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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).

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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 left-ventricular assist device. Research and Theory for Nursing Practice: An International Journal, 23(4), 279-293. 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/S0102-76382009000100010

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

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

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

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.

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