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.

First-in-human experience of left atrial appendage occlusion with the steerable FuStar sheath.

BACKGROUND: Due the wide variability of left atrial appendage morphology left atrial appendage occlusion (LAAO) remains a challenging procedure. The steerable FuStar delivery sheath was designed to allow both, transseptal access and delivery of percutaneous devices. We here report the first-in-human experience of LAAO with the FuStar sheath. METHODS: Twenty patients (76.6 ± 8.4 years; 12 (60%) males; CHA2 DS2 -VASc score: 5.0 ± 2) with non-valvular fibrillation and contraindications to oral anticoagulation underwent LAAO with the LAmbre device using the FuStar steerable sheath (Lifetech Scientific Corp., Shenzhen, China) at two german centers. RESULTS: Successful device implantation was achieved in all patients (100%). No periprocedural complications were observed. Procedure time, fluoroscopy time, contrast media, and radiation dose were 23.4 min ± 9.2, 11.9 min ± 4.1, 96.2 mL ± 45.7, and 2718.4 cG*cm2 ± 3835.3, respectively. CONCLUSION: This study demonstrates the feasibility and safety of the steerable FuStar sheath for LAAO.

Cost-effectiveness analysis of left atrial appendage occlusion compared with pharmacological strategies for stroke prevention in atrial fibrillation.

BACKGROUND: Transcatheter left atrial appendage occlusion (LAAO) is a promising therapy for stroke prophylaxis in non-valvular atrial fibrillation (NVAF) but its cost-effectiveness remains understudied. This study evaluated the cost-effectiveness of LAAO for stroke prophylaxis in NVAF. METHODS: A Markov decision analytic model was used to compare the cost-effectiveness of LAAO with 7 pharmacological strategies: aspirin alone, clopidogrel plus aspirin, warfarin, dabigatran 110 mg, dabigatran 150 mg, apixaban, and rivaroxaban. Outcome measures included quality-adjusted life years (QALYs), lifetime costs and incremental cost-effectiveness ratios (ICERs). Base-case data were derived from ACTIVE, RE-LY, ARISTOTLE, ROCKET-AF, PROTECT-AF and PREVAIL trials. One-way sensitivity analysis varied by CHADS2 score, HAS-BLED score, time horizons, and LAAO costs; and probabilistic sensitivity analysis using 10,000 Monte Carlo simulations was conducted to assess parameter uncertainty. RESULTS: LAAO was considered cost-effective compared with aspirin, clopidogrel plus aspirin, and warfarin, with ICER of US$5,115, $2,447, and $6,298 per QALY gained, respectively. LAAO was dominant (i.e. less costly but more effective) compared to other strategies. Sensitivity analysis demonstrated favorable ICERs of LAAO against other strategies in varied CHADS2 score, HAS-BLED score, time horizons (5 to 15 years) and LAAO costs. LAAO was cost-effective in 86.24 % of 10,000 simulations using a threshold of US$50,000/QALY. CONCLUSIONS: Transcatheter LAAO is cost-effective for prevention of stroke in NVAF compared with 7 pharmacological strategies. The transcatheter left atrial appendage occlusion (LAAO) is considered cost-effective against the standard 7 oral pharmacological strategies including acetylsalicylic acid (ASA) alone, clopidogrel plus ASA, warfarin, dabigatran 110 mg, dabigatran 150 mg, apixaban, and rivaroxaban for stroke prophylaxis in non-valvular atrial fibrillation management.

Undiagnosed airflow limitation is common in patients with coronary artery disease and associated with cardiac stress.

