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Device Evaluation

Percutaneous Left Atrial Appendage Closure for Cerebrovascular Accident Prevention: rationale, indications, Technical aspects, Clinical Results and Future Perspective

, , , , , , & show all
Pages 237-250 | Received 05 Dec 2019, Accepted 21 Feb 2020, Published online: 26 Mar 2020

References

  • Go AS , HylekEM, PhilipsKAet al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA, 285, 2370–2375 (2001).
  • Wolf PA , AbbottRD, KannelWB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke, 22, 983–988 (1991).
  • Coppens M , EikelboomJW, HartRGet al. The CHA2DS2-VASc score identifies those patients with atrial fibrillation and a CHADS2 score of 1 who are unlikely to benefit from oral anticoagulant therapy. Eur. Heart J., 34, 170–176 (2013).
  • Kirchhof P , BenussiS, KotechaDet al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace, 18, 1609–1678 (2016).
  • Gage BF , WatermanAD, ShannonWet al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA, 285, 2864–2870 (2001).
  • Pisters R , LaneDA, NieuwlaatR, de VosCB, CrijnsHJ, LipGY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest, 138, 1093–1100 (2010).
  • Olesen JB , LipGY, LindhardsenJet al. Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: a net clinical benefit analysis using a ‘real world’ nationwide cohort study. Thromb. Haemost., 106, 739–749 (2011).
  • Friberg L , RosenqvistM, LipGY. Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Eur. Heart J., 33, 1500–1510 (2012).
  • Ruff CT , GiuglianoRP, BraunwaldEet al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomized trials. Lancet, 383, 955–962 (2014).
  • Hart RG , PearceLA, AguilarMI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann. Intern. Med., 146, 857–867 (2007).
  • Go AS , HylekEM, ChangYet al. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice? JAMA, 290, 2685–2692 (2003).
  • Singer DE , ChangY, FangMCet al. The net clinical benefit of warfarin anticoagulation in atrial fibrillation. Ann. Intern. Med., 151, 297–305 (2009).
  • Reynolds MW , FahrbachK, HauchOet al. Warfarin anticoagulation and outcomes in patients with atrial fibrillation: a systematic review and metaanalysis. Chest, 126, 1938–1945 (2004).
  • Connolly SJ , EzekowitzMD, YusufSet al. Dabigatran versus warfarin in patients with atrial fibrillation. N. Engl. J. Med., 361, 1139–1151 (2009).
  • Patel MR , MahaffeyKW, GargJet al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N. Engl. J. Med., 365, 883–891 (2011).
  • Granger CB , AlexanderJH, McMurrayJJet al. Apixaban versus warfarin in patients with atrial fibrillation. N. Engl. J. Med., 365, 981–992 (2011).
  • Giugliano RP , RuffCT, ENGAGE AF-TIMI 48 Investigatorset al. . Edoxaban versus warfarin in patients with atrial fibrillation. N. Engl. J. Med., 369, 2093–2104 (2013).
  • Chaudhary R , SharmaT, GargJet al. Direct oral anticoagulants: a review on the current role and scope of reversal agents. J. Thromb Thrombolysis., 49(2), 271–286 ( 2019).
  • Manning WJ , WeintraubRM, WaksmonskiCA. Accuracy of transesophageal echocardiography for identifying left atrial thrombi. A prospective, intraoperative study. Ann. Intern. Med., 123, 817–822 (1995).
  • Wang Y , DiBiase L, HortonRP, NguyenT, MorhantyP, NataleA. Left atrial appendage studied by computed tomography to help planning for appendage closure device placement. J. Cardiovasc. Electrophysiol., 21, 973–982 (2010).
  • Al-Saady NM , ObelOA, CammAJ. Left atrial appendage: structure, function and role in thromboembolism. Heart, 5, 547–554 (1999).
  • Veinot JP , HarrityPJ, GentileF. Anatomy of the normal left atrial appendage: a quantitative study of age-related changes in 500 autopsy hearts: implications for echocardiographic examination. Circulation, 96, 3112–3115 (1997).
  • Di Biase L , SantangeliP, AnselminoMet al. Does the left atrial appendage morphology correlate with the risk of stroke in patients with atrial fibrillation? Results from a multicenter study. J. Am. Coll. Cardiol., 60, 531–538 (2012).
  • January CT , WannLS, CalkinsHet 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. J. Am. Coll. Cardiol., 74, 104–132 (2019).
  • Ostermayer SH , ReismanM, KramerPHet al. “Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials”. J. Am. Coll. Cardiol., 46, 9–14 (2005).
  • Holmes DR , ReddyVY, PROTECT AFInvestigatorset al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet, 15, 534–542 (2009).
  • Reddy VY , HolmesD, DoshiSK, NeuzilP, KarS. Safety of percutaneous left atrial appendage closure results from the WATCHMAN® left atrial appendage system for embolic protection in patients with AF (PROTECT AF) Clinical Trial and the Continued Access Registry. Circulation, 123, 417–424 (2011).
