Give it an intellectual shaketo see if it has life in it, actual or potential

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While Oliver Wendell Holmes, Sr., takes a seriocomic tone in his collection of essays, the ACC.10 clinical trials and education presentations that garnered the most attention from our readers were mainly focused on the potential for new or better therapies, which are not currently or widely available. These trialers are giving new methods an “intellectual shake” of sorts through well-designed evaluations.

First, EVEREST II found that the MitraClip system, a catheter-mounted device that acts like a clothespin to clip together the flaps of a leaky mitral valve and not FDA approved, is a safe and effective alternative to open-heart surgery in selected patients with mitral regurgitation.

While this new technology has the potential to join the armamentarium of treatment choices for leaky mitral valves, there are still questions that arose about the appropriate patient population, as well as study design.

The CABANA pilot study evaluated the feasibility of catheter ablation versus anti-arrhythmic drug therapy in patients with more advanced atrial fibrillation and substantial underlying cardiovascular disease. Ablative intervention was found to be more effective than drug therapy for preventing recurrent symptomatic atrial fibrillation, but even the principal investigator acknowledged that the limited number of patients and follow up time doesn’t give a complete enough picture.

For this potential therapy, the intellectual shaking will continue in the CABANA pivotal trial, which is seeking to enroll 3,000 participants and is currently recruiting patients at about 180 centers globally for further evaluation.

Even in the practice setting, readers are interested in new models of care that could potentially improve their outcomes, especially with such high-risk groups as heart failure (HF) patients. Lead author Dr. Samira Bahrainy explained that a patient’s long-term survival rate and average length of hospital stay may be reduced by the utilization of an idealized Seattle Heart Failure score, as the absence of defined goals of therapy in patients admitted with acutely decompensated HF has been associated with significant short- and long-term morbidity and mortality. The authors found they were able to reduce hospital stays by using this model.

Finally, the CONNECT trial holds both clinical and economic posability for providers treating patients with arrhythmias and heart failure. The researchers found that a wireless monitoring system that automatically sends information about an abnormal heart rhythm from a device in the patient’s chest to the cardiologist’s office significantly shortens event response time and reduces hospital costs. While these systems are not widely used, this study could provide enough evidence for wider adoption rates.

All these possibilities loom on the horizon for cardiology practices, and investigating the details of these trials can give us a glimpse into provider settings of the future, and possibly providing insight into better quality outcomes for one’s patients. And if one of these studies proves truly beneficial, Holmes words will continue to ring true: “A moment's insight is sometimes worth a life's experience.”

On these topics, or any others, please feel free to contact me.

Justine Cadet
jcadet@cardiovascularbusiness.com