Cost Analysis of Percutaneous Pulmonary Valve Replacement

Cost Analysis of Percutaneous Pulmonary Valve Replacement

Cost Analysis of Percutaneous Pulmonary Valve Replacement Scott W. Gatlin, MD, Dennis W. Kim, MD, PhD, and William T. Mahle, MD* Percutaneous pulmonar...

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Cost Analysis of Percutaneous Pulmonary Valve Replacement Scott W. Gatlin, MD, Dennis W. Kim, MD, PhD, and William T. Mahle, MD* Percutaneous pulmonary valve implantation is currently being used to treat right ventricular outflow tract obstruction or insufficiency in congenital heart disease. Presumably this alternative to surgical conduit replacement may result in cost savings owing to shorter hospital stays; however, a formal cost comparison has not been undertaken. Total hospital costs of percutaneous pulmonary valve implantation were compared to costs of surgical conduit replacement. Midterm cost-savings analysis was then modeled over 5 years using initial costs and reintervention rates. Need for surgical or transcatheter reintervention was derived from published data (5-year freedom from reintervention was assumed to be 53% for percutaneous pulmonary valves and 90% for surgical conduits). Cost of Melody valve and delivery device ($30,500) was higher than the conduit cost ($8,700), but total procedural costs were nearly identical at just less $50,000 for each procedure. When considering the increased need for reintervention in patients with Melody valves, surgical conduit revision results in moderate cost savings at 5 years after the initial procedure ($19,928 per patient). In conclusion, Melody valve implantation compares reasonably well to surgical conduit revision despite the added midterm costs, but ongoing analysis including the impact of nonsurgical options on quality-of-life measurements and improvement of reintervention rates for percutaneously placed valves needs to be considered. © 2011 Elsevier Inc. All rights reserved. (Am J Cardiol 2011;108:572–574) Percutaneous pulmonary valve implantation (PPVI) provides an alternative to surgical pulmonary valve replacement (PVR) in certain populations of patients with right ventricular outflow tract obstruction or regurgitation.1,2 The clinical effectiveness of PPVI has been promising in early trials,1,3–5 and there may be other benefits such as shorter hospital stays and avoiding a sternotomy. However the potential cost savings of such a strategy have not been described. Because PPVI provides an alternative to PVR, comparison of cost of the 2 intervention is of interest can provide an additional factor when attempting to decide between them. This study compared the costs within our institution of PPVI to the more established PVR. 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/m2, impaired right ventricular function, or New York Heart

Children’s Healthcare of Atlanta, Emory University School of Medicine, Atlanta, Georgia. Manuscript received January 20, 2011; revised manuscript received and accepted March 29, 2011. *Corresponding author: Tel: 404-256-2593; fax: 404-785-0998. E-mail address: [email protected] (W.T. Mahle). 0002-9149/11/$ – see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.amjcard.2011.03.088

Association functional class ⱖIII 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.6 All data were adjusted for inflation and expressed in 2010 American dollars.7 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.1,3,4 To analyze PVR reimplantation a recent meta-analysis of PVR results was used.8 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 pulwww.ajconline.org

Congenital Heart Disease/Cost Analysis of Percutaneous Pulmonary Valve

Table 3 Total costs for percutaneous pulmonary valve implantation and surgical pulmonary valve replacement at five years

Table 1 Hospital costs for percutaneous pulmonary valve implantation and surgical pulmonary valve replacement PPVI Costs ($) Porcine freestyle valve Melody valve Ensemble delivery catheter Physician Catheterization laboratory services Operating room and perfusion services Laboratory Radiology Pharmacy In-patient services and miscellaneous Total cost

PVR Costs ($) 8,700

24,000 6,500 4,508 11,592

20,318 9,151 3,783 685 1,326 4,137 48,099

1,806 49 146 1,246 49,846

Table 2 Combined outcome data for percutaneous pulmonary valve implantation Percent Freedom (years) McElhinney et al3 (n ⫽ 136) Lurz et al1 (n ⫽ 230)

Vezmar et al4 (n ⫽ 28)

D

R

CR PPVRI VD SF

1 (n ⫽ 65)

