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What's New

                                                                                  Heart Transplantation: Version 7.0

What’s New?

1.  Updated first year billed charges from Milliman:

See tables at the end of this Quick Reference Guide.  

2.  Annual heart transplant volume continues to slowly rise again:

Heart transplant volume had been fairly static; around 2,300 transplants per year until the last few years which has shown a gradual uptick in transplant volume (see graph). Despite the increase in volume, the number of hearts recovered has not kept pace with those in need of an organ. At the annual 2016 International Society for Heart and Lung Transplantation meeting, findings were reported on a new potential source of hearts – donation after cardiac death (DCD). This is in the early stages but holds promise to increase donation rates. The use of medical regimens and devices (bi-ventricular pacing and ventricular assist devices being the most prominent) continue to play an important role in the care of advanced heart failure patients. Management of CHF continues to improve, resulting in fewer patients being listed. There is market pressure to increase the number of heart transplant programs but for quality concerns there is a danger of a growing numbers of centers doing fewer transplants. This phenomenon is taking place internationally, not just in the US.

Source: American Journal of Transplantation
Volume 16, Issue S2, pages 115-140, 11 JAN 2016 DOI: 10.1111/ajt.13670

3.  Mechanical Assist Devices:

Mechanical assist devices (MADS) have had a pronounced effect on heart transplant outcomes over the past 10 years. Among the more novel units are some very compact ones that provide continuous flow (thus no palpable pulse), very small units for small pediatric patients, and total heart replacement units, with some of the latter having such small and relatively portable drives that patients may be discharged to home with the TAH (total artificial heart) implanted.

Left Ventricular Assist Devices (LVADs) as Destination Therapy
For an up-to-date list of centers currently approved by Medicare to use LVADs as destination therapy, refer to the site here. Rapid growth in the use of LVADs as destination therapy that many had predicted has been slow to develop, but with the FDA approval of the HeartMate II early in 2010, the situation has changed dramatically. The initial slowness of use had several causes, most of which have been overcome. First, reimbursement issues have generally now been addressed to the satisfaction of the provider community. Second, the available devices are now very reliable, with significant reduction in side effects. Third, given current technology, many experts now readily accept the devices as life-saving. There is much less variability among major transplant centers in their use of VADs since our last publication of these resource guides, and for destination devices in particular, the numbers and indications are increasing dramatically.

VADs as Bridge to Transplant
Increasing numbers of VADs are being used as bridge to transplant (see chart below). The centers within the INTERLINK Transplant Network use VADs approximately 25% (range: 10 – 55%) of the time to bridge patients pre-transplant. This is an effective strategy in as many as 80% of these patients will be transplanted successfully.  Many of the patients with LVADs will be able to go home and wait for their transplant. When one considers that all of these patients would have been confined to a hospital without the LVAD and that many would have died of complications of CHF and multi-organ failure while hospitalized waiting for their transplant, implantation of a VAD may be cost-effective in many cases.

The average cost of the VAD itself is approximately $150,000. Average billed charges for the admission where a VAD is implanted are approximately $316,000.  This cost is typically not included within a transplant case rate, but is usually billed as part of the pre-transplant expenses. If a patient can be discharged after LVAD implantation, ongoing charges tend to be minimal except for complications that may arise. The most common complications are bleeding, infection and occasionally stroke. Strokes may be mild or severe, and infections can be extremely difficult to treat. Bleeding due to the need for anticoagulation is usually relatively easy to manage. As mentioned above, the incidence of stroke on the newer devices is declining.

Following implantation of MAD, patients will typically remain hospitalized for 3 – 4weeks before they can be discharged. Prolonged hospitalization is a result of the long standing illness with severe deconditioning and multi-organ failure.  Even though the patients will improve dramatically after MAD implantation, there is a period of what can be a prolonged recovery and reconditioning that must occur, not to mention managing the unique issues of the MAD itself before someone can go home.  But, once home, the patients tend to do well.  Some may even return to work while waiting for their transplant.

Not all patients with MADs are candidates for outpatient management. This may be because of the device used, the patient’s underlying medical condition or the lack of adequate outpatient support. LVADs are probably the best devices for prolonged outpatient management. Currently, the only FDA approved device for destination therapy is the HeartMate II. There are ongoing clinical trials of other devices.

Paradoxically, MAD implantation may extend the waitlist time. The reason for this is that once a patient is placed on a MAD, they have an automatic 30 day period where they are listed as “Status 1A” or the highest priority to receive a donor heart.  But, the center can choose when to elevate the patient to “Status 1A”.  Typically, the transplant center will wait until the patient is in a good condition as he/she can be before listing the patient as “Status 1A”. While taking advantage of the patient’s ability to recover, a significant gain in functional status may prolong the waitlist time; however, this does significantly improve the outcome of the transplant and reduce post-transplant complications.  A typical waitlist time for a patient with a LVAD managed as an outpatient is 7 - 8 months.  It can be much shorter if the patient is placed at “Status 1A” immediately after the MAD implantation.

Below is a graphic depiction showing the distribution of the various reasons and stages when the transplant center determines a MAD is appropriate. This is for the period of June 23, 2006 through December 31, 2015 courtesy of the INTERMACS, a voluntary registry of all VAD activities and in which most COEs participate.

Source: INTERMACS Quarterly Statistical Report
Report, June 23, 2006 – December 31, 2015.Accessed 28 April 2016