Jai-Wun Park

Left atrial appendage closure with amplatzer cardiac plug in atrial fibrillation: Initial european experience

Background: In most patients with atrial fibrillation (AF) and stroke, there is thrombotic embolization from the left atrial appendage (LAA). Percutaneous closure of the LAA is a novel alternative for the treatment of patients with AF at a high risk of stroke, in whom long‐term anticoagulation therapy is not possible or not desired. This study details the initial experience with the Amplatzer Cardiac Plug (ACP) in humans. Methods: Investigator‐initiated retrospective preregistry data collection to evaluate procedural feasibility and safety up to 24 hr after implantation of the ACP, a nitinol device designed for percutaneous trans‐septal implantation in LAA of patients with paroxysmal, permanent, or persistent AF. Results: In 137 of 143 patients, LAA occlusion was attempted, and successfully performed in 132 (96%). There were serious complications in 10 (7.0%) patients (three patients with ischemic stroke; two patients experienced device embolization, both percutaneously recaptured; and five patients with clinically significant pericardial effusions). Minor complications were insignificant pericardial effusions in four, transient myocardial ischemia in two, and loss of the implant in the venous system in one patient. Conclusion: The implantation of the ACP device is a feasible method for percutaneous occlusion of the LAA.

Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug.

AIMSnTo investigate the safety, feasibility, and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) for stroke prevention in patients with atrial fibrillation (AF).nnnMETHODS AND RESULTSnData from consecutive patients treated in 22 centres were collected. A total of 1,047 patients were included in the study. Procedural success was 97.3%. There were 52 (4.97%) periprocedural major adverse events. Follow-up was complete in 1,001/1,019 (98.2%) of successfully implanted patients (average 13 months, total 1,349 patient-years). One-year all-cause mortality was 4.2%. No death at follow-up was reported as device-related. There were nine strokes (0.9%) and nine transient ischaemic attacks (0.9%) during follow-up. The annual rate of systemic thromboembolism was 2.3% (31/1,349 patient-years), which is a 59% risk reduction. There were 15 major bleedings (1.5%) during follow-up. The annual rate of major bleeding was 2.1% (28/1,349 patient-years), which is a 61% risk reduction. Patients with single LAAO on aspirin monotherapy or no therapy and longer follow-up had fewer cerebral and fewer bleeding events.nnnCONCLUSIONSnIn this multicentre study, LAAO with the ACP showed high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Modification in antithrombotic therapy after LAAO may result in reduction of bleeding events.

Impact of chronic kidney disease on left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation

BACKGROUNDnLeft atrial appendage occlusion (LAAO) using the Amplatzer cardiac plug (ACP) is a preventive treatment of atrial fibrillation related thromboembolism.nnnAIMnTo assess the safety and efficacy of LAAO in patients with chronic kidney disease (CKD).nnnMETHODSnAmong the ACP multicentre registry, 1014 patients (75±8yrs) with available renal function were included.nnnRESULTSnPatients with CKD (N=375, CHA2DS2-VASc: 4.9±1.5, HASBLED: 3.4±1.3) were at higher risk than patients without CKD (N=639, CHA2DS2-VASc: 4.2±1.6, HASBLED: 2.9±1.2; p<0.001 for both). Procedural (97%) and occlusion (99%) success were similarly high in all stages of CKD. Peri-procedural major adverse events (MAE) were observed in 5.1% of patients, 0.8% of death, with no difference between patients with and those without CKD (6.1 vs 4.5%, p=0.47). In patients with complete follow-up (1319 patients years), the annual stroke+transient ischaemic attack (TIA) rate was 2.3% and the observed bleeding rate was 2.1% (62 and 60% less than expected, similarly among patients with and those without CKD). Kaplan-Meier analysis showed a lower overall survival (84 vs 96% and 84 vs 93% at 1 and 2yrs. respectively; p<0.001) among patients with an eGFR <30ml/min/1.73m(2).nnnCONCLUSIONnLAAO using the ACP has a similar procedural safety among CKD patients compared to patients with normal renal function. LAAO with ACP offers a dramatic reduction of stroke+TIA rate and of bleeding rate persistent in all stages of CKD, as compared to the expected annual risk.

