- Email: [email protected]
No rat poison for me
Accepted Manuscript No rat poison for me Tsuyoshi Kaneko, MD, Sary F. Aranki, MD PII:
S0022-5223(17)31400-9
DOI:
10.1016/j.jtcvs.2017.07.009
Reference:
YMTC 11742
To appear in:
The Journal of Thoracic and Cardiovascular Surgery
Received Date: 23 June 2017 Revised Date:
0022-5223 0022-5223
Accepted Date: 6 July 2017
Please cite this article as: Kaneko T, Aranki SF, No rat poison for me, The Journal of Thoracic and Cardiovascular Surgery (2017), doi: 10.1016/j.jtcvs.2017.07.009. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less”
No rat poison for me
Division of Cardiac Surgery
M AN U
SC
Brigham and Women’s Hospital, Boston, Massachusetts
RI PT
Tsuyoshi Kaneko MD, Sary F Aranki MD
Conflict of interest: None related to this topic
Sary F Aranki, MD
TE D
Address for correspondence:
75 Francis St. Boston MA
EP
Tel: 617-738-0921
AC C
Email: [email protected]
Word Count:
Page 1
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less” Central message
AC C
EP
TE D
M AN U
SC
RI PT
Regarding valve choice, more emphasis is placed on patient preference. With the information available on internet and the future option of valve-in-valve TAVR, it is critical for physicians to provide good information.
Page 2
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less”
RI PT
In this edition of JTCVS, Anselmi and associates report on long term outcomes of bioprosthetic valves in younger patients.[1] The authors identified 416 patients aged 60 years or less who underwent bioprosthetic AVR with 98.5% complete follow-up. Overall survival at 15 years was 62.1± 4.4%, but freedom from valve-related death was 97.1±1.6%. Freedom from structural valve deterioration (SVD), was 48.5±5.5% in the actuarial analysis, and 61.4± 4.3% when calculated using competing risks. When stratified by different age groups, no significant differences in freedom from SVD was observed. Freedom from SVD was above 80% at 10 years and most occurred after the first decade of implantation.
SC
There has been a significant increase of bioprosthetic valves use in recent years. Brown et al reported on 108,687 isolated aortic valve replacements over a 10 year period from the STS database. [2] Bioprosthetic usage increased from 43.6% in 1997 to 78.4% in 2006. (Figure 1) Similar trends were seen at our institution (Figure 2A),with an increase from20% to over 60% in patients <60 years of age(figure 2 B).
EP
TE D
M AN U
What is driving younger patients to chose a bioprosthesis apart from the medical contraindications for anticoagulation? Increasing motive is the pursuit of active lifestyle . The momentum of valve choice seems to have shifted from physician recommendation to patient preference. An important aspect of valve choice is increased patient awareness from information gathered online.[3] Often times we see a patient who has already decided the valve type based internet search, and discussion with referring cardiologist. Their decision is based on a simple formula; comparing the risk of a repeat AVR versus the risk of taking anticoagulation for 10years or more. From a large STS database study, the operative mortality of repeat AVR was 4.9% [4]. In one study, the simulated lifetime risk of bleeding was 41% for a 60-year-old man. [5] Warfarin is also associated with difficulty controlling the INR within the therapeutic level, described by using the term “Time within therapeutic range (TTR)”. One study showed that in the first 6 months of initiating warfarin TTR was only 32%.[6] Patients who are not in TTR are exposed to bleeding risk if INR is higher or thromboembolism if INR is lower. This leads to the fact that warfarin is the top reason (33%) for emergency hospitalizations for drug events in older Americans. [7]
AC C
In addition, valve-in-valve TAVR (VIV-TAVR) option has changed the landscape in patient decision. Despite the uncertainty of valve durability or valve thrombosis after VIV-TAVR, avoidance of reoperation is a strong factor in valve choice. At the end of the day, one cannot argue with current statistics about valve choices. It is patient preference rather than surgeon recommendation that is driving this trend. Nevertheless, it is still crucial for physicians to provide good information to aid the understanding of true risks and benefits. We hope this and similar studies serve as a guide to patients decisions and expectations.
