PR O GRE S S I N C ARDI O VAS CU L AR D I S EAS E S 5 6 ( 2 0 14 ) 61 0–6 18
Available online at www.sciencedirect.com
ScienceDirect www.onlinepcd.com
Quality, Economics, and National Guidelines for Transcatheter Aortic Valve Replacement Peter M. Pollaka,⁎, Michael J. Mackb , David R. Holmes Jr.a a
Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN The Heart Hospital Baylor, Plano, TX
b
A R T I C LE I N FO
AB S T R A C T
Keywords:
Transcatheter aortic valve replacement (TAVR) is a transformative technology for the
Transcatheter aortic valve replacement
treatment of aortic stenosis, requiring a multidisciplinary collaboration in the form of a
Aortic stenosis
“heart team” that includes interventional cardiologists and cardiac surgeons. As this new
National guidelines
technology continues to disperse rapidly, its proper therapeutic role evolves and leads to
Quality
important questions regarding who should perform the procedure, where it should be
Cost
performed, and who should pay for it. Herein, we review the most recent guidelines
Cost-effectiveness
governing the use of TAVR in the United States and Europe. We then summarize the available registry data, which, despite its limitations, presents the clearest picture of TAVR in clinical use. Finally, we discuss the costs and relative cost-effectiveness of TAVR. Taken together, these are the elements from which the larger questions surrounding TAVR must be answered. © 2014 Elsevier Inc. All rights reserved.
The development, approval, and now widespread application of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis (AS) represent the latest watershed moment in interventional cardiology and cardiac surgery.1 AS is a lethal disease that affects ~4% of persons aged ≥85 years, which is the fastest growing segment of the population in the Western world. The average survival for patients with symptomatic, severe AS who are medically managed is only 1.8 years. Before the availability of TAVR, up to 30% of patients with symptomatic, severe AS were considered to be too high risk for surgery and left with a poor prognosis.2–4 TAVR has emerged as a successful and durable treatment option for patients who are felt to be either inoperable or at excessively high risk for conventional surgical valve replacement.5–7 There are an estimated 292,394 patients who may benefit from TAVR in Europe and North America currently, with >27,000 new potential candidates added annually.8
Although this technology has had a profound impact on the treatment of valvular heart disease (VHD), its availability prompts several important questions regarding dissemination to society, operator and institutional qualifications, appropriate patient selection, and the economic challenges regarding costs and cost-effectiveness. In this article, we discuss the complex economics surrounding TAVR, the assessment of care quality, existing registry data, and the role of registry participation for centers.
Quality measures, guidelines, and valve centers of excellence Interest in assessing and improving health care quality has surged in recent years. Ongoing changes to the United States
Statement of Conflict of Interest: see page 617. ⁎ Address reprint requests to Peter M. Pollak, MD, Mayo Clinic, 200 First Street SW, Rochester, MN 55905. E-mail address: [email protected] (P.M. Pollak). 0033-0620/$ – see front matter © 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.pcad.2014.03.001
611
PR O G RE S S I N C ARDI O V A S CU L A R D I S EA S E S 5 6 (2 0 1 4) 61 0–6 1 8
Abbreviations and Acronyms
(US) health care system involve a greater ACC = American College of emphasis on public reCardiology porting of quality as AS = aortic stenosis well as a direct link between quality and coverAUC = appropriate use criteria age (or reimbursement). AVR = aortic valve replacement We will detail the framework used for creating CMS = Center for Medicare quality performance Services metrics and discuss CV = cardiovascular how they could be incorporated into TAVR. DRG = diagnostic-related group Measurement of ICER = incremental costhealth care quality has effectiveness ratio been approached in varying combinations LOS = length of stay of four fundamental LY = life-years instruments: performance measures, appropriate NCD = National Coverage use criteria, adherence Determination to published guidelines, PARTNER = Placement of Aortic and outcome measures. Transcatheter Valve Each of these tools was developed uniquePROM = predictive risk of ly, and has strengths mortality and weakness. It is QALY = quality-adjusted lifevery likely that reimyear bursement for health SAVR = surgical aortic valve care will be increasingly replacement tied to these measures of quality assessment. STS = Society of Thoracic Surgery Accordingly, a clear unTA = transapical derstanding of them is of paramount importance. TAVR = transcatheter aortic Performance meavalve replacement sures are considered TF = transfemoral among three care domains: structure, process, THV = transcatheter heart valve and outcome measures.9 SAVR = surgical aortic valve Structure measures are dereplacement fined as a feature of a health care organization TVTR = Transcatheter Valve or clinician relating to Therapy Registry capacity for providing US = United States high-quality care. Examples of structure meaVHD = valvular heart disease sures include procedural volumes (e.g., percutaneous coronary intervention, valve surgery) and accreditation status. Process measures are defined as health care activities performed for, on behalf of, or by a patient. Examples of process measures are the rate of transfemoral access for TAVR and the system for evaluation and patient follow-up. Outcome measures include consideration of risk and benefit with both intermediate and longterm clinical outcomes (i.e., change in physiologic state that leads to a long-term health) and health outcomes (i.e., health status of a patient resulting from care either desirable or adverse). Examples of outcome measures are stroke
rates, vascular complications, and long-term quality of life measurements. Appropriate use criteria (AUC) have been developed to aid in identifying patterns of overuse for tests or procedures in many areas of cardiovascular (CV) medicine. AUC are constructed using a modified Delphi method, and reflect the cumulative judgment of an expert panel rather than consensus. Recently, the language of appropriate use criteria was changed from appropriate, inappropriate, or uncertain to appropriate, may be appropriate, or rarely appropriate. Of note, the New York State Department of Health recently decided that it would not support reimbursement for catheter procedures considered to be rarely appropriate. Currently, no AUC have been developed for TAVR. The American Heart Association/American College of Cardiology (ACC) practice guidelines are generated by a group of clinical experts who interpret and distill relevant scientific data, emphasizing best clinical evidence, into consensus recommendations. The last revision of the practice guidelines on the management of VHD was published before the approval of TAVR in the US, and therefore do not include specific recommendations. It is expected that the forthcoming update will include specific recommendations regarding TAVR. Recommendations for TAVR are available in the most recent European Society of Cardiology guidelines for the management of VHD10 (Table 1). These recommendations are distilled from published Placement Aortic Transcatheter Valve (PARTNER) trial data as well as the European experience with TAVR. In addition to the four formal recommendations on TAVR, relative and absolute contraindications also have been put forth in the European Society guidelines (Table 2). TAVR is recommended only for patients considered to be at high risk for surgery as determined by a heart team. A EuroSCORE >20% and a Society of Thoracic Surgery (STS) score >10% are offered as indicators of high surgical risk. However, it is important to note that, in the largest registry of current European TAVR practice
Table 1 – 2012 European Society of Cardiology recommendations for transcatheter aortic valve implantation (TAVI). Recommendation TAVI should only be undertaken with a multidisciplinary “heart team” including cardiologists and heart surgeons. TAVI should only be performed in hospitals with on-site cardiac surgery, TAVI is indicated in patients with severe symptomatic aortic stenosis who are not suitable for aortic valve replacement as assessed by a “heart team” and who are likely to gain improvement in their quality of life and to have a life expectancy of more than 1 year after consideration of their comorbidities. TAVI should be considered in high-risk patients with severe symptomatic aortic stenosis who may be suitable for surgery, but in whom TAVI is favored by a “heart team” based on the individual risk profile and anatomic suitability.
