Response by Lakireddy et al to Letters Regarding Article, “Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial”

Lakkireddy, Dhanunjaya; Thaler, David E.; Windecker, Stephan

doi:10.1161/circulationaha.122.059423

Cited by 8 publications

(3 citation statements)

References 2 publications

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“…Nevertheless, the lower rate of postprocedurally detected peri-device leaks of Amulet versus Watchman devices may correlate with the dual closure mechanism of the Amulet device and corresponds with former results. 25) On the whole, the procedure has been proven to have a high success rate and acceptable therapeutic burden regarding all device types.…”

Section: Long-term Efficacy and Safety Of Laac Proceduresmentioning

confidence: 99%

Long-Term Efficacy and Safety of Left Atrial Appendage Closure Procedures

et al. 2023

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The aim of the present single-center, nonrandomized, retrospective study was to assess the safety and longterm efficacy of percutaneous left atrial appendage closure (LAAC) procedures and to compare the different LAAC devices and therapeutic regimes in this respect.Medical data of 136 patients (pts) (mean age, 72.5 ± 7.6 years; score for atrial fibrillation stroke risk estimation [CHA2DS2-VASc], 4.6 ± 1.6; and score for estimation of major bleeding risk for patients on anticoagulant therapy [HAS-BLED], 2.6 ± 0.9) who underwent percutaneous LAAC procedures in Gottsegen National Cardiovascular Center from January 2010 to January 2020 were analyzed.The rates of outpatient cardiac mortality, ischemic brain event, and major bleeding were 3.8, 1, and 1.9/ 100 pt years, respectively. The rate of successful device deployment was 96.4%. There was one case of procedural mortality (0.7%), one case of device dislocation (0.7%), one case of ischemic stroke (0.7%), and one case of myocardial infarction (0.7%). Two cases of pericardial tamponades (1.5%) and four cases of major femoral complications (3%) occurred. Although the implantation success of different occluder types was similar, significant differences were found concerning procedural characteristics. Patients on single antiplatelet therapy (SAPT) in the first 3 months after the LAAC procedure did not suffer from stroke or embolic events.The present study confirmed the safety and effectivity of percutaneous LAAC. Robust relative stroke risk reduction and less pronounced but significant bleeding risk reduction were observed. Device implantation success was high. The perioperative complication rate was relatively low. The results of long-term observations regarding ischemic events confirmed the safety of using a simplified antithrombotic regime after LAAC in pts with high bleeding risk.

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Section: Long-term Efficacy and Safety Of Laac Proceduresmentioning

confidence: 99%

Long-Term Efficacy and Safety of Left Atrial Appendage Closure Procedures

et al. 2023

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“…Several left atrial appendage closure (LAAC) devices have been approved in recent years with favourable long-term data published last year [1] for the Watchman LAAC device (Boston Scientific). The AMULET IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis) [36] trial randomised patients with non-valvular atrial fibrillation (AF), not suitable as anticoagulation to LAAC with an Amulet device (n = 934) versus Watchman device (n = 944). At 3 years, there was no difference in the primary composite endpoint of CV mortality, ischaemic stroke or systemic embolism (11.1% vs. 12.7%, P = 0.31) all-cause mortality (14.6% vs. 17.9%; P = 0.07) or major bleeding (16.1% vs. 14.7%; P = 0.46).…”

