Intracranial bleeding and associated outcomes in atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion: Insights from National Inpatient Sample 2016-2020.

Background: Percutaneous left atrial appendage occlusion (LAAO) has proved to be a safer alternative for long-term anticoagulation; however, patients with a history of intracranial bleeding were excluded from large randomized clinical trials. Objective: The purpose of this study was to determine outcomes in atrial fibrillation (AF) patients with a history of intracranial bleeding undergoing percutaneous LAAO. Methods: National Inpatient Sample and International Classification of Diseases, Tenth Revision, codes were used to identify patients with AF who underwent LAAO during the years 2016-2020. Patients were stratified based on a history of intracranial bleeding vs not. The outcomes assessed in our study included complications, in-hospital mortality, and resource utilization. Result: A total of 89,300 LAAO device implantations were studied. Approximately 565 implantations (0.6%) occurred in patients with a history of intracranial bleed. History of intracranial bleeding was associated with a higher prevalence of overall complications and in-patient mortality in crude analysis. In the multivariate model adjusted for potential confounders, intracranial bleeding was found to be independently associated with in-patient mortality (adjusted odds ratio [aOR] 4.27; 95% confidence interval [CI] 1.68-10.82); overall complications (aOR 1.74; 95% CI 1.36-2.24); prolonged length of stay (aOR 2.38; 95% CI 1.95-2.92); and increased cost of hospitalization (aOR 1.28; 95% CI 1.08-1.52) after percutaneous LAAO device implantation. Conclusion: A history of intracranial bleeding was associated with adverse outcomes after percutaneous LAAO. These data, if proven in a large randomized study, can have important clinical consequences in terms of patient selection for LAAO devices.

Transcatheter Left Atrial Appendage Closure.

Atrial fibrillation is the most common arrhythmia worldwide, placing a large population at risk for potentially disabling ischemic strokes, yet an estimated 50% of eligible patients cannot tolerate or are contraindicated to receive oral anticoagulation. Within the last 15 years, transcatheter options for left atrial appendage closure (LAAC) have provided a valuable alternative to chronic oral anticoagulation for reducing risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. With newer generation devices such as Watchman FLX and Amulet gaining approval from the US Food and Drug Administration in recent years, several large clinical trials have demonstrated the safety and efficacy of transcatheter LAAC in a population intolerant to systemic anticoagulation. In this contemporary review, we discuss the indications for transcatheter LAAC and the evidence evaluating the use of various device therapies currently available or in development. We also examine current unmet challenges in intraprocedural imaging and controversies in postimplantation antithrombotic regimens. Several ongoing seminal trials are hoping to clarify the role of transcatheter LAAC as a safe, first-line option for all patients with nonvalvular atrial fibrillation.

Outcomes of percutaneous left atrial appendage occlusion device implantation in atrial fibrillation patients based on underlying stroke risk.

AIMS: To determine outcomes in atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion (LAAO) based on the underlying stroke risk (defined by the CHA2DS2-VASc score). METHODS AND RESULTS: Data were extracted from the National Inpatient Sample for calendar years 2016-20. Left atrial appendage occlusion implantations were identified on the basis of the International Classification of Diseases, 10th Revision, Clinical Modification code of 02L73DK. The study sample was stratified on the basis of the CHA2DS2-VASc score into three groups (scores of 3, 4, and ≥5). The outcomes assessed in our study included complications and resource utilization. A total of 73 795 LAAO device implantations were studied. Approximately 63% of LAAO device implantations occurred in patients with CHA2DS2-VASc scores of 4 and ≥5. The crude prevalence of pericardial effusion requiring intervention was higher with increased CHA2DS2-VASc score (1.4% in patients with a score of ≥5 vs. 1.1% in patients with a score of 4 vs. 0.8% in patients with a score of 3, P < 0.01). In the multivariable model adjusted for potential confounders, CHA2DS2-VASc scores of 4 and ≥5 were found to be independently associated with overall complications [adjusted odds ratio (aOR) 1.26, 95% confidence interval (CI) 1.18-1.35, and aOR 1.88, 95% CI 1.73-2.04, respectively] and prolonged length of stay (aOR 1.18, 95% CI 1.11-1.25, and aOR 1.54, 95% CI 1.44-1.66, respectively). CONCLUSION: A higher CHA2DS2-VASc score was associated with an increased risk of peri-procedural complications and resource utilization after LAAO. These findings highlight the importance of patient selection for the LAAO procedure and need validation in future studies.

