Direct acting oral anticoagulants (DOACs) are increasingly used as off-label alternatives to vitamin K antagonists for the treatment of left ventricular (LV) thrombus. However, efficacy data is ...limited to small case series and one meta-analysis of case reports. We aimed to determine the efficacy and safety of DOACs in treatment of LV thrombus utilizing transthoracic echocardiography (TTE) and clinical outcomes. We identified 52 patients (mean age = 64 years, 71% men) treated with a DOAC for LV thrombus (n = 26 apixaban, n = 24 rivaroxaban, and n = 2 dabigatran). Thirty-five of the 52 patients had a follow-up TTE after DOAC initiation. The primary end point was defined as resolution of LV thrombus (in patients with a subsequent TTE), or death, major bleeding requiring transfusion, intracranial hemorrhage, ischemic stroke, or peripheral embolization. An experienced echocardiographer (M.L.M.) reviewed all TTEs for presence or absence of LV thrombus without knowledge of time point or clinical data. Twenty-nine of the 35 (83%) patients who underwent follow-up TTE had resolution of LV thrombus, with a mean duration of 264 days. Of the total study population, there was 1 cardioembolic event (transient ischemic attack) 52 days after initiating DOAC, 3 gastrointestinal bleeds requiring transfusion, and 1 patient with epistaxis requiring transfusion. All patients with a hemorrhagic complication were receiving concomitant antiplatelet therapy. DOAC therapy appears promising for the treatment of LV thrombus. A larger, prospective study is warranted to confirm these results.
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 trialsPROTECT-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 followshistory 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.
In October 2007, the Food and Drug Administration mandated significant revisions to product labeling for the commercially available echocardiographic contrast agents (ECA) Definity and Optison after ...spontaneous healthcare provider reports of 4 patient deaths and ≈190 severe cardiopulmonary reactions occurring in close temporal relationship to ECA administration. Since then, multiple large ECA safety studies have been published and have included outpatients, hospitalized patients (including the critically ill), patients undergoing stress echocardiography, and patients with pulmonary hypertension. In addition, the Food and Drug Administration has convened 2 Advisory Committee meetings and the product labels for Optison and Definity have been substantially revised with a softening of safety restrictions. In this review, we will address the safety of ECA use in patients with serious cardiopulmonary conditions, patients with intracardiac shunts, and special patient populations including pulmonary hypertension, pediatrics, and pregnancy. In addition, we will discuss the confounding role of pseudocomplication in attribution of adverse events during diagnostic testing, the current status of the ECA Black Box Warning, and recommended safety precautions during ECA administration.
Direct acting oral anticoagulants (DOACs) are increasingly used for thromboembolic prophylaxis in patients with atrial fibrillation (AF). However, there is limited data to evaluate the use of DOACs ...for the treatment of pre-existing left atrial appendage thrombus. We aimed to determine the efficacy of DOACs in treatment of left atrial appendage (LAA) thrombus utilizing transesophageal echocardiographic (TEE) and clinical outcomes. In this single-center study, we identified 33 patients that were treated for LAA thrombus with DOAC. Eighteen were treated with apixaban, 10 with dabigatran, and 5 with rivaroxaban. The primary endpoint was defined as resolution of LAA thrombus (in patients undergoing TEE), or death, major bleeding requiring transfusion, intracranial hemorrhage, ischemic stroke, or peripheral embolization. In this study, 15 of the 16 patients treated with DOACs who underwent follow-up TEE had resolution of LAA thrombus, with a mean duration of 112 days. Of the 15 patients who achieved resolution of the LAA thrombus, 14 had resolution by their first follow-up TEE. In the 17 patients without a follow-up TEE, 1 died of a retroperitoneal bleed (28 days after DOAC initiation), and 1 suffered an ischemic stroke (484 days after DOAC initiation). In general, patients without a follow-up TEE were older and had more co-morbidities. Although these results are descriptive and limited in number of patients, we believe this is ample evidence that DOACs are relatively safe and efficacious in treatment of patients with AF and concomitant LAA thrombus.
