CardioSource WorldNews Interventions | The Conundrum of Cost-effective but Unaffordable Care
The Plight of High-tech New Interventional Therapies

We’re not #1! At least when it comes to health expenditures: the U.S. per capita rate of $9,146 is third (third!) to Norway’s lead at $9,715 and Switzerland’s per capita rate of $9,276. Granted, these are much smaller countries.

If you’re feeling competitive or miss no longer being first in per capita health care expenditures, then you will be happy to know that, among major countries, we remain #1 in total health expenditure as a percent of gross domestic product (GDP) (TABLE). However, we miss being #1 among all nations, beat out by tiny Tuvalu (formerly known as the Ellice Islands), a Polynesian island nation located midway between Hawaii and Australia. There you will find health care expenditures that are 19.7% of their GDP.

You probably have seen older graphics showing the U.S. as a resounding #1 in both categories, which certainly was the case. Our descent to #3 is a recent phenomenon; as of 2010, the U.S. was spending more per capita than either Norway or Switzerland—or anyone else, for that matter. And that had been the case since about 1980.

Also, you likely have seen the trends in deaths considered amenable to health care in people younger than 75 years. In an analysis of the U.S. and 18 other industrialized countries, investigators reported such deaths account, on average, for 23% of total mortality in this age group among males and 32% among females. The decline in amenable mortality in all countries averaged 16% between 1997–98 and 2002–03. The U.S. was an outlier, with a decline of only 4%. Had the U.S. reduced amenable mortality to the average rate achieved in the three top-performing countries (France, Japan, and Australia), then the U.S. would have realized 101,000 fewer deaths per year by the end of the study period.

Conundrum

This brings us to what has been called the current crisis in technology: cost-effective (based on historical measures) yet unaffordable care. Here are some numbers: if ICDs were used in patients shown to benefit in MADIT-II, the price-tag would be $15 billion per year. For LAA occlusion (based on PROTECT-AF), the applicable annual cost for expanding its use would be $13 billion. Throw in more patients receiving DES (an extra $2.4 billion based on SIRIUS) and a wider use of TAVR (PARTNER data and an additional cost of $3 billion), then these four interventional therapies would add $33.4 billion to annual health care costs.

These numbers apply to expanding established interventional technologies, but this problem is not confined to high-tech devices. Consider the new lipid-lowering agents, known as PCSK9 inhibitors: with approximately 2.6 million U.S. individuals who could potentially receive a PCSK9 inhibitor over the next 5 years, the total budgetary impact over that time period would be $19 billion (for those with familial hypercholesterolemia), $15 billion (for those who have CVD but are statin-intolerant), and $74 billion (if used for individuals with CVD but not at their low-density lipoprotein cholesterol target).

According to David J. Cohen, MD, FACC, director of cardiovascular research at Saint Luke’s Mid America Heart Institute, Kansas City, KS, there is already informal rationing in cardiovascular care, including limiting use of LV assist devices, carotid stenting, and transcatheter heart valves. Coming soon, he said, you might see limits placed on the use of PCI in stable coronary artery disease, renal stenting, LAA occlusion, and perhaps others.

From a public health standpoint, there are data to support further expansion of spending on health care over many other areas, but there is a need for continued education of the public regarding the true “value” of medical technology. Dr. Cohen also noted that even the current economic environment will continue to support innovation over iteration: technologies that provide substantial benefit and fill truly unmet clinical needs are most likely to be covered and reimbursed.

He added that study designs should emphasize clinical benefit and focus on identification of optimal populations. Also, there should be a demonstration of economic value through “real world” studies that focus on outcomes that are relevant to patients and payers (survival, QOL, and lower costs of care).

Dr. Cohen added that treatments are not “cost effective” unless they are truly effective. And for truly transformative technologies, the true value may not be immediately apparent.

Reference:

1. Nolte E, McKee CM. Health Aff (Millwood). 2008;27:58-71.

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The ‘Metastatic Cancer of Electrophysiology’
For Long-standing Persistent AF, How About Empirical LAA Isolation?

