Femoral Venous Access Research Articles

Vascular access complications after catheter ablation of ventricular arrhythmias: Impact of vascular closure devices

BackgroundVascular access site complications are the most frequent complications of percutaneous catheter ablation (CA) of ventricular arrhythmias (VAs). Whether arterial/venous vascular closure devices (VCDs) prevent vascular complications is unknown. ObjectiveWe investigated the benefit of VCDs in patients undergoing CA of VAs. MethodsConsecutive CA of VAs were included (2018–2022). Vascular accesses were obtained with ultrasound guidance. At the discretion of the operator, arterial and/or venous VCDs were used. Cases were divided into 3 groups: no use of VCDs for any arterial/venous accesses (manual compression [MC]), use of VCDs for some but not all accesses (Partial-VCDs), and use of VCDs for all accesses (Complete-VCDs). Vascular complications were classified as minor if they did not require intervention or major if they required intervention. ResultsA total of 1016 procedures were performed in 872 patients (mean age 62 ± 13 years; mean body mass index 30 ± 6 kg/m2; 27% female) during the study period. Femoral arterial access was obtained in 887 procedures (875 single access: 7.4 ± 1.5 F size; 12 two accesses: 7.3 ± 3 and 6.9 ± 1.8 F). Femoral venous access was obtained in 1014 procedures (unilateral in 17%; bilateral in 83%; mean number of access sites per patient 2.6 ± 0.7; mean size 8.4 ± 1.3 F). Hemostasis was achieved with MC in 192 procedures (19%), with Partial-VCD in 275 (27%), and with Complete-VCD in 549 (54%). A vascular complication occurred in 52 procedures (5.1%), including a minor hematoma in 3.9% and/or a major complication in 1.7%. The rate of vascular complications was 6.8% (5.2% minor and 1.6% major) in the MC group, 7.6% (5.1% minor and 3.3% major) in the Partial-VCD group, and 3.3% (2.9% minor and 0.9% major) in the Complete-VCD group (P = .014 for comparison). In multivariable analysis, Complete-VCD remained independently associated with a lower risk of vascular complications (odds ratio 0.69; 95% confidence interval 0.48–0.96; P = .036). ConclusionIn patients undergoing CA of VAs, Complete-VCD is associated with lower rates of vascular-related complications compared with MC or Partial-VCD.

Clues for diagnosing misplaced central venous catheter in the right ascending lumbar vein during right femoral venous access

The right ascending lumbar vein is difficult to detect on anteroposterior abdominal radiographs because it overlaps with the inferior vena cava on anteroposterior radiographs. Intensive observation by medical providers may be a cue for diagnosis. However, knowledge of catheter misplacement of the right ascending lumbar vein is also necessary, because misplacement cannot be suspected without that awareness.

Percutaneous closure of aortopulmonary window in a preterm infant

ABSTRACT Aorto-pulmonary window (APW) is a rare congenital heart disease. The non-restrictive types of APWs present at an early age and require early surgical correction. The transcatheter device closure in young infants pose significant challenges that include hemodynamic instability during arteriovenous loop formation and due to potential encroachment of the occlusive device on vital adjacent structures, and sizing of introducer sheaths and delivery systems. We report a successful transcatheter closure of an AP window in a 1.35 Kg preterm infant with heart failure requiring mechanical ventilation. To the best of our knowledge this is the smallest and youngest baby , wherein transcatheter device closure has been attempted for a non-restrictive aorto-pulmonary window. The procedure was done through a 4 French right femoral venous access, thus avoiding an arterial access. A 0.025 Terumo wire was maneuvered through the pulmonary artery across the APW without formation of an arteriovenous loop. The APW was successfully occluded with a Konar multi-functional device delivered via a 4-French delivery system. The baby could be successfully weaned off the ventilator and could be discharge. On 1 month follow up, baby was in good health and gaining adequate weight. Thus we conclude that careful selection of patients allows successful closure of APW, even in the smallest baby.