BACKGROUND AND OBJECTIVE: Smoking is a common risk factor for coronary artery disease (CAD) and chronic obstructive pulmonary disease (COPD). We evaluated the prevalence of undiagnosed COPD in patients with CAD and assessed the relationship between airflow obstruction and markers of cardiac stress. METHODS: We recruited prospectively consecutive patients aged >40 years without known history of chronic lung disease (e.g. asthma, COPD, bronchiectasis) who had undergone percutaneous coronary intervention (PCI) for obstructive CAD between August 2009 and October 2010. Spirometry was performed and serum ST2, a novel biomarker of cardiomyocyte stress and fibrosis, was measured by enzyme-linked immunosorbent assay. RESULTS: Among 475 subjects (mean age 64 ± 9.7, range 42-85 years, 87.2% males, 58.5% current or ex-smokers) who underwent spirometry, 51 (10.7%) had undiagnosed airflow obstruction with FEV1 /FVC ratio <70%. Of these 51 subjects, 14 (2.9%), 23 (4.8%) and 14 (2.9%) had FEV1 ≥80, 50-80 and 30-50% predicted normal, respectively. ST2 level was measured in all the subjects with undiagnosed airflow obstruction and in 290 subjects with normal lung function. There was no significant difference in left ventricular ejection fraction on echocardiogram between subjects with and without airflow obstruction. Patients with severe airflow obstruction had a higher level of cardiac stress marker ST2 than those with mild and moderate airflow obstruction (rho = -0.214, P ≤ 0.001). CONCLUSION: Undiagnosed airflow obstruction is common among patients with CAD who have undergone PCI. Severity of airflow limitation is associated with increasing cardiac stress.

How low should we target the LDL goal to improve survival for acute coronary syndrome patients in Hong Kong?

BACKGROUND: Utilization of lipid-lowering agents has been associated with improved long-term outcomes in acute coronary syndrome (ACS) patients. However, updated data regarding local use and outcomes was lacking. METHODS: We retrospectively reviewed 696 hospitalized patients in the local ACS registry of Prince of Wales Hospital during 1 January 2008 to 31 December 2009 with data retrieved using computerized clinical records of all patients. RESULTS: Among the 402 MI patients included, 104 (25.9 %) were not prescribed with statins at discharge. Percutaneous coronary intervention (PCI) not performed or planned during hospitalization (OR: 0.324, p = 0.001) and latest lower LDL-C level before discharge (OR: 0.221 for an increment of 1 mmol/L, p = 0.009) were significant independent predictors of the absence of statin prescriptions at discharge. A significantly lower all-cause mortality rate (14.4 % vs 51.7 %, p < 0.001), fewer total hospitalizations (p < 0.001) and fewer hospitalizations due to cardiovascular problems (p < 0.001) were observed in patients discharged with statins. LDL-C goal attainment of < 2.6 mmol/L resulted in a significant reduction in mortality (10.8 % vs 24.2 %, p = 0.001), but not for goal attainment of < 1.8 mmol/L. Significant difference in survival existed only when LDL-C cut-off values were above 2.4 mmol/L. CONCLUSIONS: This study revealed the under-utilization of statin therapy in eligible MI patients at discharge and unsatisfactory percentages of LDL-C goal attainment, and also reassured the role of low LDL-C reduction to < 2.6 mmol/L in the management of MI. However, the current study did not show that the lower LDL-C reduction improved survival of ACS patients. Further research should be conducted to assess the necessity of aggressive LDL-C reduction to < 1.8 mmol/L in local patients.

Management of heart failure with preserved ejection fraction in a local public hospital in Hong Kong.

BACKGROUND: Heart failure (HF) is one of the most debilitating chronic illnesses. The prevalence is expected to increase due to aging population. The current study aimed to examine the management of heart failure with preserved ejection fraction (HFpEF) including drug use pattern, direct medical cost and humanistic outcome in a local public hospital in Hong Kong. METHODS: The current study adopted the retrospective observational study design. Subjects were recruited from the Heart Failure Registry of the Prince of Wales Hospital in Hong Kong between 2006 and 2008 and completed the Minnesota Living with Heart Failure Questionnaire (MLHFQ) at 3 designated time-points conferred eligibility. Patients with significant valvular disorder were excluded. Each patient's medical record was reviewed for 12 months after the date of admission. Heart failure related admissions, clinic visits, cardiovascular drugs, laboratory tests and diagnostic tests were documented. Costs and MLHFQ scores in patients with or without hypertension, diabetes and renal impairment were compared. RESULTS: A total of 73 HFpEF patients were included. It was found that loop diuretics (93.1%, 78.1%) was the most frequently used agent for HFpEF management in both in-patient and out-patient settings. The mean 1-year direct medical cost was USD$ 19969 (1 US $ = 7.8 HK$), with in-patient ward care contributing to the largest proportion (72.2%) of the total cost. Patients with diabetes or renal impairment were associated with a higher cost of HFpEF management. Significant difference was found in the renal impairment group (median cost: USD$ 24604.2 versus USD$ 12706.8 in no impairment group, p = 0.023). The MLHFQ scores of the subjects improved significantly during the study period (p < 0.0005). CONCLUSIONS: The cost of management of HFpEF was enormous and further increased in the presence of comorbidities.

