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Background: The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk in patients undergoing transcatheter aortic valve replacement. The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale transcatheter aortic valve replacement population., Methods: Multicenter study including 10 449 patients undergoing transcatheter aortic valve replacement. Based on consensus, 21 clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to the VARC-HBR definition. The primary end point was the rate of Bleeding Academic Research Consortium type 3 or 5 bleeding at 1 year, defined as the composite of periprocedural (within 30 days) or late (after 30 days) bleeding., Results: Patients with at least 1 VARC-HBR criterion (n=9267, 88.7%) had a higher risk of Bleeding Academic Research Consortium 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very-high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under receiver operating characteristic curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very-high-risk groups (hazard ratio, 1.33 [95% CI, 1.04-1.70] and 1.97 [95% CI, 1.53-2.53], respectively)., Conclusions: The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in transcatheter aortic valve replacement. The results of the present study would support the predictive validity of the new definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes., Competing Interests: Dr Ternacle is a consultant for Abbott. Dr Modine is a consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Asmarats has received speaker fees from Edwards Lifesciences. Dr Capodanno has received payments to the institution from Medtronic and personal fees from Sanofi, Novo Nordisk, and Terumo. Dr Morice served as a shareholder and chief executive officer (CEO) of Cardiovascular European Research Center (CERC) and minor shareholder of Electroducer. Dr Garot has received proctor/advisory fees from Abbott, Biosensors, Boston Scientific, Cordis, General Electric HealthCare, and Terumo. He served as co-medical director and shareholder of CERC Contract Research Organization (CRO), organizing the Valve Academic Research Consortium for High Bleeding Risk initiative (nonprofit initiative, as per Academic Research Consortium [ARC] Charter). Dr Rodés-Cabau has received institutional research grants and consultant/speaker fees from Edwards Lifesciences and Medtronic. The other authors report no conflicts.

Background: Atrial fibrillation (AF) has been identified as a marker of advanced cardiac damage in aortic stenosis patients. However, the factors associated with poorer outcomes among AF patients in contemporary transcatheter aortic valve replacement (TAVR) practice, particularly regarding mortality and heart failure (HF)-related hospitalizations, remain largely unknown., Methods: In this multicenter study we assessed consecutive patients with a history of AF and evaluated the clinical outcomes, predictors of mortality, and HF-related hospitalization rates of those who underwent TAVR with newer generation devices using either balloon- or self-expandable valves., Results: A total of 3476 patients were included the study. After a median follow-up of 2 (interquartile range, 1-4) years, 36.4% patients had died, with 51.5% of deaths being cardiovascular-related, including 15.6% from HF. HF-related hospitalizations post-TAVR accounted for 34.8% of all hospitalizations and exhibited a significantly higher mortality risk (hazard ratio [HR], 1.54; 95% confidence interval [CI], 1.32-1.81; P < 0.001). Permanent AF emerged as an independent predictor of all-cause death or HF-related hospitalizations (HR, 1.25; 95% CI, 1.10-1.40; P < 0.001), as did other baseline characteristics, including chronic kidney disease (HR, 1.23; 95% CI, 1.09-1.38; P = 0.001), anemia (HR, 1.21; 95% CI, 1.07-1.36; P = 0.002), and New York Heart Association functional class III or IV (HR, 1.13; 95% CI, 1.01-1.27; P = 0.045). In addition, early postprocedural complications, including stroke and bleeding, also significantly increased the risk of mortality (HR, 5.52; 95% CI, 3.12-9.79; P < 0.001) and HF-related hospitalizations (HR, 1.17; 95% CI, 1.03-1.33; P = 0.014)., Conclusions: AF patients exhibited a high risk of HF-related hospitalizations in a contemporary TAVR cohort. Several baseline comorbidities and periprocedural complications, along with permanent (vs paroxysmal) AF, were associated with poorer outcomes. These findings confirm the negative impact of AF despite the continued improvements in TAVR technology and underscore the importance of early intervention and optimization of HF management to improve outcomes in this high-risk population., (Copyright © 2024 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Conflict of interest: V.D. receives speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Philips, GE healthcare, Novartis. Consultancy from Novo Nordisk, Edwards Lifesciences. The remaining authors declares no conflict of interest.

