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1.
Balrik Singh Kailey MRCP Michael Koa-Wing PhD Nilesh Sutaria PhD Tom Mott BA Afzal Sohaib PhD Norman Qureshi PhD Christine Shi MRCP Pritpal Padam MBBS James Howard PhD Prapa Kanagaratnam PhD 《Journal of cardiovascular electrophysiology》2023,34(12):2552-2562
Background
Patients with atrial fibrillation (AF) and likelihood of bleeding can undergo left atrial appendage occlusion (LAAO) as an alternative method of stroke prophylaxis. Short-term anti-thrombotic drugs are used postprocedure to offset the risk of device-related thrombus, evidence for this practice is limited.Objectives
To investigate optimal postimplant antithrombotic strategy in high bleeding-risk patients.Methods
Patients with AF and high-risk for both stroke and bleeding undergoing LAAO were advised their perioperative drug therapy by a multidisciplinary physician panel. Those deemed to be at higher risk of bleeding from anti-thrombotic drugs were assigned to minimal treatment with no antithrombotics or Aspirin-alone. The remaining patients received standard care (STG) with a 12 week course of dual-antiplatelets or anticoagulation postimplant. We compared mortality, device-related thrombus, ischemic stroke, and bleeding events during the 90 days postimplant and long-term. Event-free survival was assessed using Kaplan−Meier survival analysis, with logrank testing for statistical significance.Results
Seventy-five patients underwent LAAO of whom 63 patients (84%) had a prior serious bleeding event. The 42 patients on minimal treatment were older (74.3 ± 7.7 vs. 71.2 ± 7.2) with higher HASBLED score (3.6 ± 0.9 vs. 3.3 ± 1.2) than the 33 patients having standard care. There were no device-related thrombi or strokes in either group at 90 days postprocedure; STG had more bleeding events (5/33 vs. 0/42, p = 0.01) with associated deaths (3/33 vs. 0/42, p = 0.05). During long-term follow-up (median 2.2 years), all patients transitioned onto no antithrombotic drugs (43 patients [61%]) or a single-antiplatelet (29 patients [39%]). There was no evidence of early minimal treatment adversely affecting long-term outcomes.Conclusions
Short-term anti-thrombotic drugs may not be needed after LAAO implant in patients with high bleeding risk and could be harmful. Larger, prospective studies would be warranted to test these findings. 相似文献2.
Jean J. Noubiap MD MMed Gijo Thomas PhD Melissa E. Middeldorp PhD John L. Fitzgerald MBBS Curtis Harper CCDS Prashanthan Sanders MBBS PhD 《Journal of cardiovascular electrophysiology》2023,34(1):142-146
Objective
This study aimed to report the real-world atrial fibrillation (AF) diagnostic yield of the implantable cardiac monitor (ICM) in patients with stroke or transient ischemic attack (TIA), and compare it to patients with an ICM for unexplained syncope.Methods
We used patient data from device clinics across the United States of America with ICM remote monitoring via PaceMate™, implanted for stroke or TIA, and unexplained syncope. Patients with known AF or atrial flutter were excluded. The outcome was AF lasting ≥2 min, adjudicated by International Board of Heart Rhythm Examiners certified cardiac device specialists.Results
We included a total of 2469 patients, 51.1% with stroke or TIA (mean age: 69.7 [SD: 12.2] years, 41.1% female) and 48.9% with syncope (mean age: 67.0 [SD: 17.1] years, 59.4% female). The cumulative AF detection rate in patients with stroke or TIA was 5.5%, 8.9%, and 14.0% at 12, 24, and 36 months, respectively. The median episode duration was 73 (interquartile range: 10–456) min, ranging from 2 min to 40.9 days, with 52.3%, 28.6%, and 4.4% of episodes lasting at least 1, 6, and 24 h, respectively. AF detection was increased by age (adjusted hazard ratio [for every 1-year increase]: 1.024, 95% confidence interval: 1.008–1.040; p = .003), but was not influenced by sex (p = .089). For comparison, the cumulative detection rate at 12, 24, and 36 months were, respectively, 2.4%, 5.2%, and 7.4% in patients with syncope.Conclusion
Patients with stroke or TIA have a higher rate of AF detection. However, this real-world study shows significantly lower AF detection rates than what has been previously reported. 相似文献3.
