Dataset Information

Real-Time Internal Steam Pop Detection during Radiofrequency Ablation with a Radiofrequency Ablation Needle Integrated with a Temperature and Pressure Sensor: Preclinical and Clinical Pilot Tests.

ABSTRACT: A radiofrequency ablation (RFA) needle integrated with a temperature sensor (T-sensor) and pressure sensor (P-sensor) is designed and utilized for real-time internal steam pop monitoring during RFA. The characteristics of the sensor-integrated RFA needle (sRFA-needle) are investigated quantitatively using a pressure chamber system, and the feasibility and usability of the needle in preclinical and clinical trials is demonstrated. The sharp changes in the temperature and normalized pressure sensor signals induced by the abrupt release of hot and high-pressure steam can be clearly monitored during the steam pop phenomena. The basic mechanism of the preliminary steam pop is hypothesized and verified using in situ ultrasound imaging data and computational analysis data of the RFA procedure. Moreover, the usability of the system in clinical trials is investigated, and the steam pop phenomena during the RFA procedure are detected using T-sensor and P-sensor. The results confirm that the sensor integration on the medical needle can provide critical data for safer and more effective medical practices.

SUBMITTER: Park J

PROVIDER: S-EPMC8498861 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Real-Time Internal Steam Pop Detection during Radiofrequency Ablation with a Radiofrequency Ablation Needle Integrated with a Temperature and Pressure Sensor: Preclinical and Clinical Pilot Tests.

Park Jaeho J Cha Dong Ik DI Jeong Yongrok Y Park Hayan H Lee Jinwoo J Kang Tae Wook TW Lim Hyo Keun HK Park Inkyu I

Advanced science (Weinheim, Baden-Wurttemberg, Germany) 20210805 19

A radiofrequency ablation (RFA) needle integrated with a temperature sensor (T-sensor) and pressure sensor (P-sensor) is designed and utilized for real-time internal steam pop monitoring during RFA. The characteristics of the sensor-integrated RFA needle (sRFA-needle) are investigated quantitatively using a pressure chamber system, and the feasibility and usability of the needle in preclinical and clinical trials is demonstrated. The sharp changes in the temperature and normalized pressure senso ...[more]

PMID: 34351701

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Project description:BackgroundTransseptal puncture to achieve left atrial access is necessary for many cardiac procedures, including atrial fibrillation ablation. More recently, there has been an increasing need for left atrial access using large caliber sheaths, which increases risk of perforation associated with the initial advancement into the left atrium. We compared the effectiveness of a radiofrequency needle-based transseptal system versus conventional needle for transseptal access.MethodsThis prospective controlled trial randomized 161 patients with symptomatic paroxysmal atrial fibrillation undergoing cryoballoon pulmonary vein isolation to transseptal access with a commercially available transseptal system (radiofrequency needle plus stiff pigtail wire; RF + Pigtail group) versus conventional transseptal access (standard group). The primary outcome was time required for left atrial access. Secondary outcomes included failure of the assigned transseptal system, radiation exposure, and complications.ResultsThe median transseptal puncture time was significantly shorter using the radiofrequency needle plus stiff pigtail wire transseptal system compared with conventional transseptal (840 ± 323 vs. 956 ± 407 s, P = 0.0489). Compared to conventional transseptal puncture, fewer transseptal attempts were required (1.0 ± 0.5 RF applications vs. 1.3 ± 0.8 mechanical punctures, P = 0.0123) and the fluoroscopy time was significantly shorter (72.0 [IQR 48.0, 129.0] vs. 93.0 [IQR 60.0, 171.0] s, P = 0.0490) with the radiofrequency needle plus stiff pigtail wire transseptal system. Failure to achieve transseptal LA access with the assigned system was rarely observed (1.3% vs. 5.7%, P = 0.2192). There were no procedural complications observed with either system.ConclusionsThe use of a radiofrequency needle plus stiff pigtail wire resulted in shorter time to left atrial access and reduced fluoroscopy time compared to left atrial access using conventional transseptal equipment.Trial registrationClinicalTrials.gov identifier NCT03199703.

Project description:BACKGROUND:Ventricular tachycardia ablation is often limited by insufficient lesion creation. A novel radiofrequency catheter with an expandable lattice electrode has a larger surface area capable of delivering higher currents at a lower density to potentially increase lesion dimensions without overheating. METHODS:This 8F bidirectional irrigated catheter (Sphere-9, Affera Inc) has a 9 mm spherical lattice tip ("lattice") with an effective surface area 10-fold larger than standard linear catheters. Nine surface thermocouples provide temperature feedback to a proprietary high-current generator operating in a temperature-controlled mode. Ex vivo phase: in 11 bovine hearts, unipolar ablation at 30, 60, and 120 seconds was compared between the lattice (Tmax60°C) and a standard linear irrigated-tip catheter (40 W) at contact force of 10 g. In 5 porcine hearts, bipolar ablation was compared between the catheters (Tmax60°C versus 40 W; 60 seconds). In vivo phase: in 9 swine, ventricular ablation at Tmax60°C versus 40 W was performed for 60 seconds. In addition, direct tissue temperature at 3- and 7-mm tissue depth was measured in a thigh muscle preparation. RESULTS:Ex vivo: lattice produced deeper lesions at 30, 60, and 120 seconds application duration (6.7±1.3 versus 4.8±1.2 mm; 8.3±1.4 versus 5.4±0.8 mm; 10.0±1.6 versus 6.1±1.6 mm, respectively, P≤0.001 for all). Bipolar lesions were deeper (15.8±4.1 versus 10.5±1.4 mm, P<0.001) and more likely to be transmural (80% versus 0%, P=0.002). In vivo: lattice produced deeper lesions (10.5±1.4 versus 6.5±0.8 mm, P≤0.001). Tissue temperature at 7 mm was higher with the lattice (+15.1±2.4°C; P<0.001). The steam-pop occurrence was lower with the lattice (total: 4% versus 18%, P=0.02; in vivo 0% versus 14.2%, P=0.13). CONCLUSIONS:This novel radiofrequency system produces larger ventricular lesions compared with standard irrigated catheters and at a lower risk of tissue overheating. This may improve the efficacy of ventricular tachycardia ablation procedures while reducing the number of applications and procedural duration.

Dataset Information

Real-Time Internal Steam Pop Detection during Radiofrequency Ablation with a Radiofrequency Ablation Needle Integrated with a Temperature and Pressure Sensor: Preclinical and Clinical Pilot Tests.

Publications

Real-Time Internal Steam Pop Detection during Radiofrequency Ablation with a Radiofrequency Ablation Needle Integrated with a Temperature and Pressure Sensor: Preclinical and Clinical Pilot Tests.

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