Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device.

BACKGROUND: Perclose ProGlide (PPG) Suture-Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. AIMS: We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). METHODS: In this physician-initiated, randomized, single-center study [clinicaltrials.gov ID: NCT04632641], single-stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular-related complications and mortality. Wilcoxon rank-sum test was used to compare TTH, TTA, and TTD. RESULTS: TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p < 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. CONCLUSION: PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same-day discharge in these patients.

Risk of Atrial Fibrillation and Stroke After Bariatric Surgery in Patients With Morbid Obesity With or Without Obstructive Sleep Apnea.

Background and Purpose: Weight loss in morbidly obese patients reduces atrial fibrillation (AF); however, it is unknown whether similar benefits are maintained in patients with obstructive sleep apnea (OSA). We sought to determine whether incident AF and stroke rates are affected by OSA after weight loss and to identify predictors of AF and stroke. Methods: Differences in laparoscopic adjustable gastric banding­induced weight loss on incident AF and stroke events in those with and without OSA in the entire and in propensity-matched cohorts were determined longitudinally, and independent predictors of AF and stroke were identified. Results: Of 827 morbidly obese patients who underwent laparoscopic adjustable gastric banding (mean age, 44±11 years; mean body mass index, 49±8 kg/m2), incident AF was documented in 4.96% and stroke in 5.44% of patients during a mean 6.0±3.2-year follow-up. Despite a similar reduction in body weight (19.6% and 21% in 3 years), new-onset AF was significantly higher in patients with OSA than without OSA in the entire (1.7% versus 0.5% per year; P<0.001) and propensity-matched cohorts. Incident stroke was higher in the OSA than in the non-OSA group (2.10% versus 0.47% per year; P<0.001), but only 20% of patients with stroke had documented AF. On multivariate analysis, OSA (hazard ratio, 2.88 [95% CI, 1.45­5.73]), age, and hypertension were independent predictors of new-onset AF, and OSA (hazard ratio, 5.84 [95% CI, 3.02­11.30]), depression, and body mass index were for stroke events. Conclusions: In morbidly obese patients who underwent laparoscopic adjustable gastric banding, despite similar weight loss, patients with OSA had a higher incidence of AF and stroke than patients without OSA. Both non-AF and AF-related factors were involved in increasing stroke risk. Further investigation is warranted into whether OSA treatment helps reduce AF or stroke events in this population.

Selective downregulation of mitochondrial electron transport chain activity and increased oxidative stress in human atrial fibrillation.

Mitochondria are critical for maintaining normal cardiac function, and a deficit in mitochondrial energetics can lead to the development of the substrate that promotes atrial fibrillation (AF) and its progression. However, the link between mitochondrial dysfunction and AF in humans is still not fully defined. The aim of this study was to elucidate differences in the functional activity of mitochondrial oxidative phosphorylation (OXPHOS) complexes and oxidative stress in right atrial tissue from patients without (non-AF) and with AF (AF) who were undergoing open-heart surgery and were not significantly different for age, sex, major comorbidities, and medications. The overall functional activity of the electron transport chain (ETC), NADH:O2 oxidoreductase activity, was reduced by 30% in atrial tissue from AF compared with non-AF patients. This was predominantly due to a selective reduction in complex I (0.06 ± 0.007 vs. 0.09 ± 0.006 nmol·min(-1)·citrate synthase activity(-1), P = 0.02) and II (0.11 ± 0.012 vs. 0.16 ± 0.012 nmol·min(-1)·citrate synthase activity(-1), P = 0.003) functional activity in AF patients. Conversely, complex V activity was significantly increased in AF patients (0.21 ± 0.027 vs. 0.12 ± 0.01 nmol·min(-1)·citrate synthase activity(-1), P = 0.005). In addition, AF patients exhibited a higher oxidative stress with increased production of mitochondrial superoxide (73 ± 17 vs. 11 ± 2 arbitrary units, P = 0.03) and 4-hydroxynonenal level (77.64 ± 30.2 vs. 9.83 ± 2.83 ng·mg(-1) protein, P = 0.048). Our findings suggest that AF is associated with selective downregulation of ETC activity and increased oxidative stress that can contribute to the progression of the substrate for AF.

