Pre-operative health status and outcomes after continuous-flow left ventricular assist device implantation

doi:10.1016/j.healun.2013.09.005

The Journal of Heart and Lung Transplantation

Volume 32, Issue 12, December 2013, Pages 1249-1254

https://doi.org/10.1016/j.healun.2013.09.005 Get rights and content

Background

Health status predicts adverse outcomes in heart failure and cardiac surgery patients, but its prognostic value in left ventricular assist device (LVAD) placement is unknown.

Methods

We examined the association of pre-operative health status, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), with survival and hospitalization after LVAD using the KCCQ score as a continuous variable and stratified by KCCQ score quartile plus missing KCCQ in 1,125 clinical trial participants who received the HeartMate II (Thoratec Corp, Pleasanton, CA) as destination therapy (n = 635) or bridge to transplantation (n = 490).

Results

The mean pre-operative KCCQ score was 29.4 ± 18.7 among survivors (n = 719), and 27.1 ± 18.3 (n = 406) in those who died. In time-to-event analysis for all available follow-up using health status as a continuous variable, the pre-operative KCCQ score did not correlate with overall mortality after LVAD implantation (p = 0.178). Small absolute differences were seen between the pre-operative KCCQ quartile and 30-day survival (Q4 95% vs Q1 89% vs missing 87%; p = 0.0009 for trend), 180-day survival (Q4 83% vs Q1 76% vs missing 79%; p = 0.060 for trend), and days hospitalized at 180 days (Q4 29.8 ± 25.6 vs Q1 34.1 ± 27.1 vs missing 36.5 ± 29.9 days; p = 0.009 for trend).

Conclusion

Our findings suggest that pre-operative health status has limited association with outcomes after LVAD implantation. Although these data require further study in a diverse population, mechanical circulatory support may represent a relatively unique clinical situation, distinct from heart failure and other cardiac surgeries, in which heart failure-specific health status measures may be largely reversed.

Section snippets

Participants

We included 1,125 clinical trial participants who received the HeartMate II (Thoratec Corp, Pleasanton, CA) LVAD in the BTT clinical trial or in the DT clinical trial between 2005 and 2009. Briefly, the BTT trial was a prospective, observational study of patients who received a HeartMate II device as a BTT.1, 2 The DT trial compared the continuous-flow HeartMate II with the pulsatile HeartMate XVE in patients receiving an LVAD for DT.³ Patients were eligible for the BTT trial if they were

Baseline characteristics

Table 1 reports baseline characteristics for the 1,125 patients in the cohort, stratified by KCCQ quartiles (total n = 965) and missing KCCQ (n = 160) and consisting of 490 BTT patients and 635 DT patients. Of the 1,125 patients included in this study, 719 (64%) were alive at the time of analysis, and 406 (36%) had died. Detailed outcomes for the individual BTT and DT clinical trials have been published previously.1, 2, 3 Follow-up for the entire cohort was 1,562 patient-years. Mean duration of

Discussion

Our study found that pre-operative health status, as measured by the KCCQ, is not associated with overall post-HMII survival and is only weakly associated with a variety of 30-day and 180-day outcomes. Patients missing KCCQ data, presumably because they could not fill out the questionnaire, tended to have the highest rate of 30-day and 180-day adverse events, although absolute differences in outcomes were small. Overall, these results are in contrast to the prognostic relevance of KCCQ in

Disclosure statement

The authors thank Jerry Heatley for his statistical review of the manuscript.

Thoratec sponsored the clinical trial and provided the analytic support. L.A.A. is currently supported by grant 1K23HL105896 from National Heart, Lung and Blood Institute.

K.S.S. and D.J.F. are employees of Thoratec Corporation. J.A.S. owns the copyright to the KCCQ. None of the remaining authors have a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or

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The disease-specific HRQL measure is the Kansas City Cardiomyopathy Questionnaire (KCCQ).16 The KCCQ has well-established psychometric properties and is associated with clinical outcomes and costs.18–20 The KCCQ quantifies, from patients' perspectives, their physical limitations, symptoms, quality of life, and social limitations regarding heart failure.
Given the importance of patients' health-related quality of life (HRQL) after mechanical circulatory support (MCS) device implantation, the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) collects the Kansas City Cardiomyopathy Questionnaire (KCCQ) before and after MCS. The success of data collection and potential implications of missing data on HRQL analyses are unknown.
We examined the frequency and reasons for not collecting baseline and 3-month KCCQ data across INTERMACS sites from May 2012 to December 2013. Hierarchical logistic regression was used to examine site variability (median odds ratios [MOR]) for not collecting KCCQ data to demonstrate the degree to which some sites can collect more complete data than others.
Among 3960 and 3523 patients participating in INTERMACS before and 3 months after left ventricular assist device implantation, the KCCQ was not collected in 43.1% at baseline (range across sites, 0–100%) and 40.9% (range, 0–100%) at follow-up. The most common reasons for incomplete KCCQ data at baseline were that the patient was too sick (13.9%) and consent to participate in research was not obtained (12.4%). Significant variation across sites was observed for missingness because of patient (MOR, 2.8; P < .001) and administrative (MOR, 4.8; P < .001) reasons. The most variable patient reasons were that the patients were too stressed (MOR, 7.2; P < .001) and too busy (MOR, 10.6; P < .001). The most variable administrative reasons were that the coordinator was too busy/forgot (MOR, 7.1; P < .001) and miscellaneous reasons (MOR, 8.7; P < .001). At 3 months, significant variation persisted for both patient (MOR, 2.7; P < .001) and administrative (MOR, 3.5; P < .001) reasons. The most variability across sites was that the patient was too busy (MOR, 6.0, P < .001) and that the coordinator was too busy/forgot (MOR, 5.8; P < .001).
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Pre-operative health status and outcomes after continuous-flow left ventricular assist device implantation

Background

Methods

Results

Conclusion

Section snippets

Participants

Baseline characteristics

Discussion

Disclosure statement

J Am Coll Cardiol

J Am Coll Cardiol

J Heart Lung Transplant

J Am Coll Cardiol

J Am Coll Cardiol

Int J Cardiol

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol

Am Heart J

Am J Cardiol

Am Heart J

Use of a continuous-flow device in patients awaiting heart transplantation

N Engl J Med

Advanced heart failure treated with continuous-flow left ventricular assist device

N Engl J Med

Clinical management of continuous-flow left ventricular assist devices in advanced heart failure

J Heart Lung Transplant