Level of Class Evidence I
C
I
C
I
B
IIa
B
612
PR O GRE S S I N C ARDI O VAS CU L AR D I S EAS E S 5 6 ( 2 0 14 ) 61 0–6 18
Table 2 – Contraindications for transcatheter aortic valve implantation (TAVI) in the 2012 European Society of Cardiology guidelines.
Table 3 – Centers for Medicare Services National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR).
Absence of a “heart team” and no cardiac surgery on site Appropriateness of TAVI not confirmed by “heart team” Clinical Life expectancy 50% time at hospital with surgical program) 100 career AVR with 10 “high risk” (STS ≥6) or 25 AVR per year or 50 AVR/ 2 years with 20 in the past year Experience with peripheral bypass Experience with open retroperitoneal exposure of iliac arteries Suitable training on devices to be used Cardiologists must be BE/BC in interventional cardiology Surgeons must be BE/BC in thoracic surgery Programs >18 months: 30 TAVR (total experience) Programs 11%). The SENTINEL registry is the largest repository on TAVR from Europe, and includes in-hospital outcomes from 137 centers across 10 countries. The registry consists of 4571 patients who received the latest commercially available technology, such as the Sapien XT and 18Fr CoreValve.15 With a relatively even mix of valves used (57.3% Sapien XT), the transfemoral route was the dominant route of delivery and used in 74.2% of cases. Procedural success was high (96.5%), while major vascular complications (3.1%) and inhospital stroke (1.8%) were notably low. Conversion to open surgery (4.3%) was remarkably higher than in other registries. Perhaps most striking, there was a wide variation in use of general versus local anesthesia, varying from 100% of cases
Table 5 – Volume and outcomes for continued certification for both new and existing TAVR programs for treatment of inoperable patients. Program volume: 20 TAVR/year or 40 per 2 years 30-day all-cause mortality $60,000 based on adjustments for location alone. Hospitals with training programs also receive more reimbursement per diagnostic-related group (DRG) from
Table 7 – Summary of registry data. Total Registries Centers Patients
9 331 13,460 Avg ± SD
Age (years) Women EuroSCORE 30-day mortality 1-year mortality Stroke Procedural success Major vascular complication Pacemaker Aortic regurgitation >1+ Surgical conversion a
Weighted average.
81.6 ± 0.8 52.9% 22.4 ± 3.6% 8.7 ± 2.7% 20.5 ± 3.1% 3.0 ± 1.2% 96.4% 7.6 ± 5.5% 16.9 ± 10.4% 13.9 ± 5.6% 2.2% a
PR O G RE S S I N C ARDI O V A S CU L A R D I S EA S E S 5 6 (2 0 1 4) 61 0–6 1 8
Medicare, making a TAVR program at a private hospital less financially attractive. Medicare reimburses TAVR hospital charges using the same DRG’s as surgical aortic valve replacement (SAVR; DRG 216 through 221). The appropriate DRG is assigned based on concomitant heart catheterization and the severity of clinical comorbidities. Examples of morbidities that increase the level of DRG are renal dysfunction, chronic heart failure, and respiratory disease; major procedural complications, such as bleeding, acute stroke, and emergency surgery, also affect the DRG. Concomitant heart catheterization and more severe comorbid conditions incur significantly higher reimbursement; thus, correct selection of DRG carries important reimbursement implications for the financial viability of any TAVR program. The cost of the valve prosthesis varies widely depending on specific institutional purchasing agreements. Transcatheter heart valves themselves are significantly more expensive than surgical valves. The acquisition cost in the US for available transcatheter prostheses is approximately $30,000 to $32,500 with volume discounts, while analogous costs for surgical bioprosthetic valves are ~ $4500 to 5500. Cost-effectiveness is a metric often used when evaluating a novel technology, and reflects the cost relative to a perceived benefit. Two common expressions of cost-effectiveness are cost per quality-adjusted life-year (QALY) and the incremental costeffectiveness ratio (ICER). Many health economists have recommended using the cost per QALY metric. However, some maintain that cost-per-life-year (LY) is a more accurate metric because quality assessment is difficult to measure, and the unadjusted LY does not risk penalizing one group for a diminished perceived quality of life.32,33 It is vitally important when discussing an expensive novel technology such as TAVR to keep its cost in perspective relative to established and benchmark therapies (Fig 1). In the US, when evaluating new therapies, the cost of renal replacement therapy (i.e., dialysis) is the most common benchmark of society’s willingness to pay. The cost of dialysis is often cited as $70,000 per QALY.34 By comparison, a renal transplant costs ~ $10,000 per life-year gained. The essence of cost holds different meaning when considered from various perspectives. Patients, payers, hospitals, society, and companies who manufacture transcatheter valves all view cost in different ways. Patients focus on personal cost in terms of complication risk, discomfort, recovery time, and out-of-pocket expense. Payers, such as Medicare or other health insurance brokers, predominantly consider the financial burden of one treatment versus the other in terms of the total expected cost for a given patient over his or her life expectancy. An unseemly byproduct of this perspective is that a new therapy for patients with lethal diseases and no alternatives will always appear as a moneyloser because patients stop costing money when they die. Any therapy that keeps these highest-risk patients alive longer to incur more costs will appear unattractive from this perspective. Hospitals will view the cost of TAVR from a market perspective, balancing the ability to profit from the procedure or to attract patients who can be treated with conventional surgery but who otherwise would have been evaluated at other institutions. TAVR is currently reimbursed in the US under the
615
Cost per QALY $300,000 $250,000 $200,000 $150,000 $100,000 $50,000 $-
Fig 1 – Comparison of cost-effectiveness of transcatheter aortic valve replacement (TAVR) with other common therapies.
