Perioperative Treatment with Rivaroxaban and Dabigatran on Changes of Coagulation and Platelet Activation Biomarkers following Left Atrial Appendage Closure.

Insufficient data exist regarding the investigation of the impact of novel oral anticoagulants (NOACs) on coagulation activation biomarkers in the context of left atrial appendage closure (LAAC) and device-related thrombosis (DRT). The study was designed to investigate the changes and presence of coagulation activation biomarkers between different antithrombotic strategies following LAAC. A total of 120 nonvalvular atrial fibrillation patients intolerant of long-term anticoagulants, who underwent successful WATCHMAN closure implantation, were enrolled (rivaroxaban, n = 82; dabigatran, n = 38). Blood samples were obtained from left atrium (LA) and left atrial appendage (LAA) during the operation and fasting blood samples on the same day of LAAC and 45 days after discharge. The biochemical indicators, thrombin-antithrombin complex (TAT), soluble P-selectin (sP-selectin), von Willebrand factor (vWF), and CD40 ligand (CD40L), were measured by enzyme-linked immunosorbent assay. The primary endpoints of this study were the efficacy and safety characteristics of different antithrombotic strategies, including DRT incidence, stroke or transient ischemic attack, systemic embolism, and clinical major and nonmajor bleeding complications during the follow-up of 180 days. The results revealed that TAT, vWF, sP-selectin, and CD40L levels in vein were significantly reduced by 2.4% (p = 0.043), 5.0% (p < 0.001), 8.7% (p < 0.001), and 2.5% (p = 0.043) from their baseline levels after rivaroxaban treatment. Conversely, no significant changes were detected in the dabigatran group. Furthermore, the plasma levels of platelet activation biomarkers (CD40L and sP-selectin) in both LA and LAA groups were significantly lower after anticoagulation with rivaroxaban, as compared to dabigatran treatment (CD40L: 554.62 ± 155.54 vs. 445.02 ± 130.04 for LA p = 0.0013, 578.51 ± 156.28 vs. 480.13 ± 164.37 for LAA p = 0.0052; sP-selectin: 2849.07 ± 846.69 vs. 2225.54 ± 799.96 for LA p = 0.0105, 2915.52 ± 1402.40 vs. 2203.41 ± 1061.67 for LAA p = 0.0022). Notably, the present study suggests that rivaroxaban may be more effective in the prevention of DRT for patients undergoing LAAC.

Outcomes of Upgrading to LBBP in CRT Nonresponders: A Prospective, Multicenter, Nonrandomized, Case-Control Study.

BACKGROUND: Cardiac resynchronization therapy (CRT) nonresponders account for nearly 30% of CRT candidates. Left-bundle branch pacing (LBBP) is an alternative to CRT. OBJECTIVES: This study aimed to evaluate the feasibility, clinical efficacy, and outcomes of upgrading to LBBP in CRT nonresponders, using propensity-score matching (PSM) analysis. METHODS: CRT nonresponders were defined as those with an implantable CRT-pacemaker or CRT-defibrillator for more than 12 months who remained nonresponsive (a decrease in left ventricular end-systolic volume of <15% or a left ventricular ejection fraction [LVEF] absolute increase of <5%) after optimal medical therapy and device optimization compared with baseline. In total, 145 CRT nonresponders were prospectively enrolled and randomly divided into 2 groups: upgraded to LBBP (n = 48), and continuing biventricular pacing (BVP) (control; n = 97). PSM was performed at a 1:1 ratio, and clinical evaluation and echocardiographic assessments were compared at baseline and follow-up in paired cohorts. The primary composite endpoint for clinical outcomes (heart failure-related rehospitalization events, all-cause death, or heart transplantation) was analyzed. RESULTS: Successful upgrading to LBBP was achieved in 48/49 patients (97.96%), with a significant decrease in QRS duration (P < 0.001). In the paired LBBP group, LVEF significantly increased (baseline: 29.75% ± 7.79%; 6 months: 37.78% ± 9.25% [P < 0.001]; 12 months: 38.84% ± 12.13% [P < 0.001]) with 21/44 patients (47.73%) classified as echocardiographically responsive, whereas in the BVP control group, no significant improvement was observed (29.55% ± 6.74% vs 29.22% ± 8.10%; P = 0.840). In a multivariate logistic regression model, LV end-diastolic volume and baseline LBBB QRS morphology were independent predictors of echocardiographic response after upgrading to LBBP. At a median 24 months, the primary composite endpoint was significantly lower in the LBBP group (HR: 0.31; 95% CI: 0.14-0.72; log-rank P = 0.007). CONCLUSIONS: Upgrading to LBBP is feasible and effective in achieving significant heart function improvement and better clinical outcomes in CRT nonresponders, making it a reasonable and promising pacing strategy. (LBBP in CRT Non-Response patients; ChiCTR1900028131).

