Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy

Holmes, David R.; Kar, Saibal; Price, Matthew J.; Whisenant, Brian; Sievert, Horst; Doshi, Shephal K.; Huber, Kenneth C.; Reddy, Vivek Y.

doi:10.1016/j.jacc.2014.04.029

Cited by 1,533 publications

(1,240 citation statements)

References 29 publications

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“…Nie można w związku z tym zalecać leczenia przeciwpłytkowego w celu prewencji udaru mózgu u pacjentów z AF. [449][450][451]. Te dane wskazują, że zamykanie LAA było nie gorsze niż leczenie za pomocą VKA pod względem zapobiegania udarom mózgu u pacjentów z AF z grupy umiarkowanego ryzyka udaru, z możliwością mniejszej częstości występowania krwawień u pacjentów, u których uzyskano dane z dłuższej obserwacji [452,453].…”

Section: Leczenie Przeciwpłytkowe Jako Postępowanie Alternatywne W Stunclassified

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

Kirchhof

Benussi

Kotecha³

et al. 2016

Kardiol Pol

2,398

4,206

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Section: Leczenie Przeciwpłytkowe Jako Postępowanie Alternatywne W Stunclassified

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

Kirchhof

Benussi

Kotecha³

et al. 2016

Kardiol Pol

2,398

4,206

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“…Although this noninferiority margin is wide, it is similar to margins used in other major clinical trials in cardiology. [26][27][28][29][30][31][32] The event rates were lower than had been expected, because the number of patients with an acute coronary syndrome who were enrolled in the trial was lower than had been anticipated. However, when we used the prespecified noninferiority margin to test the actual event rate among the prespecified number of patients, we found that iFR was noninferior to FFR even when the upper limit of a one-sided 99.5% confidence interval was used.…”

mentioning

confidence: 88%

Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI

et al. 2017

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BACKGROUNDCoronary revascularization guided by fractional flow reserve (FFR) is associated with better patient outcomes after the procedure than revascularization guided by angiography alone. It is unknown whether the instantaneous wave-free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR. METHODSWe randomly assigned 2492 patients with coronary artery disease, in a 1:1 ratio, to undergo either iFR-guided or FFR-guided coronary revascularization. The primary end point was the 1-year risk of major adverse cardiac events, which were a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization. The trial was designed to show the noninferiority of iFR to FFR, with a margin of 3.4 percentage points for the difference in risk. RESULTSAt 1 year, the primary end point had occurred in 78 of 1148 patients (6.8%) in the iFR group and in 83 of 1182 patients (7.0%) in the FFR group (difference in risk, −0.2 percentage points; 95% confidence interval [CI], −2.3 to 1.8; P<0.001 for noninferiority; hazard ratio, 0.95; 95% CI, 0.68 to 1.33; P = 0.78). The risk of each component of the primary end point and of death from cardiovascular or noncardiovascular causes did not differ significantly between the groups. The number of patients who had adverse procedural symptoms and clinical signs was significantly lower in the iFR group than in the FFR group (39 patients [3.1%] vs. 385 patients [30.8%], P<0.001), and the median procedural time was significantly shorter (40.5 minutes vs. 45.0 minutes, P = 0.001). CONCLUSIONSCoronary revascularization guided by iFR was noninferior to revascularization guided by FFR with respect to the risk of major adverse cardiac events at 1 year. The rate of adverse procedural signs and symptoms was lower and the procedural time was shorter with iFR than with FFR. ( Use of Instantaneous Wave-free R atio in PCI F or the past 20 years, physiological measurements obtained during invasive procedures have been used to guide coronary revascularization. Pioneering work supported the use of flow measurements to make safe decisions about revascularization, 1,2 but this approach was soon superseded by the use of fractional flow reserve (FFR), which measures pressure as a surrogate of flow to estimate the severity of stenosis. 3-5 FFR was successful largely because of its technical simplicity and because clinical trials showed that it was associated with improved clinical outcomes after percutaneous coronary intervention (PCI). 6,7 Consequently, FFR is now included in the appropriate-use criteria for coronary angiography and in the American College of Cardiology-American Heart Association-European Society of Cardiology guidelines; despite these recommendations, its adoption remains limited. [8][9][10] FFR must be measured during maximal hyperemia, which is typically induced with the administration of a potent intravenous or intracoronary vasodilator, such as adenosine. 11 Several studies have...

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“…Device embolization may be diagnosed by fluoroscopy, chest X-ray, TTE, TOE or CCTA (Fig 7, panel C). Pericardial effusion incidence is decreasing with last generation of devices, standardization and better understanding of the procedure [2]. Pericardial effusion occurs mostly…”

Section: Complicationsmentioning

confidence: 99%

“…Two randomized-controlled trials, the PROTECT AF and PRE-VAIL studies, have shown the safety and efficacy of this procedure in patients randomized to either LAA closure with the WATCHMAN device (Boston Scientific, Natick, MA, USA) or warfarin therapy [1,2]. Two large registries in patients who were mostly contra-indicated or deemed unsuitable to long-term anticoagulation and treated with the Amplatzer Cardiac Plug (ACP) (St. Jude Medical/Abbott, St Paul, MN, USA) (ACP multicenter registry) [3] or the WATCHMAN (Ewolution registry) [4] have confirmed safety and efficacy of this procedure in this population.…”

Section: Introductionmentioning

confidence: 99%

Role of Imaging in Left Atrial Appendage Occlusion

Lempereur

Aminian

Potter

et al. 2017

ijcp

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Percutaneous left atrial appendage (LAA) occlusion is now a valid alternative to longterm oral anticoagulation in patients with non-valvular atrial fibrillation at high thromboembolism risk, especially for patients who are considered ineligible for anticoagulation. The most frequently used occluders worldwide include the WATCHAMN (Boston Scientific, Natick, MA, USA) and the Amplatzer Cardiac Plug or Amulet (St. Jude Medical/Abbott, St Paul, MN, USA) devices. Multimodality imaging is key in the understanding of 3D aspects of the LAA and surrounding structures anatomy. Imaging is essential for procedural planning, during each step of the procedure and for device surveillance after implantation. Multimodality imaging, including 2D/3D echocardiography, fluoroscopy, and cardiac computed tomography can increase the safety and efficacy of the procedure.

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Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy

Cited by 1,533 publications

References 29 publications

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI

Role of Imaging in Left Atrial Appendage Occlusion

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