Preclinical evaluation of a new left atrial appendage occluder (Lifetech LAmbre™ Device) in a canine model

OBJECTIVESnThe study evaluated the feasibility and safety of a novel left atrial appendage (LAA) occluder (LAmbre™, Lifetech Scientific Corp., China) in canines.nnnBACKGROUNDnTranscatheter LAA occlusion is comparable to warfarin in preventing atrial fibrillation-related strokes.nnnMETHODSnTwenty-two healthy dogs (28 ± 3 kg) received LAmbre implants. The device is delivered by an 8-10 French sheath and has full recapture and repositioning capabilities. All dogs received 1-week antibiotics and 4-week aspirin (80 mg daily) after implants and they were sacrificed in groups at Days 1-3 (n = 5), 1- (n = 7), 3- (n = 4) and 6-months (n = 6) for pathological examinations. Transthoracic echocardiography (TTE) was performed immediately after implant, at Day 3 and before sacrifice.nnnRESULTSnThe LAmbre was successfully implanted, retrieved, repositioned and re-implanted in all dogs. The mean implant size was 24 ± 3 mm and the device chosen was 36 ± 7% larger than the measured landing zone diameter. Improper device selection (only 21% oversizing) resulted in dislodgement and death of 1 dog on Day 3. Post-implant angiography and TTE showed well-positioned device without pericardial effusion or impingement on surrounding structures. Late complications included device-related thrombus at 1 month (n = 1) and clinically insignificant pericardial effusion at Day 3 (n = 1). Complete healing on the atrial facing surface with optimal LAA obliteration was confirmed by gross and microscopic examinations in dogs that have been followed up ≥3 months (n = 10). No infarct was detected in major organs.nnnCONCLUSIONSnOur preliminary data suggested the LAmbre™ device is feasible with high success rate in canines. Further studies are needed to evaluate its safety and efficacy.

Comparison of Efficacy and Safety of Left Atrial Appendage Occlusion in Patients Aged <75 to ≥ 75 Years.

Left atrial appendage occlusion (LAAO) is emerging as a promising alternative to oral anticoagulation. Because aged patients present a greater risk of not only cardioembolic events but also major bleeding, LAAO might represent a valid alternative as this would allow oral anticoagulation cessation while keeping cardioembolic protection. The objective of the study was to explore the safety and efficacy of LAAO in elderly patients. Data from the AMPLATZER Cardiac Plug multicenter registry were analyzed. The cohort was categorized in 2 groups (<75 vs ≥ 75 years). A total of 1,053 subjects were included in the registry. Of them, 219 were excluded because of combined procedures. As a result, 828 subjects were included (54.6% ≥ 75 years). Procedural success was high and similar in both groups (97.3%). Acute procedural major adverse events were not statistically different among groups (3.2% in <75 years vs 5.1%; p = 0.17) although stratified analysis showed a higher incidence of cardiac tamponade in elderly patients (0.5% vs 2.2%; p = 0.04). With a median follow-up of 16.8 months, no significant differences in stroke/TIA (1.9% vs 2.3%; p = 0.89) and major bleeding (1.7% vs 2.6%; p = 0.54) were observed. In conclusion, LAAO was associated with similar procedural success in patients aged <75 and ≥ 75 years although older patients had a higher incidence of cardiac tamponade. At follow-up, stroke and major bleeding rates were similar among groups.

Characterization of Cerebrovascular Events After Left Atrial Appendage Occlusion

Cardioembolic strokes are generally more lethal and disabling than other source of strokes. Data from PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) suggest that strokes after left atrial appendage occlusion (LAAO) with the Watchman device are less disabling than those in the warfarin group. No data assessing the severity of strokes after LAAO with the AMPLATZER Cardiac Plug (ACP) are available. The objective of the study was to evaluate the severity of cerebrovascular events after LAAO with the ACP in a population mostly characterized by an absolute or relative contraindication to oral anticoagulation. Data from the ACP multicenter registry were analyzed. Disabling strokes were defined as those with a modified Rankin score of 3 to 6 at 90xa0days after the event. A total of 1,047 subjects were included. The mean age and CHADS2 score were 75 ± 8xa0years and 2.8 ± 1.3, respectively. Procedural success was achieved in 97.3% and 4.9% of the patients presented procedural major adverse events. Clinical follow-up was complete in 98.2% of patients with a median of 13xa0months. There were 9 strokes (0.9%), 9 transient ischemic attacks (0.9%), and no intracranial hemorrhages (0%) at follow-up. After excluding 2 patients with pre-LAAO disability, functional assessment showed disabling events in 3 (19%) of the remaining 16 patients. The median time of presentation was 420xa0days (interquartile range 234 to 671) after LAAO, and 17 patients (94%) were on single-antiplatelet therapy when the event occurred. According to our results, cerebrovascular events after LAAO with the ACP system were infrequent and mostly nondisabling.

