HowToTreat Archive - The Cardiology Advisor Thu, 31 Mar 2022 19:18:07 +0000 en-US hourly 1 https://wordpress.org/?v=6.1.3 https://www.thecardiologyadvisor.com/wp-content/uploads/sites/17/2022/10/cropped-android-chrome-512x512-1-32x32.png HowToTreat Archive - The Cardiology Advisor 32 32 Treatment Options Beyond Statins in Drug-Resistant Hypercholesterolemia https://www.thecardiologyadvisor.com/howtotreat/treatment-options-beyond-statins-in-drug-resistant-hypercholesterolemia/ Thu, 31 Mar 2022 19:07:07 +0000 https://www.thecardiologyadvisor.com/?post_type=howtotreat&p=84712 Treatment guidelines for hypercholesterolemia vary. This article reviews the current understanding and management of drug-resistant hypercholesterolemia.

The post Treatment Options Beyond Statins in Drug-Resistant Hypercholesterolemia appeared first on The Cardiology Advisor.

]]> By Clinical Content Hub

Hypercholesterolemia is linked to the development of atherosclerotic cardiovascular disease (ASCVD) and high levels of low-density lipoprotein cholesterol (LDL-C) are a primary contributor.1 The leading cause of global morbidity and mortality is ASCVD, which includes acute coronary syndrome, myocardial infarction, and atherogenic ischemic stroke.2

Causes of Hypercholesterolemia

Familial hypercholesterolemia is caused by an autosomal-dominant mutation affecting one of several genes involved in the breakdown of cholesterol.4 Heterozygous familial hypercholesterolemia (HeFH) results when a patient inherits one mutation from a parent, whereas homozygous familial hypercholesterolemia (HoFH) occurs when a patient inherits a genetic mutation from each parent. One 1 of every 400,000 individuals will be diagnosed with HoFH and if untreated, it can lead to ASCVD in teenagers.3,6
 
For patients with familial and nonfamilial hypercholesterolemia, the risk of developing ASCVD or the severity of existing ASCVD drives patient treatment goals. The risk of existing ASCVD is calculated based on a person’s levels of LDL-C and total cholesterol in addition to contributing factors like age, sex, and the presence of hypertension and diabetes mellitus. However, risk calculators may over or underestimate the risk for ASCVD because of chronic inflammatory conditions and racial and socioeconomic factors.2

Treatment of Hypercholesterolemia

Treatment guidelines for hypercholesterolemia vary. For example, the 2020 American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) guidelines recommend an LDL-C goal as low as 55 mg/dL for patients with progressive ASCVD,7 whereas the American Heart Association/American College of Cardiology (AHA/ACC) guidelines recommend an LDL-C goal of less than 70 mg/dL for those same patients.1 Clinicians should weigh the risk vs benefit of aggressive treatment in each patient.
 
Statin therapy is the cornerstone of drug treatment for hypercholesterolemia. Unfortunately, despite statin treatment, many patients remain above their guideline-recommended LDL-C goal. The adverse effects of statins can often be dose-limiting, which can minimize the benefit of therapy. Patients who can tolerate high-intensity statin dosing may still struggle to reach their treatment goals if their baseline levels of LDL-C were high before initiation of therapy. In this case, treatment with one or more additional medications is recommended to further reduce LDL-C.

Oral Treatment Options

Several oral therapy options are available for patients with hypercholesterolemia resistant to maximally-tolerated statin dosing. Commonly used in conjunction with statins, these agents may also be used concurrently with each other. All treatment options should be provided as an adjunct to a healthy diet.
 
Ezetimibe. Ezetimibe is a first-line therapy addition to statin treatment. It has minimal adverse effects and lowers LDL-C approximately 13% to 20% by inhibiting the intestinal absorption of cholesterol.1 In the IMPROVE-IT trial (ClinicalTrials.gov Identifier: NCT00202878), patients with acute coronary syndrome who received ezetimibe plus a statin had lower LDL-C and improved cardiovascular outcomes compared with patients who received statin monotherapy.8
 
Bempedoic acid. Bempedoic acid inhibits cholesterol biosynthesis in the liver and was approved by the US Food and Drug Administration in 2020.9 Indicated as adjunct therapy for patients diagnosed with HeFH or established ASCVD, bempedoic acid lowers LDL-C by 27% to 30%,10 and a fixed-dose combination with ezetimibe can lower LDL-C by approximately 40%.11
 
