Long-Term Clinical Outcome After Alcohol Septal Ablation and Its Periprocedural Predictive Factors in Japan ― A Retrospective Observational Study
Background: Evidence is limited regarding long-term clinical outcomes after alcohol septal ablation (ASA) for patients with hypertrophic obstructive cardiomyopathy and its periprocedural predictive factors in Japan.Methods and Results: This retrospective observational study included 44 patients who...
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Published in | Circulation Journal Vol. 88; no. 1; pp. 127 - 132 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Japan
The Japanese Circulation Society
25.12.2023
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Subjects | |
Online Access | Get full text |
ISSN | 1346-9843 1347-4820 1347-4820 |
DOI | 10.1253/circj.CJ-23-0529 |
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Abstract | Background: Evidence is limited regarding long-term clinical outcomes after alcohol septal ablation (ASA) for patients with hypertrophic obstructive cardiomyopathy and its periprocedural predictive factors in Japan.Methods and Results: This retrospective observational study included 44 patients who underwent ASA between 1998 and 2022 in a single center. We evaluated the periprocedural change in variables and long-term clinical outcomes after the procedure. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. The secondary outcome was all-cause death. Using multivariable Poisson regression with robust error variance, we predicted underlying periprocedural factors related to primary outcome development. ASA decreased the median pressure gradient at the left ventricular outflow tract from 88 to 33 mmHg and reduced moderate or severe mitral regurgitation (MR), present in 53% of patients before ASA, to 16%. Over a median 6-year follow-up, the cumulative incidence of the primary outcome at 5 and 10 years was 16.5% and 25.6%, respectively. After multivariable analysis, moderate or severe MR after ASA was significantly associated with the primary outcome (relative risk 8.78; 95% confidence interval 1.34–57.3; P=0.024). All-cause mortality after ASA was 15.1% and 28.9% at 5 and 10 years, respectively.Conclusions: This study presents long-term clinical outcomes after ASA in Japan. Moderate or severe MR after ASA was significantly associated with the composite of cardiovascular death or hospitalization for heart failure. |
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AbstractList | Evidence is limited regarding long-term clinical outcomes after alcohol septal ablation (ASA) for patients with hypertrophic obstructive cardiomyopathy and its periprocedural predictive factors in Japan.BACKGROUNDEvidence is limited regarding long-term clinical outcomes after alcohol septal ablation (ASA) for patients with hypertrophic obstructive cardiomyopathy and its periprocedural predictive factors in Japan.This retrospective observational study included 44 patients who underwent ASA between 1998 and 2022 in a single center. We evaluated the periprocedural change in variables and long-term clinical outcomes after the procedure. