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Background Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. Methods We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. Results Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 +/- 18.5 vs. 42.4 +/- 18.0 cm/s, p= 0.02). Occluders implanted in DRT patients were larger (25.5 +/- 3.8 vs. 24.6 +/- 3.5 mm, p =0.03) and implanted deeper in the LAA (mean depth: 7.6 +/- 4.7 vs. 5.7 +/- 4.7 mm, p

Although antithrombotic treatment is recommended after left atrial appendage closure (LAAC), some patients require discontinuation of antithrombotic treatment after LAAC without evidence on the safety of such a strategy. We sought to evaluate outcomes of patients who had early antithrombotic treatment discontinuation after LAAC. This is a multicenter study including 1,082 patients who underwent successful LAAC. Early discontinuation of antithrombotic treatment was defined as discontinuation of all antiplatelet/anticoagulant treatment within 6 months following the procedure. A propensity-matched analysis was used to compare outcomes of patients with and without early antithrombotic treatment discontinuation. A total of 148 patients (13.7%) had early antithrombotic treatment discontinuation. In the entire population, antithrombotic treatment discontinuation patients exhibited a lower CHA(2)DS(2)-VASc score (p

OBJECTIVES Obesity may increase the risk of vascular complications in transfemoral (TF) transcatheter aortic valve replacement (TAVR) procedures. The transcarotid (TC) approach has recently emerged as an alternative access in TAVR. We sought to compare vascular complications and early clinical outcomes in obese patients undergoing TAVR either by TF or TC vascular access. METHODS Multicentre registry including obese patients undergoing TF- or TC-TAVR in 15 tertiary centres. All patients received newer-generation transcatheter heart valves. For patients exhibiting unfavourable ileo-femoral anatomic characteristics, the TC approach was favoured in 3 centres with experience with it. A propensity score analysis was performed for overcoming unbalanced baseline covariates. The primary end point was the occurrence of in-hospital vascular complications (Valve Academic Research Consortium-2 criteria). RESULTS A total of 539 patients were included, 454 (84.2%) and 85 (15.8%) had a TF and TC access, respectively. In the propensity-adjusted cohort (TF: 442 patients; TC: 85 patients), both baseline and procedural valve-related characteristics were well-balanced between groups. A significant decrease in vascular complications was observed in the TC group (3.5% vs 12% in the TF group, odds ratio: 0.26, 95% CI: 0.07–0.95, P = 0.037). There were no statistically significant differences between groups regarding in-hospital mortality (TC: 2.8%, TF: 1.5%), stroke (TC: 1.2%, TF: 0.4%) and life-threatening/major bleeding events (TC: 2.8%, TF: 3.8%). CONCLUSIONS In patients with obesity undergoing TAVR with newer-generation devices, the TC access was associated with a lower rate of vascular complications. Larger randomized studies are warranted to further assess the better approach for TAVR in obese patients.

Treatment of in-stent restenosis (ISR) remains a significant challenge. Current options include repeat stenting or drug-coated balloons. However, there is a paucity of data regarding vascular healing after these strategies. We, aimed to compare optical coherence tomography (OCT)-based vessel healing after treatment with paclitaxel-coated balloons (PCB) or everolimus-eluting stents (EES).An OCT substudy (baseline and 6-9 months) of patients from RIBS IV and RIBS V, two prospective multicenter, randomized controlled clinical trials comparing PCB vs. EES in patients with ISR was performed.Sixty-four patients were included (30 PCB and 34 EES). There were no differences in the baseline or angiographic characteristics between groups. Both groups had the same proportion of drug-eluting and bare-metal stent (BMS) ISR. Baseline OCT analysis did not show differences in the qualitative characteristics of the ISR nor the restenotic tissue burden. Follow-up OCT showed a larger mean lumen area in the EES group (6.03 ± 1.5 vs. 5.24 ± 1.3 mm 2 ; P = 0.043) but no difference in angiographic restenosis ( P = 0.66). Percentage tissue coverage was higher with PCB vs. EES (26 ± 13 vs. 19 ± 11%; P = 0.031). EES-treated ISR more frequently had uncovered struts at follow-up [21 (72%) vs. 12 (44%); P = 0.034]. Tissue covering struts more frequently had a high backscatter structure after PCB [21 (78%) vs. 16 (55%); P = 0.07].Compared with EES, ISR treated with PCB demonstrated more strut coverage with mainly high backscattering tissue. Larger OCT-defined neointimal proliferation in PCB-treated ISR did not translate into higher angiographic restenosis rates.