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: Coronary obstruction (CO) following transcatheter aortic valve replacement (TAVR) is a life-threatening complication, scarcely studied., Objectives: The authors analyzed the incidence of CO after TAVR, presentation, management, and in-hospital and 1-year clinical outcomes in a large series of patients undergoing TAVR., Methods: Patients from the Spanish TAVI (Transcatheter Aortic Valve Implantation) registry who presented with CO in the procedure, during hospitalization or at follow-up were included. Computed tomography (CT) risk factors were assessed. In-hospital, 30-day, and 1-year all-cause mortality rates were analyzed and compared with patients without CO using logistic regression models in the overall cohort and in a propensity score-matched cohort., Results: Of 13,675 patients undergoing TAVR, 115 (0.80%) presented with a CO, mainly during the procedure (83.5%). The incidence of CO was stable throughout the study period (2009-2021), with a median annual rate of 0.8% (range 0.3%-1.3%). Preimplantation CT scans were available in 105 patients (91.3%). A combination of at least 2 CT-based risk factors was less frequent in native than in valve-in-valve patients (31.7% vs 78.3%; P < 0.01). Percutaneous coronary intervention was the treatment of choice in 100 patients (86.9%), with a technical success of 78.0%. In-hospital, 30-day, and 1-year mortality rates were higher in CO patients than in those without CO (37.4% vs 4.1%, 38.3% vs 4.3%, and 39.1% vs 9.1%, respectively; P < 0.001)., Conclusions: In this large, nationwide TAVR registry, CO was a rare, but often fatal, complication that did not decrease over time. The lack of identifiable predisposing factors in a subset of patients and the frequently challenging treatment when established may partly explain these findings., Competing Interests: Funding Support and Author Disclosures The Spanish TAVI registry is managed and maintained with funding from the Interventional Cardiology Association of the Spanish Cardiology Society. Dr Ojeda has received consulting fees from Medtronic and Edwards Lifesciences; has received speaker fees from Philips and World Medical; and holds a research grant (PI21/00949) from the Spanish Ministry of Science and Innovation (Instituto de Salud Carlos III). Dr Asmarats is proctor for Abbott Vascular; and has received speaker fees from Edwards Lifesciences. Dr Amat-Santos is a proctor for Medtronic, Boston Scientific, and Meril Life. Dr Romaguera is proctor for Biosensor. Dr Moreno is a proctor for Boston Scientific and Biosensor. Dr Pan has received speaker fees from Abbott, Boston Scientific, World Medical, and Philips; and holds a research grant (PI21/00949) from the Spanish Ministry of Science and Innovation (Instituto de Salud Carlos III). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

We systematically categorized the longer-term (≥3 years) structural and functional characteristics of the ABSORB bioresorbable vascular scaffold (BVS) using optical coherence tomography imaging and coronary vasomotor reactivity testing and further compared the functional characteristics of BVS stented versus remote coronary segments. A total of 92 patients (mean age 56.4 ± 9.7 years, 22.8% women) who underwent percutaneous coronary intervention (76% with acute coronary syndrome) using the ABSORB BVS (112 lesions) were included. Optical coherence tomography analysis (38,790 visible struts) comprised in-segment quantitative lumen/plaque and semiquantitative plaque composition analysis of the neointimal pattern. Epicardial endothelium-dependent and-independent vasomotion was defined as any vasodilatation at low/intermediate intracoronary dose of acetylcholine (ACh) and