Five-year follow-up after percutaneous pulmonary valve implantation using the Venus P-valve system for patients with pulmonary regurgitation and an enlarged native right ventricular outflow tract.

BACKGROUND: Percutaneous pulmonary valve implantation (PPVI) with the self-expandable Venus P-valve system is a promising treatment for patients with pulmonary regurgitation (PR) and a native right ventricular outflow tract (RVOT). However, limited data is available regarding its midterm outcomes. This study assessed the midterm clinical and echocardiographic outcomes following Venus P-valve implantation. METHODS: From 2013 to 2018, 55 patients with moderate or severe PR after surgical RVOT repair with a transannular or RVOT patch were consecutively enrolled from six hospitals in China. Five-year clinical and echocardiographic outcomes were collected and evaluated. The primary endpoint was a freedom from all-cause mortality and reintervention. RESULTS: At 5 years, the primary endpoint was met for 96% of patients, corresponding to a freedom from all-cause mortality of 96% (95% confidence interval [CI]: 86%-99%) and freedom from reintervention of 98% (95% CI: 87%-100%). Endocarditis was reported in five patients (four patients within 1 year and one patient at 5 years) following PPVI. Transpulmonary gradient and stent orifice diameter remained stable compared to at discharge (p＞0.05). No paravalvular leak was reported while only 1 patient gradually increased to moderate PR during follow-up. Significant improvement of RV diameter and LVEF (p＜0.001) sustained over the 5-year follow-up, in consistent with remarked improved New York Heart Association(NYHA) functional class (p＜0.001). CONCLUSION: The 5-year results of the China VenusP Study demonstrated the midterm benefits of Venus P-valve implantation in the management of patients with severe PR with an enlarged native RVOT by providing sustained symptomatic and hemodynamic improvement.

Preliminary Implantation of a Novel TAVR Device With Polymeric Leaflets for Symptomatic Calcific Aortic Disease.

The indication for transcatheter aortic valve replacement to younger patients remains controversial. Here, we report a successful implantation of the first polymeric transcatheter aortic valve replacement device in a patient with severe calcific aortic stenosis. Compared with conventional valves, the novel valve has better durability, larger orifice area, and better morphological adaptability. (Level of Difficulty: Intermediate.).

First-in-human study of the K-Clip™ transcatheter annular repair system for severe functional tricuspid regurgitation.

BACKGROUND: Severe TR is associated with impaired prognosis while limited interventional options available. The purpose of this observational first-in-human experience with the K-Clip™ transcatheter tricuspid annular reconstruction system is to investigate its feasibility, safety as well as short-term clinical impact on patients with severe functional tricuspid regurgitation (TR). METHODS: In this compassionate-use, prospective, multi-center, single-arm study, 15 patients with severe symptomatic functional TR were treated with the K-Clip™ system and followed up at 30 days after discharge. Feasibility endpoints consisted of safety (major clinical cardiovascular events (MACEs), echocardiographic, clinical and functional endpoints. RESULTS: All the 15 patients (9 males, 72.67 ± 9.42 years of age) successfully received implants and no MACEs were reported throughout the study at 30 days. Between baseline and 30 days, echocardiography showed remarkable reduction of tricuspid annular circumference and area by 14.30% and 25.96%. Improvement of ≥ + 2 grade and ≥ +3 grade TR was presented in 9/15(60.00%) and 4/15(26.67%) respectively while 10/15(66.67%) of patients had ≤ moderate TR. Clinical evaluation indicated that 86.67% of patients were finally in NYHA functional class I or II (p<0.001) and overall Kansas City Cardiomyopathy Questionnaire score improved from 62.28 ± 18.97 to 77.90 ± 11.70 (p = 0.016). CONCLUSION: Our first-in-human results of the transcatheter tricuspid annular reconstruction using the K-Clip™ system demonstrated initial favorable procedural success, acceptable safety and remarkable TR reduction in consistent with significant clinical improvement. Larger-scaled prospective trials with longer follow-up duration are warranted to further determine whether these promising findings could be promoted to a broader population in the long term.

Clinical outcomes of bicuspid versus tricuspid aortic valve stenosis after transcatheter aortic valve replacement with self-expandable valves.

