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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2016

Open Access 01-12-2016 | Research

Quality of life among elderly patients undergoing transcatheter or surgical aortic valve replacement– a model-based longitudinal data analysis

Authors: Klaus Kaier, Anja Gutmann, Hardy Baumbach, Constantin von zur Mühlen, Philip Hehn, Werner Vach, Friedhelm Beyersdorf, Manfred Zehender, Christoph Bode, Jochen Reinöhl

Published in: Health and Quality of Life Outcomes | Issue 1/2016

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Abstract

Background

Quality of life (QoL) measurements reported in observational studies are often biased, since patients who failed to improve are more likely to be unable to respond due to death or impairment. In order to observe the development of QoL in patients close to death, we analyzed a set of monthly QoL measurements for a cohort of elderly patients treated for aortic valve stenosis (AS) with special consideration of the effect of distance to death.

Methods

QoL in 169 elderly patients (age ≥ 75 years), treated either with transcatheter aortic valve replacement (TAVR; n = 92), surgical aortic-valve replacement (n = 70), or drug-based therapy (n = 7), was evaluated using the standardized EQ-5D questionnaire. Over a two-year period, patients were consulted using monthly telephone interviews or outpatient visits, leading to a total of 2463 time points at which QoL values, New York Heart Association (NYHA) Functional Classification and their status of assistance were assessed. Furthermore, post-procedural clinical events and complications were monitored. Linear and ordered logistic regression analyses with random intercept were carried out, taking into account overall trends and distance to death.

Results

QoL measures decreased slightly over time, were temporarily impaired at month 1 after the initial episode of hospitalization and decreased substantially at the end of life with a measurable effect starting at the sixth from last follow-up (month) before death. Many clinical complications (bleeding complications, stroke, acute kidney injury) showed an impairment of QoL measurements, but the inclusion of lagged variables demonstrated medium term (three months) QoL impairments for access site bleeding only. All other complications are associated with event-related impairments that decreased dramatically at the second and third follow-up interviews (month) after event.

Conclusions

Distance to death shows clear effects on QoL and should be taken into account when analyzing QoL measures in the elderly patients treated for aortic valve stenosis.

Trial registration

German Clinical Trial Register Nr. DRKS00000797
Footnotes
1
Neither the extension of the time period before death to seven or more follow-up months before death, nor the extension of the post-discharge effect to two or more months showed a measurable impact on QoL measures and was therefore excluded from the regression models.
 
2
The inclusion of interaction terms between EQ-5DIndex values at baseline and time showed no substantial differences regarding their impact on EQ-5DIndex values at month 1, during year 1 post-discharge, or later than one year post-discharge.
 
3
Extension of the lagged effect did not show an impact on QoL measures and was therefore excluded from the regression models.
 
