Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study.

Authors: Mattias Duytschaever, Tom De Potter, Massimo Grimaldi...

BACKGROUND

The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System With Irreversible Electroporation [IRE]) evaluated safety and effectiveness of a fully integrated biphasic pulsed field ablation (PFA) system with a variable-loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation.

METHODS

Subjects underwent pulmonary vein (PV) isolation with the PFA system, using at least 12 applications per vein; adenosine/isoproterenol was administered to confirm entrance block. Wave I assessed initial safety, including for esophageal lesions, silent cerebral lesions, and PV stenosis. Wave II (pivotal phase) tested (1) primary safety, incidence of early-onset primary adverse events, and (2) primary effectiveness, confirmed PV isolation with freedom from documented atrial arrhythmia at 12 months. The study design specified an interim analysis to determine early success once 30 subjects reached the 12-month follow-up and all subjects reached 3-month follow-up.

RESULTS

Across 13 centers in Europe/Canada, 226 subjects were enrolled, met criteria for safety and effectiveness evaluations, and received PFA (Wave I, 40; Wave II, 186). Wave I demonstrated no esophageal thermal lesions or PV stenosis. Among 39 subjects with cerebral magnetic resonance imaging, silent cerebral lesions were detected in 4 of the first 6 subjects, after which workflow enhancements, including a 10-second pause between PFA applications, were implemented; subsequently, only 4 of 33 subjects had silent cerebral lesions. In the Wave II phase, no primary adverse events were reported. Upon declaring early success, 83 subjects reached 12-month follow-up. With 100% entrance block, PV isolation without acute reconnection was achieved in 97.1% of targeted veins. For Wave II, the primary effectiveness end point per Kaplan-Meier at the time of interim analysis was 70.9%; 12-month freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia recurrence and repeat ablation was 78.9% and 92.3%, respectively. Total procedure and transpired PFA times were 70.1±27.7 and 26.7±14.0 minutes, respectively.

CONCLUSIONS

The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system.

REGISTRATION

URL: https://www.

CLINICALTRIALS

gov; unique identifier: NCT04524364.

Topics: Humans; Atrial Fibrillation; Constriction, Pathologic; Treatment Outcome; Catheters; Europe; Pulmonary Veins; Stenosis, Pulmonary Vein; Catheter Ablation; Recurrence

PubMed: 36735937
DOI: 10.1161/CIRCEP.122.011780

Meta-Analysis Review

Authors: Xiaoli Ge, Rodrigo Cavallazzi, Chunbo Li...

BACKGROUND

Central venous access (CVA) is widely used. However, its thrombotic, stenotic and infectious complications can be life-threatening and involve high-cost therapy. Research revealed that the risk of catheter-related complications varied according to the site of CVA. It would be helpful to find the preferred site of insertion to minimize the risk of catheter-related complications. This review was originally published in 2007 and was updated in 2011.

OBJECTIVES

1. Our primary objective was to establish whether the jugular, subclavian or femoral CVA routes resulted in a lower incidence of venous thrombosis, venous stenosis or infections related to CVA devices in adult patients.2. Our secondary objective was to assess whether the jugular, subclavian or femoral CVA routes influenced the incidence of catheter-related mechanical complications in adult patients; and the reasons why patients left the studies early.

SEARCH METHODS

We searched CENTRAL (The Cochrane Library 2011, Issue 9), MEDLINE, CINAHL, EMBASE (from inception to September 2011), four Chinese databases (CBM, WANFANG DATA, CAJD, VIP Database) (from inception to November 2011), Google Scholar and bibliographies of published reviews. The original search was performed in December 2006. We also contacted researchers in the field. There were no language restrictions.

SELECTION CRITERIA

We included randomized controlled trials comparing central venous catheter insertion routes.

DATA COLLECTION AND ANALYSIS

Three authors assessed potentially relevant studies independently. We resolved disagreements by discussion. Dichotomous data on catheter-related complications were analysed. We calculated relative risks (RR) and their 95% confidence intervals (CI) based on a random-effects model.

