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Observational Study
. 2020 Jan;39(1):16-26.
doi: 10.1016/j.healun.2019.08.017. Epub 2019 Aug 28.

INTERMACS profiles and outcomes of ambulatory advanced heart failure patients: A report from the REVIVAL Registry

Michelle M Kittleson  1 , Palak Shah  2 , Anuradha Lala  3 , Rhondalyn C McLean  4 , Salpy Pamboukian  5 , Douglas A Horstmanshof  6 , Jennifer Thibodeau  7 , Keyur Shah  8 , Jeffrey Teuteberg  9 , Nisha A Gilotra  10 , Wendy C Taddei-Peters  11 , Thomas M Cascino  12 , Blair Richards  13 , Shokoufeh Khalatbari  13 , Neal Jeffries  11 , Lynne W Stevenson  14 , Douglas Mann  15 , Keith D Aaronson  12 , Garrick C Stewart  16 ; REVIVAL Investigators
Affiliations
Observational Study

INTERMACS profiles and outcomes of ambulatory advanced heart failure patients: A report from the REVIVAL Registry

Michelle M Kittleson et al. J Heart Lung Transplant. 2020 Jan.

Abstract

Background: Ambulatory patients with advanced heart failure (HF) are often considered for advanced therapies, including durable mechanical circulatory support (MCS). The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles are a commonly used descriptor of disease severity in patients receiving MCS devices, but their role in defining the prognosis of ambulatory patients is less well established, especially for Profiles 6 and 7.

Methods: Registry Evaluation of Vital Information on Ventricular Assist Devices in Ambulatory Life is a prospective observational study of 400 outpatients from 21 MCS and cardiac transplant centers. Eligible patients had New York Heart Association Class II to IV symptoms despite optimal medical and electrical therapies with a recent HF hospitalization, heart transplant listing, or evidence of high neurohormonal activation.

Results: The cohort included 33 INTERMACS Profile 4 (8%), 83 Profile 5 (21%), 155 Profile 6 (39%), and 129 Profile 7 (32%). Across INTERMACS profiles, there were no differences in age, gender, ejection fraction, blood pressure, or use of guideline-directed medical therapy. A lower INTERMACS profile was associated with more hospitalizations, greater frailty, and more impaired functional capacity and quality of life. The composite end point of death, durable MCS, or urgent transplant at 12 months occurred in 39%, 27%, 24%, and 14% subjects with INTERMACS Profiles 4, 5, 6, and 7, respectively (p = 0.004).

Conclusions: Among ambulatory patients with advanced HF, a lower INTERMACS profile was associated with a greater burden of HF across multiple dimensions and a higher composite risk of durable MCS, urgent transplant, or death. These profiles may assist in risk assessment and triaging ambulatory patients to advanced therapies.

Keywords: INTERMACS Profiles; LVAD; ambulatory heart failure; death; heart transplantation.

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Conflict of interest statement

Disclosures

Palak Shah reports Grant Support: American Heart Association/Enduring Hearts Scientist Development Grant, Merck, Haemonetrics, and Medtronic. Consulting: NuPulse CV and Ortho Clinical Diagnostics.

Keyur Shah reports being a consultant for Medtronic and Syncardia.

Jeff Teuteberg reports speaking and ad board with Medtronic.

Douglas Horstmanshof reports being a speaker/research grant for Abbott Medical.

Keith Aaronson reports the following related to the submitted work: NIH/NHLBI (contract) and outside the submitted work: Medtronic (research support and consultant [Independent Physician Quality Panel member), Abbott (research support), Procyrion (consultant), NuPulseCV (consultant), Bioventrix (research support).

No conflicts: Michelle Kittleson, Anuradha Lala, Rhondalyn McLean, Salpy Pamboukian, Jennifer Thibodeau, Nisha Gilotra, Wendy Taddei-Peters, Thomas Cascino, Neal Jeffries, Lynne Stevenson, Douglas Mann, Garrick Stewart, Blair Richards, Shokoufeh Khalatbari.

Figures

Figure 1.
Figure 1.
Distribution of INTERMACS Profiles at enrollment, 2, 6, and 12 months among survivors on medical therapy who presented for clinical follow up visits.
Figure 2.
Figure 2.
Competing events. Mutually exclusive endpoints of death, durable MCS, or urgent transplant were assessed through the end of the 12-month visit window. The cumulative incidence of each event at 410 days is shown.
Figure 3.
Figure 3.
Composite primary endpoint of death, durable MCS, or urgent transplant according to INTERMACS Profile at enrollment. Estimated survival was assessed through the end of the 12-month visit window using the Cox proportional hazard method. Incidence of the primary endpoint at 410 days is shown. The composite primary endpoint was significantly different by INTERMACS Profile (P = 0.0002).
Figure 4.
Figure 4.
Durable MCS placement according to INTERMACS Profile at enrollment. Incidence of durable MCS placement was measured through the end of the 12-month visit window using the competing risks model. Incidence of durable MCS placement at 410 days is shown. Incidence of durable MCS placement was significantly different by INTERMACS Profile ( P = 0.011).
Figure 5.
Figure 5.
Time to first heart failure hospitalization by INTERMACS Profile. This was assessed through the end of the 12-month visit window using the competing risks model. Incidence of HF hospitalization at 410 days is shown. Incidence of first heart failure hospitalization was significantly different by INTERMACS Profile (P = 0.0005).
Figure 6.
Figure 6.
Risk of the primary composite outcome, MCS, and first heart failure hospitalization by INTERMACS Profile. This was assessed during the 12-month visit window. Cox proportional hazard regression was used to estimate the risk of the primary composite outcome. Competing risk modeling, using cause-specific hazard regression, was used to estimate the risk of MCS and first heart failure hospitalization.
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References

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