Steerable Sheath Research Articles

Comparison of geographic workflow preferences with real-time dynamic regional mapping data during catheter ablation

Abstract Funding Acknowledgements Type of funding sources: None. Introduction The clinical benefit of multielectrode high-density (HD) mapping during catheter ablation has been an area of active research. One advantage of HD mapping is improved sensitivity which can lead to better visualization and substrate delineation during the procedure. In addition to the advantages offered by the multielectrode grid mapping catheter (HD Grid), a novel software enable the display of beat-to-beat, dynamic regional mapping data from the current location of HD Grid in real-time (LiveView). The optimal settings and workflows to incorporate the dynamic data into routine ablation procedures have not been explored. Purpose To examine the common settings and workflow patterns among operators from different geographies when using dynamic mapping. Methods Observational procedural data including procedure time, total RF time, workflow preference, and fluoroscopy time, were prospectively collected from operators across Europe, the U.S., and Asia Pacific countries from May to September 2020. Cases from both catheter ablation of atrial and ventricular arrhythmias were included in the analysis. Results A total of 754 cases were collected (428, 133, and 193 cases from Europe, the U.S., and the Asia Pacific region, respectively). The most commonly reported indication across all three geographies was de novo paroxysmal atrial fibrillation (223/754, 30.0%). A steerable sheath was more frequently used with the mapping catheter in Europe and U.S. compared to Asia Pacific countries. Contrary to cases from the U.S. and Asia Pacific countries where the double transseptal approach was the preferred technique for left atrial procedures (78.8% and 55.3%, respectively), the single transseptal approach was more commonly observed in European cases (233/428, 54.4%). Visualization of real-time mapping data after creation of traditional full-chamber maps were commonly observed in all three geographies. Regardless of geography, the CS catheter was commonly used a reference electrode; and the most common map appearance settings for interior projection, exterior projection, and interpolation was 7, 7, and 7 respectively. Voltage cutoff of 0.1 mV, range from 0.01 to 1.5 mV, was most frequently observed for delineating scar in atrial arrhythmia cases analyzed in this dataset. Conclusions While there is a geographical difference in ablation workflow, common settings and patterns can be observed in all three regions. This data suggests that minimal workflow changes are required to incorporate the use of dynamic data into routine procedures. Adaptation of LiveView can help improve procedure efficiency and efficacy by reducing the need for full chamber maps, identifying areas that were under ablated, and confirming ablation endpoints. Further control study examining procedure efficiency and efficacy associated with dynamic mapping may be warranted.

Steerable sheath for exclusively femoral bilateral extension of previous fenestrated endovascular aneurysm repair with iliac branch devices.

We report the treatment of type Ib endoleak after fenestrated endovascular aneurysm repair (FEVAR) with iliac branch device (IBD) to allow exclusive transfemoral access without a femoral-to-femoral through-and-through wire. The patient was treated with fenestrated endovascular aneurysm repair and showed expansion of the aneurysm owing to a type Ib endoleak. An IBD was implanted by the use of a contralateral steerable sheath for internal iliac artery catheterizing. A computed tomography scan showed the patency of the target vessels and resolution of the endoleak. The use of a steerable sheath without femoral-to-femoral through-and-through wire to bridge the internal iliac artery in patients receiving an IBD after prior EVAR is feasible and avoids the risks associated with upper extremity access.

WILD Sheath Technique: “WIre Loop Directional” Sheath for Retrograde Femoral Access in Branched Endovascular Aortic Aneurysm Repair

Branched endovascular aortic aneurysm repair (BEVAR) necessitates upper limb access (ULA) to facilitate the antegrade cannulation of downward directional branches and the placement of the bridging stent grafts. Various technical solutions to avoid ULA have been proposed and successfully applied in a limited number of cases. This can be necessary in specific clinical scenarios such as hostile aortic arch and descending thoracic aortic anatomy, or in the case of previous aortic arch and supra-aortic vessels surgery complicating the conventional approach with ULA in BEVAR. Taking inspiration from the prior description of a precursory technique, we report the application of our technique in BEVAR procedures, using standard introducer sheaths as a directional stable platform to facilitate an “All Femoral Access” (AFA) approach without the need for ULA, snaring or commercial steerable sheaths. Our concept is based on utilizing a wire loop to form a directional sheath (WILD sheath technique).