Bempedoic acid is recommended in the 2020 AACE/ACE algorithm for the management of dyslipidemia,7 but cardiovascular morbidity and mortality in patients treated with the drug are still under investigation (ClinicalTrials.gov Identifier: NCT02993406). Additionally, patients with a history of tendon disorders should avoid the drug, and uric acid levels should be monitored, especially in patients with gout.9
 
Lomitapide. Lomitapide reduces LDL-C by around 40% in patients with HoFH when used in conjunction with statin therapy.12 There is a risk for hepatotoxicity associated with the drug, so prescribing providers and patients must be registered with a Risk Evaluation and Mitigation Strategy (REMS) program.
 
Injectable Treatment Options
 
The development of injectable treatment options for drug-resistant hypercholesterolemia is rapidly expanding, and clinical practice guidelines do not include the most recently available medications.1,7 For all injectable therapies, the lack of long-term safety information and the high cost are currently the largest barriers to implementation.
 
Alirocumab and Evolovumab. Proprotein convertase subtilisin/kexin type 9 (PCSK9) regulates cholesterol metabolism.13 Alirocumab and evolocumab are monoclonal antibodies delivered by subcutaneous injection that increase the clearance of LDL-C by inhibiting PCSK9. In addition to lowering LDL-C by 50% to 60%, both alirocumab and evolocumab significantly reduce cardiovascular events in patients with ASCVD.13,14
 
The 2018 AHA/ACC clinical guidelines recommend the addition of a PCSK9 inhibitor when a patient fails to meet an LDL-C target despite a maximally tolerated statin dose plus ezetimibe. The preference for adding ezetimibe before a PCSK9 inhibitor is primarily driven by cost.1
 
Evinacumab. Given as a monthly intravenous infusion for patients with HoHF,6 evinacumab is a monoclonal antibody that enables a faster breakdown of fats in the body. Evinacumab reduces LDL-C by approximately 49% and should be added to a maximally tolerated statin dose with or without ezetimibe.15
 
Inclisiran. Unlike other injectable products, inclisiran is not a monoclonal antibody. Inclisiran is a small interfering RNA molecule that disrupts the production of PCSK9 in the liver.16 It is indicated as adjunct therapy for patients with HeFH or established ASCVD.17
 
A reduction in LDL-C of at least 50% places inclisiran on par with the efficacy of alirocumab and evolocumab.15 One notable difference is the frequency of administration. Alirocumab and evolocumab require a subcutaneous injection every 2 to 4 weeks,13,14 whereas inclisiran is administered as a subcutaneous injection as an initial dose, at 3 months, and every 6 months thereafter.17 The minimal burden of treatment could have a large impact on therapy adherence. Inclisiran is the newest therapeutic option on the market for the treatment of hypercholesterolemia.
 
Lipoprotein Apheresis
 
Lipoprotein apheresis, which removes lipoproteins by precipitation, filtration, or adsorption, is the last-resort option for the management of hypercholesterolemia despite treatment with a statin and ezetimibe. Lipoprotein apheresis is reserved for patients with HoFH or HeFH.18 Each weekly or biweekly session reduces LDL-C by approximately 50% to 70%.19 Limited apheresis centers and the large time commitment create barriers to use.
 
The development of alirocumab, evolocumab, and lomitapide have enabled patients to reduce the frequency of lipoprotein apheresis or cease the therapy entirely.19-21 Although patients receiving lipoprotein apheresis were included in trials for evinacumab, additional research is needed to understand the impact evinacumab could have on the frequency and necessity of lipoprotein apheresis.15

Which adjunct medications can reduce LDL-C by ≥45%?
Flip
Alirocumab, evolocumab, evinacumab, and inclisiran reduce LDL-C by ≥45%.

Putting It All Together

The 2018 AHA/ACC and the 2020 AACE/ACE guidelines agree that ezetimibe should be the first addition when statin monotherapy is insufficient.1,7 Beyond that, there is less guidance as drug development has provided several new therapy options.

Decisions on the escalation of therapy require a multifactorial approach. Factors such as the extent of additional LDL-C lowering required, patient preference of route of administration, risk of long-term adverse events, and cost must all be considered when selecting the next line of therapy appropriate for each individual patient.
 
