Cost-Effectiveness Analysis of Quadripolar Versus Bipolar Left Ventricular Leads for Cardiac Resynchronization Defibrillator Therapy in a Large, Multicenter UK Registry

Abstract

Objectives: The objective of this study was to evaluate the cost-effectiveness of quadripolar versus bipolar cardiac resynchronization defibrillator therapy systems.

Background: Quadripolar left ventricular (LV) leads for cardiac resynchronization therapy reduce phrenic nerve stimulation (PNS) and are associated with reduced mortality compared with bipolar leads.

Methods: A total of 606 patients received implants at 3 UK centers (319 Q, 287 B), between 2009 and 2014; mean follow-up was 879 days. Rehospitalization episodes were costed at National Health Service national tariff rates, and EQ-5D utility values were applied to heart failure admissions, acute coronary syndrome events, and mortality data, which were used to estimate quality-adjusted life-year differences over 5 years.

Results: Groups were matched with regard to age and sex. Patients with quadripolar implants had a lower rate of hospitalization than those with bipolar implants (42.6% vs. 55.4%; p = 0.002). This was primarily driven by fewer hospital readmissions for heart failure (51 [16%] vs. 75 [26.1%], respectively, for quadripolar vs. bipolar implants; p = 0.003) and generator replacements (9 [2.8%] vs. 19 [6.6%], respectively; p = 0.03). Hospitalization for suspected acute coronary syndrome, arrhythmia, device explantation, and lead revisions were similar. This lower health-care utilization cost translated into a cumulative 5-year cost saving for patients with quadripolar systems where the acquisition cost was <£932 (US $1,398) compared with bipolar systems. Probabilistic sensitivity analysis results mirrored the deterministic calculations. For the average additional price of £1,200 (US $1,800) over a bipolar system, the incremental cost-effective ratio was £3,692 per quality-adjusted life-year gained (US $5,538), far below the usual willingness-to-pay threshold of £20,000 (US $30,000).

Conclusions: In a UK health-care 5-year time horizon, the additional purchase price of quadripolar cardiac resynchronization defibrillator therapy systems is largely offset by lower subsequent event costs up to 5 years after implantation, which makes this technology highly cost-effective compared with bipolar systems.

Keywords: ACS, acute coronary syndrome; CRT, cardiac resynchronization therapy; CRTD, cardiac resynchronization defibrillator therapy device; HF, heart failure; ICER, incremental cost-effectiveness ratio; LV, left ventricular; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; PNS, phrenic nerve stimulation; QALY, quality-adjusted life-year; cardiac resynchronization therapy; cost-effectiveness; implantable cardiac defibrillator; left ventricular pacing; quadripolar lead.

Graphical abstract

Figure 1

Model Diagram and Decision Structure Used in the Economic Model This was used for each of the 5 years, although only year 1 is shown here. Y1 p is the probability of the event in year 1; actual data for year 1 are shown. ACS = acute coronary syndrome; CRT-D = cardiac resynchronization defibrillator therapy device.

Figure 2

Tornado Plot Showing the Impact of Varying the Input Parameter Values to Their Upper and Lower 95% CIs on the Base-Case ICER Hatched bars show the impact of using the lower 95% confidence interval (CI); solid bars show the impact of using the upper 95% CI. Data labels on each bar show the incremental cost-effectiveness ratio (ICER) resulting from the change in value. A shift to the right of the center line shows an ICER that denotes less favorable cost-effectiveness than the base case. ACS = acute coronary syndrome; c = cost of; HF = heart failure; hosp = hospitalization; QALY = quality-adjusted life-year; quad = quadripolar cardiac resynchronization therapy system; u = utility value.

Figure 3

Incremental Cost and Cost-Effectiveness of Implanting a Quadripolar Versus Bipolar CRT-D System, Varied by the Additional Acquisition Cost of the Quadripolar System Quadripolar (quad) leads that cost up to £932 ($1,398) more than bipolar leads result in either a cost-neutral outcome or a cost saving because of reduced health-care utilization events. CRT-D = cardiac resynchronization defibrillator therapy device; ICER = incremental cost-effectiveness ratio.

Figure 4

Cost-Effectiveness Acceptability Curve for Quadripolar Versus Bipolar CRTD The x-axis shows the willingness-to-pay threshold (i.e., the incremental cost per QALY gained). Quadripolar (Quad) CRTD is 97.1% likely to be cost-effective at £20,000 ($30,000) per QALY gained and 99.3% likely to be cost-effective at £30,000 ($45,000) per QALY gained. Abbreviations as in Figure 2.

Figure 5

Cost-Effectiveness Plane Each point represents the result of 1 of the 1,000 simulations. Points to the left of the vertical axis are simulation results in which quadripolar CRTD was more effective and less expensive than bipolar CRTD. Points to the right of the vertical axis are simulation results in which quadripolar CRTD was more effective and more expensive than bipolar CRTD. The diagonal black line is the £20,000 ($30,000) per QALY gained line (i.e., all points above this are simulation results in which the incremental cost per QALY gained was <£20,000 [$30,000]). Abbreviations as in Figure 2.