Acute safety, efficacy, and advantages of a novel cryoballoon ablation system for pulmonary vein isolation in patients with paroxysmal atrial fibrillation: initial clinical experience.

AimsCryoballoon pulmonary vein isolation (PVI) is a safe and effective treatment for atrial fibrillation (AF). Current limitations include incomplete vein occlusion due to balloon rigidity and inconsistent electrogram recording, which impairs identification of isolation. We aimed to evaluate the acute safety and performance of a novel cryoballoon system.Methods and resultsThe system includes a steerable sheath, mapping catheter, and a balloon that maintains uniform inflation pressure and size following initiation of ablation. Protocol-directed cryoablation was delivered for 180 s for isolation documented in ≤60 s, otherwise freeze duration was 240 s. Primary endpoints were acute safety and vein isolation. Pulmonary vein isolation was confirmed at ≥30 min post-isolation. Data were compared across vein locations. Thirty patients with paroxysmal AF were enrolled at two centres and underwent PVI. Pulmonary vein isolation was achieved with cryoablation only in 100% of veins (120/120). Nadir temperature was −53.1 ± 5.3°C. The number of applications to achieve PVI was 1.4 ± 0.4 per vein. Of the 120 veins, 89 were isolated with a single cryothermal application (10/30 patients required only 4 total cryoablations). There were no procedural- or device-related serious adverse events at 30 days post-procedure. A subset (24/30) of patients was followed for 1-year and 71% (17/24) remained free of atrial arrhythmias. Six patients with arrhythmia recurrence were remapped and three had durable PVI for all four veins. ConclusionIn this first human experience, the novel cryoballoon platform was safe, efficacious, and demonstrated a high proportion of successful single ablation isolation.

Impact of the combined use of intracardiac ultrasound and a steerable sheath visualized by a 3D mapping system on pulmonary vein isolation.

A novel steerable sheath visualized on a three-dimensional mapping system has become available in this era in which a durable pulmonary vein (PV) isolation (PVI) with reduced fluoroscopy is required. In 60 patients who underwent a PVI with a visualized sheath (n=30) and non-visualized conventional sheath (n=30), the fluoroscopic time and catheter stability during the PVI were analyzed. The fluoroscopic time during the transseptal access (0 [0, 0.1] vs. 1.4 [0.8, 2.3] minutes, P<.001) and PVI (0 [0, 0.1] vs. 0.4 [0.2, 1.1] minutes, P<.001) were shorter in the visualized sheath group than conventional sheath group. The procedure time during the PVI (32.0 [26.8, 36.3] vs. 41.0 [31.8, 47.3] minutes, P=.01), particularly during the right PVI (15.0 [12.8, 18.0] vs. 23.0 [15.8, 26.3] minutes, P=.009), was shorter in the visualized sheath group than conventional sheath group, however, that during the other steps was equivalent. The standard deviation of the catheter contact force during each radiofrequency application was smaller in the visualized sheath group than conventional sheath group (4.5 ± 2.7vs. 4.9 ± 3.1g, P=.001). The impedance drop for each lesion was larger in the visualized sheath group than conventional sheath group (10.7 ± 6.5vs. 9.8 ± 5.5 ohms, P<.001). The incidence of acute PV reconnections per patient (30%vs. 23%, P=.56) and per PV segment (2.5%vs. 2.3%, P=.83) were similar between the two groups. No major complications occurred in either sheath group. The use of visualized sheaths may reduce the fluoroscopic time and improve the catheter stability during the PVI.

Off the Shelf Fenestrated Stent Grafts: “Mind The Gap?”

Off the Shelf Fenestrated Stent Grafts: “Mind The Gap?”

Caudally directed in situ fenestrated endografting for emergent thoracoabdominal aortic aneurysm repair.

We previously described a transfemoral antegrade in situ laser fenestration technique (in situ fenestrated endovascular abdominal aortic aneurysm repair) for ruptured thoracoabdominal aortic aneurysms. In the present report, we have described an alternative technique of caudally directed in situ fenestrated endografts using upper extremity access for branch vessel incorporation. This technique involves partial deployment of the aortic stent graft in the thoracic aorta to achieve proximal control, followed by sequential branch incorporation using a laser probe through a steerable sheath, from the upper extremity access. The advantages of the technique include rapid proximal aortic control before branch incorporation without target vessel prestenting and separation of in situ fenestration from the target branch vessel origin, facilitating cannulation of angulated branch vessels.