Patients with HoFH have additional options such as evinacumab or lomitapide but may have a reduced or negligible response to PCSK9 inhibitors depending on the genetic mutations present.20

To help patients reach their LDL-C goals, clinicians should consider reviewing all the new medication options available and working with patients to determine the most appropriate option.

References

1. Grundy S, Stone N, Bailey A, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guideline. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.0000000000000625
 
2. Arnett D, Blumenthal R, Albert M, et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11):e596-e646. doi:10.1161/CIR.0000000000000678
 
3. Tsao C, Aday A, Almarzooq Z, et al; on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics – 2022 update: a report from the American Heart Association. Circulation. 2022;145(8):e153-e639. doi:10.1161/CIR.0000000000001052
 
4. Beheshti S, Madsen C, Varbo A, Nordestgaard B. Worldwide prevalence of familial hypercholesterolemia: meta-analysis of 11 million subjects. J Am Coll Cardiol. 2020;75(20):2553–2566. doi:10.1016/j.jacc.2020.03.057
 
5. Stanaway J, Afshin A, Gakidou E, et al. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159): 1923-1994. doi:10.1016/S0140-6736(18)32225-6
 
6. FDA approves add-on therapy for patients with genetic form of severely high cholesterol. US Food and Drug Administration. Updated April 1, 2021. Accessed February 19, 2022. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-add-therapy-patients-genetic-form-severely-high-cholesterol
 
7. Handelsman Y, Jelllinger P, Guerin C, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the management of dyslipidemia and prevention of cardiovascular disease algorithm – 2020 executive summary. Endocr Pract. 2020;26(10):1196-1224. doi:10.4158/CS-2020-0490
 
8. Cannon C, Blazing M, Giugliano R, et al; for the IMPROVE-IT Investigators. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015;372:2387-2397. doi:10.1056/NEJMoa1410489
 
9. Nexletol. Prescribing information. Esperion Therapeutics, Inc; 2020. Accessed March 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211616s000lbl.pdf
 
10. Thompson PD, MacDougall DE, Newton RS, et al. Treatment with ETC-1002 alone and in combination with ezetimibe lowers LDL cholesterol in hypercholesterolemic patients with or without statin intolerance. J Clin Lipidol. 2016;10(3):556-567. doi:10.1016/j.jacl.2015.12.025
 
11. Ballantyne CM, Laufs U, Ray KK, et al. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2020;27(6):593-603. doi:10.1177/2047487319864671
 
12. Alonso R, Cuevas A, Mata P. Lomitapide: a review of its clinical use, efficacy, and tolerability. Core Evid. 2019;14:19-30. doi:10.2147/CE.S174169
 
13. Sabatine MS, Giugliano RP, Keech AC, et al; for the FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376(18):1713-1722. doi:10.1056/NEJMoa1615664
 
14. Schwartz GG, Steg PG, Szarek M, et al; for the ODYSSEY OUTCOMES Committee and Investigators. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018;379(22):2097-2107. doi:10.1056/NEJMoa1801174
 
15. Raal F, Rosenson R, Reeskamp L, et al; for the ELIPSE HoFH Investigators. Evinacumab for homozygous familial hypercholesterolemia. N Engl J Med. 2020;383:711-720. doi:10.1056/NEJMoa2004215
 
16. Ray K, Landmesser U, Leiter L, et al. Inclisiran in patients at high cardiovascular risk with elevated LDL cholesterol. N Engl J Med. 2016;376:1430-1440. doi:10.1056/NEJMoa1615758
 
17. Leqvio. Prescribing information. Novartis Pharmaceuticals; 2021. Accessed March 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214012lbl.pdf
 
18. Baum S, Sampietro T, Datta D, et al. Effect of evolocumab on lipoprotein apheresis requirement and lipid levels: results of the randomized, controlled, open-label DE LAVAL study. J Clin Lipidol. 2019;13(6):901-909. doi:10.1016/j.jacl.2019.10.003
 
19. Kayikcioglu M. LDL apheresis and Lp (a) apheresis: a clinician’s perspective. Curr Atheroscler Rep. 2021;23(15). doi:10.1007/s11883-021-00911-w
 
20. Stefanutti C, Julius U, Watts G, et al; and the MIGHTY MEDIC Multinational Society. Toward an international consensus- integrating lipoprotein apheresis and new lipid-lowering drugs. J Clin Lipidol. 2017;11(4):858-871.e3. doi:10.1016/j.jacl.2017.04.114
 
