Diagnostic Devices Transforming The Cardiovascular Space
By Mina Jacob, Interventional Cardiologist, In By firmary Health
In the years since I started my practice, there has been a paradigm shift in the cardiovascular space. Before the era of interventional cardiology and percutaneous interventions: surgical procedures where the go to route for all cardiovascular aliments. Percutaneous cardiovascular interventions, which previously existed mostly in pediatric cardiology, expanded over the years to cover almost all cardiovascular diseases. There have been significant investments made toward the progression of interventional cardiology where developments go hand in hand with a physician’s experience.
What are the trends shaping the cardiovascular space?
There was a period of pause, during which the leading companies in the market were struggling to develop newer technologies, trying to leap from coronary interventions into the wide virgin field of percutaneous management of structural heart disease. Newly established startups migrated to the European market or were acquired by bigger companies, who could afford significant sales force and clinical liaisons that would support physicians utilizing their products.
Please shed some light on the advent of new cardiovascular devices.
Over the last few years, we saw the development of TAVR (Transcatheter Aortic Valve Replacement), percutaneous ASDs (Atrial Septal Defect), and PFOs (Patent Foramen Ovale) closure. Mitral valve clips, TMVR (Transcatheter Mitral Valve Replacement), watchman devices, and other left atrial appendage closure devices are some of the other procedures that were developed based on emerging technologies developed by various companies in the cardiovascular space. Previously, we had companies that were mostly into the surgical arena such as Edwards, and then we got companies that were mostly dedicated into intravenional cardiology like Medtronic and Boston Scientific.
"There have been significant investments made toward the progression of interventional cardiology where developments go hand in hand with a physician’s experience"
This field is growing longitudinally as we are developing more and more solutions for structural heart problems, such as mitral valve replacement, and horizontally, where there is a broader adoption of newer devices among physicians and hospitals.
What are some of the pressing challenges that the cardiovascular landscape presents?
The creation of new devices is not growing in proportion to the number of physicians who are trained to use them in their fellowships. Physicians are hesitant in adopting the technology, as they have to learn about it, how to use it, and keep up with every emerging innovation. Not every practice or city can acquire new physicians who are trained in all devices, for example, a hospital may hire a doctor trained in TAVR, but not mitral valve replacements.
Graphically, an interventional cardiology pie consists of three sectors: coronary interventions, peripheral interventions, and structural heart interventions. If we look back ten years ago, the structural heart piece of the pie was lesser than 5 percent, and now it has grown up to about 30- 40 percent of the chart.
In a recent meeting, I came across something interesting: the term PCI, which previously stood for Percutaneous Coronary Intervention, is changing to Percutaneous Cardiovascular Intervention. This is because, prior to the technology being developed, coronary intervention was 90 percent of our practice, nearly 10 percent was peripheral and zero percent structural. Today, we are doing 30 percent structural heart procedures, 30 percent peripheral, and 40 percent coronary interventions. The biggest hurdle we are facing right now that technology is developing faster than the pace at which we can train physicians to adopt it.
Another hurdle is that new devices are costly, and hospitals usually end up with a loss while trying to adopt these innovations. Although healthcare institutions want to offer sophisticated care services to their communities, they do not want to do it at a loss, because, at the end of the day, hospital administrators are trying to keep companies afloat.
Hospitals continue to go out of business due to financial losses. Hospitals are struggling to get reimbursed for high dollar devices. CMS Medicare is not willing to reimburse sufficient amounts of money to adopt these technologies. They deny hospital claims, and private insurance still considers some of the new devices as investigational equipment. This leads to us deny procedures to patients as their insurance will not pay for them and the hospital will not allow the procedure until reimbursement is possible. Reimbursement also does not cover the high costs of ancillary services and high end equipment required to adopt newer technologies.
The field of structured heart diseases is facing these two obstacles right now. Technology is growing faster than we can adopt it, but, in the meantime, CMS and private insurance are lagging behind trying to cover the expenses, and even when they do cover it, they are not doing so to motivate hospitals across the country to adopt these new technologies and offer it to patients in their community.
How does the future look for the cardiovascular Sector?
With patients demanding procedures that are minimally invasive, companies innovating new devices should not give up as I have seen hospitals inadvertently adopting newer devices developed over the years. We cannot withhold newer technologies from our patients because of financial reasons. Patients should not be denied options just because hospitals lose money on the purchase of new equipment or they are not covered by patient’s insurance .
Every company starts small, an entrepreneur may lose money, and eventually, they achieve success and recognition in the marketplace; Microsoft and Amazon are easily relatable examples. We had a few stagnant years in the mid-2000s, due to the lack of efficient methodologies and sophistication in the cardiovascular space. Cardiovascular companies were going through a lot of distress. To be in the interventional cardiovascular technology field, there was nothing in the pipeline, and we were waiting for the time to be ripe. Now, these are exciting times again, we are honored and humbled on being a part of this changing space. I am glad to have adopted these technologies, having been trained in them, and being able to offer solutions to my patients that were not around before.