Impact of beta blockers on patients undergoing transcatheter aortic valve replacement: the OCEAN-TAVI registry

Tetsuya Saito, Nobuhiro Yoshijima, Hiromu Hase, Fumiaki Yashima, Hikaru Tsuruta, Hideyuki Shimizu, Keiichi Fukuda, Toru Naganuma, Kazuki Mizutani, Motoharu Araki, Norio Tada, Futoshi Yamanaka, Shinichi Shirai, Minoru Tabata, Hiroshi Ueno, Kensuke Takagi, Akihiro Higashimori, Yusuke Watanabe, Masanori Yamamoto, Kentaro Hayashida, Tetsuya Saito, Nobuhiro Yoshijima, Hiromu Hase, Fumiaki Yashima, Hikaru Tsuruta, Hideyuki Shimizu, Keiichi Fukuda, Toru Naganuma, Kazuki Mizutani, Motoharu Araki, Norio Tada, Futoshi Yamanaka, Shinichi Shirai, Minoru Tabata, Hiroshi Ueno, Kensuke Takagi, Akihiro Higashimori, Yusuke Watanabe, Masanori Yamamoto, Kentaro Hayashida

Abstract

Objective: There is paucity of data on optimal medical treatment, including use of beta blockers for patients undergoing transcatheter aortic valve replacement (TAVR). The study aimed to investigate the association of beta blockers and clinical outcomes following TAVR.

Methods: We examined data of 2563 patients who underwent TAVR between October 2013 and May 2017 obtained from a prospective multicentre cohort registry, the optimised catheter valvular intervention-TAVI registry. We compared the 2-year cardiovascular and non-cardiovascular mortality and in-hospital outcomes between patients with and without preprocedural beta-blocker administration by propensity score matching (PSM).

Results: Preprocedural beta blockers were prescribed in 867 patients (33.8%). After PSM, the incidence of in-hospital congestive heart failure was significantly lower in patients with preprocedural beta blocker (p=0.046). No differences were found in 2-year cardiovascular and non-cardiovascular mortality. In the subgroup analyses, beta-blocker administration was associated with a lower cardiovascular mortality within 2 years in patients with a history of coronary artery bypass grafting (CABG; log-rank p=0.017), presence of peripheral artery disease (PAD; log-rank p=0.003) and brain natriuretic peptide (BNP) ≥400 pg/mL (log-rank p=0.003). When stratified by postprocedural left ventricular ejection fraction (post-LVEF), beta-blocker administration was associated with a lower cardiovascular mortality among patients with post-LVEF <50% (log-rank p=0.024).

Conclusions: Preprocedural beta-blocker administration was not associated with 2-year cardiovascular and non-cardiovascular mortality in overall, but was associated with a lower 2-year cardiovascular mortality in patients with a history of CABG, presence of PAD, BNP ≥400 pg/mL and post-LVEF <50%. The findings must be validated using randomised trials.

Keywords: aortic valve disease; beta blockers; percutaneous valve therapy.

Conflict of interest statement

Competing interests: MY, NT, TN, SS, KM and YW are clinical proctors for Edwards Lifesciences and Medtronic. MA, MT, KT, AH, HS and KH are clinical proctors of Edwards Lifesciences. HU is a clinical proctor for Medtronic.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow diagram. Of 2588 patients, 25 patients were excluded due to conversion to open surgery. Beta-blocker (−)=patients without preprocedural beta blockers; beta-blocker (+)=patients with preprocedural beta blockers. OCEAN, Optimised transCathEter vAlvular iNtervention; TAVR, transcatheter aortic valve replacement.
Figure 2
Figure 2
Kaplan-Meier curves of cardiovascular mortality and non-cardiovascular mortality in the non-matched and matched cohort. Two-year cardiovascular mortality and non-cardiovascular mortality of patients with beta-blocker administration compared with those without in the (A) non-matched and (B) matched cohort. TAVR, transcatheter aortic valve replacement.
Figure 3
Figure 3
Subgroup analyses for cardiovascular mortality. Beta-blocker (−)=patients without preprocedural beta blockers; beta-blocker (+)=patients with preprocedural beta blockers. Forest plot representing the HRs of cardiovascular mortality in patients with beta-blocker administration compared with patients without, stratified by preprocedural characteristics. AF, atrial fibrillation; AR, aortic regurgitation; BNP, brain natriuretic peptide; CABG, coronary artery bypass grafting; CAD, coronary artery disease; CKD, chronic kidney disease; LVEF, left ventricular ejection fraction; MR, mitral regurgitation; PAD, peripheral artery disease.
Figure 4
Figure 4
Cardiovascular mortality in subgroups. Kaplan-Meier curve of cardiovascular mortality in patient with and without a history of coronary artery bypass grafting (CABG), with and without presence of peripheral artery disease (PAD), with brain natriuretic peptide (BNP) ≥400 pg/mL. TAVR, transcatheter aortic valve replacement.
Figure 5
Figure 5
Subgroup analyses for non-cardiovascular mortality. Forest plot representing the HRs of non-cardiovascular mortality in patients with beta-blocker administration compared with patients without, stratified by preprocedural characteristics. BMI, body mass index; CFS, Clinical Frail Score; CKD, chronic kidney disease; COPD, chronic obstructive pulmonary disease; NYHA, New York Heart Association; PAD, peripheral artery disease.
Figure 6
Figure 6
Cardiovascular mortality stratified by left ventricular ejection fraction (LVEF). Kaplan-Meier curve of cardiovascular mortality in patient with preprocedural LVEF ≥50% or ≥50% or <50% (B). TAVR, transcatheter aortic valve replacement.

