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Published in: BMC Cardiovascular Disorders 1/2017

Open Access 01-12-2017 | Study protocol

Quality of care assessment and improvement in aortic stenosis - rationale and design of a multicentre registry (IMPULSE)

Authors: Norbert Frey, Richard P. Steeds, Antonio Serra, Eberhard Schulz, Stephan Baldus, Matthias Lutz, Christiane Pohlmann, Jana Kurucova, Peter Bramlage, David Messika-Zeitoun

Published in: BMC Cardiovascular Disorders | Issue 1/2017

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Abstract

Background

Severe aortic stenosis (AS) is a common, serious valve disease in which no effective medical therapy is available and, if not treated by intervention, has a 5-year survival of only 40–60%. Despite the availability of guidelines supporting the effective use of surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) to treat the majority of these patients, adherence to these guidelines in clinical practice is still unsatisfactory. Several recent studies have emphasised the necessity for improved communication between multidisciplinary teams, with the aim to ensure that severe AS patients receive appropriate treatment.

Methods/design

IMPULSE is a prospective, multicentre, European registry designed to gather data over 12 months on the treatment decisions made by referring physicians for patients newly diagnosed with severe AS. Each patient has a follow-up of 3 months. The study will consist of two observational phases to assess the appropriateness and rate of referral based on current guidelines prior to and after an interventional phase aiming to determine whether a simple quality of care intervention improves patient management.