same Medicare DRG as SAVR despite the transcatheter prosthesis costing ~ $25,000 more than a surgical valve. Thus, hospitals generally view a TAVR program as a loss leader. Hospitals may plan to recoup the “cost” of the TAVR program from the halo effect of increased overall valve volume and referrals that come from the prestige associated with the ability to perform TAVR, as well as the increased downstream revenue from clinical consultations and additional testing. Society has perhaps the most balanced perspective of the four, comparing the overall cost to society of a new treatment to either an established treatment or no treatment. This perspective focuses on the incremental cost-effectiveness of one treatment versus the alternative. In an analysis of the PARTNER I (Cohort B) data for TAVR cost in the United States, Reynolds and co-workers33 calculated an incremental cost of $50,200 per life-year gained ($61,889/QALY) for inoperable patients with severe AS. The analysis by Doble et al.34 from a Canadian perspective concluded similar costeffectiveness ($36,458/LY and $51,324/QALY) in inoperable patients. These costs are less than the cost of dialysis, thus falling within the established “willingness to pay” standard society generally holds. The higher cost-per-QALY relative to cost-per-LY reflects the diminished utility scores in this population even after successful TAVR. It is important to examine the cost components of TAVR in this analysis in detail. The estimated cost of the Edwards SAPIEN valve was $30,000. The index hospitalization had a mean cost of $78,542, of which $42,806 was the cost of the procedure. There were cost savings in the TAVR group from decreased hospital readmission rates in comparison to medical therapy patients (1.0 vs. 2.2). Nevertheless, followup costs through 12 months were $55,000 higher per TAVR patient than those who had medical therapy, increasing to $79,000 per TAVR patient when allowing for incremental costs associated with longer life expectancy. Thus, cost savings from effective treatment with TAVR was outpaced by incremental health care expenditure related to increased patient longevity in a population with significant morbidities. The PARTNER A clinical trial randomized high-risk patients to receive either SAVR or TAVR using a transfemoral (TF) or transapical (TA) approach. Because the overall survival and
616
PR O GRE S S I N C ARDI O VAS CU L AR D I S EAS E S 5 6 ( 2 0 14 ) 61 0–6 18
utility metrics of the patients did not vary significantly between groups, this portion of the trial allows careful comparison of the cost differences between SAVR and TAVR. In an analysis of the PARTNER A cohort, Reynolds and coworkers 35 demonstrated transfemoral (TF-TAVR) but not TA-TAVR to be economically attractive in comparison to SAVR. TF-TAVR procedures were ~ 90 minutes shorter than SAVR procedures, but cost significantly more ($36,652 vs. $14,475). This excess initial cost with TF-TAVR was offset by shorter length of stay (LOS; ~ 6 days, including ~ 2 ICU days) such that index hospitalization costs similar ($73,219 vs. $74,067). With TA-TAVR, however, the higher procedural cost ($40,368 vs. $15,076) was not offset because LOS was only 1 to 2 days shorter than SAVR. This difference highlights the considerable impact of post-procedure LOS on the economics of valve replacement. In their analysis of TAVR cost from data in the FRANCE2 French registry, Chevreul and colleagues 36 corroborate this finding. While the major adjustable impact on procedural cost is location (with the catheterization lab incurring significantly less cost than the hybrid OR), the increased LOS associated with TA approach makes it economically unfavorable compared to the TF approach when both are options. Patients on warfarin and those who suffer any complication or need a pacemaker also incur significant additional costs. Conversely, in another cost-effectiveness analysis, Doble and co-workers34 using the same PARTNER trial data and a Canadian perspective that concluded TAVR (TF or TA) was financially disadvantageous compared to SAVR with an ICER of $870,143 per life-year gained. Their analysis, however, has been criticized for combining TF-TAVR and TA-TAVR data, using a younger and healthier SAVR population for comparison, and for including older population data to predict survival in their model.37 The major component of increased procedural costs for TAVR over SAVR is the cost of the transcatheter heart valve itself, and this is expected to change driven by eventual market forces and the greater availability of competitor products. The economic dominance of a valve replacement strategy can be expressed by the difference in price between TAVR and SAVR to maintain dominance. As such TF-TAVR maintains economic dominance over SAVR so long as the difference in price between valves is < $29,390; however, for TA-TAVR to be dominant that
difference would need to be < $11,324. In other words, TF-TAVR will remain economically dominant (i.e., preferable) until the price of a transcatheter heart valve (THV) rises to > $34,667, and TA-TAVR will be economically dominated until the THV costs fall to < $16,601. The cost-effectiveness of TAVR depends considerably upon the health economy in which it is used (Table 8). In Europe, health economics are different than the US, and TAVR is employed more widely due to more rapid regulatory approval. Fairbairn and colleagues38 concluded that TAVR was economically favorable to SAVR in a cost-effectiveness analysis of highrisk patients in a United Kingdom population. Of note, this analysis is the only one to find net cost savings and increase in QALY.38 Conversely, in a single-center experience at the Erasmus Medical Center, Osnabrugge and colleagues39 demonstrated SAVR to be financially advantageous to TAVR in a propensity-matched patient population with lower in-hospital costs (€33,354 vs. €40,802) and lower costs overall at 1 year (€35,511 vs. €46,217). Neyt et al.40 drew similar conclusions in their cost analysis of Belgian patients again based upon PARTNER I data. In their study, the high ICER of TAVR versus SAVR of €750,000 was driven by the small (0.03) incremental effect on QALY. Their analysis concluded an ICER of TAVR over medical treatment for inoperable patients of €44,900. Across multiple analyses, TAVR has been found to be more cost-effective than medical therapy in inoperable patients with ICERs ranging from ~ $33,000 to ~ $55,000 per life-year gained.41 The cost-effectiveness of TAVR versus SAVR in high-risk, operable patients is less favorable and varies by analysis. In general, a lower operative risk is associated with higher and less favorable cost-effectiveness ratio for TAVR.
Summary TAVR is a transformative technology with global implications offering a new treatment option for a common and lethal disease. Quality assessment has become a prominent feature of the medical landscape, and TAVR quality metrics are an important factor for determining the appropriateness of TAVR in the treatment of patients with AS. Two fundamental components of quality health care in TAVR centers of excellence are the use of a “heart team” and participation in
Table 8 – Cost-effectiveness analyses of transcatheter aortic valve replacement (TAVR) compared with medical and surgical therapies. Country
Comparison
LY Gained
QALY Gained
Cost/LY
Cost/QALY
Cost/QALY (US$)
Reynolds et al.
US
Doble et al.
Canada
Osnabrugge et al. Fairbairn et al.
The Netherlands UK
1.3 0.027 0.600 −0.010 0.75 0.030 0.068 0.063
$50,200 $50,488 $36,458 $870,143 € 42,600 * * −£10,855
$61,889 $76,877 $51,324 ⁎
Belgium
1.6 0.041 0.850 0.013 0.88 *
$61,889 $76,877 $51,324 ⁎
Neyt et al.
