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NUR-620
DO THE BENEFITS OF CARDIAC IMPLANTABLE DEVICES OUTWEIGH THE
RISKS?
Can you imagine going through the rest of your life not being able to take a walk, go out to
dinner with your family, or feel like you have no control over your life? End stage heart disease
patients experience this type of anguish on a daily bases.
Heart transplant is considered to be the gold standard treatment for advanced heart failure
(HF) but there are not enough donor hearts available for transplant to meet the current
demand (Casida, Peters, & Magnan, 2009).
Implanted ventricular assist devices (VADs) allow heart failure patients to live longer and
with fewer heart failure symptoms while waiting for an appropriate donor heart (Casida et al.,
2009). Our position in this debate is that the benefits of cardiac implantable devices outweigh
the risks.
ETHICAL CONSIDERATIONS WITH VENTRICULAR ASSISTED DEVICES
Patients with end-stage heart failure are usually discharged to a hospice center or sent
home with inotropic drugs, but using a Ventricular Assist Device (VAD) for these patients can
help improve their quality and length of life (Stahovich, Chillcott & Dembitsky, 2007). Many of
these patients do not qualify for heart transplantation due to age or other co-morbidities
(Kirkpatrick, Fedson & Verdino, 2007). For these types of patients, implantation of a VAD is
considered a destination therapy. Destination therapy is described as a treatment that is
considered the final option for a patient (Wiegand & Kalowes, 2007).
According to Stahovich, Chillcott and Dembitsky (2007), studies have shown that certain
VADs not only prolong life, but also increase the quality of life. The results of these studies
prompted the FDA to approve some of these devices specifically for prolonged use or
destination therapy. Slaughter et al. (2009) came to the same conclusion with their study of
continuous-flow assist devices. This study showed that quality of life was improved as the
patients experienced a lower probability of stroke, reduced adverse events and
re-hospitalizations, and had a lower incidence of device repair or replacement. The researchers
also noted a significant increase in the survival rate with this type of device.
Improving quality of life is a major point in the World Health Organization’s (WHO)
(2010) definition of palliative care. Using VADs as destination therapy, therefore, is an
important aspect of providing palliative care. Early palliative care team involvement facilitates
education prior to implantation, and continued involvement supports patients and caregivers if
the decision to discontinue therapy arises (Rizzieri, Verheijde, Rady & McGregor, 2008). A good
palliative care team is able to prepare patients and caregivers for end-of-life decisions including
withdrawing or deactivating the device (Wiegand & Kalowes, 2007). VADs provide an
alternative to patients who wish to extend their life but have run out of viable treatment
options, as well as provide opportunities for later decisions regarding end of life care.
Ventricular implanted devices a bridge to transplantation
The survival rates of heart transplant patients is 90% at the 1-year follow-up point, 60% at the 10-year
interval, and represents 95% freedom from symptoms and activity limitations in survivors throughout
follow up (Lund, Matthews, & Aaronson, 2010). However, nearly 10% of patients on the heart
transplant list die each year waiting for an available donor heart (Lund et al., 2010).
Implanted left ventricular assist devices (LVADs) allow HF patients to live longer and with fewer
HF symptoms while waiting for an appropriate donor heart (Casida et al., 2009). This improves their
quality of life and allows them more freedom during the waiting period. The current technology of more
compact, portable LVADs allows many patients to be discharged to home from the hospital. Eighty
percent of LVAD patients survive to 1 year, experiencing improved HF symptoms and quality of life (Lund
et al., 2010). LVAD can stabilize or reverse organ dysfunction and pulmonary vascular hypertension,
which increases the likelihood of a successful transplant (Lund et al., 2010).
Studies have shown that patients who live with HF share several common experiences that
impact their lives including fear (which encompasses the fear of pain, death, or the future), loss of
control, and, most prominently, social isolation (Jeon, Kraus, Jowsey, & Glasgow, 2010). Patients
expressed the feeling that a loss of control over their illness was connected to deterioration in their
health, high blood pressure, shortness of breath, inability to sleep, as well as loss of independence and
financial security (Jeon et al., 2010).
Social isolation was reported as the key concept shared by study participants and included an
inability or limited capacity to participate in social events, limited opportunities to socialize with friends
and family, and being misunderstood and disrespected because of dietary restrictions (Jeon et al., 2010).
It has been noted that the patient’s perception of their illness is of primary importance when attempting
to define quality of life. For some people, enriching the quality of life is of greater importance than
prolonging life (Helito, Branco, D’Innocenzo, Machado, & Buffolo, 2008). The use of LVADs as a bridge
while waiting for heart transplant is that it provides improved quality with the promise of even greater
gains once a donor heart becomes available. The table below shows the interference in normal social
activities with families, neighbors and friends (Helito et al., 2008).
