Left atrial appendage occlusion for atrial fibrillation and bleeding diathesis

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.     

Atrial fibrillation detection using insertable cardiac monitor after stroke: A real-world cohort study

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.     

An updated systematic review and meta‐analysis of early outcomes after left atrial appendage occlusion

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.     

Non-vitamin K antagonist oral anticoagulation versus left atrial appendage occlusion for primary and secondary stroke prevention after cardioembolic stroke

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.     

Novel streamlined technique for left atrial appendage closure using a radiofrequency wire-based large access system

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.     

Left atrial appendage closure in end-stage renal disease and hemodialysis: Data from a German multicenter registry

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.     

Periprocedural myocardial infarction in patients undergoing complex versus noncomplex percutaneous coronary intervention

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.     

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion: The LAAO Italian Multicenter Registry

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.

Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials

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)     

Implanted endocardial lead characteristics and risk of stroke or transient ischemic attack

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?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.     

Medium-Term Follow-Up of Early Leaflet Thrombosis After Transcatheter Aortic Valve Replacement

Objectives

The aim of this study was to investigate medium-term outcomes in patients with leaflet thrombosis (LT).

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

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.     

First‐in‐human experience of left atrial appendage occlusion with the steerable FuStar sheath

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.

     

Intracardiac versus transesophageal echocardiography for left atrial appendage occlusion with watchman

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.     

Improved left atrial appendage closure procedural efficiency using radiofrequency transseptal wire system

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.     

Effect of patent foramen ovale closure for prevention on recurrent stroke or transient ischemic attack in selected patients with cryptogenic stroke

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.

     

How do anticoagulated atrial fibrillation patients who suffer ischemic stroke or spontaneous intracerebral hemorrhage differ?

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.     

PFO closure vs. medical therapy in cryptogenic stroke or transient ischemic attack: A systematic review and meta-analysis

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.     

A Randomized,Double-Blind,Placebo-Controlled Study of the Safety and Efficacy of Intravenous MCC-135 as an Adjunct to Primary Percutaneous Coronary Intervention in Patients with Acute Myocardial Infarction: Rationale and Design of the Evaluation of MCC-135 for Left Ventricular Salvage in Acute MI (EVOLVE) Study

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.     

Problems,Interventions and Complications in Long-Term Oral Anticoagulation Therapy

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.