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.

Cryoballoon Pulmonary Vein Isolation and Roof and Posterior Wall Debulking Using Navik 3D™: A New Technique for Atrial Fibrillation Ablation.

The success rates of traditional endocardial ablation techniques for managing atrial fibrillation remain modest. Recently, the performance of posterior wall ablation in conjunction with pulmonary vein (PV) isolation (PVI) has been reported to increase the chance of success following endocardial ablation. We report a systematic approach for the isolation of the PVs and ablation of the left atrial roof and posterior wall using a cryoballoon guided by the novel Navik 3D™ mapping system (APN Health LLC, Waukesha, WI, USA) and offer preliminary data including procedure, fluoroscopy, and cryoablation times for review. Patients (n = 52) aged 63 years ± 10 years with paroxysmal (n = 42), persistent (n = 11), or chronic (n = 2) atrial fibrillation underwent cryoballoon ablation for PVI and/or the left atrial roof, posterior wall, anterior ganglion plexi (GP), or mitral isthmus line. Lesions were accurately delivered to the PVs, left atrial roof, posterior wall, anterior GP, or mitral isthmus line as appropriate. Acute PVI was achieved in 98% of all patients, and eight (15%) required direct current cardioversion to restore sinus rhythm at the end of the procedure. The mean ± standard deviation procedure, fluoroscopy, and cryoballoon ablation times were 149 minutes ± 39 minutes, 33 minutes ± 30 minutes, and 41 minutes ± 14 minutes, respectively. The Navik 3D™ mapping system is believed to be the only available mapping system that allows for the visualization and location of the cryoballoon in three dimensions, enabling the operator to deliver contiguous, overlapping lesions on the roof and posterior wall of the left atrium. It also facilitates precise measurement of the distance between the esophageal temperature probe and the cryoballoon, thereby helping to avoid freezing damage to the esophagus.

Stent fracture, an incidental finding or a significant marker of clinical in-stent restenosis?

BACKGROUND: The predictors and clinical significance for stent fracture (SF) in drug-eluting stents (DES) remain unknown. We identified procedural factors leading to SF and its clinical consequences in DES. METHODS: Percutaneous coronary interventions were performed on 3,920 patients with DES over 12 months. In-stent restenosis (ISR) of DES was observed in 188 cases with 121 cases (64.4%) receiving a sirolimus-eluting stent (SES) and 67 (35.6%) a paclitaxol-eluting stent (PES). RESULTS: SF was identified in 35 (18.6%) of the 188 cases. The 35 cases were then compared with 153 cases of ISR without angiographic evidence of SF. SF was identified in 29 (23.9%) SES compared with 6 (9.0%) in PES (P < 0.05). With univariate analysis, additional factors associated with SF included longer mean stented segment length, male gender, overlapping stents, vessel segment angulation >75 degrees , and more stents (all P < 0.05). With multivariate adjustment, three factors, i.e., stenting on a bend >75 degrees (OR = 13.8, 95%CI 3.7 to 51; P < 0.001), SES (OR = 4.1, 95%CI 1.3 to 13.4; P < 0.018) and overlapping stented segments (OR = 3.9, 95%CI 1.1 to 14.1; P < 0.041) were statistically significant independent predictors of SF while larger stent diameter was protective (OR = 0.14, 95%CI 0.04 to 0.70; P < 0.017). CONCLUSION: SF proved to be associated with angiographically-documented clinical ISR. Although the exact mechanism is unknown, factors that appear to play a negative role in SF include vessel tortuosity, use of SES and overlapping stents. Larger stent diameter was protective. Further studies are needed to better define the factors important in the mechanism of SF.

Sudden cardiac death caused by migration of a TrapEase inferior vena cava filter: case report and review of the literature.