21. Moriarty P, Parhofer K, Babirak S, et al. Alirocumab in patients with heterozygous familial hypercholesterolemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial. Eur Heart J. 2016;37(48):3588-3595. doi:10.1093/eurheartj/ehw388
 
22. Zetia. Prescribing information. Merck/Schering-Plough Pharmaceuticals; 2007. Accessed March 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21445lbl.pdf
 
23. Juxtapid. Prescribing information. Aegerion Pharmaceuticals, Inc; 2012. Accessed March 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203858s000lbl.pdf
 
24. Praluent. Prescribing information. Regeneron, Inc.; 2015. Accessed March 3, 2022. https://www.regeneron.com/downloads/praluent_pi.pdf
 
25. Repatha. Prescribing information. Amgen Inc.; 2021. Accessed March 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125522s029s031lbl.pdf
 
26. Evkeeza. Prescribing information. Regeneron Pharmaceuticals, Inc.; 2021. Accessed March 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761181s000lbl.pdf
 
Posted by Haymarket’s Clinical Content Hub. The editorial staff of Cardiology Advisor had no role in this content’s preparation.

Reviewed March 2022

The post Treatment Options Beyond Statins in Drug-Resistant Hypercholesterolemia appeared first on The Cardiology Advisor.

]]> Left Atrial Appendage Closure for Stroke Risk Reduction in Nonvalvular Atrial Fibrillation https://www.thecardiologyadvisor.com/howtotreat/left-atrial-appendage-closure-for-stroke-risk-reduction-in-nonvalvular-atrial-fibrillation/ Mon, 08 Nov 2021 10:00:00 +0000 https://www.thecardiologyadvisor.com/?post_type=howtotreat&p=79726 Atrial fibrillation (AF) is the most clinically significant arrhythmia in clinical practice. This article discusses minimally invasive left atrial appendage closure for stroke risk reduction in nonvalvular AF.

The post Left Atrial Appendage Closure for Stroke Risk Reduction in Nonvalvular Atrial Fibrillation appeared first on The Cardiology Advisor.

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By Clinical Content Hub

By 2030, an estimated 12.1 million people in the United States will experience atrial fibrillation (AF).1 Globally, AF is the most clinically significant arrhythmia seen in clinical practice, and its prevalence has been increasing, owing to the aging population.2 The 2019 estimated global burden of AF was 59.7 million patients, which represents a 2-fold increase in cases over the past 30 years.3 Although the use of oral anticoagulation (OAC) has increased with the development of direct oral anticoagulants (DOACs),2 a large subset of patients with AF still have absolute or relative contraindications to OAC and are at increased risk for stroke.

The risk of ischemic stroke in patients with AF is 5 times that of those without AF,1 and more than 90% of AF-related ischemic strokes originate in the left atrial appendage (LAA).5 The preferred therapy for prevention of AF stroke is OAC, but occlusion of the LAA via minimally invasive device implantation is a reasonable alternative in patients for whom long-term OAC treatment is inappropriate.6

To occlude the LAA, a delivery catheter is inserted into the femoral vein and guided to the right atrium of the heart. The atrial septum is pierced, allowing the catheter to reach the left atrium. The device is deployed at the opening of the LAA, where it opens like an umbrella and occludes the remainder of the appendage. Within approximately 45 days, a thin layer of tissue has grown around and covered the occlusion device, which remains permanently in place.7 

Who Benefits From Left Atrial Appendage Occlusion (LAAO)?

Treatment with LAAO is ideal for patients with nonvalvular AF with a CHADS2 score of 2 or greater or patients with a CHA2DS2-VASc score of 3 or greater who are not good candidates for long-term OAC.6 The CHADS2  score ranges from 0 to 6 and assigns 1 point each for the presence of congestive heart failure, hypertension, age 75 years and older, and diabetes mellitus, and 2 points for the presence of stroke/transient ischemic attack. The CHA2DS2-VASc score encompasses congestive heart failure, hypertension, age 75 years and older (doubled), diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism (doubled), vascular disease, age 65 to 74 years, and female vs male sex category.6 Nonpharmacologic alternatives to OAC may be preferred for patients with a history of bleeding or risk of bleeding, advanced renal failure, high risk of falls, and a risk of drug-drug interactions, or when there are concerns about adherence to therapy.5

