disease, 32.6% had single-territory vascular disease, and 5.1% had multisite artery disease. Patients with known vascular disease were older and were more likely to be men and to have more co-morbidities. After IPSW, the TLF rate incrementally increased with the number of diseased vascular beds (3.16%, 4.44%, and 6.42% for no, single, and multisite artery disease, respectively, P < 0.01 for all comparisons). This was also true for all-cause death (2.22%, 3.28%, and 5.29%, P < 0.01 for all comparisons) and cardiac mortality (1.26%, 1.91%, and 3.62%, P ≤ 0.01 for all comparisons). CONCLUSIONS: Patients with previously known vascular disease experienced an increased risk of adverse cardiovascular events and mortality post-PCI. This risk is highest among patients with multisite artery disease.Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02188355.

Morphological characteristics of lesions with thin cap fibroatheroma-a substudy from the COMBINE (OCT-FFR) trial.

AIMS: To study if any qualitative or quantitative optical coherence tomography (OCT) variables in combination with thin cap fibroatheroma (TCFA) patients could improve the identification of lesions at risk for future major adverse cardiac events (MACEs). METHODS AND RESULTS: From the combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT-FFR) trial database (NCT02989740), we performed a detailed assessment OCT qualitative and quantitative variables in TCFA carrying diabetes mellitus (DM) patients with vs. without MACE during follow-up. MACEs were defined as a composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization, and hospitalization for unstable angina. From the 390 fractional flow reserve (FFR)-negative DM patients, 98 (25.2%) had ≥1 OCT-detected TCFA, of which 13 (13.3%) had MACE and 85 (86.7%) were event-free (non-MACE). The baseline characteristics were similar between both groups; however, a smaller minimal lumen area (MLA) and lower mean FFR value were observed in MACE group (1.80 vs. 2.50 mm2, P = 0.01, and 0.85 vs. 0.89, P = 0.02, respectively). Prevalence of healed plaque (HP) was higher in the MACE group (53.85 vs. 21.18%, P = 0.01). TCFA were predominantly located proximal to the MLA. TCFA area was smaller in the MACE group, while no difference was observed regarding the lesion area. CONCLUSION: Within TCFA carrying patients, a smaller MLA, lower FFR values, and TCFA location adjacent to a HP were associated with future MACE. Carpet-like measured lesion area surface was similar, while the TCFA area was smaller in the MACE arm, and predominantly located proximal to the MLA.

Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study.

INTRODUCTION AND OBJECTIVES: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. METHODS: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. RESULTS: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. CONCLUSIONS: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.

Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial.

About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness. Since continuation of OAC is associated with the ancillary benefit that it simplifies periprocedural management, the primary outcome is first analysed for non-inferiority; if non-inferiority is proven, superiority will be tested. Recruitment started in November 2020, and the trial will continue until a total of 858 patients have been included and followed for 90 days. In summary, POPular PAUSE TAVI is the first randomised clinical trial to assess the safety and efficacy of periprocedural continuation versus interruption of OAC in patients undergoing TAVI.

Clinical Performance of a Paclitaxel Drug-Coated Balloon in Real-World Percutaneous Coronary Intervention Practice: The PEARL Registry.

BACKGROUND: Randomized controlled trials for in-stent restenosis (ISR) and de novo lesions in small-diameter vessels have shown promising results, but data on DCB use in real-world practice are still scarce. The aim of the PEARL (Paclitaxel-Eluting Angioplasty Balloon in the Real-World) registry was to evaluate the safety and efficacy of a paclitaxel DCB in real-world percutaneous coronary intervention (PCI) practice. METHODS: Between 2014 and 2019, a total of 513 patients treated with the Protégé paclitaxel DCB (Wellinq) were prospectively included at 4 hospitals in the Netherlands. The primary endpoint was 2-year major adverse cardiac event (MACE), defined as cardiac death, target-vessel myocardial infarction, or target-lesion revascularization (TLR). RESULTS: DCB was used for ISR in 382 patients and for de novo lesions in 131 patients. Acute coronary syndrome was the reason for presentation in 58.9% of patients. At lesion level, 34.1% of lesions were classified as type B2 and 36.1% as type C. Predilation was performed in 62.2% and noncompliant DCB was used in 40.7% of lesions. DCB-related procedural complications were infrequent (3.3%, mostly coronary dissection [2.3%]). Bailout stenting was required in 3.1%. MACE during 2-year follow-up occurred in 17.1% of patients treated for ISR and 9.7% of patients treated for de novo lesions. The incidence of TLR was 11.7% of ISR patients and 2.9% of de novo patients. History of coronary artery bypass grafting and lesion length were predictors of MACE in patients treated for ISR. CONCLUSION: The use of Protégé paclitaxel DCB for PCI of ISR and de novo lesions is safe and effective during 2-year follow-up.