An updated systematic review and meta‐analysis of early outcomes after left atrial appendage occlusion
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Charan Yerasi MD Mohamad Lazkani MD Prathik Kolluru MD Varun Miryala MD Jae Kim MD Harsha Moole MD Abhishek C. Sawant MD MPH Michael Morris MD Ashish Pershad MD 《Journal of interventional cardiology》2018,31(2):197-206
Background
Left atrial appendage occlusion (LAAO) is a promising intervention for stroke prevention in patients with non‐valvular atrial fibrillation (NVAF). Early outcomes following LAAO have been published in many studies with variable results.Objective
This updated meta‐analysis aims to provide a summary of the early outcomes of LAAO.Methods
Medline/Pubmed, Ovid Journals, Clinical trials, Abstract meetings, Cochrane databases were searched from January 1st, 1999 to November 30th, 2016.Results
This meta‐analysis included 49 studies involving 12 415 patients. The median age was 73.5 years (IQR 72‐75 years) and 43% were males. Hypertension and diabetes were present in 36% and 15% of the population, respectively. There was a prior history of stroke and congestive heart failure in 14% and 18% of the population, respectively. The median CHADS2 score was 2.9 (IQR 2.6‐3.3) and the median HASBLED score was 3.3 (IQR 3‐4). LAAO implantation was successful in 96.3% of patients (95.40‐97.08, I2 = 76.1%). The pooled proportion of all‐cause mortality was 0.28% (0.19‐0.38, I2 = 0%). The pooled proportion of all‐cause stroke was 0.31% (0.22‐0.42, I2 = 9.4%), major bleeding requiring transfusion was 1.71% (1.13‐2.41, I2 = 73.2%), and pericardial effusion was 3.25% (2.46‐4.14, I2 = 79%). Sub analysis of randomized clinical trials comparing LAAO devices to warfarin showed lower mortality (P = 0.03) with similar bleeding risk (P = 0.20) with LAAO.Conclusions
This meta‐analysis concludes that LAAO occlusion is a safe and effective stroke prevention strategy in patients with NVAF. 相似文献4.
Luís Paiva José Coelho Sérgio Barra Marco Costa João Sargento-Freitas Luís Cunha Lino Gonçalves 《Revista portuguesa de cardiologia》2021,40(5):357-365
IntroductionThis study aimed to evaluate the performance of non-vitamin K antagonist oral anticoagulation (NOAC) in patients with previous stroke and non-valvular atrial fibrillation (AF) compared with left atrial appendage occlusion (LAAO) in primary and secondary stroke prevention settings.MethodsThis was a prospective, single-center, non-randomized cohort study of 302 consecutive patients with non-valvular AF and at high risk for stroke. Two treatment strategies were compared: LAAO (n=91) and long-term treatment with NOAC (n=149). The primary outcome was the composite endpoint of death, stroke and major bleeding. Propensity score and cause-of-death analyses were performed to compare outcomes.ResultsIn a mean follow-up of 13 months, there were 30 deaths (LAAO 8.8% vs. NOAC 14.8%), five strokes (LAAO 1.1% vs. NOAC 2.7%) and six major bleeds (LAAO 1.1% vs. NOAC 3.4%). There was a non-significant trend for a lower incidence of the primary endpoint in the LAAO group (11.0% vs. 20.9%; HR 0.42, 95% CI 0.17-1.05, p=0.064). Considering only secondary prevention LAAO patients (34.1% of the LAAO group), there was also a non-significant lower incidence of the primary endpoint (LAAO 6.5% vs. 20.9%; HR 0.30, 95% CI 0.07-1.39, p=0.12). While about a fifth of LAAO patients stopped antiplatelet treatment six months after device implantation due to recurrent minor bleeding, no adverse cardiovascular event or major bleeding occurred in this subset of patients.ConclusionIn this registry-based study, LAAO was a reasonable alternative to NOAC for the prevention of a composite endpoint of all-cause mortality, stroke and major bleeding in patients at high risk for stroke. 相似文献
5.
Issa K. Asfour MD Mohanad Elchouemi Carola Gianni MD PhD Rami Helmy David R. Tschopp MD Rodney P. Horton MD Andrea Natale MD Amin Al-Ahmad MD 《Journal of cardiovascular electrophysiology》2023,34(8):1690-1697
Introduction
Transseptal puncture (TSP) to allow for large delivery sheath left atrial (LA) access remains a challenging aspect of LA appendage closure (LAAC) in patients with prior history of TSP, thick or lipomatous septum, atrial septal aneurysms, or other complex cardiac anatomies. This study investigates the use of the VersaCross large access (VLA) system (Baylis Medical/Boston Scientific) to improve procedural efficiency of LAAC compared to the standard needle workflow.Methods and Results
Fifty LAAC procedures using WATCHMAN FLX between November 2021 and September 2022 were retrospectively analyzed comparing the VLA workflow (n = 25) to the standard needle workflow (n = 25). Study primary endpoint was time to procedural efficiency, and secondary endpoints included TSP time, acute LAAC success, fluoroscopy use, device recaptures, and periprocedural complications. Acute LAAC was successfully completed in all cases with no intraprocedural complications. TSP time was faster, but not significant, using the VLA workflow compared to the standard RF needle workflow (2.6 ± 1.1 min vs. 3.0 ± 1.8 min, p = 0.38). Time to WATCHMAN sheath in LA from TSP was 27% faster (1.5 ± 0.8 min vs. 2.1 ± 0.9 min; p = 0.03), and time to WATCHMAN release from TSP was 19% faster (10.5. ± 2.5 min vs. 13.0 ± 3.7 min; p = 0.01) with the VLA workflow. Overall procedure time was 15% faster (30.4 ± 5.1 min vs. 36.0 ± 6.6 min; p = 0.003) using VLA. Fluoroscopy time was 25% lower (4.0 ± 2.2 min vs. 5.5 ± 2.3 min; p = 0.003) and fluoroscopy dose was 60% lower (97.0 ± 91.7 mGy vs. 241.8 ± 240.6 mGy; p = 0.01) and more consistent [F-test, p ˂ 0.0001] using the VLA workflow compared to the needle workflow.Conclusion
The VLA system streamlines LAAC procedures, improving LAAC efficiency and reducing fluoroscopy use by allowing for de novo dilation of the septum for large-bore delivery sheaths, and reducing device exchanges and delivery sheath manipulation. 相似文献6.
