Real-world results of oesophageal protection from a temperature control device during left atrial ablation.
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ABSTRACT:
SUBMITTER: Leung LWM
PROVIDER: S-EPMC10228621 | biostudies-literature | 2023 May
REPOSITORIES: biostudies-literature
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Real-world results of oesophageal protection from a temperature control device during left atrial ablation.
Leung Lisa W M LWM Toor Pavandeep P Akhtar Zaki Z Bajpai Abhay A Li Anthony A Sohal Manav M Gallagher Mark M MM
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology 20230501 5
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Project description:AimsThermal injury to the oesophagus is an important cause of life-threatening complication after ablation for atrial fibrillation (AF). Thermal protection of the oesophageal lumen by infusing cold liquid reduces thermal injury to a limited extent. We tested the ability of a more powerful method of oesophageal temperature control to reduce the incidence of thermal injury.Methods and resultsA single-centre, prospective, double-blinded randomized trial was used to investigate the ability of the ensoETM device to protect the oesophagus from thermal injury. This device was compared in a 1:1 randomization with a control group of standard practice utilizing a single-point temperature probe. In the protected group, the device maintained the luminal temperature at 4°C during radiofrequency (RF) ablation for AF under general anaesthesia. Endoscopic examination was performed at 7 days post-ablation and oesophageal injury was scored. The patient and the endoscopist were blinded to the randomization. We recruited 188 patients, of whom 120 underwent endoscopy. Thermal injury to the mucosa was significantly more common in the control group than in those receiving oesophageal protection (12/60 vs. 2/60; P = 0.008), with a trend toward reduction in gastroparesis (6/60 vs. 2/60, P = 0.27). There was no difference between groups in the duration of RF or in the force applied (P value range= 0.2-0.9). Procedure duration and fluoroscopy duration were similar (P = 0.97, P = 0.91, respectively).ConclusionThermal protection of the oesophagus significantly reduces ablation-related thermal injury compared with standard care. This method of oesophageal protection is safe and does not compromise the efficacy or efficiency of the ablation procedure.
| S-EPMC7868886 | biostudies-literature
Project description:BackgroundTranscatheter left atrial appendage occlusion (LAAO) has emerged as an alternative treatment for stroke prevention in patients with atrial fibrillation (AF) at high risk of thromboembolism, who cannot tolerate long-term oral anticoagulation (OAC). Questions persist regarding effectiveness and safety of this treatment and the optimal post-interventional antithrombotic regimen after LAAO.MethodsWe retrospectively gathered data from 428 patients who underwent percutaneous LAAO in 6 Italian high-volume centres, aimed at describing the real-world utilization, safety, and effectiveness of LAAO procedures, also assessing the clinical outcomes associated with different antithrombotic strategies.ResultsAmong the entire population, 20 (4.7 %) patients experienced a combination of pericardial effusion and periprocedural major bleeding: 8 (1.9 %) pericardial effusion, 1 (0.3 %) fatal bleeding, and 3 (0.7 %) non-fatal procedural major bleeding. Patients were discharged with different antithrombotic regimens: dual (DAPT) (27 %) or single (SAPT) (26 %) antiplatelet therapy, OAC (27 %), other antithrombotic regimens (14 %). Very few patients were not prescribed with antithrombotic drugs (6 %). At a medium 523 ± 58 days follow-up, 14 patients (3.3 %) experienced all-cause death, 6 patients (1.4 %) cardiovascular death, 3 patients (0.7 %) major bleeding, 10 patients (2.6 %) clinically relevant non-major bleeding, and 3 patients (0.7 %) ischemic stroke. At survival analysis, with DAPT as the reference group, OAC therapy was associated with better outcomes.ConclusionsOur findings confirm that LAAO is a safe procedure. Different individualized post-discharge antithrombotic regimens are now adopted, likely driven by the perceived thrombotic and hemorrhagic risk. The incidence of both ischemic and bleeding events tends to be low.
