المؤلفون: Kar, Saibal^1,2 (AUTHOR) saibalkar60@gmail.com, Doshi, Shephal K.³ (AUTHOR) skdoshi@pacificheart.com, Sadhu, Ashish⁴ (AUTHOR) asadhumd@gmail.com, Horton, Rodney⁵ (AUTHOR) rodney.horton@gmail.com, Osorio, Jose⁶ (AUTHOR) josoriomd@gmail.com, Ellis, Christopher⁷ (AUTHOR) christopher.ellis@vumc.org, Stone, James⁸ (AUTHOR) JStone@nmhs.net, Shah, Manish⁹ (AUTHOR) shah.heart@gmail.com, Dukkipati, Srinivas R.¹⁰ (AUTHOR) srinivas.dukkipati@mountsinai.org, Adler, Stuart¹¹ (AUTHOR) swadler@healtheast.org, Nair, Devi G.¹² (AUTHOR) drdevignair@gmail.com, Kim, Jamie¹³ (AUTHOR) jamie.kim@cmc-nh.org, Wazni, Oussama¹⁴ (AUTHOR) waznio@ccf.org, Price, Mathew J.¹⁵ (AUTHOR) price.matthew@scrippshealth.org, Asch, Federico M.¹⁶ (AUTHOR) federico.asch@medstar.net, Holmes, David R.¹⁷ (AUTHOR) holmes.david@mayo.edu, Shipley, Robert D.¹⁸ (AUTHOR) rshipley@gmail.com, Gordon, Nicole T.¹⁸ (AUTHOR) Nikki.gordon@comcast.net, Allocco, Dominic J.¹⁸ (AUTHOR) Dominic.Allocco@bsci.com, Reddy, Vivek Y. (AUTHOR) vivek.reddy@mountsinai.org

المصدر: Circulation. 5/4/2021, Vol. 143 Issue 18, p1754-1762. 9p.

مصطلحات موضوعية: *ATRIAL fibrillation, *LEFT heart atrium, *PERICARDIAL effusion, *GOAL (Psychology), *CARDIAC surgery, *RESEARCH, *RESEARCH methodology, *MEDICAL cooperation, *EVALUATION research, *TREATMENT effectiveness, *COMPARATIVE studies, *HEART atrium, *LONGITUDINAL method

الشركة/الكيان: UNITED States. Food & Drug Administration

مستخلص: Background: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative.Methods: This was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up.Results: A total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHA2DS2-VASc score was 4.2±1.5. The incidence of the primary safety end point was 0.5% with a 1-sided 95% upper CI of 1.6%, meeting the performance goal of 4.2% (P<0.0001). The incidence of the primary effectiveness end point was 100%, with a 1-sided 95% lower CI of 99.1%, again meeting the performance goal of 97.0% (P<0.0001). Device-related thrombus was reported in 7 patients, no patients experienced pericardial effusion requiring open cardiac surgery, and there were no device embolizations.Conclusions: LAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.govTest; Unique identifier: NCT02702271. [ABSTRACT FROM AUTHOR]

المؤلفون: Dukkipati, Srinivas R.¹, Kar, Saibal², Holmes, David R.³, Doshi, Shephal K.⁴, Swarup, Vijendra⁵, Gibson, Douglas N.⁶, Maini, Brijeshwar⁷, Gordon, Nicole T.⁸, Main, Michael L.⁹, Reddy, Vivek Y.¹, Holmes, David R Jr³ (AUTHOR)

المصدر: Circulation. 8/28/2018, Vol. 138 Issue 9, p874-885. 12p.

مصطلحات موضوعية: *THROMBOSIS, *ATRIAL fibrillation, *DISEASE incidence, *TRANSESOPHAGEAL echocardiography, *TRANSIENT ischemic attack, *STROKE, *VENTRICULAR ejection fraction, THROMBOEMBOLISM prevention

مستخلص: Background: In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors, and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation.Methods: We studied the device arms of 4 prospective Food and Drug Administration trials: PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (n=463); PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) (n=269); CAP (Continued Access to PROTECT AF registry) (n=566); and CAP2 (Continued Access to PREVAIL registry) (n=578). Surveillance transesophageal echocardiographs were performed at 45 days and 12 months in all patients, and also at 6 months in the randomized control trials. We assessed both the incidence of DRT during these transesophageal echocardiographs (and other unscheduled transesophageal echocardiographs), and clinical outcomes of postprocedure stroke or systemic embolism (SSE) and adjusted for CHA2DS2-VASC and HAS-BLED scores.Results: Of 1739 patients who received an implant (7159 patient-years follow-up; CHA2DS2-VASc=4.0), DRT was seen in 65 patients (3.74%). The rates of SSE with and without DRT were 7.46 and 1.78 per 100 patient-years (adjusted rate ratio, 3.55; 95% confidence interval [CI], 2.18-5.79; P<0.001), and ischemic SSE rates were 6.28 and 1.65 per 100 patient-years (adjusted rate ratio, 3.22; 95% CI, 1.90-5.45, P<0.001). On multivariable modeling analysis, the predictors of DRT were as follows: history of transient ischemic attack or stroke (odds ratio [OR], 2.31; 95% CI, 1.26-4.25; P=0.007), permanent atrial fibrillation (OR, 2.24; 95% CI, 1.19-4.20; P=0.012); vascular disease (OR, 2.06; 95% CI, 1.08-3.91; P=0.028); left atrial appendage diameter (OR, 1.06 per mm increase; 95% CI, 1.01-1.12; P=0.019); left ventricular ejection fraction (OR, 0.96 per 1% increase; 95% CI, 0.94-0.99; P=0.009). DRT and SSE both occurred in 17 of 65 patients (26.2%). Of the 19 SSE events in these patients with DRT, 9 of 19 (47.4%) and 12 of 19 (63.2%) occurred within 1 and 6 months of DRT detection. Conversely, after left atrial appendage closure, most SSEs (123/142, 86.62%) occurred in patients without DRT.Conclusions: After left atrial appendage closure with Watchman, DRT (≈3.7%) is not frequent but, when present, is associated with a higher rate of stroke and systemic embolism. [ABSTRACT FROM AUTHOR]

