Heart Failure Patients
G. M
ASCIOLI, A. C
URNIS, L. B
ONTEMPI, T. B
ORDONALI, L. D
EIC
ASThe rapidly growing incidence of heart failure (HF) is going to have an extremely large impact on costs for the management of decompensated patients. It has been calculated [1] that within the next 20 years, the preva- lence of HF in Western countries will double, rising from 5.3 millions of per- sons suffering from this syndrome to 10.6 millions. Data furnished by the Italian Ministry of Health for the year 2000 showed that DRG 127 (cardiac failure and shock) already account for 13.5% of the total number of hospital admissions, with a mean of 9.6 hospital days: this means that – in Italy – 2.5% of the total number of hospital stays are due to HF [2]. If we consider that the course of HF is worse than that of lung cancer [3] in terms of fre- quent hospital re-admissions, and that hospitalisation represents the major component of the total expenditure on management of HF, it is easy to see that the economics of caring for these patients is set to grow exponentially.
What is cost-effectiveness? When a new therapy is introduced into treat- ment, four things can happen
– The new therapy is more effective than previous treatment, but at a major cost, or
– It is less effective and more expensive, or
– It is less effective but also less expensive, or, finally (and this is what we call cost-effective)
– It is more effective and less expensive
Many trials have now demonstrated that CRT is an effective tool for treat- ing patients with episodes of acute HF refractory to optimised medical ther- apy. The results derived from PATH-CHF, MUSTIC, MIRACLE, and COM- PANION [4–7] are all concordant and demonstrate not only that CRT can
Department and Chair of Cardiology, Spedali Civili and University of Brescia, Italy
improve quality of life, but also that it affects instrumental and objective parameters, such as distance walked in the 6-min walking test, peak oxygen consumption during the effort test, ejection fraction as measured by echocardiography, etc. (Tables 1, 2).
Not only ‘soft’ end-points are improved: CRT also demonstrated a signifi- cant impact in relation to survival. In the COMPANION trial [7] the reduc- tion in mortality almost reached statistical significance in the CRT-only group and was statistically significant in the CRT-D group (D=defibrillator).
Even if the study was not designed to demonstrate this particular end-point, nevertheless the key message that can be obtained from the study is extremely important.
Table 1.Effect of CRT on quality of life (QoL) and functional capacity
Study QoL Score NYHA Class
French Pilot [8] (n = 50) +
InSync Europe [9] (n = 103) + +
InSync ICD [10] (n = 84) + +
MIRACLE [6] (n = 453) + +
MIRACLE ICD [11] (n = 247) + +
MUSTIC [5] (n = 67) + +
PATH-CHF [4] (n = 41) + +
CONTAK CD [12] (n = 203) + +
+, improved; NYHA, New York Heart Association
Table 2.Effects of CRT on heart efficiency and disease progression
Study LVEF MR LVEDV/LVESV LV Filling time
Queen Mary Hospital [13] + - - +
MIRACLE [6] + - - +
MUSTIC [5] - +
MIRACLE ICD [11] = = - +
LVEF, left ventricular ejection fraction; MR, mitral regurgitation; LVEDV, left ventric- ular end-diastolic volume; LVESV, left ventricular end-systolic volume; +, increased;
–, decreased; =, unchanged
The CARE-HF [14] study will address this issue, investigating whether CRT-P (without defibrillation back-up) could reduce mortality in patients with severe HF in comparison with optimised medical therapy.
In terms of the economical point of view, only two studies have specifical- ly addressed this topic, but other trials have investigated reduction in hospi- tal care after implantation of CRT devices (Table 3). This latter effect of CRT can be considered as a surrogate end-point of cost-effectiveness, considering – as has already been mentioned – that hospital care constitutes the main component of expenditure in HF management.
In the study by Braunschweig et al. [15], 16 patients in whom a biventric- ular device was implanted showed, in the 40 days after CRT, a significant reduction (82%) in HF-related hospitalisation and a 79% reduction in hospi- talisation for all causes. Similar results were obtained in our study [16], in which 30 patients with a biventricular device implanted were followed in the year before and the year after implantation. At the end of follow-up, there was a 93% reduction in total hospital admissions and a 28% increase in out- patient visits: this translated into a 76% reduction of total hospital care. In the year before implantation, the expenditure was €12 784 per patient, com- pared with € 9663 per patient (device cost included) in the year after device implantation, so that economical breakeven was obtained only 1 year after implantation.
In the subanalysis of the MUSTIC study [11] there was a seven-fold decrease in monthly hospitalisations (0.14/month during the pacemaker-off period vs. 0.02/month in the pacemaker-on period). In the MIRACLE study [6], the reduction of event-free survival rate in the CRT group was 50%
(absolute increase –11%), even if there was a 8.8% rate of device-related hos- pitalisations. In the same study, there was a 77% reduction in the number of total days of hospitalisation for worsening HF and a 59% reduction in days of hospitalisation due to all causes.
Table 3.Effects of CRT on hospitalisations
Study Admissions Stay Hospital days due to HF
Karolinska Hospital, Sweden [15] (n = 16) – – –79%
Belfast, Northern Ireland [18] (n = 22) – – –96%
BRESCIA, Italy [16] (n = 30) – – –93% (all causes)
MIRACLE [6] (n = 453) – – –77%
MUSTIC [5] (n = 67) – –86%
PATH-CHF [4] (n = 41) – – –77%
–, decreased
A preliminary analysis of 40 patients with at least 3 years of follow-up who underwent implantation in our centre seems to demonstrate that the positive cost-efficacy ratio is also maintained over the long term.
In conclusion, physicians who deal daily with HF patients now have a new
‘more-than-promising’ weapon in the struggle against this epidemic.
CRT seems to induce – at least in carefully selected patients – reverse remodelling [12] of the dilated heart, regardless the aetiology of dilation. It is extremely hard to calculate ‘costs’ in a health service like the Italian one, due to the fact that our system is funded and not reimbursed, so that speak- ing of DRG values is not directly related to costs. Nevertheless, many studies, and our study too (derived from an Italian experience), have demonstrated that a significant reduction in hospital care can be derived from biventricu- lar pacing, and, however costs are calculated, a reduction in hospitalisations
does equate to a reduction of costs.It will be difficult to calculate the cost per year of life saved, but there is already a great deal of evidence that CRT can be considered a cost-effective procedure.
References
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