Case report: a breathtaking complication after ablation-using multi-modal imaging for timely diagnosis of acquired pulmonary vein stenosis and its implication for effective management.

Background: Acquired pulmonary vein stenosis (PVS) is a rare, but serious, complication that can develop after treatment with ablations for atrial fibrillation. Prompt diagnosis is difficult because it can often present similarly to other pulmonary disease processes. Case summary: We describe a 62-year-old female with history of persistent symptomatic atrial fibrillation that resolved status post two radio-frequency ablations who presents with ongoing dyspnoea, productive cough, pleuritic chest pain, and haemoptysis over multiple admissions. She was misdiagnosed with recurrent pneumonias and pulmonary embolism that failed to improve her symptoms. She was referred to our centre for further evaluation finding severe stenosis in the left superior pulmonary vein with complete obliteration of the left inferior pulmonary vein on computed tomography scan. Multi-modal imaging including an echocardiogram and pulmonary angiogram was used to confirm the diagnosis. Percutaneous intervention with transvenous pulmonary vein venoplasty with pulmonary vein stenting of the left upper pulmonary vein was offered which resolved the patient's aforementioned symptoms. Conclusion: Prompt diagnosis of acquired pulmonary vein stenosis is critical to plan for effective management. Our case highlights the need to consider PVS with a high index of clinical suspicion when a patient's medical history is significant for a prior history of ablation. We also review the use of multi-modal imaging to diagnose and plan for effective management with percutaneous intervention.

Iatrogenic Atrial Septal Defect Closure Through the Steerable Guide Catheter: Description of Technique and Single-Center Experience.

OBJECTIVES: To introduce a novel method of direct iatrogenic atrial septal defect (iASD) closure through the MitraClip steerable guide catheter (SGC). BACKGROUND: MitraClip implantation requires transseptal puncture and the creation of an iASD. There are relatively rare instances, such as hemodynamically significant shunting or concerns for embolus, where iASD must be closed during index procedure. In these instances, it may be beneficial to not give up access to left atrium. METHODS: We retrospectively reviewed all iASD closures during MitraClip implantation at our institution from 2015 to 2020. Cases where an ASD occluder was deployed directly through SGC were included. RESULTS: Eleven patients had immediate iASD closure through the SGC. Indications for using this method included concern for paradoxical embolus, large defect size and/or significant shunting. Closure device sizes ranged from 8 to 22 mm. Mean time from removal of clip delivery system to occlusion of iASD was 14.6 minutes. There were no procedural complications related to iASD closure using this method. CONCLUSION: Closure of iASD intra-procedurally directly through transseptal guide sheath via the method described was safe and allowed for continuous left atrium access.

Association of advanced age with procedural complications and in-hospital outcomes from left atrial appendage occlusion device implantation in patients with atrial fibrillation: insights from the National Inpatient Sample of 36,065 procedures.

BACKGROUND: Age-stratified analyses of atrial fibrillation (AF) patients undergoing percutaneous left atrial appendage occlusion (LAAO) are limited. The purpose of current study was to compare in-hospital outcomes in elderly AF patients (age > 80 years) to a relatively younger cohort (age £ 80 years) after LAAO. METHODS: Data were extracted from National Inpatient Sample for calendar years 2015-2018. LAAO device implantations were identified on the basis of International Classification of Diseases, 9th and 10th Revision, Clinical Modification codes of 37.90 and 02L73DK. The outcomes assessed in our study included complications, inpatient mortality, and resource utilization with LAAO. RESULTS: A total of 36,065 LAAO recipients were included in the final analysis, of which 34.6% (n=12,475) were performed on elderly AF patients. Elderly AF patients had a higher prevalence of major complications (6.7% vs. 5.7%, p < 0.01) and mortality (0.4% vs. 0.1%, p < 0.01) after LAAO device implantation in the crude analysis. After multivariate adjustment of potential confounders, age > 80 years was associated with increased risk of inpatient mortality (adjusted odds ratio [aOR] 4.439, 95% confidence interval [CI] 2.391-8.239) but not major complications (aOR 1.084, 95% CI 0.971-1.211), prolonged length of stay (aOR 0.943, 95% CI 0.88-1.101), or increased hospitalization costs (aOR 0.909, 95% CI 0.865-0.955). CONCLUSION: Over 1 in 3 LAAO device implantations occurred in elderly AF patients. After adjusting for potential confounding variables, advanced age was associated with inpatient mortality, but not with other LAAO procedural-related outcomes including major complications, prolonged length of stay, or increased hospitalization costs.

