Left Atrial Appendage Occlusion During Cardiac Surgery: A 75-Year-Old Journey.

Journal of the American Heart Association(2023)

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HomeJournal of the American Heart AssociationVol. 12, No. 10Left Atrial Appendage Occlusion During Cardiac Surgery: A 75‐Year‐Old Journey Open AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citations ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toOpen AccessEditorialPDF/EPUBLeft Atrial Appendage Occlusion During Cardiac Surgery: A 75‐Year‐Old Journey Rajesh Kabra, Rakesh Gopinathannair and Dhanunjaya Lakkireddy Rajesh KabraRajesh Kabra *Correspondence to: Rajesh Kabra, MD, Kansas City Heart Rhythm Institute, 5100 W 110th St, Second Floor, Overland Park, KS 66211. Email: E-mail Address: [email protected] https://orcid.org/0000-0002-5118-2962 , Kansas City Heart Rhythm Institute, , Overland Park, , KS, , USA, Search for more papers by this author , Rakesh GopinathannairRakesh Gopinathannair https://orcid.org/0000-0003-4611-3687 , Kansas City Heart Rhythm Institute, , Overland Park, , KS, , USA, Search for more papers by this author and Dhanunjaya LakkireddyDhanunjaya Lakkireddy https://orcid.org/0000-0002-1492-2693 , Kansas City Heart Rhythm Institute, , Overland Park, , KS, , USA, Search for more papers by this author Originally published15 May 2023https://doi.org/10.1161/JAHA.123.030127Journal of the American Heart Association. 2023;12:e030127This article is a commentary on the followingCost Implications of Left Atrial Appendage Occlusion During Cardiac Surgery: A Cost Analysis of the LAAOS III TrialOther version(s) of this articleYou are viewing the most recent version of this article. Previous versions: May 15, 2023: Ahead of Print Atrial fibrillation (AF) is the most commonly seen arrhythmia in clinical practice, associated with a 5‐fold increased risk of stroke in the absence of anticoagulation.1 AF‐related strokes are associated with increased morbidity and mortality compared with strokes from other causes and represent a significant economic burden to the society.2Left atrial appendage (LAA) has been shown to be the most common source of thrombus formation and subsequent stroke/systemic embolism in patients with AF.3 There are several possible mechanisms that might contribute to pathophysiological features of LAA.4 AF leads to impairment of conduit function of LAA with decrease in LAA flow velocity, increased stagnation of blood, and resulting thrombus formation. AF predisposes to a prothrombotic state with endothelial dysfunction, activation of coagulation factors, and increased markers for platelet activation and aggregation. Persistent AF also leads to remodeling and fibrosis of left atrium, especially LAA, which may be a substrate for focal triggers or reentrant arrhythmias, which perpetuate AF.In patients with AF undergoing cardiac surgery, concomitant surgical LAA closure offers an option for stroke prevention strategy. Prophylactic surgical excision of LAA for stroke prevention was first reported by John Madden in 1948.5 Subsequently, in a case series of patients undergoing Cox‐Maze procedures for AF, which also included surgical excision of LAA, there was a significant decrease in the risk of stroke.6 Currently, there are multiple techniques for surgical LAA closure. These include epicardial suture, endocardial suture, ligation loops, resection and suture, surgical stapler, or closure devices, like AtriClip.7 The main challenge with several of these techniques has been to ensure long‐term LAA exclusion. Incomplete surgical ligation and presence of LAA stump were noted to be independent risk factors for stroke and systemic thromboembolism in patients with AF, independent of conventional risk stratification scores.8 Epicardial and endocardial suture techniques are associated with high rates of incomplete occlusion and residual flow through the suture line into the LAA. The LAAOS (Left Atrial Appendage Occlusion) I pilot study randomized patients with AF having risk factors for stroke who were undergoing coronary artery bypass grafting to LAA occlusion using either suture technique or stapler versus control. Complete LAA occlusion was achieved in only 45% (5/11) of the patients using suture and in 72% (24/33) using a stapler.9 In the LAAOS II study, complete LAA occlusion was achieved in all the patients with either amputation and closure technique or stapler technique.10The LAAOS III study was a multicenter randomized study to assess if LAA closure during cardiac surgery for another indication in patients with AF with a congestive heart failure, hypertension, age ≥75 (2 points), diabetes, stroke (2 points), vascular disease, age 65 to 74 and sex category (female) (CHA2DS2‐VASc) score of ≥2 reduces the risk of ischemic transient ischemic attack/stroke or systemic embolism.11 Of the total study population, 2379 patients were randomized to LAA occlusion group and 2391 patients were randomized to no‐occlusion group. The patients, research personnel, and providers (other than the surgeons) were blinded to the treatment arm. The mean age of patients was 71 years, and