Short-term VAD support worsens high emergency transplant outcomes: Spanish study

Ventricular assist devices have been in the news recently as both a bridge-to-transplant and as a substitute for heart transplantation. I personally know several patients who have had successful heart transplants after being on VAD's and the conclusions of this article suggest that VAD's not be used for severe heart failure patients.


Worse Postoperative Outcomes for Critically Ill Patients Bridged to Urgent Heart Transplantation With VADs Than With Conventional Therapy, Study Suggests

ScienceDaily (Aug. 28, 2011) — Postoperative outcomes of severe heart failure patients bridged with short-term VADs to urgent (- status UNOS 1A) heart transplantation are significantly worse than those of patients bridged with conventional support, recent data of the Spanish National Heart Transplant Registry suggest.

Spanish investigators led by Drs. Eduardo Barge-Caballero and Marisa Crespo-Leiro from the Hospital Universitario A Coruña conducted a multi-institutional retrospective study of 704 patients with critical heart failure, who underwent urgent, high-priority heart transplantation in 15 Spanish hospitals from January, 2000 to December, 2009. One hundred and seven patients had been supported with short-term VADs before transplantation, while the remaining 597 had been bridged with conventional therapy, that included intravenous inotropes, invasive mechanical ventilation and / or intraaortic balloon pump. Implanted VADs were paracorporeal pulsatile-flow devices in 58 cases and extracorporeal continuous-flow ones in 47. Interestingly, mean waiting list time was extremely short, around 5 days, a characteristic fact of the well-organized Spanish high-emergency organ procurement and allocation system.

Despite fairly similar pre-transplant clinical status and end-organ function, VAD bridged patients showed a higher incidence of severe surgical bleeding, longer bypass times and higher rates of primary graft failure than conventionally bridged patients, so as resulting in a significantly reduced post-transplant survival.

In Dr. Barge-Caballero´s opinion, "our data suggest that routine short-term VAD implantation in stable patients awaiting high-emergency heart transplantation should not be recommended, at least in countries with expected short waiting list times, as this strategy might compromise heart transplant outcomes." For the main investigator of the study, "short-term VAD support as a bridge to high-emergency heart transplantation should be reserved for critically ill patients with a deteriorating haemodynamic status, in which conventional therapy is not enough to ensure adequate peripheral perfusion and to avoid irreversible end-organ damage."

This research was presented at the European Society of Cardiology in Paris, France, August 28, 2011.

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Michigan Heart program brings together doctors and patients to celebrate new leases on life

By Garret Ellison | The Grand Rapids Press

GRAND RAPIDS –Harry Konynenbelt spoke three simple words on Sunday that together signaled pride, perseverance and promise of the future not just for himself, but the hospital program that saved his life.

“I’m number eight,” said the 61-year-old grandfather from Hudsonville.

That would be eight of the 10 heart transplant recipients to get a new lease on life through Spectrum Health’s new transplant program at the Fred and Lena Meijer Heart Center in Grand Rapids that was certified by the United Network of Organ Sharing last year.

Several of the transplant recipients as well as a dozen or more ventricular assist device patients gathered Sunday at the Frederick Meijer Gardens and Sculpture Park for a day of support and mingling with doctors and hospital staff.

The get-together followed a golf outing sponsored by the Wizard Foundation, started by the family of Rhan Bentley, the program's first patient last November. Bentley was not at the gathering but Spectrum staff said he is "doing great."

“To be honest, it’s good therapy for us to see you living your lives,” Michael Dickinson, the heart failure program medical director told the gathered crowd.

There was a lot of love in the room for Spectrum doctors from both transplant and assist device patients, who undergo regular check-ups with the hospital the rest of their lives.

Konynenbelt, who got his new heart on March 15 after a little more than two months on the waiting list, said Dickinson told him one day while he was in the hospital that a heart had come in the night before, but it went to another patient.

“(It) wasn’t right for you, he told me.” said Konynenbelt, adding that was a sign that “you’ve got the best (doctors) in the world and they’re looking out just for you.”

Charlie Nawrot, 53, of Grand Rapids got a new heart on Jan 3 and said the staff at Spectrum are “very personable. They take care of you.”

