Cheney’s heart doesn’t miss a spin / July 15, 2010

After five heart attacks, former Vice President Dick Cheney’s ticker has taken a beating. Last week, he said that he underwent surgery to install a new heart pump. What he got was a LVAD, or left ventricular assist device, which is made for people like Cheney who need a little help pumping blood because their hearts aren’t keeping up. The pump runs something like a drill bit, continuously rotating at 9,000 rotations per minute rather than squeezing and releasing, so Cheney now officially has no pulse, according to Dr. Stuart D. Russell, chief of heart failure and transplantation at Johns Hopkins’ Comprehensive Transplant Center. But what he’s likely getting in return, says Russell, who is not involved in Cheney’s care, is a better quality and quantity of life. Cheney said in a statement that he had “increasing congestive heart failure,” which afflicts about 5 million Americans whose hearts have weakened over time. In most candidates for the device, the amount of blood squeezed out with each beat is significantly reduced – normal is 55 percent or greater and Cheney was likely more in the 10-15 percent range. That makes the people grow tired quickly after doing minor chores such as dressing.

Pumps have been around for about three decades, but this version by Thoratech Corp., at about five years old, gives people a 60 percent survival rates after 2 years. There’s not a lot of data on this pump after that. Drug therapy, in contrast, gives patients about a 10 percent survival rate. “That’s a lot better than 10 percent on the pills,” Russell said. “Some would say going from 10 percent to 60 percent is phenomenal.” Some patients use the device, Russell said, as a bridge to a transplant. But Cheney, at 69, might not be a candidate. In that case it’s a “destination therapy,” meaning this is his treatment destination. But Russell says that he could live 4,5 or 6 years with this pump and new ones already are in development. And “6 years for a 69-year-old who has had 5 heart attacks is significant,” he said.

Russell said those who get this pump are generally in the hospital 14 to 21 days and start to feel normal after two to three months. The device requires an energy source, so the people have a line coming out of their skin near their belly that need to be hooked up to a battery pack during the day — it can be worn holster-style if Cheney prefers. It also needs to be plugged into an energy source at night. It can’t get submerged, so wearers can’t swim but they can shower. They also need to take anti-coagulation drugs. They are also at increased risk of infection and gastrointestinal tract infections. “People generally can get back to a fairly normal lifestyle,” Russell said. “The vast majority do well.”


I turned to a journalist who knows a lot about such issues – Mary Knudson, co-author with Edward K. Kasper M.D. of Living Well with Heart Failure, the Misnamed, Misunderstood Condition. Here are Mary’s comments:

“The main problems I saw with coverage of former Vice President Dick Cheney getting a device implanted to treat his worsening heart failure was absence of reporting about the huge risks associated with this procedure. Below are some points to include in balanced reporting about an LVAD:

A left ventricular assist device (LVAD) can be an effective means of treating heart failure short term, but is much riskier and more complex than implanting a pacemaker. The LVAD is a pump that does the work for a weak left ventricle, removing blood from the left ventricle and pumping it into the aorta where it then flows to the rest of the body. The newer model smaller pump is implanted in the chest and has tubes leading to the left ventricle and aorta and another that goes outside the body to connect to a computerized controller. The controller can be worn on the waist and operated by batteries. The LVAD is used in people with heart failure that is so severe, medications do not prevent shortness of breath and fatigue. The device is used in someone with end-stage heart failure as a bridge to keep a person alive until he can get a heart transplant or as a final treatment that may prolong his life up to 10 months to two years or sometimes longer.

While the LVAD can dramatically improve the quality of a person’s life by relieving the symptoms that prevent activity, it is a procedure that carries a great deal of risk. Death can occur during the procedure, in the first few days after it, or after the person returns home. Risks include infection, blood clots, bleeding, device failure, and quite a few others. Using the newest model of LVAD, a person can go about daily activities by carrying with him a couple of sets of battery replacements and then at night connecting the LVAD to a laptop computer that is plugged in to an electrical outlet. Or the person might work at an office or at home with the LVAD plugged through the computer to an electrical outlet. The LVAD has come a long way from the noisy large stationary power sources patients were tethered to. Newer units are smaller, portable for hours, and quieter. But the risks are the same and this device is used as a last resort.”

