Objectives
This study sought to evaluate the feasibility, safety, and efficacy of the Ultraseal device for left atrial appendage closure (LAAC) (Cardia, Eagan, Minnesota) in patients with nonvalvular atrial fibrillation at high bleeding risk.Background
The Ultraseal device is a novel bulb-and-sail designed LAAC device, with an articulating joint enabling conformability to heterogeneous angles and shapes of appendage anatomy.Methods
This was a multicenter study including consecutive patients undergoing LAAC with the Ultraseal device at 15 Canadian and European sites. Periprocedural and follow-up events were systematically collected, and transesophageal echocardiography at 45 to 180 days post-procedure was routinely performed in all centers but 3.Results
A total of 126 patients (mean age 75 ± 8 years; mean CHA2DS2-VASc score 5 ± 2; mean HAS-BLED score 4 ± 1) were included. The device was successfully implanted in 97% of patients. A major periprocedural adverse event occurred in 3 (2.4%) patients (clinically relevant pericardial effusion [n = 1], stroke [n = 1], device embolization [n = 1]). Ninety percent of patients were discharged on single or dual antiplatelet therapy. Follow-up transesophageal echocardiography was available in 89 (73%) patients, with no cases of large (>5 mm) residual leak and 5 (5.6%) cases of device-related thrombosis (all successfully treated with anticoagulation therapy). At a median follow-up of 6 (interquartile range: 3 to 10) months, the rates of stroke and transient ischemic attack were 0.8% and 0.8%, respectively, with no systemic emboli. None of the events occurred in patients with device-related thrombosis.Conclusions
In this initial multicenter experience, LAAC with the Ultraseal device was associated with a high implant success rate and a very low incidence of periprocedural complications. There were no late device-related clinical events and promising efficacy results were observed regarding thromboembolic prevention at midterm follow-up. Larger studies are further warranted to confirm the long-term safety and efficacy of this novel device. 相似文献Objectives
This study sought to evaluate the feasibility, safety, and efficacy of intracardiac echocardiography (ICE)–guided versus transesophageal echocardiography (TEE)–guided left atrial appendage occlusion (LAAO) by the use of Amplatzer Cardiac Plug or Amulet devices included in a large Italian registry.Background
TEE is widely used for LAAO procedure guidance. ICE may be a potential alternative imaging modality in LAAO.Methods
Data from 604 LAAO procedures performed in 16 Italian centers were reviewed. ICE-guided LAAO was performed in 187 patients, whereas TEE was used in 417 patients. Procedural success was defined as LAAO without occurrence of pericardial tamponade, stroke, systemic embolism with end organ damage, major bleeding, and device embolization. Stroke, transient ischemic attack, major bleeding, overall and cardiovascular death were analyzed.Results
CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65 to 74 years, sex category) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores were similar between the ICE and TEE groups. TEE implied lower procedural (delta 12 min) and fluoroscopy time (delta 5 min) when compared with ICE. Procedural success was similarly high (≥94%) between the TEE and ICE groups with a complication rate of 6.5% for TEE versus 4.2% for ICE (odds ratio: 1.468; 95% confidence interval: 0.681 to 3.166; p = 0.327). At median follow-up of 451 days (interquartile range: 162 to 899 days), the rate of cerebral ischemic events was similar between TEE-guided and ICE-guided procedures.Conclusions
ICE-guided LAAO by means of Amplatzer devices may represent a second alternative imaging modality after an appropriate learning curve and bearing in mind that pre-procedural computed tomography imaging is mandatory. When comparing ICE with TEE, TEE remains the gold standard. 相似文献Background
Arrhythmias, conduction abnormalities, and intracardiac thrombus are common in patients with cardiac amyloidosis (CA). Outcomes of direct-current cardioversion (DCCV) for atrial arrhythmias in patients with CA are unknown.Objectives
This study sought to examine DCCV procedural outcomes in patients with CA.Methods
Patients with CA scheduled for DCCV for atrial arrhythmias from January 2000 through December 2012 were identified and matched 2:1 with control patients by age, sex, type of atrial arrhythmia, and date of DCCV.Results
