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.

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.

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.

Cardiac Image Registration: Rotational Error Correction and Gated Stabilization for Cardiac Motion.

Background: Dynamic motion of the heart due to cardiac and respiratory cycles, and rotation from varying patient positions between imaging modalities, can cause errors during cardiac image registration. This study used phantom, patient and animal models to assess and correct these errors. Methods and Results: Rotational errors were identified and corrected using different phantom orientations. ECG-gated fluoro images were aligned with similarly gated CT images in 9 patients, and accuracy assessed during atrial fibrillation (AF) and sinus rhythm. A tracking algorithm corrected errors due to respiration; 4 independent observers compared 25 respiration sequences to an automated method. Following correction of these errors, target registration error was assessed. At 20 mm and 30 mm from the phantom model's center point with an in-plane rotation of 8 degrees, measured error was 2.94 mm and 5.60 mm, respectively, and the main error identified. A priori method accurately predicted ECG location in only 38% (p=0.0003) of 313 R-R intervals in AF. A posteriori method accurately gated the ECG during AF and sinus rhythm in 97% and 98% of 375 beats evaluated, respectively (p=NS). Tracking algorithm for ECG-gated motion compensation was identified as good or fair 96% of the time, with no difference between observers and automated method (chi-square=25; p=NS). Target registration error in phantom and animal models was 1.75±1.03 mm and 0 to 0.5 mm, respectively. Conclusions: Errors during cardiac image registration can be identified and corrected. Cardiac image stabilization can be achieved using ECG gating and respiration.

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.

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.

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.