Medical SAVR Medical SAVR Medical SAVR SAVR SAVR
€44,900 €750,000 €157,000 −£21,380
$60,166 $1,005,000 $210,380 $33,376
Abbreviation: SAVR, surgical aortic valve replacement.
0.130
PR O G RE S S I N C ARDI O V A S CU L A R D I S EA S E S 5 6 (2 0 1 4) 61 0–6 1 8
a registry program. TAVR is an expensive therapy with costs driven largely by procurement of the valve itself, yet it appears cost-effective for inoperable patients. The costeffectiveness of TAVR when compared to SAVR remains unsettled and is most influenced by valve cost, LOS, and delivery approach (i.e., TF vs. TA).
Statement of Conflict of Interest
13.
14.
15.
Disclosure(s): The authors have no relevant financial disclosures. 16. REFERENCES 17. 1. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106:3006-3008. 2. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368:1005-1011. 3. Clark MA, Arnold SV, Duhay FG, et al. Five-year clinical and economic outcomes among patients with medically managed severe aortic stenosis: results from a Medicare claims analysis. Circ Cardiovasc Qual Outcomes. 2012;5:697-704. 4. Bach DS, Cimino N, Deeb GM. Unoperated patients with severe aortic stenosis. J Am Coll Cardiol. 2007;50:2018-2019. 5. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597-1607. 6. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-2198. 7. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686-1695. 8. Osnabrugge RL, Mylotte D, Head SJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013;62:1002-1012. 9. Donabedian A. The quality of care. How can it be assessed? JAMA. 1988;260:1743-1748. 10. Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012;42:S1-S44. 11. Holmes Jr DR, Mack MJ, Kaul S, et al. 2012 ACCF/AATS/SCAI/ STS expert consensus document on transcatheter aortic valve replacement: developed in collaboration with the American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Mended Hearts, Society of Cardiovascular Anesthesiologists, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. Catheter Cardiovasc Interv. 2012;79:1023-1082. 12. Tommaso CL, Bolman III RM, Feldman T, et al. Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: operator and institutional requirements for transcatheter valve repair and
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28. 29.
30.
617
replacement, part 1: transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2012;143:1254-1263. Leon MB, Piazza N, Nikolsky E, et al. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011;57:253-269. Mack MJ, Brennan JM, Brindis R, et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA. 2013;310:2069-2077. Di Mario C, Eltchaninoff H, Moat N, et al. The 2011–12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients. EuroIntervention. 2013;8:1362-1371. Gilard M, Eltchaninoff H, Iung B, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012;366:1705-1715. Beckmann A, Hamm C, Figulla HR, et al. The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis. Thorac Cardiovasc Surg. 2012;60:319-325. Hamm CW, Mollmann H, Holzhey D, et al. The German Aortic Valve Registry (GARY): in-hospital outcome. Eur Heart J. 2013. Zahn R, Gerckens U, Grube E, et al. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J. 2011;32:198-204. Zahn R, Gerckens U, Linke A, et al. Predictors of one-year mortality after transcatheter aortic valve implantation for severe symptomatic aortic stenosis. Am J Cardiol. 2013;112:272-279. Moat NE, Ludman P, de Belder MA, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011;58:2130-2138. Goel SS, Ige M, Tuzcu EM, et al. Severe aortic stenosis and coronary artery disease—implications for management in the transcatheter aortic valve replacement era: a comprehensive review. J Am Coll Cardiol. 2013;62:1-10. Rodes-Cabau J, Webb JG, Cheung A, et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010;55:1080-1090. Rodes-Cabau J, Webb JG, Cheung A, et al. Long-term outcomes after transcatheter aortic valve implantation: insights on prognostic factors and valve durability from the Canadian multicenter experience. J Am Coll Cardiol. 2012;60:1864-1875. Tamburino C, Capodanno D, Ramondo A, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011;123:299-308. Ussia GP, Barbanti M, Petronio AS, et al. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J. 2012;33:969-976. Bosmans JM, Kefer J, De Bruyne B, et al. Procedural, 30-day and one year outcome following CoreValve or Edwards transcatheter aortic valve implantation: results of the Belgian national registry. Interact Cardiovasc Thorac Surg. 2011;12:762-767. Linke A. The ADVANCE TAVR Registry. Miami: TCT. 2012. Thomas M, Schymik G, Walther T, et al. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010;122:62-69. Thomas M, Schymik G, Walther T, et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of
618
31.
32.
33.
34.
35.
PR O GRE S S I N C ARDI O VAS CU L AR D I S EAS E S 5 6 ( 2 0 14 ) 61 0–6 18
transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011;124:425-433. Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012;60: 1438-1454. Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LB. Recommendations of the panel on cost-effectiveness in health and medicine. JAMA. 1996;276:1253-1258. Reynolds MR, Magnuson EA, Wang K, et al. Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B). Circulation. 2012;125:1102-1109. Doble B, Blackhouse G, Goeree R, Xie F. Cost-effectiveness of the Edwards SAPIEN transcatheter heart valve compared with standard management and surgical aortic valve replacement in patients with severe symptomatic aortic stenosis: a Canadian perspective. J Thorac Cardiovasc Surg. 2013;146: 52-60. [e3]. Reynolds MR, Magnuson EA, Lei Y, et al. Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of
36.
37.
38.
39.
40.
41.
Aortic Transcatheter Valves) trial (Cohort A). J Am Coll Cardiol. 2012;60:2683-2692. Chevreul K, Brunn M, Cadier B, et al. Cost of transcatheter aortic valve implantation and factors associated with higher hospital stay cost in patients of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Arch Cardiovasc Dis. 2013;106:209-219. Osnabrugge RL, Kappetein AP. Impact of methodology and assumptions in a cost-effectiveness analysis on transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2013;145:607. Fairbairn TA, Meads DM, Hulme C, et al. The cost-effectiveness of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis at high operative risk. Heart. 2013;99:914-920. Osnabrugge RL, Head SJ, Genders TS, et al. Costs of transcatheter versus surgical aortic valve replacement in intermediate-risk patients. Ann Thorac Surg. 2012;94:1954-1960. Neyt M, Van Brabandt H, Devriese S, Van De Sande S. A cost-utility analysis of transcatheter aortic valve implantation in Belgium: focusing on a well-defined and identifiable population. BMJ Open. 2012;2. Boothroyd LJ, Spaziano M, Guertin JR, et al. Transcatheter aortic valve implantation: recommendations for practice based on a multidisciplinary review including costeffectiveness and ethical and organizational issues. Can J Cardiol. 2013;29:718-726.