BACKGROUND: There is a lack of available data on specific prognostic comparisons between transcatheter aortic valve replacement (TAVR) using self-expandable valves (SEV) in patients with stenotic Type 0, Type 1 bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV). OBJECTIVES: To evaluate the association between aortic valve morphology and outcomes following self-expandable TAVR. METHODS: Consecutive patients with aortic stenosis(AS) undergoing self-expandable TAVR were enrolled and categorized into three groups (Type 0/Type 1 BAV or TAV) according to the Sievers classification. The primary endpoint was a composite of all-cause mortality and rehospitalization for heart failure (HF) within 2 years. Secondary outcomes included procedural complications and major cardiovascular events observed in clinical follow-ups. Clinical outcomes at 2 years following TAVR were compared among three groups using Kaplan-Meier curve and multivariable Cox proportional hazards regression models. RESULTS: A total of 344 AS patients (Type 0: 86; Type 1: 109; TAV: 149) were enrolled. The presence of moderate or severe paravalvular leak (PVL) was significantly higher in patients with Type 0 and Type 1 BAV versus TAV (10.47% vs. 16.51% vs. 6.71%, p = 0.043). All-cause 30-day mortality (2.33% vs. 0.92% vs. 2.68%, p = 0.626) and 2-year mortality (3.49% vs. 5.50% vs. 6.71%, p = 0.657) was comparable among the three groups. However, rehospitalization for HF within 2 years was significantly higher in Type 1 BAV (11.63% vs. 20.18% vs. 8.72%, p = 0.020). Multivariate Cox analysis showed that a higher STS score, Type 1 BAV morphology and excess leaflet calcification (≥ median calcium volume (CV) of the entire population) were independent predictors for HF rehospitalization. Additional intragroup Kaplan‒Meier analysis showed that excess leaflet calcification could predict higher long-term mortality and rehospitalization risk for HF(HR (95% CI): 3.430 (1.166-10.090), log rank p = 0.017) in Type 1 BAV patients. CONCLUSION: Outcomes of self-expandable TAVR in BAV-AS patients might vary depending on valve subtypes. BAV patients with excess leaflet calcification and a raphe, especially calcified, had an increased risk of moderate PVL and HF readmission in mid-to-long term follow-ups.

Identification of recurrent variants implicated in disease in bicuspid aortic valve patients through whole-exome sequencing.

Bicuspid aortic valve (BAV) is the most common congenital heart defect in human beings, with an estimated prevalence in the general population of between 0.5 and 2%. Moreover, BAV is the most common cause of aortic stenosis in the pediatric population. Patients with BAV may have no symptoms for life, and some of them may progress to aortic stenosis. Genetic factors increase the susceptibility and development of BAV. However, the pathogenesis and BAV are still unclear, and more genetic variants are still needed for elucidating the molecular mechanism and stratification of patients. The present study carried out screening of variants implicated in disease in BAV patients. The whole-exome sequencing (WES) was performed in 20 BAV patients and identified 40 different heterozygous missense mutations in 36 genes (MIB2, FAAH, S100A1, RGS16, MAP3K19, NEB, TTN, TNS1, CAND2, CCK, KALRN, ATP10D, SLIT3, ROS1, FABP7, NUP205, IL11RA, NPR2, COL5A1, CUBN, JMJD1C, ANXA7, TRIM8, LGR4, TPCN2, APOA5, GPR84, LRP1, NCOR2, AKAP11, ESRRB, NGB, AKAP13, WWOX, KCNJ12, ARHGEF1). The mutations in these genes were identified as recurrent variants implicated in disease by in silico prediction tool analysis. Nine genes (MIB2, S100A1, TTN, CCK, NUP205, LGR4, NCOR2, ESRRB, and WWOX) among the 36 genes were identified as variants implicated in disease via unanimous agreement of in silico prediction tool analysis and sequenced in an independent cohort of 137 BAV patients to validate the results of WES. BAV patients carrying these variants demonstrated reduced left ventricular ejection fractions (LVEF) (63.8 ± 7.5% vs. 58.4 ± 5.2%, P < 0.001) and larger calcification volume [(1129.3 ± 154) mm3 vs. (1261.8 ± 123) mm3, P < 0.001]. The variants in TTN, NUP205 and NCOR2 genes are significantly associated with reduced LVEF, and the variants in S100A1, LGR4, ESRRB, and WWOX genes are significantly associated with larger calcification volume. We identified a panel of recurrent variants implicated in disease in genes related to the pathogenesis of BAV. Our data speculate that these variants are promising markers for risk stratification of BAV patients with increased susceptibility to aortic stenosis.

Evaluation of electrophysiological characteristics and ventricular synchrony: An intrapatient-controlled study during His-Purkinje conduction system pacing versus right ventricular pacing.