Thomas Fink MD Christina Paitazoglou MD Martin W. Bergmann MD Makoto Sano MD PhD Ahmad Keelani MD Vanessa Sciacca MD Mohammed Saad MD Charlotte Eitel MD Christian-Hendrik Heeger MD Carsten Skurk MD Ulf Landmesser MD Holger Thiele MD Thomas Stiermaier MD Georg Fuernau MD Jan-Christian Reil MD Norbert Frey MD Karl-Heinz Kuck MD Roland R. Tilz MD Marcus Sandri MD Ingo Eitel MD 《Catheterization and cardiovascular interventions》2023,101(3):610-619
Background
Left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). OAC treatment has been proven feasible in mild-to-moderate chronic kidney disease (CKD). In contrast, the optimal antithrombotic management of AF patients with end-stage renal disease (ESRD) is unknown and LAAC has not been proven in these patients in prospective randomized clinical trials.Objectives
The objective of this study is to evaluate safety and efficacy of LAAC in patients with ESRD.Methods
Patients undergoing LAAC were collected in a German multicenter real-world observational registry. A composite endpoint consisting of the occurrence of ischemic stroke/transient ischemic attack, systemic embolism, and/or major clinical bleeding was assessed. Patients with ESRD were compared with propensity score-matched patients without severe CKD. ESRD was defined as a glomerular filtration rate < 15 ml/min/1.73 m2 or chronic hemodialysis treatment.Results
A total of 604 patients were analyzed, including 57 with ESRD and 57 propensity-matched patients. Overall, 596 endocardial and 8 epicardial LAAC procedures were performed. Frequency of major complications was 7.0% (42/604 patients) in the overall cohort, 8.8% (5/57 patients) in patients with ESRD, and 10.5% (6/57 patients) in matched controls (p = 0.75). The estimated event-free survival of the combined endpoint after 500 days was 90.7 ± 4.5% in patients with ESRD and 90.2 ± 5.5% in matched controls (p = 0.33).Conclusions
LAAC had comparable procedural safety and clinical efficacy in patients with ESRD and patients without severe CKD. 相似文献7.
Raffaele Piccolo MD PhD Attilio Leone MD Fiorenzo Simonetti MD Marisa Avvedimento MD Domenico Angellotti MD Lina Manzi MD Nicola Verde MD Carmen Anna Maria Spaccarotella MD Luigi Di Serafino MD PhD Plinio Cirillo MD PhD Giuseppe Gargiulo MD PhD Giuliana Fortunato MD PhD Anna Franzone MD PhD Giovanni Esposito MD PhD 《Catheterization and cardiovascular interventions》2023,102(2):212-220
Background
Limited data are available on the risk of periprocedural myocardial infarction (MI) in patients undergoing complex versus noncomplex percutaneous coronary intervention (PCI).Methods
We assessed the risk of periprocedural MI according to the fourth Universal definition of myocardial infarction (UDMI) and several other criteria among patients undergoing elective PCI in a prospective, single-center registry. Complex PCI included at least one of the following: 3 coronary vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, treatment of chronic total occlusion, and use of rotational atherectomy.Results
Between 2017 and 2021, we included 1010 patients with chronic coronary syndrome, of whom 226 underwent complex PCI (22.4%). The rate of periprocedural MI according to the fourth UDMI was significantly higher in complex compared to noncomplex PCI patients (26.5% vs. 14.5%, p < 0.001). Additionally, periprocedural MI was higher in the complex PCI group using SCAI (4% vs. 1.1%, p = 0.009), ARC-2 (13.7% vs. 8.0%, p = 0.013), ISCHEMIA (5.8% vs. 1.7%, p = 0.002), and EXCEL criteria (4.9% vs. 2.0%, p = 0.032). SYNTAX periprocedural MI occurred at low rates in both groups (0.9% vs. 0.6%, p = 0.657). Complex PCI was an independent predictor of the fourth UDMI periprocedural MI (odds ratio [OR] 1.54, 95% confidence interval [CI]: 1.04–2.27, p = 0.031).Conclusions
In patients with chronic coronary syndrome undergoing elective PCI, complex PCI is associated with a significantly higher risk of periprocedural MI using multiple definitions. These findings highlight the importance of considering upfront this risk in the planning of complex PCI procedures. 相似文献8.