Nawrot’s surgery was one of four that took place in January, a busy month for the heart transplant program said Dr. Asghar Khaghani, head transplant surgeon. They performed four procedures that month alone.

He said it’s not unusual for transplant centers to see a spike in procedures twice a year.
Khaghani, who came to Grand Rapids from a world-renowned transplant program in London, said it was very important for Spectrum to hit their initial target of 10 to 12 procedures they hoped for at the program inception.

The track record is important because the hospital carries the program cost on the front-end. Each transplant is expected to cost about $544,500 and the program is expected to lose about $2 million in the first year.

Hospital leaders expect a net loss of about $226,600 per transplant because of the assumption that two-thirds of patients will not be able to pay.

Khaghani, who has an unusually high number of procedures under his belt — over 1,000 — said Spectrum’s program can easily handle about one procedure per week, but for the next couple years, he thinks 20 to 25 surgeries per year is a good mark.

He called the program “quite standardized” already. Changes will come in the form of new medications and the decision-making on who should be getting transplantation, which he expects to evolve due to the advances in artificial heart device technology.

Advances for that as well as in the ventricular assist device (VAD) — a mechanical circulatory device that is used to partially or completely replace the function of a failing heart — make demand for transplants hard to predict.

Neither device is typically considered a permanent replacement option, although they are used that way with some patients due to age or other factors.

Khaghani believes within about five years, more patients will be getting artificial hearts than actual transplantation because the organ supply can’t meet the patient demand, and the devices are becoming more reliable and durable.

Former auto body shop manager Jim Butts, 57, of Greenville, said mobility on the VAD is “as much as you want to do, within reason.”

Butts, who had congestive heart failure, hunts with bow and gun, snowmobiles, rides a four-wheel off-road vehicle every day, and goes out on a boat.

“I’ve had six open heart operations and I refuse to lose,” he said.

Nearby, former Grand Rapids gynecologist Kathy Williams said her father, Wayne Collins, 77, of Reading, nearly didn’t make it through the hospital bureaucracies in Kalamazoo and Coldwater before getting referred to Grand Rapids for surgery.

“I raised my voice and said ‘he’s going to be dead by the next time you have an appointment scheduled for him,’” she said. “I had to be like that.”

“I’m really happy with all the care he got through the steps,” she said. “But if he didn’t have someone who knew how to push, who to talk to and what they fight for.”

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Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ or tissue transplant. Organs can save lives, corneas renew vision, and tissue may help to restore someone's ability to walk, run or move freely without pain. Life Begins with You

Wireless Power Could Cut Cord for Patients with Implanted Heart Pumps

Released: 7/12/2011 3:40 PM EDT

Source: University of Washington

Newswise — Mechanical pumps to give failing hearts a boost were originally developed as temporary measures for patients awaiting a heart transplant. But as the technology has improved, these ventricular assist devices commonly operate in patients for years, including in former vice-president Dick Cheney, whose implant this month celebrates its one-year anniversary.

Prolonged use, however, has its own problems. The power cord that protrudes through the patient’s belly is cumbersome and prone to infection over time. Infections occur in close to 40 percent of patients, are the leading cause of rehospitalization, and can be fatal.

Researchers at the University of Washington and the University of Pittsburgh Medical Center have tested a wireless power system for ventricular assist devices. They recently presented the work in Washington, D.C. at the American Society for Artificial Internal Organs annual meeting, where it received the Willem Kolff/Donald B. Olsen Award for most promising research in the development of artificial hearts.

Joshua Smith, a UW associate professor of computer science and electrical engineering who moved to the UW from Intel Research Seattle, has for the past six years been working on wireless power. The concept is a variation on inductive power, in which a transmitting coil sends out electromagnetic waves at a certain frequency and a receiving coil absorbs the energy and uses it to charge a battery. Electric toothbrush charging stations and cell phone charging pads use a similar system, except that in both those cases the tool has to actually touch the charger and be held in a fixed position.

Smith and colleagues at the UW and Intel devised an inductive system that adjusts the frequency and other parameters as the distance or orientation between the transmitter and receiver coils changes, allowing for flexible yet efficient wireless power over medium distances.