OBJECTIVES TO BACKGROUND: To compare electromechanical ventricular synchrony when pacing from different sites, including right ventricular apex pacing (RVAP), right ventricular septum pacing (RVSP), His bundle pacing (HBP), left bundle branch pacing (LBBP), and RVSP during unipolar pacing from the ring electrode of LBBP lead (RVSPring ) in each patient and evaluate the correlations between electrophysiological characteristics and ventricular synchrony. METHODS: Twenty patients with complete atrioventricular block indicated for dual-chamber pacemaker implantation were included in the study. Unipolar pacing at different sites, including RVAP, RVSP, HBP, LBBP, and RVSPring , was successively performed in each patient. The pacing characteristics and echocardiogram parameters were collected and compared among intrinsic rhythm and pacing at different sites. RESULTS: Similar to HBP (114.84 ± 18.67 ms), narrower paced QRSd was found in LBBP (116.15 ± 11.60 ms) as compared to RVSPring (135.11 ± 13.68 ms), RVSP (141.65 ± 14.26 ms), and RVAP (160.15 ± 19.35 ms) (p < .001). LBBP showed comparable pacing parameters to RVAP or RVSP and was significantly better than HBP, with maintained cardiac function. TS-12-SD was significantly improved in LBBP (41.80 ± 20.97 ms) than RVAP (69.70 ± 32.42 ms, p = .003) and RVSP (63.30.56 ± 32.53 ms, p = .018) but similar to HBP (51.50 ± 25.67 ms, p = .283) or RVSPring (57.80 ± 25.65 ms, p = .198). Among these pacing strategies, negative values of interventricular mechanical delay (IVMD) were only identified in LBBP (-19.25 ± 18.43 ms), significantly different from RVAP (35.00 ± 30.72 ms), RVSP (22.85 ± 22.05 ms), HBP (5.20 ± 18.64 ms), and RVSPring (16.00 ± 26.76 ms (all p < .05). Using Pearson's analysis, Sti-LVAT was positively correlated with QRS duration, IVMD, TS-12-SD, LVEDV, and LVESV, while a negative relationship could be observed for left ventricular ejection fraction. CONCLUSIONS: His-Purkinje conduction system pacing (HPCSP) achieved better electrical and mechanical synchrony than conventional RV pacing. For interventricular synchrony, only LBBP initiated earlier LV activation than RV, in accordance with the right bundle branch block (RBBB) pattern of paced QRS during LBBP. Sti-LVAT might be a good parameter correlating with LV systolic function and mechanical synchrony.

Aortic valve morphology and paravalvular leak regression after a self-expandable transcatheter aortic valve replacement.

Aims: The study aimed to compare paravalvular leak (PVL) changes after a transcatheter aortic valve replacement (TAVR) with self-expandable prosthesis between different aortic valve morphologies and evaluate the impact of paravalvular leak regression on clinical prognosis. Methods: Patients with aortic stenosis (AS) successfully treated with a self-expandable TAVR who were followed up for at least 1 year at our centre were consecutively enrolled from January 2016 to August 2019. Paired serial changes in paravalvular leak and other haemodynamic parameters by echocardiography were collected and compared between the bicuspid valve (BAV) and tricuspid aortic valve (TAV). A logistic regression model was used to explore the predictors of paravalvular leak regression (<1 grade) 1 year after transcatheter aortic valve replacement, while its impact on subsequent clinical outcomes (all-cause mortality and rehospitalisation for heart failure (HF)) was further evaluated using Kaplan-Meier analysis. Results: A total of 153 bicuspid valve and 114 tricuspid aortic valve patients were finally enrolled; haemodynamic parameters and paravalvular leak severity were comparable before the discharge between the two groups. The peak transaortic velocity, mean transvalvular gradient, and effective orifice area all significantly improved (p < 0.05) without intergroup differences at all follow-up timepoints. Significant paravalvular leak reduction was observed only in the TAV group (1.75% vs. 4.39%, p = 0.029), while moderate paravalular leak was still more prevalent in BAV (7.19% vs. 1.75%, p = 0.041) at the 1-year follow-up. Multivariable analyses identified the bicuspid valve, asymmetric calcification, and undersizing as independent predictors of failure of the 1-year paravalvular leak reduction in patients with mild or moderate paravalvular leak after discharge. Patients without a paravalvular leak reduction within 1 year showed a relatively higher 2-year all-cause mortality and HF (HR: 5.994, 95% CI: 1.691-21.240, and p = 0.053) rates thereafter. Conclusion: In AS patients after self-expandable transcatheter aortic valve replacement, paravalvular leak regression within 1 year was less prevalent in bicuspid valve morphology. The failure of paravalvular leak reduction might lead to an increased risk of poorer prognosis in the long run.

Cardiac resynchronization therapy via left bundle branch pacing vs. optimized biventricular pacing with adaptive algorithm in heart failure with left bundle branch block: a prospective, multi-centre, observational study.

