Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial.

OBJECTIVES: The objective of this study is to investigate the use of cutting balloon (CB) inflated at high pressure compared with noncompliant balloon (NCB) for the treatment of calcified coronary lesions. BACKGROUND: No data are available regarding the safety and efficacy of CB inflated at high pressure in coronary artery calcifications. METHODS: Patients with calcified lesions (more than 100° of calcium demonstrated at baseline intravascular ultrasound) were randomized. Primary endpoint of the study was the final minimal stent area (MSA) and stent symmetry in the calcific segment. Secondary endpoints included rate of device failure and the 1-year rate of target lesion revascularization, target vessel revascularization, and major adverse cardiovascular events. RESULTS: From September 2019 to June 2021, a total of 100 patients were included and randomized; 13 patients were excluded for major protocol deviations. Lesions were complex (type B2/C n = 61 [71.2%]) with a mean arch of calcium of 266 ± 84°, a calcium length of 12 ± 6.6 mm. CB was inflated at comparable atmospheres when compared with NCB (18.3 ± 5 vs. 19 ± 4.5, p = 0.46). In the per-protocol population, the final MSA at the level of the calcium site was significantly higher in the CB group (8.1 ± 2 vs. 7.3 ± 2.1, p = 0.035) with a higher eccentricity index achieved in the CB group (0.84 ± 0.07 vs. 0.8 ± 0.08, p = 0.013). Three device failure occurred in the CB group. One-year follow-up outcomes were comparable. CONCLUSIONS: Treatment of calcified lesions with high-pressure CB has a good safety profile and is associated with a larger MSA and higher eccentricity of the stent at the level of the calcium site compared with NCB.

Practical guide to prevention of contrast-induced acute kidney injury after percutaneous coronary intervention.

Contrast-induced acute kidney injury (CI-AKI) represents a common but serious complication of percutaneous coronary interventions (PCI)-and in general of all those examinations requiring iodinated contrast injection-which affects not only renal function but also long-term prognosis. While several prophylactic approaches were designed in order to prevent CI-AKI, most failed to demonstrate clear benefits in randomized trials, and their implementation is therefore discouraged in clinical practice. The most notorious examples include pre-procedural bicarbonate or N-acetylcysteine, and preprocedural withdrawal of ACE inhibitors/Angiotensin receptor blockers. Those strategies that were instead demonstrated effective include the appropriate use of preprocedural hydration, reduction in contrast volume utilization, adoption of techniques for zero- or ultra-low-contrast procedures, and pharmacological treatments with statins. In this brief review, we summarize the main preventive strategies into brief and pragmatic recommendations designed to improve everyday clinical practice.

Iatrogenic aorta-coronary dissection: Case report and systematic review.

OBJECTIVES AND BACKGROUND: Iatrogenic aorto-coronary dissection (ICD) is one of the most feared complications of interventional cardiology. Although rare, it is characterized by anterograde coronary ischemia and a concomitant aortic dissection, with potentially fatal consequences. METHODS: We present an example case of IACD and an accurate case-series review of the literature including 125 published cases. RESULTS: There were no significant predisposing factors and the IACD occurred equally in elective and urgent procedures. A significant number of IACDs were associated with CTO procedures. The factors associated with a worse outcome were hemodynamic instability, the presence of anterograde ischemia, and the extent of dissection according to the Dunning classification. Bail-out stenting was the most used strategy and its failure was associated with mortality. CONCLUSION: The main features of IACD are anterograde ischemia, retrograde dissection, and hemodynamic instability, each of them should be addressed with no time delay, possibly with bailout stenting, the most employed exit-strategy. According to our proposed algorithm, a shock team approach is required to coordinate the interdisciplinary skills and enabled patients to receive the best treatment.

Computed tomography analysis of coronary ostia location following valve-in-valve transcatheter aortic valve replacement with the ACURATE neo valve: Implications for coronary access.

BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) is an emerging alternative to re-do surgery. However, the challenge of coronary access (CA) following ViV-TAVR is a potential limitation as TAVR expands to younger lower-risk populations. OBJECTIVES: Using post-implantation computed tomography (CT) scans to evaluate the geometrical relationship between coronary ostia and valve frame in patients undergoing ViV-TAVR with the ACURATE neo valve. METHODS: Post-implant CT scans of 18 out of 20 consecutive patients treated with the ACURATE neo valve were analyzed. Coronary ostia location in relation to the highest plane (HP) (highest point of the ACURATE neo or surgical valve) was determined. Ostia located below the highest plan were further subclassified according to the gap available between the transcatheter heart valve frame and ostium (transcatheter-to-coronary [TTC] distance). The impact implantation depth has on these geometrical relationships was evaluated. RESULTS: A total of 21 out of 36 coronary ostia (58%) were located below the level of the HP with the left coronary artery (36%) more likely to be affected than the right (22%). Further sub-classification of these ostia revealed a large (>6 mm), moderate (4-6 mm), and small (<4 mm) TTC distance in 57% (12/21), 38% (8/21), and in 6% (1/18) of cases, respectively. At an implantation depth <4 mm compared to >4 mm, all ostia were located below the HP with no difference in post-procedural mean gradients (14.5 mmHg ± 4.7 vs. 12.6 mmHg ± 5.8; p = .5, 95%CI 3.8-7.5). CONCLUSIONS: CA following ACURATE neo implantation for ViV-TAVR could potentially be challenging in a significant proportion of patients and specific consideration should be given to the implantation depth.

Incidence, predictors, and clinical impact of bleeding recurrence in patients with prior gastrointestinal bleeding undergoing LAAC.

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.

Diagnosis and Management of Failed Surgical Tricuspid Valve Annuloplasty.

PURPOSE OF THE REVIEW: Annular-based strategies for treating tricuspid valve (TV) regurgitation do not always have satisfactory long-term outcomes. Management of failed TV annuloplasty can be challenging and requires a dedicated heart team approach. This review explores the treatment options available for failed TV annuloplasty. RECENT FINDINGS: Recent developments and novel percutaneous treatment options have emerged as promising alternatives for patients with failed TV annuloplasty. Leaflet-based interventions, valve-in-valve procedures, transcatheter tricuspid valves and new-generation trans-caval valves are all feasible options, which can assure good results whilst minimizing risks for the patient. Failure of tricuspid annuloplasty is not uncommon amongst patients treated with either a tricuspid ring or suture-based device. The complex anatomy, physiology and clinical risk profile should be carefully evaluated on an individual patient-by-patient basis in order to select the most appropriate clinical and percutaneous treatment strategy. Different transcatheter tricuspid valve repair or replacement techniques may provide an attractive alternative treatment option for managing this challenging patient cohort.

Perceval sutureless valve migration treated by valve-in-valve with a CoreValve Evolut Pro.

In the last years, the use of sutureless devices in frail patients with severe aortic stenosis has increased thanks to their "easier and faster" technique of implantation in comparison to conventional surgery. Results from metanalysis show comparable outcomes in comparison to transcatheter aortic valve replacement (TAVR) in terms of mortality, stroke incidence, and rate of pace-maker implantation. The incidence of para-valvular leak (PVL) is even lower for sutureless devices than for TAVR. The few cases described are generally due to incomplete decalcification or incorrect valve sizing and consequent stent distortion. To our knowledge this is the first case describing PVL with massive aortic regurgitation due to early partial embolization of a Perceval valve and its successfully treatment with valve-in-valve by using a self-expanding TAVR device.

New interventional solutions in calcific coronary atherosclerosis: drill, laser, shock waves.

In the percutaneous treatment of coronary stenoses, it is essential to take into account the presence of calcifications as this influences the short- and long-term post-procedural outcomes. Today in the catheterization laboratory, there are several tools for the treatment of calcium; exploiting the different operating mechanisms, possibly even combining them together, is part of a modern approach to coronary angioplasty that aims to optimize results. To this end, each procedure must be properly planned and, in this perspective, intracoronary imaging (such as optical coherence tomography and intravascular ultrasound) is an essential aid to guide the procedure and show results.

Anatomic and procedural associations of transcatheter heart valve displacement following Evolut R implantation.