“I’m a surgeon and just read your wire story about Dick Cheney getting a Left Ventricular Assist Device (LVAD) placed. The story downplays the seriousness of that procedures…once you’ve got an LVAD in place, it means your heart is essentially incapable of working on its own and has no potential to improve. While LVAD outcomes have been improving, and some patients live months or even years with one of these devices in place, this is a HUGE operation with MAJOR associated morbidity and mortality. If he’s not listed for a heart transplant, his days are seriously numbered. Life on an LVAD isn’t something I’d wish on my worst enemy…an axiom that this situation really tests. He’s in for a rough time.”


What is a left ventricular assist device (LVAD)?
The left ventricle is the large, muscular chamber of the heart that pumps blood out to the body. A left ventricular assist device (LVAD) is a battery-operated, mechanical pump-type device that’s surgically implanted. It helps maintain the pumping ability of a heart that can’t effectively work on its own. These devices are available in most heart transplant centers.

When is an LVAD used?
This device is sometimes called a “bridge to transplant.” People awaiting a heart transplant often must wait a long time before a suitable heart becomes available. During this wait, the patient’s already-weakened heart may deteriorate and become unable to pump enough blood to sustain life. An LVAD can help a weak heart and “buy time” for the patient.

How does an LVAD work?
A common type of LVAD has a tube that pulls blood from the left ventricle into a pump. The pump then sends blood into the aorta (the large blood vessel leaving the left ventricle). This effectively helps the weakened ventricle. The pump is placed in the upper part of the abdomen. Another tube attached to the pump is brought out of the abdominal wall to the outside of the body and attached to the pump’s battery and control system. LVADs are now portable and are often used for weeks to months. Patients with LVADs can be discharged from the hospital and have an acceptable quality of life while waiting for a donor heart to become available.

Promising study results for LVADs
In a study published in Circulation in 2005, LVADs restored failing hearts in some patients with heart failure, eliminating the need for a transplant. According to an abstract presented at the American Heart Association’s 2005 Scientific Sessions, LVADs reduced the risk of death in end-stage heart failure patients by 50 percent at six and 12 months and extended the average life span from 3.1 months to more than 10 months.


Leonor Childers wearing her battery back, pictured with daughter and infant son

DA Approves Left Ventricular Assist System for Severe Heart Failure Patients
Device Provides Support for Those Who Are Not Acceptable Transplant Candidates

The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation. The HeartMate II is already FDA-approved for use in patients awaiting further, perhaps more complex treatment, such as transplants. Heart assist devices are surgically implanted mechanical pumps that help the heart’s ventricle pump blood to the rest of the body. HeartMate II consists of a small, lightweight blood pump implanted in a patient’s chest just below the heart. An electrical cable that powers the blood pump passes through the patient’s skin to an external controller worn around the patient’s waist.

A physician designates the pump’s speed based upon clinical need. The device is designed to sound an alarm upon malfunction or other potentially drastic changes that could impact the pump’s operation. “The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment.” In a randomized clinical study of 200 participants at 38 centers, 46 percent of 134 participants with the HeartMate II were still living after two years with no disabling stroke or need for a reoperation for device replacement or repair compared with 11 percent of 66 participants in the control group. In addition, data collected in a separate registry of smaller stature women and men indicated that the device worked well in this specific population. As a condition of the FDA’s approval, the company will conduct a post-approval study to further evaluate the device’s performance. The data will be recorded in the Interagency Registry of Mechanical Assisted Circulatory Support (INTERMACS) and made available when the post-approval study is concluded. The INTERMACS is a clinical outcomes registry managed by the FDA, the National Heart, Lung and Blood Institute at the National Institutes of Health, the Centers for Medicare & Medicaid Services and participating hospitals and companies.

FDA Approves New Device Investigated at AGH for Patients With Advanced Heart Failure / 17/02/2010

A revolutionary heart assist technology investigated for several years at Allegheny General Hospital (AGH) has been approved by the FDA for patients with advanced heart failure who do not qualify for heart transplantation. Called the Thoratec® HeartMate II® Left Ventricular Assist System (LVAS), the device is now available as “destination therapy” – or long-term treatment for those patients. Approximately six million Americans suffer from congestive heart failure and 600,000 new cases are diagnosed each year, according to the American Heart Association. The prognosis for patients with advanced heart failure is poor, with projected one-year mortality rates exceeding those of other terminal diseases such as AIDs, leukemia, and lung cancer. Though transplantation offers hope for approximately 2,000 advanced heart failure patients each year, more than 250,000 patients have no viable treatment option and are considered at high risk for repeated hospitalizations, severely diminished quality of life and limited life expectancy. For the 50,000-100,000 heart failure patients in the U.S. who do not qualify for a heart transplant, due to age or other extenuating circumstances, long-term therapy with HeartMate II may be a life-saving option, said Srinivas Murali, MD, director of AGH’s Division of Cardiovascular Medicine and Medical Director of AGH’s Gerald McGinnis Cardiovascular Institute.

