Data show that 89% of individuals treated for persistent AFiB remained symptom-free for up to 15 months after using the product.
Abbott announced results from the PERSIST-END study, which showed that 89% of individuals treated for persistent atrial fibrillation (AFiB) with the company’s TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) remained symptom-free for up to 15 months after the procedure.
Additionally, the results demonstrated that because of more effective therapy, individuals reported significant quality-of-life improvements and more than a 50% reduction in the use of health care resources.
“Like many arrhythmias, persistent AFib can be difficult to treat, and to date we have had relatively few approaches approved specifically to treat this condition,” Douglas Gibson, MD, site principal investigator and director of cardiac electrophysiology at Scripps Prebys Cardiovascular Institute in San Diego, California, said in a statement. “The results of the PERSIST-END study show that Abbott's TactiCath SE can help physicians ensure the majority of our persistent AFib patients will remain symptom-free following their therapy and will go on to experience dramatic improvements in their quality of life.”
AFib is normally categorized into 3 types: long-standing persistent, paroxysmal, or persistent. Long-standing is defined as an abnormal heart rhythm that lasts longer than 1 year, paroxysmal lasts less than a week, and persistent lasts between 1 week and a year.
The trial met all its primary effectiveness, quality-of-life, and safety endpoints. The rate of series adverse events was 3.1%, which is consistent with the results of other studies. Additionally, the overall primary effectiveness endpoint showed that 61.6% of individuals remained free from arrhythmia recurrence, any new or increased class 1/3 antiarrhythmic drugs, repeat ablation, or cardioversion.
TactiCath SE was previously approved for paroxysmal AFib, and the data from the PERSIST-END study supported approval of the additional indication in persistent AFib in 2021.
TactiCath SE is used as part of a cardiac ablation procedure, a minimally invasive method that allows physicians to treat the condition at the source by selectively disrupting the area of the heart generating abnormal heart beats.
The catheter provides physicians essential and immediate feedback when the tip of the ablation catheter connects with the tissue within the heart, which can help improve the accuracy and consistency of the procedure.
It is used in conjunction with the company’s Advisor HD Grid Mapping catheter, the EnSite Omnipolar Technology, and the EnSite X EP System.
“Ablation therapy is an increasingly important option for people living with cardiac arrhythmias, because it allows physicians to treat the cause of the arrhythmia at its source. However, it can be a challenging procedure, because the right amount of pressure needs to be applied to the heart wall to be effective but not so much as to cause other problems,” Christopher Piorkowski, MD, chief medical officer of electrophysiology business at Abbott, said in the statement.
The findings were presented at the annual meeting of the Heart Rhythm Society, which took place from April 29, 2022, to May 1, 2022.
Study finds 89% of individuals treated for persistent atrial fibrillation using Abbott’s ablation device remain symptom-free for at least 15 months. Abbott. News release. April 29, 2022. Accessed April 29, 2022. https://abbott.mediaroom.com/2022-04-29-Study-Finds-89-of-Patients-Treated-for-Persistent-Atrial-Fibrillation-Using-Abbotts-Ablation-Device-Remain-Symptom-Free-for-at-Least-15-Months