Patients with intracranial bleeding and atrial fibrillation treated with left atrial appendage occlusion: Results from the Amplatzer Cardiac Plug registry.

BACKGROUNDnIn patients with non-valvular atrial fibrillation (NVAF), intracranial bleeding (ICB) constitutes a very challenging situation in which the rate of both ischemic and hemorrhagic events is increased. In these patients, left atrial appendage occlusion (LAAO) might represent a very valid alternative.nnnOBJECTIVESnTo investigate the procedural safety and long-term outcome of patients undergoing LAAO therapy due to previous ICB.nnnMETHODSnData from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients were analyzed. Patients with previous ICB as indication for LAAO were compared to patients with other indications.nnnRESULTSnA total of 198 patients (18.9%) with previous ICB were identified. The CHA2DS2-VASc score was similar (4.5±1.5 vs. 4.4±1.6, p=0.687) and the HAS-BLED score was higher in patients with previous ICB compared to those without (3.5±1.1 vs. 3.1±1.2, p<0.001). No significant differences in peri-procedural major adverse events were observed (2.5 vs 5.4%, p=0.1). Patients with previous ICB were more frequently on single acetylsalicylic acid therapy after LAAO (42.4% vs. 28.3%; p<0.001). With an average follow-up of 1.3years, the observed annual stroke/TIA rate (procedure and follow-up) for patients with previous ICB was 1.4% (75% relative risk reduction). The observed annual major bleeding rate (procedure and follow-up) for patients with previous ICB was 0.7% (89% relative risk reduction).nnnCONCLUSIONSnIn patients with NVAF and previous ICB, LAAO seemed to be a safe procedure and was associated with a significant reduction in stroke/TIA and a remarkably low frequency of major bleeding during follow-up.

Self-Expandable Device for Percutaneous Closing of Left Atrial Appendage With Organized Thrombus in a Patient With Permanent Atrial Fibrillation

While a left atrial appendage (LAA) occlusion device may reduce the risk of cardioembolic stroke in patients with nonvalvular atrial fibrillation, an antithromboembolic strategy for patients with an organized thrombus in the LAA is still unclear. The present case is the first report of percutaneous closing of an LAA and organized thrombus with a self-expandable LAA occlusion device without complication. This minimally invasive intervention is a potential treatment option in a patient with significant risk of recurrent thromboembolism.

Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation and Previous Major Gastrointestinal Bleeding (from the Amplatzer Cardiac Plug Multicenter Registry)

History of major gastrointestinal (GI) bleeding may represent a frequent clinical indication for left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). This study aims to investigate the procedural safety and long-term outcome of patients with previous major GI bleeding (MGIB) who underwent LAAO. Data from the Amplatzer Cardiac Plug multicenter registry on 1,047 patients were analyzed. Patients with previous MGIB as indication for LAAO were compared with patients without previous MGIB. A total of 151 patients (14.4%) with previous MGIB were identified. Periprocedural major bleeding events were more frequent in patients with previous MGIB (4.0% vs 0.8%, pxa0= 0.001). With an average follow-up of 1.3xa0years, the observed annual rate of stroke/transient ischemic attack and major bleeding for patients with previous MGIB were 2.1% (61.4% relative reduction according to the Congestive Heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, Age 65-74, and Sex (female) [CHA2DS2-VASc] score) and 4.6% (20.1% relative reduction according to the expected rate based on the Hypertension, Abnormal renal/liver function (1 point each), Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs/alcohol concomitantly (1 point each) [HAS-BLED] score), respectively. In conclusion, in patients with non-valvular atrial fibrillation and previous MGIB, LAAO was associated with a low annual rate of stroke/transient ischemic attack. Periprocedural major bleeding events were more frequent in this specific population although the annual major bleeding rate showed a 20.1% relative risk reduction according to the HAS-BLED score.

The novel application of intraprocedural cardiac computed tomography for left atrial appendage occlusion.

A 67-year-old woman with persistent atrial fibrillation (CHA2DS2VASc: 6 and HAS BLED: 4) who experienced recurrent stroke and intracranial bleeding on Apixaban was considered for left atrial appendage (LAA) occlusion with Amplatzer Cardiac Plug (ACP). An angiography shared multi-detector computed tomography system (MDCT) was applicable in this procedure ( Panels A …