OBJECTIVES: This study aimed to predict the displacement of self-expanding transcatheter heart valves (THV) during final deployment. BACKGROUND: Accurate device positioning during transcatheter aortic valve implantation (TAVI) is crucial for optimal results. METHODS: At our institution, 103 patients who underwent transfemoral TAVI with Evolut R were retrospectively identified. Multiple linear regression models were created, and a predictor equation was built to quantify the factors that may affect THV behavior. RESULTS: Multiple linear regression analysis for THV displacement on the left coronary cusp (LCC) identified the angle between the THV and the ascending aorta (ATA), predilation, and less operator experience as independent predictors of upward displacement, whereas estimated glomerular filtration rate (eGFR) was inversely related with THV behavior (95% confidence interval: 0.219 to 0.340, 0.447 to 2.092, 0.165 to 1.757, and -0.053 to -0.011, respectively). Predictors of THV displacement on the noncoronary cusp side could not be identified using this model. CONCLUSIONS: The ATA at the point of recapture, predilation, and less operator experience were independent predictors of upward displacement of THV on the LCC side. eGFR was an independent predictor of THV downward displacement on the LCC side. Of them, the ATA was the strongest predictor. Physicians may need to adjust this angle adequately before deployment to achieve the appropriate position.

Long-term follow-up of covered stent implantation for various coronary artery diseases.

OBJECTIVES: The aims of this study were to evaluate the long-term clinical outcomes after coronary covered stent (CS) implantation and to compare the results according to the indications. BACKGROUND: To date, data on the long-term follow-up of coronary CS are limited, and no studies have been conducted to compare outcomes on the basis of specific lesions treated. METHODS: A total of 190 consecutive patients (212 lesions) implanted with CS and surviving until discharge between May 1997 and February 2017 were enrolled in this retrospective study. Clinical outcomes were evaluated and compared using the Gehan-Breslow-Wilcoxon test. RESULTS: CS was mainly used for the treatment of a saphenous vein graft (SVG) (51.4%), followed by coronary artery perforation (CAP) (25.0%) and coronary artery aneurysm (CAA) (11.8%). The median follow-up duration was 6.0 (interquartile range: 1.6-13.5) years. Target vessel myocardial infarction (MI), target vessel occlusion, target lesion revascularization, and stent thrombosis, frequently occurred in the early follow-up period (7.3%, 16.6%, 21.5%, and 8.9% at 1 year, respectively) and continued to increase throughout the long-term follow-up (14.8%, 38.6%, 38.7%, and 17.8% at 10 years, respectively). Target vessel occlusion, target vessel MI, and ST were not identified in CAA with superiority to CAP (Gehan-Breslow-Wilcoxon p-value = 0.010, 0.047, and 0.046, respectively). SVG had a higher rate of target vessel occlusion than CAA (p = 0.004). CONCLUSIONS: Clinical events after CS implantation frequently occurred in the early period and steadily increased in the long-term period. CS implantation in CAA was associated with fewer adverse cardiac events and may lead to safe and acceptable outcomes. However, CS implanted in CAP and SVG are associated with a high risk of long-term cardiac events.

Temporary Transvenous Pacemaker Implantation during Carotid Endarterectomy in Patients with Trifascicular Block.