المؤلفون: Natale, Andrea (AUTHOR), Kar, Saibal (AUTHOR), Holmes, David (AUTHOR)

المصدر: Circulation. 4/26/2022, Vol. 145 Issue 17, pe847-e848. 2p.

مصطلحات موضوعية: *STROKE prevention, *PROSTHETICS, *RESEARCH, *STROKE, *RESEARCH methodology, *ARTIFICIAL implants, *ATRIAL fibrillation, *EVALUATION research, *COMPARATIVE studies, *RANDOMIZED controlled trials, *HEART atrium

مستخلص: Amplatzer Amulet Left Atrial Appendage Occluder versus Watchman Device for Stroke Prophylaxis (Amulet IDE): a randomized, controlled trial. Procedure-related complications such as pericardial effusion and device embolization were significantly higher in the Amulet group (P=0.02). [Extracted from the article]

المؤلفون: Gertz, Zachary M., Herrmann, Howard C., Lim, D. Scott, Kar, Saibal, Kapadia, Samir R., Reed, Grant W., Puri, Rishi, Krishnaswamy, Amar, Gersh, Bernard J., Weissman, Neil J., Asch, Federico M., Grayburn, Paul A., Kosmidou, Ioanna, Redfors, Björn, Zhang, Zixuan, Abraham, William T., Lindenfeld, JoAnn, Stone, Gregg W., Mack, Michael J.

المصدر: Circulation: Cardiovascular Interventions; Apr2021, Vol. 14 Issue 4, pe010300-e010300, 1p

مستخلص: Supplemental Digital Content is available in the text. Background: Atrial fibrillation (AF), mitral regurgitation (MR), and left ventricular (LV) ejection fraction have a complex interplay. We evaluated the role of AF in patients with heart failure and moderate-to-severe or severe secondary MR enrolled in the randomized COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) and its impact on mechanisms and outcomes with the MitraClip. Methods: Patients in the COAPT trial were stratified by the presence (n=327) or absence (n=287) of a history of AF and by assignment to treatment group. Clinical, echocardiographic, and outcome measures were assessed. The primary outcome was the composite rate of death or heart failure hospitalization at 24 months. Results: Patients with history of AF were older and more often male. They had a higher LV ejection fraction, larger left atrial volumes and mitral valve orifice areas, smaller LV volumes, and similar MR severity. Patients with AF compared with those without a history of AF had a higher unadjusted (hazard ratio [HR], 1.32 [95% CI, 1.06–1.64], P =0.01) and adjusted (HR, 1.30 [1.03–1.64], P =0.03) 2-year rate of the primary outcome. Treatment with the MitraClip compared with guideline-directed medical therapy alone reduced death or heart failure hospitalization in both those with (HR, 0.61 [0.46–0.82]) and without (HR, 0.46 [0.33–0.66]) a history of AF (P int=0.18). Treatment with the MitraClip was associated with a lower risk of stroke in patients with a history of AF (HR, 0.18 [0.04–0.86]) but not in those without a history of AF (HR, 1.64 [0.58–4.62]; P int=0.02). Conclusions: In the COAPT trial, patients with a history of AF had larger left atrial and mitral valve orifice areas with higher LV ejection fraction and smaller LV volumes, suggesting an atrial mechanism contribution to functional MR. Despite the worse prognosis of heart failure patients with a history of AF, MR reduction with the MitraClip still afforded substantial clinical benefits. Treatment with MitraClip was associated with a lower risk of stroke in patients with a history of AF. Registration: URL: https://www.clinicaltrials.govTest; Unique identifier: NCT01626079. [ABSTRACT FROM AUTHOR]

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المؤلفون: Price, Matthew J. (AUTHOR), Gibson, Doug N. (AUTHOR), Kar, Saibal (AUTHOR)

المصدر: Circulation. 4/26/2022, Vol. 145 Issue 17, pe849-e849. 1p.

مصطلحات موضوعية: *STROKE prevention, *PROSTHETICS, *RESEARCH, *STROKE, *RESEARCH methodology, *ATRIAL fibrillation, *ARTIFICIAL implants, *EVALUATION research, *COMPARATIVE studies, *RANDOMIZED controlled trials, *HEART atrium