Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure.

Официальное название

Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure The Frail-LAAC Study

Обзор

To assess the prevalence and severity of frailty in patients undergoing LAAC, as well as its association to peri-procedural and long-term outcomes and quality of life.

Подробное описание

Transcatheter left atrial appendage closure (LAAC) has emerged as an alternative to anticoagulation for preventing thromboembolic events in patients with non-valvular atrial fibrillation and relative or absolute contraindications to oral anticoagulation (OAC).

Procedural safety and success are now excellent with approximately 98% of successful procedures without major complications. LAAC seems to offer persisting protection against ischemic events in long-term reports, while also decreasing bleeding risk by reducing antithrombotic treatment intensity. However, patients undergoing LAAC in real-world practice are a high-risk population with a high rate of adverse events, mainly not related to the LAAC device-procedure. As a prophylactic intervention, the beneficial effects of LAAC increase over time, as more potential adverse events (ischemic and haemorrhagic) are prevented. Thus, it took approximately 5 years to reach cost-effectiveness (favoring LAAC versus oral anticoagulation) in the pooled data from PROTECT-AF and PREVAIL randomized controlled trials. Patients that experience early death after LAAC do not fully benefit from the costly procedure - that can be therefore considered futile. In a recent study, close to 1 on 5 LAAC recipient had either died or suffered from a major ischemic event within the first year after the procedure highlighting the need for better patient selection before LAAC.

The definition of frailty is nonconsensual and has constantly evolved in the literature. Nonetheless, there is a general agreement that frailty is a multidimensional concept involving many domains (such as nutrition, mobility, strength and cognitive) and that frail patients are a high-risk population and vulnerable to stressors and adverse outcomes. Thus, considering this global definition, assessing frailty using multidomain scales is more appropriate to discriminate frail to non-frail patients.

Frailty and its association to adverse events are well-known in transcatheter aortic valve replacement (TAVR). Despite being performed in a high-risk population, frailty has not yet been studied in LAAC although it could be a potent indicator for futile or harmful procedures. The implementation of frailty assessment into the routine practice could help identify vulnerable patients who will most likely less benefit from the LAAC procedure. Therefore, in this prospective multicenter trial, the investigators seek to explore frailty and its consequences in LAAC recipients.

Первичные конечные точки

• Prevalence of frailty [Срок оценки: Baseline (before transcatheter Left Atrial Appendage Closure)]
• Prevalence of frailty [Срок оценки: Baseline (before transcatheter Left Atrial Appendage Closure)]
• Rate of all-cause mortality [Срок оценки: 1-year follow-up]
• Rate of ischemic events [Срок оценки: 1-year follow-up]
• Rate of all-cause mortality and ischemic events [Срок оценки: 1-year follow-up]

Вторичные конечные точки (7)

• Rate of All-cause mortality [Срок оценки: 2, 3, 4 and 5-year follow-up]
• Rate of ischemic events [Срок оценки: 2, 3, 4 and 5-year follow-up]
• Rate of all-cause mortality and ischemic events [Срок оценки: 2-, 3-, 4- and 5-year follow-up]
• Rate of Rehospitalisation [Срок оценки: 1-, 2-, 3-, 4- and 5-year follow-up]
• Number of participants discharged to a healthcare facility [Срок оценки: 1-month follow-up]
• Rate of bleeding [Срок оценки: 1-, 2-, 3-, 4- and 5-year follow-up]
• Changes in quality of life [Срок оценки: Baseline (before transcatheter Left Atrial Appendage Closure) and 1-year follow-up]

Критерии участия

Критерии включения

• Transcatheter LAAC with any approved device
• Age ≥18 years old

Критерии исключения

• Unable to provide informed consent
• Severe neuropsychiatric impairment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• IUCPQ_UL — Québec

Публикации

• Asmarats L, Rodes-Cabau J. Percutaneous Left Atrial Appendage Closure: Current Devices and Clinical Outcomes. Circ Cardiovasc Interv. 2017 Nov;10(11):e005359. doi: 10.1161/CIRCINTERVENTIONS.117.005359. PMID 29146668
• Boersma LV, Schmidt B, Betts TR, Sievert H, Tamburino C, Teiger E, Pokushalov E, Kische S, Schmitz T, Stein KM, Bergmann MW; EWOLUTION investigators. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J. 2016 Aug;37(31):2465-74. doi: 10.1093/eurheartj/ehv730. Epub 2016 Jan 27. PMID 26822918
• Landmesser U, Tondo C, Camm J, Diener HC, Paul V, Schmidt B, Settergren M, Teiger E, Nielsen-Kudsk JE, Hildick-Smith D. Left atrial appendage occlusion with the AMPLATZER Amulet device: one-year follow-up from the prospective global Amulet observational registry. EuroIntervention. 2018 Aug 3;14(5):e590-e597. doi: 10.4244/EIJ-D-18-00344. PMID 29806820
• Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4. PMID 29103847
• Holmes DR Jr, Reddy VY, Gordon NT, Delurgio D, Doshi SK, Desai AJ, Stone JE Jr, Kar S. Long-Term Safety and Efficacy in Continued Access Left Atrial Appendage Closure Registries. J Am Coll Cardiol. 2019 Dec 10;74(23):2878-2889. doi: 10.1016/j.jacc.2019.09.064. PMID 31806131
• Mesnier J, Cruz-Gonzalez I, Peral V, Nombela-Franco L, Freixa X, Laffond AE, Mas-Llado C, McInerney A, Regueiro A, O'Hara G, Rodes-Cabau J. Ten-Year Outcomes Following Percutaneous Left Atrial Appendage Closure in Patients With Atrial Fibrillation and Absolute or Relative Contraindications to Chronic Anticoagulation. Circ Cardiovasc Interv. 2021 Aug;14(8):e010821. doi: 10.1161/CIRCINTERVENTIONS.12 PMID 34266312
• Panikker S, Lord J, Jarman JW, Armstrong S, Jones DG, Haldar S, Butcher C, Khan H, Mantziari L, Nicol E, Hussain W, Clague JR, Foran JP, Markides V, Wong T. Outcomes and costs of left atrial appendage closure from randomized controlled trial and real-world experience relative to oral anticoagulation. Eur Heart J. 2016 Dec 7;37(46):3470-3482. doi: 10.1093/eurheartj/ehw048. Epub 2016 Mar 1. PMID 26935273
• Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019 Oct 12;394(10206):1365-1375. doi: 10.1016/S0140-6736(19)31786-6. PMID 31609228

Идентификаторы

NCT: NCT05257954 · Frail-LAAC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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