Interventional cardiology is primarily applied to the treatment of coronary artery disease (CAD, also known as coronary heart disease), which is a specific cardiovascular illness. CAD encompasses myocardial infarction (MI) and angina pectoris, diseases that account for over half of all CAD cases.
One of the most commonly performed surgical procedures used to treat CAD is balloon angioplasty (PCI). Following several years of substantial declines, the PCI procedure volume has recently stabilized and is expected to grow at low-single digits over the next few years, outside of COVID-19-related fluctuations.
PCI Angioplasty Procedure Trends
Growth in the U.S. interventional cardiology market is highly correlated with the growth of annual procedural volumes, particularly the angiography and angiography procedures. The two largest segments in the total interventional cardiology market are the coronary stent market and the vascular closure device (VCD) market. Both markets are strongly correlated with cardiac catheterization procedure volume, which, in turn, is primarily driven by PCI and angiography procedures.
In the past, over-stenting was heavily scrutinized, with numerous studies estimating that approximately 30% of coronary stenting procedures performed were unnecessary. As a result, the average number of stents used per PCI procedure declined as the market adjusted to the newly presented clinical evidence. Other devices and accessories associated with the procedure also experienced a decline in sales volume.
Recently, the angioplasty procedure fluctuations have stabilized, and the procedural volumes are expected to finally experience positive growth. One of the factors driving angioplasty procedural growth is the increased focus on complex PCI patients. In particular, the development of specialized devices, like hemostasis valves and extension guide catheters, allows complex cases to be treated through minimally invasive treatments rather than through coronary artery bypass graft (CABG) procedures. A particular area that manufacturers and physicians believe is not being fully addressed by interventional techniques is the complex and higher-risk indicated patient (CHIP) population.
In 2019, the CMS added 17 cardiac procedures to the list of ASC-approved procedures, including angioplasty procedures. In addition to this, the CMS added reimbursement policies for six CPT codes covering coronary angioplasty with or without placement of stents within the ASC setting. This reimbursement change will move more PCI and angiography procedures into ASCs. With standalone angiographies, ASCs will save the Medicare program money, resulting in a lower total spend and a higher number of procedures performed.
Impact of COVID19 on Procedures
During the first few months of the COVID-19 pandemic, many states across the U.S. canceled or scaled back on non-essential elective surgeries, which includes all interventional cardiology and minimally invasive procedures, to make space for patients with the COVID-19 coronavirus. As a result, the number of angioplasty procedures bottomed out in April and May before beginning to recover in June and beyond. The latest market study indicates that the angioplasty procedures are expected to return to their pre-COVID levels in late 2021 / early 2022.
Most states across the U.S. experienced record low numbers for angiographies and angioplasties performed. In some hard-hit regions, hospital procedures were down an astonishing 80% from regular monthly numbers. The largest U.S. for-profit hospital operator, HCA Healthcare Inc, claimed it had witnessed a 70% decline in outpatient surgeries in April 2020 compared with the year before, while inpatient admissions declined 30%.
Angioplasty Procedural Forecast
The growth of the US Interventional Cardiology market is highly correlated to annual fluctuations in two procedure types — diagnostic angiography and angioplasty procedures (PCI). These procedures have experienced a rapid turnaround, from decline to growth, over the past few years.
According to the latest market study by iData Research, it is estimated that the number of angioplasty procedures performed in the US will exceed an astounding 1 million in 2026. This growth in procedures will drive the US Interventional Cardiology market size to reach $4.1 billion in the same year.