Utility of unipolar recordings for complex Wolff-Parkinson-White ablation.

Radiofrequency ablation has been shown to be a safe and effective treatment strategy for the management of symptomatic patients with Wolff-Parkinson-White syndrome. It is supported by a success rate of 95% and a recurrence rate of less than 5%. However, ablation of accessory pathways can be challenging at times. The causes for failure can be grouped into three categories - unusual location of the pathway, technical difficulties in delivering the ablation and localization error [1]. In this case report we are reporting a case of a young male who presented to us with symptomatic Wolff-Parkinson-White syndrome with two failed prior ablations at another institution. This case illustrates the importance of knowing accurate localization and course of the accessory pathway by utilizing the unipolar and bipolar electrograms simultaneously during radiofrequency ablation.

Cardiac resynchronization therapy in patients with challenging anatomy due to venous anomalies or adult congenital heart disease.

BACKGROUND: Cardiac resynchronization therapy (CRT) has proven salutary effects in patients with congestive heart failure, systolic dysfunction, and electromechanical dyssynchrony in the setting of ischemic, nonischemic, and congenital cardiomyopathy. While CRT device implants have become routine in the adult ischemic or nonischemic cardiomyopathy populations, patients with congenital heart disease offer special challenges due to unusual anatomic variations. METHODS: A comprehensive assessment of anatomic abnormalities is essential prior to implant. In addition, implant techniques and equipment must be tailored to the expected anatomy. A flexible approach is necessary-implant may require equipment and techniques adapted from vascular intervention. CONCLUSION: This article describes our approach to CRT implant in patients with congenital heart disease, and is illustrated by reports of several cases.

Left ventricular pacing in right ventricular cardiomyopathy: blessing or blunder?

Arrhythmogenic right ventricular dysplasia (ARVD) predominantly involves the right ventricle, and myocardium is progressively replaced by fat and fibrous tissue in the apex, base, and outflow tract regions. This pathology, and the progressive nature of the disease, poses special challenges for implant and subsequent appropriate functioning of an implantable cardioverter-defibrillator. This case report describes a solution to problems during lead placement in patients with ARVD.

Age-Based Trends in the Outcomes of Percutaneous Left Atrial Appendage Occlusion: Insights from a Real-World Database.

The age-based trends in-hospital outcomes in patients with percutaneous left atrial appendage occlusion (LAAO) are unknown. Using the National Readmission Database from 2016 to 2019, patients who underwent LAAO were divided into 2 age groups: 60 to 79 and ≥80 years. The primary objective was to evaluate the age-based trends in the outcomes related to LAAO. The secondary objectives were to evaluate the mean cost and total cumulative cost of readmissions in both age groups in 2019. We identified 58,818 patients who underwent LAAO, of whom 36,964 (63%) were aged 60 to 79 years, and 21,854 (37%) were ≥80 years. The hospital mortality, pericardial complications, acute kidney injury, and in-hospital cardiac arrest did not change over time. The risk-adjusted postoperative stroke and bleeding requiring blood transfusion decreased in patients aged ≥80 years (p trend 0.03 for both outcomes). The length of stay decreased, and early discharge rates increased over time in both the unadjusted and risk-adjusted models in both age groups. The risk-adjusted 90-day readmission rates also decreased in patients aged ≥80 years. The inflation-adjusted cost did not change over time on the unadjusted and adjusted analyses. The total cumulative all-cause 90-readmission cost for both groups in 2019 was $31.7 million. Most outcomes after LAAO either improved or did not change from 2016 to 2019. Hospital mortality has remained <0.5% consistently since 2016. The risk-adjusted postoperative stroke, bleeding, and 90-day readmission rates improved in elderly vulnerable patients aged ≥80 years. The inflation-adjusted cost did not improve despite the decreasing length of stay and improving early discharge rates.