Sergio Berti Luigi Emilio Pastormerlo Gennaro Santoro Elvis Brscic Matteo Montorfano Luigi Vignali Paolo Danna Claudio Tondo Marco Rezzaghi Gianpiero D’Amico Amerigo Stabile Salvatore Saccà Giuseppe Patti Antonio Rapacciuolo Arnaldo Poli Paolo Golino Paolo Magnavacchi Francesco Meucci Giuseppe Tarantini 《JACC: Cardiovascular Interventions》2018,11(11):1086-1092
Objectives
This study sought to evaluate the feasibility, safety, and efficacy of intracardiac echocardiography (ICE)–guided versus transesophageal echocardiography (TEE)–guided left atrial appendage occlusion (LAAO) by the use of Amplatzer Cardiac Plug or Amulet devices included in a large Italian registry.Background
TEE is widely used for LAAO procedure guidance. ICE may be a potential alternative imaging modality in LAAO.Methods
Data from 604 LAAO procedures performed in 16 Italian centers were reviewed. ICE-guided LAAO was performed in 187 patients, whereas TEE was used in 417 patients. Procedural success was defined as LAAO without occurrence of pericardial tamponade, stroke, systemic embolism with end organ damage, major bleeding, and device embolization. Stroke, transient ischemic attack, major bleeding, overall and cardiovascular death were analyzed.Results
CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65 to 74 years, sex category) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores were similar between the ICE and TEE groups. TEE implied lower procedural (delta 12 min) and fluoroscopy time (delta 5 min) when compared with ICE. Procedural success was similarly high (≥94%) between the TEE and ICE groups with a complication rate of 6.5% for TEE versus 4.2% for ICE (odds ratio: 1.468; 95% confidence interval: 0.681 to 3.166; p = 0.327). At median follow-up of 451 days (interquartile range: 162 to 899 days), the rate of cerebral ischemic events was similar between TEE-guided and ICE-guided procedures.Conclusions
ICE-guided LAAO by means of Amplatzer devices may represent a second alternative imaging modality after an appropriate learning curve and bearing in mind that pre-procedural computed tomography imaging is mandatory. When comparing ICE with TEE, TEE remains the gold standard. 相似文献9.
《JACC: Cardiovascular Interventions》2022,15(9):950-961
ObjectivesThe aim of this study was to compare outcomes among patients from the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) left atrial appendage occlusion (LAAO) trials with matched patients from the National Cardiovascular Data Registry LAAO Registry using patient-level data.BackgroundPatients undergoing LAAO in clinical practice generally have more comorbidities than trial participants.MethodsPropensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models.ResultsA total of 1,904 registry patients were matched to 667 trial LAAO patients; 1,010 registry patients were matched to 348 warfarin patients. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention (3.8% vs 0.6%, P < 0.001), periprocedural ischemic stroke (0.9% vs 0.2%, P = 0.005), and failed device implantation (7.5% vs 3.6%, P < 0.001). The 425-day risk of ischemic stroke in trial LAAO patients was higher than in registry patients (2.70% vs 1.21%; HR: 1.951; P = 0.03); warfarin patients had comparable rates of ischemic stroke compared with registry patients (1.15% vs 1.29%; HR: 0.728; P = 0.57). Hemorrhagic stroke risk was similar among trial LAAO and registry patients (P = 0.88). Hemorrhagic stroke risk was greater among warfarin patients versus registry patients (1.44% vs 0.20%; HR: 5.871, P = 0.03). Mortality was lower in trial LAAO patients than in registry patients (2.92% vs 6.23%; HR: 0.477; P = 0.004), a difference attributable to noncardiovascular deaths. Mortality was similar (P = 0.44) among trial warfarin (4.48%) and registry (5.86%) patients.ConclusionIn clinical practice, patients who meet trial criteria and undergo LAAO experience a lower risk of ischemic stroke, a similar risk of hemorrhagic stroke, and a higher risk of death after implant versus LAAO trial patients. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation [PROTECT-AF], NCT00129545; Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL], NCT01182441) 相似文献
10.
Vaibhav R. Vaidya Christopher V. DeSimone Samuel J. Asirvatham Vishnu M. Chandra Amit Noheria David O. Hodge Joshua P. Slusser Alejandro A. Rabinstein Paul A. Friedman 《Journal of interventional cardiac electrophysiology》2014,41(1):31-38
Introduction
Patent foramen ovale (PFO) has been recently implicated as a strong predictor of stroke or transient ischemic attack (TIA) in patients with implanted pacemaker or defibrillation leads. Leads in the right heart can form thrombi that embolize to the pulmonary circulation and raise pulmonary pressure. This increases right-to-left shunting through PFO or intrapulmonary shunts and can result in paradoxical embolism. We sought to determine whether certain lead characteristics confer a higher thrombogenic risk resulting in stroke/TIAs in patients either with or without a PFO.Methods
We retrospectively analyzed 5,646 patients (mean age 67.3?±?16.3 years, 64 % male) who had endocardial device leads implanted in 2000–2010. We performed univariate and multivariate-adjusted proportional hazards models to determine association of lead characteristics with stroke/TIA during follow-up.Results
On univariate analysis, passively fixated tined leads were associated with more stroke/TIAs (HR 1.77, 95 % CI 1.27, 2.47; p?0.001), whereas presence of defibrillation coil was associated with fewer stroke/TIAs (HR 0.59, 95 % CI 0.42–0.84; p?=?0.003). Number of leads per patient, presence of atrial lead, maximum lead size, tip shape, and type of insulating material were not associated with stoke/TIA. On multivariate analyses adjusting for age, sex, diagnosis of PFO, and prior history of stroke/TIA, the presence of tined leads was associated with stroke/TIA (HR 1.41, 95 % CI 1.00–1.97; p?=?0.049). Defibrillation coils were no longer associated with lower stroke/TIA on multivariate analysis.Conclusions
Most physical characteristics of contemporary leads do not impact rate of stroke/TIA among patients receiving implantable devices. The presence of a PFO is a major risk factor for stroke/TIA in patients with endovascular leads. 相似文献11.