nitroglycerine, assessed using quantitative coronary angiography. At a median time of 3.2 years follow-up, 79.8% of BVS segments still demonstrated visible struts with a predominant neointimal fibrotic healing pattern in 84% of BVS segments, with 99.5% of struts demonstrating coverage with apposition. Compared with remote segments, BVS segments demonstrated less endothelium-dependent vasodilatation at low (p = 0.06) and intermediate ACh doses (p = 0.04). Hypertension, longer time interval from index percutaneous coronary intervention, and the degree of in-BVS segment neointimal volume (p <0.03 for all) were each independently associated with abnormal BVS endothelium-dependent vasomotor function. Endothelium-independent function was more likely preserved in non-BVS (remote) segments compared with BVS segments (p = 0.06). In conclusion, at 3+ years post-ABSORB BVS insertion, the rate of complete scaffold resorption was low and residual strut presence was high, with a dominant fibrous healing response contributing toward neointimal hyperplasia and endothelium-dependent and-independent vasomotor dysfunction., Competing Interests: Disclosures Dr. Amat-Santos has received a nonconditional grant from Abbott. Dr. Latib is a consultant for Abbott, Boston Scientific, Medtronic, and Philips. The remaining authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

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: Sutureless-surgical aortic valve replacement (SU-SAVR) has been proposed as a surgical alternative for treating aortic stenosis, which facilitates a minimally invasive approach. While some studies have compared the early outcomes of SU-SAVR versus transcatheter aortic valve replacement (TAVR), most data were obtained in high-risk patients and/or limited to in-hospital outcomes. This study aimed to compare in-hospital and midterm clinical outcomes following SU-SAVR and TAVR in low-risk patients with aortic stenosis., Methods: A total of 806 consecutive low-risk (EuroSCORE II <4%) patients underwent TAVR or SU-SAVR between 2011 and 2020 in 2 centers. A 1:1 propensity score matching was performed and identified 171 pairs with similar characteristics that were included in the analysis. Baseline characteristics, in-hospital and follow-up events (defined according to Valve Academic Research Consortium-2) were collected., Results: Baseline characteristics were well balanced between groups, with a median EuroSCORE II of 1.9% (1.3%-2.5%) in both SU-SAVR and TAVR groups ( P =0.85). There were no statistically significant differences regarding in-hospital mortality (SU-SAVR: 4.1%, TAVR: 1.8%, P =0.199) and stroke (SU-SAVR: 2.3%, TAVR: 2.9%, P =0.736), but SU-SAVR recipients exhibited higher rates of bleeding and new-onset atrial fibrillation, higher residual transvalvular gradients ( P <0.001), and a lower rate of pacemaker implantation ( P =0.011). After a median follow-up of 2 (1-3) years, there were no differences between groups in all-cause mortality (hazard ratio, 0.97 [95% CI, 0.52-1.82], P =0.936) and stroke (hazard ratio, 0.83 [95% CI, 0.32-2.15], P =0.708), but SU-SAVR was associated with a higher risk of heart failure hospitalization (hazard ratio, 5.38 [95% CI, 1.88-15.38], P =0.002)., Conclusions: In low-risk patients with aortic stenosis, TAVR was associated with improved in-hospital outcomes (except for conduction disturbances) and valve hemodynamics, compared with SU-SAVR. Although similar mortality and stroke rates were observed at 2-year follow-up, the risk of heart failure hospitalization was higher among SU-SAVR patients. These results may contribute to reinforce TAVR over SU-SAVR for the majority of such patients. Graphic Abstract: A graphic abstract is available for this article.