Inappropriate shocks in patients with Fidelis® lead fractures: impact of remote monitoring and the lead integrity algorithm.

INTRODUCTION: The role of remote monitoring combined with lead integrity algorithm (LIA) in patients with Fidelis (Medtronic Inc., Minneapolis, MN, USA) lead fractures is not well defined. METHODS: We retrospectively identified patients with Fidelis lead fractures at our institution, documenting all pertinent data (remote monitoring use, clinical presentation, lead fracture diagnosis criteria). Patients were classified into subgroups based on the type of home monitoring and whether LIA was uploaded before lead fracture. Subgroups were compared based on delivery of inappropriate shocks (IS). RESULTS: A total of 131 patients (mean age 62 ± 16 years, 70% male, 69% primary prevention implants) were followed until lead fracture (average 32 ± 12 months). IS were delivered in 21% of patients (n = 11/52) with LIA versus 52% (n = 41/79) without LIA, P < 0.001. LIA significantly decreased the number of IS (2.1 ± 1.0 IS vs 7.9 ± 12 IS, P < 0.001) and significantly increased the number of patients diagnosed through audible alert (P < 0.001). Wireless monitoring significantly decreased the time interval to reprogram defibrillators OFF (mean 1.5 ± 1 days vs 15.6 ± 18 days with nonwireless CareLink [Medtronic Inc.] and 12.4 ± 20 days without CareLink, P < 0.001); 14% of patients with LIA and wireless monitoring combined received IS. Without LIA, 63% of patients with wireless monitoring received IS. CONCLUSION: This study confirms that LIA significantly decreases IS therapy in patients with Fidelis lead fractures. Wireless technology enhances LIA benefits by significantly shortening time to reprogram defibrillators. However, despite the "best scenario" of combining LIA and wireless monitoring, 14% of patients with lead fractures still get IS. Further refinements of detection algorithms are required to eliminate this significant clinical problem.

Characterizing Recurrence Following Hybrid Ablation in Patients With Persistent Atrial Fibrillation.

PURPOSE: It is widely accepted that atrial fibrillation (AF) accounts for half of arrhythmia recurrences following endocardial catheter ablation of AF. An epicardial-endocardial approach (hybrid) has emerged as an alternative to endocardial ablation alone for the treatment of AF, yet recurrence after a hybrid procedure has not been well characterized. This retrospective study is aimed at characterizing recurrence following hybrid ablation for patients with persistent AF. METHODS: Patients with persistent AF (N=108) received both endocardial and epicardial ablation of the posterior left atrial wall using catheter ablation and a small midline surgical approach (hybrid). Presence of atrial flutter or AF was determined with ambulatory monitoring (n=22) or electrocardiogram analysis (n=86) at each follow-up visit. Recurrence mode was confirmed by electrophysiology study for those patients undergoing subsequent catheter ablation after hybrid ablation. RESULTS: Patients were followed for a mean ± standard deviation of 25 ± 14 months. Of patients who had a recurrence, 53% (n=33) were in atrial flutter and 47% (n=29) were in AF. Of those who had a recurrence with atrial flutter, 14 received repeat ablation for either left (n=11) or left/right (n=3) atrial flutter and 3 received AF ablation. Half of ablations for atrial flutter recurrence following the hybrid procedure involved the mitral isthmus. CONCLUSIONS: Atrial flutter accounts for about half of arrhythmia recurrences post-hybrid ablation. If catheter ablation of the mitral isthmus is considered during the hybrid procedure to prevent subsequent occurrence of perimitral flutter, bidirectional block must be performed to ensure a complete line of block.

Incessant interfascicular reentrant ventricular tachycardia as a result of catheter ablation of the right bundle branch: case report and review of the literature.

A 72-year-old woman developed incessant interfascicular (IF) ventricular tachycardia immediately after successful right bundle branch (RBB) catheter ablation for the treatment of sustained bundle branch reentrant tachycardia. Catheter ablation of the left bundle branch and the left anterior fascicle was successful in eliminating the tachycardia (in 2 different sessions). This report discusses the direct link between the creation of an RBB block and the development of IF tachycardia, in our case, and in prior cases of IF reentry reported in the literature.

