Science of Healing the Heart; In a Surprise, a Temporary Device Provides a Long-Term Cure

September 30, 2013, 7:26 p.m. ET

Science of Healing the Heart

In a Surprise, a Temporary Device Provides a Long-Term Cure


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Doctors have discovered that a heart pump designed to help keep patients alive until a transplant becomes available may actually help the heart heal itself. WSJ’s Larry Greenberg explains how it could bring new hope to seriously ill patients. (Photo: Getty)

A mechanical pump that was invented as a temporary life support for patients with advanced heart failure is emerging as a potential tool to help hearts heal and function for the long term on their own. The device, called an LVAD, takes over most of the heart’s main pumping function and was designed initially to enable patients to survive until a donor heart became available for transplant. But doctors have discovered to their surprise that the heart can get better on the pump. When they remove it later to perform a transplant, the heart is sometimes dramatically improved.“An LVAD is like putting the heart on the disabled list,” says Joseph Woo, surgical director of the heart transplant and LVAD program at the University of Pennsylvania in Philadelphia. As with sidelined athletes, taking the heart out of the game to ease its workload appears to enable it to recover.

Now doctors are mounting a multicenter clinical trial to see if using the left-ventricular assist device—the LVAD’s full name—as a “bridge to recovery” might eventually become a viable new option for some of the thousands of patients with advanced heart failure, one of medicine’s most debilitating ailments.

Congestive heart failure is characterized by an enlarged heart which loses its ability to effectively propel blood to the rest of the body. In advanced disease, fluid collects in the lungs and lower legs, leaving patients so short of breath that walking just a few steps is an ordeal. Among nearly six million Americans with heart failure, an estimated 150,000 have the disease in an advanced stage where a transplant or LVAD become potential options. Most LVAD patients are men, between the ages of 40 and 79.

Based on a small number of patients who have already tried the approach, the heart can get “almost back but not quite back to normal,” says Eduardo Rame, medical director of mechanical circulatory support at Penn, a leader of the new trial.

Recent advances in LVAD technology, plus a treatment protocol successfully championed in England by Emma Birks, director of heart failure, transplantation and mechanical support at University of Louisville, are fueling hope that more patients’ hearts can recover sufficiently to function on their own. It would be “much better for patients to potentially do well on their own hearts again,” says Dr. Birks, who is heading up the new study. With a heart transplant, there is a risk the body could reject the donated heart, for which patients must take immunosuppressant drugs. There also is a paucity of donor organs for all who need one.

Last year, 2,379 patients received a heart transplant in the U.S., according to the United Network for Organ Sharing, a private nonprofit group that manages the nation’s organ-transplant program. The number has remained relatively stable for several years, reflecting a plateauing in the number of donor organs available.

The new study is funded by ThoratecCorp., THOR +1.00% of Pleasanton, Calif., which makes the Heartmate II, the most popular LVAD currently on the market.

For reasons not fully understood, when an LVAD is implanted in a patient with heart failure, the enlarged heart shrinks in a process doctors call reverse remodeling and can regain at least some of its lost function. An aggressive regimen of heart-failure and other drugs contributes to the benefit.

Joe Bellettiere of South Philadelphia illustrates the potential for the approach. Four years ago, when he was 19, a diseased heart muscle that had troubled him since birth triggered two life-threatening episodes of acute heart failure that robbed him of his breath and resulted in extended hospital stays. Initially, doctors recommended a transplant. But at Hospital of the University of Pennsylvania he met Dr. Rame, who encouraged him to consider an LVAD to help his heart recover.

“Either way, I had to get open-heart surgery and both things were going to make me better,” Mr. Bellettiere says. He opted for the chance to try a new idea and to avoid drugs to prevent rejection of a donor heart. The treatment included regular exercise and an aggressive regimen of medication.

His LVAD was implanted in October 2009, during which doctors also repaired a leaky valve in his heart. Nearly 18 months later, Mr. Bellettiere’s heart had recovered to the point where doctors performed a second open-heart operation to “explant” the device.

The first day after his discharge two weeks later, “I walked a mile,” he says. “I didn’t get out of breath. It was definitely a great feeling.” Now 23 and with a year-and-a-half under his belt with his recovered heart working on its own, he’s planning to go back to school.