Longstanding persistent atrial fibrillation (AF) is the most challenging type of AF to treat with catheter ablation. During 5-year follow-up, Roland R. Tilz, MD, and colleagues noted that of 202 such patients treated with circumferential pulmonary vein isolation (PVI), single- and multiple ablation procedure success was 20% and 45%, respectively.¹ Compare that to the single procedure success rate seen in patients with paroxysmal AF (40% at 1 year and 30% at 5 years) and for multiple procedures (> 80% and > 60% at 5 years).^2,3

In an editorial accompanying the paper by Tilz et al., longstanding persistent AF was referred to as ‘the metastatic cancer of electrophysiology’: It is one of the most difficult problems to treat and until recently, with no options, patients were expected to learn to live with their burden.⁴ The authors of the commentary, all from St. David’s Medical Center, Austin, TX, wrote: “At least two-thirds of the population improved after a long follow-up. This is not an inconsequential number and would be seen as a major victory in cancer medicine.”

Several studies have shown that, in addition to pulmonary vein (PV) isolation, other areas may be the source of initiation and maintenance of AF in patients. The most common non-PV sites are the superior vena cava, the ligament of Marshall, the coronary sinus, the crista terminalis, the left atrial posterior wall, and the left atrial appendage (LAA).

Luigi Di Biase, MD, PhD, FACC, is director of arrhythmia services, section head of electrophysiology, and associate professor of medicine (cardiology) at Einstein/Montefiore in New York City, NY. Di Biase and colleagues think that the latter is an under-recognized trigger site of AF. In one study of nearly 4,000 patients, they reported that LAA appears to be responsible for arrhythmias in 27% of patients presenting for repeat procedures.⁵ They concluded that isolation of the LAA “could achieve freedom from atrial fibrillation in patients presenting for a repeat procedure when arrhythmias initiating from this structure are demonstrated.”

Empirical LAA Isolation

Di Biase and colleagues recently reported their results treating patients with longstanding persistent AF using empirical electrical isolation of the LAA plus extensive PV antrum and non-PV trigger ablation (n = 85; group 1) versus extensive ablation alone (n = 88; group 2) in a multicenter randomized trial. (The effects of LAA isolation in addition to PV isolation has not been investigated before in a prospective randomized fashion.)

Empirical isolation of the LAA improved the long-term freedom from AF without increasing complications. Specifically, at 12-month follow-up, freedom from recurrence after a single procedure (and without anti-arrhythmic drug therapy) was seen in 48 (56%) of the patients with empirical LAA isolation vs. 25 (28%) in the ablation-only group (p = 0.001). In group 2, about one-third of patients showed firing from LAA during isoproterenol testing but a sustained arrhythmia was observed in only eight of these patients and LAA was isolated in these patients.

Sixty-two patients (27 group 1; 35 group 2) underwent a second procedure and LAA isolation was performed in all of these patients undergoing repeat ablation. After an average of 1.3 procedures, success at 24-month follow-up was 65 (76%) in group 1 and 49 (56%) in group 2 (p = 0.003).

After adjusting for age, sex, and left atrial diameter, LAA isolation plus standard ablation was associated with a 55% reduction in overall recurrence (HR: 0.45; p = 0.004).

The mean radiofrequency time was significantly longer with empirical LAA isolation (93.1 ± 26.2 minutes versus 77.4 ± 29.9 minutes; p < 0.001). But there were no significant differences in safety endpoints when LAA was empirically added to extensive ablation.

At ESC 2015, where the data were presented, the discussant for the trial was Professor Gerhard Hindricks, MD, director of the department of electrophysiology at Leipzig University Heart Center, Germany. The results, he said, “are interesting and important, as they add new information about the potential role of LAA triggers in patients with longstanding persistent atrial fibrillation.”

However, overall he considers the trial hypothesis generating rather than fully conclusive. Further studies are necessary, he said, before LAA isolation can be recommended as an integral part of catheter ablation of longstanding persistent AF.

References:

1. Tilz R, Rillig A, Thum A, et al. J Am Coll Cardiol. 2012;60:1921-9.
2. Weerasooriya R, Khairy P, Litalien J. J Am Coll Cardiol. 2011;57:160-6.
3. Medi C, Sparks PB, Morton JB, et al. J Cardiovasc
4. Electrophysiol. 2011;22:137-41.
5. Burkhardt J, Di Biase L, Natale A. J Am Coll Cardiol. 2012;60:1930-32.
6. Di Biase L, Burkhardt JD, Mohanty P, et al. Circulation. 2010;122:109-18.

Read the full May/June issue of CardioSource WorldNews Interventions at ACC.org/CSWNI

Keywords: CardioSource WorldNews Interventions, Atrial Fibrillation, Catheter Ablation, Cost-Benefit Analysis, Defibrillators, Implantable, Health Care Costs, Pulmonary Veins

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