Incremental value of global systolic dyssynchrony in determining the occurrence of functional mitral regurgitation in patients with left ventricular systolic dysfunction.

AIMS: The aim of this study was to assess the contribution of left ventricular (LV) systolic dyssynchrony to functional mitral regurgitation (MR). METHODS AND RESULTS: Patients (n = 136) with LV systolic dysfunction (ejection fraction <50%) and at least mild MR were prospectively recruited. The effective regurgitant orifice area (EROA) was assessed by the proximal isovelocity surface area method. Left ventricular global systolic dyssynchrony [the maximal difference in time to peak systolic velocity among the 12 LV segments (Ts-Dif)] and regional systolic dyssynchrony (the delay between the anterolateral and posteromedial papillary muscle attaching sites) were assessed by tissue Doppler imaging. Left ventricular global and regional remodelling, systolic function, indices of mitral valvular and annular deformation were also measured. The size of the EROA correlated with the degrees of mitral deformation, LV remodelling, systolic function, and systolic dyssynchrony. By multivariate logistic regression analysis, the mitral valve tenting area (OR = 1.020, P < 0.001) and the Ts-Dif (OR = 1.011, P = 0.034) were independent determinants of significant functional MR (defined by EROA ≥20 mm(2)). From the receiver-operating characteristic curve, the tenting area of 2.7 cm(2) (sensitivity 83%, specificity 82%, AUC 0.86, P < 0.001) and the Ts-Dif of 85 ms (sensitivity 66%, specificity 72%, AUC 0.74, P < 0.001) were associated with significant functional MR. The assessment of Ts-Dif showed an incremental value over the mitral valve tenting area for determining functional MR (χ(2) = 53.92 vs.49.11, P = 0.028). CONCLUSION: This cross-sectional study showed that LV global, but not regional systolic dyssynchrony, is a determinant of significant functional MR in patients with LV systolic dysfunction, and is incremental to the tenting area that is otherwise the strongest factor for mitral valve deformation.

Mean platelet volume levels predict pulmonary artery hypertension in patients with atrial septal defect.

INTRODUCTION: Some reports have shown increased platelet aggregation and activation in patients with pulmonary artery hypertension (PAH). Mean platelet volume (MPV) is a simple and easy method of assessing platelet function. We aimed to investigate the mean platelet volume levels in patients with atrial septal defect (ASD) and the association between MPV levels and pulmonary artery hypertension. METHOD: One hundred and forty consecutive patients (42 males and mean age 35 +/- 9 y) and forty healthy controls (15 males and mean age 35 +/- 4 y) were enrolled in the study between December 2008 and February 2011. RESULTS: The ASD group demonstrated a significantly higher right ventricular size and pulmonary artery pressure than the control group (42 +/- 4 mm vs. 36 +/- 3 mm and 43 +/- 12 mmHg vs. 32 +/- 11 mmHg; P < 0.001 and P < 0.001, respectively). MPV levels were higher in the ASD group than the control group (9.3 +/- 1.2 fl vs. 8.6 +/- 0.8 fl, P < 0.001). There was a significant, positive correlation between MPV and systolic pulmonary artery pressure (PAP) (r = 0.542 and P < 0.001) in the ASD group. MPV was also significantly correlated with right ventricular size but not ASD diameter in the ASD group (r = 0.441, P < 0.001 and r = 0.126, P = 0.268, respectively). In receiver operating characteristics curve analysis, the cut-off value of MPV levels was > 8.7 fl and had 82% sensitivity and 63% specificity in predicting pulmonary artery hypertension. CONCLUSION: In the present study, we found that MPV levels, an indicator of platelet activation, were significantly higher in patients with ASD and correlated with systolic pulmonary artery pressure and right ventricular diameter.