BACKGROUND: The risk of severe perioperative bradyarrhythmias in patients with chronic left bundle branch, or bifascicular block, and an additional first-degree atrioventricular block undergoing carotid endarterectomy (CEA) has never been specifically addressed. In this study, we aimed to investigate whether these conduction abnormalities entail an increased risk of hemodynamic compromise during CEA and the role of temporary transvenous pacemaker (TTVPM) implantation as a prophylactic measure in this subgroup of patients. METHODS: Between June 2006 and June 2013, 37 CEAs were performed in 31 patients (29 men, mean age 76 ± 6 years), in whom a TTVPM was implanted for a trifascicular block. Thirty-seven concurrent, consecutive patients operated for other vascular pathologies also with a prophylactic TTVPM for an asymptomatic trifascicular block served as controls. Adverse events were considered: pacemaker activation, block progression, bradycardia ≤40 beats/min, and asystole. RESULTS: Study and control groups were overall comparable. No perioperative mortality was recorded. All patients undergoing CEA were asymptomatic for syncope preoperatively. Among them, in 34 cases, indication for TTVPM was based on preoperative EKG, and in 4, a pacemaker activation was recorded. Three additional patients were also included in the study group in whom TTVPM was implanted due to the occurrence of adverse advents, and not prophylactically. In 2 of these, severe bradycardia with eventual asystole occurred intraoperatively. In both cases, the procedure was discontinued and rescheduled for the following day after a TTVPM was implanted. In the last additional case, the patient had a block progression on day 1 after an uneventful CEA and was emergently treated with a TTVPM. Overall, 7 adverse events were recorded in the study group, and none in the control group (P < 0.011). Morbidity in the CEA group also included 1 myocardial infarction, 1 minor stroke, 1 surgical revision for cervical hematoma, 1 new-onset atrial fibrillation, and 1 femoral artery pseudoaneurysm. CONCLUSIONS: In our experience, TTVPM implantation was a clinically useful adjunct in patients with trifascicular block submitted to CEA, as compared with other vascular surgical procedures. However, the risks inherent to CEA in this subgroup of patients suggest that surgical treatment may not be warranted for those with asymptomatic carotid disease.

Relationships, Current Issues, Safety and Efficacy of Oral Anticoagulation in Cancer Patients with Atrial Fibrillation.

A relationship between malignancy and impaired hemostasis has been proven, and balancing clotting and bleeding risks can be challenging. Half of cancer patients with atrial fibrillation (AF) do not receive any oral anticoagulation (OAC). Using PubMed on the relationship between cancer and AF and their association with hemostasis, targeting studies comparing vitamin K antagonists (VKAs) and direct OAC (DOAC) strategies in AF cancer patients, three RCTs (>3000 patients) and eight observational studies (>250,000 patients) comparing different OACs were retrieved. The VKA prescribed was always warfarin. Dabigatran was the only DOAC not analyzed in the RCTs but the most used in non-randomized studies, whereas edoxaban-treated patients were the majority in the RCTs. Overall, the DOAC patients showed similar or lower rates of efficacy (thromboembolic) and safety (bleeding) outcomes compared to the VKA patients. DOACs are subject to fewer interactions with antineoplastic agents. DOACs may be preferable to VKAs as a thromboembolic prophylaxis in cancer patients with non-valvular AF.

Sirolimus-coated balloon in acute and chronic coronary syndromes: subanalysis of the EASTBOURNE registry.

INTRODUCTION AND OBJECTIVES: The PEACE study (Performance of a sirolimus-eluting balloon strategy in acute and chronic coronary syndromes) investigated for the first time whether a sirolimus-coated balloon (SCB) (Magic Touch, Concept Medical, India) is associated with different outcomes depending on whether it is used in acute coronary syndromes (ACS) or chronic coronary syndromes (CCS). METHODS: This was a post-hoc analysis from the all-comers EASTBOURNE Registry (NCT03085823). Out of 2083 patients enrolled, an SCB was used to treat 968 (46.5%) ACS and 1115 (53.5%) CCS patients. The primary endpoint was target lesion revascularization at 12 months, while secondary endpoints were angiographic success and major adverse cardiovascular events. RESULTS: Baseline demographics, mean reference vessel diameter and mean lesion length were comparable between ACS and CCS. Predilatation was more commonly performed in ACS (P=.007). SCB was inflated at a standard pressure in both groups with a slight trend toward longer inflation time in ACS. Angiographic success was high in both groups (ACS 97.4% vs CCS 97.7%, P=.820) with limited bailout stenting. Similarly, at 12 months the cumulative incidence of target lesion revascularization (ACS 6.6% vs CCS 5.2%, P=.258) was comparable between ACS and CCS. Conversely, a higher rate of major adverse cardiovascular events in acute presenters was mainly driven by myocardial infarction recurrencies (ACS 10.4% vs CCS 8.3%, P=.009). In-stent restenosis showed a higher proportion of target lesion revascularization and major adverse cardiovascular events than de novo lesions, independently of the type of presentation at the index procedure. CONCLUSIONS: This SCB shows good performance in terms of acute and 1-year outcomes independently of the clinical presentation.

Systematic Review and Meta-Analysis of Oral Anticoagulant Therapy in Atrial Fibrillation Cancer Patients.