Not all patients benefit from LAAOs, however, and it is important for clinicians to differentiate between LAA stroke risk vs overall stroke risk when identifying patients who would benefit from LAAO. For example, a patient with risk factors for cardioembolic stroke, such as a complex aortic plaque, would still have a high risk of stroke despite undergoing LAAO; likewise, a patient who requires OAC for an indication independent of AF would still require OAC after device implantation.8 Although such patients may benefit from LAAO, risk-benefit evaluations can be complicated.9

Devices Approved by the US Food and Drug Administration

The Watchman LAA closure device (Boston Scientific Corporation) demonstrated noninferiority to warfarin for the composite outcome of stroke, systemic embolism, and cardiovascular death and was associated with a large decrease in the rate of hemorrhagic stroke.10 The Watchman was also one of several LAAO devices found to be noninferior to DOACs.11

The Watchman device is approved for patients for treatment with OAC is recommended and considered suitable,7 as initial enrollments in the pivotal trials did not include patients with OAC contraindications. The ongoing ASAP-TOO trial (ClinicalTrials.gov Identifier: NCT02928497) will assess the safety and effectiveness of the Watchman in patients for whom OAC is contraindicated.12 Most recently, the FDA approved the Watchman FLX, the frame shape of which is different from that of the original product.7

The Amplatzer Amulet LAA occluder device (Abbott) was approved by the FDA in August 2021 after demonstrating noninferiority to the Watchman device.13 Study inclusion criteria differed from those of the original Watchman device trials, and the FDA approval statement only specifies that patients must be able to tolerate short-term OAC.

Medication Management Following Implantation

Medication management following implantation can vary by patient and device. The PROTECT-AF (ClinicalTrials.gov Identifier: NCT00129545) and PREVAIL (ClinicalTrials.gov Identifier: NCT01182441) trials evaluating the Watchman device used warfarin and aspirin for 45 days, followed by clopidogrel plus aspirin for 6 months, followed by aspirin only indefinitely.8 Recently, postprocedural use of DOACs was found to be noninferior to warfarin, giving healthcare providers more freedom to choose the appropriate regimen for a particular patient.14

For patients undergoing LAAO with the Amplatzer Amulet device, medication management following the procedure is similar to that of the Watchman device. Alternatively, patients may be placed immediately on a dual antiplatelet regimen of clopidogrel and aspirin for the first 6 months and switched to monotherapy with aspirin thereafter (ClinicalTrials.gov Identifier: NCT02879448).15

Risks of left atrial appendage closure
Flip
During the Watchman clinical trials, a small percentage of people experienced stroke, clots around the device, or pericardial effusion.

LAAO Device Complications

Overall complication rates associated with LAAO therapy have declined since the approval of the Watchman device, because the implantation procedure has been modified to minimize hazards.16 That said, LAAO is not without risk. In a recently published study comparing LAAO with the Amplatzer Amulet device vs the Watchman device for stroke prophylaxis, major bleeding events and device-related thrombosis were observed in approximately 10% and 4% of patients, respectively, independent of the device used.15 Although pericardial effusion is a risk with either device, use of the Amplatzer Amulet was associated with a notably higher rate of development of pericardial effusion more than 2 days after the procedure (1.9% vs 0.4% with use of the Watchman device).13

A recent evaluation of data on more than 49,000 patients in the National Cardiovascular Data Registry LAAO Registry who underwent LAAO with the Watchman device highlighted alarming differences in procedural outcomes based on patient sex; women were twice as likely to experience major bleeding and pericardial effusion, and were more likely than men to have a longer hospital stay or die.17 The FDA released a letter to healthcare providers stating that the agency believes the benefits of LAAO continue to outweigh its risks, but that the FDA would work with device manufacturers to gain a better understanding of the issue.18 Because only the original Watchman device was evaluated,18 it is currently unknown whether the Watchman FLX and Amplatzer Amulet devices pose similar risks to women.

Despite these risks and possible complications, LAAO procedures using the Watchman, Watchman FLX, or Amplatzer Amulet device represent a safe and effective alternative to OAC for stroke prevention in patients with nonvalvular AF. Clinicians should assess individual risks of stroke and bleeding, well as other possible OAC-related concerns, to identify patients most likely to benefit from LAAO.

References

1. Atrial fibrillation. Centers for Disease Control and Prevention website. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm Updated September 27, 2021. Accessed October 20, 2021.