Available online at www.sciencedirect.com
ScienceDirect www.onlinepcd.com
Quality, Economics, and National Guidelines for Transcatheter Aortic Valve Replacement Peter M. Pollaka,⁎, Michael J. Mackb , David R. Holmes Jr.a a
Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, MN The Heart Hospital Baylor, Plano, TX
b
A R T I C LE I N FO
AB S T R A C T
Keywords:
Transcatheter aortic valve replacement (TAVR) is a transformative technology for the
Transcatheter aortic valve replacement
treatment of aortic stenosis, requiring a multidisciplinary collaboration in the form of a
Aortic stenosis
“heart team” that includes interventional cardiologists and cardiac surgeons. As this new
National guidelines
technology continues to disperse rapidly, its proper therapeutic role evolves and leads to
Quality
important questions regarding who should perform the procedure, where it should be
Cost
performed, and who should pay for it. Herein, we review the most recent guidelines
Cost-effectiveness
governing the use of TAVR in the United States and Europe. We then summarize the available registry data, which, despite its limitations, presents the clearest picture of TAVR in clinical use. Finally, we discuss the costs and relative cost-effectiveness of TAVR. Taken together, these are the elements from which the larger questions surrounding TAVR must be answered. © 2014 Elsevier Inc. All rights reserved.
The development, approval, and now widespread application of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis (AS) represent the latest watershed moment in interventional cardiology and cardiac surgery.1 AS is a lethal disease that affects ~4% of persons aged ≥85 years, which is the fastest growing segment of the population in the Western world. The average survival for patients with symptomatic, severe AS who are medically managed is only 1.8 years. Before the availability of TAVR, up to 30% of patients with symptomatic, severe AS were considered to be too high risk for surgery and left with a poor prognosis.2–4 TAVR has emerged as a successful and durable treatment option for patients who are felt to be either inoperable or at excessively high risk for conventional surgical valve replacement.5–7 There are an estimated 292,394 patients who may benefit from TAVR in Europe and North America currently, with >27,000 new potential candidates added annually.8
Although this technology has had a profound impact on the treatment of valvular heart disease (VHD), its availability prompts several important questions regarding dissemination to society, operator and institutional qualifications, appropriate patient selection, and the economic challenges regarding costs and cost-effectiveness. In this article, we discuss the complex economics surrounding TAVR, the assessment of care quality, existing registry data, and the role of registry participation for centers.
Quality measures, guidelines, and valve centers of excellence Interest in assessing and improving health care quality has surged in recent years. Ongoing changes to the United States
Statement of Conflict of Interest: see page 617. ⁎ Address reprint requests to Peter M. Pollak, MD, Mayo Clinic, 200 First Street SW, Rochester, MN 55905. E-mail address: [email protected] (P.M. Pollak). 0033-0620/$ – see front matter © 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.pcad.2014.03.001
611
PR O G RE S S I N C ARDI O V A S CU L A R D I S EA S E S 5 6 (2 0 1 4) 61 0–6 1 8
Abbreviations and Acronyms
(US) health care system involve a greater ACC = American College of emphasis on public reCardiology porting of quality as AS = aortic stenosis well as a direct link between quality and coverAUC = appropriate use criteria age (or reimbursement). AVR = aortic valve replacement We will detail the framework used for creating CMS = Center for Medicare quality performance Services metrics and discuss CV = cardiovascular how they could be incorporated into TAVR. DRG = diagnostic-related group Measurement of ICER = incremental costhealth care quality has effectiveness ratio been approached in varying combinations LOS = length of stay of four fundamental LY = life-years instruments: performance measures, appropriate NCD = National Coverage use criteria, adherence Determination to published guidelines, PARTNER = Placement of Aortic and outcome measures. Transcatheter Valve Each of these tools was developed uniquePROM = predictive risk of ly, and has strengths mortality and weakness. It is QALY = quality-adjusted lifevery likely that reimyear bursement for health SAVR = surgical aortic valve care will be increasingly replacement tied to these measures of quality assessment. STS = Society of Thoracic Surgery Accordingly, a clear unTA = transapical derstanding of them is of paramount importance. TAVR = transcatheter aortic Performance meavalve replacement sures are considered TF = transfemoral among three care domains: structure, process, THV = transcatheter heart valve and outcome measures.9 SAVR = surgical aortic valve Structure measures are dereplacement fined as a feature of a health care organization TVTR = Transcatheter Valve or clinician relating to Therapy Registry capacity for providing US = United States high-quality care. Examples of structure meaVHD = valvular heart disease sures include procedural volumes (e.g., percutaneous coronary intervention, valve surgery) and accreditation status. Process measures are defined as health care activities performed for, on behalf of, or by a patient. Examples of process measures are the rate of transfemoral access for TAVR and the system for evaluation and patient follow-up. Outcome measures include consideration of risk and benefit with both intermediate and longterm clinical outcomes (i.e., change in physiologic state that leads to a long-term health) and health outcomes (i.e., health status of a patient resulting from care either desirable or adverse). Examples of outcome measures are stroke
rates, vascular complications, and long-term quality of life measurements. Appropriate use criteria (AUC) have been developed to aid in identifying patterns of overuse for tests or procedures in many areas of cardiovascular (CV) medicine. AUC are constructed using a modified Delphi method, and reflect the cumulative judgment of an expert panel rather than consensus. Recently, the language of appropriate use criteria was changed from appropriate, inappropriate, or uncertain to appropriate, may be appropriate, or rarely appropriate. Of note, the New York State Department of Health recently decided that it would not support reimbursement for catheter procedures considered to be rarely appropriate. Currently, no AUC have been developed for TAVR. The American Heart Association/American College of Cardiology (ACC) practice guidelines are generated by a group of clinical experts who interpret and distill relevant scientific data, emphasizing best clinical evidence, into consensus recommendations. The last revision of the practice guidelines on the management of VHD was published before the approval of TAVR in the US, and therefore do not include specific recommendations. It is expected that the forthcoming update will include specific recommendations regarding TAVR. Recommendations for TAVR are available in the most recent European Society of Cardiology guidelines for the management of VHD10 (Table 1). These recommendations are distilled from published Placement Aortic Transcatheter Valve (PARTNER) trial data as well as the European experience with TAVR. In addition to the four formal recommendations on TAVR, relative and absolute contraindications also have been put forth in the European Society guidelines (Table 2). TAVR is recommended only for patients considered to be at high risk for surgery as determined by a heart team. A EuroSCORE >20% and a Society of Thoracic Surgery (STS) score >10% are offered as indicators of high surgical risk. However, it is important to note that, in the largest registry of current European TAVR practice
Table 1 – 2012 European Society of Cardiology recommendations for transcatheter aortic valve implantation (TAVI). Recommendation TAVI should only be undertaken with a multidisciplinary “heart team” including cardiologists and heart surgeons. TAVI should only be performed in hospitals with on-site cardiac surgery, TAVI is indicated in patients with severe symptomatic aortic stenosis who are not suitable for aortic valve replacement as assessed by a “heart team” and who are likely to gain improvement in their quality of life and to have a life expectancy of more than 1 year after consideration of their comorbidities. TAVI should be considered in high-risk patients with severe symptomatic aortic stenosis who may be suitable for surgery, but in whom TAVI is favored by a “heart team” based on the individual risk profile and anatomic suitability.