References

    1. Nadir MA, Wei L, Elder DHJ, et al. . Impact of renin-angiotensin system blockade therapy on outcome in aortic stenosis. J Am Coll Cardiol 2011;58:570–6. 10.1016/j.jacc.2011.01.063
    1. Yamamoto K, Yamamoto H, Takeuchi M, et al. . Risk factors for progression of degenerative aortic valve disease in the Japanese- the Japanese aortic stenosis study (JASS) prospective analysis. Circ J 2015;79:2050–7. 10.1253/circj.CJ-15-0499
    1. Rossi A, Temporelli PL, Cicoira M, et al. . Beta-Blockers can improve survival in medically-treated patients with severe symptomatic aortic stenosis. Int J Cardiol 2015;190:15–17. 10.1016/j.ijcard.2015.04.083
    1. Hansson NH, Sörensen J, Harms HJ, et al. . Metoprolol reduces hemodynamic and metabolic overload in asymptomatic aortic valve stenosis patients: a randomized trial. Circ Cardiovasc Imaging 2017;10:1–9. 10.1161/CIRCIMAGING.117.006557
    1. Makkar RR, Fontana GP, Jilaihawi H, et al. . Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med 2012;366:1696–704. 10.1056/NEJMoa1202277
    1. Leon MB, Smith CR, Mack MJ, et al. . Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016;374:1609–20. 10.1056/NEJMoa1514616
    1. Reardon MJ, Van Mieghem NM, Popma JJ, et al. . Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 2017;376:1321–31. 10.1056/NEJMoa1700456
    1. Mack MJ, Leon MB, Thourani VH, et al. . Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019;380:1695–705. 10.1056/NEJMoa1814052
    1. Popma JJ, Deeb GM, Yakubov SJ, et al. . Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 2019;380:1706–15. 10.1056/NEJMoa1816885
    1. Ochiai T, Saito S, Yamanaka F, et al. . Renin-Angiotensin system blockade therapy after transcatheter aortic valve implantation. Heart 2018;104:644–51. 10.1136/heartjnl-2017-311738
    1. Inohara T, Manandhar P, Kosinski AS, et al. . Association of renin-angiotensin inhibitor treatment with mortality and heart failure readmission in patients with transcatheter aortic valve replacement. JAMA 2018;320:2231–40. 10.1001/jama.2018.18077
    1. Kappetein AP, Head SJ, Généreux P, et al. . Updated standardized endpoint definitions for transcatheter aortic valve implantation: the valve academic research Consortium-2 consensus document. EuroIntervention 2012;8:782–95. 10.4244/EIJV8I7A121
    1. Lang RM, Badano LP, Mor-Avi V, et al. . Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of echocardiography and the European association of cardiovascular imaging. J Am Soc Echocardiogr 2015;28:e14:1–39. 10.1016/j.echo.2014.10.003
    1. Baumgartner H, Hung J, Bermejo J, et al. . Recommendations on the echocardiographic assessment of aortic valve stenosis: a focused update from the European association of cardiovascular imaging and the American Society of echocardiography. J Am Soc Echocardiogr 2017;30:372–92. 10.1016/j.echo.2017.02.009
    1. Maisel A. B-Type natriuretic peptide levels: diagnostic and prognostic in congestive heart failure: what's next? Circulation 2002;105:2328–31. 10.1161/01.CIR.0000019121.91548.C2
    1. Maisel A, Mueller C, Adams K, et al. . State of the art: using natriuretic peptide levels in clinical practice. Eur J Heart Fail 2008;10:824–39. 10.1016/j.ejheart.2008.07.014
    1. CIBIS-Ⅱ Investigators nad Committees The cardiac insufficiency bisoprolol study II (CIBIS-II): a randomised trial. Lancet 1999;353:9-13.