AIMS: The purpose of our study was to evaluate the feasibility and efficacy of cardiac resynchronization therapy (CRT) via left bundle branch pacing (LBBP-CRT) compared with optimized biventricular pacing (BVP) with adaptive algorithm (BVP-aCRT) in heart failure with reduced left ventricular ejection fraction ≤35% (HFrEF) and left bundle branch block (LBBB). METHODS AND RESULTS: One hundred patients with HFrEF and LBBB undergoing CRT were prospectively enrolled in a non-randomized fashion and divided into two groups (LBBP-CRT, n = 49; BVP-aCRT, n = 51) in four centres. Implant characteristics and echocardiographic parameters were accessed at baseline and during 6-month and 1-year follow-up. The success rate for LBBP-CRT and BVP-aCRT was 98.00% and 91.07%. Fused LBBP had the greatest reduced QRS duration compared to BVP-aCRT (126.54 ± 11.67 vs. 102.61 ± 9.66 ms, P < 0.001). Higher absolute left ventricular ejection fraction (LVEF) and △LVEF was also achieved in LBBP-CRT than BVP-aCRT at 6-month (47.58 ± 12.02% vs. 41.24 ± 10.56%, P = 0.008; 18.52 ± 13.19% vs. 12.89 ± 9.73%, P = 0.020) and 1-year follow-up (49.10 ± 10.43% vs. 43.62 ± 11.33%, P = 0.021; 20.90 ± 11.80% vs. 15.20 ± 9.98%, P = 0.015, P = 0.015). There was no significant difference in response rate between two groups while higher super-response rate was observed in LBBP-CRT as compared to BVP-aCRT at 6 months (53.06% vs. 36.59%, P = 0.016) and 12 months (61.22% vs. 39.22%, P = 0.028) during follow-up. The pacing threshold was lower in LBBP-CRT at implant and during 1-year follow-up (both P < 0.001). Procedure-related complications and adverse clinical outcomes including heart failure hospitalization and mortality were not significantly different in two groups. CONCLUSIONS: The feasibility and efficacy of LBBP-CRT demonstrated better electromechanical resynchronization and higher clinical and echocardiographic response, especially higher super-response than BVP-aCRT in HFrEF with LBBB.

The Impact of Dabigatran and Rivaroxaban on Variation of Platelet Activation Biomarkers and DRT Following Percutaneous Left Atrial Appendage Closure.

Background: The current post-procedure antithrombotic recommendation for left atrial appendage closure (LAAC) remains empiric. This study was designed to compare variations in platelet activation biomarkers and device-related thrombosis (DRT) under different antithrombotic regimens following LAAC. Methods: This study enrolled 105 consecutive patients with atrial fibrillation who underwent LAAC successfully and received post-procedure anticoagulation with either dabigatran (N = 33) or rivaroxaban (N = 72). After 3 months of anticoagulation treatment, thromboelastogram was used to evaluate thrombin receptor-activating peptide (TRAP)-induced platelet aggregation (PA). Measurements of platelet activation biomarkers, including thrombin-antithrombin complex (TAT), P-selectin, von Willebrand disease (vWF), and CD40L, were performed immediately before the LAAC procedure and after 3 months of post-procedure anticoagulation. Repeated transesophageal echocardiography was performed to evaluate DRT during follow-ups. Results: Three (4.2%) patients in the rivaroxaban and 4 (12.1%) patients in the dabigatran group experienced DRT events (odds ratio (OR) = 0.315, 95% confidence interval (95%CI): 0.066-1.489, p = 0.129) during follow-ups. The TRAP-induced PA was statistically significantly higher in the dabigatran group (62.9% vs 59.7%, p = 0.028*). Statistically significant increases in plasma concentration of TAT, P-selectin, and vWF were observed after 3 months of exposure to dabigatran when compared with rivaroxaban. An increased expression of platelet activation biomarkers was observed in DRT subjects compared with non-DRT subjects in terms of P-selectin and vWF (65.28 ± 13.93 ng/L vs 32.14 ± 12.11 ng/L, p = 0.037; 501.92 ± 106.48 U/L vs 280.98 ± 54.10 U/L, p = 0.045; respectively). Multivariate regression analysis indicated that the use of dabigatran might be an independent predictor of DRT (p = 0.022; OR = 4.366, 95%CI: 0.434-10.839). Furthermore, the CHA2DS2-VASc score (OR = 2.076, p = 0.016) and CD40L levels (OR = 1.015, p = 0.021) were independent predictors of increased D-dimer levels. Conclusions: Post-LAAC anticoagulation with dabigatran may increase the risk of DRT by enhancing platelet reactivity. In light of this potential increased risk in DRT, the authors recommend against using dabigatran for post-procedural anticoagulation in patients who have undergone LAAC.

Pericardial Effusion During the Perioperative Period for Left Atrial Appendage Closure.