Significant mitral regurgitation (MR) frequently coexists in patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). These patients have worse clinical outcomes than those with non-significant MR, especially if MR persists after treatment of the aortic stenosis. The optimal treatment approach for this challenging high-risk population is not well defined.This review aims to present the current literature on concomitant significant MR in the TAVR population, and to provide a comprehensive algorithmic approach for clinical decision-making in this challenging cohort of patients.Concomitant mitral and aortic valve disease is a complex clinical entity. An exhaustive and comprehensive assessment of patient's clinical characteristics and mitral valve anatomy and function is required in order to assess the surgical risk, predict the MR response after AVR and evaluate the feasibility of percutaneous MV treatment if necessary. Further developments in transcatheter techniques will expand the indications for double valve treatment in operable and inoperable patients with concomitant significant MR and aortic stenosis.

Background Gastrointestinal bleeding (GIB) is associated with a high recurrence rate and a prior GIB episode is common in real-world left atrial appendage closure (LAAC) recipients. The present study sought to evaluate the clinical characteristics and outcomes of patients with prior GIB undergoing LAAC, and to determine the factors associated with and clinical impact of GIB recurrence. Methods Multicenter study including 277 consecutive patients who underwent percutaneous LAAC and had prior GIB. All-cause death, all bleeding, GIB recurrence, and clinical ischemic stroke were recorded. Results After a median follow-up of 17 (interquartile range: 6-37) months post-LAAC, the rates of death, bleeding, GIB recurrence, and ischemic stroke were 14.0 per 100 person-year (PY), 29.3 per 100 PY, 17.7 per 100 PY, and 1.1 per 100 PY, respectively. GIB recurrence occurred within 3 months post-LAAC in 55.8% of patients. A previous lower GIB (vs. upper or unclassified) (HR: 1.76; 95% CI: 1.09-2.82; p = .020) and eGFR < 45 mL/min (HR: 1.70; 95% CI:1.04-2.67; p = .033) determined an increased risk of GIB recurrence. By multivariable analysis, eGFR < 45 mL/min (HR: 2.72; 95% CI: 1.70-4.34; p < .001), GIB recurrence following LAAC (HR: 2.15; 95% CI: 1.33-3.46; p = .002), diabetes mellitus (HR: 1.77; 95% CI: 1.10-2.84; p = .018), and age (HR: 1.06; 95% CI: 1.03-1.10; p < .001) were associated with an increased mortality. Conclusions Patients with prior GIB undergoing LAAC exhibited a relatively low rate of GIB recurrence, and prior lower GIB and moderate-to-severe chronic kidney disease determined an increased risk. GIB recurrence was associated with an increased mortality.

Objectives To investigate the outcomes of deferred coronary revascularization in patients with non-significant in-stent restenosis (ISR) by physiological assessment. Background The pathophysiology and natural history of ISR is markedly different from de-novo stenoses. There is a paucity of data on the safety of deferral of revascularization of ISR using physiological assessment. Methods In this single centre study, using a propensity-score matched analysis, we compared the long-term clinical outcomes of patients with ISR and de-novo disease deferred based on intracoronary physiology. Matching was on a 1:2 basis of ISR to de-novo stenosis. The primary end point was major adverse cardiovascular events (MACE) a composite of all-cause mortality, target lesion revascularization or target vessel myocardial infarction at 36 months. Results Matched cohorts of 56 ISR and 112 de-novo stenoses were analyzed. The median percentage stenosis was 50% in both groups (p = 0.403). Deferral was based on fractional flow reserve (FFR). The mean FFR was 0.86 across both groups (p = 0.942). At 36-months, freedom from MACE was similar between groups; 86.2% versus 92.8% log rank p=0.180 for ISR and de-novo lesions, respectively. Neither were there differences in the individual components of MACE. Conclusions Deferral of coronary revascularization in patients with ISR based on its functional impact is associated to similar long-term safety as in de-novo coronary stenosis.