| S-EPMC10979264 | biostudies-literature
Project description:BackgroundIn the recent ESC/EACTS guidelines, left atrial appendage (LAA) occlusion or exclusion in patients undergoing (thoracoscopic) atrial fibrillation (AF) ablation surgery is recommended. The Watchman device (WD, Boston Scientific, Minnesota) has proved to reduce the risk of thromboembolic events by closing of the LAA, yet no data exist on WD implantation during surgical AF ablation. The objective is to determine if WD implantation is safe and feasible in a hybrid AF ablation setting (i.e., combination of thoracoscopic epicardial surgical and endocardial catheter ablation) and could become subject of further testing to serve as a bail-out in cases in which surgical LAA occlusion methods cannot be applied, due to, for example, severe adhesions.MethodsIn this prospective, single center, pilot study, 10 consecutive patients undergoing a hybrid ablation qualifying for LAA exclusion (CHA2DS2-VASc ≥ 1) were included. At the end of the hybrid ablation, the LAA was occluded endocardially using the WD. The feasibility endpoint was successful implantation. The safety endpoint concerned major complications.ResultsOne patient was excluded and replaced because the LAA was insufficiently visible on transesophageal echocardiography. In 10/11 patients, device delivery was successful (mean time: 35 minutes). No major complications occurred. Transesophageal echocardiography after 6 weeks and 6 months showed successful occlusion of the LAA without significant peridevice flow.ConclusionImplantation of the WD seems to be feasible and safe in the setting of hybrid AF ablation and could be an alternative to epicardial occlusion in surgical AF ablation procedures. Larger studies are required to confirm these findings. This trial is registered with NCT02471131.
| S-EPMC6739757 | biostudies-literature
Project description:AimsThe FLXibility Post-Approval Study collected data on unselected patients implanted with a WATCHMAN FLX in a commercial clinical setting.Methods and resultsPatients were implanted with a WATCHMAN FLX per local standard of care, with a subsequent first follow-up visit from 45 to 120 days post-implant and a final follow-up at 1-year post-procedure. A Clinical Event Committee adjudicated all major adverse events and TEE/CT imaging results were adjudicated by a core laboratory. Among 300 patients enrolled at 17 centres in Europe, the mean age was 74.6 ± 8.0 years, mean CHA2DS2-VASc score was 4.3 ± 1.6, and 62.1% were male. The device was successfully implanted in 99.0% (297/300) of patients. The post-implant medication regimen was DAPT for 87.3% (262/300). At first follow-up, core-lab adjudicated complete seal was 88.2% (149/169), 9.5% (16/169) had leak <3 mm, 2.4 (4/169) had leak ≥3 mm to ≤5 mm, and 0% had >5 mm leak. At 1 year, 93.3% (280/300) had final follow-up; 60.5% of patients were on a single antiplatelet medication, 21.4% were on DAPT, 5.6% were on direct oral anticoagulation, and 12.1% were not taking any antiplatelet/anticoagulation medication. Adverse event rates through 1 year were: all-cause death 10.8% (32/295); CV/unexplained death 5.1% (15/295); disabling and non-disabling stroke each 1.0% (3/295, all non-fatal); pericardial effusion requiring surgery or pericardiocentesis 1.0% (3/295); and device-related thrombus 2.4% (7/295).ConclusionThe WATCHMAN FLX device had excellent procedural success rates, high LAA seal rates, and low rates of thromboembolic events in everyday clinical practice.