Endovascular retrieval of a migrated contraceptive implant into the pulmonary artery : case report and review of literature

BackgroundThe migration of contraceptive devices into pulmonary arteries is extremely rare, reported to be 1 in 100,000.Case presentationA 19-year-old female presented no sensation of a contraceptive implant in her arm which had been placed one year prior. A CT scan confirmed that the implant had migrated into the left lower segmentary pulmonary artery. After a multidisciplinary meeting, an endovascular approach was attempted. Following right femoral venous access, a 8F NeuronMax® introducer was placed into the left pulmonary artery under fluoroscopic guidance. The contraceptive device was removed using a 25-mm loop snare, with a proximal capture technique. The patient was discharged the following day, with no reported complications.ConclusionIn cases of contraceptive device migration, the first medical decision involves deciding between removal or 'watching and waiting'. Previous reports describe two removal options: endovascular or surgical approaches. Fourteen reports have been published, with high technical success and low rates of complications. The loop snare technique is described as the optimal technique for an endovascular approach. Due to their invasive nature, surgical approaches should be reserved for cases of endovascular removal failure, after evaluating risks and benefits.Graphical

Abstract 16659: Neo LVOT Prediction With the Innovalve TMVR System - CT Preliminary Results

Introduction: The Innovalve TMVR is a novel self-expandable trans-catheter mitral valve prosthesis, delivered trans-septally using femoral venous access. It is deployed in an intra-valvular posterior position after sub-valvular anchoring by rotation of 6 circumferential arms. LV outflow tract (LVOT) compromise is of great concern in TMVR. A predicted Neo LVOT area of 170 mm 2 is the currently accepted cut-off for LVOT obstruction. Hypothesis: CT can accurately predict the Neo LVOT area prior to Innovalve TMVR procedure. Methods: CT was performed as a screening tool to evaluate the Neo LVOT area prior to Innovalve TMVR procedure. CT protocol: Retrospectively ECG gated with full cardiac cycle coverage. CT was performed before and after the procedure. Predicted Neo LVOT (pNLVOT) was calculated using a dedicated simulation valve prior to TMVR, actual Neo LVOT (aNLVOT) was calculated with the inserted valve in place following TMVR. The native LVOT (nLVOT) area, the predicted % LVOT reduction (nLVOT area-pNLVOT area /nLVOT area), the actual % LVOT reduction (nLVOT area-aNLVOT area /nLVOT area) and the difference between them (pNLVOT%-aNLVOT%) were calculated. Results: One hundred patients were screened for Innovalve TMVR procedure based on Neo LVOT criteria. pNLVOT≥ 170 mm 2 was found in 11 patients (11%), (7 males) average age 68±10 years, these patients underwent Innovalve TMVR procedure. The median calculated LVOT was 647.8+/-260 mm 2 (range 373-1312), the median pNLVOT reduction was 16% ±15 (range 3-53), the median aNLVOT reduction was 5%±14 (range -5-40) and the median difference between the pNLVOT and aNLVOT was 8±12 (range -4-31). In 8/11 patients (73%), the aNLVOT was larger than the pNLVOT (range difference 1 to 31%). In 3/11 patients (27%), the aNLVOT was smaller than the pNLVOT (range difference -1 to -4%). Conclusions: Underestimation of neoLVOT reduction, was uncommon and documented only minor and clinically insignificant difference between the pNLVOT and aNLVOT. As overestimation of NLVOT reduction allows a margin of safety for MTVR, we conclude that CT can serve as reliable NLVOT screening tool.

Abstract 18651: Case Report: Transcatheter Edge-to-Edge Repair in a 59-Year-Old Patient With Mitral Regurgitation and Challenging Anatomy

Re-intervention for patients with mitral valve disease is a growing challenge. We present a 59-year-old male with a history of a congenitally bicuspid aortic valve. He had valve and root replacement for aortic regurgitation in his 30s and two subsequent sternotomies for prosthesis failure and endocarditis. After admission with acute pulmonary edema, there was persistent NYHA class II-III dyspnea. Echo showed severe (grade IV) mitral regurgitation due to the dehiscence of a 32mm mitral annuloplasty ring. The coaptation point of the leaflets was posterior to the posterior aspect of the ring. No regurgitation was observed through the ring’s central orifice, but the tissue was seen on its posterior aspect, suggesting torn posterior leaflet or healed vegetation. The left ventricle was mildly dilated, and the LVEF was 53%. The right ventricle was moderately dilated with severe functional tricuspid regurgitation with a normally functioning aortic valve prosthesis. After extensive discussion, due to his multiple previous surgeries and challenging anatomy, the patient was deemed unsuitable for surgical treatment. There is some limited registry data to support TEER as a safe and feasible alternative to surgery in this cohort. He underwent successful implantation of two clip devices in the A2/P2 and A2/P2b positions via a trans-septal approach under a general anesthetic. Femoral venous access was used. Some useful learning points relate to the challenges posed by the unusual anatomy in terms of imaging and trajectory. No MVARC complications. Postoperatively the LVEF was 55% with a mean transvalvular gradient of 5mmHg and only mild (grade I) transvalvular MR. At three months the patient reported an improvement of overall functional status. This successful case of “clip-in-ring” TEER illustrates one of the expanding indications for existing trans-catheter valvular therapies as well as the potential for creative application of TEER in helping patients with high surgical risk.