Background: Biological data suggest that short-term anticoagulation would be more effective than dual antiplate -let therapy (DAPT) to reduce the thrombotic risk following left atrial appendage closure (LAAC). This study sought to assess the safety and efficacy of direct oral anticoagulation (DOAC) versus DAPT immediately post-LAAC. Methods: Multicenter study including 592 consecutive patients with relative contraindication to chronic anticoagulation who underwent LAAC and received either DAPT or DOAC for 1-3 months. Each patient receiving DOAC was matched with 2 patients on DAPT based on propensity-score (propensity-matched population of 285 patients). Outcomes recorded were death, stroke, non-procedural related severe bleeding, serious adverse event (SAE: composite of death, stroke, bleeding) and early (within 3 months post-LAAC) device-related thrombosis (DRT). Results: Early outcomes (within 3-month post-LAAC) did not significantly differ between groups, but a numeri-cally higher rate of early death (3.7% vs. 1.1%), non-procedural related severe bleeding (7.4% vs. 3.2%), and SAE (11.1% vs. 5.3%) were observed in patients receiving DAPT. After a median follow-up of 22 (8-38) months, similar outcomes were observed in DAPT and DOAC groups regarding death (HR: 1.18; 95% CI: 0.58-2.37; p = 0.652), stroke (HR: 1.01; 95% CI: 0.22-5.45; p = 0.908), non-procedural related severe bleeding (HR: 1.68; 95% CI: 0.69-4.12; p = 0.257), and SAE (HR: 1.28; 95% CI: 0.73-2.24; p = 0.383). DRT was identified in 4 patients (2.6%) receiving DAPT versus 0 patient receiving DOAC (p = 0.162). Conclusions: Short-term DOAC following LAAC in patients with contraindications to chronic anticoagulation was safe and tended to associate with a lower rate of SAE and DRT compared to DAPT. (c) 2021 Elsevier B.V. All rights reserved.

BackgroundPercutaneous coronary intervention (PCI) of the ostium of the left circumflex artery (LCx) is technically challenging. The aim of this study was to compare long-term clinical outcomes of ostial PCI located in the LCx versus the left anterior descending artery (LAD) in a propensity-matched population.MethodsConsecutive patients with a symptomatic isolated ‘de novo’ ostial lesion of the LCx or LAD treated with PCI were included. Patients with a stenosis of >40% in the left main (LM) were excluded. A propensity score matching was performed to compare both groups. The primary endpoint was target lesion revascularisation (TLR); other endpoints included target lesion failure and an analysis of the bifurcation angles.ResultsFrom 2004 to 2018, 287 consecutive patients with LAD (n=240) or LCx (n=47) ostial lesions treated with PCI were analysed. After the adjustment, 47 matched pairs were obtained. The mean age was 72±12 years and 82% were male. The LM–LAD angle was significantly wider than the LM–LCx angle (128°±23° vs 108°±24°, p=0.002). At a median follow-up of 5.5 (IQR 1.5–9.3) years, the rate of TLR was significantly higher in the LCx group (15% vs 2%); with an HR of 7.5, 95% CI 2.1 to 26.4, pConclusionsIsolated ostial LCx PCI was associated with an increase in the rate of TLR compared with ostial LAD PCI at long-term follow-up. Larger studies evaluating the optimal percutaneous approach at this location are needed.

Mitral valve disease, and in particular mitral regurgitation, is a common clinical entity. Until recently, surgical repair and replacement were the only therapeutic options available, leaving many patients untreated mostly due to excessive surgical risk. Over the last number of years, huge strides have been made regarding percutaneous, catheter-based solutions for mitral valve disease. Transcatheter repair procedures have most commonly been used, and in recent years there has been exponential growth in the number of devices available for transcatheter mitral valve replacement. Furthermore, the evolution of these devices has resulted in both smaller delivery systems and a shift towards transeptal access, negating the need for surgical incisions. In line with these advancements, and clinical trials demonstrating promising outcomes in carefully selected cases, recent guidelines have strengthened their recommendations for these devices. It is appropriate, therefore, to now review the current transcatheter repair and replacement devices available and the evidence for their use.

OBJECTIVE The heart team (HT) approach plays a key role in selecting the optimal treatment strategy for patients with aortic stenosis (AS). However, little is known about the HT decision process and its impact on outcomes. The aim of this study was to identify the factors associated with the HT decision and evaluate clinical outcomes according to the treatment choice. METHODS The study included a total of 286 consecutive patients with AS referred for discussion in the weekly HT meeting in a cardiovascular institute over 2 years. Patients were stratified according to the selected therapeutic approach: medical treatment (MT), surgical (SAVR), or transcatheter (TAVR) aortic valve replacement. Baseline characteristics involved in making a therapeutic choice were identified and a decision-making tree was built using classification and regression tree methodology. RESULTS Based on HT discussion, 53 patients were assigned to SAVR, 210 to TAVR, and 23 to MT. Older patients (≥88 years old) were mainly assigned to TAVR or MT according to the logistic EuroSCORE (