Transjugular Transcatheter Tricuspid Valve Replacement: Early Compassionate Use Outcomes.

BACKGROUND: Data on procedural and early outcomes after transjugular transcatheter tricuspid valve replacement (TTVR) are limited. OBJECTIVES: This study sought to evaluate first-in-man procedural and clinical outcomes after transjugular TTVR with a special focus on patients who received large device sizes in whom TTVR outcomes have been questioned. METHODS: The retrospective registry included patients who underwent TTVR using the LuX-Valve Plus system (Jenscare Biotechnology Co Ltd) for symptomatic tricuspid regurgitation (TR) from January 2022 until February 2024 at 15 international centers in a compassionate use setting. The endpoints were procedural TR reduction, in-hospital death, adverse events, and 1-month survival. We further stratified results according to the size of the implanted device (<55 vs ≥55 mm). RESULTS: The registry included a total of 76 patients at a median age of 78 years (Q1-Q3: 72-83 years, 47.4% women). TR was reduced to ≤2+ and ≤1+ in 94.7% and 90.8% of patients (75.0% of patients received TTVR devices ≥55 mm) with well-sustained results at 1-month follow-up (TR ≤2+ in 95.0% and ≤1+ 86.8%). Residual TR was paravalvular in all cases. In-hospital death occurred in 4 patients (5.3%). Four patients (5.3%) underwent cardiac surgery during index hospitalization. Major in-hospital bleeding events occurred in 5 patients (6.6%). New in-hospital pacemaker implantation was required in 3.9% of patients in the overall cohort (5.7% in "pacemaker-naive" individuals). No cases of valve thrombosis, stroke, myocardial infarction, or pulmonary embolism were observed. At 1-month follow-up, survival was 94.4%, and NYHA functional class significantly improved. One further patient received a pacemaker, 1 further bleeding event occurred, and 2 patients underwent reintervention or surgery within the first 30 days after TTVR. No differences in procedural outcomes or adverse events were observed after stratification for valve size. CONCLUSIONS: Transjugular TTVR appears to be a safe and effective treatment option for patients with severe TR with comparable outcomes in very large tricuspid anatomies.

Safety and efficacy of the DragonFly system for transcatheter valve repair of degenerative mitral regurgitation: one-year results of the DRAGONFLY-DMR trial.

BACKGROUND: Severe degenerative mitral regurgitation (DMR) can cause a poor prognosis if left untreated. For patients considered at prohibitive surgical risk, transcatheter edge-to-edge repair (TEER) has become an accepted alternative therapy. The DragonFly transcatheter valve repair system is an innovative evolution of the mitral TEER device family to treat DMR. AIMS: Herein we report on the DRAGONFLY-DMR trial (ClinicalTrials.gov: NCT04734756), which was a prospective, single-arm, multicentre study on the safety and effectiveness of the DragonFly system. METHODS: A total of 120 eligible patients with prohibitive surgical risk and DMR ≥3+ were screened by a central eligibility committee for enrolment. The study utilised an independent echocardiography core laboratory and clinical event committee. The primary endpoint was the clinical success rate, which measured freedom from all-cause mortality, mitral valve reintervention, and mitral regurgitation (MR) >2+ at 1-year follow-up. RESULTS: At 1 year, the trial successfully achieved its prespecified primary efficacy endpoint, with a clinical success rate of 87.5% (95% confidence interval: 80.1-92.3%). The rates of major adverse events, all-cause mortality, mitral valve reintervention, and heart failure hospitalisation were 9.0%, 5.0%, 0.8%, and 3.4%, respectively. MR ≤2+ was 90.4% at 1 month and 92.0% at 1 year. Over time, left ventricular reverse remodelling was observed (p<0.05), along with significant improvements in the patients' functional and quality-of-life outcomes, shown by an increase in the New York Heart Association Class I/II from 32.4% at baseline to 93.6% at 12 months (p<0.001) and increased Kansas City Cardiomyopathy Questionnaire (KCCQ) score of 31.1±18.2 from baseline to 12 months (p<0.001). CONCLUSIONS: The DRAGONFLY-DMR trial contributes to increasing evidence supporting the safety and efficacy of TEER therapy, specifically the DragonFly system, for treating patients with chronic symptomatic DMR 3+ to 4+ at prohibitive surgical risk.

