Abstract
Long-term mechanical circulatory support devices, especially left ventricular assist devices, are being increasingly utilized in the management of end-stage heart failure either as bridge to heart transplantation, recovery or as destination therapy. However, current technology for controllers and alarm systems for left ventricular assist devices does not permit their implantation in eligible patients with visual impairment. We report two patients in whom the decrease in visual acuity was a significant factor in determining eligibility for long-term mechanical circulatory support.
Case 1
A 46-year-old obese (BMI: 38) Caucasian woman with a 9-year history of nonischemic dilated cardiomyopathy was admitted in New York Heart Association (NYHA) Class IV heart failure. In the previous 18 months, she was admitted on multiple occasions for the management of her congestive heart failure (CHF). On admission, she was treated with intravenous diuretic and dobutamine therapy and volume status was stabilized. Her obesity (BMI: 38) was considered to be a contraindication for heart transplantation. Considering her Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Profile 3/4, she was evaluated for long-term mechanical circulatory support device (MCSD) for destination therapy (DT). She had lost sight in both her eyes as a teenager following an accident. In spite of her disability, she had successfully raised her family with the help of her spouse and was only recently separated. While her hemodynamic profile was consistent with patients who would benefit from placement of a left ventricular assist devices (LVAD), her visual impairment and her inability to visually identify the various alarms and communicate with the care-givers, in case of a device emergency, was considered a significant obstacle in the device management. A further consideration was the lack of a reliable around-the-clock care-giver. Having lived independently, our patient refused to consider living at a nursing care facility following LVAD therapy. After consideration of other comorbidities, and discussion with the patient, she was discharged on maximal medical therapy. She subsequently succumbed to her heart failure in 3 months.
Case 2
A 52-year-old Caucasian male with a history of insulin-dependent diabetes mellitus was admitted in NYHA Class IV heart failure and was considered to be in INTERMACS Profile 3/4. Following admission, he had one episode of cardiac arrest and was successfully resuscitated. His vision was compromised by development of severe proliferative retinopathy, secondary to his long-standing insulin-dependent diabetes mellitus leading to blindness in his right eye and a decreased visual acuity in the left eye. In view of the emergency nature of the situation, a formal grading protocol for the retinopathy was not utilized. A preoperative assessment was made of his ability to identify the alarms and also to change the battery pack and manipulate the controllers. He was aided in battery changes by small protrusions on the ends of the battery that enabled him to orient the batteries into the proper position and align them into the chargers appropriately. In addition, after some practice, he was able to independently use both the system controller and the power base unit and recharge the batteries. He had sufficient vision to identify the various components of the system and was able to differentiate and identify individual audible, and their associated visual, alarms on the monitor. In addition, he had an around-the-clock care-giver who could identify any LVAD malfunctions, monitor the status of the battery life and also provide driveline care and inspection. He underwent redo sternotomy and placement of a HeartMate® XVE LVAD as DT. Subsequently, he lived for 12 months, after which he succumbed to urosepsis. During this period as an outpatient, he did not report any problems with device management attributable to impaired vision.
Discussion
Nephropathy is considered a late sign of microvascular complication of diabetes mellitus and appears 10–15 years after the onset of diabetes in 20–40% of patients in the form of microalbuminuria. A total of 58% of Type 1 and 80% of Type 2 diabetic patients develop some form of retinopathy in 5–10 years, and this condition afflicts 90% of those patients at 15–20 years with varying degrees of visual impairment Citation[1]. Several studies have demonstrated the association between development of CHF and diabetic retinopathy, and it is postulated to reflect progression of atherosclerotic microvascular disease Citation[2]. The treatment options for patients with end-stage heart failure include medical management, heart transplantation or mechanical circulatory support. LVADs are an established therapeutic option for patients with end-stage, medically refractory heart failure Citation[3–5]. The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial was a prospective randomized control trial comparing medical management (n = 61) with a HeartMate XVE LVAD device (n = 68) in patients with NYHA Class IV heart failure. The rates of survival were 25 and 52% at 1 year, and 8 and 23% at 2 years for the medical therapy and LVAD groups, respectively Citation[6]. Since the publication of REMATCH, several studies have demonstrated improved outcomes with both pulsatile and continuous-flow ventricular assist devices in this very difficult-to-manage patient population Citation[7,8]. With improvements in device technology and in patient survival following MCSD therapy Citation[7,9,10], there is debate regarding consideration for long-term circulatory support during the early stages of CHF. Under these circumstances, a small segment of the patient population with CHF is likely to have visual problems, which would impact on their selection for MCSD.
Of concern in patients with severe diabetic retinopathy is the development of retinal and vitreous microhemorrhages – a well-known, but complex, pathologic process associated with this disease. Previously, it has been advocated that life-saving interventions, such as thrombolytic therapy for acute myocardial infarction, should not be withheld in patients with diabetic retinopathy owing to the low risk of bleeding complication (<0.05% in the Global Utilization of Streptokinase and TPA for Occluded coronary arteries [GUSTO-I] experience) Citation[11]. We take a similar perspective regarding the use of life-saving ventricular assist devices. Nevertheless, close communication and involvement with an ophthalmologist is critical to determine the risks for, and the management of, ocular complications that might develop in patients requiring long-term anticoagulation and antiplatelet therapy for their LVADs. Fortunately, in our experience, retinal or vitreous bleeding has not been a problem in this population.
Modifications have been made to provide tactile sensation to patients in the form of small protrusions on the batteries to help them orient and change the battery on their own and align them properly while using the power base unit. However, the current alarm system for device malfunction consists of warning lights, an audio tone (steady tones or beeps) and alarm messages flashing on the screen. With visual impairment, and in the absence of a care-giver, it is difficult, if not impossible, for the patient to identify the nature of the problem. A particular feature that would make a significant difference would be the addition of a voice message indicating the nature of the problem to the patient. In addition, consideration should be given to using home-surveillance cameras and computer-based cameras to communicate directly with the coordinators at the implanting center to enable them to troubleshoot, identify and assist, and advise the patient in an emergency.
Conclusion
With minor modifications in the currently available technology, LVADs have the potential to be useful therapeutic options providing a good quality of life in patients with decreased visual acuity, provided that there is availability of reliable care-givers or willingness to be in a long-term care facility.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
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