Discussion

Data will be analysed firstly, to determine the appropriateness of treatment decisions for the management of severe AS in current European clinical practice, and secondly, to evaluate the effectiveness of facilitated data relay from a designated echocardiography department nurse to the referring physician early after diagnosis in improving quality of care. Additionally, variables will be identified that are associated with inappropriate decision-making. Collectively, the aim will be to design a clinical pathway that will improve the timely management of patients with newly diagnosed severe AS.
Literature
1.
go back to reference Eveborn GW, Schirmer H, Heggelund G, Lunde P, Rasmussen K. The evolving epidemiology of valvular aortic stenosis. the Tromso study. Heart. 2013;99(6):396–400. Epub 2012/09/04. eng.CrossRefPubMed Eveborn GW, Schirmer H, Heggelund G, Lunde P, Rasmussen K. The evolving epidemiology of valvular aortic stenosis. the Tromso study. Heart. 2013;99(6):396–400. Epub 2012/09/04. eng.CrossRefPubMed
2.
go back to reference Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, 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(11):1002–12. Epub 2013/06/04. eng.CrossRefPubMed Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, 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(11):1002–12. Epub 2013/06/04. eng.CrossRefPubMed
3.
go back to reference Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, 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(4):S1–44. Epub 2012/08/28. eng.CrossRefPubMed Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, 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(4):S1–44. Epub 2012/08/28. eng.CrossRefPubMed
4.
go back to reference Ross Jr J, Braunwald E. Aortic stenosis. Circulation. 1968;38(1 Suppl):61–7. Epub 1968/07/01. eng.PubMed Ross Jr J, Braunwald E. Aortic stenosis. Circulation. 1968;38(1 Suppl):61–7. Epub 1968/07/01. eng.PubMed
5.
go back to reference Baumgartner H, Hung J, Bermejo J, Chambers JB, Evangelista A, Griffin BP, et al. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. Eur J Echocardiogr. 2009;10(1):1–25.CrossRefPubMed Baumgartner H, Hung J, Bermejo J, Chambers JB, Evangelista A, Griffin BP, et al. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. Eur J Echocardiogr. 2009;10(1):1–25.CrossRefPubMed
6.
go back to reference Evangelista A, Flachskampf FA, Erbel R, Antonini-Canterin F, Vlachopoulos C, Rocchi G, et al. Echocardiography in aortic diseases: EAE recommendations for clinical practice. Eur J Echocardiogr. 2010;11(8):645–58.CrossRefPubMed Evangelista A, Flachskampf FA, Erbel R, Antonini-Canterin F, Vlachopoulos C, Rocchi G, et al. Echocardiography in aortic diseases: EAE recommendations for clinical practice. Eur J Echocardiogr. 2010;11(8):645–58.CrossRefPubMed
7.
go back to reference Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin 3rd JP, Guyton RA, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(22):e57–185.CrossRefPubMed Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin 3rd JP, Guyton RA, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(22):e57–185.CrossRefPubMed
8.
go back to reference Brown JM, O'Brien SM, Wu C, Sikora JA, Griffith BP, Gammie JS. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg. 2009;137(1):82–90. Epub 2009/01/22. eng.CrossRefPubMed Brown JM, O'Brien SM, Wu C, Sikora JA, Griffith BP, Gammie JS. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J Thorac Cardiovasc Surg. 2009;137(1):82–90. Epub 2009/01/22. eng.CrossRefPubMed
9.
go back to reference Bakaeen FG, Chu D, Huh J, Carabello BA. Is an age of 80 years or greater an important predictor of short-term outcomes of isolated aortic valve replacement in veterans? Ann Thorac Surg. 2010;90(3):769–74. Epub 2010/08/25. eng.CrossRefPubMed Bakaeen FG, Chu D, Huh J, Carabello BA. Is an age of 80 years or greater an important predictor of short-term outcomes of isolated aortic valve replacement in veterans? Ann Thorac Surg. 2010;90(3):769–74. Epub 2010/08/25. eng.CrossRefPubMed
10.
go back to reference Florath I, Albert A, Boening A, Ennker IC, Ennker J. Aortic valve replacement in octogenarians: identification of high-risk patients. Eur J Cardiothorac Surg. 2010;37(6):1304–10. Epub 2010/02/02. eng.CrossRefPubMed Florath I, Albert A, Boening A, Ennker IC, Ennker J. Aortic valve replacement in octogenarians: identification of high-risk patients. Eur J Cardiothorac Surg. 2010;37(6):1304–10. Epub 2010/02/02. eng.CrossRefPubMed
11.
go back to reference Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003;24(13):1231–43.CrossRefPubMed Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003;24(13):1231–43.CrossRefPubMed
12.
go back to reference Sharony R, Grossi EA, Saunders PC, Schwartz CF, Ciuffo GB, Baumann FG, et al. Aortic valve replacement in patients with impaired ventricular function. Ann Thorac Surg. 2003;75(6):1808–14. Epub 2003/06/26. eng.CrossRefPubMed Sharony R, Grossi EA, Saunders PC, Schwartz CF, Ciuffo GB, Baumann FG, et al. Aortic valve replacement in patients with impaired ventricular function. Ann Thorac Surg. 2003;75(6):1808–14. Epub 2003/06/26. eng.CrossRefPubMed
13.
go back to reference Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597–607.CrossRefPubMed Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597–607.CrossRefPubMed
14.
go back to reference Buellesfeld L, Wenaweser P, Gerckens U, Mueller R, Sauren B, Latsios G, et al. Transcatheter aortic valve implantation: predictors of procedural success--the Siegburg-Bern experience. Eur Heart J. 2010;31(8):984–91.CrossRefPubMed Buellesfeld L, Wenaweser P, Gerckens U, Mueller R, Sauren B, Latsios G, et al. Transcatheter aortic valve implantation: predictors of procedural success--the Siegburg-Bern experience. Eur Heart J. 2010;31(8):984–91.CrossRefPubMed
15.
go back to reference Piazza N, Grube E, Gerckens U, den Heijer P, Linke A, Luha O, et al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval. Euro Intervention. 2008;4(2):242–9.PubMed Piazza N, Grube E, Gerckens U, den Heijer P, Linke A, Luha O, et al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval. Euro Intervention. 2008;4(2):242–9.PubMed