HeartMate II is the first and only continuous flow chronic LVAS to receive FDA approval for both bridge-to-transplantation and destination therapy. AGH participated in the clinical trial of the device and is now one of a select number of advanced cardiac centers in the nation qualified to offer the state-of-the-art therapy on a routine basis. “This technology is a breakthrough for a large group of patients whose therapeutic options until now have been severely limited. The HeartMate II provides cost-effective, long-term circulatory support in a manner that does not merely keep a person with end stage heart failure alive, but maximizes their quality of life. We are thrilled to have played a role in the development this exciting new treatment alternative,” said Raymond Benza, MD, medical director of AGH’s Advanced Heart Failure, Transplantation, Mechanical Circulatory Support and Pulmonary Hypertension Program

In 2009, AGH performed 36 successful implantations of ventricular assist devices and currently has three patients using the HeartMate II as destination therapy. The hospital is recognized regionally and nationally as a leading center for the treatment of heart failure, offering heart transplantation services as well as access to an array of cutting edge investigational heart assist devices. The mechanical circulatory support program at AGH has Joint Commission accreditation and was one of the first programs in the country to receive this distinction. According to Stephen Bailey, MD, director of AGH’s Division of Cardiac Surgery and Surgical Director of Cardiac Transplantation and Mechanical Circulatory Support, LVADs take over the pumping ability of a weakened heart’s left ventricle, which pumps oxygen rich blood received from the lungs to the rest of the body.

Heartmate II is a fully portable LVAD that allows patients to remain active and lead a relatively normal life. Uniquely designed to have a much longer functional life than conventional pulsatile devices, HeartMate II is much lighter and quieter than its predecessors. The device is made of smooth titanium and powered by a rotary pumping mechanism with only one moving part. “The Heartmate II is capable of pumping up to 10 liters of blood per minute, covering the full output of a healthy heart. Its smaller size makes it easier to implant and allows us to use this device in women and small adults. The system’s transcutaneous lines are also much smaller and less prone to complications,” Dr. Bailey said. Weighing approximately 12 ounces and about the size of a D-cell battery, the HeartMate II connects to the heart via a polyester tube that is bored into the left ventricle. Blood dumps straight from the left ventricle into the pump, where a turbine spinning at 8,700 rpm propels blood through the aorta. The system is powered by a small battery pack the patient wears over his shoulders, which is connected to the internal device via a small catheter line threaded through the skin.

Approved as a bridge-to-transplantation device in 2008, HeartMate II’s recent approval by the FDA for destination therapy followed a successful clinical trial of 200 patients enrolled at 38 centers. The study was a prospective, randomized clinical trial. Patients, who did not qualify for heart transplantation, were assigned to treatment with HeartMate II LVAS or to treatment with the earlier generation HeartMate® XVE LVAS (control group) on a 2-1 basis, respectively. The study concluded that treating patients with HeartMate II leads to dramatically improved survival (68 and 58 percent at one and two years), functional capacity (80% restored to and sustained at NYHA Class I or II through two years; doubling in six-minute walk test) and substantial improvement in quality of life.

Additional positive results demonstrated with the device included:
• Dramatic improvements in functional capacity and quality life for both bridge-to-transplantation and destination therapy. At baseline, 96 percent of DT trial patients were NYHA Class IV/IIIB. Seventy five percent improved to Class I or II at 3 months and 80 percent were Class I or II at 24 months.
• Significant reduction of adverse events with HeartMate II , including bleeding, infection and stroke.
• Substantial and sustained improvement in the HM II patients’ 6-minute walk test. The number of meters walked at two years more than doubled from baseline. At two years, HeartMate II patients achieved a median 6-minute walk of 372 meters, more than the distance of 4 American football fields. This improvement in 6-minute walk is a 3-fold improvement observed in Class IV patients during a previous study with the earlier generation device.