Philipp Ruile Jan Minners Philipp Breitbart Simon Schoechlin Michael Gick Gregor Pache Franz-Josef Neumann Manuel Hein 《JACC: Cardiovascular Interventions》2018,11(12):1164-1171
Objectives
The aim of this study was to investigate medium-term outcomes in patients with leaflet thrombosis (LT).Background
The clinical significance of early LT after transcatheter aortic valve replacement, diagnosed by computed tomography angiography in approximately 10% of patients, is uncertain.Methods
In this observational study, computed tomographic angiography was performed a median of 5 days after transcatheter aortic valve replacement and assessed for evidence of LT. Follow-up consisted of clinical visits, telephone contact, or questionnaire.Results
LT was diagnosed in 120 of 754 patients (15.9%). Patients with LT were less likely male (36.7% vs. 47.0%, p = 0.045), with a lower rate of atrial fibrillation (28.3% vs. 41.5%, p = 0.008). Peri- and post-procedural characteristics were comparable between groups (e.g., valve implantation technique; p = 0.116). During a median follow-up period of 406 days, there were no significant differences in the primary endpoint of all-cause mortality and the secondary combined endpoint of stroke and transient ischemic attack between patients with LT and those without LT (18-month Kaplan-Meier estimate for mortality 86.6% vs. 85.4%, p = 0.912; for stroke- or transient ischemic attack–free survival 98.5% vs. 96.8%, p = 0.331). In univariate and multivariate analyses, LT was not predictive of either endpoint, whereas male sex (p = 0.03), atrial fibrillation (p = 0.002), and more than mild paravalvular leak (p = 0.015) were associated with all-cause mortality.Conclusions
In this prospective observational cohort undergoing post–transcatheter aortic valve replacement computed tomographic angiography, LT was not associated with increased mortality or rates of stroke over a follow-up period of 406 days. 相似文献12.
David R. Holmes Jr. Saibal Kar Matthew J. Price Brian Whisenant Horst Sievert Shephal K. Doshi Kenneth Huber Vivek Y. Reddy 《Journal of the American College of Cardiology》2014
Background
In the PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) trial that evaluated patients with nonvalvular atrial fibrillation (NVAF), left atrial appendage (LAA) occlusion was noninferior to warfarin for stroke prevention, but a periprocedural safety hazard was identified.Objectives
The goal of this study was to assess the safety and efficacy of LAA occlusion for stroke prevention in patients with NVAF compared with long-term warfarin therapy.Methods
This randomized trial further assessed the efficacy and safety of the Watchman device. Patients with NVAF who had a CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes mellitus, and previous stroke/transient ischemic attack) score ≥2 or 1 and another risk factor were eligible. Patients were randomly assigned (in a 2:1 ratio) to undergo LAA occlusion and subsequent discontinuation of warfarin (intervention group, n = 269) or receive chronic warfarin therapy (control group, n = 138). Two efficacy and 1 safety coprimary endpoints were assessed.Results
At 18 months, the rate of the first coprimary efficacy endpoint (composite of stroke, systemic embolism [SE], and cardiovascular/unexplained death) was 0.064 in the device group versus 0.063 in the control group (rate ratio 1.07 [95% credible interval (CrI): 0.57 to 1.89]) and did not achieve the prespecified criteria noninferiority (upper boundary of 95% CrI ≥1.75). The rate for the second coprimary efficacy endpoint (stroke or SE >7 days’ postrandomization) was 0.0253 versus 0.0200 (risk difference 0.0053 [95% CrI: –0.0190 to 0.0273]), achieving noninferiority. Early safety events occurred in 2.2% of the Watchman arm, significantly lower than in PROTECT AF, satisfying the pre-specified safety performance goal. Using a broader, more inclusive definition of adverse effects, these still were lower in PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial than in PROTECT AF (4.2% vs. 8.7%; p = 0.004). Pericardial effusions requiring surgical repair decreased from 1.6% to 0.4% (p = 0.027), and those requiring pericardiocentesis decreased from 2.9% to 1.5% (p = 0.36), although the number of events was small.Conclusions
In this trial, LAA occlusion was noninferior to warfarin for ischemic stroke prevention or SE >7 days’ post-procedure. Although noninferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. Procedural safety has significantly improved. This trial provides additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy. 相似文献13.
First‐in‐human experience of left atrial appendage occlusion with the steerable FuStar sheath
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Caroline Kleinecke MD Omar Gomez Monterrosas MD Giancarla Scalone MD Yat‐Yin Lam Eun‐Seok Shin MD Barbara Bellmann MD Johannes Brachmann MD Jai‐Wun Park MD 《Journal of interventional cardiology》2018,31(4):532-537
Background
Due the wide variability of left atrial appendage morphology left atrial appendage occlusion (LAAO) remains a challenging procedure. The steerable FuStar delivery sheath was designed to allow both, transseptal access and delivery of percutaneous devices. We here report the first‐in‐human experience of LAAO with the FuStar sheath.Methods
Twenty patients (76.6 ± 8.4 years; 12 (60%) males; CHA2DS2‐VASc score: 5.0 ± 2) with non‐valvular fibrillation and contraindications to oral anticoagulation underwent LAAO with the LAmbre device using the FuStar steerable sheath (Lifetech Scientific Corp., Shenzhen, China) at two german centers.Results
Successful device implantation was achieved in all patients (100%). No periprocedural complications were observed. Procedure time, fluoroscopy time, contrast media, and radiation dose were 23.4 min ± 9.2, 11.9 min ± 4.1, 96.2 mL ± 45.7, and 2718.4 cG*cm2 ± 3835.3, respectively.Conclusion
This study demonstrates the feasibility and safety of the steerable FuStar sheath for LAAO.14.