Abstract 16590: Left Ventricular Remodelling Following Transcatheter Mitral Valve Replacement With the Innovalve System

Introduction: Transcatheter Mitral Valve Replacement (TMVR) using a trans-septal approach is a new therapeutic option for patients with severe mitral regurgitation (MR). However, both surgical as well as currently under-testing trans-catheter approach, are shown to cause decrease in LV function. The Innovalve TMVR is a novel self-expandable transcatheter mitral valve prosthesis, delivered trans-septally using femoral venous access. It is deployed in an intravalvular posterior position after subvalvular anchoring by rotation of 6 circumferential arms Hypothesis: TMVR procedure (Innovalve system) leads to LV anatomical and functional changes Methods: CT was performed before the Innovalve TMVR procedure, and after 3 to 6 months. CT protocol included retrospective ECG gating with full cardiac cycle coverage. LV end diastolic and end systolic diameters (LVEDD, LVESD) were measured in the left ventricular outflow tract orientation at the most basal level. Tip to tip papillary muscle distance was measured in the short axis orientation at the most basal slice demonstrating the papillary muscle tips. LV ejection fraction (LVEF) was calculated using the end systolic and end diastolic volumes. All measurements were performed at end systole and end diastole before MTVR and after 3-6 months using a dedicated platform (3Mensio). Results: Ten patients (7 males) average age 69+/-10 years, underwent the Innovalve TMVR procedure. Average LVESD decreased from 52±15 mm at baseline to 44±15mm (P=0.016) at 3-6 months. Similarly, LVEDD decreased from 60±14 mm at baseline, to 52±13mm at 3-6 months (P=0.039). Average papillary muscle tip to tip distance at end diastole (ED) decreased from 31.7±7mm at baseline to 28.4±6.5mm at 3-6 months (P=0.047).A trend of LVEF improvement was evident with an increase from 35%±12 average at baseline compared with 39%±12 average after 3-6 months (P=0.346). Conclusions: These preliminary results show that the TMVR procedure using the Innovalve system may result in favourable LV reverse remodelling changes including reduction of LVESD, LVEDD and ED papillary muscle distances, with improved LVEF. This encouraging data might suggest favourable postprocedural structural LV change.

Abstract 18056: Transhepatic and Trans-Patent Foramen Ovale Ablation of Atrial Fibrillation in the Setting of Chronic Inferior Vena Cava Occlusion: Addressing Complex Anatomic Hurdles and Achieving Therapeutic Success

Background: Rhythm control for atrial fibrillation (AF) is the preferred approach for symptomatic patients, particularly those with reduced ejection fraction. Catheter ablation primarily consists of pulmonary vein isolation via a transseptal approach. In patients with chronic occlusion of inferior vena cava (IVC), surgical ligation of IVC, or congenital venous system abnormalities, conventional femoral venous access may not feasible. Case Report: A 78-year-old male with history of Hypertension, diabetes, coronary artery disease, bilateral DVTs s/p thrombectomy, prior IVC stenting, presented with persistent, symptomatic AF on apixaban. Given a moderately reduced EF of 40-45%, amiodarone intolerance, and contraindication to other AADs, he was referred for catheter ablation. CT venogram showed chronically occluded IVC with patent hepatic veins, therefore transhepatic access to the right atrium was obtained. Transesophageal echocardiography (TEE) was planned for transseptal puncture; however, this showed an incidental PFO. This PFO was easily engaged using a manual modification of a VersaCross transseptal sheath and after entering the left atrium, the sheath was exchanged with a bi-directional sheath (Vizigo). Using this single left atrial access, pulmonary vein isolation and posterior wall isolation were performed. The transhepatic access site was closed with coil embolization to prevent track bleeding (figure 1). Conclusion: We present a case where successful AF ablation was achieved via percutaneous transhepatic approach, with improvised utilization of a conveniently located PFO. This was guided by pre-operative CT, and intra-operative TEE which allowed us to minimize any transseptal puncture related complications. The utilization of a multidisciplinary team comprising electrophysiologists, advanced imaging cardiologists and interventional radiologists is invaluable in executing complex procedures of this nature.