A comparative study of Cardi-O-Fix septal occluder versus Amplatzer septal occluder in percutaneous closure of secundum atrial septal defects.

AIM: We sought to investigate the safety and efficacy of Cardio-O-Fix septal occluder (CSO) in percutaneous closure of atrial septal defects (ASD) as compared to the Amplatzer septal occluder (ASO). METHODS: A consecutive of 351 patients received transcatheter ASD closure with CSO or ASO from July 2004 to October 2010 were studied. The ASDs were divided into simple- (isolated defects <26 mm) or complex-types (isolated defect ≥26 mm, double or multifenestrated defects). The procedures were guided by fluoroscopy and transthoracic or transesophageal echocardiography. Clinical and echocardiographic follow-ups were arranged before discharge, at 1 month and then every 6-month after implantation. RESULTS: During the study period, 185 (125 males, aged 18.5 ± 15.6 years) and 166 (103 males, aged 21.0 ± 15.7 years) patients attempted CSO and ASO implants, respectively. The CSO group had similar ASD and device sizes, prevalence of complex lesions (17 vs. 16%, P = 0.796), procedural times and success rates (97% vs. 96%, P = 0.635) as compared to the ASO group. Acute residual shunts were less prevalent in CSO than ASO group and most shunts closed spontaneously at 6-month follow-ups. The average equipment cost per patient was lower in CSO group (US$ 4,100 vs. US$ 5,900, P < 0.001). The prevalence of device embolization and atrial arrhythmia (all <2%) were similar in both patient groups. CONCLUSION: Transcatheter ASD occlusion with CSO is safe and effective and it appeared to be an attractive alternative to ASO in closing simple-type ASD because of its relatively low cost.

Bleeding of new oral anticoagulants for stroke prevention in atrial fibrillation: a meta-analysis of randomized controlled trials.

PURPOSE: Oral direct factor Xa inhibitors and oral direct thrombin inhibitors are new oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation (AF). We systematically reviewed their risk of major bleeding and efficacy in thromboembolism reduction in AF. METHODS: Eligible randomized controlled trials evaluating NOACs for stroke prevention in AF patients were identified from a systematic search of MEDLINE, EMBASE and the Cochrane database. Risk ratios (RRs) and 95 % confidence intervals (CIs) were calculated using a Mantel-Haenzel random-effects model. RESULTS: A total of 13 studies (n = 61,406) were included. Oral direct factor Xa inhibitors were more effective in reducing stroke and systemic embolism compared to controls (RR 0.71, 95 % CI 0.54-0.92, P = 0.009) or vitamin K antagonists (VKAs) (RR 0.84, 95 % CI 0.74-0.94, P = 0.002), with no significant difference in major and clinically relevant non-major (CRNM) bleeding (against controls: RR 0.94, 95 % CI 0.75-1.18, P = 0.60; against VKAs: RR 0.90, 95 % 0.69-1.17, P = 0.44). Oral direct thrombin inhibitors were associated with an improved major and CRNM bleeding profile (both comparisons: RR 0.88, 95 % CI 0.78-0.98, P = 0.02) and a significant reduction in stroke and systemic embolism (against controls: RR 0.79, 95 % CI 0.66-0.93, P = 0.006; against VKAs: RR 0.78, 95 % CI 0.66-0.93, P = 0.006). CONCLUSIONS: Oral direct factor Xa inhibitors and oral direct thrombin inhibitors are more effective in reducing stroke and systemic embolism without increasing the risk of major bleeding compared to traditional oral anticoagulants. This favorable risk-benefit balance should be further confirmed by long-term, large-scale safety studies.