A case of flecainide-induced hyponatremia.

We present a case of flecainide-induced hyponatremia in a 67-year-old woman who was treated for paroxysmal atrial tachycardia. She developed dizziness after starting flecainide and was found to be hyponatremic with a sodium level of 122 mmol/L (decreased from 136 mmol/L). Work-up failed to reveal other causes of hyponatremia. She was not on diuretics, laxatives, or herbal medications. After discontinuation of flecainide, her symptoms and sodium levels improved. Hyponatremia is a previously unrecognized entity as an adverse effect of flecainide. We will discuss the clinical presentation, lab findings, and a possible explanation for this patient's unusual reaction to flecainide.

Pacing lead implantation without live fluoroscopy: feasibility of acute success in the live canine model.

INTRODUCTION: Fluoroscopic visualization for transvenous pacing lead placement necessitates lead shielding to minimize radiation exposure. An electromagnetic (EM) navigation system that integrates real-time intracardiac tracking within an anatomic navigation environment may provide an effective alternative for lead delivery that obviates live fluoroscopy. We assessed feasibility of pacing lead implantation with electromagnetic tracking guided solely by radiographic virtual navigation and compared this to fluoroscopy-guided implants in a canine model. METHODS: Seven mongrel dogs with normal hearts were randomized to 47 pacing lead placements in the right atrium (RA) or right ventricle (RV) guided by single-plane fluoroscopy, or an experimental EM navigation system guided by registered fluoroscopic snapshots obtained before implant (EMN). Ability to achieve successful lead delivery acutely was assessed, and pacing parameters as well as fluoroscopy and implant times were measured. Means were compared using a paired t-test. RESULTS: All lead delivery attempts were acutely successful. One atrial lead dislodged with EMN, resulting in 46 successful pacing attempts. There was no statistical difference in pacing parameters and time for lead placement between the approaches (EMN vs fluoroscopic navigation [mean +/- SD]: RA threshold 1.15 V +/- 0.98 V vs 1.95 V +/- 0.98 V [P = NS], RV threshold 1.18 V +/- 0.58 V vs 1.42 V +/- 0.63 V [P = NS], implant time 4:38 +/- 2:37 minutes vs 4:44 +/- 2:38 minutes [P = NS]). No live fluoroscopy was required for EMN implants. CONCLUSION: Pacing lead placement with an EM system guided by preprocedural fluoroscopic views is feasible and comparable to fluoroscopic navigation, and avoids the use of live fluoroscopy.

Periprocedural anticoagulation for atrial fibrillation ablation.

BACKGROUND: Catheter ablation for atrial fibrillation (AF) can increase risk of left atrial (LA) thrombi and stroke. Optimal periprocedural anticoagulation has not been determined. OBJECTIVE: We report the role of administering warfarin and aspirin without low molecular weight heparin in patients undergoing AF ablation. METHODS: A total of 207 patients underwent ablation for AF. Transesophageal echocardiography (TEE) guided transseptal puncture and ruled out clot in the LA. After first puncture, the sheath was flushed with heparin (5,000 Units/mL). After second puncture, a bolus of 80 units/kg of heparin was given, followed by an infusion to maintain activated clotting time (ACT) around 300-350 seconds. Warfarin was stopped and aspirin was started (325 mg/day) 3 days preprocedure. Warfarin was restarted on the day of the procedure. Both medications were continued for 6 weeks postablation. Warfarin was continued for 6 months in patients with prior history of persistent or recurrent AF. Thirty-seven patients who showed smoke in the LA on TEE were given low molecular weight heparin postprocedure until international normalized ratio (INR) was therapeutic. RESULTS: Thirty-two patients had persistent and 175 had paroxysmal AF; 87 were cardioverted during ablation. Two patients had transient ischemic attack (TIA) on the sixth and eighth days, respectively, following ablation, with complete recovery. Both had subtherapeutic INRs. CONCLUSION: In patients without demonstrable clot or smoke in the LA, starting aspirin 3 days prior and warfarin immediately post-radiofrequency ablation, without low molecular weight heparin, with meticulous anticoagulation during the procedure, appears to be a safe mode of anticoagulation.