Abstract 17847: Typical Right Atrial Flutter Ablation Using Subclavian Venous Access in Patients With Interrupted or Occluded Inferior Vena Cava

Introduction: Ablation for typical atrial flutter (AFL) traditionally involves vascular access from the femoral vein to facilitate advancing catheters through the Inferior Vena Cava (IVC) to the right atrium (RA). In patients with interrupted or occluded IVC, this procedure is challenging to perform. We report a case series of typical right AFL ablation using subclavian access in interrupted or occluded IVC. Cases: A 63-year-old female with typical AFL refractory to medical therapy was referred for radiofrequency ablation (RFA). She had a history of surgically corrected atrial septal defect at age 4 years with known IVC interruption draining into RA via an azygous venous extension. Another case involved a 41-year-old male with quadriplegia and typical AFL who underwent an attempted RFA from femoral access that was aborted due to massive thrombosis of IVC. Decision making: In both cases, two sheaths were placed into the left subclavian venous system using ultrasound guidance. A coronary sinus catheter and irrigated tip ablation catheter were advanced into the coronary sinus and RA respectively. Additionally, in the second case, an intracardiac echocardiography probe was inserted via separate venous access. Using the electroanatomic mapping system, entrainment and activation mapping confirmed a tricuspid isthmus-dependent AFL. RFA was performed using an open irrigated RFA catheter in a linear fashion resulting in the termination of the tachycardia to sinus rhythm. In the first case, ablation extended from the tricuspid annulus to the os of the hepatic vein at the 06:00 position. Post ablation, hemostasis was achieved using a suture-mediated closure device. At follow-up, both patients were asymptomatic without evidence of AFL on extended-duration cardiac monitoring. Conclusion: In patients with interrupted or occluded IVC, the subclavian veins can be accessed for mapping and ablation of typical AFL when traditional femoral venous access is challenging.

The use of distal femoral venous access for pulmonary vein cryoballoon ablation and left atrial appendage occluder implantation: randomized study design and preliminary results

Aim. This study aims to compare the results of the distal femoral access with the classic approach in patients undergoing pulmonary vein cryoballoon ablation and left atrial appendage occluder implantation.Methods. The primary results of the 1:1 randomized single-center study are presented. The study group recruited 47 patients who underwent the catheter-based procedure using ultrasound-assisted distal femoral access. 38 patients with traditional ultrasound-guided proximal femoral access were involved in the control group.Results. Total 85 patients were included: 47 in the study group and 38 in the control group. The median age was 61 years, and pulmonary vein cryo-ablation was performed in 84%. 95% of patients were taking direct oral anticoagulants. In the study group, the most frequent topographic and anatomical variant was the location of the superficial femoral vein on the lateral side from the artery (81%), whereas in the control group it was on the medial side (81%). The median access time was 30 s in the study group for the right leg and 35 s for the left leg. In the control group, access time was 33 s and 39 s for the right and left leg respectively. Unintentional arterial puncture occurred more frequently in both groups when the vein was fully overlapped by the artery for both right and left legs, but the differences were statistical unsignificant (p>0.05 and p=0.09 in the main group, p=0.24 and p=0.72 in the control group). In a correlation analysis, neither body mass index (p=0.19) nor femoral circumference (p=0.19 for right and p=0.06 for left legs) influenced the access time and did not increase the number of unintended arterial punctures. Two patients in the control group required additional manual hemostasis. There was no postprocedural venous thrombosis in both groups. Back pain was observed only in patients in the control group.Conclusion. The efficacy and safety of the distal femoral access approach are comparable to the traditional proximal approach. Earlier postprocedural activation of patients can help improve quality of life.