    1. MERIT-HF group Effect of metoprolol CR / XL in chronic heart failure : Metoprolol CR / XL Randomised Intervention Trial in Congestive Heart Failure. Lancet 2001;353:2001–7.
    1. Packer M, Bristow MR, Cohn JN, et al. . The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. N Engl J Med 1996;334:1349–55. 10.1056/NEJM199605233342101
    1. Bouleti C, Amsallem M, Touati A, et al. . Early and late outcomes after trans-catheter aortic valve implantation in patients with previous chest radiation. Heart 2016;102:1044–51. 10.1136/heartjnl-2015-309101
    1. Younis A, Orvin K, Nof E, et al. . The effect of periprocedural beta blocker withdrawal on arrhythmic risk following transcatheter aortic valve replacement. Catheter Cardiovasc Interv 2019;93:1361–6. 10.1002/ccd.28017
    1. Etminan M, Jafari S, Carleton B, et al. . Beta-Blocker use and COPD mortality: a systematic review and meta-analysis. BMC Pulm Med 2012;12:48. 10.1186/1471-2466-12-48
    1. Blessberger H, Kammler J, Domanovits H, et al. . Perioperative beta-blockers for preventing surgery-related mortality and morbidity. Cochrane Database Syst Rev 2018;3:CD004476. 10.1002/14651858.CD004476.pub3
    1. Kawashima H, Watanabe Y, Kozuma K, et al. . Comparison of midterm outcomes of transcatheter aortic valve implantation in patients with and without previous coronary artery bypass grafting. Heart Vessels 2018;33:1229–37. 10.1007/s00380-018-1166-9
    1. Abramowitz Y, Chakravarty T, Jilaihawi H, et al. . Impact of Preprocedural B-type natriuretic peptide levels on the outcomes after transcatheter aortic valve implantation. Am J Cardiol 2015;116:1904–9. 10.1016/j.amjcard.2015.09.031
    1. Fanaroff AC, Manandhar P, Holmes DR, et al. . Peripheral artery disease and transcatheter aortic valve replacement outcomes: a report from the Society of thoracic Surgeons/American College of cardiology transcatheter therapy registry. Circ Cardiovasc Interv 2017;10:e005456. 10.1161/CIRCINTERVENTIONS.117.005456
    1. Ewe SH, Ajmone Marsan N, Pepi M, et al. . Impact of left ventricular systolic function on clinical and echocardiographic outcomes following transcatheter aortic valve implantation for severe aortic stenosis. Am Heart J 2010;160:1113–20. 10.1016/j.ahj.2010.09.003
    1. Satiroglu O, Kocaman SA, Karadag Z, et al. . Relationship of the angiographic extent of peripheral arterial disease with coronary artery involvement. J Pak Med Assoc 2012;62:644–9.
    1. Zhang H, Yuan X, Zhang H, et al. . Efficacy of long-term β-blocker therapy for secondary prevention of long-term outcomes after coronary artery bypass grafting surgery. Circulation 2015;131:2194–201. 10.1161/CIRCULATIONAHA.114.014209
    1. Feringa HHH, Bax JJ, Hoeks S, et al. . A prognostic risk index for long-term mortality in patients with peripheral arterial disease. Arch Intern Med 2007;167:2482–9. 10.1001/archinte.167.22.2482
    1. Cleland JGF, Bunting KV, Flather MD, et al. . Beta-Blockers for heart failure with reduced, mid-range, and preserved ejection fraction: an individual patient-level analysis of double-blind randomized trials. Eur Heart J 2018;39:26–35. 10.1093/eurheartj/ehx564
    1. Fiuzat M, Wojdyla D, Pina I, et al. . Heart Rate or Beta-Blocker Dose? Association With Outcomes in Ambulatory Heart Failure Patients With Systolic Dysfunction: Results From the HF-ACTION Trial. JACC Heart Fail 2016;4:109–15. 10.1016/j.jchf.2015.09.002

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