Association of heart failure with procedural complications and in-hospital outcomes from left atrial appendage occlusion device implantation in patients with atrial fibrillation: insights from the national inpatient sample of 62 980 procedures.

AIMS: To determine outcomes in atrial fibrillation (AF) patients undergoing percutaneous left atrial appendage occlusion (LAAO) with concomitant heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: Data were extracted from National Inpatient Sample for calendar years 2015-2019. LAAO device implantations were identified on the basis of ICD-10-CM code of 02L73DK. The outcomes assessed in our study included complications, in-patient mortality, and resource utilization. A total of 62 980 LAAO device implantations were studied. HFpEF (14.4%, n = 9040) and HFrEF (11.2%, n = 7100) were associated with a higher prevalence of major complications and in-patient mortality in crude analysis. In the multivariate model adjusted for potential confounders, HFpEF and HFrEF were not associated with major complications [adjusted odds ratio (aOR) 1.04, 95% confidence interval (CI) 0.93-1.16 and aOR 1.07, 95% CI 0.95-1.21] or in-patient mortality (aOR 1.48, 95% CI 0.85-2.55 and aOR 1.26, 95% CI 0.67-2.38). HFpEF and HFrEF were associated with prolonged length of stay (LOS) > 1 day (aOR 1.41, 95% CI 1.31-1.53 and aOR 1.66, 95% CI 1.53-1.80) and increased hospitalization costs > median cost 24 752$ (aOR 1.26, 95% CI 1.19-1.34 and aOR 1.21, 95% CI 1.13-1.29). CONCLUSION: The prevalence of HF in AF patients undergoing percutaneous LAAO was approximately 26%. HF was not independently associated with major complications and in-patient mortality but was associated with prolonged LOS and higher hospitalization costs.

MitraClip Implantation Guided by Volumetric Intracardiac Echocardiography: Technique and Feasibility in Patients Intolerant to Transesophageal Echocardiography.

Transesophageal echo (TEE) guidance is essential for successful MitraClip implantation. In patients intolerant to TEE, options are limited. Three patients, with contraindications to TEE, underwent MitraClip implantation using volumetric intracardiac echo (vICE). All patients had severe symptomatic degenerative mitral regurgitation (MR) and had successful implantation of at least one clip with reduction of MR to ≤2+ maintained at 30d follow-up. All patients had improvement in functional status without any adverse clinical, clip, or vICE related events. We discuss in detail the technical considerations and limitations to performing the MitraClip procedure with vICE guidance.

Adjunctive use of fluoroscopy during MitraClip implantation reduces procedural complexity: The parallax technique.

BACKGROUND: During MitraClip implantation sub-valvular correction of trajectory and/or alignment may increase adverse clip or leaflet events. With systematic adjunctive use of fluoroscopy ("Parallax technique"), we aimed to assess parameters that minimize the need for corrective measures and help increase procedural efficiency. METHODS: We retrospectively analyzed 30 patients without (Fl-) and 39 patients utilizing adjunctive fluoroscopy (Fl+) during MitraClip implantation. After establishing trajectory and supra-valvular alignment, the Parallax technique was utilized. Trajectory and alignment are maintained during advancement. RESULTS: All patients had 3 or 4+ MR. There were no differences in baseline demographics. The average number of clips (Fl- vs Fl+) was 1.72 ± 0.8 vs 1.59 ± 0.5, p = .57. For the first clip, the need for sub-valvular alignment (80% vs. 36%, p = .0001), eversion with retraction back to left atrium (23% vs. 10%, p = .001) and the number of grasps (2.3 ± 1.2 vs 1.4 ± 0.9) was reduced. The time from transseptal puncture to first clip deployment (71 ± 21 vs 44 ± 16 min, p = .01) was reduced. Procedural success was achieved in all but one patient in the Fl- group (p = ns). There were no differences noted for in-hospital or 30-day outcomes. CONCLUSIONS: Systematic use of a simple and easy to implement "Parallax technique" was associated with reduced need for sub-valvular manipulation and was associated with improved procedural times. Further larger scale studies are needed to assess the applicability of the technique.

Laser Atherectomy for Infrapopliteal Lesions in Patients With Critical Limb Ischemia.

