Methods

With approval of the institutional review board of Children’s Healthcare of Atlanta, a retrospective analysis was undertaken examining the costs incurred by PPVI and PVR for children 8 to 17.9 years of age. Procedures were performed from January 2004 through December 2010. During the study period 33 subjects underwent surgical conduit revision and 6 subjects had placement of a Melody valve (Medtronic, Minneapolis, Minnesota). Indications for PVR at our institution include a right ventricular outflow tract gradient >40 mm Hg despite attempts at balloon valvuloplasty, moderate to severe pulmonary regurgitation (>35%) with right ventricular end-diastolic volume >165 ml/m ² , impaired right ventricular function, or New York Heart Association functional class ≥III symptoms. The PVR cohort was limited only to those subjects who required conduit revision. The general practice is to admit patients undergoing PVR the morning of surgery and after operation to be admitted to a dedicated cardiac intensive care unit. Patients undergoing PPVI are likewise admitted on the morning of their procedure but are observed for approximately 24 to 48 hours after their procedure in a non-intensive care setting.

This cost model is limited to costs incurred from time of hospital admission onward. Costs incurred in the evaluation before intervention were assumed to be equivalent. The cost model included direct hospital costs for items such as pharmaceuticals, laboratory testing, and device (valve) costs. Labor costs for ancillary personnel were derived from median hourly wages for hospital personnel such as nurses and respiratory therapists. Physician professional fees were derived from current procedural terminology codes and Medicare reimbursement rates. Although several valved conduits are commercially available, our institutional preference, Medtronic Freestyle® Heart Valve (Minneanapolis, Minnesota), was used in our base scenario calculations because it is a commonly used option and has a cost in the midrange of available conduits. All data were adjusted for inflation and expressed in 2010 American dollars.

Midterm costs were estimated using reintervention data for PPVI and PVR at 5 years after the initial procedure. Data were taken from 3 series to estimate the likelihood of surgical and catheter reintervention for PPVI. To analyze PVR reimplantation a recent meta-analysis of PVR results was used. For the purposes of this study, it was assumed that a repeat PPVI or repeat PVR incurred the same hospital cost as the initial procedure.

Also taken into account to help analyze midterm costs were available data on valve dysfunction, which could necessitate additional intervention. In 1 study percutaneous valve dysfunction was defined as moderate or greater pulmonary regurgitation, mean Doppler right ventricular outflow tract gradient ≥40 mm Hg, or reintervention ; in another study, it was defined as right ventricle to pulmonary artery peak Doppler gradient >60 mm Hg and/or right ventricle to aortic systolic pressure ratio >0.7. Studies used to provide surgical valve failure rates have defined valve dysfunction as significant pulmonary regurgitation and/or right ventricular outflow tract gradient >40 mm Hg (defined by peak-to-peak catheter gradients or mean echocardiographic Doppler gradients).

Results

Median hospital length of stay for the PPVI and PVR groups were 2 and 4 days, respectively (p = 0.001). For the PVR cohort median duration of intensive care unit stay was 29 hours (range 20 to 139). Median duration of mechanical respiratory support was 16 hours (range 8 to 63). All subjects who underwent PPVI were admitted directly to the step-down unit and did not require intensive care unit admission.

Hospital costs, physician fees, and device costs are listed in Table 1 for PPVI and PVR. Although the cost for the Melody device and Ensemble (Medtronic, Minneapolis, Minnesota) delivery catheter was higher than its more established surgical counterpart, hospital costs and physician fees were lower. This resulted in almost equivalent total costs. Data taken from PPVI trials to help calculate and analyze midterm costs are listed in Table 2 . “Catheter reintervention” refers to reimplantation of a percutaneous pulmonary valve and other interventions such as balloon dilation of the existing pulmonary valve. Based on total initial costs presented in Table 1 and published PPVI data presented in Table 2 , the total cost at 5 years was calculated for an average PPVI. In a similar manner, using a surgical reoperation rate of 1.9% per year and a balloon angioplasty or valvuloplasty rate of 3% at 5 years, the total cost of an average PVR was calculated. These data are presented in Table 3 and resulted in a midterm cost savings of $19,928 for PVR compared to PPVI.

Table 2

Combined outcome data for percutaneous pulmonary valve implantation

	Percent Freedom (years)	D	R	CR	PPVRI	VD	SF
McElhinney et al (n = 136)	1 (n = 65)	99	98	95	97	94	78
	2 (n = 24)	99	96	88	90	86
Lurz et al (n = 230)	1		93	95
	2.5		86	87
	4		84	73
	6		70	73
Vezmar et al (n = 28)	1	100	91	91		91
	2	100	83	80		80
	3	100	83	80		80

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