the mean CHA2DS2‐VASc score was 4.2. Although continuous anticoagulation was recommended in both the groups, only 76.8% of the patients in both the groups stayed on anticoagulation at 3 years. Over a mean period of 3.8 years of follow‐up, stroke or systemic embolism occurred in 114 patients (4.8%) in the occlusion group versus 168 patients (7.0%) in the no‐occlusion group (hazard ratio [HR], 0.67 [95% CI, 0.53–0.85]; P=0.001). After excluding the first 30 days after surgery (which are known to be associated with higher risk of stroke), the primary outcome was 2.7% in the occlusion group versus 4.6% in the nonocclusion group (HR, 0.58 [95% CI, 0.42–0.80]). There was no significant difference in the initial hospital length of stay, incidence of perioperative bleeding, heart failure, or death.In the current study published in this issue of the Journal of the American Heart Association (JAHA), Eqbal et al used the LAAOS III study data to assess the cost implications of LAA occlusion during the surgery from the perspective of Centers for Medicare and Medicaid Services.12 The average cost of LAA occlusion per patient in the study was compared with the Medicare/Centers for Medicare and Medicaid Services reimbursement of the cardiovascular events for all participants in the study. The authors hypothesized that the concomitant LAA occlusion would be either cost saving or cost neutral compared with no LAA occlusion. They used US unit costs for LAA occlusion materials as well as the diagnosis‐related group reimbursements to all hospitalized events during the study. LAA occlusion was performed by any of the following techniques: cut and sew (55.7%), stapler (11.2%), closure device (15.1%), closure from within (13.8%), or other approved suture‐based techniques (4.1%). The authors reported that total cost per participant was $3878 in the LAA occlusion group versus $4490 in the nonocclusion group, which is a mean difference of −$612 (95% CI, −$1276 to $45). A reduction in stroke was the primary driver for the cost saving in the LAA occlusion group. Cost saving with LAA occlusion was noted in all the subgroup analysis, including men, women, age <72 years, age ≥72 years, CHA2DS2‐VASc score ≤4, CHA2DS2‐VASc score >4, concomitant valve procedure, and other concomitant procedures. In the sensitivity analyses, suture and stapler techniques for LAA occlusion resulted in cost saving, but LAA occlusion with closure device was more expensive. The authors concluded that concomitant LAA occlusion in patients with AF with a CHA2DS2‐VASc score of ≥2 undergoing cardiac surgery was more cost saving than no LAA occlusion.In the LAAOS III study, most of the patients underwent cut‐and‐sew technique, closure devices, or staplers. However, 4.1% of the patients had suture‐based LAA occlusion, which has historically been associated with increased reconnection rates. The authors did not report the effectiveness of each individual technique in attaining long‐term LAA occlusion and stroke prevention. Further randomized studies are needed to determine the efficacy of these techniques in achieving long‐term LAA isolation and stroke prevention. The authors only included the direct costs to the health care systems and not the indirect costs, like out‐of‐hospital patient costs, cost for patient rehabilitation, as well as other nonmedical costs (loss of productivity for the patients as well the caregivers). The costs associated with the cardiac surgery outside LAA occlusion were not included as they were not influenced by the intervention. The mean bypass time was only 5 minutes more (95% CI, 3–8 minutes) in LAA occlusion group and hence no additional cost to the extra time was included.Although LAA closure with percutaneous devices offers an alternative to oral anticoagulation, LAAOS III study was not designed to offer surgical LAA occlusion as an alternative to anticoagulation. All the patients were required to continue oral anticoagulation following the cardiac surgery and surgical occlusion, as in the control group with no LAA occlusion. Oral anticoagulation is associated with an increase in bleeding risk, and the direct oral anticoagulants are often more expensive than warfarin. Surgical LAA occlusion during concomitant cardiac surgery might be an economically more cost‐saving option, if it completely replaces oral anticoagulation. Future randomized studies are needed to address the following questions to advance the field of surgical exclusion of LAA. Which surgical LAA occlusion technique is most efficacious at long‐term LAA closure in patients with AF without leaving significant stump and has best long‐term outcomes of stroke reduction, mortality benefits, decreased arrhythmias, and economic advantages?Can the surgical LAA exclusion eliminate the need for long‐term anticoagulation in patients with AF with high CHA2DS2‐VASc scores?How does stand‐alone surgical LAA exclusion compare with percutaneous LAA closure in terms of arrhythmia burden, stroke prevention, and anticoagulation discontinuation?Is there any prophylactic role of concomitant surgical LAA exclusion in patients without AF undergoing cardiac