Delayed radiofrequency ablation efficacy in slow pathway ablation: a case report.

BackgroundThe delayed effect of radiofrequency (RF) ablation was described in cases of accessory pathway and premature ventricular contraction ablation, as well as delayed atrioventricular (AV) block after slow pathway ablation.Case summaryWe report a case of a female patient with AV nodal re-entry tachycardia (AVNRT), in whom the first electrophysiology study ended with acute failure of slow pathway ablation, despite using long steerable sheath, both right and left-sided ablation with >15 min of RF energy application and repeatedly achieving junctional rhythm. Six weeks afterwards, during scheduled three-dimensional electroanatomical mapping procedure, there was no proof of dual AV nodal conduction nor could the tachycardia be induced. Also, the patient did not have palpitations between the two procedures nor during the 12-month follow-up period.DiscussionThis case illustrates that watchful waiting for delayed RF ablation efficacy in some cases of AVNRT ablation could be reasonable, in order to reduce the risk of complications associated with slow pathway ablation.

Ipsilateral Iliac Branch Repair Using a Looped Wire, Precannulated Gate Technique

Purpose To describe a novel, entirely ipsilateral femoral technique for distal endograft extension using the Gore Iliac Branch Endoprosthesis. Technique Femoral arterial access is obtained on the side of the intended repair, and a 16F sheath is inserted over a stiff wire. A looped wire is used to pre-cannulate the internal gate of the IBE device prior to insertion, and the device is then positioned and deployed. This through-wire guides access over the IBE flow divider and into the internal gate with a steerable sheath. The internal iliac artery is then selected, and a Viabahn VBX balloon-expandable stent (W.L. Gore, Flagstaff, AZ) is advanced into position and deployed. We present the successful completion of this technique in 4 patients. Conclusion This novel technique allows distal endograft extension with an IBE device using only ipsilateral femoral access and is particularly useful for patients with aneurysmal iliac degeneration in the setting of prior open or endovascular aneurysm repair. This eliminates the need for upper extremity access or contralateral femoral access and navigation across the steep flow divider.

A percutaneous approach to create tricuspid regurgitation in swine: a model for transcatheter tricuspid valve therapy assessment.

The purpose of this study was to develop a simple and effective percutaneous approach to create tricuspid regurgitation in swine. Eleven pigs (71.68 ± 7.70kg, 3 male) were involved in this study. A grasping forceps was introduced into the right ventricle through a steerable sheath under fluoroscopic guidance and used to disrupt the tricuspid valve apparatus by avulsing leaflet or chordae tendineae repeatedly. Transthoracic echocardiography and right ventricular angiography were used to evaluate the degree of tricuspid regurgitation created. Ten of the 11 pigs (90.91%) achieved severe tricuspid regurgitation and 1 (9.09%) obtained moderate tricuspid regurgitation immediately after the procedure. Heart rate of the pigs significantly increased immediately after tricuspid regurgitation creation compared to baseline (88.64 ± 23.24 vs. 76.00 ± 15.30bpm, P = 0.02), but recovered to normal level at one month follow-up (77.09 ± 11.97bpm, P = 0.85). The right atrium, tricuspid valve annulus, and right ventricle dilated obviously one month after tricuspid regurgitation creation (dimension changes: 3.01 ± 0.35 vs. 3.56 ± 0.40cm, P = 0.02; 2.92 ± 0.36 vs. 3.37 ± 0.39cm, P = 0.01; 3.06 ± 0.42 vs. 3.60 ± 0.47cm, P = 0.03 respectively). Autopsy findings showed that rupture of leaflet and/or chordae tendineae finally led to the tricuspid regurgitation. Severe tricuspid regurgitation can be created by a simple and effective percutaneous approach with a grasping forceps in swine model and right heart dilation can be observed consistently at one-month follow-up. This model will be valuable in pre-clinical studies for developing new tricuspid valve repair or replacement technique to treat severe tricuspid regurgitation.