(1) Introduction: Cancer and atrial fibrillation (AF) are increasingly coexisting medical challenges. These two conditions share an increased thrombotic and bleeding risk. Although optimal regimens of the most suitable anti-thrombotic therapy are now affirmed in the general population, cancer patients are still particularly understudied on the matter; (2) Aims And Methodology: This metanalysis (11 studies (incl. 266,865 patients)) aims at evaluating the ischemic-hemorrhagic risk profile of oncologic patients with AF treated with oral anticoagulants (vitamin K antagonists vs. direct oral anticoagulants); (3) Results: In the oncological population, DOACs confer a benefit in terms of the reduction in ischemic, hemorrhagic and venous thromboembolic events. However, ischemic prevention has a non-insignificant bleeding risk, lower than Warfarin but significant and higher than the non-oncological patients; (4) Conclusions: Anticoagulation with DOACs provides a higher safety profile with respect to VKAs in terms of stroke reduction and a relative bleeding reduction risk. Further studies are needed to better assess the optimal anticoagulation strategy in cancer patients with AF.

Long Stent Implantation on the Left Anterior Descending Coronary Artery at a Follow-Up of More Than Five Years.

BACKGROUND: Stent implantation represents the standard of care in coronary intervention. While a short stent implanted on a focal lesion located on the left anterior descending artery (LAD) seems a reasonable alternative to an internal mammary implant, the same for long stents is still debated. METHODS: We reported the long-term data of 531 consecutive patients who underwent Percutaneous Coronary Intervention (PCI) with long stents in two highly specialized centres. The main inclusion criteria were the implantation of stents longer than 30 mm on the LAD and a minimum follow-up (FU) of five years. The primary endpoint was mortality, and the secondary endpoints were any myocardial infarction (MI), target vessel and lesion revascularization (TVR and TLR, respectively), and stent thrombosis (ST) observed as definite, probable, or possible. RESULTS: In this selected population with characteristics of complex PCI (99.1%), the long-term follow-up (mean 92.18 ± 35.5 months) estimates of all-cause death, cardiovascular death, and any myocardial infarction were 18.3%, 10.5%, and 9.3%, respectively. Both all-cause and cardiovascular deaths are significantly associated with three-vessel disease (HR 6.8; confidence of interval (CI) 95% 3.844-11.934; p < 0.001, and HR 4.7; CI 95% 2.265-9.835; p < 0.001, respectively). Target lesion (TLR) and target vessel revascularization (TVR) are associated with the presence of three-lesion disease on the LAD (HR 3.4; CI 95% 1.984-5.781; p < 0.001; HR 3.9 CI 95% 2.323-6.442; p < 0.001, respectively). Re-PCI for any cause occurred in 31.5% of patients and shows an increased risk for three-lesion stenting (HR 4.3; CI 95% 2.873-6.376; p < 0.001) and the treatment of bifurcation with two stents (HR 1.6; 95% CI 1.051-2.414; p = 0.028). Stent thrombosis rate at the 5-year FU was 4.4% (1.3% definite; 0.9% probable; 2.1% possible), including a 1.7% rate of very-late thrombosis. The stent length superior to 40 mm was not associated with poor outcomes (all-cause death p = 0.349; cardiovascular death p = 0.855; MI p = 0.691; re-PCI p = 0.234; TLR p = 0.805; TVR p = 0.087; ST p = 0.189). CONCLUSION: At an FU of longer than five years, patients treated with stents longer than 30 mm in their LAD showed acceptable procedural results but poor outcomes.

Symptomatic vs. non-symptomatic device-related thrombus after LAAC: a sub-analysis from the multicenter EUROC-DRT registry.

BACKGROUND: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited. AIMS: This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed. METHODS: The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared. RESULTS: Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37-558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%). CONCLUSION: Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events.

Mother-in-Child Assisted Tracking (MiCAT): A Mechanical Technique to Overcome Severe Radial Artery Spasm.

