Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial
Background:The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Japan Trial was developed to assess the safety and effectiveness of the 17-mm Avalus bioprosthesis (Medtronic, Minneapolis, MN, USA) in patients undergoing surgical aortic valve replacement.Methods and Results:The primary endpoin...
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| Published in | Circulation Journal Vol. 85; no. 7; pp. 1035 - 1041 |
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| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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Japan
The Japanese Circulation Society
25.06.2021
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| Abstract | Background:The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Japan Trial was developed to assess the safety and effectiveness of the 17-mm Avalus bioprosthesis (Medtronic, Minneapolis, MN, USA) in patients undergoing surgical aortic valve replacement.Methods and Results:The primary endpoint in the trial was the percentage of patients achieving the composite of at least 1 class improvement in New York Heart Association (NYHA) functional class at 1 year compared with baseline and effective orifice area index (EOAI) of 0.6 cm2/m2or greater at 1-year after implantation, compared with a performance goal of 60%. The present study reports outcomes through 2 years. Eleven patients were implanted (10 [91%] female, median age 78.3 years). From baseline to 1 year, 10 subjects (91%) showed an improvement in NYHA classification. At 1 year, mean (±SD) EOAI was 0.82±0.17 cm2/m2, with 10 patients (91%) having an EOAI ≥0.6 cm2/m2. As such, 9 of 11 patients (82%) successfully met the primary endpoint. One death occurred between the 1- and 2-year follow-up visits, unrelated to the valve. There were no valve reinterventions, explants, or device deficiencies through 2 years.Conclusions:The PERIGON Japan Trial met its primary endpoint. Surgical implantation of the 17-mm Avalus aortic bioprosthesis can be performed with an acceptable incidence of device-related adverse events, and the valve performs effectively based on echocardiographic findings. |
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| AbstractList | The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Japan Trial was developed to assess the safety and effectiveness of the 17-mm Avalus bioprosthesis (Medtronic, Minneapolis, MN, USA) in patients undergoing surgical aortic valve replacement.BACKGROUNDThe PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Japan Trial was developed to assess the safety and effectiveness of the 17-mm Avalus bioprosthesis (Medtronic, Minneapolis, MN, USA) in patients undergoing surgical aortic valve replacement.The primary endpoint in the trial was the percentage of patients achieving the composite of at least 1 class improvement in New York Heart Association (NYHA) functional class at 1 year compared with baseline and effective orifice area index (EOAI) of 0.6 cm2/m2or greater at 1-year after implantation, compared with a performance goal of 60%. The present study reports outcomes through 2 years. Eleven patients were implanted (10 [91%] female, median age 78.3 years). From baseline to 1 year, 10 subjects (91%) showed an improvement in NYHA classification. At 1 year, mean (±SD) EOAI was 0.82±0.17 cm2/m2, with 10 patients (91%) having an EOAI ≥0.6 cm2/m2. As such, 9 of 11 patients (82%) successfully met the primary endpoint. One death occurred between the 1- and 2-year follow-up visits, unrelated to the valve. There were no valve reinterventions, explants, or device deficiencies through 2 years.METHODS AND RESULTSThe primary endpoint in the trial was the percentage of patients