A novel procedure of puncture to access the pulmonary venous atrium in complex congenital heart disease with surgical correction

BackgroundIn complex congenital heart disease, supraventricular arrhythmia develops long term after surgical repair. The arrhythmia could have pharmacological tolerance and sometimes be fatal. We report our experiences with puncturing tough or calcified surgical repair material to access the pulmonary venous atrium for the purpose of the management of arrhythmia in complex congenital heart disease with surgical correction. MethodsFrom June 2016, subsequent 9 patients underwent the procedure. Their age at the procedure ranged from 11 to 43 years old (median 26.4 years old). Surgical procedures were Mustard procedure (XenomedicaⓇ) in 6, lateral tunnel total cavo-pulmonary connection with autologous pericardium in 2, and extra-cardiac total cavo-pulmonary connection with expanded polytetrafluoroethylene (ePTFE) tube in 1. ResultsMulti-planar reconstruction imaging by cardiac computed tomography was done for making plans before the procedures. Under intracardiac echocardiography guidance, an 8 French steerable sheath was perpendicularly adjusted to target objects. The sharpened edge of 0.014 inch guide wire penetrated with gentle forward force. Subsequently, the puncture site was dilated from a small balloon to a large one step by step. In all patients, penetration was successfully completed. Catheter ablation was achieved in 8 patients and a pacemaker was implanted through the re-canalized superior caval vein in 1 patient. No complications were recorded. ConclusionThe trans-catheter puncture of the synthetic or calcified material is safe and feasible, although careful planning is required with imaging. A steerable sheath could easily be controlled to the make appropriate angle to the target object for preventing slippage and conveying effective force.

A case report of pulmonary vein isolation with radiofrequency catheter using superior vena cava approach in patient with paroxysmal atrial fibrillation and inferior vena cava filter.

BackgroundTransseptal puncture and pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF) are generally performed via the inferior vena cava (IVC). However, in cases where the IVC is inaccessible, a specific strategy may be needed.Case summaryAn 86-year-old woman with paroxysmal AF and an IVC filter in situ was referred to our hospital for ablation therapy. An IVC filter for pulmonary embolism and deep venous thrombosis had been implanted 15 years prior, therefore we selected a transoesophageal echocardiography (TOE)-guided transseptal puncture using a superior vena cava (SVC) approach. After the single transseptal puncture, we performed fast anatomical mapping, voltage mapping by multipolar mapping catheter, and then PVI by contact force-guided radiofrequency catheter using a steerable sheath. Following the ablation, bidirectional conduction block between the four pulmonary veins and the left atrium was confirmed by both radiofrequency and mapping catheter. No complications occurred and no recurrence of AF was documented in the 12 months after the procedure.DiscussionWhen performing a transseptal puncture during AF ablation, an SVC approach, via access through the right internal jugular vein, enables the sheath to directly approach the left atrium without angulation and improves operability of the ablation catheter. Combining the use of general anaesthesia, TOE, a steerable sheath, and contact force-guided ablation may contribute to achieving minimally invasive PVI with a single transseptal puncture via an SVC approach.

Nonhomogeneous force application during typical flutter ablation explains local difficulties in lesion creation

Introduction – The current scientific literature suggests similar or even better catheter contact on caval regions of the cavo-tricuspid isthmus (CTI) compared to the more medial or annular part. Yet CTI ablation can be challenging owing to instability at the inferior vena cava (IVC) edge. No study specifically addressed the issue of catheter-tissue contact on caval/mid/annular regions of the CTI. Methods – Twenty-seven patients (22 men, 67±12 years) underwent typical atrial flutter ablation with a contact force (CF) sensing catheter (Tacticath 75, Abott) and were prospectively included. Operators aimed at optimizing CF for all RF pulses. The product of CF, time (force-time integral; FTI) and delivered power (FTPI) has been proposed as an estimate of lesion size. In a subset of 8 consecutive pts, electrograms (EGM) of all RF lesions were analyzed. Annular CTI was defined as sites showing both atrial and ventricular near-field bipolar EGM. Mid CTI sites had only atrial near field bipolar EGM on both distal and proximal dipoles (or distal only in case of superior-to-inferior approach). Caval sites had near-field bipolar EGM only in distal dipole, while the proximal one was inferiorly located. Results – Complete persistent (at 30 min) CTI block was obtained in all patients. A steerable sheath was used in 12 pts (44%). Procedure duration was 93±30 min, RF delivery time 10±6 min, fluoroscopy time 14±8 min. Mean CF was 15.8±5.9 g. CF was significantly lower (11.1±9.7 g) at the caval CTI than at mid CTI (19.9±11.8 g) and annular CTI (20±12.2 g; p=0.001). CF and FTI were higher during sinus rhythm than during Fl (23.2±15.3 vs 18.5±15.4 g, p=0.04 and 677±432 vs 532±357 gs, p=0.03). Use of a sheath improved mean CF (24.4±12.5 vs 18.4±14.9 g, p=0.01) but this was not significant at caval sites (17.5±11.4 vs 12.6±10.7 g, p=0.31). Conclusion – Applied forces are significantly lower at the IVC edge during CTI ablation. This supports the use of a steerable sheath in challenging cases.