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. The secondary outcome was all-cause death. Using multivariable Poisson regression with robust error variance, we predicted underlying periprocedural factors related to primary outcome development. ASA decreased the median pressure gradient at the left ventricular outflow tract from 88 to 33 mmHg and reduced moderate or severe mitral regurgitation (MR), present in 53% of patients before ASA, to 16%. Over a median 6-year follow-up, the cumulative incidence of the primary outcome at 5 and 10 years was 16.5% and 25.6%, respectively. After multivariable analysis, moderate or severe MR after ASA was significantly associated with the primary outcome (relative risk 8.78; 95% confidence interval 1.34-57.3; P=0.024). All-cause mortality after ASA was 15.1% and 28.9% at 5 and 10 years, respectively.METHODS AND RESULTSThis retrospective observational study included 44 patients who underwent ASA between 1998 and 2022 in a single center. We evaluated the periprocedural change in variables and long-term clinical outcomes after the procedure. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. The secondary outcome was all-cause death. Using multivariable Poisson regression with robust error variance, we predicted underlying periprocedural factors related to primary outcome development. ASA decreased the median pressure gradient at the left ventricular outflow tract from 88 to 33 mmHg and reduced moderate or severe mitral regurgitation (MR), present in 53% of patients before ASA, to 16%. Over a median 6-year follow-up, the cumulative incidence of the primary outcome at 5 and 10 years was 16.5% and 25.6%, respectively. After multivariable analysis, moderate or severe MR after ASA was significantly associated with the primary outcome (relative risk 8.78; 95% confidence interval 1.34-57.3; P=0.024). All-cause mortality after ASA was 15.1% and 28.9% at 5 and 10 years, respectively.This study presents long-term clinical outcomes after ASA in Japan. Moderate or severe MR after ASA was significantly associated with the composite of cardiovascular death or hospitalization for heart failure.CONCLUSIONSThis study presents long-term clinical outcomes after ASA in Japan. Moderate or severe MR after ASA was significantly associated with the composite of cardiovascular death or hospitalization for heart failure. Evidence is limited regarding long-term clinical outcomes after alcohol septal ablation (ASA) for patients with hypertrophic obstructive cardiomyopathy and its periprocedural predictive factors in Japan. This retrospective observational study included 44 patients who underwent ASA between 1998 and 2022 in a single center. We evaluated the periprocedural change in variables and long-term clinical outcomes after the procedure. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. The secondary outcome was all-cause death. Using multivariable Poisson regression with robust error variance, we predicted underlying periprocedural factors related to primary outcome development. ASA decreased the median pressure gradient at the left ventricular outflow tract from 88 to 33 mmHg and reduced moderate or severe mitral regurgitation (MR), present in 53% of patients before ASA, to 16%. Over a median 6-year follow-up, the cumulative incidence of the primary outcome at 5 and 10 years was 16.5% and 25.6%, respectively. After multivariable analysis, moderate or severe MR after ASA was significantly associated with the primary outcome (relative risk 8.78; 95% confidence interval 1.34-57.3; P=0.024). All-cause mortality after ASA was 15.1% and 28.9% at 5 and 10 years, respectively. This study presents long-term clinical outcomes after ASA in Japan. Moderate or severe MR after ASA was significantly associated with the composite of cardiovascular death or hospitalization for heart failure. Background: Evidence is limited regarding long-term clinical outcomes after alcohol septal ablation (ASA) for patients with hypertrophic obstructive cardiomyopathy and its periprocedural predictive factors in Japan.Methods and Results: This retrospective observational study included 44 patients who underwent ASA between 1998 and 2022 in a single center. We evaluated the periprocedural change in variables and long-term clinical outcomes after the procedure. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. The secondary outcome was all-cause death. Using multivariable Poisson regression with robust error variance, we predicted underlying periprocedural factors related to primary outcome development. ASA decreased the median pressure gradient at the left ventricular outflow tract from 88 to 33 mmHg and reduced moderate or severe mitral regurgitation (MR), present in 53% of patients before ASA, to 16%. Over a median 6-year follow-up, the cumulative incidence of the primary outcome at 5 and 10 years was 16.5% and 25.6%, respectively. After multivariable analysis, moderate or severe MR after ASA was significantly associated with the primary outcome (relative risk 8.78; 95% confidence interval 1.34–57.3; P=0.024). All-cause mortality after ASA was 15.1% and 28.9% at 5 and 10 years, respectively.Conclusions: This study presents long-term clinical outcomes after ASA in Japan. Moderate or severe MR after ASA was significantly associated with the composite of cardiovascular death or hospitalization for heart failure. |
ArticleNumber | CJ-23-0529 |
Author | Maruo, Takeshi Sawayama, Yuichi Tanaka, Hiroyuki Kadota, Kazushige Nakagawa, Yoshihisa Kubo, Shunsuke Ohya, Masanobu Ono, Sachiyo |
Author_xml | – sequence: 1 fullname: Ono, Sachiyo organization: Department of Cardiovascular Medicine, Kurashiki Central Hospital – sequence: 1 fullname: Kadota, Kazushige organization: Department of Cardiovascular Medicine, Kurashiki Central Hospital – sequence: 1 fullname: Ohya, Masanobu organization: Department of Cardiology, Saiseikai Noe Hospital – sequence: 1 fullname: Sawayama, Yuichi organization: Department of Cardiovascular Medicine, Shiga University of Medical Science – sequence: 1 fullname: Kubo, Shunsuke organization: Department of Cardiovascular Medicine, Kurashiki Central Hospital – sequence: 1 fullname: Tanaka, Hiroyuki organization: Department of Cardiovascular Medicine, Kurashiki Central Hospital – sequence: 1 fullname: Nakagawa, Yoshihisa organization: Department of Cardiovascular Medicine, Shiga University of Medical Science – sequence: 1 fullname: Maruo, Takeshi organization: Department of Cardiovascular Medicine, Kurashiki Central Hospital |
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Usefulness of von Willebrand factor activity indexes to predict therapeutic response in hypertrophic cardiomyopathy. Am J Cardiol 2016; 117: 436–442, doi:10.1016/j.amjcard.2015.11.016. 25. Veselka J, Tomašov P, Januška J, Krejčí J, Adlová R. Obstruction after alcohol septal ablation is associated with cardiovascular mortality events. Heart 2016; 102: 1793–1796, doi:10.1136/heartjnl-2016-309699. 10. Singh K, Qutub M, Carson K, Hibbert B, Glover C. A meta analysis of current status of alcohol septal ablation and surgical myectomy for obstructive hypertrophic cardiomyopathy. Catheter Cardiovasc Interv 2016; 88: 107–115, doi:10.1002/ccd.26293. 13. Veselka J, Jensen MK, Liebregts M, Januska J, Krejci J, Bartel T, et al. Long-term clinical outcome after alcohol septal ablation for obstructive hypertrophic cardiomyopathy: Results from the Euro-ASA registry. Eur Heart J 2016; 37: 1517–1523, doi:10.1093/eurheartj/ehv693. 18. Fernandez R, Nappi F, Horvath SA, Guigui SA, Mihos CG. Echocardiographic and clinical outcomes of patients undergoing septal myectomy plus anterior mitral leaflet extension for hypertrophic cardiomyopathy. Rev Cardiovasc Med 2021; 22: 983–990, doi:10.31083/j.rcm2203107. 