Biosense Webster Announces Positive Clinical Outcomes with QDOT Micro Catheter for Atrial Fibrillation Ablation

Nov 10, 2023 09:32 CST Updated 09:32

Biosense Webster

Developer of Diagnostic and Therapeutic Devices for Arrhythmia

Source of the article:Heart NotCome;Editor:Huang Chuyan

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On November 2, 2023, Biosense Webster, Inc., a Johnson & Johnson Medical Technologies companyBiosense Webster announcedThe latest research data using its QDOT Micro Catheter.

# Biosense Webster Announces New Discoveries

The research results were published in the "CardiovascularJournal of Electrophysiology, the results showed that the product improved the control of AFib.Through QDOT micro-ablation therapy, the patient's symptoms were alleviated, and their overall quality of life improved.

QDOT Micro Catheter is the next-generation radiofrequency (RF) ablation catheter, utilizing advanced high-power ablation technology. It offers improved temperature monitoring, optimized irrigation, and higher signal resolution. In QMODE+, it delivers ablations at 90 watts for up to four seconds. Standard QMODE provides RF ablation at up to 50 watts for durations of up to 60 seconds.QDOT Micro Catheter Received CE Mark in 2020 and FDA Approval in 2022.

Q-FFICIENCY evaluated the safety and 12-month efficacy of the catheter in patients with paroxysmal AFib.The study found that control of AFib and relief of AFib symptoms improved by 99% and 93.1%, respectively.At the same time, 87.9% of the patients experienced meaningful clinical improvement in their quality of life.

Biosense Webster President Jasmina Brooks said, "AFib imposes a heavy burden on patients' daily lives and healthcare resources, including clinic visits, medication costs and side effects, as well as hospitalizations. At Biosense Webster, we focus on improving patient outcomes while providing innovative solutions for doctors treating the growing number of AFib patients today. As demonstrated by the Q-FFICIENCY study results, the use of the temperature-controlled QDOT Micro catheter allows physicians to provide personalized treatment for each patient.""Customized treatment plans for patients, reduced surgical time, and brought significant benefits to patients by improving their quality of life."

# More Research Details

This latest data builds on the positive results of Q-FFICIENCY released by QDOT Micro in May this year.In that study, 86% of patients did not experience symptom recurrence.The main adverse events related to the catheter remained at a low level of 1.8%.

Q-FFICIENCY is a prospective, multicenter, non-randomized study that investigated patients with drug-refractory, symptomatic paroxysmal AFib.They used QDOT Micro for PV isolation, with very high power and short duration as the primary ablation mode.

The primary safety endpoint of Biosense Webster is the incidence of major adverse events within 7 days after ablation.It set the primary efficacy endpoint as the absence of documented recurrence of atrial tachyarrhythmia, as well as acute procedural failure, repeat ablation, and antiarrhythmic drug (AAD) failure.The study met its primary safety and efficacy endpoints.

Q-FFICIENCY uses the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) tool to assess quality of life.This questionnaire measures symptoms, daily activities, treatment issues, and satisfaction at baseline and throughout the 12 months.

Biosense Webster Reports 79.9% Reduction in Class I/III AAD.More than half of the participants stopped using all AADs after ablation.The cardioversion rate during the evaluation period decreased by 93.9% compared to the 12 months before ablation.Hospitalization rates after ablation have also decreased.Kaplan-Meier estimates that 80.9% and 88.8% of patients will not be hospitalized for any reason and for cardiovascular causes within 12 months, respectively.

Dr. Ayman A. Hussein stated, "The research findings highlightAdvantages of Using QDOT Micro for AFib Treatment.Hussein serves as the Director of the Cardiac Electrophysiology Outcomes Research Program and the AFib Center at Cleveland Clinic, and he has also authored publications on the research findings.

Hussein said, "This research is related to the previous releaseThe data from the Q-FFICIENCY study, combined, shows that the unique design of the QDOT Micro catheter enhances efficiency and efficacy without compromising safety. The benefits of treatment using this state-of-the-art tool are evident for both patients and physicians.

# Understanding the QDOT Micro Catheter

Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, which may lead to the formation of blood clots in the heart, increasing the risk of stroke, heart failure, and other heart-related complications.Atrial fibrillation is the most common type of arrhythmia, affecting approximately 37.5 million people worldwide.By 2030, the number of patients with atrial fibrillation is expected to increase by 70%.

QDOT Micro Catheter is a new generation of radiofrequency (RF) ablation catheter that utilizes advanced high-energy ablation technology.The catheter has been improved in temperature monitoring, optimized in irrigation, and features higher signal resolution.In the QMODE+ settingsThe QDOT Micro catheter can deliver ablations at 90 watts for up to 4 seconds. StandardThe QMODE can perform radiofrequency ablation at 50 watts for up to 60 seconds.QDOT Micro Catheter Received CE Mark in 2020 and FDA Approval in 2022.

Biosense Webster says that the catheter designed by the company manages temperature in real time by intelligently adjusting power and/or irrigation fluid output to control the temperature.Temperature control can safely utilize higher average RF power.

Osorio stated that the QDOT Micro catheter is versatile with a unique design, capable of providing personalized treatment for patients. He added that the catheter offers flexibility for physicians while optimizing the surgical workflow.

The system is also integrated with the CARTO 3 system. Biosense Webster says that this enables efficient and consistent lesion creation by streamlining workflows and reducing procedure time. Real-world evidence shows that the use of QMODE+ reduces procedure time by 48%, and QMODE reduces it by 36%.Operation Time. The relevant surgery lasts 60 minutes or less.

# About Biosense Webster

Biosense Webster, Inc. is a professional medical device company under Johnson & Johnson in the United States, dedicated to researching and developing electrophysiological interventional diagnosis and treatment products. It provides comprehensive solutions for arrhythmia diseases to physicians and patients. With its excellent and innovative technology, Biosense has long been a world leader in 3D mapping systems and software. Currently, Biosense Webster, Inc. has more than 5,000 employees in over 50 countries worldwide and is also the inventor of the world's first deflectable catheter.

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