16.
go back to reference Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, 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(1):62–9.CrossRefPubMed Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, 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(1):62–9.CrossRefPubMed
17.
go back to reference Chan RH, Shaw JL, Hauser TH, Markson LJ, Manning WJ. Guideline adherence for echocardiographic follow-Up in outpatients with at least moderate valvular disease. J Am Soc Echocardiogr. 2015;28(7):795–801. Epub 2015/04/07. eng.CrossRefPubMed Chan RH, Shaw JL, Hauser TH, Markson LJ, Manning WJ. Guideline adherence for echocardiographic follow-Up in outpatients with at least moderate valvular disease. J Am Soc Echocardiogr. 2015;28(7):795–801. Epub 2015/04/07. eng.CrossRefPubMed
18.
go back to reference Freed BH, Sugeng L, Furlong K, Mor-Avi V, Raman J, Jeevanandam V, et al. Reasons for nonadherence to guidelines for aortic valve replacement in patients with severe aortic stenosis and potential solutions. Am J Cardiol. 2010;105(9):1339–42. Epub 2010/04/21. eng.CrossRefPubMed Freed BH, Sugeng L, Furlong K, Mor-Avi V, Raman J, Jeevanandam V, et al. Reasons for nonadherence to guidelines for aortic valve replacement in patients with severe aortic stenosis and potential solutions. Am J Cardiol. 2010;105(9):1339–42. Epub 2010/04/21. eng.CrossRefPubMed
19.
go back to reference Iung B, Messika-Zeitoun D, Cachier A, Delahaye F, Baron G, Tornos P, et al. Actual management of patients with asymptomatic aortic valve disease: how practice fits with guidelines. Am Heart J. 2007;153(4):696–703. Epub 2007/03/27. eng.CrossRefPubMed Iung B, Messika-Zeitoun D, Cachier A, Delahaye F, Baron G, Tornos P, et al. Actual management of patients with asymptomatic aortic valve disease: how practice fits with guidelines. Am Heart J. 2007;153(4):696–703. Epub 2007/03/27. eng.CrossRefPubMed
20.
go back to reference Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005;26(24):2714–20.CrossRefPubMed Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005;26(24):2714–20.CrossRefPubMed
21.
go back to reference Rosenhek R, Iung B, Tornos P, Antunes MJ, Prendergast BD, Otto CM, et al. ESC working group on valvular heart disease position paper: assessing the risk of interventions in patients with valvular heart disease. Eur Heart J. 2012;33(7):822–8. 8a, 8b. Pubmed Central PMCID: 3345545.CrossRefPubMed Rosenhek R, Iung B, Tornos P, Antunes MJ, Prendergast BD, Otto CM, et al. ESC working group on valvular heart disease position paper: assessing the risk of interventions in patients with valvular heart disease. Eur Heart J. 2012;33(7):822–8. 8a, 8b. Pubmed Central PMCID: 3345545.CrossRefPubMed
22.
go back to reference Chambers JB, Ray S, Prendergast B, Taggart D, Westaby S, Grothier L, et al. Specialist valve clinics: recommendations from the British heart valve society working group on improving quality in the delivery of care for patients with heart valve disease. Heart. 2013;99(23):1714–6.CrossRefPubMed Chambers JB, Ray S, Prendergast B, Taggart D, Westaby S, Grothier L, et al. Specialist valve clinics: recommendations from the British heart valve society working group on improving quality in the delivery of care for patients with heart valve disease. Heart. 2013;99(23):1714–6.CrossRefPubMed
23.
go back to reference Lancellotti P, Rosenhek R, Pibarot P, Iung B, Otto CM, Tornos P, et al. ESC working group on valvular heart disease position paper--heart valve clinics: organization, structure, and experiences. Eur Heart J. 2013;34(21):1597–606.CrossRefPubMed Lancellotti P, Rosenhek R, Pibarot P, Iung B, Otto CM, Tornos P, et al. ESC working group on valvular heart disease position paper--heart valve clinics: organization, structure, and experiences. Eur Heart J. 2013;34(21):1597–606.CrossRefPubMed
24.
go back to reference Taggu W, Topham A, Hart L, Carr-White G, Sulke N, Patel NR, et al. A cardiac sonographer led follow up clinic for heart valve disease. Int J Cardiol. 2009;132(2):240–3.CrossRefPubMed Taggu W, Topham A, Hart L, Carr-White G, Sulke N, Patel NR, et al. A cardiac sonographer led follow up clinic for heart valve disease. Int J Cardiol. 2009;132(2):240–3.CrossRefPubMed
25.
go back to reference Shojania KG, McDonald KM, Wachter RM, Owens DK. Closing The Quality Gap: A Critical Analysis of Quality Improvement Strategies, Volume 1—Series Overview and Methodology. Technical Review 9 (Contract No. 290-02-0017 to the Stanford University-UCSF Evidence-based Practices Center). AHRQ Publication No. 04-0051-1. Rockville, MD: Agency for Healthcare Research and Quality. Shojania KG, McDonald KM, Wachter RM, Owens DK. Closing The Quality Gap: A Critical Analysis of Quality Improvement Strategies, Volume 1—Series Overview and Methodology. Technical Review 9 (Contract No. 290-02-0017 to the Stanford University-UCSF Evidence-based Practices Center). AHRQ Publication No. 04-0051-1. Rockville, MD: Agency for Healthcare Research and Quality.
26.
go back to reference Walsh JM, McDonald KM, Shojania KG, Sundaram V, Nayak S, Lewis R, et al. Quality improvement strategies for hypertension management: a systematic review. Med Care. 2006;44(7):646–57. Epub 2006/06/27. eng.CrossRefPubMed Walsh JM, McDonald KM, Shojania KG, Sundaram V, Nayak S, Lewis R, et al. Quality improvement strategies for hypertension management: a systematic review. Med Care. 2006;44(7):646–57. Epub 2006/06/27. eng.CrossRefPubMed
Metadata
Title
Quality of care assessment and improvement in aortic stenosis - rationale and design of a multicentre registry (IMPULSE)
Authors
Norbert Frey
Richard P. Steeds
Antonio Serra
Eberhard Schulz
Stephan Baldus
Matthias Lutz
Christiane Pohlmann
Jana Kurucova
Peter Bramlage
David Messika-Zeitoun
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Cardiovascular Disorders / Issue 1/2017
Electronic ISSN: 1471-2261
DOI
https://doi.org/10.1186/s12872-016-0439-4

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