| S-EPMC10062328 | biostudies-literature
Project description:AimsCurrent guidelines for the optimal ablation strategy for persistent atrial fibrillation (PerAF) remain unclear. While our previous RCT confirmed the favourable prognosis of aggressive ablation, real-world evidence is still lacking.Methods and resultsAmong 4833 PerAF patients undergoing catheter ablation at 10 centres, two groups were defined: regular ablation (PVI-only or PVI plus anatomical ablation) and aggressive ablation (anatomical plus electrogram-guided ablation), with 1560 patients each after propensity score (PS) matching. The primary endpoint was 12-month AF/atrial tachycardia (AT) recurrence-free survival off anti-arrhythmic drugs after a single procedure. Additional PS matching was performed within the regular group between PVI-only and anatomical ablation (n = 455 each). Furthermore, anatomical ablation from the regular group was independently matched with aggressive ablation (n = 1362 each). At 12 months, the aggressive group showed superior AF/AT-free survival (66.2% vs. 59.3%, P < 0.001; HR 0.745), similar AT recurrence (12.0% vs. 11.3%, P = 0.539), and significantly higher procedural AF termination (67.0% vs. 21.0%, P < 0.001) than regular group. Moreover, patients with AF termination had improved AF/AT-free survival (72.3% vs. 55.2%, P < 0.001). Safety endpoints did not differ significantly between the two groups. Both the ablation outcomes and AF termination rate showed increasing trends with the extent of ablation aggressiveness but declined with extremely aggressive ablation. After additional PS matching, within the regular group, no statistical differences were observed though AF/AT-free survival in the anatomical group was slightly higher than the PVI-only group (60.7% vs. 55.6%, P = 0.122); while aggressive ablation showed improved AF/AT-free survival compared to anatomical ablation alone from regular group (67.5% vs. 59.9%, P < 0.001).ConclusionAggressive ablation achieved more favourable outcomes than regular ablation, and moderately aggressive ablation may be associated with better clinical outcomes. AF termination is a reliable ablation endpoint.
| S-EPMC11920505 | biostudies-literature
Project description:BackgroundA left ventricular assist device (LVAD) is a life-saving but intensive therapy for patients with end-stage heart failure. We evaluated the healthcare consumption in a cohort of LVAD patients in our centre over 6 years.MethodsAll patients with a primary LVAD implantation at the University Medical Centre Utrecht in Utrecht, the Netherlands from 2016 through 2021 were included in this analysis. Subsequent hospital stay, outpatient clinic visits, emergency department visits and readmissions were recorded.ResultsDuring the investigated period, 226 LVADs were implanted, ranging from 32 in 2016 to 45 in 2020. Most LVADs were implanted in patients aged 40-60 years, while they were supported by or sliding on inotropes (Interagency Registry for Mechanically Assisted Circulatory Support class 2 or 3). Around the time of LVAD implantation, the median total hospital stay was 41 days. As the size of the LVAD cohort increased over time, the total annual number of outpatient clinic visits also increased, from 124 in 2016 to 812 in 2021 (p = 0.003). The numbers of emergency department visits and readmissions significantly increased in the 6‑year period as well, with a total number of 553 emergency department visits and 614 readmissions. Over the years, the annual number of outpatient clinic visits decreased by 1 per patient-year follow-up, while the annual numbers of emergency department visits and readmissions per patient-year remained stable.ConclusionThe number of patients supported by an LVAD has grown steadily over the last years, requiring a more specialised healthcare in this particular population.
| S-EPMC11336021 | biostudies-literature
Project description:BackgroundLeft atrial appendage (LAA) occlusion is an alternative therapy for atrial fibrillation patients who have high embolic risk and contraindications to anticoagulant therapy.ObjectiveTo evaluate the feasibility, safety, and mid-term outcomes of percutaneous LAA occlusion, including device-related thrombosis.MethodsSixty consecutive patients who had undergone percutaneous LAA occlusion with AMPLATZER™ Amulet™ device from September 2015 to March 2018 were enrolled. Patients were followed for 21 ± 15 months (median - 20 months, interquartile range - 9 to 27 months). The postprocedural assessment was done at the 1(st), 6(th), and 12(th) month. Patients were clinically evaluated, and transesophageal echocardiography was performed at each visit. We evaluated the condition of normality of variables using the Kolmogorov-Smirnov test. P-values < 0.05 were statistically significant.ResultsThe most common indication for the procedure was major bleeding with anticoagulants (n: 53, 88.3%). The procedure was completed successfully in 59 (98.3%) patients. Periprocedural mortality was observed in one patient. Postprocedural antiplatelet treatment was planned as dual or single antiplatelet therapy or low-dose anticoagulant therapy in 52 (88.1%), 2 (3.4%), and 5 (8.5%) patients, respectively. We found no clinically significant cerebrovascular events, device-related thrombus, or embolization in any patient during the follow-up. Two (3.4 %) patients presented significant peri-device leak (>3 mm) at the 1st month evaluation, which disappeared at the 12th month follow-up.ConclusionWe concluded that LAA occlusion using the Amulet™ LAA occluder can be performed with high procedural success and acceptable outcomes.