A Modified Through and Through Guidewire Steerable Sheath Technique for Transfemoral Access to Visceral Arteries with Hostile Anatomy

A Modified Through and Through Guidewire Steerable Sheath Technique for Transfemoral Access to Visceral Arteries with Hostile Anatomy

Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysm Using Total Percutaneous Transfemoral Approach

Fenestrated and branched endovascular aortic repair has gained widespread acceptance as an alternative option to open surgical repair in patients with thoracoabdominal aortic aneurysms . Incorporation of the renal and mesenteric arteries is possible using fenestrations or directional branches, with either off the shelf or custom designs that are tailored to the patient anatomy. Fenestrations are ideally suited for target vessels that have origin in narrower aortic segments with transverse or upgoing orientation, whereas directional branches are preferentially selected to incorporate vessels with down-going orientation with origin in large aortic segments. Traditionally, directional branches are accessed via the upper extremity approach for placement of bridging stents into the target vessels. Recent developments in steerable sheath technology have allowed total transfemoral access, decreasing the risks of cerebrovascular emboli associated with manipulations across the aortic arch. We describe the technical pitfalls of Fenestrated and branched endovascular aortic repair of thoracoabdominal aortic aneurysms using total trans-femoral access.

Abstract 15817: Transcatheter Closure of Paramitral Leaks: Use of the Agilis™ Nxt Steerable Sheath to Aid Device Placement

Introduction: Paramitral leak (PML) has been reported in 5-17% of patients after surgical prosthetic mitral valve replacements. Transcatheter closure of PML has emerged as a Class IIa alternative to surgical repair by the AHA/ACC. Reaching all areas around the mitral annulus for device delivery from a transseptal approach can be difficult. We describe our center’s experience utilizing a transseptal approach with use of a steerable sheath and real-time 3D echo to facilitate closure. Methods: Retrospective review of cases of transcatheter PML repair from 9/09 to 2/19 at Mount Sinai Medical Center. Results: 32 patients underwent 43 catheterizations for PML closure (see Table 1). Indications for PML repair were CHF in (78%) and hemolysis (22%). 25/32 were bioprosthetic valves and the rest mechanical (7/32; table). PML’s could be crossed in 41/43 attempts (95%). Location of leaks/devices demonstrated in Figure 1. The median number of devices placed at one cath was 1 (range 1-3) and the most commonly used device was the Amplatzer muscular VSD device (64/71devices; 90%). 9/32 (28%) required an additional cath to complete PML closure. At last cath, clinical PML closure was achieved in 26/32 (81%) pts attempted. 3/32 (9%) had hemolysis from residual PML after closure and required surgical mitral valve replacement. Aside from failed attempts or those requiring repeat cath, there were no serious complications. Conclusions: Use of the Agilis™ NxT Steerable Sheath allowed closure of the majority of PML encountered. Success rates were high though a large percentage required additional caths to achieve success. Serious complications were uncommon.