Table from Helito et al., 2008.
COST ASSOCIATED WITH VENTRICULAR ASSIST DEVICES
The prognosis for patients suffering from heart disease is poor, with nearly half of patients dying
within four years of the diagnosis (Wilson, Mudge, Stewart, & Givertz, 2009). However, today, there are
implantable device options for patients who are recovering from cardiac surgery, waiting for a
transplant, or unstable enough for transplant and need comfort or stabilization (Wilson et al., 2009).
Ventricular assist devices (VAD’s) are beneficial, as there are not nearly enough donors for those who
need heart transplant (Casida, Peter, & Magnam, 2009).
In the past, VAD’s have been associated with increase healthcare costs resulting from infection,
hospitalization, and device malfunction (Slaughter et al., 2009). Newer devices, such as the continuous
flow left ventricular assist device (Heartmate II), are associated with decreased adverse events and
decreased hospitalizations (Slaughter et al., 2009). The Heartmate II is more durable and lasts longer
than earlier devices. Further, the Heartmate II has shown a decrease in infection rates because it is a less
invasive surgical implant (Slaughter et al., 2009). Use of this VAD helps reduce healthcare costs by
decreasing the risk of expensive and life-threatening adverse events.
Medicare, Medicaid, and most other insurance companies (Wilson et al., 2009) pay for
ventricular assist devices. Surgical implantation and hospitalization is costly, but are covered if the Food
and Drug Administration (FDA) has approved the device and it is used correctly (Wilson et al., 2009).
Therefore, the patient does not shoulder the largest burden of cost.
Implantation of a VAD allows patients, which would otherwise be hospitalized, to be discharged
to home (Casida, 2005). While patients need nursing care following implantation of the device, nurses
have successfully trained family members or other support persons to provide care at home (Casida,
2005). Savings are realized in allowing patients to be home rather than hospitalized. This also results in
savings in costs related to in-home nursing care, and allows the patient to recover in a comfortable,
familiar environment (Casida, 2005).
PATIENT OUTCOMES ASSOICATED WITH VENTRICULAR ASSISSTED DEVICES
Ventricular assist devices have been successfully utilized for years as bridges to cardiac
transplantation. In 2001, a trial of the VAD device was performed and was called the REMATCH study,
which stands for Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive
Heart Failure. The VAD used in this study was the HeartMate VE (Long et al., 2005). The REMATCH study
was conducted between October 1997 and August 2003. REMATCH showed that the long-term use of
this VAD device significantly improved survival, functional capacity, symptoms and quality of life in
patients with advanced heart failure who were not heart transplant candidates (Long et al., 2005).
REMATCH also studied the 1- and 2-year survival rates of patients with this VAD. REMATCH showed a
48% reduction in deaths for those patients receiving a VAD compared to those receiving only medical
therapy (Slaughter et al., 2009). Survival rates at one year were 52% compared to 25% for medical
therapy, and at 2 years, the survival rate for patients with a VAD was 23%, compared to only 8% of those
patients receiving medical therapy (Slaughter et al., 2009). Studies have also shown that those patients
implanted with this VAD device later in the trial (after the year 2000) had an improved survival rate of
38% at 2 years (Long et al., 2005).
Due to the positive results of the REMATCH study, in November of 2002 the FDA approved the use of
the HeartMate XVE ventricular assist device, a newer and improved VAD, for use in Destination Therapy
(DT). According to Long et al. (2005), 69% of the patients were ongoing, 31% had died, and nine patients
had more than three hundred days of VAD support. Post implantation complications for those with a
VAD include sepsis, VAD failure, right heart failure/arrhythmia, and multi-system organ failure (Long et
al., 2005). However, Long et al. (2005) noted that there was a 40% decrease in death from any cause in
the DT group as compared to the REMATCH group. In REMATCH patients, the most common causes of
death were sepsis and VAD failure (Long et al., 2005). In the DT trial, patients had an 8.3-fold lower
death rate from infection than REMATCH patients (Long et al., 2005). Overall, DT patients were 2.1
times less likely than REMATCH patients to experience an adverse event (Long, et al., 2005).
As has been shown, VAD therapy has significantly improved survival and quality of life compared with
optimal medical management for patients with end-stage heart failure (Park et al., 2005). The
REMATCH study showed that VAD intervention nearly halved the mortality seen in those who received
only state-of-the-art medical therapy and consequently succumbed to heart disease at a rate of 92% at 2
years (Park et al., 2005). Those in the Destination Therapy study had an even greater improvement in
quality of life than those in the REMATCH study. Reasons for this are attributed to device improvements
and better patient management (Long et al., 2005). Better patient management in the DT study
included proper patient selection, nutritional support, infection control, and perioperative and
postoperative care (Long et al., 2005).