CASE: A 43-year-old female presented with sudden onset of palpitations, chest pain, and shortness of breath associated with hypoxemia. A helical computed tomography (CT) scan of the chest revealed a large saddle pulmonary embolism. Intravenous tPA relieved the shortness of breath and improved the hypoxemia. Inferior vena cava (IVC) filter (TrapEase, Cordis Corp., Miami, FL, USA) was placed. On day 6 of her hospitalization, she went into cardiopulmonary arrest while walking back from the rest room. The patient died despite a prolonged attempt at cardiopulmonary resuscitation. At that time, ventricular tachycardia and then ventricular fibrillation were recorded. Autopsy of the heart showed the IVC filter entrapped within the tricuspid valve. DISCUSSION: The incidence of IVC filter migration ranges from 0.3 to 6% with rare migration to the heart or lung (0.1-1.25%). Sudden cardiac death from migration of IVC filter is extremely rare. We report the first case of sudden cardiac death caused by migration of the TrapEase filter to the heart. There are two reports in the literature of death from migrating Greenfield and Antheor filters. CONCLUSION: An IVC filter migration to the heart, although rare, can cause serious arrhythmia and sudden cardiac death.

Effect of electrical stimulation on arteriogenesis and angiogenesis after bilateral femoral artery excision in the rabbit hind-limb ischemia model.

The effects of electrical stimulation (ES) on arteriogenesis (the opening of preexisting collaterals) and angiogenesis (formation of new capillaries) were studied after acute bilateral hind limb ischemia was induced via bilateral femoral artery excision in a rabbit model. The study evaluated the rabbit hind limbs' normal response to acute ischemia and to application of ES by calculating changes in arterial and capillary densities. Comparisons were made with our prior study, in which the femoral artery was unilaterally excised, as we attempted to expand on the topics of arteriogenesis and angiogenesis. Twelve adult New Zealand white rabbits were randomly assigned to 1 of 2 series. In Series 1, the control group, both femoral arteries were excised and no ES was applied. In Series 2, both femoral arteries were excised and ES was applied to the left limb. One lead was implanted into the left adductor muscle near the site of the excised left femoral artery (Series 2), and a stimulator (Thera, Medtronic, Inc, Minneapolis, MN) was implanted in a separate pocket. ES was applied at a rate of 3 V, 30 contractions per minute, beginning immediately after surgery and continuously for 1 month. Angiography was performed in all 12 rabbits 1 month after surgery to establish the anatomy of the collateral vessels and to demonstrate that the femoral artery stump continued to be an end artery. Contrast-opacified arteries (COAs) that crossed the grid's midline, and the total number of grid lines intersected by COAs, were tallied according to an established method. Capillary density was calculated as the number of capillaries per square millimeter of muscle. In Series 1, after 1 month, the number of COAs crossing the grid's midline was 4.5 +/-1.5 on the left and 4.8 +/-1.2 on the right side. In Series 2, the number of COAs crossing the grid's midline was 7.9 +/-1.8 on the left side (p<0.05 vs Series 1) and 5.9 +/-1.6 on the right side of the same rabbit (p=NS vs Series 1). In Series 1, 36.7 +/-5.4 and 30.5 +/-7.7 total intersections were crossed by COAs on the left and right sides, respectively. In Series 2, total grid intersections crossed by COAs were 48.4 +/-8.5 and 47.5 +/-9.1 in the left and right sides, respectively (p<0.001 vs series 1). Baseline capillary density before femoral artery excision was 180.2 +/-21.3/mm(2). The capillary densities on the left sides were 94.2 +/-19.1 and 264.5 +/-7.6 in Series 1 and 2, respectively (p<0.001). The right sides showed a similar pattern with capillary densities of 88.5 +/-37.2 and 135.8 +/-6.8 (p<0.05) in Series 1 and 2, respectively. When capillary density was compared on the left and right sides of the same rabbit in Series 2, a statistically significant increase was also found; 264.5 +/-7.6 vs 135.8 +/-6.8 (p<0.001) in the left and right sides, respectively. Comparisons of the effect of electrical stimulation and the body's normal physiologic response to acute ischemia revealed a significant increase in the opening of preexisting collaterals (arteriogenesis) and the promotion of capillary density (angiogenesis) with the use of electrical stimulation.