2. Freedman B, Hindricks G, Banerjee A, et al. World Heart Federation roadmap on atrial fibrillation – a 2020 update. Global Heart. 2021;16(1):41. doi:10.5334/gh.1023

3. Kornej J, Benjamin EJ, Magnani JW. Atrial fibrillation: global burdens and global opportunities. Heart. 2021;107:516-518. doi:10.1136/heartjnl-2020-318480

4. Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of atrial fibrillation in the 21st century: novel methods and new insights. Circ Res. 2020;127(1):4-20. doi:10.1161/CIRCRESAHA.120.316340

5. Holmes Jr DR, Alkhouli M, Reddy V. Left atrial appendage occlusion for the unmet clinical needs of stroke prevention in non-valvular atrial fibrillation. Mayo Clin Proc. 2019;94(5):P864-874. doi:10.1016/j.mayocp.2018.09.025

6. January CT, Wann LS, Calkins H, et al. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in collaboration with the Society of Thoracic Surgeons. Circ. 2019;140(2):e125-e151. doi:10.1161/CIR.0000000000000665

7. US Food and Drug Administration. WATCHMAN left atrial appendage closure device with delivery system and WATCHMAN FLX left atrial appendage closure device with delivery system – P130013/S035. Updated August 11, 2020. Accessed October 20, 2021.

8. Valderrabano M. Left atrial appendage occlusion: indications and expectations. Presented at: Southwest Valve Summit; October 5-6, 2018; Houston, Texas.

9. Boersma LV, Ince H, Kische S, et al, for the EWOLUTION investigators. Evaluating real-world clinical outcomes in atrial fibrillation patients receiving the Watchman left atrial appendage closure technology: final 2-year outcome data of the EWOLUTION trial focusing on history of stroke and hemorrhage. Circ Arrhythm Electrophysiol. 2019;12(4):e006841. doi:10.1161/CIRCEP.118.006841

10. Reddy VY, Doshi SK, Kar S, et al. 5-Year Outcomes After Left Atrial Appendage Closure: from the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 201719;70(24):2964-2975. doi:10.1016/j.jacc.2017.10.021

11. Diener HC, Landmesser U. Percutaneous left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation. Future Neurol. Published online July 3, 2020. doi:10.2217/fnl-2020-0001

12. Assessment of the WATCHMAN device in patients unsuitable for oral anticoagulation (ASAP-TOO). ClinicalTrials.gov Identifier: NCT02928497. Updated March 26, 2021. Accessed October 20, 2021. https://clinicaltrials.gov/ct2/show/NCT02928497

13. US Food and Drug Administration. PMA P200049: FDA Summary of Safety and Effectiveness Data. Amplatzer™ Amulet™ Left Atrial Appendage Occluder.  Updated October 4, 2021. Accessed October 20, 2021.

14. Fry E, Bollempali H, Suarez K, Banchs J, Michel J. Watchman outcomes comparing post-implantation anticoagulation with warfarin versus direct oral anticoagulants. J Interv Card Electrophysiol. 2021;61:137-144. doi:10.1007/s10840-020-00790-2

15. Lakkireddy D, Thaler D, Ellis C, et al. AmplatzerTM AmuletTM left atrial appendage occluder vs WatchmanTM device for stroke prophylaxis (AMULET IDE): a randomized controlled trial. Circ. Published online August 30, 2021. doi:10.1161/CIRCULATIONAHA.121.057063

16. Sawant AC, Seibolt L, Sridhara S, et al. Operator experience and outcomes after transcatheter left atrial appendage occlusion with the Watchman device. Cardiovasc Revascularization Med. 2020;21(4):467-472. doi:10.1016/j.carrev.2019.08.001

17. Darden D, Duong T, Du C, et al.  Sex differences in procedural outcomes among patients undergoing left atrial appendage occlusion: insights from the NDCR LAAO registry. JAMA Cardiol. Published online August 11, 2021. doi:10.1001/jamacardio.2021.3021

18. US Food and Drug Administration. Left atrial appendage occlusion (LAAO) devices potentially associated with procedural outcome differences between women and men – letter to health care providers. Updated September 27, 2021. Accessed October 20, 2021.

Posted by Haymarket’s Clinical Content Hub. The editorial staff of Cardiology Advisor had no role in this content’s preparation.

Reviewed November 2021

The post Left Atrial Appendage Closure for Stroke Risk Reduction in Nonvalvular Atrial Fibrillation appeared first on The Cardiology Advisor.

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