Level of Class Evidence I
C
I
C
I
B
IIa
B
612
PR O GRE S S I N C ARDI O VAS CU L AR D I S EAS E S 5 6 ( 2 0 14 ) 61 0–6 18
Table 2 – Contraindications for transcatheter aortic valve implantation (TAVI) in the 2012 European Society of Cardiology guidelines.
Table 3 – Centers for Medicare Services National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR).
Absence of a “heart team” and no cardiac surgery on site Appropriateness of TAVI not confirmed by “heart team” Clinical Life expectancy 50% time at hospital with surgical program) 100 career AVR with 10 “high risk” (STS ≥6) or 25 AVR per year or 50 AVR/ 2 years with 20 in the past year Experience with peripheral bypass Experience with open retroperitoneal exposure of iliac arteries Suitable training on devices to be used Cardiologists must be BE/BC in interventional cardiology Surgeons must be BE/BC in thoracic surgery Programs >18 months: 30 TAVR (total experience) Programs 11%). The SENTINEL registry is the largest repository on TAVR from Europe, and includes in-hospital outcomes from 137 centers across 10 countries. The registry consists of 4571 patients who received the latest commercially available technology, such as the Sapien XT and 18Fr CoreValve.15 With a relatively even mix of valves used (57.3% Sapien XT), the transfemoral route was the dominant route of delivery and used in 74.2% of cases. Procedural success was high (96.5%), while major vascular complications (3.1%) and inhospital stroke (1.8%) were notably low. Conversion to open surgery (4.3%) was remarkably higher than in other registries. Perhaps most striking, there was a wide variation in use of general versus local anesthesia, varying from 100% of cases
Table 5 – Volume and outcomes for continued certification for both new and existing TAVR programs for treatment of inoperable patients. Program volume: 20 TAVR/year or 40 per 2 years 30-day all-cause mortality $60,000 based on adjustments for location alone. Hospitals with training programs also receive more reimbursement per diagnostic-related group (DRG) from
Table 7 – Summary of registry data. Total Registries Centers Patients
9 331 13,460 Avg ± SD
Age (years) Women EuroSCORE 30-day mortality 1-year mortality Stroke Procedural success Major vascular complication Pacemaker Aortic regurgitation >1+ Surgical conversion a
Weighted average.
81.6 ± 0.8 52.9% 22.4 ± 3.6% 8.7 ± 2.7% 20.5 ± 3.1% 3.0 ± 1.2% 96.4% 7.6 ± 5.5% 16.9 ± 10.4% 13.9 ± 5.6% 2.2% a
PR O G RE S S I N C ARDI O V A S CU L A R D I S EA S E S 5 6 (2 0 1 4) 61 0–6 1 8
Medicare, making a TAVR program at a private hospital less financially attractive. Medicare reimburses TAVR hospital charges using the same DRG’s as surgical aortic valve replacement (SAVR; DRG 216 through 221). The appropriate DRG is assigned based on concomitant heart catheterization and the severity of clinical comorbidities. Examples of morbidities that increase the level of DRG are renal dysfunction, chronic heart failure, and respiratory disease; major procedural complications, such as bleeding, acute stroke, and emergency surgery, also affect the DRG. Concomitant heart catheterization and more severe comorbid conditions incur significantly higher reimbursement; thus, correct selection of DRG carries important reimbursement implications for the financial viability of any TAVR program. The cost of the valve prosthesis varies widely depending on specific institutional purchasing agreements. Transcatheter heart valves themselves are significantly more expensive than surgical valves. The acquisition cost in the US for available transcatheter prostheses is approximately $30,000 to $32,500 with volume discounts, while analogous costs for surgical bioprosthetic valves are ~ $4500 to 5500. Cost-effectiveness is a metric often used when evaluating a novel technology, and reflects the cost relative to a perceived benefit. Two common expressions of cost-effectiveness are cost per quality-adjusted life-year (QALY) and the incremental costeffectiveness ratio (ICER). Many health economists have recommended using the cost per QALY metric. However, some maintain that cost-per-life-year (LY) is a more accurate metric because quality assessment is difficult to measure, and the unadjusted LY does not risk penalizing one group for a diminished perceived quality of life.32,33 It is vitally important when discussing an expensive novel technology such as TAVR to keep its cost in perspective relative to established and benchmark therapies (Fig 1). In the US, when evaluating new therapies, the cost of renal replacement therapy (i.e., dialysis) is the most common benchmark of society’s willingness to pay. The cost of dialysis is often cited as $70,000 per QALY.34 By comparison, a renal transplant costs ~ $10,000 per life-year gained. The essence of cost holds different meaning when considered from various perspectives. Patients, payers, hospitals, society, and companies who manufacture transcatheter valves all view cost in different ways. Patients focus on personal cost in terms of complication risk, discomfort, recovery time, and out-of-pocket expense. Payers, such as Medicare or other health insurance brokers, predominantly consider the financial burden of one treatment versus the other in terms of the total expected cost for a given patient over his or her life expectancy. An unseemly byproduct of this perspective is that a new therapy for patients with lethal diseases and no alternatives will always appear as a moneyloser because patients stop costing money when they die. Any therapy that keeps these highest-risk patients alive longer to incur more costs will appear unattractive from this perspective. Hospitals will view the cost of TAVR from a market perspective, balancing the ability to profit from the procedure or to attract patients who can be treated with conventional surgery but who otherwise would have been evaluated at other institutions. TAVR is currently reimbursed in the US under the
615
Cost per QALY $300,000 $250,000 $200,000 $150,000 $100,000 $50,000 $-
Fig 1 – Comparison of cost-effectiveness of transcatheter aortic valve replacement (TAVR) with other common therapies.