| S-EPMC7020865 | biostudies-literature
Project description:Left atrial appendage (LAA) was shown to harbor triggers and substrate for atrial arrhythmia, electrical isolation of the LAA can be a potential treatment. We describe the use of a novel device that combines electrical isolation of the LAA using pulsed field ablation and mechanical LAA occlusion in a single procedure. (Level of Difficulty: Advanced.).
| S-EPMC10544081 | biostudies-literature
Project description:IntroductionRadiofrequency catheter ablation is a common treatment for atrial fibrillation (AF), during which thermal esophageal injury may rarely occur and lead to an atrio-esophageal fistula. Therefore, we studied the utility of the Circa S-Cath™ multi-sensor luminal esophageal temperature (LET) probe to prevent esophageal thermal injury.Methods and resultsThirty-six patients, enrolled prospectively, underwent circumferential or segmental pulmonary vein isolation for treatment of AF. A maximum ablation electrode temperature of 42ºC was programmed for automatic power delivery cutoff. In addition, energy delivery was manually discontinued when the maximum LET on any sensor of the probe rose abruptly (i.e. ˃0.2ºC) or exceeded 39º C. Esophagoscopy was performed immediately after ablation in 18 patients (with the temperature probe still in place) and at approximately 24 hours after ablation in 18 patients. Esophageal lesions were classified as likely traumatic or thermally related. Of the 36 patients enrolled in the study, 21 had persistent and 15 had paroxysmal AF, average LVEF 57±16% and CHA2DS2VASc score 1.6±1.2 (range 0-4). Average maximum LET was 37.8±1.4ºC, power delivery 31.1±8 watts and ablation electrode temperature 36.4±4.1ºC. Average maximum contact force was 44.5±20.5 grams where measured. Only 1 patient (<3%) had an esophageal lesion that could potentially represent thermal injury and 4 patients (11.1%) had minor traumatic mechanical injury.ConclusionsLET guided titration of power and duration of energy application, using an insulated multi-sensor esophageal temperature probe, is associated with a low risk of esophageal thermal injury during AF ablation. In only rare cases, LET monitoring resulted in the need to manipulate the esophagus to avoid unacceptable temperature rises, that could not be achieved by adjustment of power and duration of energy application.
| S-EPMC8691294 | biostudies-literature
Project description:BackgroundMany patients with atrial fibrillation (AF) discontinued oral anticoagulation (OAC) therapy after successful catheter ablation. We aimed to determine the real-world risks and consequences of discontinuing OAC use after catheter ablation for AF.MethodsPatients who underwent successful catheter ablation for AF from January 2004 to December 2020 were divided into continued long-term OAC (On-OAC, n = 1062) and discontinued (Off-OAC, n = 1055) groups. The long-term outcomes including thromboembolic events, major bleeding, all-cause mortality and major adverse cardiovascular events (MACE), were compared between the two groups.ResultsThe CHA2DS2-VASc score was 3.44 ± 1.12. After a mean follow-up of 37.09 months, thromboembolism risk was higher and major bleeding risk was lower in the Off-OAC than in the On-OAC group (Both log-rank P < 0.001). CHA2DS2-VASc score-stratified subgroup analysis showed similar cumulative event rates between the two groups in men and women with scores of 2 and 3 (intermediate risk for stroke), respectively, (P > 0.05), except for a higher major bleeding rate in the On-OAC group (P = 0.002). Patients at high risk for stroke (men and women with scores ≥3 and ≥ 4) had better non-thromboembolic and non-MACE results (Both log-rank P < 0.05).ConclusionMen with a CHA2DS2-VASc score of 2 and women with a score of 3 had a relatively low incidence of stroke events after successful catheter ablation for AF and may be safe for anticoagulation cessation. Greater benefits from long-term OAC were observed in men with CHA2DS2-VASc score ≥3 and women with score ≥4.
| S-EPMC11237919 | biostudies-literature