The past 60 years has seen a remarkable period of intervention in the field of cardiology, much of it specifically having to do with interventional cardiology. Advances in diagnostic tools, medications, statistical methods, and trial design have been profound and the impact on patient care and outcomes has been extraordinary. Alongside these improvements have been equally dramatic developments and improvements in therapeutic options, including surgical and percutaneous options. It is amazing to think that the era of cardiac surgery only really started 60 years ago with Dwight Harkness’s remarkable reporting on successful removal of shrapnel from the hearts of numerous soldiers during World War II. When one considers the rapid advancement of PCI, from plain balloon angioplasty, to atherectomy, stenting, and drug-eluting stenting, all leading to a dramatic change in patient outcomes, it is easy to forget how much has changed in such a short period of time. Consider the patient presenting with “tombstone” ECG. When this occurred on a patient during my medical school training, the tombstone on the ECG truly reflected the outcome of the patient. Today, it is a surprise if such a patient does not walk out of the hospital in a couple of days, since that patient would of course be typically treated with rapid PCI and the placement of a stent, commonly with an excellent prognosis. Yes, technology, knowledge, and therapeutic advancements have dramatically changed the medical landscape over each of our professional lives.
However, I have concerns that this reign might be over in the coming years. Certainly the medical community will continue to study therapeutic options and develop improvements and refinements. But I am fearful that there will be a reduction in the development of new devices, which is the cornerstone of many of the advancements in the field of interventional cardiology.
In part, this may be a correction. It seems there was a period of possibly irrational exuberance a few years ago, during which the interest in finding the next blockbuster, like stent technology, drove many investors and inventors to put a lot of money into projects with only a glimmer of financial success in the future. The economic turndown of 2008 has clearly affected investors’ willingness to take chances and it may be that the “golden era” of innovation has seen its peak. However, the difference in economic investment in new technology is dramatic. It has been estimated that the number of venture capitalists and others investing in new medical device development has dropped to 10% of what it was only a few years ago. That’s right — 90% of venture capital companies investing in medical devices a few years ago are no longer investing in medical devices.
Some may point to the 2.3% tax put on devices by the Affordable Care Act and claim this has contributed to a disincentive to invest in innovative device therapies. This may be an oversimplification, as the loss of income due to this tax may be compensated by increasing numbers of patients with insurance under Obamacare. There are arguments for and against the impact of the device tax on willingness to invest in device technology, but I am more struck by another reason why investors may be reluctant to invest in medical technology, namely, the remarkably protracted period of time it takes to bring a new device to the US market. Three recent cardiovascular devices highlight this point.
The first human MitraClip was implanted 10 years ago. A reasonably sized, carefully performed randomized trial demonstrated a clinical value to the device, although not meeting the primary endpoint it set for itself. We are still awaiting FDA approval and availability in the US for this technology, even though it has established itself as being of value in patients with mitral regurgitation who are not ideal surgical candidates. Instead, the FDA has required a second randomized trial.
Similarly, the Watchman device has shown that it has a favorable impact in the prevention of stroke in patients with non-valvular atrial fibrillation compared with warfarin in the PROTECT II randomized trial. However, a second trial, PREVAIL, was required, and the device still is not approved and widely available in the US, but is being used with good clinical outcomes in other parts of the world.
Even TAVR, which has enjoyed widespread acceptance and uptake in the US, and led to a great deal of economic success for Edwards LifeSciences, could be viewed as having had unnecessary delays. After the impressive success seen with PARTNER, Edwards was obliged to perform a second randomized trial to justify the approval of a second-generation device with a lower-profile delivery system. It is unclear to me why a randomized trial was necessary, rather than instead simply proving safety, since the changes are modifications of the prior approved device and delivery system.
As interventional cardiologists, we have enjoyed remarkable growth and development in the tools available to us, which has led to dramatic changes in our patient outcomes. However, it seems that the era of rapid development of technology is being reigned in. It is already the case that we are impacted by the slow processes for approval, since there are many therapies that are not available in the US yet have become established in other parts of the world. However, innovative therapies are simply going to dry up, not only here, but worldwide, if there is no longer a sound economic reason to invest in device technology, and it seems that is where we are headed. This has already had an impact on our profession, but this impact will be even greater moving forward.
Dr Goldberg is the Director of the Cardiac Catheterization Laboratory at University of Washington in Seattle, Washington. He has no conflicts of interest regarding the content herein. You can contact him via Email at firstname.lastname@example.org