achieving the composite of at least 1 class improvement in New York Heart Association (NYHA) functional class at 1 year compared with baseline and effective orifice area index (EOAI) of 0.6 cm2/m2or greater at 1-year after implantation, compared with a performance goal of 60%. The present study reports outcomes through 2 years. Eleven patients were implanted (10 [91%] female, median age 78.3 years). From baseline to 1 year, 10 subjects (91%) showed an improvement in NYHA classification. At 1 year, mean (±SD) EOAI was 0.82±0.17 cm2/m2, with 10 patients (91%) having an EOAI ≥0.6 cm2/m2. As such, 9 of 11 patients (82%) successfully met the primary endpoint. One death occurred between the 1- and 2-year follow-up visits, unrelated to the valve. There were no valve reinterventions, explants, or device deficiencies through 2 years.The PERIGON Japan Trial met its primary endpoint. Surgical implantation of the 17-mm Avalus aortic bioprosthesis can be performed with an acceptable incidence of device-related adverse events, and the valve performs effectively based on echocardiographic findings.CONCLUSIONSThe PERIGON Japan Trial met its primary endpoint. Surgical implantation of the 17-mm Avalus aortic bioprosthesis can be performed with an acceptable incidence of device-related adverse events, and the valve performs effectively based on echocardiographic findings. Background:The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Japan Trial was developed to assess the safety and effectiveness of the 17-mm Avalus bioprosthesis (Medtronic, Minneapolis, MN, USA) in patients undergoing surgical aortic valve replacement.Methods and Results:The primary endpoint in the trial was the percentage of patients achieving the composite of at least 1 class improvement in New York Heart Association (NYHA) functional class at 1 year compared with baseline and effective orifice area index (EOAI) of 0.6 cm2/m2or greater at 1-year after implantation, compared with a performance goal of 60%. The present study reports outcomes through 2 years. Eleven patients were implanted (10 [91%] female, median age 78.3 years). From baseline to 1 year, 10 subjects (91%) showed an improvement in NYHA classification. At 1 year, mean (±SD) EOAI was 0.82±0.17 cm2/m2, with 10 patients (91%) having an EOAI ≥0.6 cm2/m2. As such, 9 of 11 patients (82%) successfully met the primary endpoint. One death occurred between the 1- and 2-year follow-up visits, unrelated to the valve. There were no valve reinterventions, explants, or device deficiencies through 2 years.Conclusions:The PERIGON Japan Trial met its primary endpoint. Surgical implantation of the 17-mm Avalus aortic bioprosthesis can be performed with an acceptable incidence of device-related adverse events, and the valve performs effectively based on echocardiographic findings. The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Japan Trial was developed to assess the safety and effectiveness of the 17-mm Avalus bioprosthesis (Medtronic, Minneapolis, MN, USA) in patients undergoing surgical aortic valve replacement. The primary endpoint in the trial was the percentage of patients achieving the composite of at least 1 class improvement in New York Heart Association (NYHA) functional class at 1 year compared with baseline and effective orifice area index (EOAI) of 0.6 cm /m or greater at 1-year after implantation, compared with a performance goal of 60%. The present study reports outcomes through 2 years. Eleven patients were implanted (10 [91%] female, median age 78.3 years). From baseline to 1 year, 10 subjects (91%) showed an improvement in NYHA classification. At 1 year, mean (±SD) EOAI was 0.82±0.17 cm /m , with 10 patients (91%) having an EOAI ≥0.6 cm /m . As such, 9 of 11 patients (82%) successfully met the primary endpoint. One death occurred between the 1- and 2-year follow-up visits, unrelated to the valve. There were no valve reinterventions, explants, or device deficiencies through 2 years. The PERIGON Japan Trial met its primary endpoint. Surgical implantation of the 17-mm Avalus aortic bioprosthesis can be performed with an acceptable incidence of device-related adverse events, and the valve performs effectively based on echocardiographic findings. |