Intracardiac versus transesophageal echocardiography for left atrial appendage occlusion with watchman
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Antonio H. Frangieh MD Jasmina Alibegovic MD Christian Templin MD Oliver Gaemperli MD Slayman Obeid MD Robert Manka MD Erik W. Holy MD Willibald Maier MD Thomas F. Lüscher MD Ronald K. Binder MD 《Catheterization and cardiovascular interventions》2017,90(2):331-338
Background: Left atrial appendage occlusion (LAAO) is mostly performed by transesophageal echocardiography (TEE) guidance. Intracardiac echocardiography (ICE) may be an alternative imaging modality for LAAO that precludes the need for general anesthesia or sedation. Methods and Results: All consecutive single center, single operator LAAO candidates were analyzed. Baseline clinical and procedural characteristics and in‐hospital outcomes were compared between patients in whom a Watchman was implanted with ICE vs. TEE guidance. In 76 consecutive patients the Watchman device was deployed under ICE in 32 patients (42%) and under TEE guidance in 44 patients (58%). Baseline characteristics were comparable between groups, except that patients in the TEE group were older (81 [75–85] years vs. 75 [68–80] years, P = 0.007). Total injected contrast media as well as fluoroscopy time were comparable between groups (90 ml [54–140] vs. 85 ml [80–110], P = 0.86 and 7.9 min [6.4–15.5] vs. 9.8 min [7.0–13.2], P = 0.51, for TEE vs. ICE, respectively). However, time from femoral venous puncture to transseptal puncture and to closure was longer in the ICE group (14 min [7.3–20] vs. 6 min [3.3–11], P = 0.007 and 48 min [40–60] vs. 34.5 min [27–44], P = 0.003, respectively). In the TEE group one patient suffered esophageal erosion with bleeding, which was managed conservatively and one non‐LAAO related in‐hospital mortality occurred in an 88‐year‐old patient. Device implantation success rate was 100% in both groups. No device embolization, no significant peri‐device leak, no tamponade, no stroke, and no access site bleeding occurred in any patient. Total hospital stay for stand‐alone LAAO was comparable between groups (2 days [2–2] vs. 2 days [2–3.3], P = 0.17, in ICE vs. TEE, respectively). Conclusions: ICE guidance for LAAO with the Watchman device is feasible and comparable to TEE and may become the preferred imaging modality for LAAO. © 2016 Wiley Periodicals, Inc. 相似文献
15.
Cameron Whitler DO Brittni McClellan MD Harshil Patel MD Dhruv Rajpurohit DO Frank Kalaba MD Herman Kado MD Shukri David MD Dipak Shah MD FHRS 《Catheterization and cardiovascular interventions》2023,101(2):460-467
Objective
The radiofrequency (RF) needle has been shown to improve transseptal puncture efficiency and safety compared to mechanical needles. This study aimed to investigate the use of VersaCross RF transseptal wire system (Baylis Medical) to improve procedural efficiency of left atrial appendage closure (LAAC) compared to the standard RF needle-based workflow.Methods
Eighty-one LAAC procedures using WATCHMAN FLX were retrospectively analyzed comparing the standard RF needle-based workflow to a RF wire-based workflow. Study primary endpoint was time to WATCHMAN device release, and secondary endpoints were transseptal puncture time, LAAC success, fluoroscopy use, and procedural complications.Results
Twenty-five cases using standard RF needle-based workflow were compared to 56 cases using the RF wire-based workflow. Baseline patient characteristics were similar between both groups. LAAC was successful in all patients with no differences in intraprocedural complication rates (p = 0.40). Transseptal puncture time was 1.3 min faster using the RF wire-based workflow compared to the standard RF needle-based workflow (6.5 ± 2.3 vs. 7.8 ± 2.3 min, p = 0.02). Overall, time to final WATCHMAN device release was 4.5 min faster with the RF wire-based workflow compared to the RF needle-based workflow (24.6 ± 5.6 vs. 29.1 ± 9.6 min, p = 0.01). Fluoroscopy time was 21% lower using the RF wire-based workflow (7.6 ± 2.8 vs. 9.6 ± 4.4 min; p = 0.05) and fluoroscopy dose was 67% lower (47.1 ± 35.3 vs. 144.9 ± 156.9 mGy, p = 0.04) and more consistent (F-test, p ˂ 0.0001).Conclusions
The RF wire-based workflow streamlines LAAC procedures, improving LAAC efficiency and safety by reducing fluoroscopy, device exchanges, and delivery sheath manipulation. 相似文献16.