Section: Structural: Catheter Based Left Atrialmentioning

confidence: 99%

Advances in Clinical Cardiology 2022: A Summary of Key Clinical Trials

et al. 2023

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Introduction: Over the course of 2022, numerous key clinical trials with valuable contributions to clinical cardiology were published or presented at major international conferences. This review seeks to summarise these trials and to reflect on their clinical context. Methods: The authors reviewed clinical trials presented at major cardiology conferences during 2022, including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), Transcatheter Cardiovascular Therapeutics (TCT), American Heart Association (AHA), European Heart Rhythm Association (EHRA), Society for Cardiovascular Angiography and Interventions (SCAI), TVT-The Heart Summit (TVT) and Cardiovascular Research Technologies (CRT). Trials with a broad relevance to the cardiology community and those with potential to change current practice were included. Results: A total of 93 key cardiology clinical trials were identified for inclusion. Interventional cardiology data included trials evaluating the use of new generation novel stent technology and new intravascular physiology strategies such as quantitative flow ratio (QFR) to guide revascularisation in stable and unstable coronary artery disease. New trials in acute coronary syndromes and intervention focused on long-term outcomes of optimal medical therapy (OMT), revascularisation in ischaemic dysfunction and left main (LM) intervention. Structural intervention trials included latest data on optimal timing and anticoagulation strategies in transcatheter aortic valve replacement (TAVR), in addition to expanding evidence in mitral and tricuspid valve interventions. Heart failure data included trials with sodium-glucose cotransporter 2 (SGLT2) inhibitors, iron replacement and novel drugs such as omecamtiv. Prevention trials included new data on proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors and polypill strategies. In electrophysiology, new data regarding optimal timing of ablative therapy for atrial fibrillation (AF) in addition to novel screening strategies were evaluated. Conclusion: This article presents a summary of key clinical cardiology trials published and presented during the past year and should be of interest to both practising clinicians and researchers.

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“…Die Komplikationsrate innerhalb von 7 Tagen nach Intervention liegt in Registern und randomisierten Studien um 3 %, wobei es sich hierbei um konservativ therapierbare Perikardergüsse und Gefäßkomplikationen handelt. Klinisch apparente ischämische Schlaganfälle werden durch die Intervention bei < 0,1 % aller Patienten induziert 20 . Nach Implantation wird in der Praxis entsprechend dem Blutungsrisiko der Patienten eine zeitlich begrenzte Therapie mit Plättcheninhibitoren oder oralen Antikoagulantien für 3–6 Monate durchgeführt, bis eine Endothelialisierung des Devices mutmaßlich abgeschlossen ist.…”

Section: Linksseitiger Vorhofohrverschluss – Eine Alternative Therapi...unclassified

Perkutaner Vorhofohrverschluss nach Schlaganfall

Skurk¹,

Häusler²,

Endres³

et al. 2022

Nervenheilkunde

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ZUSAMMENFASSUNGDer katheterbasierte Verschluss des linken Vorhofohrs stellt bei Patienten mit Vorhofflimmern, welche nicht für eine Langzeittherapie mit oralen Antikoagulanzien geeignet sind, eine potenzielle Therapieoption zur Reduktion des Schlaganfallrisikos dar. Die Weiterentwicklung der Device- und Implantationstechnik führte in den letzten Jahren zu einer Verbesserung des Sicherheitsprofils der Behandlungsmethode. Das Therapieprinzip wird durch neue Daten unterstützt, die die Wirksamkeit des operativen Verschlusses des linken Vorhofohrs zusätzlich zur Antikoagulation im Rahmen von kardiochirurgischen Eingriffen zeigen. Aktuell wird der katheterbasierte Verschluss des linken Vorhofohres in verschiedenen Patientenpopulationen in randomisierten Studien evaluiert. Die Datenlage, die Einsatzgebiete und randomisierte Studien unter besonderer Berücksichtigung der CLOSURE-AF-Studie sollen in der vorliegenden Übersichtsarbeit diskutiert werden.

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Response by Lakireddy et al to Letters Regarding Article, “Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial”

Cited by 8 publications

References 2 publications

Long-Term Efficacy and Safety of Left Atrial Appendage Closure Procedures

Long-Term Efficacy and Safety of Left Atrial Appendage Closure Procedures

Advances in Clinical Cardiology 2022: A Summary of Key Clinical Trials

Perkutaner Vorhofohrverschluss nach Schlaganfall

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