Page 3
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less” References
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M AN U
SC
RI PT
1. Anselmi A, Flecher E, Chabanne C, Ruggieri VG, Langanay T, Corbineau H, Leguerrier A, Verhoye JP. Long-Term Follow-up of Bioprosthetic Aortic Valve Replacement in Patients Aged 60 Years or Less. J Thorac Cardiovasc Surg. 2017. 2. Brown JM, O’Brien SM, Wu C, Sikola JH, 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;137:82-90. 3. Kaneko T, Cohn LH, Aranki SF. Tissue valve is the preferred option for patients aged 60 and older. Circulation. 2013;128(12):1365-71. 4. Kaneko T, Vassileva CM, Englum B, Kim S, Yammine M, Brennan M, Suri RM, Thourani VH, Jacobs JP, Aranki S. Contemporary Outcomes of Repeat Aortic Valve Replacement: A Benchmark for Transcatheter Valve-in-Valve Procedures. Ann Thorac Surg. 2015;100:1298-304. 5. van Geldorp MWA, Jamieson WRE, Kappetein AP, Ye J, Fradet GJ, Eijkemans MJC, Grunkemeier GL, Bogers AJJC, Takkenberg JJM. Patient outcome after aortic valve replacement with a mechanical or biological prosthesis: weighing lifetime anticoagulantrelated event risk against reoperation risk. J Thorac Cardiovasc Surg. 2009;137:881–886. 6. Beyth RJ, Quinn L, Landefeld CS. A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin. A randomized, controlled trial. Ann Intern Med. 2000 Nov 7;133:687-695. 7. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365:2002-12.
Page 4
ACCEPTED MANUSCRIPT
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Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less”
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Figure 1. Use of Bioprosthetic valve versus Mechanical valve in North America comprising 108,687 patients in 10 years from the Society of Thoracic Surgeons National Database. Brown et al. J Thorac Cardiovasc Surg. 2009, with permission from Elsevier.
Page 5
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less”
Use of Bioprosthetic versus Mechanical Valves 100%
RI PT
90% 80% 70%
SC
60% 50% 40% 30%
Mechanical 20%
EP
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0%
TE D
10%
M AN U
Percent of patients
Bioprostheses
AC C
Figure 2. (A) The use of mechanical and bioprosthesis at the Brigham and Women’s Hospital
Page 6
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less”
RI PT
Use of Bioprostheses by Age 100%
> 70 years 90%
SC
80%
60 – 70 years
M AN U
60% 50% 40%
20% 10%
AC C
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0%
TE D
30%
<60 years
EP
Percent of patients
70%
Figure 2. (B) The ratio of Bioprosthetic valve use by different age groups at the Brigham and Women’s Hospital
Page 7
AC C
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M AN U
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ACCEPTED MANUSCRIPT
S0022-5223(17)31400-9
DOI:
10.1016/j.jtcvs.2017.07.009
Reference:
YMTC 11742
To appear in:
The Journal of Thoracic and Cardiovascular Surgery
Received Date: 23 June 2017 Revised Date:
0022-5223 0022-5223
Accepted Date: 6 July 2017
Please cite this article as: Kaneko T, Aranki SF, No rat poison for me, The Journal of Thoracic and Cardiovascular Surgery (2017), doi: 10.1016/j.jtcvs.2017.07.009. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less”
No rat poison for me
Division of Cardiac Surgery
M AN U
SC
Brigham and Women’s Hospital, Boston, Massachusetts
RI PT
Tsuyoshi Kaneko MD, Sary F Aranki MD
Conflict of interest: None related to this topic
Sary F Aranki, MD
TE D
Address for correspondence:
75 Francis St. Boston MA
EP
Tel: 617-738-0921
AC C
Email: [email protected]
Word Count:
Page 1
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less” Central message
AC C
EP
TE D
M AN U
SC
RI PT
Regarding valve choice, more emphasis is placed on patient preference. With the information available on internet and the future option of valve-in-valve TAVR, it is critical for physicians to provide good information.
Page 2
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less”
RI PT
In this edition of JTCVS, Anselmi and associates report on long term outcomes of bioprosthetic valves in younger patients.[1] The authors identified 416 patients aged 60 years or less who underwent bioprosthetic AVR with 98.5% complete follow-up. Overall survival at 15 years was 62.1± 4.4%, but freedom from valve-related death was 97.1±1.6%. Freedom from structural valve deterioration (SVD), was 48.5±5.5% in the actuarial analysis, and 61.4± 4.3% when calculated using competing risks. When stratified by different age groups, no significant differences in freedom from SVD was observed. Freedom from SVD was above 80% at 10 years and most occurred after the first decade of implantation.
SC
There has been a significant increase of bioprosthetic valves use in recent years. Brown et al reported on 108,687 isolated aortic valve replacements over a 10 year period from the STS database. [2] Bioprosthetic usage increased from 43.6% in 1997 to 78.4% in 2006. (Figure 1) Similar trends were seen at our institution (Figure 2A),with an increase from20% to over 60% in patients <60 years of age(figure 2 B).