Cardiac image integration implications for atrial fibrillation ablation.

Cardiac image registration using computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, and fluoroscopy is currently being investigated and clinically used for atrial fibrillation (AF) ablation. Cardiac image registration, in the context of left atrium, is intermodal, with the acquired image and the real-time reference image residing in different image spaces, and involves optimization, where one image space is transformed into the other. Geometry-based methods, which include using fiducial points and/or surface-based techniques, are usually used for cardiac image registration. During fiducial point registration, fiducial points are either external skin markers or manually determined by marking anatomical landmarks, using mapping catheters. Usually, a minimum of three non collinear points are needed for optimal registration. Recently, a catheter placed inside the coronary sinus has also been used as a fiducial marker for the purpose of registration. During surface registration, the process involves characterizing surfaces in each of the images and deriving the best transformation between them. Unlike rigid body registration, such as has been extensively used in imaging the brain, cardiac image registration is unique and challenging. In addition to the errors inherent in intermodal registration, such as errors in pixel and voxel dimension and errors due to fiducial point selection, there are errors specific to cardiac image registration, i.e., errors due to cardiac motion during the cardiac cycle and due to respiration. This review addresses the basic principles of registration and the inherent registration errors as they relate to cardiac imaging and registration.

Atrial fibrillation ablation complications.

Atrial fibrillation (AF) is a common arrhythmia. Although significant work still needs to be done, recent advances in understanding the mechanisms of AF have led to the development of elegant catheter mapping techniques for ablation of AF, complemented by the evolution of various imaging and navigational technologies. Due to the complexity of the arrhythmia, and the significant length of time needed to successfully ablate in the left atrium, it is imperative that an acceptable risk-benefit profile be defined. Various complications, some of them serious, have been reported in the last several years. This review addresses the potential risks of AF ablation and how to avoid some of these complications.

The beneficial effect of weight reduction on adverse cardiovascular outcomes following bariatric surgery is attenuated in patients with obstructive sleep apnea.

Weight loss after bariatric surgery is associated with reduction in adverse cardiovascular outcomes; however, the impact of obstructive sleep apnea (OSA) on reduction of cardiovascular outcomes after bariatric surgery in morbidly obese patients is not known. We retrospectively assessed differences in cardiovascular events after laparoscopic adjustable gastric banding (LAGB)-induced weight loss in patients with and without OSA before and after propensity score matching for age, sex, body mass index (BMI), and major comorbidities between the two groups and determined predictors of poor outcomes. OSA was present in 222 out of 830 patients (27 per cent) who underwent LAGB between 2001 and 2011. Despite a similar reduction in BMI (20.0 and 20.8 per cent), a significantly higher percentage of cardiovascular events were observed in patients with than without OSA (35.6 vs 6.9 per cent; p < 0.001) at 3 years (mean follow-up 6.0 ± 3.2; range: 0.5 to 13 years). The differences in the cumulative endpoint of new onset stroke, heart failure, myocardial infarction, venous thrombosis, and pulmonary embolism between the OSA and non-OSA groups were maintained after propensity matching. Patients with OSA treated with continuous positive airway pressure (CPAP) during sleep [n = 66] had lower cardiovascular event rates at 30 months compared with those not treated (p < 0.041). OSA (hazard ratio: 6.92, 95% CI: 3.39-14.13, p < 0.001) remained an independent predictor of cardiovascular events after multivariate analysis. Thus, patients with OSA, despite a similar initial weight loss after LAGB, had a higher incidence of cardiovascular events compared with a propensity-matched group without OSA. Treatment with CPAP appears to reduce such events.

Biventricular pacing and QT interval prolongation.

