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Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study
David Hildick-Smith, Ulf Landmesser, A John Camm, Hans-Christoph Diener, Vince Paul, Boris Schmidt, Magnus Settergren, Emmanuel Teiger, Jens Erik Nielsen-Kudsk, Claudio Tondo on behalf of the Amulet Observational Study Investigators
Summary By: Adriana C. Mares - Founder & President, The Institute of Cardiology at El Paso
Overall Study Question:
What is the efficacy and safety of LAAO with Amplatzer™ Amulet™ device among patients with atrial fibrillation?
Study Summary:
Investigators conducted a prospective global observational cohort study that enrolled 1,088 patients with atrial fibrillation that were eligible for LAAO. Implant and 1-3 months post-LAAO transesophageal echocardiography (TEE) were performed and evaluated by a CoreLab. The primary endpoint was a composite of ischemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. The Kaplan–Meier method was used to calculate event rates at 2 years post-procedure for mortality, the composite of ischemic stroke, systemic embolism, and cardiovascular death, and device-related thrombus (DRT) (Mukherjee, 2020; Hildick-Smith et al., 2020).
Out of 1,088 patients aged 75.2 ± 8.5 years, 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants (OACs). Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone (Mukherjee, 2020; Hildick-Smith et al., 2020).
Closure measured by peridevice flow was <3 mm in 98.4% at follow-up TEE. DRT was seen in 1.6% of cases. Cardiovascular death or ischemic stroke occurred in 8.7% of patients at 2 years. The ischemic stroke rate was 2.2%/year—a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2) (Mukherjee, 2020; Hildick-Smith et al., 2020).
My Insights:
Despite oral anticoagulants been the gold-standard treatment for stroke prevention in patients with non-valvular AF, some patients can’t be treated with long term use of any form of OAC as it poses a risk for thromboembolic events based on CHADS2 or CHA2DS2-VASc scores and are contraindicated in patients who are at high risk for bleeding. Thus, this study investigated the safety and efficacy of LAAO with the Amplatzer Amulet occluder among patients that pose the aforementioned risks.
According to Hortsmann and colleagues, percutaneous LAAO could be an alternative stroke prevention; perhaps this supports the article been summarized as Hildick-Smith and colleagues concluded that ischemic stroke rate was reduced by 67% compared to the predicted risk with the Amplatzer Amulet device (Hildick-Smith et al., 2020).
A number of key trials have compared the use of warfarin pharmacological therapy and implementation of LAAO device in preventing ischemic stroke/systemic thromboembolism; which LAAO has extensively been reported to be a reasonable alternative approach for preventing embolic events in patients with AF who are deemed not eligible for anticoagulation (Moussa et al., 2019).
That being the case, it is important to note that AHA/ACC guidelines have no recommendations for LAAO, yet the ESC guidelines have class IIb (B) recommendation for LAAO in patients with AF and contraindications for long-term anticoagulation. Also, Australian guidelines recommend considering LAAO in patients with non-valvular AF at moderate to high risk of stroke and with contraindications to OAC (Moussa et al., 2019). Nonetheless, LAAO efficacy may differ in outcomes of rate reduction of ischemic stroke, device associated thrombus, peri-device flow due to the geometric variability of the LAA ostium and/or use of LAAO devices* that differ in shape, size, indication, and implantation techniques (Moussa et al., 2019). All in all, among AF patients at high risk of bleeding and deemed not candidates for anticoagulation, warfarin therapy may be inferior to LAAO for prevention in stroke. However, clinical guidelines have yet to be developed on the use of LAAO which meets itself a range of factors related to the device and LAA ostium which could influence its efficacy and safety.
*Watchman device (only FDA approved device for LAAO), Percutaneous LAA Transcatheter Occlusion (PLAATO) device, and Amplatzer Cardiac Plug
Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study
David Hildick-Smith, Ulf Landmesser, A John Camm, Hans-Christoph Diener, Vince Paul, Boris Schmidt, Magnus Settergren, Emmanuel Teiger, Jens Erik Nielsen-Kudsk, Claudio Tondo on behalf of the Amulet Observational Study Investigators
Summary By: Adriana C. Mares - Founder & President, The Institute of Cardiology at El Paso
Overall Study Question:
What is the efficacy and safety of LAAO with Amplatzer™ Amulet™ device among patients with atrial fibrillation?
Study Summary:
Investigators conducted a prospective global observational cohort study that enrolled 1,088 patients with atrial fibrillation that were eligible for LAAO. Implant and 1-3 months post-LAAO transesophageal echocardiography (TEE) were performed and evaluated by a CoreLab. The primary endpoint was a composite of ischemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. The Kaplan–Meier method was used to calculate event rates at 2 years post-procedure for mortality, the composite of ischemic stroke, systemic embolism, and cardiovascular death, and device-related thrombus (DRT) (Mukherjee, 2020; Hildick-Smith et al., 2020).
Out of 1,088 patients aged 75.2 ± 8.5 years, 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants (OACs). Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone (Mukherjee, 2020; Hildick-Smith et al., 2020).