Transcatheter creation of a Potts shunt with the Occlutech Atrial Flow Regulator: Feasibility in a pig model

BackgroundCreation of a Potts shunt, a connection between the left pulmonary artery (LPA) and descending aorta (DAo), improves functional status and survival in drug-refractory suprasystemic pulmonary arterial hypertension. We investigated a new approach to transcatheter Potts shunt creation in pigs. Methods and resultsIn six pigs, a steerable SureFlex sheath was used to optimize the trajectory of perforation from the DAo into LPA using a 0.035″ radiofrequency wire. The combination of a larger perforation, stiffer radiofrequency wire and smooth dilator-to-sheath transition allowed sheath entry into the LPA without requiring an arterio-venous wire circuit. The Occlutech Atrial Flow Regulator (AFR), a double-disc device with a central fenestration, was deployed through this sheath with apposition of the distal disc to the posterior LPA wall and the proximal disc to the anterior DAo wall. The AFR is compliant and crumpling of the central fenestration was resolved by balloon dilation. It was feasible to implant a stent within the fenestration (n = 3). Aortography confirmed a left-to-right shunt through the AFR without contrast extravasation. Autopsy demonstrated anchoring of both discs against the vessel walls, patency of the fenestration and secure placement of the stent with no intra-thoracic bleeding. ConclusionsIn an acute pig model, we have demonstrated the feasibility of creating a transcatheter Potts shunt with a simplified technique using a steerable sheath, a double-disc device with a central fenestration that acts as the shunt channel and optional stenting of the fenestration.

Outcomes Of Manifest Right Free Wall Accessory Pathway Ablation: Data From A Single Center

Right free wall (RFW) accessory pathways (AP) typically present anatomical challenges to ablation leading to high rates of procedural failure and recovery of AP conduction. Patients with a diagnosis of Wolff-Parkinson-White Syndrome (WPW) and a manifest RFW AP undergoing an electrophysiology study (EPS) or an ablation at our center between 01/01/2008 and 08/01/2019 were identified from our databases using diagnosis codes and manual chart review. Twenty-one patients with manifest RFW AP underwent EPS, all of which were targeted for ablation. Single procedure success rate was 19 / 21 (90.5%). Of the 19 successful cases, 4 (17.4%) patients were found to have recurrent right free wall pathway conduction at follow-up and each underwent a successful 2nd procedure (9.5%). Fluoroscopic and 3D electroanatomic mapping software was used in all cases to guide ablation. A 4 mm or 8 mm non-irrigated radiofrequency (RF) ablation catheter was used in 76% of cases while an 8 mm cryo-catheter was used in one case. More than one type of ablation catheter was used in four cases (16%). A steerable sheath was used in 68% of cases. In a tertiary center, RFW AP ablation has high acute success (>90%) but approximately 21% of patients with initially successful ablation required a 2nd procedure for recurrence of pathway conduction. A combination of a large tip ablation catheter and a steerable sheath were used in most cases.

Total Percutaneous Femoral Approach for Branched Custom-Made Device Endovascular Repair of Thoracoabdominal Aneurysm.

Thoracoabdominal aortic aneurysm (TAAA) is a challenging vascular condition to manage. Traditionally, open surgical repair has been the standard of treatment. Endovascular repair for TAAA has gained much popularity because it is a minimally invasive approach that results in better mortality and morbidity profiles. We report a case of TAAA successfully treated with a custom-made multi-branch device through a total femoral approach with the use of a steerable sheath for branch cannulation and deployment of bridging stents to targeted visceral vessels. This approach avoided complications related to upper extremity access, such as stroke, and allowed shorter operative time with better workstation ergonomics.

Improved stability of steerable sheath access by femoro-femoral crossover wire in branched stent graft repair of complex thoraco-abdominal aortic aneurysms.

PurposeThe purpose of this study was to describe a technique to catheterize antegrade branches of a branched aortic endograft by using a steerable sheath stabilized by a through-and-through wire via a femoral access.TechniqueAfter implantation of a branched endovascular graft, a steerable 8.5 F sheath is advanced from the femoral access. After placing the sheath proximal to the branches, a 0.014″ through-and-through wire is established to the contralateral femoral access which is held under slight traction after the curved tip of the sheath is brought into the 180° position. Then catheterization, wire exchange and deployment of the bridging stent is done in standard fashion.ConclusionThe use of a through-and-through wire with a steerable sheath for retrograde femoral access adds stability and precision to this technique. It has the potential to reduce the risk of preoperative stroke in complex aortic endovascular repair by avoiding upper extremity access.