INTRODUCTION: The purpose of this study was to examine BiV pacing-dependent changes in QT interval and the related potential for proarrhythmia. Biventricular (BiV) pacing has emerged as a promising therapy for patients with advanced congestive heart failure (CHF) and bundle branch block (BBB). METHODS AND RESULTS: One hundred and seventy-six consecutive patients (123 men and 53 women; mean age 67 +/- 16 years) with ischemic (n = 128) or nonischemic (n = 48) cardiomyopathy in New York Heart Association Class II (8%) or III (92%) CHF (ejection fraction 24 +/- 9%) underwent atrial synchronous BiV pacing. The QRS, QT, and JT intervals were measured at 30 minutes after initiation of BiV pacing, at 24 hours, and at 1 month postimplant. QT interval was defined as the time interval between the initial deflection of the QRS complex and the point at which the T wave crossed the isoelectric line. At baseline, the average QRS duration was 178 +/- 10 ms, attributable to left BBB (n = 158) or intraventricular conduction delay (n = 18). BiV pacing resulted in a small but statistically significant reduction in QRS duration (148 +/- 9 ms during BiV pacing vs 178 +/- 10 ms at baseline [P < 0.0001]), yet the QT increased to 470 +/- 34 ms with BiV pacing versus 445 +/- 32 ms at baseline [P < 0.0001]). The JTc interval during BiV pacing was significantly shorter than during LV pacing (290 +/- 9 ms vs 320 +/- 20 ms, P < 0.0001). During a mean follow-up of 24 +/- 6 months, one patient developed recurrent torsade de pointes. That was eliminated once left ventricular pacing was discontinued. CONCLUSION: Biventricular pacing prolongs QT interval. However, the occurrence of torsade de pointes is uncommon.

Computed tomography-fluoroscopy image integration-guided catheter ablation of atrial fibrillation.

INTRODUCTION: This study examines the feasibility of atrial fibrillation (AF) ablation using registered three-dimensional computed tomography (CT) images of the left atrium with fluoroscopy. METHODS AND RESULTS: A total of 50 consecutive patients with symptomatic AF refractory to medical therapy (32 paroxysmal, 18 persistent, age 55 +/- 10 years) were randomized to undergo a catheter-based AF ablation procedure with or without the CT-fluoroscopy guidance system. All patients underwent preprocedural contrast-enhanced CT imaging and segmentation of the left atrium. For the CT-fluoroscopy group, circumferential lesions encompassing the pulmonary vein (PV) antrum and linear lesions along the roof of the left atrium between the superior PVs and the mitral isthmus were created on the CT image, which was registered with real-time fluoroscopy. The registered images were then used to navigate the ablation catheters to the sites of planned ablation. After the ablation sites were completed, any remaining PV potentials were isolated with electrophysiological guidance. In the control patients, the same technique was performed without using the CT-fluoro guidance system. CT scans were accurately registered to fluoroscopic images with minimal manual correction. Operators could navigate catheters on the registered images to preplanned, extraostial sites for ablation. CT-fluoroscopy guidance decreased procedure duration and fluoro times (P < 0.05). At a mean follow-up of 9 +/- 2 months, 21 patients (84%) in the CT-fluoro guidance group and 16 patients (64%) in the control group have had no recurrence of AF. CONCLUSION: CT-fluoroscopic-guided left atrial ablation is feasible and allows appropriate catheter manipulation in the left atrium.

Mapping techniques for atrial fibrillation ablation.

Atrial fibrillation (AF) is a common arrhythmia. Although significant work still needs to be done, recent advances in understanding the mechanism of AF have led to the development of elegant catheter mapping techniques for ablation of AF. These improved mapping techniques are complemented by an evolution in various imaging and navigational technologies, several of which can now be combined in a process called registration, so that the physician no longer needs to rely solely on a mental image of the anatomy of the left atrium and the pulmonary vein while attempting to ablate the region. Ongoing advances in mapping technique will increase safety and efficacy and it is likely that AF ablation will become the first-line therapy in most patients with this complicated arrhythmia.