Objectives: To analyze the predictors of pericardial effusion (PE) during the perioperative period of the left atrial appendage closure procedure in our center. Methods: A total of 624 consecutive patients with non-valvular AF undergoing LAAC from May 2014 to October 2019 were involved in this study. Patients were divided into groups depending on whether they showed no PE, intraoperative PE or postoperative PE. We analyzed the predictors of PE during the perioperative period of the LAAC procedure. Results: (1) Of the 624 patients in our population (age 68.2 ± 9.1 years, 63% male, CHA2DS2-VASc score 3.4 ± 1.6), 30 patients experienced PE in the perioperative period, including 10 intraoperative PE and 20 postoperative PE. (2) A total of 26 (86.6%) patients had mild PE. 4 (13.4%) patients had pericardial tamponade, 2 (6.7%) of which were intraoperative, and the other 2 (6.7%) postoperative. (3) Significant differences were measured in relation to female sex, intraoperative time, combined procedures, changes in sinus rhythm, device retrieval times and duration of hospitalization between 2 groups (no PE occurred, intraoperative PE), P values were 0.039, 0.024, 0.004, 0.015, 0.003 and 0.039. Conclusions: Female sex, paroxysmal AF, changing in sinus rhythm, device retrieval times and intraoperative time all had a positive association with PE during the perioperative period.

Clinical Efficacy and Safety Comparison of Rivaroxaban and Dabigatran for Nonvalvular Atrial Fibrillation Patients Undergoing Percutaneous Left Atrial Appendage Closure Operation.

Objective: Due to the clinical complexity of warfarin, novel oral anticoagulation (NOAC) has been a feasible and safe alternative anticoagulant approach during left atrial appendage closure (LAAC). This study was designed to compare the efficacy and safety of rivaroxaban and dabigatran for nonvalvular atrial fibrillation patients undergoing percutaneous LAAC. Methods: One single and prospective cohort study was performed among patients who received anticoagulation with dabigatran or rivaroxaban. All patients were medicated with a 3-month course of NOAC to facilitate device endothelialization, followed by dual antiplatelet therapy until 6 months, then lifelong aspirin after discharge. Repeated transesophageal echocardiography was scheduled to evaluate thrombosis formation on occluders and thrombus dissolution ability. Results: A total of 262 consecutive patients were initially enrolled. A final number of 250 patients were analyzed; two patients were excluded due to procedure failure and 10 patients had a loss of follow-up; 97 were from the dabigatran group and 153 from the rivaroxaban group. Three patients (1.9%) in the rivaroxaban group and eight (8.2%) in the dabigatran group were experiencing device-related thrombosis (DRT) events during follow-ups. Cumulative Kaplan-Meier estimates showed that the incidence of DRT was lower under rivaroxaban medication during the 6-month follow-ups (p = 0.038*, OR = 3.843, 95%CI: 0.991-14.836). The transesophageal echocardiography (TEE) results showed that the average length and width of DRT in the rivaroxaban group was significantly lower compared with that in the dabigatran group (2.16 vs. 1.60 mm, p = 0.017*, and 1.71 vs. 1.30 mm, p = 0.003*, respectively). The thrombosis dissolved after the switch from dabigatran or rivaroxaban to warfarin within the target range, represented by the average length and width of thrombus with the cooperation of secondary TEE for the dabigatran and rivaroxaban groups (0.64 vs. 0.40 mm, p = 0.206, and 0.43 vs. 0.27 mm, p = 0.082, respectively). No significant difference was found between the two groups with respect to the levels of coagulation parameters, cardiac function, and bleeding events. Conclusion: Compared to dabigatran, post-procedural rivaroxaban anticoagulation might be advantageous in preventing DRT complications expected after LAAC, without increasing the risk of hemorrhage.

Clinical outcomes of bivalirudin versus heparin in atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion.

BACKGROUND: Prior studies have suggested that patients with atrial fibrillation (AF) referred for left atrial appendage occlusion (LAAO) are confronted with considerable risk of periprocedural thromboembolism and hemmorhagic events. The purpose of this study was to evaluate the safety and feasibility of bivalirudin during LAAO. METHODS: This retrospective, observational study included 420 AF patients who were evaluated as being at high risk of stroke or bleeding and indicated for LAAO at our center between June 2018 and June 2019 (158 with bivalirudin and 262 with heparin). The primary outcome was the incidence of any bleeding within 48 hours of LAAO. Secondary outcomes were major adverse cardiac events (MACE) between 48 hours and 60 days post-procedure and overall bleeding events during follow up. RESULTS: No significant difference was observed between bivalirudin and heparin for major periprocedural bleeding (1.27% for bivalirudin vs. 2.29% for heparin, P=0.716) or minor bleeding (1.27% vs. 1.15%, P>0.9). At 48 hours post-procedure, strokes occurred at a rate of 0.63% in the bivalirudin group and 1.15% in the heparin group (P>0.9), and one case treated with bivalirudin developed systemic embolization. At 60 days, the rates of MACE (1.90% vs. 2.29%, P>0.9), a device-related thrombus (DRT) (1.27% vs. 1.52%, P>0.9), and overall bleeding events (5.06% vs. 4.96%, P=0.963) were comparable between the 2 cohorts. Upon Kaplan-Meier survival analysis, early safety during the 60-day follow-up was 93.67% in the bivalirudin group and 91.60% in the heparin group (P=0.570). CONCLUSIONS: Bivalirudin has a comparable safety and efficacy profile to heparin as an intraprocedural anticoagulant, but currently, it should still be reserved for patients in which heparin is contraindicated.

