Makers of devices for ablation for atrial fibrillation (AF) have struggled at times to overcome clinician skepticism, but a new report in a respected medical journal might persuade some of those cardiologists. A study of nearly 28,000 AF patients in South Korea demonstrated that device therapy yielded lower rates of death and admission for heart failure compared to medical therapy, suggesting that ablation is a valid alternative to medical therapy, at least for patients in Asia.

An article in the Journal of the American Heart Association noted that there is still some controversy over whether catheter ablation for AF improves survival and other outcomes. The study, a retrospective analysis of nearly 195,000 records from the Korean National Health Insurance database, located nearly 9,200 patients treated with ablation between January 2005 and December 2015, along with more than 18,700 concurrent patients treated via medical therapy.

After weighting, the two cohorts exhibited similar background characteristics, and follow-up averaged 43 months post-treatment. The objective of the study was to compare the relative rates of death, admission for heart failure, and ischemic stroke/systemic embolism, both separately and as a composite measure. The enrollees were all diagnosed with AF for the first time, although patients with valvular AF and previous cardiac electric implant were excluded.

Patients undergoing device therapy for their AF were less than half as likely to experience the composite outcome (2.5 per 100 person-years vs. 6.4 on medical therapy), the authors said. All-cause death likewise favored device treatment (1.0 per 100 person-years vs. 3.6), as did heart failure readmission (0.7 and 1.9) and ischemic stroke/systemic embolism (1.1 and 2.8).

Market for devices exploding in Asia

Bolstering the positive returns from the JAHA study, the market for ablation and other catheters in South Korea and in Asia in general seem ripe for device makers. According to a report by Decision Resources Group (DRG), now a part of Clarivate, the market for ablation catheters is expected to grow from less than $400 million in 2018 to more than $900 million by 2028. For South Korea, the volume of ablation procedures should jump by a compound annual growth rate (CAGR) of 12.8% over that same span, tops for any market in the region and substantially greater than the regional average growth rate of 9.2%. A distant second place goes to mainland China, which is expected to increase by 9.4%, while Singapore and Australia should also see increases of more than 9%.

Despite the procedural volume growth, average sales prices (ASPs) will not see the same kind of uptick, according to the report’s author, Suraj Nair. The ASP for ablation catheters in South Korea grew by more than 3% last year, which should closely parallel the growth this year. However, ASPs for these devices are expected to flatten and even decrease by the end of the forecast period, for a CAGR of 1.4%. This closely tracks what will happen in the other Asian nations with the exception of India, where prices are expected to fall by 2.4%. ASPs for the other catheters in the report are expected to follow suit in terms of trends, although diagnostic catheter ASPs may absorb an even greater hit by 2028.

Nair told BioWorld that multiple factors are at work where ASPs are concerned. “In most countries, electrophysiology and ablation devices are reimbursed to cover for the cost of the device and acts as a cap on the maximum selling price of the product,” he said, adding that competition further help in reducing the cost of the products.

Nair said that while the electrophysiology market in South Korea is growing at a rapid clip, local production is starting to fill some of that demand. In addition to price control strategies under the South Korean national health system, local production will help to take a bite out of prices, although South Korea’s population of those older than 65 is expanding as well, increasing the target population for ablation.

India’s NPPA exerts no apparent leadership on prices

India’s National Pharmaceutical Pricing Authority (NPPA) “does help in regulating the prices of pharmaceuticals,” Nair said, adding that medical devices are handled in much the same way as drugs, “and thus their prices come under the purview of NPPA, which has been putting price caps on the medical devices such as stents already.” However, he said there is little evidence that NPPA serves as a leader for other nations in terms of pricing control, inasmuch as pricing continues to vary according to the existing reimbursements frameworks in these countries.

Nair said the Hong Kong market is heavily dependent on imports, primarily from the U.S., and thus the tensions between Hong Kong and Beijing “might not have a direct effect on the volume of sales. A potential area which might be affected is the re-export/ shipment of medical devices to China through Hong Kong,” he said, given that Hong Kong serves as a shipping point for “a huge amount of medical devices entering China.”

Electrophysiology and ablation devices in these markets are experiencing a fairly rare growth phase in most Asian countries, and ablation has gained much in terms of acceptability for safety and effectiveness for arrhythmias. This has combined with the post-World War II birth cohort meeting its age of cardiological need, and consequently, Nair said, “we are currently seeing more patients shifting towards ablation. In the later years, we do expect the demand being fully met and thus the rate of growth of the market stabilizing.”

The market for transseptal needles covers both diagnostic and device implant usage, and Nair said much of the coming increase in demand for these devices is likely to be driven by device implants.

Nair said it is difficult to forecast whether any damage to China’s economy stemming from its handling of the COVID-19 pandemic might suppress utilization of the devices described in the report. “A drop in the growth rate of the market is expected due to the pandemic in 2020,” he said, which will be driven nearly entirely by the direct economic impact of the pandemic.

There does not appear to be any concern that the nations listed in the report are short of cardiologists or clinical infrastructure to handle current demand. On the other hand, Nair said, “the situation is changing in many developing countries. Cardiologists specializing in electrophysiology are needed to perform these procedures. Thus, in countries such as China and India, newer health care professionals will be needed to be trained to meet the demand. Secondly, these countries will need to build newer facilities,” such as electrophysiology and cath labs, he said.

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