Literature
1.
Thaden JJ, Nkomo VT, Enriquez-Sarano M. The global burden of aortic stenosis. Prog Cardiovasc Dis. 2014;56(6):565–71.CrossRefPubMed
2.
Iung B, Vahanian A. Epidemiology of acquired valvular heart disease. Can J Cardiol. 2014;30(9):962–70.CrossRefPubMed
3.
Reynolds MR, Magnuson EA, Wang K, Thourani VH, Williams M, Zajarias A, Rihal CS, Brown DL, Smith CR, Leon MB. Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results from the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial (Cohort A). J Am Coll Cardiol. 2012;60(6):548–58.CrossRefPubMed
4.
Vigl M, Niggemeyer E, Hager A, Schwedler G, Kropf S, Bauer U. The importance of socio-demographic factors for the quality of life of adults with congenital heart disease. Qual Life Res. 2011;20(2):169–77.CrossRefPubMed
5.
Schoormans D, Mulder BJ, van Melle JP, Pieper PG, van Dijk AP, Sieswerda GT, Hulsbergen-Zwarts MS, Plokker TH, Brunninkhuis LG, Vliegen HW. Illness perceptions of adults with congenital heart disease and their predictive value for quality of life two years later. Eur J Cardiovasc Nurs. 2014;13(1):86–94.CrossRefPubMed
6.
Chatterjee S, Kumbhani DJ, Sardar P, Chakraborty A, Biondi-Zoccai G, Sabharwal MS, Ro R, Pratap B, Bavishi CP, Bangalore S. Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: an updated review of literature. Curr Cardiol Rep. 2014;16(4):473.CrossRefPubMed
7.
Deutsch MA, Bleiziffer S, Elhmidi Y, Piazza N, Voss B, Lange R, Krane M. Beyond adding years to life: health-related quality-of-life and functional outcomes in patients with severe aortic valve stenosis at high surgical risk undergoing transcatheter aortic valve replacement. Curr Cardiol Rev. 2013;9(4):281–94.CrossRefPubMedPubMedCentral
8.
Georgiadou P, Sbarouni E, Karavolias GK, Voudris V. Transcatheter aortic valve implantation: restoring the qualities of life in old age. Age Ageing. 2013;42(1):21–6.CrossRefPubMed
9.
Horrocks J, Closs J, Astin F. Quality of life in older adults with aortic stenosis: a narrative review. Int J Older People Nurs. 2014;9(3):227–46.CrossRefPubMed
10.
Kim CA, Rasania SP, Afilalo J, Popma JJ, Lipsitz LA, Kim DH. Functional status and quality of life after transcatheter aortic valve replacement: a systematic review. Ann Intern Med. 2014;160(4):243–54.CrossRefPubMedPubMedCentral
11.
Sehatzadeh S, Doble B, Xie F, Blackhouse G, Campbell K, Kaulback K, Chandra K, Goeree R. Transcatheter aortic valve implantation (TAVI) for treatment of aortic valve stenosis: an evidence update. Ont Health Technol Assess Ser. 2013;13(1):1–40.
12.
Shan L, Saxena A, McMahon R, Wilson A, Newcomb A. A systematic review on the quality of life benefits after aortic valve replacement in the elderly. J Thorac Cardiovasc Surg. 2013;145(5):1173–89.CrossRefPubMed
13.
Kaier K, Gutmann A, Vach W, Sorg S, Siepe M, von Zur Mühlen C, Moser M, Blanke P, Beyersdorf F, Zehender M, Bode C, Reinöhl J. " Heart Team" decision making in elderly patients with symptomatic aortic valve stenosis who underwent AVR or TAVI-a look behind the curtain. Results of the prospective TAVI Calculation of Costs Trial (TCCT). EuroIntervention. 2014. doi:10.​4244/​EIJY14M12_​06. [Epub ahead of print].
14.
Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res. 2005;14(6):1523–32.CrossRefPubMed
15.
Greiner W, Claes C, Busschbach JJV, von der Schulenburg J-MG. Validating the EQ-5D with time trade off for the German population. Eur J Health Econ. 2005;6(2):124–30.CrossRefPubMed
16.
Kappetein AP, Head SJ, Genereux P, Piazza N, Van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013;145(1):6–23.CrossRefPubMed
17.
Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A. 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 Heart J. 2012;33(19):2451–96.CrossRefPubMed
18.
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(1):52–60.CrossRefPubMed
19.
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(3):e001032.CrossRefPubMedPubMedCentral
20.
Reynolds MR, Magnuson EA, Lei Y, Wang K, Vilain K, Li H, Walczak J, Pinto DS, Thourani VH, Svensson LG. 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 Aortic Transcatheter Valves) trial (Cohort A). J Am Coll Cardiol. 2012;60(25):2683–92.CrossRefPubMed
21.
Simons CT, Cipriano LE, Shah RU, Garber AM, Owens DK, Hlatky MA. Transcatheter aortic valve replacement in nonsurgical candidates with severe, symptomatic aortic stenosis a cost-effectiveness analysis. Circ Cardiovasc Qual Outcomes. 2013;6(4):419–28.CrossRefPubMed
22.
Orlando R, Pennant M, Rooney S, Khogali S, Bayliss S, Hassan A, Moore D, Barton P. Cost-effectiveness of transcatheter aortic valve implantation (TAVI) for aortic stenosis in patients who are high risk or contraindicated for surgery: a model-based economic evaluation. Health Technol Assess. 2013;17(33):1–86.CrossRefPubMedPubMedCentral
23.
Brecker S, Mealing S, Padhiar A, Eaton J, Sculpher M, Bosmans J, Gerckens UJ, Wenaweser P, Tamburino C, Bleiziffer S. Cost-utility of transcatheter aortic valve implantation for inoperable patients with severe aortic stenosis treated by medical management: a UK cost-utility analysis based on patient-level data from the ADVANCE study. Open Heart. 2014;1(1):e000155.CrossRefPubMedPubMedCentral
24.
Eaton J, Mealing S, Thompson J, Moat N, Kappetein P, Piazza N, Busca R, Osnabrugge R. Is transcatheter aortic valve implantation (TAVI) a cost-effective treatment in patients who are ineligible for surgical aortic valve replacement? A systematic review of economic evaluations. J Med Econ. 2014;17(5):365–75.CrossRefPubMed
25.
Indraratna P, Ang SC, Gada H, Yan TD, Manganas C, Bannon P, Cao C. Systematic review of the cost-effectiveness of transcatheter aortic valve implantation. J Thorac Cardiovasc Surg. 2014;148(2):509–14.CrossRefPubMed
26.
Gada H, Kapadia SR, Tuzcu EM, Svensson LG, Marwick TH. Markov model for selection of aortic valve replacement versus transcatheter aortic valve implantation (without replacement) in high-risk patients. Am J Cardiol. 2012;109(9):1326–33.CrossRefPubMed
27.
Fairbairn TA, Meads DM, Hulme C, Mather AN, Plein S, Blackman DJ, Greenwood JP. 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(13):914–20.CrossRefPubMed
28.
Gada H, Agarwal S, Marwick TH. Perspective on the cost-effectiveness of transapical aortic valve implantation in high-risk patients: Outcomes of a decision-analytic model. Ann Cardiothorac Surg. 2012;1(2):145.PubMedPubMedCentral
29.
Watt M, Mealing S, Eaton J, Piazza N, Moat N, Brasseur P, Palmer S, Sculpher M. Cost-effectiveness of transcatheter aortic valve replacement in patients ineligible for conventional aortic valve replacement. Heart. 2012;98(5):370–6.CrossRefPubMed
30.
Reynolds MR, Magnuson EA, Wang K, Lei Y, Vilain K, Walczak J, Kodali SK, Lasala JM, O'Neill WW, Davidson CJ. 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(9):1102–9.CrossRefPubMed
Metadata
Title
Quality of life among elderly patients undergoing transcatheter or surgical aortic valve replacement– a model-based longitudinal data analysis
Authors
Klaus Kaier
Anja Gutmann
Hardy Baumbach
Constantin von zur Mühlen
Philip Hehn
Werner Vach
Friedhelm Beyersdorf
Manfred Zehender
Christoph Bode
Jochen Reinöhl
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2016
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/s12955-016-0512-9

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