Paravalvular leak (PVL) is a serious complication of surgical valve replacement, often affecting elderly, multimorbid, high-risk patients. The risk of surgical intervention is often prohibitive in these cases, and so percutaneous PVL closure emerged as a feasible and effective management strategy, with a low complication rate. Specific devices for closure of PVL's are currently not widely available, and so PVLs are closed using generic vascular closure devices, which may result in residual paravalvular regurgitation or even closure device displacement. Although rare, late displacement of the closure device with prosthetic impingement can be life threatening, requiring urgent intervention.We present a case of a seventy-year-old gentleman with rheumatic heart disease and multiple previous mechanical aortic and mitral valve replacements. After repeated admissions for decompensated heart failure, secondary to paravalvular mitral regurgitation, a percutaneous paravalvular leak closure was performed with successful reduction of the leak. He represented 30 days later with cardiogenic shock and multiorgan failure secondary to torrential central mitral regurgitation caused by late displacement of the closure device with mitral prosthesis impingement. Due to an excessively high surgical risk, his case was successfully managed percutaneously with retrieval of the displaced device and closure of the PVL using two Amplatzer Vascular Plug III devices. At the six-month review, he remains asymptomatic.Percutaneous PVL closure is an effective strategy for patients with prohibitive surgical risk. Late closure device displacement can be a life-threatening complication. Our case demonstrates that percutaneous management of this complication is feasible even in patients presenting in extremis.

Unplanned hospital readmissions after transcatheter aortic valve replacement (TAVR) are frequent and have been associated with a poor prognosis. We sought to determine the trends in the incidence and causes of unplanned hospital readmission after TAVR in patients receiving new-generation devices (NGDs) vs early-generation devices (EGDs).The study population consisted of 1802 consecutive TAVR recipients (863 EGDs and 939 NGDs). Early and late readmissions were defined as those occurring ≤30 days and30 days to 1-year post TAVR, respectively.A total of 986 unplanned hospital readmissions (cardiac cause, 38.4%; non-cardiac cause, 61.6%) were recorded at a median time of 110 days (interquartile range [IQR], 37-217) post TAVR. The rates of early (12.3% vs 9.4%; P=.046) and late (39.1% vs 31.6%; P.01) readmission were lower in the NGD population. In the NGD group, major/life-threatening periprocedural bleeding (hazard ratio [HR], 2.40, 95% confidence interval [CI], 1.06-5.42; P=.04) and estimated glomerular filtration rate (eGFR)60 mL/min at hospital discharge (HR, 1.80; 95% CI, 1.15-2.83; P=.01) were associated with an increased risk of early readmission post TAVR. Chronic obstructive pulmonary disease (HR, 1.42; 95% CI, 1.07-1.88; P=.02), eGFR60 mL/min (HR, 1.43; 95% CI, 1.11-1.84; P.01), and combining antiplatelet and anticoagulation therapy (HR, 1.37; 95% CI, 1.01-1.85; P=.04) determined an increased risk of late readmission.TAVR recipients receiving NGDs exhibited a significant but modest reduction in unplanned hospital readmissions, with about one-third of patients still requiring rehospitalization at 1-year follow-up in the contemporary TAVR era. Non-cardiac comorbidities, periprocedural bleeding events, and intensive antithrombotic therapy determined an increased risk.

Morbidly obese (MO) patients are increasingly undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) for severe aortic stenosis (AS). However, the best therapeutic strategy for these patients remains a matter for debate.Our aim was to compare the periprocedural and mid-term outcomes in MO patients undergoing TAVR versus SAVR.A multicentre retrospective study including consecutive MO patients (body mass index ≥40 kg/mAfter matching, periprocedural complications, including blood transfusion (14.1% versus 48.1%; p0.001), stage 2-3 acute kidney injury (3.99% versus 10.1%; p=0.002), hospital-acquired pneumonia (1.7% versus 5.8%; p=0.005) and access site infection (1.5% versus 5.5%; p=0.013), were more common in the SAVR group, as was moderate to severe patient-prosthesis mismatch (PPM; 9.9% versus 39.4%; p0.001). TAVR patients more frequently required permanent pacemaker implantation (14.4% versus 5.6%; p0.001) and had higher rates of ≥moderate residual aortic regurgitation (3.3% versus 0%; p=0.001). SAVR was an independent predictor of moderate to severe PPM (hazard ratio [HR] 1.80, 95% confidence interval [CI]: 1.25-2.59; p=0.002), while TAVR was not. In-hospital mortality was not different between groups (3.9% for TAVR versus 6.1% for SAVR; p=0.171). Two-year outcomes (including all-cause and cardiovascular mortality, and readmissions) were similar in both groups (log-rank p0.05 for all comparisons). Predictors of all-cause 2-year mortality differed between the groups; moderate to severe PPM was a predictor following SAVR (HR 1.78, 95% CI: 1.10-2.88; p=0.018) but not following TAVR (p=0.737).SAVR and TAVR offer similar mid-term outcomes in MO patients with severe AS, however, TAVR offers some advantages in terms of periprocedural morbidity.