VersaCross Transseptal System for Mitral Transcatheter Edge-To-Edge Repair With the PASCAL Repair Platform

BackgroundVersaCross is a novel radiofrequency transseptal solution that may improve the efficiency and workflow of transseptal puncture (TSP). The aim of this study was to compare the VersaCross transseptal system with mechanical needle systems during mitral transcatheter edge-to-edge repair (M-TEER) with the PASCAL device. MethodsThis is a single-center retrospective study of consecutive patients who underwent M-TEER with the PASCAL. Transseptal puncture was undertaken with either a mechanical needle or the VersaCross wire. The primary endpoints were success of TSP and successful delivery of the Edwards sheath on the chosen delivery wire. Secondary endpoints included number of wires used, tamponade rate, interval from femoral venous access to TSP and first PASCAL device deployment, procedural death, and stroke. ResultsThirty-three consecutive patients (10 with mechanical needle, 23 with VersaCross) who underwent M-TEER with the Edwards PASCAL device were identified. All patients had successful TSP. In the mechanical needle group, the Edwards sheath was successfully delivered on the Superstiff Amplatz wire in all cases. In the VersaCross arm, the radiofrequency wire was used successfully for delivery of the sheath in all cases. There were no cases of pericardial effusion/tamponade in either arm. Interval from femoral venous access to TSP and to deployment of the first PASCAL device was shorter with the VersaCross system. Significantly fewer wires were used with VersaCross. There were no procedural deaths or strokes in either group. ConclusionsVersaCross appears a safe and effective method of TSP and for delivery of the 22Fr sheath for M-TEER with PASCAL.

Mitral annular electrogram morphology - a balanced signal does not identify the anatomical annulus

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): British Heart Foundation Background Electrogram morphology is used to identify the atrio-ventricular annuli during catheter ablation procedures with a "balanced" signal considered to represent the annuli. However, anatomical studies highlight a significantly greater mass of ventricular myocardium compared to atrial myocardium at the valve plane suggesting the correct electrical signature of the anatomical annulus may not be a balanced signal. Purpose To identify the relationship between atrial and ventricular electrogram components at the anatomically defined mitral valve annulus. Methods Mapping of the mitral annulus was performed in patients undergoing ablation for paroxysmal atrial fibrillation. Following femoral venous access and trans-septal puncture, left atrial anatomy was defined using rotational angiography performed using a 100ml contrast injection 4 seconds prior to X-ray acquisition, during rapid pacing and apnoea while covering 200 degrees at 40 degrees/s. A SmartTouch SF ablation catheter (Biosense Webster) was advanced into the left atrium and used to record intracardiac electrograms at four positions around the mitral annulus and at five predetermined levels ranging from ventricular to atrial (Figure, panel A). Data analysis was performed using OpenEP (https://openep.io). For each electrogram, the distance to the mitral valve plane and the amplitudes of atrial and ventricular electrogram components were calculated (Figure, panel B and C). Mean electrogram component amplitudes were calculated including all points recorded within ±2.5mm of the mitral valve plane. For each patient, a linear regression model was fitted and used to identify the atrial/ventricular ratio at the anatomically defined mitral valve annulus (Figure, panel D). Results The protocol was completed in 9 patients, including analysis of 240 atrial or ventricular electrogram components. Within ±2.5mm of the anatomically defined mitral valve annulus, the mean recorded amplitudes of atrial and ventricular electrogram components was 0.15±0.17mV and 1.35±1.27mV, respectively (A/V ratio 1:9). Using the linear regression model, the ventricular electrogram component was calculated to be 16.5±11.6 times greater in amplitude than the atrial electrogram component at the mitral valve plane (A/V ratio 1:16). The use of a balanced signal to identify the mitral valve annulus resulted in a positional error of -7.9±9.5mm (i.e. identifying a level which is approximately ~8mm too "atrial" compared to the anatomically defined annulus). Conclusion The conventional use of a "balanced" electrogram signal does not identify the anatomical mitral valve annulus. An atrial/ventricular electrogram ratio between 1:9 and 1:16 best approximates the mitral valve annular plane determined by left atrial rotational angiography. These findings have relevance in target site selection for an accessory pathway and the ventricular extent of linear ablation at the mitral isthmus.

General anesthesia in spontaneous respiration with intravenous ketamine in patients undergoing pulsed-field ablation