BACKGROUND: Severe radial artery spasm (RAS) and tortuosity may hinder guide catheter advancement and manipulation, requiring the arterial access site to be changed. We describe the safety and the effectiveness of a technique designed to facilitate guide catheter advancement when faced with severe RAS. METHODS AND RESULTS: We present our single-center experience using a novel mother-in-child assisted tracking (MiCAT) technique used to overcome severe RAS and facilitate guide catheter advancement to the aortic root. The MiCAT system consists of a 125 cm 4-Fr multipurpose (MP) diagnostic catheter inserted inside and protruding beyond a guiding catheter. The entire system can be advanced as one over a .035˝ guidewire into the aortic root. Procedural success was defined as achievement of the intended procedure without switching to an alternative access site with no vascular complications. The MiCAT system was utilized in 22 (0.59%) out of 3392 patients who underwent angiography between October 2019 and January 2021, with severe RAS hindering advancement of a 6 Fr guiding catheter despite conventional pharmacological therapy. MiCAT was successfully achieved via the left (55%) and right (45%) radial access routes using different 6-Fr guiding catheters. Procedural success was 100% and no vascular access or arterial complications were observed. CONCLUSIONS: In our early experience, the MiCAT technique was a safe and effective strategy to facilitate guide catheter advancement.

Early Discontinuation of Antithrombotic Treatment Following Left Atrial Appendage Closure.

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 CHA2DS2-VASc score (p <0.001) and a higher rate of previous gastrointestinal bleeding episodes (p = 0.01) compared with patients without discontinuation. After a median follow-up of 2.1 (1,1-3.1) years after antithrombotic treatment discontinuation, the rates of death, ischemic stroke, and major bleeding were 12.1, 0.6, and 3.3 per 100 patient-years. In 119 matched pairs with similar baseline characteristics, antithrombotic treatment discontinuation patients had a similar risk of death (hazard ratio [HR] 1.06, 95% confidence interval [CI] 0.65 to 1.71, p = 0.82), ischemic stroke (HR 0.39, 95% CI 0.04 to 3.79, p = 0.42) and major bleeding (HR 1.48, 95% CI 0.56 to 3.88, p = 0.43) compared with those without discontinuation. In conclusion, antithrombotic treatment was discontinued in 1 of 7 selected patients within 6 months after LAAC, and this was not associated with an increased risk of death or thromboembolic events after a median follow-up of 2 years. These data support the safety of shorter periods of antithrombotic therapy after LAAC in high bleeding risk patients based on clinician judgment. Further trials are warranted.

Incidence and Predictors of Early Death in Patients Undergoing Percutaneous Left Atrial Appendage Closure.

BACKGROUND: Left atrial appendage closure (LAAC) aims to prevent ischemic events in patients with atrial fibrillation. As a preventive procedure, early death after LAAC could render the procedure futile. OBJECTIVES: The authors sought to evaluate the incidence and factors associated with early death in LAAC recipients. METHODS: This was a multicenter study including consecutive patients undergoing LAAC in a 10-year period (2009-2019). Death was considered early when occurring in the first year after LAAC. RESULTS: A total of 807 patients (mean age 76 ± 8 years, mean CHA2DS2-VASc score 4.5 ± 1.5) were included. Early death occurred in 125 patients (15.5%). In the multivariable analysis, factors associated with early death after LAAC were older age HR: 1.03; 95% CI: 1.01-1.06 per year; P = 0.01), lower body mass index (HR: 0.92; 95% CI: 0.88-0.97 per 1 kg/m2 increase; P < 0.001), diabetes (HR: 1.71; 95% CI: 1.19-2.47; P = 0.002), prior heart failure (HR: 1.74; 95% CI: 1.20-2.53; P = 0.001), and lower estimated glomerular filtration rate (HR: 1.09; 95% CI: 1.05-1.13 per 5 mL/min/1.73 m2 decrease; P < 0.001). There was a stepwise increase in risk of early death within the first year of LAAC with the combination of different risk factors (up to 48.9% in the presence of >3 risk factors). CONCLUSIONS: In this multicenter international registry, close to 1 in 6 patients died within the first year of LAAC. Older age, low body mass index, impaired estimated glomerular filtration rate, prior diabetes, and prior heart failure are independently associated with an increased risk. The risk of early death appeared to be prohibitive (∼50%) in the presence of >3 of these risk factors.