Closure measured by peridevice flow was <3 mm in 98.4% at follow-up TEE. DRT was seen in 1.6% of cases. Cardiovascular death or ischemic stroke occurred in 8.7% of patients at 2 years. The ischemic stroke rate was 2.2%/year—a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2) (Mukherjee, 2020; Hildick-Smith et al., 2020).
My Insights:
Despite oral anticoagulants been the gold-standard treatment for stroke prevention in patients with non-valvular AF, some patients can’t be treated with long term use of any form of OAC as it poses a risk for thromboembolic events based on CHADS2 or CHA2DS2-VASc scores and are contraindicated in patients who are at high risk for bleeding. Thus, this study investigated the safety and efficacy of LAAO with the Amplatzer Amulet occluder among patients that pose the aforementioned risks.
According to Hortsmann and colleagues, percutaneous LAAO could be an alternative stroke prevention; perhaps this supports the article been summarized as Hildick-Smith and colleagues concluded that ischemic stroke rate was reduced by 67% compared to the predicted risk with the Amplatzer Amulet device (Hildick-Smith et al., 2020).
A number of key trials have compared the use of warfarin pharmacological therapy and implementation of LAAO device in preventing ischemic stroke/systemic thromboembolism; which LAAO has extensively been reported to be a reasonable alternative approach for preventing embolic events in patients with AF who are deemed not eligible for anticoagulation (Moussa et al., 2019).
That being the case, it is important to note that AHA/ACC guidelines have no recommendations for LAAO, yet the ESC guidelines have class IIb (B) recommendation for LAAO in patients with AF and contraindications for long-term anticoagulation. Also, Australian guidelines recommend considering LAAO in patients with non-valvular AF at moderate to high risk of stroke and with contraindications to OAC (Moussa et al., 2019). Nonetheless, LAAO efficacy may differ in outcomes of rate reduction of ischemic stroke, device associated thrombus, peri-device flow due to the geometric variability of the LAA ostium and/or use of LAAO devices* that differ in shape, size, indication, and implantation techniques (Moussa et al., 2019). All in all, among AF patients at high risk of bleeding and deemed not candidates for anticoagulation, warfarin therapy may be inferior to LAAO for prevention in stroke. However, clinical guidelines have yet to be developed on the use of LAAO which meets itself a range of factors related to the device and LAA ostium which could influence its efficacy and safety.
*Watchman device (only FDA approved device for LAAO), Percutaneous LAA Transcatheter Occlusion (PLAATO) device, and Amplatzer Cardiac Plug
Figure 2. The AMPLATZER Cardiac Plug shown (a) mounted on its delivery catheter and (b) properly deployed at the ostium of the left atrial appendage. Reprinted from “Left Atrial Appendage Exclusion for Stroke Prevention in Atrial Fibrillation,” by T. K. Patel, 2012, Cardiology Research and Practice, 1–8.
References
Hildick-Smith, D., Landmesser, U., Camm, A. J., Diener, H.-C., Paul, V., Schmidt, B., … Tondo, C. (2020). Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study. European Heart Journal. https://doi.org/10.1093/eurheartj/ehaa169
Horstmann, S., Zugck, C., Krumsdorf, U., Rizos, T., Rauch, G., Geis, N., Hardt, S., & Veltkamp, R. (2014). Left atrial appendage occlusion in atrial fibrillation after intracranial hemorrhage. Neurology, 82(2), 135–138. https://doi.org/10.1212/WNL.0000000000000022
Moussa Pacha, H., Al-Khadra, Y., Soud, M., Darmoch, F., Moussa Pacha, A., & Alraies, M. C. (2019). Percutaneous devices for left atrial appendage occlusion: A contemporary review. World journal of cardiology, 11(2), 57–70. https://doi.org/10.4330/wjc.v11.i2.57
Mukherjee DP. LAAO With the Amplatzer Amulet Device. https://www.acc.org/latest-in-cardiology/journal-scans/2020/04/13/12/44/left-atrial-appendage-occlusion-with. Published April 13, 2020. Accessed April 17, 2020.
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Hildick-Smith, D., Landmesser, U., Camm, A. J., Diener, H.-C., Paul, V., Schmidt, B., … Tondo, C. (2020). Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study. European Heart Journal. https://doi.org/10.1093/eurheartj/ehaa169
Horstmann, S., Zugck, C., Krumsdorf, U., Rizos, T., Rauch, G., Geis, N., Hardt, S., & Veltkamp, R. (2014). Left atrial appendage occlusion in atrial fibrillation after intracranial hemorrhage. Neurology, 82(2), 135–138. https://doi.org/10.1212/WNL.0000000000000022
Moussa Pacha, H., Al-Khadra, Y., Soud, M., Darmoch, F., Moussa Pacha, A., & Alraies, M. C. (2019). Percutaneous devices for left atrial appendage occlusion: A contemporary review. World journal of cardiology, 11(2), 57–70. https://doi.org/10.4330/wjc.v11.i2.57
Mukherjee DP. LAAO With the Amplatzer Amulet Device. https://www.acc.org/latest-in-cardiology/journal-scans/2020/04/13/12/44/left-atrial-appendage-occlusion-with. Published April 13, 2020. Accessed April 17, 2020.
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