Intracardiac echocardiographic imaging with a cartosound module for guidance of left atrial appendage closure: a comparative study with transesophageal echocardiographic imaging.

PURPOSE: In most clinical trials, intracardiac echocardiography (ICE) has provided fewer views than the four standard views provided by transesophageal echocardiography (TEE) when assessing left atrial appendage closure (LAAC) devices. This study aimed to determine if ICE guided by the CartoSound system achieve adequate high-quality views and similar clinical outcomes as TEE during LAAC. METHODS: This study prospectively enrolled 202 patients who underwent LAAC using either ICE (n = 69), TEE (n = 121), or a combination of ICE and TEE (n = 12) as the procedural imaging under local anesthesia. A novel multi-angled "FLAVOR" approach was used for assessment in the ICE group. RESULTS: ICE allowed visualization of the implanted devices in all patients at all proposed angles with long-axis views while two-dimensional (2D) TEE showed short-axis views in 1 or 2 angles in 24.2% of cases, which was more prevalent when the pulmonary ridge was covered by the occluder. In the combined ICE-TEE cohort, 2D-TEE failed to detect peri-device leak in 1 patient. The complication rates were similar between the ICE and TEE groups. Shorter fluoroscopy time, lower radiation dose and contrast usage were founded in the ICE group. At first TEE follow-up, the rate and degree of peri-device leak were similar between the ICE and TEE groups. CONCLUSION: A systematic ICE protocol using a CartoSound module to guide LAAC was reliable for comprehensive long-axis imaging assessment compared with 2D/3D TEE under local anesthesia with a shorter fluoroscopy time, lower radiation dose, and less use of contrast.

Feasibility and safety of a percutaneous and non-fluoroscopic procedure for left atrial appendage closure in patients for whom fluoroscopy presents risk: a cohort study.

Background: Most patients undergoing left atrial appendage closure (LAAC) are older adult individuals with atrial fibrillation (AF) and many comorbidities, which may elevate the risk for complications associated with contrast agents with the fluoroscopic image-guided procedure. This retrospective cohort study of patients with AF at high risk for use of contrast agents compared the feasibility and safety of LAAC using percutaneous and non-fluoroscopic procedure with transesophageal echocardiography (TEE) as the only image guidance relative to those under fluoroscopic image guidance. Methods: In this retrospective study, we enrolled 126 patients with AF who underwent LAAC from September 2017 to December 2020. Patients were divided into 2 groups based on the imaging guidance modality: a TEE group (n=32) and a fluoroscopic group (n=94). We analyzed the differences in complete closure rates and device- and procedure-related complications between the 2 groups. Continuous variables were assessed using the Student t-test or Mann-Whitney test, while categorical variables were evaluated using Pearson chi-squared test or Fisher exact test. Propensity-score matching was used to adjust for baseline differences. Results: Propensity-score matching yielded 25 pairs of patients with similarly distributed age (72.9±6.9 vs. 73.1±4.9 years; P=0.925), gender (10:15 vs. 11:14; P>0.99), weight (68.3±11.2 vs. 68.1±12.3 kg; P=0.948), and alanine aminotransferase level (20.0±9.8 vs. 22.5±14.2 U/L; P=0.482). The LAA was successfully occluded in all patients, and the TEE group showed similar results to the fluoroscopic group in terms of success rate (100% vs. 100%; P>0.99) and hospitalization duration [5.0 (IQ1-IQ3: 3.0-7.0) vs. 5.0 (IQ1-IQ3: 3.0-6.0) days; P=0.498]. The groups also demonstrated comparable complication rates, with 1 (4.2%) case of pericardial effusion and 1 (4.2%) case of residual shunt in the TEE group, and 5 (20%) cases of residual shunt, 1 (4.2%) case of pericardial effusion, 1 (4.2%) case of myocardial infarction, and 1 (4.2%) case of access-related complications in the fluoroscopic group. There were no deaths. The overall incidence rate of procedure-related complications (6.2% vs. 18.1%, P=0.153) at mean 22.2±4.5 months follow-up between the 2 groups was similar. Conclusions: In patients with AF of high risk for use of contrast agents, LAAC under non-fluoroscopic guidance appears feasible and safe with similar outcomes to that under fluoroscopic guidance.