Effect of patent foramen ovale closure for prevention on recurrent stroke or transient ischemic attack in selected patients with cryptogenic stroke
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Minsu Kim MD Sihoon Kim MD Jeonggeun Moon MD Pyung Chun Oh MD Yae Min Park MD Dong Hoon Shin MD Yeong‐Bae Lee MD Ji Yeon Lee MD Hee Young Hwang MD Woong Chol Kang MD 《Journal of interventional cardiology》2018,31(3):368-374
Objectives
This study was sought to evaluate the effectiveness of patent foramen ovale (PFO) closure in selected patients (PFO shunt grade more than moderate) with cryptogenic stroke (CS).Background
Whether closure of PFO is an effective treatment for prevention of CS is still unclear.Methods
Consecutive 158 patients (mean age: 49.9 years old, closure group: 67 patients, medication group: 91 patients) were enrolled. The primary end point was a composite of recurrent stroke and transient ischemic attack.Results
Baseline characteristics were similar between the two groups, except age which was younger in the closure group (47.7 ± 10.8 vs 51.9 ± 9.9, P = 0.013), and the presence of shunt at rest was more common in the closure group (35.8% vs 10.4%, P = 0.000). Procedural success was 94.0%. Over a mean follow‐up of 27.8 months, a total of six primary end point, all of which were strokes, occurred only in the medication group (6.6% vs 0%, P = 0.039). Stroke‐free survival rate was significantly higher in the closure group (P = 0.026)Conclusions
Our study showed that PFO closure may be an effective treatment strategy to prevent recurrent stroke or TIA for patients with CS if it is conducted in selective patients who have PFO shunt more than moderate grade.17.
Heidi Lehtola Juha Hartikainen Päivi Hartikainen Tuomas Kiviniemi Ilpo Nuotio Antti Palomäki Antti Ylitalo K.E. Juhani Airaksinen Pirjo Mustonen 《Clinical cardiology》2018,41(5):608-614
Background
Atrial fibrillation (AF) increases risk of ischemic stroke, and oral anticoagulation (OAC) increases risk of intracerebral hemorrhage (ICH). This study aimed to compare OAC‐treated AF patients with an ischemic stroke/transient ischemic attack (TIA) or spontaneous ICH as their first lifetime cerebrovascular event, especially focusing on patients with therapeutic international normalized ratio (INR).Hypothesis
We assumed that in AF patients suffering ischemic stroke/TIA or ICH, patient characteristics could be different in patients with therapeutic INR than in patients with warfarin.Methods
FibStroke is a multicenter, retrospective registry collating details of AF patients with ischemic stroke/TIA or intracranial hemorrhage in 2003–2012. This substudy included AF patients on OAC with first lifetime ischemic stroke/TIA or spontaneous ICH.Results
A total of 1457 patients with 1290 ischemic strokes/TIAs and 167 ICHs were identified. Of these, 553 (42.9%) strokes/TIAs and 96 (57.5%) ICHs occurred in patients with INR within therapeutic range. During OAC with therapeutic INR, congestive heart failure (odds ratio [OR]: 2.33, 95% confidence interval [CI]: 1.18–4.58) and hypercholesterolemia (OR: 2.52, 95% CI: 1.51–4.19) were more common in patients with ischemic stroke/TIA, whereas a history of bleeding (OR: 0.30, 95% CI: 0.11–0.82) was less common when compared with patients with ICH. In the whole cohort, renal impairment (OR: 1.86, 95% CI: 1.23–2.80) and mechanical valve prosthesis (OR: 4.41, 95% CI: 1.32–14.7) were overrepresented in patients with stroke/TIA, whereas aspirin use (OR: 0.52, 95% CI: 0.30–0.91) and high INR (OR: 0.40, 95% CI: 0.33–0.48) were overrepresented in patients with ICH.Conclusions
In anticoagulated AF patients with therapeutic INR and first lifetime cerebrovascular event, congestive heart failure and hypercholesterolemia were associated with ischemic stroke/TIA and history of bleeding with ICH. 相似文献18.
Background/objectives
This study aims to assess whether patent foramen ovale (PFO) closure is superior to medical therapy in preventing recurrence of cryptogenic ischemic stroke or transient ischemic attack (TIA).Methods
We searched PubMed for randomized trials which compared PFO closure with medical therapy in cryptogenic stroke/TIA using the items: “stroke or cerebrovascular accident or TIA” and “patent foramen ovale or paradoxical embolism” and “trial or study”.Results
Among 650 potentially eligible articles, 3 were included including 2303 patients. There was no statistically significant difference between PFO-closure and medical therapy in ischemic stroke recurrence (1.91% vs. 2.94% respectively, OR: 0.64, 95%CI: 0.37–1.10), TIA (2.08% vs. 2.42% respectively, OR: 0.87, 95%CI: 0.50–1.51) and death (0.60% vs. 0.86% respectively, OR: 0.71, 95%CI: 0.28–1.82). In subgroup analysis, there was significant reduction of ischemic strokes in the AMPLATZER PFO Occluder arm vs. medical therapy (1.4% vs. 3.04% respectively, OR: 0.46, 95%CI: 0.21–0.98, relative-risk-reduction: 53.2%, absolute-risk-reduction: 1.6%, number-needed-to-treat: 61.8) but not in the STARFlex device (2.7% vs. 2.8% with medical therapy, OR: 0.93, 95%CI: 0.45–2.11). Compared to medical therapy, the number of patients with new-onset atrial fibrillation (AF) was similar in the AMPLATZER PFO Occluder arm (0.72% vs. 1.28% respectively, OR: 1.81, 95%CI: 0.60–5.42) but higher in the STARFlex device (0.64% vs. 5.14% respectively, OR: 8.30, 95%CI: 2.47–27.84).Conclusions
This meta-analysis does not support PFO closure for secondary prevention with unselected devices in cryptogenic stroke/TIA. In subgroup analysis, selected closure devices may be superior to medical therapy without increasing the risk of new-onset AF, however. This observation should be confirmed in further trials using inclusion criteria for patients with high likelihood of PFO-related stroke recurrence. 相似文献19.
