Heart disease remains America's No. 1 killer. Fear of dying from a sudden heart attack or stroke, or fear of failing to prevent one, drives a lot of medical decisions.
Last week, research on several fronts, timed for release during the annual American Heart Association meeting, raised serious questions about how the nation spends about $200 billion each year on cardiac care.
The bottom line is that in an era when quality and cost matter, providers and insurers must pay close attention to the evidence on the outcomes, safety and expense of different approaches for treating heart disease.
Let's take a quick spin through the latest evidence—or lack thereof.
A new government-funded study on the most common affliction leading to coronary events—high blood pressure—found that lowering the target systolic pressure standard from 140 to 120 could lower the risk of a heart attack or stroke by 27%. While that sounds impressive, the absolute reduction in risk in the SPRINT trial showed you would need to treat 200 people to prevent one event, and 300 people to prevent one death.
Most anti-hypertension drugs are generic, so the cost for treating a single patient isn't large. But when there are 17 million people in the U.S. who would qualify for intervention, those costs mount up quickly.
There were also serious safety issues in the group more aggressively treated. For every 100 patients shooting for the lower target, there were four severe side effects including kidney problems, fainting or life-threatening low blood pressure.
Another study released last week looked at the long-term effects of inserting stents in patients with coronary artery blockages—a mainstay operation of hospitals' cardiac catheterization labs.
Fifteen years after patients with coronary artery blockages entered the so-called COURAGE trial, there was no difference in overall mortality between groups receiving either a stent or clot-busting drugs, which is a much cheaper approach.
That has been known at least since 2007, and probably helps account for the slow but steady drop in total percutaneous coronary interventions (PCIs) being performed in the nation's cardiac cath labs in recent years.
It also probably motivated the nation's medical-device manufacturers to step up their search for new PCI-friendly technologies, since anything done to the heart during a PCI can be marketed as substantially cheaper than a full-blown heart surgery.
And they've been fairly successful. Just to name a few of the latest “wow” technologies coming out of device industry labs: Abbott Laboratories introduced the MitraClip to repair leaky heart valves; Boston Scientific introduced the Watchman to prevent strokes in atrial fibrillation patients; and St. Jude Medical introduced the CardioMems, a wireless remote blood pressure monitoring device that can be inserted in the coronary arteries of heart failure patients.
But, like stents before the COURAGE trial, the clinical trials behind these new technologies offer scant proof of improving outcomes. Last week, the CMS proposed restricting payment for the Watchman until it gets better data on its efficacy in lowering stroke risk.
That comes only a few months after a report in JAMA Internal Medicine triggered a Food and Drug Administration safety warning letter to the manufacturer of another PCI-inserted device for lowering stroke risk in AFib patients: the Lariat, which was invented by a California-based start-up called SentreHeart. The device had received FDA approval as a follow-on abdominal surgical suture under the agency's problematic 510(k) process, which doesn't require any clinical trials.
Many hospitals across the country are grappling with the problem of excess capacity in their cath labs. Routine PCIs increasingly are being shifted to outpatient settings, while more serious cases are being reserved for the in-hospital labs or regional centers of excellence.
That's causing a serious drop in PCI demand at some institutions, which are responding by asking the invasive cardiologists on staff to conduct rounds on patients or work at least part-time in the emergency department.
No one is talking about stranded assets—yet. But the absence of solid medical evidence should give pause to anyone thinking about a major expansion of their cath lab capacity.