“Most people’s intuition about wireless power is that as the receiver gets further away, you get less power,” Smith said. “But with this technique there’s a regime where the efficiency actually doesn’t change with distance.”

In what Smith calls the “magic regime,” power stays constant over distances about the same as the diameter of the coil – meaning a one-foot transmitter coil could deliver consistent power over a distance of a foot, or a four-inch coil could transmit power over a distance of four inches.

That’s not far, but it’s enough to bridge the skin and tissue to reach a medical implant.

Four years ago, Smith’s system attracted the interest of a heart surgeon who had been experimenting with using traditional induction to transfer power, but was hampered by misalignment, unwanted heat generation, and ranges that were limited to a few millimeters.

“My primary interest is to help heart failure patients recover, and they can only recover if they are not tethered to a battery or external power supply so they can exercise and train their heart to recover,” said Dr. Pramod Bonde, a heart surgeon at the University of Pittsburgh Medical Center. “With wireless technology patients can be free and they can have a chance to move around and exercise like normal human beings.”

Using the wireless system means no power cord poking through the skin, dramatically reducing the risk of infection and improving the patient’s quality of life.

Researchers envision a vest that could hold an external transmitter coil connected to a power cord or battery. A small receiver coil implanted under the patient’s skin would connect to a battery that holds enough power for about two hours, meaning the patient could be completely free for short periods of time to take a bath or go for a swim (current users of heart pumps cannot do either).

Longer term, the researchers imagine additional power transmitters placed under a patient’s bed or chair, allowing patients to sleep, work or exercise at home unencumbered.

Results presented at the meeting showed the system could power a commercial heart pump running underwater using a receiver coil as small as 4.3 cm (1.7 inches) across. The power transmitted reliably with an efficiency of about 80 percent. Next the researchers hope to test the system with a heart pump implanted in an animal.

“The potential for wireless power in medical fields goes far beyond powering artificial hearts,” Dr. Bonde said. “It can be leveraged to simplify sensor systems, to power medical implants and reduce electrical wiring in day-to-day care of the patients.”

Co-authors are UW doctoral students Alanson Sample and Benjamin Waters.

Collaborators at Intel Corp. are working on applications of the system to recharge consumer electronics. In addition to the heart pump, Smith is pursuing an application using wireless power to recharge ocean instruments underwater.

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Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ or tissue transplant. Organs can save lives, corneas renew vision, and tissue may help to restore someone's ability to walk, run or move freely without pain. Life Begins with You

New heart pump being tested in Canada, considered bridge to transplant

By: Nelson Wyatt, The Canadian Press

MONTREAL - Lauza Legere's heart is beating strong this Valentine's Day but not because she's been poked with Cupid's arrow.

She's helping test the C-Pulse Heart Assist System, a new device that rhythmically squeezes her aorta and pumps blood to her damaged heart.

"I feel much better than before," Legere said in a telephone interview, explaining that before she got the pump it was hard to even take a breath.

"I stopped every two or three words because I was out of breath. I wasn't able to walk. With the pump, it helps my heart to get the oxygen that I wasn't able to have."

Dr. Renzo Cecere of the McGill University Health Centre says Legere is the first person in Canada to get the device, which reduces blood clots that can cause strokes.

He is currently conducting trials on the pump and hopes to implant 12 devices in the next 18 months.

''There are probably thousands of patients who might benefit from a pump like this," said the doctor, who is director of the Mechanical Heart Assist Program and surgical director of the MUHC's transplant program.

"This would be an effective therapy as a so-called bridge to transplant. Alternatively, some patients would receive this as what we call destination therapy — this is their last and only option."

The device is basically a cuff around the aorta, the artery that pumps blood from the heart to the rest of the body. A balloon inside the device inflates and deflates with each heartbeat, pumping the blood through the heart.

There is no need to make incisions into the heart or any major blood vessels during the implantation of the device, which is run by an external battery and mini-computer. Both are worn on the outside of the body.

Patients also don't need to take anti-clotting medications after surgery.

Legere, who lives in Laval, Que., suffered a heart attack last Aug. 25 and was in bad shape, said Cecere.

"She came to my office in a wheelchair, extremely short of breath, very poor quality of life and no other option," Cecere said in a telephone interview.