Abstract Funding Acknowledgements Type of funding sources: None. Background Thermal ablation of atrial fibrillation (AF) by means of radiofrequency or cryo-balloon is usually performed under general anesthesia, deep sedation, or conscious sedation at operator’s discretion and based on the general condition of the patient. However, a standardized sedation protocol when performing a non-thermal ablation, such as pulsed-field ablation (PFA) through irreversible cellular electroporation, has not been well established. Purpose We report our preliminary experience of a general anesthesia in spontaneous respiration protocol with ketamine used at a high-volume center during ablation of AF with a new PFA system. Methods All consecutive patients (pts) undergoing AF ablation with PFA at our center were included. Our sedation protocol consists of intravenous administration of midazolam (1+1 mg), fentanyl (25+25+25+25 mcg/kg) at low doses before local anesthesia with lidocaine (200mg) administration. Patients underwent sedation under spontaneous respiration by administering oxygen (4-6 l/min) through a face mask with nasal cannula. Local anesthesia was performed before the percutaneous femoral venous access. Soon after the trans-septal puncture, heparin (1 mg/kg) and atropine (1 mg, to mitigate anticipated bradycardia) were injected, followed by a second bolus of midazolam (1 mg). Ketamine adjunct (1 mg/kg) was then injected about 5 minutes before the first PFA delivery which was titrated to effect based on patient’s condition, response and changes in vital signs (total ketamine adjunction of 2 mg/kg). For quantitative assessment the Numeric Rating Scale for Pain (NRS) was applied. For qualitative assessment a 3-levels satisfaction evaluation was retrieved. The ablation endpoint was PVI as assessed by entrance and exit block. Results Forty-two pts were included in this analysis (mean age of 66±9 years,72% were male, CHA2DS2VASc score=2 [IQR 1–3], median body mass index 24[20-48]kg/m2, 35% had respiratory diseases – e.g. asthma, OSAS, COPD –). At baseline, before sedation, mean systolic blood pressure was 140.5+20.1mmHg and mean oxygen saturation was 97.9+2.1%. PVI was achieved in all the patients. The number of PFA applications to reach PVI was 33.4+3 (time to PVI = 25+4min). In two cases additional PFA lesion sets were deployed outside the PVs. Lab occupancy time was 122±32min, skin-to-skin time was 78±35min and fluoroscopy time was 23±14min. All the patients achieved a NRS ≤ 3. Satisfaction level was found to be acceptable in all procedures by both the patient and the primary operator (Score equal to 0). No major procedure-related adverse events were reported. Conclusion The PFA procedure has a short execution time. The standardized anesthetic protocol with the administration of drugs with rapid onset and pharmacological offset at low doses was effective and safe with an optimal degree of patient and operator satisfaction.

PO-05-204 MULTI-CENTER CLINICAL OUTCOMES OF A NO-IMPLANT INTERATRIAL SHUNT FOR HEART FAILURE WITH PRESERVED AND REDUCED EJECTION FRACTION: UPDATE FROM THE EARLY FEASIBILITY ALLEVIATE-HF PROGRAM

Chronic heart failure (HFpEF and HFrEF) remains an important area of unmet need despite current best medical therapies available. Implantable interatrial shunt devices may improve quality of life and functional capacity with favorable safety signals but require permanent implantation to maintain patency. We report the 6-month clinical outcomes of a no-implant approach to interatrial shunting across three studies: ALLEVIATE-HF-1 and ALLEVIATE-HF-2 for HFpEF, and a dedicated HFrEF study. Patients aged ≥ 40 years, NYHA class II, III or ambulatory IV and elevated left atrial pressure (PCWP) during supine ergometry were included in the studies. Baseline assessments included echocardiography, exercise right heart catheterization, KCCQ and 6MWT. Femoral venous access and standard transseptal catheterization techniques were employed. The device was utilized to excise a segment of the interatrial septum using a pulse of radiofrequency energy to create a shunt under fluoroscopic and echocardiographic guidance. A total of 28 HFpEF and 5 HFrEF patients were enrolled. Mean LVEF was 60 ± 8% and 30 ± 8% in HFpEF and HFrEF patients, respectively. Procedures were successful with no device or procedure-related adverse events. Six-month outcomes are reported in the table. TTE and CT confirmed all shunts assessed maintained patency (n=30). No device or procedure-related serious adverse events occurred upon discharge and through 6 months. This early feasibility clinical experience demonstrates procedural safety and feasibility of the Alleviant no-implant interatrial shunt creation with a promising efficacy signal through 6 months in patients with HFpEF and HFrEF. Enrollment for the forthcoming randomized sham-controlled pivotal study (ALLAY-HF) is anticipated to begin early 2023.

Ultrasound guidance for femoral venous access in patients undergoing pulmonary vein isolation: A quasi-randomized study.