Treatment and Management of Upper Extremity Dysfunction Following Transradial Percutaneous Coronary Intervention: A Prospective Cohort Study.

BACKGROUND: The transradial artery access is the benchmark approach in transradial percutaneous coronary intervention (TR-PCI). The purpose of this study was to evaluate the different complications, treatments, and outcome of upper extremity dysfunction following a TR-PCI. METHODS: This was a prospective cohort substudy of patients with access-site complications. The study population consisted of 433 patients treated with TR-PCI. Referral to the hand center was mandated if the patient experienced new-onset or increase of preexistent symptoms in the upper extremity. Patients were followed up to the last control visit (5-7 months after the index procedure) at the hand center. Outcome results were categorized in "symptom-free," "improvement of symptoms," and "no improvement." RESULTS: Forty-one (9% of total) patients underwent assessment at the hand center. Most frequent referral indication was pain in the intervention arm. Women, preexisting sensibility disorder, and osteoarthritis in the intervention arm were associated with increased odds of referral. The most common complications diagnosed were carpal tunnel syndrome (n = 18) and osteoarthritis (n = 15). Thirty patients required further medical treatment. Immobilization therapy was most applied. Seventeen (4% of total) patients had persisting symptoms despite medical treatment. CONCLUSIONS: The occurrence of complications in the upper extremity after a TR-PCI is small. Despite medical treatment, symptoms persisted in 4% of all patients treated with TR-PCI. Possible explanations for the persisting symptoms are exacerbation of latent osteoarthritis and carpal tunnel syndrome by trauma-induced edema. Awareness of TR-PCI-induced complications among all specialists is essential to optimize patient care.

Clinical Outcomes of Percutaneous Coronary Intervention for Bifurcation Lesions According to Medina Classification.

Background Coronary bifurcation lesions (CBLs) are frequently encountered in clinical practice and are associated with worse outcomes after percutaneous coronary intervention. However, there are limited data around the prognostic impact of different CBL distributions. Methods and Results All CBL percutaneous coronary intervention procedures from the prospective e-Ultimaster (Prospective, Single-Arm, Multi Centre Observations Ultimaster Des Registry) multicenter international registry were analyzed according to CBL distribution as defined by the Medina classification. Cox proportional hazards models were used to compare the hazard ratio (HR) of the primary outcome, 1-year target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization), and its individual components between Medina subtypes using Medina 1.0.0 as the reference category. A total of 4003 CBL procedures were included. The most prevalent Medina subtypes were 1.1.1 (35.5%) and 1.1.0 (26.8%), whereas the least prevalent was 0.0.1 (3.5%). Overall, there were no significant differences in patient and procedural characteristics among Medina subtypes. Only Medina 1.1.1 and 0.0.1 subtypes were associated with increased target lesion failure (HR, 2.6 [95% CI, 1.3-5.5] and HR, 4.0 [95% CI, 1.6-9.0], respectively) at 1 year, compared with Medina 1.0.0, prompted by clinically driven target lesion revascularization (HR, 3.1 [95% CI, 1.1-8.6] and HR, 4.6 [95% CI, 1.3-16.0], respectively) as well as cardiac death in Medina 0.0.1 (HR, 4.7 [95% CI, 1.0-21.6]). No differences in secondary outcomes were observed between Medina subtypes. Conclusions In a large multicenter registry analysis of coronary bifurcation percutaneous coronary intervention procedures, we demonstrate prognostic differences in 1-year outcomes between different CBL distributions, with Medina 1.1.1 and 0.0.1 subtypes associated with an increased risk of target lesion failure.

Prognosis of PCI in AMI setting in the elderly population: Outcomes from the multicenter prospective e-ULTIMASTER registry.