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.

Atrial dysfunction and interatrial dyssynchrony predict atrial high rate episodes: insight into the distinct effects of right atrial appendage pacing.

INTRODUCTION: Right atrial (RA) appendage pacing may prolong atrial conduction time (ACT). This study aimed to investigate if RA appendage pacing can induce intra- and interatrial dyssynchrony and if atrial dysfunction and dyssynchrony can predict atrial high rate episodes (AHREs) in the first year after pacing. METHODS AND RESULTS: Patients implanted with dual-chamber pacemakers for symptomatic bradycardia were enrolled. Cumulative percentage of RA appendage pacing (Cum%AP) during 1-year follow-up and AHREs were recorded. Full Doppler echocardiography studies were performed before implantation and 1 year after pacing. ACT and peak atrial velocities (Sm-la, Em-la, Am-la) were measured. One hundred ten patients (age 70.5 ± 11 years; 53 males) were recruited and completed 1-year follow-up. ACT of both RA and left atrial (LA) were more prolonged in patients with Cum%AP > 75% than those with <25%. Intra- and interatrial dyssynchrony was more obvious in patients with Cum%AP > 75% (22.3 ± 12.2 milliseconds vs 9.5 ± 6.2 milliseconds; 53.9 ± 29.7 milliseconds vs 19.7 ± 17.3 milliseconds; both P < 0.001). AHREs occurred in 29% of patients. Atrial pump function and interatrial dyssynchrony independently predicted AHREs in multivariate analysis. Receiver operating characteristic curve provided a cutoff value of Am-la <5.3 cm/s, which predicted AHREs with a sensitivity of 71% and a specificity of 75% (area under the curve, 0.822; P < 0.001). CONCLUSION: RA appendage pacing causes atrial conduction delay with intra- and interatrial dyssynchrony. Atrial dysfunction and interatrial dyssynchrony are related to AHREs in the first year after pacing.

Long-term effect of bosentan therapy on cardiac function and symptomatic benefits in adult patients with Eisenmenger syndrome.

BACKGROUND: Bosentan improves symptoms in patients with Eisenmenger syndrome (ES). This study evaluated the effect of long-term bosentan therapy on cardiac function and its relation to symptomatic benefits in ES patients. METHODS AND RESULTS: Twenty-three consecutive adult ES patients (15 with ventricular septal defect, 6 with atrial septal defect, and 2 with patent ductus arteriosus) underwent standard and tissue Doppler echocardiography before and 24 ± 9 months after bosentan therapy. Echocardiographic measurements included pulmonary arterial systolic pressure (PASP), myocardial performance index (MPI), tricuspid and lateral mitral annular pulsed-wave tissue Doppler systolic (Sa) and early diastolic (Ea) long-axis motions. Patients' World Health Organization (WHO) functional class, 6-minute walk distance (6MWD), and systemic arterial oxygen saturations (SaO(2)) were also recorded. The PASP, WHO functional class, 6MWD, and SaO(2) all improved (118 ± 22 to 111 ± 19 mm Hg, 3.2 ± 0.4 to 2.4 ± 0.5, 286 ± 129 m to 395 ± 120 m, and 84.6 ± 6.5% to 88.8 ± 3.9%, respectively; all P < .01) after therapy. There was also significant improvement in right ventricular (RV) MPI (by 23.9%: 0.46 ± 0.15 to 0.35 ± 0.09) and biventricular long-axis function (tricuspid Sa and Ea: 6.7 ± 1.5 to 8.8 ± 1.7 cm/s and 5.7 ± 1.3 to 7.0 ± 1.2 cm/s, respectively; lateral Sa and Ea: 6.8 ± 1.3 to 8.4 ± 1.5 cm/s and 7.6 ± 2.0 to 8.5 ± 2.1 cm/s, respectively; all P < .05). Posttherapy RV MPI was moderately correlated with PASP and 6MWD. CONCLUSIONS: Sustained improvement of pulmonary arterial hypertension and RV function in ES patients was evident 2 years after bosentan therapy, and this may provide insights on the symptomatic benefits gained in these patients.