8. Ommen SR, Mital S, Burke MA, Day SM, Deswal A, Elliott P, et al. 2020 AHA/ACC guideline for the diagnosis and treatment of patients with hypertrophic cardiomyopathy. J Am Coll Cardiol 2020; 76: e159–e240, doi:10.1016/j.jacc.2020.08.045. 6. Ommen SR, Maron BJ, Olivotto I, Maron MS, Cecchi F, Betocchi S, et al. Long-term effects of surgical septal myectomy on survival in patients with obstructive hypertrophic cardiomyopathy. J Am Coll Cardiol 2005; 46: 470–476, doi:10.1016/j.jacc.2005.02.090. 3. Maron MS, Olivotto I, Zenovich AG, Link MS, Pandian NG, Kuvin JT, et al. Hypertrophic cardiomyopathy is predominantly a disease of left ventricular outflow tract obstruction. Circulation 2006; 114: 2232–2239, doi:10.1161/circulationaha.106.644682. 5. Pelliccia F, Alfieri O, Calabrò P, Cecchi F, Ferrazzi P, Gragnano F, et al. Multidisciplinary evaluation and management of obstructive hypertrophic cardiomyopathy in 2020: Towards the HCM heart team. Int J Cardiol 2020; 304: 86–92, doi:10.1016/j.ijcard.2020.01.021. 21. Rubin DB, Schenker N. Multiple imputation in health-care databases: An overview and some applications. Stat Med 1991; 10: 585–598, doi:10.1002/sim.4780100410. 23. Sorajja P, Pedersen WA, Bae R, Lesser JR, Jay D, Lin D, et al. First experience with percutaneous mitral valve plication as primary therapy for symptomatic obstructive hypertrophic cardiomyopathy. J Am Coll Cardiol 2016; 67: 2811–2818, doi:10.1016/j.jacc.2016.03.587. 16. Nakamura K, Toba T, Otake H, Kakizaki S, Fujimoto D, Takahashi Y, et al. Real-world clinical outcomes of percutaneous transluminal septal myocardial ablation for patients with drug-refractory hypertrophic obstructive cardiomyopathy: Results from a retrospective multicenter registry of non-high-volume centers. Heart Vessels 2022; 37: 1937–1946, doi:10.1007/s00380-022-02100-4. 24. Kimmelstiel C, Everett KD, Jain P, Miyashita S, Botto R, Resor C, et al. Transcatheter mitral intervention relieves dynamic outflow obstruction and reduces cardiac workload in hypertrophic cardiomyopathy. Circ Heart Fail 2022; 15: e009171, doi:10.1161/CIRCHEARTFAILURE.121.009171. 11. Sorajja P, Ommen SR, Holmes DR, Dearani JA, Rihal CS, Gersh BJ, et al. Survival after alcohol septal ablation for obstructive hypertrophic cardiomyopathy. Circulation 2012; 126: 2374–2380, doi:10.1161/circulationaha.111.076257. 1. Maron MS, Olivotto I, Betocchi S, Casey SA, Lesser JR, Losi MA, et al. Effect of left ventricular outflow tract obstruction on clinical outcome in hypertrophic cardiomyopathy. N Engl J Med 2003; 348: 295–303, doi:10.1056/nejmoa021332. 4. Dybro AM, Rasmussen TB, Nielsen RR, Andersen MJ, Jensen MK, Poulsen SH. Randomized trial of metoprolol in patients with obstructive hypertrophic cardiomyopathy. J Am Coll Cardiol 2021; 78: 2505–2517, doi:10.1016/j.jacc.2021.07.065. 22. Patlolla SH, Schaff HV, Nishimura RA, Eleid MF, Geske JB, Ommen SR. Impact of race and ethnicity on use and outcomes of septal reduction therapies for obstructive hypertrophic cardiomyopathy. J Am Heart Assoc 2023; 12: e026661, doi:10.1161/jaha.122.026661. 2. Geske JB, Ong KC, Siontis KC, Hebl VB, Ackerman MJ, Hodge DO, et al. Women with hypertrophic cardiomyopathy have worse survival. Eur Heart J 2017; 38: 3434–3440, doi:10.1093/eurheartj/ehx527. 15. Tsuchikane E, Takeda Y, Kobayashi T, Yachiku K, Nasu K, Kobayashi Y, et al. Percutaneous transluminal septal myocardial ablation for hypertrophic obstructive cardiomyopathy: Initial and follow-up results in the first 27 patients. Circ J 2003; 67: 763–767, doi:10.1253/circj.67.763. 7. Kitaoka H, Tsutsui H, Kubo T, Ide T, Chikamori T, Fukuda K, et al. JCS/JHFS 2018 guideline on the diagnosis and treatment of cardiomyopathies. Circ J 2021; 85: 1590–1689, doi:10.1253/circj.CJ-20-0910. 20. Veselka J, Liebregts M, Cooper R, Faber L, Januska J, Kashtanov M, et al. Prediction of sudden cardiac arrest after alcohol septal ablation for hypertrophic obstructive cardiomyopathy: ASA-SCARRE risk score. Am J Cardiol 2022; 184: 120–126, doi:10.1016/j.amjcard.2022.08.028. 19. Zou G. A Modified Poisson regression approach to prospective studies with binary data. Am J Epidemiol 2004; 159: 702–706, doi:10.1093/aje/kwh090. 22 23 24 25 10 11 12 13 14 15 16 17 18 19 1 2 3 4 5 6 7 8 9 20 21 38057102 - Circ J. 2023 Dec 25;88(1):133-134. doi: 10.1253/circj.CJ-23-0846 |