BACKGROUND: Elderly patients with ST-elevation myocardial infarction (STEMI) who undergo percutaneous coronary intervention (PCI) are usually excluded from major trials. HYOPTHESIS: This study sought to assess 1-year clinical outcomes following PCI with a drug-eluting stent in patients older than 80 years old with STEMI. METHODS: The large all-comer, multicontinental e-ULTIMASTER registry included 7507 patients with STEMI who underwent PCI using the Ultimaster stent. The primary clinical endpoint was 1-year target lesion failure, a composite of cardiac death (CD), target vessel-related myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). RESULTS: There were 457 (6.1%) patients in the elderly group (≥80 years old) that were compared to 7050 (93.9%) patients <80 years. The elderly patients included more female patients and had significantly more comorbidities and had more complex coronary anatomy. The primary endpoint occurred in 7.2% of the elderly, compared to 3.1% of the younger group (p < .001). All-cause mortality was significantly higher among the elderly group compared to the younger group (10.1% vs. 2.3%, p < .0001), as well as CD (6.1% vs. 1.6%, p < .0001), but not TV-MI (1.1% vs. 0.7%, p = .34) or CD-TLR (1.1% vs. 1.4%, p = .63). CONCLUSION: Elderly patients with STEMI presentation had a higher incidence of the composite endpoint than younger patients. All-cause and CD were higher for elderly patients compared to patients younger than 80 years old. However, there was no difference in the incidence of TV-MI or target lesion revascularizations. These findings suggest that PCI for STEMI in elderly patients is relatively safe.

Thin-Cap Fibroatheroma Rather Than Any Lipid Plaques Increases the Risk of Cardiovascular Events in Diabetic Patients: Insights From the COMBINE OCT-FFR Trial.

BACKGROUND: Autopsy studies have established that thin-cap fibroatheromas (TCFAs) are the most frequent cause of fatal coronary events. In living patients, optical coherence tomography (OCT) has sufficient resolution to accurately differentiate TCFA from thick-cap fibroatheroma (ThCFA) and not lipid rich plaque (non-LRP). However, the impact of OCT-detected plaque phenotype of nonischemic lesions on future adverse events remains unknown. Therefore, we studied the natural history of OCT-detected TCFA, ThCFA, and non-LRP in patients enrolled in the prospective multicenter COMBINE FFR-OCT trial (Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients). METHODS: In the COMBINE FFR-OCT trial, patients with diabetes and ≥1 lesion with a fractional flow reserve >0.80 underwent OCT evaluation and were clinically followed for 18 months. A composite primary end point of cardiac death, target vessel-related myocardial infarction, target-lesion revascularization, and hospitalization for unstable angina was evaluated in relation to OCT-based plaque morphology. RESULTS: A total of 390 patients (age 67.5±9 years; 63% male) with ≥1 nonischemic lesions underwent OCT evaluation: 284 (73%) had ≥1 LRP and 106 (27%) non-LRP lesions. Among LRP patients, 98 (34.5%) had ≥1 TCFA. The primary end point occurred in 7% of LRP patients compared with 1.9% of non-LRP patients (7.0% versus 1.9%; hazard ratio [HR], 3.9 [95% CI, 0.9-16.5]; P=0.068; log rank-P=0.049). However, within LRP patients, TCFA patients had a much higher risk for primary end point compared with ThCFA (13.3% versus 3.8%; HR, 3.8 [95% CI, 1.5-9.5]; P<0.01), and to non-LRP patients (13.3% versus 1.9%; HR, 7.7 [95% CI, 1.7-33.9]; P<0.01), whereas ThCFA patients had risk similar to non-LRP patients (3.8% versus 1.9%; HR, 2.0 [95% CI, 0.42-9.7]; P=0.38). Multivariable analyses identified TCFA as the strongest independent predictor of primary end point (HR, 6.79 [95% CI, 1.50-30.72]; P=0.013). CONCLUSIONS: Among diabetes patients with fractional flow reserve-negative lesions, patients carrying TCFA lesions represent only one-third of LRP patients and are associated with a high risk of future events while patients carrying LRP-ThCFA and non-LRP lesions portend benign outcomes. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02989740.

Myval versus alternative balloon- and self-expandable transcatheter heart valves: A central core lab analysis of conduction disturbances.