MAIN RESULTS

We identified 5854 citations from the initial search strategy; 28 references were then identified as potentially relevant. Of these, we Included four studies with data from 1513 participants. We undertook a priori subgroup analysis according to the duration of catheterization, short-term (< one month) and long-term (> one month) defined according to the Food and Drug Administration (FDA).No randomized controlled trial (RCT) was found comparing all three CVA routes and reporting the complications of venous stenosis.Regarding internal jugular versus subclavian CVA routes, the evidence was moderate and applicable for long-term catheterization in cancer patients. Subclavian and internal jugular CVA routes had similar risks for catheter-related complications. Regarding femoral versus subclavian CVA routes, the evidence was high and applicable for short-term catheterization in critically ill patients. Subclavian CVA routes were preferable to femoral CVA routes in short-term catheterization because femoral CVA routes were associated with higher risks of catheter colonization (14.18% or 19/134 versus 2.21% or 3/136) (n = 270, one RCT, RR 6.43, 95% CI 1.95 to 21.21) and thrombotic complications (21.55% or 25/116 versus 1.87% or 2/107) (n = 223, one RCT, RR 11.53, 95% CI 2.80 to 47.52) than with subclavian CVA routes. Regarding femoral versus internal jugular routes, the evidence was moderate and applicable for short-term haemodialysis catheterization in critically ill patients. No significant differences were found between femoral and internal jugular CVA routes in catheter colonization, catheter-related bloodstream infection (CRBSI) and thrombotic complications, but fewer mechanical complications occurred in femoral CVA routes (4.86% or 18/370 versus 9.56% or 35/366) (n = 736, one RCT, RR 0.51, 95% CI 0.29 to 0.88).

AUTHORS' CONCLUSIONS

Subclavian and internal jugular CVA routes have similar risks for catheter-related complications in long-term catheterization in cancer patients. Subclavian CVA is preferable to femoral CVA in short-term catheterization because of lower risks of catheter colonization and thrombotic complications. In short-term haemodialysis catheterization, femoral and internal jugular CVA routes have similar risks for catheter-related complications except internal jugular CVA routes are associated with higher risks of mechanical complications.

Topics: Bacterial Infections; Catheter-Related Infections; Catheterization, Central Venous; Constriction, Pathologic; Femoral Vein; Humans; Jugular Veins; Randomized Controlled Trials as Topic; Subclavian Vein; Venous Thrombosis

PubMed: 22419292
DOI: 10.1002/14651858.CD004084.pub3

Randomized Controlled Trial

Authors: Moussa Mansour, Edward P Gerstenfeld, Chinmay Patel...

AIMS

When it occurs, pulmonary vein (PV) stenosis after atrial fibrillation (AF) ablation is associated with significant morbidity. Even mild-to-moderate PV narrowing may have long-term implications. Unlike thermal ablation energies, such as radiofrequency (RF) or cryothermy, pulsed field ablation (PFA) is a non-thermal modality associated with less fibrotic proliferation. Herein, we compared the effects of PFA vs. thermal ablation on PV narrowing after AF ablation.

METHODS AND RESULTS

ADVENT was a multi-centre, randomized, single-blind study comparing PFA (pentaspline catheter) with thermal ablation-force-sensing RF or cryoballoon (CB)-to treat drug-refractory paroxysmal AF. Pulmonary vein diameter and aggregate cross-sectional area were obtained by baseline and 3-month imaging. The pre-specified, formally tested, secondary safety endpoint compared a measure of PV narrowing between PFA vs. thermal groups, with superiority defined by posterior probability > 0.975. Among subjects randomized to PFA (n = 305) or thermal ablation (n = 302), 259 PFA and 255 thermal ablation (137 RF and 118 CB) subjects had complete baseline and 3-month PV imaging. No subject had significant (≥70%) PV stenosis. Change in aggregate PV cross-sectional area was less with PFA (-0.9%) than thermal ablation (-12%, posterior probability > 0.999)-primarily driven by the RF sub-cohort (-19.5%) vs. CB sub-cohort (-3.3%). Almost half of all PFA PV diameters did not decrease, but the majority (80%) of RF PVs decreased, regardless of PV anatomic location.

CONCLUSION

In this first randomized comparison of PFA vs. thermal ablation, PFA resulted in less PV narrowing-thereby underscoring the qualitatively differential and favourable impact of PFA on PV tissue.

Topics: Humans; Pulmonary Veins; Constriction, Pathologic; Single-Blind Method; Treatment Outcome; Atrial Fibrillation; Catheter Ablation; Stenosis, Pulmonary Vein

PubMed: 38305503
DOI: 10.1093/europace/euae038

Authors: Kathleen J Ozsvath, Ruth L Bush

Topics: Constriction, Pathologic; Humans; Varicose Ulcer; Vascular Surgical Procedures; Veins; Wound Healing

PubMed: 32387337
DOI: 10.1016/j.jvsv.2020.04.024

Review

Authors: Panagiotis Kitrou, Konstantinos Katsanos, Dimitrios Karnabatidis...

Symptomatic central venous stenosis and occlusion remains the gordian knot of vascular access. Advances in techniques, like sharp recanalization, allowed for improved success rates in crossing these difficult lesions. There is also increasing evidence of new devices in treating central venous stenosis and, at the same time, improving the time needed between interventions. High-pressure balloons, paclitaxel-coated balloons, bare metal stents and covered stents have been tested with an aim to offer additional treatment options, although obstacles still exist. In the current review, authors describe relevant techniques and options, provide the evidence and evaluate the actual implementation of these devices in this demanding field.