| Author | Murakami, Hirohisa Yaku, Hitoshi Yamaguchi, Atsushi Gearhart, Elizabeth Yamanaka, Katsuhiro Fujita, Tomoyuki Komiya, Tatsuhiko Zaikokuji, Kenta Okita, Yutaka Nakajima, Hiroyuki Fukumura, Yoshiaki |
| Author_xml | – sequence: 1 fullname: Yaku, Hitoshi organization: Kyoto Prefectural University of Medicine – sequence: 1 fullname: Fujita, Tomoyuki organization: National Cerebral and Cardiovascular Center – sequence: 1 fullname: Nakajima, Hiroyuki organization: Saitama Medical University International Medical Center – sequence: 1 fullname: Fukumura, Yoshiaki organization: Tokushima Red Cross Hospital – sequence: 1 fullname: Gearhart, Elizabeth organization: Medtronic – sequence: 1 fullname: Okita, Yutaka organization: Takatsuki General Hospital – sequence: 1 fullname: Yamanaka, Katsuhiro organization: Kobe University Hospital – sequence: 1 fullname: Yamaguchi, Atsushi organization: Jichi Medical University Saitama Medical Center – sequence: 1 fullname: Komiya, Tatsuhiko organization: Kurashiki Central Hospital – sequence: 1 fullname: Murakami, Hirohisa organization: Hyogo Brain and Heart Center – sequence: 1 fullname: Zaikokuji, Kenta organization: Sakakibara Heart Institute |
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| Cites_doi | 10.1161/CIRCINTERVENTIONS.118.007396 10.1016/j.athoracsur.2017.08.059 10.1055/s-0033-1363498 10.1177/0218492311419449 10.1161/CIRCINTERVENTIONS.114.001681 10.15420/icr.2018.22.1 10.1007/s00392-014-0713-3 10.1093/ejcts/ezx066 10.1016/j.athoracsur.2007.12.031 10.1093/ejcts/ezw247 10.1093/icvts/ivv284 10.1016/j.jjcc.2014.05.001 10.1080/14779072.2018.1524295 10.1016/j.jtcvs.2018.03.171 10.1161/CIRCULATIONAHA.118.038408 10.1016/j.athoracsur.2018.01.090 10.1253/circj.CJ-13-1068 10.1055/s-0035-1563669 |
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Rodes-Cabau J, Pibarot P, Suri RM, Kodali S, Thourani VH, Szeto WY, et al. Impact of aortic annulus size on valve hemodynamics and clinical outcomes after transcatheter and surgical aortic valve replacement: Insights from the PARTNER Trial. Circ Cardiovasc Interv 2014; 7: 701–711. 12. Hoffmann G, Ogbamicael SA, Jochens A, Frank D, Lutter G, Cremer J, et al. Impact of patient-prosthesis mismatch following aortic valve replacement on short-term survival: A retrospective single center analysis of 632 consecutive patients with isolated stented biological aortic valve replacement. Thorac Cardiovasc Surg 2014; 62: 469–474. 4. Ohira S, Miyata H, Doi K, Motomura N, Takamoto S, Yaku H. Risk model of aortic valve replacement after cardiovascular surgery based on a National Japanese Database. Eur J Cardiothorac Surg 2017; 51: 347–353. 7. Domoto S, Niinami H, Uwabe K, Koike H, Tabata M, Morita K, et al. 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J Heart Valve Dis 1996; 5(Suppl 3): S289–S293. 1. Klautz RJM, Kappetein AP, Lange R, Dagenais F, Labrousse L, Bapat V, et al. Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Eur J Cardiothorac Surg 2017; 52: 425–431. 21. Geis NA, Chorianopoulos E, Kallenbach K, Andre F, Pleger ST, Karck M, et al. Feasibility of sheathless transfemoral aortic valve implantation in patients with small access vessel diameters. Clin Res Cardiol 2014; 103: 775–780. 2. Sabik JF 3rd, Rao V, Lange R, Kappetein AP, Dagenais F, Labrousse L, et al. One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis. J Thorac Cardiovasc Surg 2018; 156: 1368–1377.e1365. 22. Okamoto Y, Yamamoto K, Sugimoto T, Yoshii S. Early and late outcomes of aortic valve replacement with aortic annular enlargement: A propensity analysis. Thorac Cardiovasc Surg 2016; 64: 410–417. 11 22 12 23 13 14 15 16 17 18 19 1 2 3 4 5 6 7 8 9 20 10 21 |