99 98

95

97

94

2 (n ⫽ 24) 1

99 96 93

88 95

90

86

2.5 4 6 1

86 84 70 100 91

87 73 73 91

91

2 3

100 83 100 83

80 80

80 80

573

78

CR ⫽ catheter reintervention; D ⫽ death; R ⫽ reoperation (conduit exchange); SF ⫽ stent fracture; VD ⫽ valve dysfunction (right ventricular outflow tract obstruction ⬎40 to 60 mm Hg).

monary regurgitation, mean Doppler right ventricular outflow tract gradient ⱖ40 mm Hg, or reintervention3; 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 ⬎0.7.4 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).6,9 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,

Initial total cost Surgical redo rate Balloon valvuloplasty/angioplasty rate* Percutaneous valve reimplantation rate* Total cost at 5 years

PPVI

PVR

$49,846 25% 5% 22% $72,837

$48,099 10% 3% $52,909

* Based on best estimate from data available from reported percutaneous pulmonary valve implantation data.1,3,4

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 2.1,3,4 “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 2,1,3,4 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 year8 and a balloon angioplasty or valvuloplasty rate of 3% at 5 years,9 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. Mortality from both procedures is reported to be quite low and considered equivalent for the purposes of this analysis.8 Our base case estimate of freedom from valve dysfunction after PPVI was derived from available data and calculated to be 93%, 85%, and 80% at 1 year, 2 years, and 3 years after valve implantation.3,4 After PVR freedom from valve dysfunction has been reported to be 66% and 47% at 5 and 10 years after valve placement.9 Discussion The clinical effectiveness of PPVI has been shown to compare favorably to PVR in its effect on the right ventricle.1,3–5 Although the device cost of the Melody valve and Ensemble delivery catheter was higher than the cost of xenograft valved conduits surgically placed in the right ventricular outflow tract, cumulative procedural costs of the 2 interventions were nearly identical at just less $50,000. PVR data were consistent with bundled costs in adults as measured by recent Medicare analysis.10 Midterm costs at 5 years after valve placement resulted in savings of $19,928 at 5 years after the initial procedure for an average PVR compared to an average PPVI. These midterm savings are due to higher rates of valve replacement and intervention after PPVI. A preliminary European economic analysis had contrasting conclusions, finding that PPVI was more cost effective than PVR.11 Specifically, they found that the repeat PPVI rate could be up to 17% per year before PVR became as cost effective as PPVI.11 However, this preliminary analysis assumed device costs of ⬍$20,000, which does not agree with current U.S. market rates.11 Our calculation of higher midterm cost for PPVI raises several concerns that are currently unavoidable. The percu-

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taneous pulmonary valve is a relatively new technology— its first reported use in a human was in 200012—and there are a total of just ⬎500 cases worldwide on last report.1 As with most new technology, the relative per-unit production costs may decrease as the demand for its use increases. This would result in a decrease over time of immediate and midterm costs associated with PPVI. Similarly, because PPVI is a newly adopted technology, there has been a learning curve in the early use of the device. Device modifications have resulted in improvements in results, but at this point the reported data continue to include results from the more problematic initial designs.1 A more rigorous standardized approach to patient selection has also been theorized to improve results of PPVI.3 These improvements have resulted in reported outcomes that likely underestimate the current performance of the percutaneous pulmonary valve. As the number of patients followed after PPVI increases, the detrimental effect on reported outcomes of cases performed before these improvements will become less significant. Our calculations for midterm costs assume that the same criteria were used for reintervention and reoperation after PPVI and PVR. This assumption is not necessarily accurate. To this point PPVIs have been performed in a controlled environment with standardized follow-up.1,3–5,13 This has allowed patients who meet certain criteria to receive valve replacements in an efficient and uniform manner with a repeat PPVI or a PVR. In contrast, PVRs have been performed for a longer period and in significantly more patients.14 This large population likely has a diverse pattern of follow-up spanning multiple institutions and practitioners leading to less stringent and consistent intervention criteria. Also pertinent to this argument is the potential delay in surgical reoperation of PVR despite clinical indications because of the attitudes of patients and surgeons when considering reoperations.9 These factors may result in a relatively low reoperation rate in patients with PVR compared to similarly matched controls with PPVI and may lead to patients lingering with ventricular dysfunction while waiting for PVR despite indications that would result in a PPVI. The societal cost that is incurred during recovery times from PPVI and PVR and from right ventricular dysfunction before intervention should also be taken into account. A shorter hospital stay, 2 days in our institution and 1 in many others,3 and the potential for patients and parents to resume their normal activities more quickly after an interventional procedure than those who have had open-heart surgery15 affect the societal cost. This theoretically could allow adult patients and parents of minors to return to work sooner. Although the tangible effects of these advantages of PPVI