BACKGROUND: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing. AIMS: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients 70). For patients 4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the 70 groups. In the

ObjectiveLeft atrial appendage (LAA) thrombus has heretofore been considered a contraindication to percutaneous LAA closure (LAAC). Data regarding its management are very limited. The aim of this study was to analyse the medical and invasive treatment of patients referred for LAAC in the presence of LAA thrombus.MethodsThis multicentre observational registry included 126 consecutive patients referred for LAAC with LAA thrombus on preprocedural imaging. Treatment strategies included intensification of antithrombotic therapy (IAT) or direct LAAC. The primary and secondary endpoints were a composite of bleeding, stroke and death at 18 months, and procedural success, respectively.ResultsIAT was the preferred strategy in 57.9% of patients, with total thrombus resolution observed in 60.3% and 75.3% after initial and subsequent IAT, respectively. Bleeding complications and stroke during IAT occurred in 9.6% and 2.9%, respectively, compared with 3.8% bleeding and no embolic events in the direct LAAC group before the procedure. Procedural success was 90.5% (96.2% vs 86.3% in direct LAAC and IAT group, respectively, p=0.072), without cases of in-hospital thromboembolic complications. The primary endpoint occurred in 29.3% and device-related thrombosis was found in 12.8%, without significant difference according to treatment strategy. Bleeding complications at 18 months occurred in 22.5% vs 10.5% in the IAT and direct LAAC group, respectively (p=0.102).ConclusionIn the presence of LAA thrombus, IAT was the initial management strategy in half of our cohort, with initial thrombus resolution in 60% of these, but with a relatively high bleeding rate (~10%). Direct LAAC was feasible, with high procedural success and absence of periprocedural embolic complications. However, a high rate of device-related thrombosis was detected during follow-up.

Intravascular imaging using both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have become important tools in the Interventional Cardiologists armamentarium. However, in some centers, intravascular imaging is not widely employed. A number of reasons for this may exist, including lack of training in the use of intravascular imaging. Co-registration with angiography may be a helpful tool for those beginning to use both IVUS and OCT in the cath lab, and may reduce the learning curve associated with its use. For experienced operators, co-registration can shorten procedure time and lessen contrast use which may be particularly important when performing complex or multivessel PCI. As a research tool, co-registration can allow for accurate comparison of interval intravascular images. In this review, we will discuss how to acquire co-registered images using both IVUS and OCT systems, and the potential advantages of this technology over non-co-registered images, and indeed angiography alone.

This study reports procedural and short-term clinical outcomes from a real-world series with the use of coronary lithotripsy in the context of primary angioplasty in ST-segment elevation myocardial infarction (STEMI).This was a prospective registry conducted at 2 hospitals, which included 10 patients who presented a culprit calcified lesion within acute STEMI and underwent coronary lithotripsy during primary angioplasty, between July 2019 and July 2020. Mean age was 69.2 ± 11.8 years, and there was a high proportion of hypertension (70%) and dyslipidemia (60%). All lesions (type B/C) were predilated with a semicompliant balloon. Coronary lithotripsy was performed in all cases once macroscopic thrombus was successfully retrieved by thrombus aspiration catheter. Before lithotripsy, rotational atherectomy was used in 1 case and cutting balloon was used in 2 cases. On average, coronary lithotripsy required the use of 1 lithotripsy balloon (range, 1-2) delivering a mean of 70 pulses. Two lithotripsy balloons were ruptured during lithotripsy therapy without any adverse event. Successful coronary lithotripsy was achieved in 90%. There were no periprocedural cardiac complications.Coronary lithotripsy seems to be a safe and effective technique in patients with STEMI and a culprit calcified lesion undergoing primary angioplasty for calcium modification in the absence of angiographic thrombus, and a suitable option to achieve adequate stent expansion and apposition.

Transcatheter aortic valve replacement (TAVR) is an established treatment for patients with symptomatic severe aortic stenosis. In recent years, an emphasis has been placed on simplification of the procedure. Balloon predilation was initially considered a mandatory step to cross and prepare the stenotic aortic valve, but several studies demonstrated the feasibility of performing TAVR without balloon valvuloplasty. Balloon postdilation of the implanted valve is sometimes required to optimise results, although many patients do not require this step. Contemporary consensus advocates an individualised approach to TAVR procedures and so balloon pre- and post-dilation are performed selectively. This review aims to outline the advantages and disadvantages of balloon pre- and post-dilation and to identify the scenarios in which they are required during TAVR procedures.

