Targeted Navigation, Brilliant Outcomes in Tianjin: Tianjin Medical University General Hospital Successfully Completes First RhythPulse® PFA Procedures in the Region Using Xuanyu Medical's Innovative System

Patient One, female, 74 years old, with Grade 2 hypertension and a personal history of previous cerebral infarction, visited the General Hospital due to paroxysmal atrial fibrillation. Her stroke risk score was 4, and her bleeding risk score was also 4, indicating medium to high risk. After comprehensive consideration of the patient’s physical condition and long-term prognosis, and to reduce the possibility of recurrent stroke, Professor Cai Heng's team, following thorough communication with the patient’s family, chose non-thermal ablation energy pulsed field for a one-stop PFA+LAAC procedure. Irreversible electroporation was utilized to induce apoptosis of target myocardial cells instead of using thermal energy, thereby minimizing the potential for long-term pulmonary vein stenosis.

The surgery was performed under deep sedation. Based on the patient's anatomical characteristics, ShineyoMedical's RhythPulse® 15mm circular PFA catheter was used to perform pulsed field ablation with the support of a 3D system. Complete isolation of all four pulmonary veins was achieved with just 40 sets of bipolar biphasic pulse discharges, and the entire ablation procedure lasted only 25 minutes. Ultrasound observation showed that the ablation target area was bright, without noticeable edema or changes in other tissue structures. Subsequently, left atrial appendage closure was successfully performed, concluding the operation with success.

Patient Two: Female, 62 years old, with Grade 2 hypertension, a past medical history of cerebral infarction, gallstones with cholecystitis. She reported sudden palpitations and chest tightness three years ago and was admitted to the hospital for paroxysmal atrial fibrillation through an outpatient electrocardiogram. Given the patient's multiple underlying conditions and intolerance to prolonged supine positioning, and considering surgical efficiency and the risk of rebleeding, Professor Cai Heng's team, after careful consultation with the patient’s family, decided to use the RhythPulse® PFA system for pulsed field ablation. Targeted unilateral coated electrode discharges reduced ineffective discharges and minimized the potential for complications, while also significantly shortening operation time to reduce the burden on the patient.

The surgery was performed under deep sedation. Based on the preoperative CT measurements of the patient's left atrium and pulmonary vein sizes, the ShineyoMedical RhythPulse® 15mm circular PFA catheter was selected for pulsed field ablation, supported by a 3D mapping system. During the procedure, ICE indicated good contact between the electrode tip ablation ring and the pulmonary vein. The electrical potential disappeared instantly upon energy delivery. The entire ablation process lasted only 20 minutes with a total of 38 energy deliveries. Post-procedure voltage mapping confirmed 100% isolation of all four pulmonary veins without any gaps. The surgery was successfully completed within 1.5 hours, and the patient was safely returned to the ward.

Post-operation, Professor Cai Heng highly recognized the efficiency and safety of RhythPulse® PFA Pulsed Field Ablation System independently developed by ShineyoMedical. The patented technology of the RhythPulse® PFA Pulse Ablation Catheter features a single-sided coated electrode that reduces ineffective discharges into the blood, minimizing the occurrence of microbubbles. Additionally, compared to traditional radiofrequency ablation procedures, pulsed field ablation significantly reduces trauma and irritation to patients during surgery, greatly enhancing patient comfort during the procedure and offering better advantages in postoperative recovery. This provides clinicians with more options to improve patient outcomes.