surgery?Stroke is a devastating complication of AF, and stroke prevention is the cornerstone of AF management. American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines recommend anticoagulation for stroke prevention in the high‐risk patients with AF, based on the CHA2DS2‐VASc score.13 Percutaneous LAA closure has class IIb recommendation in patients with AF at increased risk of stroke who have contraindications to long‐term anticoagulation. Surgical occlusion of the LAA has a class IIb recommendation for patients with AF undergoing cardiac surgery. The current study by Eqbal et al is an important step in the field of surgical exclusion of LAA, demonstrating the economic benefit of this treatment. Using LAAOS III study database, the authors concluded that concomitant surgical LAA occlusion during cardiac surgery in patients with AF with a CHA2DS2‐VASc score of ≥2 is economically advantageous based on number of strokes prevented. In the subgroup analysis, the economic advantage was seen with use of the cut‐and‐sew technique as well as stapler but not with closure device. However, inclusion of indirect costs associated with stroke (rehabilitation cost and loss of productivity to patient and caregivers) may possibly make all the closure options economically advantageous. Finally, there may be significantly more cost savings if future randomized clinical studies demonstrate that anticoagulation can be safely discontinued after receiving surgical AF exclusion.DisclosuresDr Kabra is a consultant for Volta Medical. Dr Gopinathannair is a consultant for Abbott Medical, is a speaker for Sanofi, and is on the Medical Advisory Board for Pacemate. Dr Lakkireddy is a consultant for Abbott, Acutus, AltaThera, Boston Scientific, Biosense Webster, and Medtronic.Footnotes*Correspondence to: Rajesh Kabra, MD, Kansas City Heart Rhythm Institute, 5100 W 110th St, Second Floor, Overland Park, KS 66211. Email: rajesh.kabra@hcahealthcare.comThis article was sent to Saket Girotra, MD, SM, Associate Editor, for editorial decision and final disposition.See Article by Eqbal et al.For Disclosures, see page 3.REFERENCES1 Tsao CW, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker‐Smith CM, Beaton AZ, Boehme AK, Buxton AE, et al. Heart disease and stroke statistics‐2023 update: a report from the American Heart Association. Circulation.2023; 147:e93–e621. doi: 10.1161/CIR.0000000000001123LinkGoogle Scholar2 Li X, Tse VC, Au‐Doung LW, Wong ICK, Chan EW. The impact of ischaemic stroke on atrial fibrillation‐related healthcare cost: a systematic review. Europace.2017; 19:937–947. doi: 10.1093/europace/euw093CrossrefMedlineGoogle Scholar3 Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996; 61:755–759. doi: 10.1016/0003-4975(95)00887-XCrossrefMedlineGoogle Scholar4 Di Biase L, Natale A, Romero J. 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Left atrial appendage occlusion during cardiac surgery to prevent stroke. N Engl J Med.2021; 384:2081–2091. doi: 10.1056/NEJMoa2101897CrossrefMedlineGoogle Scholar12 Eqbal A, Tong W, Lamy A, Belley‐Cote E, Paparella D, Bogachev‐Prokophiev A, Royse AG, Reents W, Deveraux PJ, Brady K, et al. Cost implications of left atrial appendage occlusion during cardiac surgery: a cost analysis of the LAAOS III trial. J Am Heart Assoc.2023. doi: 10.1161/JAHA.122.028716LinkGoogle Scholar13 January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, 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. Circulation.2019; 140:e125–e151. doi: 10.1161/CIR.0000000000000665LinkGoogle Scholar eLetters(0)eLetters should relate to an article recently published in the journal and are not a forum for providing unpublished data. Comments are reviewed for appropriate use of tone and language. Comments are not peer-reviewed. Acceptable comments are posted to the journal website only. Comments are not published in an issue and are not indexed in PubMed. Comments should be no longer than 500 words and will only be posted online. References are limited to 10. Authors of the article cited in the comment will be invited to reply, as appropriate.Comments and feedback on AHA/ASA Scientific Statements and Guidelines should be directed to the AHA/ASA Manuscript Oversight Committee via its Correspondence page.Sign In to Submit a Response to This Article Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesCost Implications of Left Atrial Appendage Occlusion During Cardiac Surgery: A Cost Analysis of the LAAOS III TrialAdam Eqbal, et al. Journal of the American Heart Association. 2023;12 May 16, 2023Vol 12, Issue 10 Article InformationMetrics Copyright © 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley BlackwellThis is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.https://doi.org/10.1161/JAHA.123.030127PMID: 37183870 Originally publishedMay 15, 2023 KeywordsEditorialsatrial fibrillationleft atrial appendage closurestrokePDF download SubjectsAtrial FibrillationCardiovascular SurgeryCost-Effectiveness
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atrial appendage occlusion,left atrial appendage,cardiac surgery
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