References_xml | – reference: 11. Sorajja P, Ommen SR, Holmes DR, Dearani JA, Rihal CS, Gersh BJ, et al. Survival after alcohol septal ablation for obstructive hypertrophic cardiomyopathy. Circulation 2012; 126: 2374–2380, doi:10.1161/circulationaha.111.076257. – reference: 9. Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, et al. 2014 ESC guidelines on diagnosis and management of hypertrophic cardiomyopathy: The Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J 2014; 35: 2733–2779, doi:10.1093/eurheartj/ehu284. – reference: 23. Sorajja P, Pedersen WA, Bae R, Lesser JR, Jay D, Lin D, et al. First experience with percutaneous mitral valve plication as primary therapy for symptomatic obstructive hypertrophic cardiomyopathy. J Am Coll Cardiol 2016; 67: 2811–2818, doi:10.1016/j.jacc.2016.03.587. – reference: 17. Blackshear JL, Kusumoto H, Safford RE, Wysokinska E, Thomas CS, Waldo OA, et al. Usefulness of von Willebrand factor activity indexes to predict therapeutic response in hypertrophic cardiomyopathy. Am J Cardiol 2016; 117: 436–442, doi:10.1016/j.amjcard.2015.11.016. – reference: 5. Pelliccia F, Alfieri O, Calabrò P, Cecchi F, Ferrazzi P, Gragnano F, et al. Multidisciplinary evaluation and management of obstructive hypertrophic cardiomyopathy in 2020: Towards the HCM heart team. Int J Cardiol 2020; 304: 86–92, doi:10.1016/j.ijcard.2020.01.021. – reference: 2. Geske JB, Ong KC, Siontis KC, Hebl VB, Ackerman MJ, Hodge DO, et al. Women with hypertrophic cardiomyopathy have worse survival. Eur Heart J 2017; 38: 3434–3440, doi:10.1093/eurheartj/ehx527. – reference: 12. Veselka J, Krejci J, Tomasov P, Zemanek D. Long-term survival after alcohol septal ablation for hypertrophic obstructive cardiomyopathy: A comparison with general population. Eur Heart J 2014; 35: 2040–2045, doi:10.1093/eurheartj/eht495. – reference: 20. Veselka J, Liebregts M, Cooper R, Faber L, Januska J, Kashtanov M, et al. Prediction of sudden cardiac arrest after alcohol septal ablation for hypertrophic obstructive cardiomyopathy: ASA-SCARRE risk score. Am J Cardiol 2022; 184: 120–126, doi:10.1016/j.amjcard.2022.08.028. – reference: 14. Cui H, Schaff HV, Wang S, Lahr BD, Rowin EJ, Rastegar H, et al. Survival following alcohol septal ablation or septal myectomy for patients with obstructive hypertrophic cardiomyopathy. J Am Coll Cardiol 2022; 79: 1647–1655, doi:10.1016/j.jacc.2022.02.032. – reference: 19. Zou G. A Modified Poisson regression approach to prospective studies with binary data. Am J Epidemiol 2004; 159: 702–706, doi:10.1093/aje/kwh090. – reference: 4. Dybro AM, Rasmussen TB, Nielsen RR, Andersen MJ, Jensen MK, Poulsen SH. Randomized trial of metoprolol in patients with obstructive hypertrophic cardiomyopathy. J Am Coll Cardiol 2021; 78: 2505–2517, doi:10.1016/j.jacc.2021.07.065. – reference: 7. Kitaoka H, Tsutsui H, Kubo T, Ide T, Chikamori T, Fukuda K, et al. JCS/JHFS 2018 guideline on the diagnosis and treatment of cardiomyopathies. Circ J 2021; 85: 1590–1689, doi:10.1253/circj.CJ-20-0910. – reference: 13. Veselka J, Jensen MK, Liebregts M, Januska J, Krejci J, Bartel T, et al. Long-term clinical outcome after