Primary ventricular fibrillation (PVF) is a dreadful complication of ST segment elevation myocardial infarction (STEMI). Scarce data are available regarding PVF prognosis since primary percutaneous coronary intervention (PPCI) became routine practice in STEMI. Our aim was to compare 30-day and 1-year mortality for patients with and without PVF (including out-of-hospital and in-hospital PVF) within a regional registry of PPCI-treated STEMI patients. This prospective multicenter registry included all consecutive STEMI patients treated with PPCI from January 2010 to December 2014. Patients were classified as non-PVF or PVF, with further subdivision into out-of-hospital and in-hospital PVF. We analyzed 30-day and 1-year all-cause mortality in groups. The registry included 10,965 patients. PVF occurred in 949 patients (8.65%), including 74.2% out-of-hospital and 25.8% in-hospital PVF. Compared with the non-PVF group, PVF patients were younger; less commonly diabetic; more frequently had anterior wall STEMI, higher Killip-Kimball class, and left main disease; and showed significantly higher 24-hour (5.1% vs 1.1%), 30-day (18.5% vs 4.7%), and 1-year mortality (23.2% vs 7.9%) (all p <0.001). Mortality did not differ in out-of-hospital versus in-hospital PVF. After multivariable adjustment, PVF remained associated with all-cause 30-day (2.32, 95% CI: 1.91 to 2.82, p <0.001) and 1-year (HR: 1.59, 95% CI: 1.13 to 2.24, p = 0.008) mortality. In conclusion, we present the largest registry of PVF patients in the era of routine PPCI in STEMI. Although overall STEMI mortality has declined, PVF emerged as a predictor of both 30-day and 1-year mortality. These data warrant prospective validation and proper identification and protection of high-risk patients., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Introduction and Objectives: Stent thrombosis (ST) is a life-threatening complication after stent implantation. Intravascular ultrasound is able to discern most causes of ST. The aim of this study was to compare intravascular ultrasound findings between bare-metal stents (BMS) and drug-eluting stents (DES) in patients with late (31 days to 1 year) or very late ST (> 1 year)., Methods: Of 250 consecutive patients with late or very late ST in 7 Spanish institutions, 114 patients (45.5% BMS and 54.5% DES) were imaged with intravascular ultrasound. Off-line intravascular ultrasound analysis was performed to assess malapposition, underexpansion, and neoatherosclerosis., Results: The median time from stent implantation to ST was 4.0 years with BMS and 3.4 years with DES (P = .04). Isolated malapposition was similarly observed in both groups (36.5% vs 46.8%; P = .18) but was numerically lower with BMS (26.6% vs 48.0%; P = .07) in patients with very late ST. Isolated underexpansion was similarly observed in both groups (13.5% vs 11.3%; P = .47). Isolated neoatherosclerosis occurred only in patients with very late ST and was more prevalent with BMS (22.9%) than with DES (6.0%); P = .02. At 2.9 years' follow-up, there were 0% and 6.9% cardiac deaths, respectively (P = .06) and recurrent ST occurred in 4.0% and 5.2% of patients, respectively (P = .60)., Conclusions: Malapposition was the most common finding in patients with late and very late ST and is more prevalent with DES in very late ST. In contrast, neoatherosclerosis was exclusively observed in patients with very late ST and mainly with BMS., (Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction and Objectives: Risk stratification in non-ST-elevation acute coronary syndrome makes use of clinical variables that can identify patients at an increased risk of complications. Our objective was to identify clinical variables that predict significant stenosis (i.e., >50%) of the left main coronary artery in high-risk patients who have had a first episode of non-ST-elevation acute coronary syndrome but who do not have a history of coronary artery disease., Methods: The study included 102 high-risk patients with no history of coronary artery disease who were admitted because of non-ST-elevation acute coronary syndrome. All underwent coronary angiography. Patients were divided into two groups: those with significant left main coronary artery stenosis (n=14) and those without (n=88)., Results: Univariate analysis showed that the variables significantly associated with left main coronary artery stenosis were age >65 years (57.1% vs 15.9%, P=.002), diabetes mellitus (71.4% vs 33.0%, P=.006), chronic renal failure (28.6% vs 5.7%, P=.019), left heart failure (71.4% vs 6.8%, P< .0001), cardiogenic shock (21.4% vs 1.1%, P=.008), and a low left ventricular ejection fraction at admission (49.9% [14.7%] vs 58.8% [9.9%], P=.044). In the multivariate analysis, the only significant independent predictor of left main coronary artery disease was left heart failure., Conclusions: The presence of left heart failure at initial assessment of high-risk patients with non-ST-elevation acute coronary syndrome but without a history of coronary artery disease could be a useful predictor of significant left main coronary artery disease.