Introduction Left bundle branch block (LBBB) and permanent pacemaker (PM) are frequent complications after transcatheter aortic valve implantation (TAVI), but few predictors have been reported. Purpose This study sought to determine the relationship between left ventricular outflow tract (LVOT) morphology and the development of conduction disturbances after TAVI. Methods From 1/2020 to 12/2020 consecutive patients who underwent TAVI and an analyzable CT scan in our center were selected. Patients were categorized according to the LVOT morphology into three groups. The delta value between mean aortic root diameter (AA-d) and mean LVOT-d were calculated, and divided into terciles. In patients in the third tercile the AA-d was greater than LVOT-d and was defined as tapered-LVOT (group 1). First and second terciles had tubular or flared-LVOT shape and were defined as group 2. We compared conductance disorders after TAVI with and without tapered-LVOT. Primary endpoint was the combined of new-onset of transient/persistent LBBB, and PM. Factors with p Results Among 98 eligible patients thirty-two patients (33%) presented a tapered-LVOT (Group 1) and 66 (67%) had tubular or flared-LVOT morphology (group 2). The mean age was 80.5±5.5 years and 60% were female. Baseline characteristics were similar between groups except for the incidence of dyslipidemia that was higher in group 2. The primary study endpoint was significantly higher in group 1 (78% vs. 59%: p=0.036). After adjusting for confounding factors, this relationship remained statistically significant (OR: 2.81 (CI95%: 1–7.96), p 0.046). Independent predictors of conduction disturbance were: tapered-LVOT, prior coronary artery disease and prior surgical valve replacement. Conclusions After TAVI, patients presenting a tapered-LVOT morphology have a 2.8-fold greater risk to develop LBBB or require permanent PM when compared to another LVOT shapes. Funding Acknowledgement Type of funding sources: None.

espanolIntroduccion y objetivos: Una proporcion significativa de pacientes sometidos a implante percutaneo de valvula aortica (TAVI) presenta indicacion de anticoagulacion oral por fibrilacion auricular. En estos pacientes, con frecuencia el riesgo hemorragico es alto. El objetivo del estudio fue comparar los resultados clinicos en pacientes tratados con dosis baja de apixaban o con acenocumarol, un antagonista de la vitamina K (AVK). Metodos: Registro observacional multicentrico que incluyo pacientes sometidos a TAVI tratados con dosis baja de apixaban (2,5 mg/12 h) o AVK, en ambos casos sin tratamiento antiplaquetario asociado. Se llevo a cabo un emparejamiento por puntuacion de propension para seleccionar dos cohortes comparables. Se recabo la informacion de los 12 meses posteriores al procedimiento. Se consideraron objetivos coprimarios de eficacia (muerte, infarto de miocardio e ictus) y de seguridad (hemorragias BARC ≥ 2). Resultados: Se incluyeron 236 pacientes y se obtuvieron 2 grupos de 64 pacientes comparables en cuanto a caracteristicas basales. Solo 19 (30%) cumplieron estrictamente los criterios de ajuste a la baja de la dosis de apixaban. A los 12 meses, la incidencia de muerte, infarto de miocardio e ictus fue comparable (12,5% con AVK frente a 9,3% con apixaban; p = 0,5), pero la incidencia de hemorragia BARC ≥ 2 fue significativamente mayor en el grupo de AVK (7,8 frente a 0%; p = 0,02). La mayoria de los eventos tromboticos en el grupo de apixaban se observaron en pacientes con reduccion de dosis no ajustada a criterios. Conclusiones: En este registro de pacientes con TAVI y fibrilacion auricular, el uso de la dosis baja de apixaban en comparacion con el uso de AVK, sin antiagregantes concomitantes, se asocio a una menor incidencia de hemorragias mayores con una incidencia similar de eventos tromboembolicos. EnglishIntroduction and objectives: A significant amount of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for oral anticoagulation due to atrial fibrillation. In these patients the bleeding risk is often high. The purpose of this study was to compare the clinical outcomes of patients treated with low doses of apixaban or the vitamin K antagonist (VKA) acenocumarol in this setting. Methods: Multicenter observational registry including patients treated after TAVI with low doses of apixaban (2.5 mg/12 hours) or VKA both without associated antiplatelet therapy. Propensity score matching was conducted to select 2 comparable cohorts. Data were gathered for 12 months following the procedure. Coprimary endpoints of efficacy (death, myocardial infarction, and stroke) and safety (bleeding BARC ≥ 2) were considered. Results: A total of 236 patients were included. They were divided into 2 comparable groups of 64 patients each. Only 19 patients (30%) strictly met the dose adjustment criteria for apixaban. The rate of death, myocardial infarction, and stroke was similar at the 12-month follow-up (12.5% with VKA vs 9.3% with apixaban, P = .5), but the rate of bleeding BARC ≥ 2 was significantly higher in the VKA group (7.8% vs 0%; P = .02). Most of the events seen in the apixaban group occurred in patients with incorrect dose titration. Conclusions: In this registry of patients treated with TAVI and atrial fibrillation the use of low-dose apixaban compared to VKA—both without antiplatelet agents—was associated to a lower rate of actionable bleeding and a similar rate of thrombotic events.

