Thomas Morrow, MD

A tiny new implantable heart pump transmits speed, power consumption, and blood flow data directly to the cardiac center

Thomas Morrow, MD

Heart failure affects over 5 million Americans with an additional 670,000 cases diagnosed each year. Most are effectively treated conservatively with medication. But thousands each year progress to the point of needing more, such as surgery.

Although heart transplantation is the desired therapy for patients with end-stage cardiac failure, the limited availability of donors (2,322 last year) has created a need for a nonbiologic left-ventricular-cardiac-assist device (LVAD).

The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial demonstrated a dramatic 48 percent reduction in death for end-stage congestive heart failure patients when an LVAD was used compared to matched controls undergoing optimal medical management.

The first device, a pulsatile-acting pump, was approved for patient use by the FDA in October 1994. Since then, new developments have focused on continuous-flow devices that use either a centrifugal pump or an axial flow impeller. These designs can be made much more compact and have better reliability. Of interest, the patients may not actually have a pulse, something that is key to evaluation of an unconscious patient. This means that a patient without a pulse may still be alive.

Two categories

Although some patients, notably those with a cardiomyopathy, may need temporary assistance until their heart heals, most fall into two categories: destination therapy — when the patient is not a candidate for a transplant and the LVAD is the only option — and bridge therapy — where the patient is placed on an LVAD in anticipation of a transplant. Overall outcomes are positive.

One study of 281 patients determined that 79 percent of patients received a transplant, recovered cardiac function, and had the device removed, or remained alive with on-going LVAD support at the end of the 18-month study. The median time to transplantation was 118 days (range 10–545). Of those who remained on an LVAD, 82 percent were alive at 6 months, 73 percent at one year, and 72 percent at 18 months, clearly demonstrating the durability of LVAD therapy.

Although the pumps are typically used for a year or two until death or transplant, one notable patient, Peter Houghton, survived and actually thrived on an LVAD for seven years. During this time, he completed a 91–mile charity walk, hiked widely in the American West and Europe, published two books, and flew in an ultralight airplane.

Outpatient management

Initially, all LVAD patients were managed in the hospital. This changed rapidly, and now most patients are managed as outpatients, a cumbersome ordeal for patients who live far from the cardiac centers (126 hospitals in the United States performed heart transplants last year) that specialize in this management.

Obviously the follow-up care of these patients is complex. In addition to receiving anticoagulation, each patient must practice strict aseptic technique, as LVADs are not totally implantable since they must be connected to power sources. It is also necessary to monitor several flow parameters of the device.

Most patients are seen every other week or monthly. Given that some heart centers have more than 200 patients on an LVAD, a large clinical staff is needed. Routine distance monitoring of the speed of the device and its power consumption — surrogates for the patient’s overall cardiac function — is routine for all LVADs. An echocardiogram is needed to obtain an accurate measurement of blood flow, a key clinical measure. But this may all soon change!

Latest generation

The latest generation of LVAD, the Micromed Heart Assist 5, has a miniature ultrasonic flow probe incorporated in the actual pump. This allows it not only to monitor and report speed and power consumption, but also to report the actual flow of blood, a remarkable improvement in overall function of the device and something that will inevitably allow for better care of these patients. It weighs a mere 92 grams.

Already approved in Europe, it is under review by the FDA. And at the risk of sounding like a late-night infomercial, I can say, “But that’s not all!”

An important development in the overall care of LVAD patients is on the horizon in the United States and has already started in Europe. Micromed has joined with Numerex to provide a scalable web- and cellular-based monitoring system unlike any other. Numerex brought its machine-to-machine remote communication and management expertise to complement Micromed’s health care technology strengths.

Remote monitoring

This partnership will allow automated nondelayed remote monitoring of the three key parameters — speed, power consumption and blood flow — that will alert the cardiac center to abnormalities via the Internet. These measurements will also be able to be plotted over periods of 4 hours, 7 days, and 30 days.

Continuous monitoring without the need to travel to a center will result in considerable improvement in the patient’s quality of life and is likely to improve their overall satisfaction. It is also likely to lead to much more efficient management, allowing for fewer cardiac specialists at the cardiac centers.

LVAD use will probably expand as pump technology and follow-up management are further improved.

Although a fully implantable pump with power supply and controller is still a goal, the Micromed Heart Assist 5 is worthy of being highlighted as Tomorrow’s Medicine.

Thomas Morrow, MD, is the immediate past president of the National Association of Managed Care Physicians. He has 24 years of managed care experience at the payer or health plan level. Contact him at
The author is a director in the value-based health department at Genentech. He has had no other industry affiliations in the past three years. The views expressed in Tomorrow’s Medicine are the author’s alone.

Managed Care’s Top Ten Articles of 2016

There’s a lot more going on in health care than mergers (Aetna-Humana, Anthem-Cigna) creating huge players. Hundreds of insurers operate in 50 different states. Self-insured employers, ACA public exchanges, Medicare Advantage, and Medicaid managed care plans crowd an increasingly complex market.

Major health care players are determined to make health information exchanges (HIEs) work. The push toward value-based payment alone almost guarantees that HIEs will be tweaked, poked, prodded, and overhauled until they deliver on their promise. The goal: straight talk from and among tech systems.

They bring a different mindset. They’re willing to work in teams and focus on the sort of evidence-based medicine that can guide health care’s transformation into a system based on value. One question: How well will this new generation of data-driven MDs deal with patients?

The surge of new MS treatments have been for the relapsing-remitting form of the disease. There’s hope for sufferers of a different form of MS. By homing in on CD20-positive B cells, ocrelizumab is able to knock them out and other aberrant B cells circulating in the bloodstream.

A flood of tests have insurers ramping up prior authorization and utilization review. Information overload is a problem. As doctors struggle to keep up, health plans need to get ahead of the development of the technology in order to successfully manage genetic testing appropriately.

Having the data is one thing. Knowing how to use it is another. Applying its computational power to the data, a company called RowdMap puts providers into high-, medium-, and low-value buckets compared with peers in their markets, using specific benchmarks to show why outliers differ from the norm.
Competition among manufacturers, industry consolidation, and capitalization on me-too drugs are cranking up generic and branded drug prices. This increase has compelled PBMs, health plan sponsors, and retail pharmacies to find novel ways to turn a profit, often at the expense of the consumer.
The development of recombinant DNA and other technologies has added a new dimension to care. These medications have revolutionized the treatment of rheumatoid arthritis and many of the other 80 or so autoimmune diseases. But they can be budget busters and have a tricky side effect profile.

Shelley Slade
Vogel, Slade & Goldstein

Hub programs have emerged as a profitable new line of business in the sales and distribution side of the pharmaceutical industry that has got more than its fair share of wheeling and dealing. But they spell trouble if they spark collusion, threaten patients, or waste federal dollars.

More companies are self-insuring—and it’s not just large employers that are striking out on their own. The percentage of employers who fully self-insure increased by 44% in 1999 to 63% in 2015. Self-insurance may give employers more control over benefit packages, and stop-loss protects them against uncapped liability.