are difficult to calculate accurately, physicians and their patients likely take these advantages into account when making a decision regarding intervention. 1. Lurz P, Gaudin R, Taylor AM, Bonhoeffer P. Percutaneous pulmonary valve implantation. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu 2009:112–117. 2. Momenah TS, El Oakley R, Al Najashi K, Khoshhal S, Al Qethamy H, Bonhoeffer P. Extended application of percutaneous pulmonary valve implantation. J Am Coll Cardiol 2009;53:1859 –1863. 3. McElhinney DB, Hellenbrand WE, Zahn EM, Jones TK, Cheatham JP, Lock JE, Vincent JA. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation 2010;122:507–516. 4. Vezmar M, Chaturvedi R, Lee KJ, Almeida C, Manlhiot C, McCrindle BW, Horlick EM, Benson LN. Percutaneous pulmonary valve implantation in the young 2-year follow-up. JACC Cardiovasc Interv 2010; 3:439 – 448. 5. Khambadkone S, Coats L, Taylor A, Boudjemline Y, Derrick G, Tsang V, Cooper J, Muthurangu V, Hegde SR, Razavi RS, Pellerin D, Deanfield J, Bonhoeffer P. Percutaneous pulmonary valve implantation in humans: results in 59 consecutive patients. Circulation 2005; 112:1189 –1197. 6. Fiore AC, Rodefeld M, Turrentine M, Vijay P, Reynolds T, Standeven J, Hill K, Bost J, Carpenter D, Tobin C, Brown JW. Pulmonary valve replacement: a comparison of three biological valves. Ann Thorac Surg 2008;85:1712–1718; discussion 8. 7. CPI inflation calculator. United States Department of Labor, 2010. Available at: http://data.bls.gov/cgi-bin/cpicalc.pl. Accessed on December 10, 2010. 8. Cheung EW, Wong WH, Cheung YF. Meta-analysis of pulmonary valve replacement after operative repair of tetralogy of Fallot. Am J Cardiol 2010;106:552–557. 9. Oosterhof T, Meijboom FJ, Vliegen HW, Hazekamp MG, Zwinderman AH, Bouma BJ, van Dijk AP, Mulder BJ. Long-term follow-up of homograft function after pulmonary valve replacement in patients with tetralogy of Fallot. Eur Heart J 2006;27:1478 –1484. 10. Lyle NA. How Medicare changes will affect your cardiovascular service line. Healthc Financ Manage 2007;61:86 –94. 11. Coats L, Sun L, Deanfield J, Mcginley P, Bonhoeffer P, Mcguire A. Right ventricular outflow tract dysfunction percutaneous pulmonary valve implantation: a cost-effective strategy for management of right ventricular outflow tract dysfunction (ACC abstract). J Am Coll Cardiol 2006;114(suppl 945):239A–240A. 12. Bonhoeffer P, Boudjemline Y, Saliba Z, Merckx J, Aggoun Y, Bonnet D, Acar P, Le Bidois J, Sidi D, Kachaner J. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet 2000;356:1403–1405. 13. Zahn EM, Hellenbrand WE, Lock JE, McElhinney DB. Implantation of the melody transcatheter pulmonary valve in patients with a dysfunctional right ventricular outflow tract conduit early results from the U.S. clinical trial. J Am Coll Cardiol 2009;54:1722-1719. 14. Stark J. The use of valved conduits in pediatric cardiac surgery. Pediatr Cardiol 1998;19:282–288. 15. Quek SC, Hota S, Tai BC, Mujumdar S, Tok MY. Comparison of clinical outcomes and cost between surgical and transcatheter device closure of atrial septal defects in Singapore children. Ann Acad Med Singap 2010;39:629 – 633.