Impact of Thrombocytopenia in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion: A Propensity-Matched Comparison of 190 Consecutive Watchman Implantations.

Objectives: The purpose of this study was to provide data on the long-term efficacy and safety of left atrial appendage occlusion (LAAO) in patients with atrial fibrillation (AF) and chronic thrombocytopenia (cTCP). Methods: Between January 2016 and December 2018, a total of 32 AF patients with thrombocytopenia (platelet count <100*10∧9/L) undergoing LAAO at our center were identified and their outcomes were compared with a propensity-matched cohort (match ratio 1:5) of patients without cTCP who had also been indicated for LAAO. Results: Between the cTCP patients and the control group, no difference was found on the incidence of stroke (0 vs. 3.13%, p = 0.592), systematic thromboembolisation (0 vs. 0.63%, p > 0.9) and device-related thrombus (DRT) (3.13 vs. 2.50%, p > 0.9). Major (12.50 vs. 3.75%, p = 0.065) and minor bleeding (15.63 vs. 1.25%, p = 0.002) was more frequent in cTCP patients but no statistical difference was reached in major bleeding. Moreover, thrombocytopenia was also identified as an independent predictor of any bleeding events (OR: 8.150, 95% CI: 2.579-25.757, p < 0.001), while an inverse relationship between higher absolute platelet count and stroke events was revealed (OR: 1.015; 95% CI: 1.002~1.029, p = 0.022). However, in both groups we saw a significant reduction in observed annualized rates of non-procedural complications compared with the predicted values. In the cTCP and control groups, clinical thromboembolism was reduced by 100 and 74.32%, and major bleeding by 42.47 and 71.67%, respectively. Conclusion: Our preliminary results indicate that LAAO using the Watchman device could be a safe and effective means of preventing stroke in AF patients with or without thrombocytopenia, but bleeding complications should be monitored intensively in cTCP patients.

Comparison of fluoroscopy and transesophageal echocardiogram for intra-procedure device surveillance assessment during implantation of Watchman.

OBJECTIVES: To evaluate intraprocedural assessments using transesophageal echocardiography (TEE) and fluoroscopy during left atrial appendage occlusion (LAAO) with the WATCHMAN device. METHOD: A total of 208 patients with non-valvular atrial fibrillation (AF) undergoing LAAO were included in this study[101 standard procedures (retrospective cohort) and 107 with fluoroscopy-alone approach (prospective cohort). Individual device position, anchoring, compression and peri-device leak (PDL) were successively analyzed based on TEE and fluoroscopy in the retrospective cohort to summarize detailed fluoroscopic assessments for prospective application. Clinical outcomes were assessed between two cohorts. RESULTS: For retrospective cohort, TEE and fluoroscopy agreed on device position and anchoring. Compression upon fluoroscopy was well correlated with 2D-TEE (r = 0.908) and the difference in overall detection of PDL was not statistically significant between two imaging modalities (p = 0.304). For the prospective cohort with fluoroscopy-guidance alone, implantation success was similar to that of the retrospective cohort (98.13% vs 100%, p = 0.498). The incidence rate of major clinical adverse events was relatively higher in prospective cohort during hospitalization and follow-up but did not reach significant difference (5.61% vs 1.98%; 0.99% vs 0.93%, p > 0.05). Moreover, the prospective group presented with shorter procedural duration, shorter in-hospital stay and lower total hospitalization cost than retrospective group. CONCLUSION: LAAO performed by experienced operators in large volume centers is feasible under fluoroscopy guidance. However, there is still a trend in favor of TEE for greater procedural safety and more complete LAA seal. We suggest that this minimalist approach could be proposed in cases with contraindication to general anesthesia and/or TEE.

The feasibility and safety of left bundle branch pacing vs. right ventricular pacing after mid-long-term follow-up: a single-centre experience.