BACKGROUND: Infrapopliteal (IP) lesions are common in patients with critical limb ischemia (CLI). Optimal revascularization strategies including the use of adjunctive atherectomy have the potential to improve the outcomes for these patients. OBJECTIVE: To compare laser atherectomy (LA) vs. balloon angioplasty alone for the treatment of IP lesions in patients with CLI. METHODS: This was a two-center retrospective study of patients with CLI who underwent endovascular interventions for IP lesions. One and 2-year target lesion revascularization (TLR) was the primary outcome. One and 2-year limb loss and major adverse limb events (MALE) were secondary outcomes. Propensity score matching was performed. A Cox regression analysis was used to compare 1- and 2-year outcomes of the two groups. Logistic regression analysis was used to compare the two groups in terms of bail-out stenting and procedural complications. RESULTS: A total of 313 patients with CLI were included; 76 were treated with LA. There was a high degree of lesion complexity in both groups. Consistent with the application of LA in the most complex lesions, lesions in the LA group were significantly longer (165.7 mm vs. 94.1 mm; p < 0.001) and were more frequently TASC C/D (82% vs. 45%; p < 0.001). In-stent restenosis (ISR) lesions were also more common among the LA group (14% vs. 0.4%; p < 0.001). Thrombotic lesions were present in 11% of the LA group vs. 4% in the no LA group (p = 0.04). CTOs were also more common in the LA group (58% vs. 43%; p = 0.024). After propensity matching, there was no difference in the 1 or 2-year TLR rates between the two groups. Similarly, there were no differences between the two groups in terms of 1 or 2-year limb loss or 2-year major adverse limb events. CONCLUSIONS: LA is safe and effective for IP lesions in patients with CLI. There was a higher baseline angiographic complexity in patients treated with LA, suggesting that operators tend to use LA for the treatment of more complicated lesions. There was no difference among the two groups in 1- or 2-year outcomes of TLR of major amputation.

An Allosteric Shift in CD11c Affinity Activates a Proatherogenic State in Arrested Intermediate Monocytes.

Intermediate monocytes (iMo; CD14+CD16+) increase in number in the circulation of patients with unstable coronary artery disease (CAD), and their recruitment to inflamed arteries is implicated in events leading to mortality following MI. Monocyte recruitment to inflamed coronary arteries is initiated by high affinity ß2-integrin (CD11c/CD18) that activates ß1-integrin (VLA-4) to bind endothelial VCAM-1. How integrin binding under shear stress mechanosignals a functional shift in iMo toward an inflammatory phenotype associated with CAD progression is unknown. Whole blood samples from patients treated for symptomatic CAD including non-ST elevation MI, along with healthy age-matched subjects, were collected to assess chemokine and integrin receptor levels on monocytes. Recruitment on inflamed human aortic endothelium or rVCAM-1 under fluid shear stress was assessed using a microfluidic-based artery on a chip (A-Chip). Membrane upregulation of high affinity CD11c correlated with concomitant activation of VLA-4 within focal adhesive contacts was required for arrest and diapedesis across inflamed arterial endothelium to a greater extent in non-ST elevation MI compared with stable CAD patients. The subsequent conversion of CD11c from a high to low affinity state under fluid shear activated phospho-Syk- and ADAM17-mediated proteolytic cleavage of CD16. This marked the conversion of iMo to an inflammatory phenotype associated with nuclear translocation of NF-κB and production of IL-1ß+ We conclude that CD11c functions as a mechanoregulator that activates an inflammatory state preferentially in a majority of iMo from cardiac patients but not healthy patients.

Active smoking is associated with higher rates of incomplete wound healing after endovascular treatment of critical limb ischemia.

The association between active smoking and wound healing in critical limb ischemia (CLI) is unknown. Our objective was to examine in a retrospective cohort study whether active smoking is associated with higher incomplete wound healing rates in patients with CLI undergoing endovascular interventions. Smoking status was assessed at the time of the intervention, comparing active to no active smoking, and also during follow-up visits at 6 and 9 months. Cox regression analysis was conducted to compare the incomplete wound healing rates of the two groups during follow-up. A total of 264 patients (active smokers: n = 41) were included. Active smoking was associated with higher rates of incomplete wound healing in the 6-month univariate Cox regression analysis (hazard ratio (HR) for incomplete wound healing: 4.54; 95% CI: 1.41-14.28; p = 0.012). The 6-month Kaplan-Meier (KM) estimates for incomplete wound healing were 91.1% for the active smoking group versus 66% for the non-current smoking group. Active smoking was also associated with higher rates of incomplete wound healing in the 9-month univariable (HR for incomplete wound healing: 2.32; 95% CI: 1.11-4.76; p = 0.026) and multivariable analysis (HR for incomplete wound healing: 9.09; 95% CI: 1.06-100.0; p = 0.044). The 9-month KM estimates for incomplete wound healing were 75% in the active smoking group versus 54% in the non-active smoking group. In conclusion, active smoking status at the time of intervention in patients with CLI is associated with higher rates of incomplete wound healing during both 6- and 9-month follow-up.

