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Thermocool smart touch sf catheter

Manufactured by Johnson & Johnson
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The Thermocool Smart Touch SF catheter is a medical device designed for use in electrophysiology procedures. It features a temperature sensor and a force sensor to provide real-time feedback to the clinician during the procedure.

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9 protocols using thermocool smart touch sf catheter

1

Catheter-based Ablation Procedure for Cardiac Arrhythmia

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After puncturing jugular and femoral veins, under the guidance of X-ray or intracardiac echocardiography, a decapolar catheter was inserted into the coronary sinus, and a single transseptal puncture was made with a Swartz sheath (Abbott, Chicago, USA). After the transseptal puncture, Heparin was given at a dose of 100 U/kg body weight, and it was given again to keep the activated clotting time between 300 and 350 s. Under the direction of an electro-anatomy mapping system (EAM; Biosense Webster, Irvine, USA), mapping and ablation were performed by experienced electrophysiological doctors, using a Pentaray mapping catheter (Biosense Webster, Irvine, USA) and Thermocool Smart touch SF catheter (Biosense Webster, Irvine, USA). Ablation points were marked automatically according to VisiTag (Biosense Webster, Irvine, USA) settings. (The size of the lesion tag was set at 2.5 mm, minimum time 3 s.) Throughout the process, the irrigation flow was 15 ml per minute and the radiofrequency (RF) power was set to 45 W.
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2

Radiofrequency Ablation for Cavotricuspid Isthmus

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CTI linear ablation was performed by integrating the right atrial images using an irrigation catheter (ThermoCool Smart Touch SF catheter; Biosense Webster Inc., Diamond Bar, CA, USA). Radiofrequency energy was delivered at 35 W. Ablation was guided using an automated annotation system (VISITAG module; Biosense Webster Inc., Diamond Bar, CA, USA). The parameters were set as follows: (1) catheter stability range of motion, < 3 mm; (2) catheter stability duration, > 3 s; (3) contact force, > 3 g, time, > 25%; (4) tag size, 4 mm in diameter. At the beginning of this study, the target AI for CTI ablation was unknown; therefore, we adopted a target AI value of 400 following that of atrial fibrillation a type of atrial arrhythmia14 (link). The initial CTI ablation line was created using a single line. To evaluate the conduction gap location, additional ablation was not performed before the initial CTI ablation line was created. A successful CTI block was defined as follows: first, the right atrial activation sequence of the duodecapolar catheter (Inquiry; Abbott) positioned around the tricuspid annulus was counterclockwise (medial to lateral) during CS ostium pacing; second, differential pacing was observed1 (link),2 . If the initial ablation line did not create a conduction block, an additional ablation was performed to complete the block.
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3

Radiofrequency Catheter Ablation for Atrial Fibrillation

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Preparation for RFCA followed the same procedure as for cryoballoon ablation except for one more femoral puncture to perform double transseptal puncture. After the 3D mapping of the LA geometry with ICE (SOUNDSTAR®, Biosence Webster, Diamond Bar, CA), the map was integrated with the previously acquired cardiac CT. A variable circular mapping catheter (LASSOTM, Biosence Webster) was introduced into the LA, and electroanatomic mapping of the LA was performed with the guidance of a 3D navigation system (CARTO®, Biosence Webster). A quadripolar deflectable 3.5-mm irrigated-tip catheter with contact-force monitoring (THERMOCOOL SMARTTOUCH® SF catheter, Biosense Webster) was advanced into each PV antrum. PV isolation was achieved by creating a wide antral circumferential ablation lesion under CARTO guidance. PVI alone was performed in PAF patients, but posterior wall isolation (PWI) in conjunction with PVI was performed selectively in PersAF patients at the operator’s discretion.
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4

Ablation Parameters and Lesion Sizes of RF Ablation

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To provide complementary information on the ablation parameters and the lesion sizes between 40 W and 30 W RF ablation at the target AI of 450, we conducted a preclinical in vivo experiment using four mongrel dogs (32 ± 6.8 kg, males). General anesthesia was induced using intravenous tiletamine/zolazepam (Zoletil®, 5 mg/kg; Virbac S/A) and maintained using isoflurane gas (1%–2% oxygen). The animals were intubated and mechanically ventilated. Under sterile conditions, an open‐tip irrigated CF‐sensing catheter (Thermocool SmartTouch SF catheter, Biosense Webster Inc) was positioned in the right atrium (RA) and right ventricle (RV). Ablation was performed with the target AI of 450 (CF 10‐15 g) at the RA and RV using 40 W and 30 W, respectively. The ablation parameters, including CF, ablation time, RF power, baseline impedance, impedance drop, FTI, and AI were measured. The presence of steam pop at each ablation point was recorded. After ablation, the lesion size and depth were measured at each point. The protocol for this study was approved by the Institutional Animal Care and Use Committee of the Seoul National University Hospital (IACUC 18‐0076‐S1A0). The protocol conforms to the best practices, as defined by the Guide for the Care and Use of Laboratory Animals.
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5