same Medicare DRG as SAVR despite the transcatheter prosthesis costing ~ $25,000 more than a surgical valve. Thus, hospitals generally view a TAVR program as a loss leader. Hospitals may plan to recoup the “cost” of the TAVR program from the halo effect of increased overall valve volume and referrals that come from the prestige associated with the ability to perform TAVR, as well as the increased downstream revenue from clinical consultations and additional testing. Society has perhaps the most balanced perspective of the four, comparing the overall cost to society of a new treatment to either an established treatment or no treatment. This perspective focuses on the incremental cost-effectiveness of one treatment versus the alternative. In an analysis of the PARTNER I (Cohort B) data for TAVR cost in the United States, Reynolds and co-workers33 calculated an incremental cost of $50,200 per life-year gained ($61,889/QALY) for inoperable patients with severe AS. The analysis by Doble et al.34 from a Canadian perspective concluded similar costeffectiveness ($36,458/LY and $51,324/QALY) in inoperable patients. These costs are less than the cost of dialysis, thus falling within the established “willingness to pay” standard society generally holds. The higher cost-per-QALY relative to cost-per-LY reflects the diminished utility scores in this population even after successful TAVR. It is important to examine the cost components of TAVR in this analysis in detail. The estimated cost of the Edwards SAPIEN valve was $30,000. The index hospitalization had a mean cost of $78,542, of which $42,806 was the cost of the procedure. There were cost savings in the TAVR group from decreased hospital readmission rates in comparison to medical therapy patients (1.0 vs. 2.2). Nevertheless, followup costs through 12 months were $55,000 higher per TAVR patient than those who had medical therapy, increasing to $79,000 per TAVR patient when allowing for incremental costs associated with longer life expectancy. Thus, cost savings from effective treatment with TAVR was outpaced by incremental health care expenditure related to increased patient longevity in a population with significant morbidities. The PARTNER A clinical trial randomized high-risk patients to receive either SAVR or TAVR using a transfemoral (TF) or transapical (TA) approach. Because the overall survival and
616
PR O GRE S S I N C ARDI O VAS CU L AR D I S EAS E S 5 6 ( 2 0 14 ) 61 0–6 18
utility metrics of the patients did not vary significantly between groups, this portion of the trial allows careful comparison of the cost differences between SAVR and TAVR. In an analysis of the PARTNER A cohort, Reynolds and coworkers 35 demonstrated transfemoral (TF-TAVR) but not TA-TAVR to be economically attractive in comparison to SAVR. TF-TAVR procedures were ~ 90 minutes shorter than SAVR procedures, but cost significantly more ($36,652 vs. $14,475). This excess initial cost with TF-TAVR was offset by shorter length of stay (LOS; ~ 6 days, including ~ 2 ICU days) such that index hospitalization costs similar ($73,219 vs. $74,067). With TA-TAVR, however, the higher procedural cost ($40,368 vs. $15,076) was not offset because LOS was only 1 to 2 days shorter than SAVR. This difference highlights the considerable impact of post-procedure LOS on the economics of valve replacement. In their analysis of TAVR cost from data in the FRANCE2 French registry, Chevreul and colleagues 36 corroborate this finding. While the major adjustable impact on procedural cost is location (with the catheterization lab incurring significantly less cost than the hybrid OR), the increased LOS associated with TA approach makes it economically unfavorable compared to the TF approach when both are options. Patients on warfarin and those who suffer any complication or need a pacemaker also incur significant additional costs. Conversely, in another cost-effectiveness analysis, Doble and co-workers34 using the same PARTNER trial data and a Canadian perspective that concluded TAVR (TF or TA) was financially disadvantageous compared to SAVR with an ICER of $870,143 per life-year gained. Their analysis, however, has been criticized for combining TF-TAVR and TA-TAVR data, using a younger and healthier SAVR population for comparison, and for including older population data to predict survival in their model.37 The major component of increased procedural costs for TAVR over SAVR is the cost of the transcatheter heart valve itself, and this is expected to change driven by eventual market forces and the greater availability of competitor products. The economic dominance of a valve replacement strategy can be expressed by the difference in price between TAVR and SAVR to maintain dominance. As such TF-TAVR maintains economic dominance over SAVR so long as the difference in price between valves is < $29,390; however, for TA-TAVR to be dominant that
difference would need to be < $11,324. In other words, TF-TAVR will remain economically dominant (i.e., preferable) until the price of a transcatheter heart valve (THV) rises to > $34,667, and TA-TAVR will be economically dominated until the THV costs fall to < $16,601. The cost-effectiveness of TAVR depends considerably upon the health economy in which it is used (Table 8). In Europe, health economics are different than the US, and TAVR is employed more widely due to more rapid regulatory approval. Fairbairn and colleagues38 concluded that TAVR was economically favorable to SAVR in a cost-effectiveness analysis of highrisk patients in a United Kingdom population. Of note, this analysis is the only one to find net cost savings and increase in QALY.38 Conversely, in a single-center experience at the Erasmus Medical Center, Osnabrugge and colleagues39 demonstrated SAVR to be financially advantageous to TAVR in a propensity-matched patient population with lower in-hospital costs (€33,354 vs. €40,802) and lower costs overall at 1 year (€35,511 vs. €46,217). Neyt et al.40 drew similar conclusions in their cost analysis of Belgian patients again based upon PARTNER I data. In their study, the high ICER of TAVR versus SAVR of €750,000 was driven by the small (0.03) incremental effect on QALY. Their analysis concluded an ICER of TAVR over medical treatment for inoperable patients of €44,900. Across multiple analyses, TAVR has been found to be more cost-effective than medical therapy in inoperable patients with ICERs ranging from ~ $33,000 to ~ $55,000 per life-year gained.41 The cost-effectiveness of TAVR versus SAVR in high-risk, operable patients is less favorable and varies by analysis. In general, a lower operative risk is associated with higher and less favorable cost-effectiveness ratio for TAVR.
Summary TAVR is a transformative technology with global implications offering a new treatment option for a common and lethal disease. Quality assessment has become a prominent feature of the medical landscape, and TAVR quality metrics are an important factor for determining the appropriateness of TAVR in the treatment of patients with AS. Two fundamental components of quality health care in TAVR centers of excellence are the use of a “heart team” and participation in
Table 8 – Cost-effectiveness analyses of transcatheter aortic valve replacement (TAVR) compared with medical and surgical therapies. Country
Comparison
LY Gained
QALY Gained
Cost/LY
Cost/QALY
Cost/QALY (US$)
Reynolds et al.
US
Doble et al.
Canada
Osnabrugge et al. Fairbairn et al.
The Netherlands UK
1.3 0.027 0.600 −0.010 0.75 0.030 0.068 0.063
$50,200 $50,488 $36,458 $870,143 € 42,600 * * −£10,855
$61,889 $76,877 $51,324 ⁎
Belgium
1.6 0.041 0.850 0.013 0.88 *
$61,889 $76,877 $51,324 ⁎
Neyt et al.