Left atrial appendage closure with AMPLATZER cardiac plug for stroke prevention in atrial fibrillation: initial Asia-Pacific experience.

BACKGROUND: Left atrial appendage (LAA) is the main source of left atrial thrombus that causes stroke in patients with non-valvular atrial fibrillation (NVAF). This study reported the initial safety, feasibility, and 1-yr clinical outcomes following AMPLATZER cardiac plug (ACP) implantation in Asia-Pacific region. METHODS: Twenty NVAF patients (16 males, age 68 ± 9 yr) with high risk for developing cardioembolic stroke (CHADS(2) score: 2.3 ± 1.3) and contraindications to warfarin received ACP implants from June 2009 to May 2010. Patients received general anesthesia (n = 9) or controlled propofol sedation (n = 11) and the procedures were guided by fluoroscopy and transesophageal echocardiography (TEE). Clinical follow-up was arranged at 1 month and then every 3 months after implantation, whereas, a TEE was scheduled at 1 month upon completion of dual anti-platelet therapy. RESULTS: The LAA was successfully occluded in 19/20 patients (95%) at two Asian centers. One procedure was abandoned because of catheter-related thrombus formation. Other complications included coronary artery air embolism (n = 1) and TEE-attributed esophageal injury (n = 1). The median procedural and fluoroscopic times were 79 (IQR: 59-100) and 18 (IQR 12-27) minutes, respectively. The mean size of implant was 23.6 ± 3.1 mm. The average hospital stay was 1.8 ± 1.1 days. Follow-up TEE showed all the LAA orifices were sealed without device-related thrombus formation. No stroke or death occurred at a mean follow-up of 12.7 ± 3.1 months. CONCLUSIONS: Our preliminary data suggested LAA closure with ACP is safe, feasible with encouraging 1-yr clinical outcomes. Further large-scaled trials are needed to confirm the efficacy of this device.

Acute effects of right ventricular apical pacing on left atrial remodeling and function.

BACKGROUND: The acute effects of right ventricular apical (RVA) pacing on left atrial (LA) function in patients with normal ejection fraction are not clear. METHODS: A total of 94 patients (age 68.1 ± 11.1 years, 26 men) with implanted RVA-based dual-chamber pacemakers were recruited into this study. Patients who were pacemaker-dependent, in persistent atrial fibrillation or left ventricular ejection fraction <45% were excluded. Echocardiography (iE33, Philips, Andover, MA, USA) was performed during intrinsic ventricular conduction (V-sense) and RVA pacing (V-pace) with 15 minutes between switching modes. The total maximal LA volume (LAV(max)), preatrial contraction volume (LAV(pre)), and minimal volume (LAV(min)) were assessed by area-length method. Peak systolic, early diastolic, and peak late diastolic (atrial contractile) velocity (Sm-la, Em-la, and Am-la) and strain (ɛs-la, ɛe-la, and ɛa-la) were measured by color-coded tissue Doppler imaging (TDI) in four mid-LA walls at apical four- and two-chamber views. RESULTS: During V-pace, LA volumes increased significantly compared with V-sense (LAV(max): 52.0 ± 18.8 vs 55.2 ± 21.1 mL, P = 0.005; LAV(pre): 39.8 ± 16.4 vs 41.3 ± 16.6 mL, P = 0.014; LAV(min): 27.4 ± 14.0 vs 29.1 ± 15.1 mL, P = 0.001). TDI parameters showed significant reduction in Sm-la and Em-la. Furthermore, ɛs-la, ɛe-la, and ɛa-la decreased significantly, especially in patients with preexisting diastolic dysfunction (all P < 0.01). CONCLUSIONS: RVA pacing acutely induced LA enlargement and impaired atrial contractility. Patients with preexisting diastolic dysfunction may be more vulnerable to develop LA dysfunction and remodeling after acute RVA pacing.