Routine ultrasound (US) guidance for femoral venous access to decrease vascular complications of atrial fibrillation (AF) ablation procedures has been advocated. However, the benefit has not been unequivocally demonstrated by randomized-trial data. Consecutive patients undergoing pulmonary vein isolation (PVI) on uninterrupted anticoagulant treatment were included. A quasi-random allocation to either US-guided or conventional puncture group was based on which of the two procedure rooms the patient was scheduled in, with only one of the rooms equipped with a US machine including a vascular transducer. The same four novice operators in rotation, with no relevant previous experience in US-guided vascular access performed venous punctures in both rooms. Major and minor vascular complications and the rate of prolonged hospitalization were compared. Major vascular complication was defined as groin hematoma, arteriovenous fistula, or pseudoaneurysm. Hematoma was considered as a major vascular complication if it met type 2 or higher Bleeding Academic Research Consortium criteria (requiring nonsurgical, medical intervention by a health care professional; leading to hospitalization or increased level of care, or prompting evacuation). Of the 457 patients 199 were allocated to the US-guided puncture group, while the conventional, palpation-based approach was performed in 258 cases. Compared with the conventional technique, USguidance reduced the rate of any vascular complication (11.63% vs. 2.01%, p < .0001), including both major (4.26% vs. 1.01%, p = .038) and minor (7.36% vs. 1.01%, p = .001) vascular complications. In addition, the rate of prolonged hospitalization was lower in the US-guided puncture group (5.04% vs. 1.01%, p = .032). The use of US for femoral vein puncture in patients undergoing PVI decreased the rate of both major and minor vascular complications. This quasi-randomized comparison strongly supports adapting routine use of US for AF ablation procedures.

A swine model of pulmonary embolism with human-derived thrombi

Objectives: The development and evaluation of percutaneous thrombectomy devices for pulmonary embolism (PE) pose a need for standardized large in vivo models with representative anatomical and physiological conditions and clots analogs. In this study, we present a swine model of PE model employing human-derived clot analogs. Material and Methods: Baseline angiographic and physiological pressure measurements were obtained in six adult Yorkshire pigs (45–65 kg) and results were benchmarked for interspecies comparison with published human data using fluoroscopic examinations, intra-arterial pressure measurements, and histologic studies. Then, clot analogs were created ex vivo employing banked human blood and a subset incubated in iodinated contrast for fluoroscopic visualization. Clot analogs were then embolized via a femoral venous access and angiographic/physiological consequences were evaluated. Results: The main, right, and left pulmonary artery diameters were 24 ± 1.1 mm, 16.5 ± 0.8 mm, and 12.6 ± 1.2 mm, respectively. The angle between the main pulmonary artery at the bifurcation point was approximately 90–95°. The clot analogs were heterogeneous and had increased fibrin content along the clot length. The overall composition was 96.63% red blood cell (RBC)/3.37% fibrin in the initial section, 48.85% RBC/51.15% fibrin in the intermediate section, and 3.44% RBC/96.56% fibrin in the final section. Embolization of the clot analogs resulted in distal occlusion of the right and left pulmonary arteries. Conclusions: This swine model coupled with clot analog is able to accurately mimic human anatomical and physiological conditions in PE making it feasible for the evaluation of pulmonary thrombectomy devices.

Chemotherapy delivering port catheter fracture and migration into the heart: a life-threatening accident during neck dissection

Objectives: port catheter fracture and migration could be an iatrogenic life-threatening complication. We aimed to sensitize head and neck surgeons to this complication. Observation: a 61-years old man was referred to our surgery department for management of T3N0M0 laryngeal cancer after failure of preservative treatment. The patient had received 2 cycles of chemotherapy and was judged a bad responder. A total laryngectomy with bilateral neck dissection was indicated. The port catheter was kept in place for possible further chemotherapy treatment. During neck dissection the catheter fractured and migrated. Post operative CT scan showed the distal part of the catheter bulging in the right cardiac chambers. The patient was transferred to an interventional cardiology unit where the foreign body was successfully retrieved using femoral venous access. Conclusion: port catheters are a real potential danger because of the risk of fracture and migration of the distal part. Removal of these devices should be performed in collaboration with medical care oncologists before every neck intervention.

Ambulatory pulmonary vein isolation workflow using the Perclose ProglideTM suture-mediated vascular closure device: the PRO-PVI study.