  • Reddy VY , SievertH, HalperinJet al. PROTECT AF steering committee and investigators, percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA, 312, 1988–1998 (2014).
  • Holmes DR , KarS, PriceMJet al. Prospective randomized evaluation of the WATCHMAN® left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J. Am. Coll. Cardiol., 64, 1–12 (2014).
  • Reddy VY , DoshiSK, PREVAILand PROTECT AF Investigatorset al. 5-Year outcomes after left atrial appendage closure: from the PREVAIL and PROTECT AF trials. J. Am. Coll. Cardiol., 70, 2964–2975 (2017).
  • Holmes DR , DoshiSK, KarSet al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: a patient-level meta-analysis. J. Am. Coll. Cardiol., 65, 2614–2623 (2015).
  • Boersma LV , InceH, EWOLUTION Investigatorset al. . Efficacy and safety of left atrial appendage closure with WATCHMAN® in patients with or without contraindication to oral anticoagulation: 1-year follow-up outcome data of the EWOLUTION trial. Heart Rhythm, 14, 1302–1308 (2017).
  • Reddy VY , Möbius-WinklerS, MillerMAet al. Left atrial appendage closure with the WATCHMAN® device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study with WATCHMAN® left atrial appendage closure technology). J. Am. Coll. Cardiol., 61, 2551–2556 (2013).
  • Holmes DR , ReddyVY, BuchbinderMet al. The assessment of the WATCHMAN® device in patients unsuitable for oral anticoagulation (ASAP-TOO) trial. Am. Heart J., 189, 68–74 (2017).
  • FDA Approval for WATCHMAN® Device . http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130013a.pdf
  • Viles-Gonzalez JF , KarS, DouglasPet al. The clinical impact of incomplete left atrial appendage closure with the WATCHMAN® device in patients with atrial fibrillation: a PROTECT AF (percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation) substudy. J. Am. Coll. Cardiol., 59, 923–929 (2012).
  • Mohanty S , GianniC, TrivediCet al. Risk of thromboembolic events after percutaneous left atrial appendage ligation in patients with atrial fibrillation: long-term results of a multicenter study. Heart Rhythm, 17, 175–181 (2020).
  • Schwartz RS , HolmesDR, Van TasselRAet al. Left atrial appendage obliteration: mechanisms of healing and intracardiac integration. J. Am. Coll. Cardiol. Intv., 3, 870–877 (2010).
  • Saw J , Nielsen-KudskJE, BergmannMet al. Antithrombotic therapy and device-related thrombosis following endovascular left atrial appendage closure. J. Am. Coll. Cardiol. Intv., 12, 1067–1076 (2019).
  • Søndergaard L , WongY-H, ReddyVYet al. Propensity-matched comparison of oral anticoagulation versus antiplatelet therapy after left atrial appendage closure with WATCHMAN®. J. Am. Coll. Cardiol. Intv., 12, 1055–1063 (2019).
  • Goitein O , FinkN, HayIet al. Cardiac CT angiography (CCTA) predicts left atrial appendage occluder device size and procedure outcome. Int. J. Cardiovasc. Imaging, 33, 739–747 (2017).
  • Goitein O , FinkN, GuettaVet al. Printed MDCT 3D models for prediction of left atrial appendage (LAA) occluder device size: a feasibility study. EuroIntervention, 13, e1076–1079 (2017).
  • US FDA . Executive summary P130013 prepared for the October 8, 2014 meeting of the Circulatory System Devices Panel (2015). https://webcache.googleusercontent.com/search?q=cache:9TH_oSwNBo8J
  • Dörr M , NohturfftV, BrasierNet al. The WATCH AF Trial: SmartWATCHes for detection of atrial fibrillation. JACC Clin. Electrophysiol., 5, 199–208 (2019).
  • Turakhia MP , DesaiM, HedlinHet al. Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart study. Am. Heart J., 207, 66–75 (2019).
  • Friedman DJ , PicciniJP, WangTet al. Association between left atrial appendage occlusion and readmission for thromboembolism among patients with atrial fibrillation undergoing concomitant cardiac surgery. JAMA, 319, 365–374 (2018).
  • Kuwata S , ViereckeJ, GloeklerS, MaisanoF, MeierB, NietlispachF. Left atrial appendage closure for “primary primary” prevention during percutaneous closure of septal defects in patients with large atria but no atrial fibrillation. Cardiol J., 25, 179–187 (2018).
  • Attia ZI , NoseworthyPA, Lopez-JimenezFet al. An artificial intelligence-enabled ECG algorithm for the identification of patients with atrial fibrillation during sinus rhythm: a retrospective analysis of outcome prediction. Lancet, 394, 861–867 (2019).
  • Ma Z , ChengG, WangP, KhalighiB, KhalighiK. Clinical model for predicting warfarin sensitivity. Sci. Rep., 9, 12856 (2019).
  • Labovitz DL , ShafnerL, ReyesGil M, VirmaniD, HaninaA. Using artificial intelligence to reduce the risk of nonadherence in patients on anticoagulation therapy. Stroke, 48, 1416–1419 (2017).

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