Transjugular mitral valve repair with the MitraClip: A step-by-step guide.

The MitraClip procedure is carried out almost exclusively via the transfemoral approach. However, in some patients transfemoral delivery of MitraClip is not technically feasible (e.g., occluded inferior vena cava or tortuous/obstructive iliofemoral venous anatomy). The technical considerations and challenges of the MitraClip procedure are amplified when an alternate route is considered. We describe a successful case of MitraClip performed via the right internal jugular (IJ) approach in a patient with a flail A3 scallop and previous mitral valve repair. We reviewed prior cases in the literature and discuss step-by-step the pertinent clinical and technical considerations for performing this procedure via the transjugular route. In summary, the right IJ access site provides a reasonable alternative to perform the MitraClip procedure in cases where femoral access is contraindicated or prohibitive. A thorough understanding of the technical considerations is crucial in improving procedural success rates.

A novel clock-face method for characterizing peridevice leaks after left atrial appendage occlusion.

OBJECTIVES: To propose a novel method for mapping leak location and frequency to a clock-face representation of the left atrial appendage (LAA) ostium. BACKGROUND: LAA occlusion with the Watchman device (WD) is an established therapy to reduce thromboembolic events in patients with atrial fibrillation (AF) and intolerance to long-term oral anticoagulation. Postimplantation leaks are known sequelae, but leak locations and characteristics are poorly described. METHODS: We retrospectively reviewed 101 consecutive WD implants from April 2015 to February 2018. Leak locations from 6-week post-implant transesophageal echocardiograms were mapped to a clock-face representation of the LAA ostium: 12:00 as cranial near the limbus, 3:00 as anterior toward the pulmonary artery, 6:00 as caudal near the mitral annulus, and 9:00 as posterior. Patient demographics, LAA dimensions, and procedural characteristics were also collected. RESULTS: Thirty-four patients had ≥1 leak totaling 45 leaks at 6-week follow-up. Baseline patient demographics showed a mean age 77, CHA2 DS2 VASc 4.69, and 64% of patients with permanent AF. No patient had a detectable leak at the time of implant. At 6 weeks, mean leak size was 2.67 ± 0.89 mm with no leak over 5 mm (largest 4.60 mm). Most leaks occurred along the posterior 6:00-12:00 segment (39/45) and the 6:00-9:00 quadrant (16/45). CONCLUSION: Six-week post-WD implant leaks localize to the posterior LAA ostium. This could result from the elliptical LAA orifice, differential LAA tissue composition, or implantation technique. This study provides a novel method for describing the location of post-implant leaks and serves as the basis for further investigations.

Development and validation of a predictive score for anterograde crossing of infrapopliteal chronic total occlusions: (The Infrapop-CTO Score).

BACKGROUND: Patients with critical limb ischemia often have infrapopliteal (IP) chronic total occlusions (CTOs). While revascularization is indicated to prevent major amputation, anterograde crossing of these lesions can be challenging, with high failure rates. OBJECTIVE: To develop and validate a scoring system that can adequately predict successful anterograde crossing of infrapopliteal CTOs. METHODS AND RESULTS: A total of 213 IP CTOs (147 successfully crossed with the anterograde approach vs. 66 where anterograde crossing failed) were included in the analysis. Backwards stepwise selection (p for retention <.05) was used to create a multivariable logistic regression model for the prediction of successful anterograde crossing using variables that were found to have a p < .1 in univariate analysis. The model was internally validated with bootstrapping and demonstrated excellent discriminatory ability (C-statistic 0.78 and Hosmer-Lemeshow p value = .61). A point score based on the beta-coefficient of the model variables was created, with one point assigned for presence of a noncentral (blunt) stump, one point for severe calcification at the entry site, and two points each for non-restenotic lesions or lesion length > 200 mm. The score was shown to have an excellent discriminatory ability for successful crossing, with low scores (0-2) associated with low failure rates (10%) and high scores associated with high failure rates (79%). CONCLUSIONS: The Infrapop-CTO score can stratify the procedural complexity of IP CTOs based on the likelihood of successful anterograde crossing. This score may help to direct optimal approaches toward infrapopliteal revascularization of patients with critical limb ischemia.