Introduction and objectives: A significant amount of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for oral anticoagulation due to atrial fibrillation. In these patients the bleeding risk is often high. The purpose of this study was to compare the clinical outcomes of patients treated with low doses of apixaban or the vitamin K antagonist (VKA) acenocumarol in this setting. Methods: Multicenter observational registry including patients treated after TAVI with low doses of apixaban (2.5 mg/12 hours) or VKA both without associated antiplatelet therapy. Propensity score matching was conducted to select 2 comparable cohorts. Data were gathered for 12 months following the procedure. Coprimary endpoints of efficacy (death, myocardial infarction, and stroke) and safety (bleeding BARC ≥ 2) were considered. Results: A total of 236 patients were included. They were divided into 2 comparable groups of 64 patients each. Only 19 patients (30%) strictly met the dose adjustment criteria for apixaban. The rate of death, myocardial infarction, and stroke was similar at the 12-month follow-up (12.5% with VKA vs 9.3% with apixaban, P = .5), but the rate of bleeding BARC ≥ 2 was significantly higher in the VKA group (7.8% vs 0%; P = .02). Most of the events seen in the apixaban group occurred in patients with incorrect dose titration. Conclusions: In this registry of patients treated with TAVI and atrial fibrillation the use of low-dose apixaban compared to VKA—both without antiplatelet agents—was associated to a lower rate of actionable bleeding and a similar rate of thrombotic events.

Background There is a paucity of outcome data on patients who are morbidly obese (MO) undergoing transcatheter aortic valve replacement. We aimed to determine their periprocedural and midterm outcomes and investigate the impact of obesity phenotype. Methods and Results Consecutive patients who are MO (body mass index, ≥40 kg/m 2 , or ≥35 kg/m 2 with obesity‐related comorbidities; n=910) with severe aortic stenosis who underwent transcatheter aortic valve replacement in 18 tertiary hospitals were compared with a nonobese cohort (body mass index, 18.5–29.9 kg/m 2 , n=2264). Propensity‐score matching resulted in 770 pairs. Pre–transcatheter aortic valve replacement computed tomography scans were centrally analyzed to assess adipose tissue distribution; epicardial, abdominal visceral and subcutaneous fat. Major vascular complications were more common (6.6% versus 4.3%; P =0.043) and device success was less frequent (84.4% versus 88.1%; P =0.038) in the MO group. Freedom from all‐cause and cardiovascular mortality were similar at 2 years (79.4 versus 80.6%, P =0.731; and 88.7 versus 87.4%, P =0.699; MO and nonobese, respectively). Multivariable analysis identified baseline glomerular filtration rate and nontransfemoral access as independent predictors of 2‐year mortality in the MO group. An adverse MO phenotype with an abdominal visceral adipose tissue:subcutaneous adipose tissue ratio ≥1 (VAT:SAT) was associated with increased 2‐year all‐cause (hazard ratio [HR], 3.06; 95% CI, 1.20–7.77; P =0.019) and cardiovascular (hazard ratio, 4.11; 95% CI, 1.06–15.90; P =0.041) mortality, and readmissions (HR, 1.81; 95% CI, 1.07–3.07; P =0.027). After multivariable analysis, a (VAT:SAT) ratio ≥1 remained a strong predictor of 2‐year mortality (hazard ratio, 2.78; P =0.035). Conclusions Transcatheter aortic valve replacement in patients who are MO has similar short‐ and midterm outcomes to nonobese patients, despite higher major vascular complications and lower device success. An abdominal VAT:SAT ratio ≥1 identifies an obesity phenotype at higher risk of adverse clinical outcomes.

BACKGROUND Very few data exist on percutaneous mitral valve repair (PMVr) in unstable patients with concomitant moderate-severe mitral regurgitation (MR). The purpose of this systematic review was to evaluate baseline characteristics, management and clinical outcomes of critically ill patients undergoing PMVr with MitraClip. METHODS We conducted a systematic review of the published data on MitraClip from its first use in 2003 to December 2020. Studies referring to critically ill patients in cardiogenic shock or acute refractory pulmonary edema were included. A total of 40 publications including 254 patients with significant MR (Grade 4 in 91%) were included. RESULTS Mean age was 70 ± 12 years with mean Euroscore II and STS of 21 ± 13 and 20.5 ± 16, respectively. Clinical presentation was with cardiogenic shock and acute myocardial infarction in 72.8 and 60.0% of patients, respectively. Device success was achieved in 238 (93.7%) patients with a significant reduction in MR (Grade ≤ 2 in 91.8%, p