Background:The SALUTE trial was a prospective, multicenter, single-arm trial to confirm the safety and efficacy of the WATCHMAN left atrial appendage closure (LAAC) device for stroke prevention in ...patients with nonvalvular atrial fibrillation (NVAF) in Japan.Methods and Results:A total of 54 subjects (including 12 roll-in subjects) with a WATCHMAN implant procedure were followed in 10 investigational centers. Follow-up visits were performed up to 2 years post-implant. The baseline CHA2DS2-VASc score was 3.6±1.6 and the baseline HAS-BLED score was 3.0±1.1. All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal. The effective LAAC rate was maintained at 100% from 45 days to 12 months post-implant, achieving the prespecified performance goal. During follow-up, 1 subject died of heart failure, and 3 had ischemic strokes, but there were no cases of hemorrhagic stroke or systemic embolism. All events were adjudicated as unrelated to the WATCHMAN device/procedure by the independent Clinical Events Committee. All 3 ischemic strokes were classified as nondisabling based on no change in the modified Rankin scale score.Conclusions:Final results of the SALUTE trial demonstrated that the WATCHMAN LAAC device is an effective and safe alternative nonpharmacological therapy for stroke risk reduction in Japanese NVAF patients who are not optimal candidates for lifelong anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT 03033134)
Described herein is a 49-year-old black man with advanced polycystic renal disease, on hemodialysis for 6 years, who during his last 12 days of life had his vegetations on the aortic valve extend to ...the mitral and tricuspid valves, through the aortic wall to produce diffuse pericarditis, to the atrioventricular node to produce complete heart block, and embolize to cerebral arteries producing multiple brain infarcts, to a branch on the left circumflex coronary artery producing acute myocardial infarction, and to mesenteric arteries producing bowel infarction.
Left atrial appendage closure with the WATCHMAN device is an alternative to anticoagulation for stroke prevention in selected patients with atrial fibrillation (AF). LA device-related thrombus (DRT) ...is poorly defined and understood. We aimed to (1) develop consensus echocardiographic diagnostic criteria for DRT; (2) estimate the incidence of DRT; and (3) determine clinical event rates in patients with DRT. In phase 1 (training), a training manual was developed and reviewed by 3 echocardiographers with left atrial appendage closure device experience. All available transesophageal (TEE) studies in the WATCHMAN left atrial appendage system for embolic protection in patients with atrial fibrillation (PROTECT-AF) trial patients with suspected DRT were reviewed in 2 subsequent phases. In phase 2 (primary blind read), each reviewer independently scored each study for DRT, and final echo criteria were developed. Unanimously scored studies were considered adjudicated, whereas all others were reevaluated by all reviewers in phase 3 (group adjudication read). DRT was suspected in 35 of 485 patients by the site investigator, the echocardiography core laboratory, or both; 93 of the individual TEE studies were available for review. In phase 2, 3 readers agreed on 67 (72%) of time points. Based on phases 1 and 2, 5 DRT criteria were developed. In phase 3, studies without agreement in phase 2 were adjudicated using these criteria. Overall, at least 1 TEE was DRT positive in 27 (5.7%) PROTECT-AF patients. Stroke, peripheral embolism, or cardiac/unexplained death occurred in subjects with DRT at a rate of 3.4 per 100 patient-years follow-up. In conclusion, DRT were identified on at least 1 TEE in 27 PROTECT-AF patients, indicating a DRT incidence of 5.7%. Primary efficacy events in patients with DRT occurred at a rate of 3.4 per 100 patient-years follow-up, intermediate in frequency between event rates previously reported for the overall device and warfarin arms in PROTECT-AF.
A 34‐year‐old woman with history of surgical correction (Takeuchi procedure) of anomalous left coronary artery from the pulmonary artery (ALCAPA) presented with reduced left ventricular ejection ...fraction of 48% and severe ischemia quantified as 21% by stress Positron Emission Tomography (PET) scan. A coronary angiogram revealed ostial 90% stenosis of the left main coronary artery (LMCA). A guidewire (Sion Blue, Asahi Intecc USA, Inc., Santa Ana, CA) was navigated robotically and after pre‐dilation with 3.5 × 15 mm cutting balloon, the lesion length was measured by marking the distal end of the lesion with the balloon marker and withdrawing back robotically to the ostium of the LMCA. A 3.5 × 16 mm drug‐eluting stent was deployed robotically after intravascular ultrasound (IVUS) with good results. The main advantage of robotic percutaneous coronary intervention includes the precise measurement and positioning of the stent. Since the guide catheter and balloon can be adjusted without guide catheter and device interaction, precise placement of stent is possible by advancing the device distal to the lesion, positioning the guide catheter just proximal to the proximal edge of the stent and pulling the guidecatheter and device back as a unit. Final IVUS after post‐dilation with 4.0 noncompliant and 5.0 compliant balloon revealed precise placement at the ostium and full stent expansion.
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