Topics: Humans; Constriction, Pathologic; Treatment Outcome; Vascular Diseases; Veins; Stents; Renal Dialysis; Vascular Patency; Angioplasty, Balloon; Arteriovenous Shunt, Surgical

PubMed: 37460644
DOI: 10.1007/s00270-023-03461-7

Authors: S H Sundararajan, A D Ramos, V Kishore...

BACKGROUND AND PURPOSE

Dural venous sinus stenosis has been associated with idiopathic intracranial hypertension and isolated venous pulsatile tinnitus. However, the utility of characterizing stenosis as intrinsic or extrinsic remains indeterminate. The aim of this retrospective study was to review preprocedural imaging of patients with symptomatic idiopathic intracranial hypertension and pulsatile tinnitus, classify the stenosis, and assess a trend between stenosis type and clinical presentation while reviewing the frequencies of other frequently seen imaging findings in these conditions.

MATERIALS AND METHODS

MRVs of 115 patients with idiopathic intracranial hypertension and 43 patients with pulsatile tinnitus before venous sinus stent placement were reviewed. Parameters recorded included the following: intrinsic or extrinsic stenosis, prominent emissary veins, optic nerve tortuosity, cephalocele, sella appearance, poststenotic fusiform enlargement versus saccular venous aneurysm, and internal jugular bulb diverticula. χ cross-tabulation statistics were calculated and recorded for all data.

RESULTS

Most patients with idiopathic intracranial hypertension (75 of 115 sinuses, 65%) had extrinsic stenosis, and most patients with pulsatile tinnitus (37 of 45 sinuses, 82%) had intrinsic stenosis. Marked optic nerve tortuosity was more common in idiopathic intracranial hypertension. Cephaloceles were rare in both cohorts, with an increased trend toward the presence in idiopathic intracranial hypertension. Empty sellas were more common in idiopathic intracranial hypertension. Cerebellar tonsils were similarly located at the foramen magnum level in both cohorts. Saccular venous aneurysms were more common in pulsatile tinnitus. Internal jugular bulb diverticula were similarly common in both cohorts.

CONCLUSIONS

In this cohort, most patients with idiopathic intracranial hypertension had extrinsic stenosis, and most patients with pulsatile tinnitus had intrinsic stenosis. Awareness and reporting of these subtypes may reduce the underrecognition of potential contributory stenoses in a given patient's idiopathic intracranial hypertension or pulsatile tinnitus.

Topics: Adult; Aged; Cohort Studies; Constriction, Pathologic; Cranial Sinuses; Female; Humans; Male; Middle Aged; Pseudotumor Cerebri; Retrospective Studies; Tinnitus

PubMed: 33414231
DOI: 10.3174/ajnr.A6890

Authors: Chaobo Bai, Zhiying Chen, Yuchuan Ding...

OBJECTIVES

To compare the long-term safety and efficacy of stenting in correcting cerebral venous sinus stenosis (CVSS) and internal jugular venous stenosis (IJVS).

METHODS

Patients confirmed with CVSS or IJVS by imaging were enrolled in this real-world study from 2014 through 2021. Clinical characteristics and long-term outcomes of these two diseases entities post-stenting were followed up and compared.

RESULTS

Three hundred and nineteen patients were enrolled in this study, with a mean age of 48.83 years and a BMI of 25.08 on average. In which, 144 patients underwent stenting, the stenotic segments were corrected and the venous blood flow was restored immediately post-stenting. At 6.15 ± 1.67 days follow-up, significant improvement was observed in headache, tinnitus, insomnia, ICP, and mean pressure gradient in both groups (all p < 0.05). At 30.53 ± 4.41 months follow-up post-stenting, the headache, tinnitus, visual loss, papilledema, and insomnia were attenuated remarkably or even completely disappeared. The Frisen papilledema grade scores declined from 2 (0-4) to 1 (0-3) in IJVS group and from 4 (1-5) to 1 (0-4) in CVSS group compared to the baseline. One hundred and twenty-seven out of the 144 patients (95.5%) maintained sufficient blood flow verified by followed up computed tomographic venography or contrast-enhanced magnetic resonance angiography. Adverse events related to stenting included three cases of intraluminal restenosis and three cases of in-stent thrombosis, no intracranial hemorrhage, venous thromboembolisms, stent-adjacent stenosis, and stent displacement occurred.

INTERPRETATION

Using stents to correct IH and related neurological issues has shown to be a safe and effective approach for both IJVS and CVSS.

