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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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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