Portable Power Source Lets Cardiac Patients Await a Permanent Donor at Home
A new artificial heart ventricular pump uses a power driver shrunken to 3 percent of its original weight, yet is able to generate enough energy to maintain optimum pumping capacity
by Larry Greenemeier / July 13, 2010

They say home is where the heart is, but until recently patients who had suffered biventricular failure could survive only with the help of an artificial heart tethered to large, immobile driver system to maintain blood circulation while they awaited a heart transplant. This could be changing; artificial heart–maker SynCardia Systems, Inc., in Tucson, Ariz., last month announced that three patients surgically implanted with the company’s technology have been able to walk out of their respective hospitals and wait for donated replacement hearts in the comfort of their own homes.

These departures were made possible by SynCardia’s six-kilogram Freedom portable driver, which blows packets of air through two clear tubes (each about one centimeter in diameter) connected to the company’s temporary Total Artificial Heart. These air packets force the blood in the implanted artificial heart’s ventricles to be pumped to the rest of the body. The 75-centimeter-long tubes run from the artificial ventricles, exiting the body just below the rib cage. They connect to the Freedom driver, which can be worn in a backpack or shoulder bag. SynCardia’s temporary Total Artificial Heart—previously known as the CardioWest temporary Total Artificial Heart—is designed to replace the two ventricles (lower chambers) of a person’s original heart while still relying on the natural left and right atria (upper chambers) and aorta (main artery) to supply the pumped blood to the rest of the body, says SynCardia CEO Rodger Ford. The pulmonary artery also remains intact. The company’s artificial heart, which costs about $125,000, has been approved by the U.S. Food and Drug Administration since October 2004 as a bridge for transplant patients dying from end-stage failure of their hearts’ right and left ventricles, which collect blood from the atria and pump it to the lungs and body, respectively.

The SynCardia’s artificial heart’s volume is 70 cubic centimeters, which Ford says is small enough to fit into about 75 percent of males and 25 percent of females. The company is developing a 50-cubic-centimeter heart expected to be small enough to fit all adults as well as some teenagers. SynCardia has received conditional approval from the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom portable driver in the U.S. An IDE allows a device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application, which SynCardia obtained from the FDA. As part of that trial, 30 stable Total Artificial Heart patients (as opposed to those still recovering from surgery) must be discharged from the hospital using the Freedom driver for 90 days (or shorter if they can find a donor heart in that time frame).

The study’s purpose is to determine whether the Freedom driver is a suitable pneumatic pump for stable Total Artificial Heart patients, and if it can be safely used at home, Ford says. There are several portable Freedom drivers in use in Europe and one in the U.S. The company expects more to follow in the latter because 22 hospitals here are seeking permission from their institutional review boards to offer Freedoms to artificial heart patients. Originally, patients were tethered via a 1.5-meter-long tube to a 180-kilogram driver system—nicknamed “Big Blue”—until they could find a donor heart to replace SynCardia’s technology. The company saw the opportunity to create the Freedom while it was developing a 23-kilogram alternative in-hospital driver to the Big Blue system. The 23-kilogram Companion driver has been available in Europe since October 2009; SynCardia plans to submit it for FDA approval in September.

A challenge to shrinking down the driver technology to three percent of its original weight was to retain enough energy output to operate the artificial heart. The Freedom driver has a primary motor as well as a backup in case there is a problem with the main system; the motors operate a piston, which compresses air and then pushes it through the tubes to power the artificial heart. SynCardia has plans to further shrink its driver technology, although Ford says current technology would prevent the device from weighing less than four kilograms. The downsizing could be done over the next two years and would mostly come from using a smaller motor controller, smaller lithium ion batteries (the Freedom uses two) and replacing analogue components with digital technology.

SynCardia’s technology is one of a few available to people suffering from heart failure. The only other FDA-approved artificial heart is AbioMed’s AbioCor, which is a self-contained replacement heart with an internal battery charged by a transcutaneous energy transmission (TET) system, meaning that no wires or tubes penetrate the skin and therefore there is less risk of infection. The AbioCor is intended for end-stage heart failure patients who have a life expectancy of less than 30 days and are not eligible for a natural heart implant. Another technology, left ventricular assist devices (LVAD), have been on the market since 1994 for heart patients awaiting a permanent transplant, but they work only if a recipient’s heart can still function to some degree on its own. An LVAD generally consists of a tube that pulls blood from the damaged heart’s left ventricle into a pump, which then sends blood into the aorta, assisting the weakened ventricle. The pump, placed in the upper part of the abdomen, has a second tube that extends outside the body through the abdominal wall, where it is attached to the pump’s battery and control system.