| References_xml | – reference: 14. Watanabe Y, Hayashida K, Takayama M, Mitsudo K, Nanto S, Takanashi S, et al. First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation: The Massy study group vs. the PREVAIL JAPAN trial. J Cardiol 2015; 65: 112–116. – reference: 11. Fallon JM, DeSimone JP, Brennan JM, O’Brien S, Thibault DP, DiScipio AW, et al. The incidence and consequence of prosthesis-patient mismatch after surgical aortic valve replacement. Ann Thorac Surg 2018; 106: 14–22. – reference: 10. Freitas-Ferraz AB, Tirado-Conte G, Dagenais F, Ruel M, Al-Atassi T, Dumont E, et al. Aortic stenosis and small aortic annulus. Circulation 2019; 139: 2685–2702. – reference: 16. Rodes-Cabau J, Pibarot P, Suri RM, Kodali S, Thourani VH, Szeto WY, et al. Impact of aortic annulus size on valve hemodynamics and clinical outcomes after transcatheter and surgical aortic valve replacement: Insights from the PARTNER Trial. Circ Cardiovasc Interv 2014; 7: 701–711. – reference: 17. Deeb GM, Chetcuti SJ, Yakubov SJ, Patel HJ, Grossman PM, Kleiman NS, et al. Impact of annular size on outcomes after surgical or transcatheter aortic valve replacement. Ann Thorac Surg 2018; 105: 1129–1136. – reference: 9. Sato M, Suenaga E, Koga S, Kawasaki H. Aortic valve replacement with smaller valve size. Asian Cardiovasc Thorac Ann 2011; 19: 314–319. – reference: 22. Okamoto Y, Yamamoto K, Sugimoto T, Yoshii S. Early and late outcomes of aortic valve replacement with aortic annular enlargement: A propensity analysis. Thorac Cardiovasc Surg 2016; 64: 410–417. – reference: 15. Head SJ, Reardon MJ, Deeb GM, Van Mieghem NM, Popma JJ, Gleason TG, et al. Computed tomography-based indexed aortic annulus size to predict prosthesis-patient mismatch. Circ Cardiovasc Interv 2019; 12: e007396. – reference: 5. Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, et al. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines 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 (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2008; 52: e1–e142. – reference: 7. Domoto S, Niinami H, Uwabe K, Koike H, Tabata M, Morita K, et al. Comparison of early haemodynamics of 19-mm aortic valve bioprostheses in patients with a small aortic annulus. Interact Cardiovasc Thorac Surg 2016; 22: 19–25. – reference: 12. Hoffmann G, Ogbamicael SA, Jochens A, Frank D, Lutter G, Cremer J, et al. Impact of patient-prosthesis mismatch following aortic valve replacement on short-term survival: A retrospective single center analysis of 632 consecutive patients with isolated stented biological aortic valve replacement. Thorac Cardiovasc Surg 2014; 62: 469–474. – reference: 8. Yoshikawa K, Fukunaga S, Arinaga K, Hori H, Nakamura E, Ueda T, et al. Long-term results of aortic valve replacement with a small St. Jude medical valve in Japanese patients. Ann Thorac Surg 2008; 85: 1303–1308. – reference: 13. Franzen SF, Huljebrant IE, Konstantinov IE, Nylander E, Olin CL. Aortic valve replacement for aortic stenosis in patients with small aortic root. J Heart Valve Dis 1996; 5(Suppl 3): S284–S288. – reference: 6. Minakata K, Tanaka S, Okawa Y, Shimamoto M, Kaneko T, Takahara Y, et al. Long-term outcome of the carpentier-edwards pericardial valve in the aortic position in Japanese patients. Circ J 2014; 78: 882–889. – reference: 19. Overtchouk P, Modine T. A comparison of alternative access routes for transcatheter aortic valve implantation. Expert Rev Cardiovasc Ther 2018; 16: 749–756. – reference: 20. Overtchouk P, Modine T. Alternate access for TAVI: Stay clear of the chest. Interv Cardiol 2018; 13: 145–150. – reference: 1. Klautz RJM, Kappetein AP, Lange R, Dagenais F, Labrousse L, Bapat V, et al. Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Eur J Cardiothorac Surg 2017; 52: 425–431. – reference: 3. Watanabe Y, Morice M, Kozuma K, Yamamoto M, Kawashima H, Yashima F, et al. Comparison of aortic annulus dimensions between Japanese and European patients undergoing transcatheter aortic valve implantation as determined by multi-detector computed tomography: Results from the OCEAN-TAVI (Optimised transCathEter vAlvular interveNtion) registry and a European single-centre cohort. AsiaIntervention 2016; 2: 49–56. – reference: 4. Ohira S, Miyata H, Doi K, Motomura N, Takamoto S, Yaku H. Risk model of aortic valve replacement after cardiovascular surgery based on a National Japanese Database. Eur J Cardiothorac Surg 2017; 51: 347–353. – reference: 21. Geis NA, Chorianopoulos E, Kallenbach K, Andre F, Pleger ST, Karck M, et al. Feasibility of sheathless transfemoral aortic valve implantation in patients with small access vessel diameters. Clin Res Cardiol 2014; 103: 775–780. – reference: 23. Kitamura M, Satoh M, Hachida M, Endo M, Hashimoto A, Koyanagi H. Aortic valve replacement in small aortic annulus with or without annular enlargement. J Heart Valve Dis 1996; 5(Suppl 3): S289–S293. – reference: 18. Stamou SC, Lin N, James T, Rothenberg M, Lovitz L, Faber C, et al. Alternative access versus transfemoral transcatheter aortic valve replacement in nonagenarians. J Invasive Cardiol 2019; 31: 171–175. – reference: 2. Sabik JF 3rd, Rao V, Lange R, Kappetein AP, Dagenais F, Labrousse L, et al. One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis. J Thorac Cardiovasc Surg 2018; 156: 1368–1377.e1365. – ident: 3 – ident: 18 – ident: 15 doi: 10.1161/CIRCINTERVENTIONS.118.007396 – ident: 17 doi: 10.1016/j.athoracsur.2017.08.059 – ident: 5 – ident: 12 doi: 10.1055/s-0033-1363498 – ident: 9 doi: 10.1177/0218492311419449 – ident: 16 doi: 10.1161/CIRCINTERVENTIONS.114.001681 – ident: 20 doi: 10.15420/icr.2018.22.1 – ident: 21 doi: 10.1007/s00392-014-0713-3 – ident: 1 doi: 10.1093/ejcts/ezx066 – ident: 13 – ident: 8 doi: 10.1016/j.athoracsur.2007.12.031 – ident: 4 doi: 10.1093/ejcts/ezw247 – ident: 7 doi: 10.1093/icvts/ivv284 – ident: 14 doi: 10.1016/j.jjcc.2014.05.001 – ident: 19 doi: 10.1080/14779072.2018.1524295 – ident: 2 doi: 10.1016/j.jtcvs.2018.03.171 – ident: 10 doi: 10.1161/CIRCULATIONAHA.118.038408 – ident: 11 doi: 10.1016/j.athoracsur.2018.01.090 – ident: 6 doi: 10.1253/circj.CJ-13-1068 – ident: 22 doi: 10.1055/s-0035-1563669 – ident: 23 |
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| Snippet | Background:The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Japan Trial was developed to assess the safety and effectiveness of the 17-mm Avalus... The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Japan Trial was developed to assess the safety and effectiveness of the 17-mm Avalus bioprosthesis... |
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| SubjectTerms | Aged Aortic regurgitation Aortic stenosis Aortic Valve - diagnostic imaging Aortic Valve - surgery Aortic Valve Stenosis - surgery Bovine pericardial tissue valve Female Heart Valve Prosthesis Implantation Humans Japan Male Surgical aortic valve Treatment Outcome |
| Title | Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial |
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| ispartofPNX | Circulation Journal, 2021/06/25, Vol.85(7), pp.1035-1041 |
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