The leading reason for delayed discharge after pulmonary vein isolation (PVI) is vascular complications. This study aimed to evaluate feasibility, safety, and efficacy of the Perclose Proglide™ suture-mediated vascular closure in ambulatory PVI, report complications, patient satisfaction, and cost of this approach. Patients scheduled for PVI were enrolled prospectively in an observational design. Feasibility was assessed as % discharged the day of procedure. Efficacy was analysed as acute access site closure rate, time to reach haemostasis, time to ambulate, and time to discharge. Safety analysis consisted of vascular complications at 30 days. Cost analysis was reported using direct and indirect cost analysis. A 1:1 propensity matched control cohort was used for comparing time to discharge to usual workflow. Of 50 enrolled patients, 96% were discharged on the same day. 100% of devices were successfully deployed. Immediate (<1 min) haemostasis was reached in 30 patients (62.5%). Mean time to discharge was 5:48 ± 1:03 h (vs. 10:16 ± 1:21 h in the matched cohort, P < 0.0001). Patients reported high level of satisfaction with the post-operative time. No major vascular complication occurred. Cost analysis showed a neutral impact compared to the standard of care. The use of the closure device for femoral venous access after PVI led to safe discharge of patients within 6 h from the intervention in 96% of the population. This approach could minimize the overcrowding of healthcare facilities. The gain in post-operative recovery time improved patients' satisfaction and balanced the economic cost of the device.

Novel Epicardial Access Technique Facilitated by Carbon Dioxide Insufflation of the Pericardium for Ablation of Ventricular Arrhythmias: Lessons From the Early Experience From a Single Centre in Australia.

Epicardial access for mapping and ablation of the epicardial substrate may be required in catheter ablation of ventricular tachycardias (VT). However, high complication rates are associated with the standard epicardial access approach. Recently, a novel method of intentional coronary vein (CV) exit with pericardial CO2 insufflation to facilitate epicardial access has been described. This study describes our initial experience with this technique. Patients undergoing epicardial VT ablation between 1 February 2021 to 31 May 2022 at the Royal Prince Alfred Hospital, Sydney, NSW, were included in this study. Via femoral venous access, a branch of the coronary sinus was sub-selected and intentional CV exit was performed with a high tip load coronary angioplasty wire. A microcatheter was then advanced over the wire into the pericardial space, followed by pericardial CO2 insufflation, facilitating subxiphoid pericardial puncture. Five (5) patients underwent epicardial access for VT mapping and ablation. All patients had successful intentional CV exit and CO2 facilitated epicardial access. The mean time to successful epicardial access was 37.2±17.5 minutes. With increasing operator experience, there was improvement in epicardial access times, with the fifth case requiring only 13 minutes. There was one case of inadvertent right ventricular puncture (without haemodynamic or ventilatory compromise) due to inappropriate CO2 insufflation into the right ventricle. Epicardial access was successful on the second attempt. This is the first case series of epicardial access facilitated by CO2 insufflation in Australia. This technique enabled successful epicardial access in all patients in our early experience, with no adverse outcomes from epicardial access. With increasing operator experience, this technique may allow for more widespread adoption of up-front epicardial access for the treatment of VT.

Transpulmonary thermodilution: A revised correction formula for global end-diastolic volume index derived after femoral indicator injection.

Transpulmonary thermodilution (TPTD) is usually performed by jugular indicator injection. In clinical practice, femoral venous access is often used instead, resulting in substantial overestimation of global end-diastolic volume index (GEDVI). A correction formula compensates for that. The objective of this study is to first evaluate the efficacy of the currently implemented correction function and then further improve this formula. The performance of the established correction formula was investigated in our prospectively collected dataset of 98 TPTD measurements from 38 patients with both, jugular and femoral venous access. Subsequently, a new correction formula was developed: cross validation revealed the favourite covariate combination and a general estimating equation provided the final version, which was tested in a retrospective validation on an external dataset. Investigating the current correction function revealed a considerable reduction of bias compared to no correction. Concerning the objective of formula development, the covariate combination of GEDVI obtained after femoral indicator injection, age and body surface area is even favoured, when compared to the parameters of the previously published correction formula, as a further reduction of mean absolute error (68 vs. 61 ml/m2), a better correlation (0.90 vs. 0.91) and an increased adjusted R2 (0.72 vs 0.78) is noticed in the cross validation results. Of particular clinical importance is, that more measurements were correctly assigned to the same GEDVI category (decreased / normal / increased) using the revised formula, compared with the gold standard of jugular indicator injection (72.4 vs. 74.5%). In a retrospective validation, the newly developed formula showed a greater reduction of bias (to 2 vs. 6 %) than the currently implemented formula. The currently implemented correction function partly compensates for GEDVI overestimation. Applying the new correction formula on GEDVI measured after femoral indicator administration enhances the informative value and reliability of this preload parameter.