CA patients (n = 58, mean age 69 ± 9 years, 81% male) were included. CA patients had a significantly higher cardioversion cancellation rate (28% vs. 7%; p < 0.001) compared with control patients, mainly due to intracardiac thrombus identified on transesophageal echocardiogram (13 of 16 [81%] vs. 2 of 8 [25%]; p = 0.02); 4 of 13 of the CA patients (31%) with intracardiac thrombus on transesophageal echocardiogram received adequate anticoagulation ≥3 weeks and another 2 of 13 (15%) had arrhythmia duration <48 h. DCCV success rate (90% vs. 94%; p = 0.4) was not different. Procedural complications were more frequent in CA versus control patients (6 of 42 [14%] vs. 2 of 106 [2%]; p = 0.007); complications in CA included ventricular arrhythmias in 2 and severe bradyarrhythmias requiring pacemaker implantation in 2. The only complication in the control group was self-limited bradyarrhythmias.Conclusions
Patients with CA undergoing DCCV had a significantly high cancellation rate mainly due to a high incidence of intracardiac thrombus even among patients who received adequate anticoagulation. Although the success rate of restoring sinus rhythm was high, tachyarrhythmias and bradyarrhythmias complicating DCCV were significantly more frequent in CA patients compared with control patients. 相似文献Background
Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated.Objectives
The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis.Methods
The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently.Results
In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points.Conclusions
In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed. 相似文献Background
Transesophageal echocardiography operators (TEEOP) provide critical imaging support for percutaneous structural cardiac intervention procedures. They stand close to the patient and the associated scattered radiation.Objectives
This study sought to investigate TEEOP radiation dose during percutaneous structural cardiac intervention.Methods
Key personnel (TEEOP, anesthetist, primary operator [OP1], and secondary operator) wore instantly downloadable personal dosimeters during procedures requiring TEE support. TEEOP effective dose (E) and E per unit Kerma area product (E/KAP) were calculated. E/KAP was compared with C-arm projections. Additional shielding for TEEOP was implemented, and doses were measured for a further 50 procedures. Multivariate linear regression was performed to investigate independent predictors of radiation dose reduction.Results
In the initial 98 procedures, median TEEOP E was 2.62 μSv (interquartile range [IQR]: 0.95 to 4.76 μSv), similar to OP1 E: 1.91 μSv (IQR: 0.48 to 3.81 μSv) (p = 0.101), but significantly higher than secondary operator E: 0.48 μSv (IQR: 0.00 to 1.91 μSv) (p < 0.001) and anesthetist E: 0.48 μSv (IQR: 0.00 to 1.43 μSv) (p < 0.001). Procedures using predominantly right anterior oblique (RAO) and steep RAO projections were associated with high TEEOP E/KAP (p = 0.041). In a further 50 procedures, with additional TEEOP shielding, TEEOP E was reduced by 82% (2.62 μSv [IQR: 0.95 to 4.76] to 0.48 μSv [IQR: 0.00 to 1.43 μSv] [p < 0.001]). Multivariate regression demonstrated shielding, procedure type, and KAP as independent predictors of TEEOP dose.Conclusion
TEE operators are exposed to a radiation dose that is at least as high as that of OP1 during percutaneous cardiac intervention. Doses were higher with procedures using predominantly RAO projections. Radiation doses can be significantly reduced with the use of an additional ceiling-suspended lead shield. 相似文献Background. Clinical predictors of thromboembolism in patients with nonvalvular AF have been identified, but their mechanistic links remain unclear. TEE provides imaging of the left atrium, its appendage and the proximal thoracic aorta, potentially clarifying stroke mechanisms in patients with AF.
Methods. Cross-sectional analysis of TEE features correlated with low, moderate and high thromboembolic risk during aspirin therapy among 786 participants undergoing TEE on entry into the Stroke Prevention in Atrial Fibrillation III trial.
Results. TEE features independently associated with increased thromboembolic risk were appendage thrombi (relative risk [RR] 2.5, p = 0.04), dense spontaneous echo contrast (RR 3.7, p < 0.001), left atrial appendage peak flow velocities ≤20 cm/s (RR 1.7, p = 0.008) and complex aortic plaque (RR 2.1, p < 0.001). Patients with AF with a history of hypertension (conferring moderate risk) more frequently had atrial appendage thrombi (RR 2.6, p < 0.001) and reduced flow velocity (RR 1.8, p = 0.003) than low risk patients. Among low risk patients, those with intermittent AF had similar TEE features to those with constant AF.
Conclusions. TEE findings indicative of atrial stasis or thrombosis and of aortic atheroma were independently associated with high thromboembolic risk in patients with AF. The increased stroke risk associated with a history of hypertension in AF appears to be mediated primarily through left atrial stasis and thrombi. The presence of complex aortic plaque distinguished patients with AF at high risk from those at moderate risk of thromboembolism. 相似文献