Off Script: A Monumental, First-World Victory vs an Enduring First-World Failure

SAN DIEGO, CA—The astonishing results of the COAPT trial were released this morning at the TCT 2018 Main Arena to a full auditorium, a collective gasp, and spontaneous applause. I suppose this may have been what it felt like to watch Andreas Gruentzig present the results of the first coronary angioplasty 44 years ago. Much will be said and written about this trial in the years to come, but some things deserve to be discussed in the moment. For those of us who have struggled with symptomatic heart failure patients with significant mitral regurgitation, the trial likely ushers in a new era of device-based therapeutic options. Rarely have we seen such a definitive procedural benefit for every hard, primary clinical endpoint and for every secondary qualitative study outcome. The magnitude of benefit was also remarkable, with a number needed to treat of 3.1 to prevent one hospitalization and 5.9 to prevent one death over 2 years. For a cohort of patients who, on optimal medical therapy had a 46% chance of death at 2 years, the procedure may offer a new lease on life.

The investigators have to be commended for their discipline and exemplary methodology, since many trials similar to this studying new indications postapproval have had difficulty with enrollment and staying the course with significant crossover. The MitraClip was originally approved in 2013, but restricted to the indication of primary mitral regurgitation. Around the world however, most MitraClips have been implanted for secondary mitral regurgitation in heart failure, in the hopes that the clip could help this broader group of patients. Initial, nonrandomized results looked promising, leading many of us struggling to look after these sick patients to stretch hard to find primary mitral valve problems in patients with secondary mitral regurgitation so that they, too, would meet the indication for implantation. We could also see that they did well when the procedure was performed.

Today’s results were especially surprising given the negative findings of the recently reported European MITRA-FR study which had generally similar enrollment criteria, but which was half the size and performed for half the duration. On analysis, important differences were present between both studies which may have contributed to the contrary outcomes—worse mitral regurgitation, with less dilated ventricles and more rigorous medical therapy in the COAPT patients. These findings likely hint at the boundaries of who should be referred for the procedure and will likely prompt us to continue to refine optimal selection. I believe it’s time for a new Class I recommendation.

Having spent a lot of time with my colleagues from around the world at this meeting, however, it must be said that today’s victory is predominantly a first-world victory. The developing world continues to benefit from the fruits of our well-funded, very costly, and non-cost-effective bazaar of medical device innovation, but much of what is developed takes years to become affordable elsewhere. Many of the recent superstars of interventional cardiology development: TAVR, left atrial appendage occlusion, the MitraClip device, percutaneous LVAD support, ECMO and PFO closure remain out of reach of the 99%. It’s a high fence and most of the world, accepting of the gradients of wealth and their implications, continue to remain on the other side, waiting to be let in.

A Developing-World Success, a First-World Challenge

Prior to the late-breaking trial, I had the privilege this morning of being a discussant at a Cath Lab of the Future: Telemedicine and Robotics moderated abstract session. A remarkable body of work spanning 20 years was presented by Dr. Sameer Mehta highlighting the impact and success of the LATIN (Lumen Americas Telemedicine Infarct Network) collaboration and the work of his LUMEN global foundation. Through grueling on the ground education and simple infrastructure efforts, he has been instrumental in the development of hub and spoke STEMI networks for low- and middle-income countries utilizing simple telemedicine transmission protocols coupled with pragmatic triage pathways solutions that take into account unique, local geopolitical barriers to care. In Latin America alone, the LATIN program has generated 700,000 telemedicine encounters and the data on display today demonstrated a dramatic, significant improvement in population STEMI care with impressive improvements in access to care, outcomes, and cost of care.

I was struck at one point by the realization that the prehospital activation system on display here was superior to that in my home state of Arizona. The fundamental, simple idea of getting an ECG performed remotely (whether in an ambulance, a clinic, or small emergency room) transmitted, interpreted accurately, and if appropriate, resulting in an optimal care pathway activation towards a hub has not been consistently achieved in our first-world country. I am constantly frustrated by the Byzantine reasons I am told why this is not achievable. I can send a selfie to you any time of the day from almost anywhere in the US. Why can’t I always get that ECG of my STEMI to you?

We may have to look across the fence for that answer.