The doctor said Legere, who is in her mid-50s, was not a suitable candidate for a transplant at that moment and that other medical treatments weren't working for her.

Legere had the C-Pulse implanted last Dec. 21.

The pump, which was invented in New Zealand, is based on a concept that's been around for 30 years, Cecere said. In the past, the technique has been used on heart patients who need additional, temporary support after surgery.

"It's based on the concept of a balloon which is inserted in the aorta (which) inflates and deflates in synchrony with the heart's rhythm," he explained.

"That concept was applied to a device which is implantable and can be operated on the long term versus the original device which was a short-term device."

The pump can be stopped and disconnected for a short period so the patient can take a shower or go for a brief swim.

"They may not have that assist, that extra boost that the pump provides but it shouldn't be tragic for them," Cecere said.

"This is why it can be extremely well tolerated for the patient to disconnect the pump and carry out some activities.''

Legere, whose next step may be a heart transplant when she's healthy enough and a donor heart is available, said she's hooked up to the machine 23 out of 24 hours.

"If I'm disconnected too long, I start breathing like before."

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Your generosity can save or enhance the lives of up to fifty people with heart, kidneys, liver, lungs, pancreas and small intestine transplants (see allotransplantation). One tissue donor can help by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ or tissue transplant. Organs can save lives, corneas renew vision, and tissue may help to restore someone's ability to walk, run or move freely without pain. Life Begins with You

Post heart transplant mortality seen higher with pretransplant ventricular assist device support

A bridge too far? Posttransplant mortality seen higher with pretransplant VAD support

By Steve Stiles theheart.org

Worcester and Boston, MA - Transplant-listed patients supported on a ventricular assist device (VAD) while awaiting a donor heart are more likely to die within the first six months after the surgery than transplanted patients who hadn't been bridged with a VAD, according to an analysis based on United Network for Organ Sharing (UNOS) data that date from several years to more than a decade ago [1]. The mortality increase in bridged patients dissipated after the six-month posttransplant period but appeared again five years later.

Given these findings, according to the authors, led by Dr Vishnu Patlolla (University of Massachusetts Medical School, Worcester), "we cannot recommend VAD implantation with a view to improving posttransplant survival for patients who are stable on intravenous inotropic therapy."

The group goes on to acknowledge that their data are based on early-generation pulsatile-pump VADs and can't be extrapolated to the newer continuous-flow models, "which are gaining popularity."

Their analysis appears in the January 20, 2008 issue of the Journal of the American College of Cardiology.

In an accompanying editorial [2], Dr Leslie Miller (Washington Hospital Center, Washington, DC) notes that the continuous-flow VADs "have been shown to have significantly better survival and quality of life and significantly lower adverse events than the previous generation of pulsatile devices."

Moreover, he writes, "the outcomes with medical therapy of status-1 patients with and without VAD support have improved over the past five years, and a more recent examination of the data would be helpful in determining whether the observations made are accurate in the current era."

Another expert in this patient population, Dr Randall C Starling (Cleveland Clinic, OH), said to heartwire that the report from Patlolla et al "is thought-provoking and hypothesis-generating," but he doesn't believe it will change practice at his institution. "I think it's going to raise questions, but it's not going to answer questions."

In the analysis of adults undergoing first-time, single-organ heart transplantation in the US from 1995 to 2004, 1433 patients were bridged with intracorporeal VADs (including devices from Thoratec Corp and WorldHeart) and 448 were bridged with extracorporeal VADs (including devices from Thoratec and Abiomed). They were compared with 9455 transplant candidates classified as UNOS status 1 who were not bridged with a VAD. The median follow-up times were 36.5, 24.4, and 49 months, respectively.

For a table of hazard ratios and references to other studies that question the validity of these findings read the full article.

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Register to be a donor in Ontario or Download Donor Cards from Trillium Gift of Life Network
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In Great Britain, register at NHS Organ Donor Register

In Australia, register at Australian Organ Donor Register

Your generosity can save up to eight lives with heart, kidneys, liver, lungs, pancreas and small intestine transplants. One tissue donor can help up to 100 other people by donating skin, corneas, bone, tendon, ligaments and heart valves