EP
TE D
M AN U
What is driving younger patients to chose a bioprosthesis apart from the medical contraindications for anticoagulation? Increasing motive is the pursuit of active lifestyle . The momentum of valve choice seems to have shifted from physician recommendation to patient preference. An important aspect of valve choice is increased patient awareness from information gathered online.[3] Often times we see a patient who has already decided the valve type based internet search, and discussion with referring cardiologist. Their decision is based on a simple formula; comparing the risk of a repeat AVR versus the risk of taking anticoagulation for 10years or more. From a large STS database study, the operative mortality of repeat AVR was 4.9% [4]. In one study, the simulated lifetime risk of bleeding was 41% for a 60-year-old man. [5] Warfarin is also associated with difficulty controlling the INR within the therapeutic level, described by using the term “Time within therapeutic range (TTR)”. One study showed that in the first 6 months of initiating warfarin TTR was only 32%.[6] Patients who are not in TTR are exposed to bleeding risk if INR is higher or thromboembolism if INR is lower. This leads to the fact that warfarin is the top reason (33%) for emergency hospitalizations for drug events in older Americans. [7]
AC C
In addition, valve-in-valve TAVR (VIV-TAVR) option has changed the landscape in patient decision. Despite the uncertainty of valve durability or valve thrombosis after VIV-TAVR, avoidance of reoperation is a strong factor in valve choice. At the end of the day, one cannot argue with current statistics about valve choices. It is patient preference rather than surgeon recommendation that is driving this trend. Nevertheless, it is still crucial for physicians to provide good information to aid the understanding of true risks and benefits. We hope this and similar studies serve as a guide to patients decisions and expectations.
Page 3
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less” References
AC C
EP
TE D
M AN U
SC
RI PT
1. Anselmi A, Flecher E, Chabanne C, Ruggieri VG, Langanay T, Corbineau H, Leguerrier A, Verhoye JP. Long-Term Follow-up of Bioprosthetic Aortic Valve Replacement in Patients Aged 60 Years or Less. J Thorac Cardiovasc Surg. 2017. 2. Brown JM, O’Brien SM, Wu C, Sikola JH, 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;137:82-90. 3. Kaneko T, Cohn LH, Aranki SF. Tissue valve is the preferred option for patients aged 60 and older. Circulation. 2013;128(12):1365-71. 4. Kaneko T, Vassileva CM, Englum B, Kim S, Yammine M, Brennan M, Suri RM, Thourani VH, Jacobs JP, Aranki S. Contemporary Outcomes of Repeat Aortic Valve Replacement: A Benchmark for Transcatheter Valve-in-Valve Procedures. Ann Thorac Surg. 2015;100:1298-304. 5. van Geldorp MWA, Jamieson WRE, Kappetein AP, Ye J, Fradet GJ, Eijkemans MJC, Grunkemeier GL, Bogers AJJC, Takkenberg JJM. Patient outcome after aortic valve replacement with a mechanical or biological prosthesis: weighing lifetime anticoagulantrelated event risk against reoperation risk. J Thorac Cardiovasc Surg. 2009;137:881–886. 6. Beyth RJ, Quinn L, Landefeld CS. A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin. A randomized, controlled trial. Ann Intern Med. 2000 Nov 7;133:687-695. 7. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365:2002-12.
Page 4
ACCEPTED MANUSCRIPT
M AN U
SC
RI PT
Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less”
AC C
EP
TE D
Figure 1. Use of Bioprosthetic valve versus Mechanical valve in North America comprising 108,687 patients in 10 years from the Society of Thoracic Surgeons National Database. Brown et al. J Thorac Cardiovasc Surg. 2009, with permission from Elsevier.
Page 5
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less”
Use of Bioprosthetic versus Mechanical Valves 100%
RI PT
90% 80% 70%
SC
60% 50% 40% 30%
Mechanical 20%
EP
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0%
TE D
10%
M AN U
Percent of patients
Bioprostheses
AC C
Figure 2. (A) The use of mechanical and bioprosthesis at the Brigham and Women’s Hospital
Page 6
ACCEPTED MANUSCRIPT Prepared for JTCVS editorial “Long-Term Follow-up of Bio AVR in Patients Aged 60years of less”
RI PT
Use of Bioprostheses by Age 100%
> 70 years 90%
SC
80%
60 – 70 years
M AN U
60% 50% 40%
20% 10%
AC C
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0%
TE D
30%
<60 years
EP
Percent of patients
70%
Figure 2. (B) The ratio of Bioprosthetic valve use by different age groups at the Brigham and Women’s Hospital
Page 7
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ACCEPTED MANUSCRIPT