BACKGROUND: Several studies have compared surface electrocardiographic changes following different self-expandable (SE) (Evolut (Medtronic, USA); Acurate (Boston Scientific, USA); Portico (Abbott, USA); and Allegra (NVT, Germany)) and balloon-expandable (BE) Sapien-3 (Edwards Lifesciences, USA) transcatheter heart valves. We aimed to compare these prosthesis with the novel Myval BE prosthesis (Meril Life, India). METHODS: Academic European registry of consecutive patients with severe aortic stenosis who received any of the 6 aforementioned valves. Baseline, post-procedural, and discharge 12­leads electrocardiograms (ECG) were centrally analyzed and compared. RESULTS: A total of 1131 patients were included: 135 Myval (11.9%), 290 Sapien-3 (25.6%), 298 Evolut (26.3%), 180 Acurate (15.9%), 125 Portico (11.1%), and 103 Allegra (9.1%). There were no baseline differences in intraventricular conduction disturbances rate. Compared to the novel BE Myval, there were similar procedural and in-hospital outcomes. Similar rates of early new permanent pacemaker implant (PPI) were observed amongst Myval (7.4%), Sapien-3 (13.4%), and Acurate (9.1%), but Evolut, Portico, and Allegra presented significantly higher rates (18.5%, p = 0.003; 29.5% p < 0.001 and 22%, p = 0.001, respectively). Central analysis of ECGs, unraveled significant prolongation of the PR segment with Evolut, Portico and Allegra whereas Evolut, Acurate, and Portico showed significant QRS widening compared to Myval. However, at discharge no differences in PR segment duration were observed while, Evolut, and Portico- but not Acurate, Allegra or Sapien-3 - still presented significant widening of QRS segment compared to Myval. CONCLUSIONS: After blinded central ECG analysis, the novel Myval balloon-expandable prosthesis was associated with a low rate of early conduction disturbances.

A randomized comparison of manual versus mechanical thrombus removal in primary percutaneous coronary intervention in the treatment of ST-segment elevation myocardial infarction (TREAT-MI).

OBJECTIVES: The objective of this study was to compare the efficacy and long-term clinical outcome of manual thrombus aspiration with the Export catheter (Medtronic, Minneapolis, MN) versus mechanical thrombus cutting/aspiration with the X-sizer system (eV3, White Bear Lake, MN) in primary percutaneous coronary intervention (PPCI). BACKGROUND: In PPCI for acute ST-segment elevation myocardial infarction (STEMI), markers of myocardial reperfusion are improved with adjunctive thrombectomy. Previous studies of different devices showed a variability in performance, suitability, and short-term clinical outcome. In current literature, no direct comparison is available. METHODS: We prospectively randomized 201 patients admitted for PPCI for STEMI to either the Export catheter or the X-sizer prior to stent deployment. Technical success in advancing to and across the lesion, improvement of flow, reduction of thrombus, and the effect on ST-segment resolution were examined. The primary endpoint of the follow-up study was the combined endpoint of cardiac death, recurrent myocardial infarction (MI), or target-vessel revascularization (TVR) at 3 years. RESULTS: Although the Export catheter was more successfully deployed, other procedural parameters were similar with a trend toward better ST-segment resolution (56.6% vs. 44%; P = 0.06) as compared to the X-sizer system. The occurrence of the primary clinical endpoint at 3 years was 22.2% and 18.6%, respectively (HR 1.20; 95% CI 0.65-2.22; P = 0.35). CONCLUSION: Despite shorter procedural times, better lesion crossing, and fewer complications, both surrogate endpoints as well as 3-year clinical follow-up were similar with the use of the Export catheter as compared to the X-sizer system.

One-year performance of thin-strut cobalt chromium sirolimus-eluting stent versus thicker strut stainless steel biolimus-eluting coronary stent: a propensity-matched analysis of two international all-comers registries.

OBJECTIVES: Recent improvements in coronary stent design have focussed on thinner struts, different alloys and architecture, more biocompatible polymers, and shorter drug absorption times. This study evaluates safety and efficacy of a newer generation thin-strut cobalt chromium sirolimus-eluting coronary stent (SES, Ultimaster) in comparison with a second-generation thicker strut stainless steel biolimus-eluting stent (BES, Nobori) in percutaneous coronary intervention (PCI) practice. METHODS: A propensity score analysis was performed to adjust for differences in baseline characteristics of 8137 SES patients and 2738 BES patients of two PCI registries (e-Ultimaster and NOBORI 2). An independent clinical event committee adjudicated all endpoint-related adverse events. RESULTS: The use of SES, as compared with BES was associated with a significantly lower rate of myocardial infarction (MI) (1.2% vs 2.2%; P = 0.0006) and target vessel-related MI (1.1% vs 1.8%; P = 0.002) at 1 year. One-year composite endpoints of all predefined endpoints were lower in patients undergoing SES implantation (target lesion failure: 3.2% vs 4.1%; P = 0.03, target vessel failure: 3.7% vs 5.0%; P = 0.003, patient-oriented composite endpoint 5.7% vs 6.8%; P = 0.03). No significant differences between SES and BES were observed in all-cause death (2.0% vs 1.6%; P = 0.19), cardiac death (1.2% vs 1.2%; P = 0.76) or stent thrombosis (0.6% vs 0.8%; P = 0.43). CONCLUSIONS: These findings suggest an improved clinical safety and efficacy of a newer generation thin-strut SES as compared with a second-generation thicker strut BES.