AIMS: The aim of this study is to prospectively assess the feasibility and safety of left bundle branch pacing (LBBP) when compared with right ventricular pacing (RVP) during mid-long-term follow-up in a large cohort. METHODS AND RESULTS: Patients (n = 554) indicated for pacemaker implantation were prospectively and consecutively enrolled and were non-randomized divided into LBBP group and RVP group. The levels of cTnT and N-terminal pro-B type natriuretic peptide were measured and compared within 2 days post-procedure between two groups. Implant characteristics, procedure-related complications, and clinical outcomes were also compared. Pacing thresholds, sensing, and impedance were assessed during procedure and follow-up. Left bundle branch pacing was feasible with a success rate of 94.8% with high incidence of LBB potential (89.9%), selective LBBP (57.8%), and left deviation of paced QRS axis (79.7%) with mean Sti-LVAT of 65.07 ± 8.58 ms. Paced QRS duration was significantly narrower in LBBP when compared with RVP (132.02 ± 7.93 vs. 177.68 ± 15.58 ms, P < 0.0001) and the pacing parameters remained stable in two groups during 18 months follow-up. cTnT elevation was more significant in LBBP when compared with RVP within 2 days post-procedure (baseline: 0.03 ± 0.03 vs. 0.02 ± 0.03 ng/mL, P = 0.002; 1 day post-procedure: 0.13 ± 0.09 vs. 0.04 ± 0.03 ng/mL, P < 0.001; 2 days post-procedure: 0.10 ± 0.08 vs. 0.03 ± 0.08 ng/mL, P < 0.001). The complications and cardiac outcomes were not significantly different between two groups. CONCLUSION: Left bundle branch pacing was feasible in bradycardia patients associated with stable pacing parameters during 18 months follow-up. Paced QRS duration was significantly narrower than that of RVP. Though cTnT elevation was more significant in LBBP within 2 days post-procedure, the complications, and cardiac outcomes were not significantly different between two groups.

Reference value of perimeter-derived diameter assessed by three-dimensional transesophageal echocardiography in left atrial appendage occluder size selection.

BACKGROUND: The aim of this study was to investigate the utility of perimeter-derived diameter (PDD) measured by three-dimensional (3D) transesophageal echocardiography (TEE) in predicting the size of left atrial appendage (LAA) occluder. METHODS AND RESULTS: Left atrial appendage landing zone diameter (LZD) was measured by two-dimensional (2D) TEE, 3DTEE, and digital subtraction angiography (DSA) as LZD-2Dmax, LZD-2Dmean, LZD-3Dmax, LZD-3Dmean, LZD-PDD, LZD-DSAmax, respectively, before and during transcatheter LAA closure with Watchman devices in 100 patients. A difference of one or more device size intervals between the predicted size and the size actually implanted was defined as mismatching. Seventy-eight patients were followed up by TEE to obtain occluder compression ratio. The correlation between LZD and the final implanted occluder size was 0.559, 0.641, 0.754, 0.760, 0.782, and 0.848 for LZD-2Dmax, LZD-2Dmean, LZD-3Dmax, LZD-3Dmean, LZD-PDD and LZD-DSAmax, respectively (P < .001). Matching ratio between the size predicted by retrospective measurements of LZD and the device size actually implanted was 65%, 57%, 66%, 63%, 70%, and 83% for LZD-2Dmax, LZD-2Dmean, LZD-3Dmax, LZD-3Dmean, LZD-PDD and LZD-DSAmax, respectively. There was no significant difference in LZD value, matching ratio, and compression ratio between the patients with eccentric and noneccentric LAA landing zone (P > .05). Compression ratio of the mismatching subjects was higher than that in the matching subjects when evaluated by LZD-2Dmean, LZD-3Dmean, and LZD-PDD (P < .05). CONCLUSIONS: Landing zone diameter derived from LAA perimeter measured by preprocedure 3DTEE showed reference value for LAA occluder size selection, providing superior correlation and matching ratio with the final implanted size and indicating the adjustment of oversizing.

Closure Device-Related Thrombosis After Anticoagulation With Dabigatran in Patients Undergoing Percutaneous Left Atrial Appendage Closure: Case Reports and Literature Review.

Percutaneous left atrial appendage closure (LAAC) is an effective and safe operation strategy for stroke prevention in patients who are diagnosed with atrial fibrillation (AF) but cannot tolerate long term anticoagulation medication. We presented four rare cases of thrombosis formation on the occluder device. After the LAAC operation was successfully performed on patients, they followed a course of anticoagulation with dabigatran (110 mg b.i.d.), and device-related thrombosis (DRT) occurred as indicated by a transesophageal echocardiogram (TEE) during the follow-up period. Regressions were achieved after replacing dabigatran with rivaroxaban or warfarin for more than 1 month. No thrombosis or bleeding-related complications occurred in subsequent follow-ups.