Deliargyris EN Upadhya B Applegate RJ Kontos JL Kutcher MA Riesmeyer JS Sane DC 《Journal of thrombosis and thrombolysis》2005,19(3):147-153
Objectives: To examine the frequency of cerebrovascular complications among patients receiving abciximab (AB) undergoing PCI with prior intracranial hemorrhage (ICH) or recent (< 2 years) ischemic strokes.Background: AB improves clinical outcomes in high-risk patients undergoing percutaneous coronary intervention (PCI); however, the safety of AB in patients with prior stroke has not been adequately studied.Methods: A database review of 7,244 consecutive PCIs, from 7/97 to 10/01, identified 6,190 PCIs performed with AB among which 515 interventions were performed in patients with prior stroke history [ICH or recent ischemic stroke, (n = 101) and remote (> 2 years) ischemic stroke, (n = 414)].Results: The post-PCI stroke rate was significantly higher in patients with prior stroke (2.06% vs. 0.35%, p < 0.001 for all stroke; 0.38% vs. 0.03%, p = 0.023 for ICH). The incidence of ICH among the AB-treated group was 0.065%; a history of prior stroke did not increase the incidence of ICH in the AB-treated group (0.39% vs. 0.0%, p = ns). Moreover, the post-PCI stroke rate was similar between the prior ICH or recent ischemic stroke–group and remote ischemic stroke-group (2 vs. 1.9%; OR: 1.03; 95% CI: 0.21–4.90; p = ns for all strokes; 2% vs. 1.5%; OR: 1.4; 95% CI: 0.27–6.91; p = ns for ischemic stroke). Importantly, no ICH occurred in patients with recent ischemic or any prior ICH stroke.Conclusions: Abciximab, in addition to aspirin, heparin and ADP-inhibitors does not increase the risk of stroke in patients with prior stroke undergoing PCI. 相似文献
20.
Stöllberger C Finsterer J Länger T Schneider B Wehinger C Hopmeier P Slany J 《Journal of thrombosis and thrombolysis》2002,14(1):65-72
Background: If problems, interventions and complications occurring during oral anticoagulation (OAC) are related with age, indication for OAC, hypertension, diabetes, previous stroke, and number of additional drugs.
Material and Methods: Clinical characteristics, additional drugs, problems, interventions and complications of outpatients whose OAC was controlled between two years were registered. Potential gastrointestinal and urologic bleeding sources were eliminated prior to initiation of OAC. Five-hundred-seventy-nine patients (mean age 65 years, 44% female) were observed for 590 patient-years.
Results: Medical problems occurred in 352/100 patient-years (% p-y), organisational problems in 276% p-y, interventions in 636% p-y and complications in 13.8% p-y. Patients >65 years had less organisational problems (254 vs. 302% p-y, p = 0.0092) and interventions (574 vs. 713% p-y, p = 0.0003) than patients 65 years. The 35 patients with heart valve prosthesis had more life-threatening and fatal complications (12% p-y) than the 360 patients with atrial fibrillation (1.0% p-y), 128 patients with venous thromboembolism or 56 patients with other indications (0.0% p-y, p = 0.0024). Problems, interventions and complications were not related with hypertension (n = 297), diabetes (n = 97) or previous stroke (n = 90). Patients with >3 additional drugs/day had a higher complication rate than patients with 3 drugs/day (21 vs. 8.7% p-y, p = 0.0238). Patients with complications had more headache (27 vs. 20% p-y, p = 0.0036), chest pain (45 vs. 27% p-y, p = 0.0150), abdominal pain (25 vs. 15% p-y, p = 0.0350) and pain in the limbs (55 vs. 42% p-y, p = 0.0044) than patients without complications.
Conclusions: By careful monitoring, eliminating potential bleeding sources, treating pain adequately and minimizing additional drugs the complications of OAC can be kept low.
Abbreviated abstract. Aim of the study was to assess if problems, interventions and complications occurring during oral anticoagulation (OAC) in 579 outpatients (mean age 65 years, 44% female) are related with age, indication for OAC, cardiovascular risk factors and number of additional drugs. During 590 patient-years medical problems occurred in 352/100 patient-years (% p-y), organisational problems in 276% p-y, interventions in 636% p-y and complications in 13.8% p-y. Patients >65 years had less organisational problems (254 vs. 302% p-y, p = 0.0092) and interventions (574 vs. 713% p-y, p = 0.0003) than patients 65 years. Patients with heart valve prosthesis had more life-threatening and fatal complications (12% p-y) than atrial fibrillation (1.0% p-y) or venous thromboembolism (p = 0.0024). Problems, interventions and complications were not related with cardiovascular risk factors. Patients with >3 additional drugs/day had a higher complication rate than patients with 3 drugs/day (21 vs. 8.7% p-y, p = 0.0294). By careful monitoring the complications of OAC can be kept low. 相似文献