Use of Lithotripsy in a Calcified Saphenous Vein Graft.

Percutaneous coronary interventions in saphenous vein grafts can pose a variety of challenges, such as severely calcified lesions. If these lesions are nondilatable, lithotripsy can arguably be a proper tool for lesion preparation. We present a case in which a nondilatable, calcified saphenous vein graft was successfully treated using Shockwave lithotripsy. (Level of Difficulty: Intermediate.).

Diastolic stiffness of the failing diabetic heart: importance of fibrosis, advanced glycation end products, and myocyte resting tension.

BACKGROUND: Excessive diastolic left ventricular stiffness is an important contributor to heart failure in patients with diabetes mellitus. Diabetes is presumed to increase stiffness through myocardial deposition of collagen and advanced glycation end products (AGEs). Cardiomyocyte resting tension also elevates stiffness, especially in heart failure with normal left ventricular ejection fraction (LVEF). The contribution to diastolic stiffness of fibrosis, AGEs, and cardiomyocyte resting tension was assessed in diabetic heart failure patients with normal or reduced LVEF. METHODS AND RESULTS: Left ventricular endomyocardial biopsy samples were procured in 28 patients with normal LVEF and 36 patients with reduced LVEF, all without coronary artery disease. Sixteen patients with normal LVEF and 10 with reduced LVEF had diabetes mellitus. Biopsy samples were used for quantification of collagen and AGEs and for isolation of cardiomyocytes to measure resting tension. Diabetic heart failure patients had higher diastolic left ventricular stiffness irrespective of LVEF. Diabetes mellitus increased the myocardial collagen volume fraction only in patients with reduced LVEF (from 14.6+/-1.0% to 22.4+/-2.2%, P<0.001) and increased cardiomyocyte resting tension only in patients with normal LVEF (from 5.1+/-0.7 to 8.5+/-0.9 kN/m2, P=0.006). Diabetes increased myocardial AGE deposition in patients with reduced LVEF (from 8.8+/-2.5 to 24.1+/-3.8 score/mm2; P=0.005) and less so in patients with normal LVEF (from 8.2+/-2.5 to 15.7+/-2.7 score/mm2, P=NS). CONCLUSIONS: Mechanisms responsible for the increased diastolic stiffness of the diabetic heart differ in heart failure with reduced and normal LVEF: Fibrosis and AGEs are more important when LVEF is reduced, whereas cardiomyocyte resting tension is more important when LVEF is normal.

Potentially increased incidence of scaffold thrombosis in patients treated with Absorb BVS who terminated DAPT before 18 months.

AIMS: The aim of this study was to investigate the impact of dual antiplatelet therapy (DAPT) termination on late and very late scaffold thrombosis (ScT) in patients treated with the Absorb bioresorbable vascular scaffold (BVS). METHODS AND RESULTS: Data from the registries of three centres were pooled (808 patients). To investigate the effect of DAPT termination on ScT after a minimum of six months, we selected a subgroup ("DAPT study cohort" with 685 patients) with known DAPT status >6 months and excluded the use of oral anticoagulants and early ScT. In this cohort, definite/probable ScT incidence for the period on DAPT was compared to ScT incidence after DAPT termination. ScT incidence was 0.83 ScT/100 py with 95% confidence interval (CI): 0.34-1.98. After DAPT termination, the incidence was higher (1.77/100 py; 95% CI: 0.66-4.72), compared to the incidence on DAPT (0.26/100 py, 95% CI: 0.04-1.86; p=0.12) and increased within the month after DAPT termination (6.57/100 py, 95% CI: 2.12-20.38; p=0.01). No very late ScT occurred in patients who continued on DAPT for a minimum of 18 months. CONCLUSIONS: The incidence of late and very late definite/probable ScT was acceptable. The incidence was low while on DAPT but potentially higher when DAPT was terminated before 18 months.