With serious adverse events from infection, bleeding, and device malfunction, VAD recipients still
had an improved survival rate and experienced a superior quality of life over those on medical therapy
(Park et al., 2005). These results are very encouraging and support the hope that there will be
continued improvement in survival and adverse events, as improvements continue to be made to the
VAD devices and in patient selection and management.
CLOSING COMMENTS
Regardless of your opinion on ventricular assist devices, patients have the right to have the best
treatment available. Research has shown that implanted ventricular devices allow heart patients to live
longer, having fewer heart failure symptoms while waiting for a donor heart. Quality of life is improved
with ventricular devices by allowing patients more freedom during the waiting period for a donor heart.
With ten percent of patients on heart transplant lists dying each year, which treatment option would
you want for yourself or a family member? With costs of ventricular implantation covered by most
insurance, and eighty percent of ventricular assist device patients surviving one year with improved
heart failure symptoms, the benefits are obvious. It should be further noted that ventricular assist
devices stabilize or reverse organ dysfunction or pulmonary hypertension, to increase transplant
success. Therefore, our position is that the benefits of cardiac implantable devices outweigh the risks.
References:
Casida, J. (2005). The lived experience of spouses of patients with a left ventricular assist device before heart
transplantation. American Journal of Critical Care, 14(2), 145-151.
Casida, J., Peters, R., & Magnan, M.(2009). Self-care demands of persons living with an implantable leftventricular assist device. Research and Theory for Nursing Practice: An International Journal, 23(4), 279293. doi:10.1891/1541-6577.23.4.279
Helito, R., Branco, J., D;Innocenzo, M., Machado, R., & Buffolo, E. (2008). Quality of life in heart transplant
candidates. Revista Brasileira de Cirurgia Cardiovascular, 24(1), 50-57. doi:10.1590/S010276382009000100010
Jeon, Y., Kraus, S., Jowsey, T., Glasgow, N. (2010). The experience of living with chronic heart failure: a narrative
review of qualitative studies. BMC Health Services Research, 10(77). Doi:10.1186/1472-6963-10-77
Long, J. W., Kfoury, A. G., Slaughter, M. S., Silver, M., Milano, C., Rogers, J., Delgado, R., & Frazier, O. H. (2005).
Long-term destination therapy with the HeartMate XVE left ventricular assist device: Improved
outcomes since the REMATCH study. Congestive Heart Failure, 11(3), pp. 133-138. Retrieved from
http://www3.interscience.wiley.com/search/allsearch?mode=quicksearch&products=journal&WISsearc
h2=17517133&WISindexid2=issn&contentTitle=Congestive+Heart+Failure&contextLink=blah&contentOID=11853
7099&WISsearch1=long-term+destination+therapy+with+the+HeartMate+XVE&WISindexid1=WISall
Lund, L., Matthews, J., & Aaronson, K. (2010). Patient selection for left ventricular assist devices. European
Journal of Heart Failure. Advance online publication. Doi:10.1093/eurjhf/hfq006
Park, S. J., Tector, A., Piccioni, W., Raines, E., Gelijns, A., Moskowitz, A., Rose, E., Holman, W., Furukawa, S.,
Frazier, O. H., & Dembitsky, W. (2005). Left ventricular assist devices as destination therapy: Anew look
at survival. The Journal of Thoracic and Cardiovascular Surgery, 129, pp. 9-17. Retrieved from
http://jtcs.ctsnetjournals.org/cgi/content/full/129/1/9
Slaughter, M. S., Rogers, J. G., Milano, C. A., Russell, S. D., Conte, J. V., Feldman, D., Sun, B., Tatooles, A. J.,
Delgado, R. M., Long, J. W., Wozniak, T. C., Ghumman, W., Farrar, D. J., Frazier, O. H. (2009). Advanced
heart failure treated with continuous-flow left ventricular assist device. The New England Journal of
Medicine, 361(23), pp. 2241-2251. Retrieved from
https://fsuvista.ferris.edu/webct/urw/lc972774758011.tp975592426041/RelativeResourceManager/sfsi
d/1247868813041
Slaughter, M., Rogers, J., Milano, C., Russell, S., Conte, J., Feldman, D., et al. (2009). Advanced heart failure
treated with continuous-flow left ventricular assist device. New England Journal of Medicine, 361(23),
2241-2251
Wilson, S., Mudge, G., Stewart, G., & Givertz, M. (2009). Evaluation for a ventricular assist device: selecting the
appropriate candidate. Circulation, 119(16), 2225-2232.