Medical SAVR Medical SAVR Medical SAVR SAVR SAVR
€44,900 €750,000 €157,000 −£21,380
$60,166 $1,005,000 $210,380 $33,376
Abbreviation: SAVR, surgical aortic valve replacement.
0.130
PR O G RE S S I N C ARDI O V A S CU L A R D I S EA S E S 5 6 (2 0 1 4) 61 0–6 1 8
a registry program. TAVR is an expensive therapy with costs driven largely by procurement of the valve itself, yet it appears cost-effective for inoperable patients. The costeffectiveness of TAVR when compared to SAVR remains unsettled and is most influenced by valve cost, LOS, and delivery approach (i.e., TF vs. TA).
Statement of Conflict of Interest
13.
14.
15.
Disclosure(s): The authors have no relevant financial disclosures. 16. REFERENCES 17. 1. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106:3006-3008. 2. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368:1005-1011. 3. Clark MA, Arnold SV, Duhay FG, et al. Five-year clinical and economic outcomes among patients with medically managed severe aortic stenosis: results from a Medicare claims analysis. Circ Cardiovasc Qual Outcomes. 2012;5:697-704. 4. Bach DS, Cimino N, Deeb GM. Unoperated patients with severe aortic stenosis. J Am Coll Cardiol. 2007;50:2018-2019. 5. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597-1607. 6. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-2198. 7. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366:1686-1695. 8. Osnabrugge RL, Mylotte D, Head SJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013;62:1002-1012. 9. Donabedian A. The quality of care. How can it be assessed? JAMA. 1988;260:1743-1748. 10. Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012;42:S1-S44. 11. Holmes Jr DR, Mack MJ, Kaul S, et al. 2012 ACCF/AATS/SCAI/ STS expert consensus document on transcatheter aortic valve replacement: developed in collaboration with the American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Mended Hearts, Society of Cardiovascular Anesthesiologists, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. Catheter Cardiovasc Interv. 2012;79:1023-1082. 12. Tommaso CL, Bolman III RM, Feldman T, et al. Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: operator and institutional requirements for transcatheter valve repair and
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28. 29.
30.
617
replacement, part 1: transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2012;143:1254-1263. Leon MB, Piazza N, Nikolsky E, et al. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011;57:253-269. Mack MJ, Brennan JM, Brindis R, et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA. 2013;310:2069-2077. Di Mario C, Eltchaninoff H, Moat N, et al. The 2011–12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients. EuroIntervention. 2013;8:1362-1371. Gilard M, Eltchaninoff H, Iung B, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012;366:1705-1715. Beckmann A, Hamm C, Figulla HR, et al. The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis. Thorac Cardiovasc Surg. 2012;60:319-325. Hamm CW, Mollmann H, Holzhey D, et al. The German Aortic Valve Registry (GARY): in-hospital outcome. Eur Heart J. 2013. Zahn R, Gerckens U, Grube E, et al. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J. 2011;32:198-204. Zahn R, Gerckens U, Linke A, et al. Predictors of one-year mortality after transcatheter aortic valve implantation for severe symptomatic aortic stenosis. Am J Cardiol. 2013;112:272-279. Moat NE, Ludman P, de Belder MA, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011;58:2130-2138. Goel SS, Ige M, Tuzcu EM, et al. Severe aortic stenosis and coronary artery disease—implications for management in the transcatheter aortic valve replacement era: a comprehensive review. J Am Coll Cardiol. 2013;62:1-10. Rodes-Cabau J, Webb JG, Cheung A, et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010;55:1080-1090. Rodes-Cabau J, Webb JG, Cheung A, et al. Long-term outcomes after transcatheter aortic valve implantation: insights on prognostic factors and valve durability from the Canadian multicenter experience. J Am Coll Cardiol. 2012;60:1864-1875. Tamburino C, Capodanno D, Ramondo A, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011;123:299-308. Ussia GP, Barbanti M, Petronio AS, et al. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J. 2012;33:969-976. Bosmans JM, Kefer J, De Bruyne B, et al. Procedural, 30-day and one year outcome following CoreValve or Edwards transcatheter aortic valve implantation: results of the Belgian national registry. Interact Cardiovasc Thorac Surg. 2011;12:762-767. Linke A. The ADVANCE TAVR Registry. Miami: TCT. 2012. Thomas M, Schymik G, Walther T, et al. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010;122:62-69. Thomas M, Schymik G, Walther T, et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of
618
31.
32.
33.
34.
35.
PR O GRE S S I N C ARDI O VAS CU L AR D I S EAS E S 5 6 ( 2 0 14 ) 61 0–6 18
transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011;124:425-433. Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012;60: 1438-1454. Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LB. Recommendations of the panel on cost-effectiveness in health and medicine. JAMA. 1996;276:1253-1258. Reynolds MR, Magnuson EA, Wang K, et al. Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B). Circulation. 2012;125:1102-1109. Doble B, Blackhouse G, Goeree R, Xie F. Cost-effectiveness of the Edwards SAPIEN transcatheter heart valve compared with standard management and surgical aortic valve replacement in patients with severe symptomatic aortic stenosis: a Canadian perspective. J Thorac Cardiovasc Surg. 2013;146: 52-60. [e3]. Reynolds MR, Magnuson EA, Lei Y, et al. Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of
36.
37.
38.
39.
40.
41.
Aortic Transcatheter Valves) trial (Cohort A). J Am Coll Cardiol. 2012;60:2683-2692. Chevreul K, Brunn M, Cadier B, et al. Cost of transcatheter aortic valve implantation and factors associated with higher hospital stay cost in patients of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Arch Cardiovasc Dis. 2013;106:209-219. Osnabrugge RL, Kappetein AP. Impact of methodology and assumptions in a cost-effectiveness analysis on transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2013;145:607. Fairbairn TA, Meads DM, Hulme C, et al. The cost-effectiveness of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis at high operative risk. Heart. 2013;99:914-920. Osnabrugge RL, Head SJ, Genders TS, et al. Costs of transcatheter versus surgical aortic valve replacement in intermediate-risk patients. Ann Thorac Surg. 2012;94:1954-1960. Neyt M, Van Brabandt H, Devriese S, Van De Sande S. A cost-utility analysis of transcatheter aortic valve implantation in Belgium: focusing on a well-defined and identifiable population. BMJ Open. 2012;2. Boothroyd LJ, Spaziano M, Guertin JR, et al. Transcatheter aortic valve implantation: recommendations for practice based on a multidisciplinary review including costeffectiveness and ethical and organizational issues. Can J Cardiol. 2013;29:718-726.