In 2012, LVADs were implanted in 2,113 U.S. patients, according to Intermacs, a federally funded registry maintained at the University of Alabama at Birmingham that accounts for most of such patients. That is up from 907 in 2009, an increase partly due to the Food and Drug Administration’s decision in 2010 to allow expanded use of Thoratec’s Heartmate II beyond prospective transplant patients to include long-term or permanent therapy.

Still, long-term LVAD use also comes with risks, including infection and stroke. Current versions run on batteries that need to be changed and recharged frequently.

Not every patient is likely to see the heart recover with an LVAD. Patients whose heart failure is caused by a heart attack—about 60% of all cases—aren’t good candidates for the strategy because damage to the heart muscle hinders its ability to regain effective pumping function. And heart failure is often accompanied by kidney problems that could undermine the ability of patients with advanced disease to tolerate the drug regimen that is used in the new LVAD study.

For most other patients, heart failure is caused by genetic anomalies, infection of the heart muscle, adverse reaction to drugs such as chemotherapy or unknown reasons. Because these patients’ heart muscle haven’t been deprived of blood flow—the problem with heart attacks—doctors believe there is greater potential for the underlying tissue to recover.

But Lynne Warner Stevenson, director of the cardiomyopathy and heart-failure program at Brigham and Women’s Hospital in Boston, cautions that some previous studies have found a very low rate of recovery for patients taken off an LVAD. Moreover, relieving the heart of its workload, but not so much that it gets lazy and can’t recover, is a challenge, says Dr. Stevenson, who isn’t involved in the study.

Deciding whether a patient’s heart has recovered also remains uncertain. Dr. Rame last week performed the first “turn-down” test on George Smart, a 51-year-old LVAD patient from Norristown, Pa., who could be a candidate to have the device removed. The propeller in Mr. Smart’s device that takes the workload off his heart spins 9,000 to 10,000 times a minute. Dr. Rame turned it down to about 6,400 rpms, including during an exercise test, so the heart was taking on most of its normal load. Mr. Smart did well, Dr. Rame said, but will repeat the test several times before a decision is reached on removing the LVAD.

Such tests are part of the protocol for the new study, which in addition to Penn and Louisville is being conducted at Montefiore Medical Center, in New York, and University of Utah, in Salt Lake City, with others expected to be added.

It isn’t known how long the heart’s recovery might last. But Dr. Birks offers reason for optimism. She and her colleagues published a study last year in the Journal of Thoracic and Cardiovascular Surgery comparing 40 patients who had LVADs removed with 50 others who had transplant surgery. With a follow-up as long as seven years, survival rates were at least comparable for those living with their own hearts, she says. “You still can’t predict who will and who won’t recover,” she says. “That’s what we’re trying to work out now.”

About bambooinnovator
Kee Koon Boon (“KB”) is the co-founder and director of HERO Investment Management which provides specialized fund management and investment advisory services to the ARCHEA Asia HERO Innovators Fund (, the only Asian SMID-cap tech-focused fund in the industry. KB is an internationally featured investor rooted in the principles of value investing for over a decade as a fund manager and analyst in the Asian capital markets who started his career at a boutique hedge fund in Singapore where he was with the firm since 2002 and was also part of the core investment committee in significantly outperforming the index in the 10-year-plus-old flagship Asian fund. He was also the portfolio manager for Asia-Pacific equities at Korea’s largest mutual fund company. Prior to setting up the H.E.R.O. Innovators Fund, KB was the Chief Investment Officer & CEO of a Singapore Registered Fund Management Company (RFMC) where he is responsible for listed Asian equity investments. KB had taught accounting at the Singapore Management University (SMU) as a faculty member and also pioneered the 15-week course on Accounting Fraud in Asia as an official module at SMU. KB remains grateful and honored to be invited by Singapore’s financial regulator Monetary Authority of Singapore (MAS) to present to their top management team about implementing a world’s first fact-based forward-looking fraud detection framework to bring about benefits for the capital markets in Singapore and for the public and investment community. KB also served the community in sharing his insights in writing articles about value investing and corporate governance in the media that include Business Times, Straits Times, Jakarta Post, Manual of Ideas, Investopedia, TedXWallStreet. He had also presented in top investment, banking and finance conferences in America, Italy, Sydney, Cape Town, HK, China. He has trained CEOs, entrepreneurs, CFOs, management executives in business strategy & business model innovation in Singapore, HK and China.

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