Topics: Humans; Middle Aged; Jugular Veins; Constriction, Pathologic; Papilledema; Sleep Initiation and Maintenance Disorders; Tinnitus; Headache

PubMed: 37272913
DOI: 10.1002/acn3.51822

Review

Authors: Rachael I Morris, Paul A Sobotka, Peter K Balmforth...

Cardiac output during exercise increases by as much as fivefold in the untrained man, and by as much as eightfold in the elite athlete. Increasing venous return is a critical but much overlooked component of the physiological response to exercise. Cardiac disorders such as constrictive pericarditis, restrictive cardiomyopathy and pulmonary hypertension are recognised to impair preload and cause exercise limitation; however, the effects of peripheral venous obstruction on cardiac function have not been well described. This manuscript will discuss how obstruction of the iliocaval venous outflow can lead to impairment in exercise tolerance, how such obstructions may be diagnosed, the potential implications of chronic obstructions on sympathetic nervous system activation, and relevance of venous compression syndromes in heart failure with preserved ejection fraction.

Topics: Adaptation, Physiological; Cardiac Output; Cardiovascular Diseases; Constriction, Pathologic; Exercise; Exercise Tolerance; Humans; Iliac Vein

PubMed: 32040765
DOI: 10.1007/s12265-020-09963-w

Authors: Gaurav Lakhanpal, Rick Kennedy, Sanjiv Lakhanpal...

BACKGROUND

We have previously reported that in women with a pelvic venous disorder secondary to pelvic venous insufficiency, 56% will present with an iliac vein stenosis (IVS) and ovarian vein reflux (OVR). The purpose of the present investigation was to determine whether women with combined disease can be treated using iliac vein stenting alone.

METHODS

A retrospective review of prospectively collected data at the Center for Vascular Medicine was performed. We investigated women with pelvic pain or dyspareunia secondary to combined IVS and OVR who had undergone stenting alone. The patient demographics, pre- and 6-month postoperative visual analog scale (VAS) for pain scores, stent type, stent diameter, stent length, and ovarian vein diameters were assessed. All patients had undergone diagnostic venography of their pelvic veins, left ovarian veins, and pelvic reservoirs and intravascular ultrasonography of their iliac veins.

RESULTS

From May 2016 to October 2019, 82 patients with a pelvic venous disorder secondary to IVS and OVR were identified. The present data analysis focused on 38 patients with complete pre- and postoperative VAS scores and duplex scan stent patency data at 6 months. The pelvic and dyspareunia VAS scores at the initial and 6-month follow-up visits were as follows: 6.83 ± 3.19 and 4.24 ± 2.65 and 1.72 ± 2.01 and 0.05 ± 2.0, respectively (P ≤ .001). At 6 months, 29 of the 38 women (76%) reported complete resolution of all symptoms, 26 of 28 (93%) reported complete resolution of their dyspareunia, 5 of 38 (13%) reported significant improvement, and 4 of 38 (10%) reported no improvement. The average ovarian vein diameter was 6.7 ± 2.5 mm. The average stent size and length was 18.20 ± 1.6 mm and 92.41 ± 18.5 mm, with 25 placed in the left common iliac, 2 in the right common iliac vein, and 3 bilaterally. Of the 38 patients, 7 required reintervention (18%). An untreated pelvic reservoir was observed in 17 of the 38 patients (44%). One of the two with no response and six of the patients with improvement had OVR and an untreated pelvic reservoir. The remaining 10 patients with a pelvic reservoir had experienced complete resolution of their symptoms with stenting alone.

CONCLUSIONS

Of the 38 women with pelvic pain secondary to combined IVS and OVR, 76% achieved complete symptom resolution with iliac vein stenting alone. Most of the women with a pelvic reservoir were asymptomatic and reported full symptom resolution after stenting alone. However, these data suggest that in some women, a relationship might exist between the presence of a pelvic reservoir and the persistence of symptoms. Therefore, for women with combined IVS and OVR, we recommend iliac vein stenting alone and staged ovarian vein embolization only for women with persistent symptoms.

Topics: Constriction, Pathologic; Dyspareunia; Female; Humans; Iliac Vein; Middle Aged; Ovary; Pelvic Pain; Retrospective Studies; Stents; Varicose Veins; Venous Insufficiency

PubMed: 33746048
DOI: 10.1016/j.jvsv.2021.03.006

Letter regarding article 'Focal stenosis of the sigmoid sinus causing intracranial venous hypertension: Case report, endovascular management and review of the literature'.

Authors: Halil Onder

Topics: Colon, Sigmoid; Constriction, Pathologic; Cranial Sinuses; Endovascular Procedures; Humans; Hypertension; Intracranial Hypertension; Sinus Thrombosis, Intracranial

PubMed: 26964555
DOI: 10.1177/1591019916637357