Funding Acknowledgements Type of funding sources: None. Background. Delirium is frequent in patients admitted to critical care units. Its incidence after transcatheter aortic valve implantation (TAVI) is up to 30%. Clinical and demographic factors have been related to delirium, but echocardiographic parameters have not been evaluated. Purpose. The aim of this study was to assess clinical and echocardiographic predictors of delirium in patients admitted to an acute cardiac care unit (ACCU) after transfemoral TAVI. Methods. 501 patients admitted to ACCU after TAVI were included. Delirium was evaluated by Confusion Assessment Method. Clinical cardiovascular and geriatric conditions were assessed, as well as echocardiographic parameters. Results. The incidence of delirium was 22% (110 patients). Delirium was associated with age (83.8 ± 4.6 vs 82.6 ± 6.1 years, p = 0.026), dyslipidaemia (50.0% vs 61.4%, p = 0.032), prior peripheral arterial disease (11.9% vs 5.4%, p = 0.017) and cognitive impairment (10.0% vs 1.8%, p < 0.001). There was no relationship to gender, other cardiovascular risk factors or geriatric conditions. Table shows echocardiographic parameters at baseline and after TAVI, with no statistical association with delirium. Conclusion. Delirium is a common complication after TAVI in ACCU. Age, the absence of dyslipidaemia, or the presence of cognitive impairment or prior peripheral arterial disease are clinical predictors of delirium. There are not echocardiographic predictors of delirium. Echocardiographic parametersWithout delirium(n = 391)With delirium(n = 110)p valueBaseline echocardiographic parametersLeft ventricular ejection fraction (%)57.7 ± 13.457.5 ± 14.10.912Mitral regurgitation (moderate to severe)106 (27.1)34 (30.9)0.433Pulmonary hypertension168 (43.0)53 (49.1)0.258Aortic regurgitation (moderate to severe)74 (18.9)21 (19.1)0.969Peak aortic gradient (mmHg)78.7 ± 25.278.5 ± 23.30.935Mean aortic gradient (mmHg)47.1 ± 16.146.7 ± 14.80.838Aortic valvular area (cm2)0.6 ± 0.20.6 ± 0.20.589Aortic annulus diameter (mm)22.5 ± 2.722.4 ± 2.50.615After TAVI echocardiographic parametersAortic regurgitation (moderate to severe)36 (9.3)11 (10.0)0.813Peak aortic gradient (mmHg)17.6 ± 9.617.7 ± 8.30.916Mean aortic gradient (mmHg)8.9 ± 5.49.3 ± 4.90.481Aortic valvular area (cm2)2.0 ± 0.62.2 ± 0.60.478Values are mean ± standard deviation, or n (%).

Thrombocytopenia is a common, yet poorly understood, complication after transcatheter aortic valve replacement (TAVR). Balloon-expandable transcatheter heart valve has been associated with higher incidence of thrombocytopenia, compared with self-expandable valves. The aim of this study was to analyze the incidence, clinical impact and predictors of acquired thrombocytopenia in patients undergoing TAVR.We performed an observational study from consecutive patients with severe aortic stenosis undergoing TAVR (n = 679) in a single center. Association and best cut-off point of platelet decrease with early mortality was analyzed. Patients were classified according to postprocedural percentage decrease in platelet count (PDPC), comparing clinical outcomes and analyzing predictors of platelet decrease.The median PDPC was 37.1 [IQR: 27.4-46.9]. PDPC was associated with early mortality (OR: 2.1, 95%IC: 1.7-2.5 for each 10% decrease, AUC:0.81, 95%CI:0.72-0.89) with an optimal cut-off point of 46%. PDPC≥46% and late nadir (≥4 days) were both independent predictors of early mortality (OR: 6.0 [IQR: 2.4-14.9] and OR: 5.1 [IQR: 2.2-11.6], respectively). The combination of both factors (PDPC≥46% and nadir ≥4 day) was associated with higher 2-year mortality (55.7%) compared to an early significant nadir (PDPC≥46% and nadir4 day, 28.9%) and non-significant nadir (PDPC46%, 21.0%), p 0.001. Independent predictors of PDPC≥46% were baseline platelet count, Portico™, Abbott valve, intraprocedural major vascular complication and residual aortic regurgitation ≥grade 2.The platelet count decreased almost 40% after TAVR. Late nadir and PDPC≥46% predicted short-term clinical outcomes. Concomitant late and significant platelet decrease was associated with mid-term mortality.