Contiguous PVI Lesion Ablation Protocol

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The CLOSE protocol, consisting of CF-guided PVI targeting an interlesion distance ≤6 mm has been previously described.3 5 (link) After transseptal puncture, a left atrial three-dimensional electroanatomical map was generated using CARTO 3 System with LASSO Circular Mapping Catheter (Biosense Webster, Irvine, California, USA). Ablation was performed with either a Thermocool Smarttouch Catheter or Thermocool Smarttouch SF Catheter (Biosense Webster) to obtain a contiguous lesion set for ipsilateral circumferential PVI. VISITAG SURPOINT target values were 550 for anterior and 400 for posterior. Verification of entrance block was performed for all PVs with the LASSO catheter after a 20 min waiting period.
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6

Vizigo Sheath Impact on PAF Ablation

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This was a non-randomized cohort study based on a retrospective analysis of patient-level data that was prospectively collected for ablation patients enrolled in the REAL AF Registry [13 (link)]. The registry enrolls consecutive adults (≥ 18 years) ablated with a contact force (CF) catheter at a participating site, excluding any patients enrolled in a clinical trial that would prescribe any aspect of their treatment.
The study population included patients having de novo PAF ablation performed by one of three operators at a single high-volume site between January 2018 and May 2019. Cohorts of interest were defined by procedures that utilized a Vizigo sheath (Vizigo cohort) versus those that did not (non-Vizigo cohort). All patients underwent their first left atrial ablation with the THERMOCOOL SMARTTOUCH® SF Catheter (STSF; Biosense Webster, Inc., Irvine, CA) and were evaluated according to standard clinical practices at the study site. Approval was obtained from the WCG Institutional Review Board.
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7

Pulmonary Vein Isolation with Anticoagulation

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Every patient who qualified for the procedure received vitamin K antagonists (VKA) or non-vitamin K antagonist oral anticoagulants (NOACs) for at least three months before PVI. Prothrombin time reflected by international normalized ratio (INR) was assessed systematically in patients treated with VKA in order to provide adequate anticoagulation.
A quadripolar electrode was placed in the right ventricle via the left femoral vein, while circular mapping and radiofrequency ablation electrodes or a cryoablation balloon were introduced via the right femoral vein using the Seldinger technique. Jugular access was used for coronary sinus catheterisation.
After the LA rotational angiography, a trans-septal puncture was performed under the control of an optical scope. Three-dimensional electro-anatomical mapping of left atrium was created using the CARTO®3 system (Biosense Webster, Diamond Bar, CA, USA). The patients underwent radiofrequency ablation using a ThermoCool® SmartTouch® SF catheter (Biosense Webster, Diamond Bar, CA, USA) or balloon cryoablation using an Arctic Front Advance™ catheter (Medtronic, Minneapolis, MN, USA) under the guidance of a circular mapping electrode, Lasso (Biosense Webster, Diamond Bar, CA, USA) or Achieve (Medtronic, Minneapolis, MN, USA).
Anticoagulation during the procedure involved an intravenous bolus of unfractionated heparin.
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8

Catheter Ablation for Persistent Atrial Fibrillation

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Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant-level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the Yale Open Data Access Project site at http://yoda.yale.edu.
The design of the prospective, multicenter, nonrandomized PRECEPT study has been reported elsewhere. 6 (link) The primary objectives of the study were to evaluate the safety and effectiveness of catheter ablation of drug refractory symptomatic PsAF patients using the THERMOCOOL SMARTTOUCH SF Catheter (Biosense Webster, Inc, Irvine, CA).
The institutional review board or ethics committee at each of the 27 participating centers approved the study protocol. All patients enrolled in the study provided written informed consent.
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9

Catheter Ablation with Anticoagulation Management

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The patient underwent catheter ablation while maintaining the administration of warfarin. On the day of the procedure, whether the patient was on a once-daily or twice-daily regimen of direct oral anticoagulants, the medication was temporarily withheld only in the morning. The transseptal puncture was adopted for the left atrial approach, and heparin was infused intravenously with a target-activated clotting time > 300 s. Following the obtain of three-dimensional geometry utilized by the Advisor HD Grid Mapping Catheter (Abbott Inc., Abbott Park, IL, USA) or PENTARAY NAV ECO High-Density Mapping Catheter (Biosense Webster Inc., Diamond Bar, CA, USA), pulmonary vein isolation underwent using the TactiCath Contact Force Ablation Catheter, Sensor Enabled (Abbott Inc.), or ThermoCool SmartTouch SF Catheter (Biosense Webster Inc.). Additional linear ablation was determined by each operator. In cases of cryoballoons utilized by the Arctic Front Advance (Medtronic Inc., Minneapolis, MN, USA), each pulmonary vein was isolated individually, and the roof line using the balloon was added if the operators determined it was necessary. The Perclose ProGlide suture-mediated closure system (Abbott Inc.) was utilized for the femoral venous access site closure in all patients.
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