alcohol septal ablation for obstructive hypertrophic cardiomyopathy: Results from the Euro-ASA registry. Eur Heart J 2016; 37: 1517–1523, doi:10.1093/eurheartj/ehv693. – reference: 6. Ommen SR, Maron BJ, Olivotto I, Maron MS, Cecchi F, Betocchi S, et al. Long-term effects of surgical septal myectomy on survival in patients with obstructive hypertrophic cardiomyopathy. J Am Coll Cardiol 2005; 46: 470–476, doi:10.1016/j.jacc.2005.02.090. – reference: 3. Maron MS, Olivotto I, Zenovich AG, Link MS, Pandian NG, Kuvin JT, et al. Hypertrophic cardiomyopathy is predominantly a disease of left ventricular outflow tract obstruction. Circulation 2006; 114: 2232–2239, doi:10.1161/circulationaha.106.644682. – reference: 1. Maron MS, Olivotto I, Betocchi S, Casey SA, Lesser JR, Losi MA, et al. Effect of left ventricular outflow tract obstruction on clinical outcome in hypertrophic cardiomyopathy. N Engl J Med 2003; 348: 295–303, doi:10.1056/nejmoa021332. – reference: 21. Rubin DB, Schenker N. Multiple imputation in health-care databases: An overview and some applications. Stat Med 1991; 10: 585–598, doi:10.1002/sim.4780100410. – reference: 8. Ommen SR, Mital S, Burke MA, Day SM, Deswal A, Elliott P, et al. 2020 AHA/ACC guideline for the diagnosis and treatment of patients with hypertrophic cardiomyopathy. J Am Coll Cardiol 2020; 76: e159–e240, doi:10.1016/j.jacc.2020.08.045. – reference: 22. Patlolla SH, Schaff HV, Nishimura RA, Eleid MF, Geske JB, Ommen SR. Impact of race and ethnicity on use and outcomes of septal reduction therapies for obstructive hypertrophic cardiomyopathy. J Am Heart Assoc 2023; 12: e026661, doi:10.1161/jaha.122.026661. – reference: 18. Fernandez R, Nappi F, Horvath SA, Guigui SA, Mihos CG. Echocardiographic and clinical outcomes of patients undergoing septal myectomy plus anterior mitral leaflet extension for hypertrophic cardiomyopathy. Rev Cardiovasc Med 2021; 22: 983–990, doi:10.31083/j.rcm2203107. – reference: 10. Singh K, Qutub M, Carson K, Hibbert B, Glover C. A meta analysis of current status of alcohol septal ablation and surgical myectomy for obstructive hypertrophic cardiomyopathy. Catheter Cardiovasc Interv 2016; 88: 107–115, doi:10.1002/ccd.26293. – reference: 16. Nakamura K, Toba T, Otake H, Kakizaki S, Fujimoto D, Takahashi Y, et al. 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Percutaneous transluminal septal myocardial ablation for hypertrophic obstructive cardiomyopathy: Initial and follow-up results in the first 27 patients. 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Snippet | Background: Evidence is limited regarding long-term clinical outcomes after alcohol septal ablation (ASA) for patients with hypertrophic obstructive... Evidence is limited regarding long-term clinical outcomes after alcohol septal ablation (ASA) for patients with hypertrophic obstructive cardiomyopathy and its... |
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SubjectTerms | Ablation Techniques - adverse effects Ablation Techniques - methods Alcohol septal ablation Cardiomyopathy, Hypertrophic - complications Cardiomyopathy, Hypertrophic - surgery Cardiovascular death Ethanol Heart Failure - complications Heart Failure - surgery Heart failure hospitalization Heart Septum Humans Japan Retrospective Studies Treatment Outcome |
Title | Long-Term Clinical Outcome After Alcohol Septal Ablation and Its Periprocedural Predictive Factors in Japan ― A Retrospective Observational Study |
URI | https://www.jstage.jst.go.jp/article/circj/88/1/88_CJ-23-0529/_article/-char/en https://www.ncbi.nlm.nih.gov/pubmed/37899174 https://www.proquest.com/docview/2884182017 |
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