Objectives: This study assessed the degree of endothelial dysfunction in post-acute myocardial infarction (AMI) and its subsequent status in the infarct-related artery (IRA) in patients treated with thrombolysis., Background: Coronary flow reserve alterations in the IRA after thrombolysis have been described, but the endothelium-dependent vasomotion has not been investigated, to date., Methods: Endothelial function in patients after thrombolysis was assessed by infusion of acetylcholine (ACh) at increasing doses in the IRA. Diameter changes in the distal segments were evaluated using quantitative coronary angiography. Patients with coronary atherosclerosis constituted the control group. Clinical variables, electrocardiography and biochemical markers were used to determine the timing of reperfusion and the extent of the infarct. Patients in the AMI group were re-evaluated one year later., Results: In the initial assessment, 16 patients showed a vasoconstriction response to ACh in the IRA compared to the control group (-20 +/- 21% vs. 4 +/- 4%; p < 0.01). Significant correlations between the degree of vasoconstriction and maximum value of the creatine kinase-MB fraction and number of new Q waves were observed. Of the 12 patients re-evaluated, 4 had complete occlusion of the IRA. In the remaining eight patients with patent artery, an improvement in response to ACh was observed relative to the initial study (+3 +/- 11%, vs. -19 +/- 15%, p < 0.05)., Conclusions: In patients with AMI treated with thrombolysis, severe endothelial dysfunction in the IRA is observed early. In patients who retain patency of the IRA, the endothelial dysfunction improves during the follow-up and suggests a component of stunned endothelium in the first few days post-AMI.

Introduction and Aims: In patients with coronary risk factors the presence of endothelial dysfunction in epicardial arteries has been documented. The purpose of this study was to determine whether endothelial dysfunction, documented hypercholesterolemic patients and angiographically normal coronary arteries, improves by reduction and normalization of lipid levels., Patients and Method: In 10 patients with hypercholesterolemia and normal coronary angiography, the endothelium-dependent coronary vasomotion was studied by intracoronary infusion of acetylcholine into the left anterior descending coronary artery. Vasomotion changes in response to acetylcholine were analyzed by quantitative angiography. Five patients without coronary risk factors and normal coronary arteries formed the control group. Patients with hypercholesterolemia were treated with lipid-lowering therapy (diet and lovastatin) and endothelial function was reevaluated after 24 +/- 4 months., Results: In the initial study, hypercholesterolemic patients compared with the control group showed a vasoconstrictor response to serial doses of acetylcholine(10(-6) M, 10(-5) M, 10(-4)M) indicative of endothelial dysfunction (study group: -0.3 +/- 10%, -6 +/- 4%, -18 +/- 10% vs control group: -0.6 +/- 6%, -2 +/- 6%, 3+/-6%; p < 0.01 to 10(-4) M acetylcholine dose. During follow-up hypercholesterolemic patients who a significant reduction in total cholesterol levels and LDL. Compared to first study, at follow-up, there was an improvement in the response to acetylcholine (-0.4 +/- 4%, -3 +/- 6%, -3 +/- 10%; p<0.001 vs basal values at 10(-4) M acetylcholine concentration). Reduction in total cholesterol during follow-up was related to the improvement in the vasoconstrictor response to acetylcholine (r=0.53; p< 0.05)., Conclusion: In patients with hypercholesterolemia and angiographycally normal coronary arteries with documented endothelial dysfunction, the reduction and normalization of lipid levels during follow-up may improve endothelium-dependent coronary vasomotion.

Introduction and Objectives: Coronary angioplasty leads to endothelial disruption and a further rendotelization. The aim of our study was to determine the status of endothelial function in previously dilated coronary segments without restenosis., Methods: Endothelium-dependent vasomotion was analysed in twelve patients with single vessel coronary disease six month after angioplasty by selective intracoronary doses of acetylcholine (10-6, 10-5, 10-4 M) in the previously treated artery. The control group was made up of seven patients with no evidence of significant coronary stenosis and without risk factors. Vasomotor response at the different doses of acetylcholine was determined by quantitative coronary angiography., Results: Endothelial function showed a global vasodilator response in the dilated segment at the maximum dose of acetylcholine (increase in lumen diameter 3.6 +/- 3.5%), similar to the response observed in the control group (increase of luminal diameter 3 +/- 6%; p = NS). In particular, 8 patients (67%) showed a normal endotelial function, while 4 patients (33%) showed a vasoconstrictor response. A positive correlation was detected between the response to the maximun dose of acetylcholine and the percent of residual stenosis at 6 months of follow-up (r = 0.67; p = 0.02)., Conclusions: In patients treated with coronary angioplasty without restenosis, the dilated segments frequently showed normal endothelial function. Greater residual stenosis at the dilated segment was associated with less impairment in endothelial function.