Clinical Applications

Atrial Fibrillation

Atrial fibrillation (AF) is the most common arrhythmia affecting 2 million people in the US. It is characterized by uncoordinated beating of the atria and poses a high risk of stroke. Although drugs are the first line therapy for AF, about 50% of patients are refractory to drugs. In the recent years, catheter ablation has emerged as a promising AF treatment.

One of the outstanding issues in catheter ablation today are the inconsistent endpoints, outcomes and 40-50% repeat procedures (sometimes 3rd and 4th ablations). Reported clinical outcomes studies show a wide range from 40%-85% efficacy, attributed to the complexity of the procedure and suboptimal intra-procedure and follow up mapping technology.

The current approach to paroxysmal AF mainly involves Pulmonary Vein Isolation (PVI), a specific catheter ablation procedure that isolates the pulmonary veins (most prevalent AF triggers) to prevent them from triggering the rest of the atria. Persistent AF catheter ablation is a more involved procedure involving a step-wise approach, typically beginning with PVI, followed by extensive electroanatomic mapping to identify other AF mechanisms within the atria.

Studies show that the mechanism of AF needs both causative triggers and a susceptible AF substrate to develop AF. Although the pulmonary veins are common triggers, in 30% of paroxysmal AF and almost all of persistent AF, triggers and substrates could exist anywhere in the atria (both left and right).

AF catheter ablation today will tremendously benefit from the use of a simultaneous and reliable mapping technology like ECM to guide individualized ablations to improve outcomes and reduce repeat procedures.

Ventricular Tachycardia

Ventricular tachycardia (VT) is a rapid rhythm of the ventricles that can be potentially life threatening. Ablation is the first line treatment for idiopathic VT. It is also an option for ischemic VT that has not been successfully treated with drug therapy or device (ICD) therapy (Many patients come back with frequent defibrillator shocks due to VT that affect their quality of life).

Mapping of VT is difficult as VT rhythms are generally unstable and could be polymorphic. Mapping technology that offers simultaneous single beat data is needed to identify VT mechanisms and ablation targets.  

Cardiac Resynchronization Therapy

Heart failure (HF) is the fastest growing cardiovascular disease in the US and the world. A subset of heart failure patients whose ventricles do not beat synchronously, are candidates for cardiac resynchronization therapy (CRT) which involves the implantation of a special pacemaker to stimulate both ventricles at specific times so that both beat in synchrony.  Currently, CRT pacemakers are developed and manufactured by all the big industry players.

According to clinical trial data, 70% of patients receiving a CRT device improve clinically . In addition, when coupled with an internal defibrillator (CRT-D device), there is a combined mortality benefit of 36% . There is agreement in the clinical community that success of CRT therapy is highly dependent on selecting the right patient, placing the lead in the ‘best' location for that patient and optimizing the device settings over time as the heart remodels itself under chronic pacing. 

Currently, there are about 120,000 CRT implantations and the number of implantations is projected to increase to 300,000 in the next 5 years .