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Eur J Cardiothorac Surg 2003;24:873-878
© 2003 Elsevier Science NL

Re-operation for bioprosthetic aortic structural failure – risk assessment

331–332 Burrard Building, St Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada

Received 30 December 2002; received in revised form 3 August 2003; accepted 20 August 2003.

^* Corresponding author. Tel.: +1-604-806-8383; fax: +1-604-806-8384
e-mail: wrej{at}interchange.ubc.ca

	Abstract

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
Objective: The predominant complication of bioprostheses is structural valve deterioration and the consequences of re-operation. Prosthesis choice for aortic valve replacement surgery (bioprostheses and mechanical prostheses), is influenced by valve-related complications (mortality and morbidity) of the prosthesis type chosen. The purpose of the study is to determine the mortality and risk assessment of that mortality for aortic bioprosthetic failure. Methods: From 1975 to 1999, 3356 patients received a heterograft bioprosthesis in 3530 operations. The procedures were performed with concomitant coronary artery bypass (CAB) in 1388 procedures and without in 2142 procedures. Three hundred twenty-two re-operations for structural valve deterioration were performed in 312 patients with 22 fatalities (6.8%). Of the 322 re-replacements, 36 had CAB and 286 had isolated replacement; the mortality was 8.3% (3) and 6.6% (19), respectively. Eleven predictive factors inclusive of age, concomitant CAB, urgency status, New York Heart Association (NYHA) at Re-op and year of Re-op (year periods) were considered. Results: The mortality for 1979–1986 was 6.1% (2/33); 1987–1992, 7.7% (8/104); and 1993–2000, 6.5% (12/185) (pNS). The mortality by urgency status for elective/urgent was 6.4% (19/299); and emergent, 13.0% (3/23) (pNS). The mortality for NYHA I/II was 2.0% (1/50), III 4.2% (8/191) and IV 16.0% (13/81) (P=0.00063), for gender was male 4.6% and female 13.3% (P=0.011), for age at implant ‘No’ (no re-operation) 51.6±12.2 years and ‘Yes’ (yes re-operation) 59.9±7.3 years (P=0.00004), for age at explant ‘No’ 62.6±12.7 years and ‘Yes’ 70.6±6.5 years (P=0.00001), and for age at explant <60 years 0.0% (0/110), 60–70 years 8.5% (10/117) and >70 years 12.6% (12/95) (P=0.0011). The predictive risk factor assessment by multivariate regression analysis revealed only NYHA III Odds Ratio 1.7 and IV 7.8 P=0.0082. For the period 1993–2000 of re-operations only gender was significant; age at implant, age at explant, CAB pre-Re-op, CAB concomitant with Re-op, urgency at Re-op, ejection fraction, valve lesion and NYHA at Re-op were not significant. Conclusions: Bioprosthetic aortic re-operative mortality can be lowered by re-operation in low rather than medium to severe NYHA functional class. The routine evaluation of patients can achieve earlier low risk re-operative surgery.

Key Words: Aortic bioprostheses • Re-operative risk assessment • Optimal timing of re-operation

	1. Introduction

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
The predominant complication of bioprostheses is structural valve deterioration and the consequences of re-operative management. The choice of prosthesis for aortic valve replacement surgery – bioprostheses (allografts, autografts and heterografts) and mechanical prostheses – is influenced predominantly by valve-related complications (mortality and morbidity) of the prosthesis type. The purpose of this study is to determine the mortality and the risk assessment of that mortality for aortic bioprosthetic failure.

The replacement of diseased native valves usually results in satisfactory symptomatic and hemodynamic benefit which usually remains unaltered until the valve prosthesis commences to fail or fails abruptly. Controversy exists regarding bioprosthetic re-operations, whether there is an incremental effect to mortality compared to the primary operation and what risk factors are contributing to that mortality. The documented mortality of bioprosthetic re-replacement for structural valve deterioration ranges from 3 to 7% in most series, depending on risk factors and patient status [1–6].

The literature provides documentation on the factors that increase the risk of re-operation for all complications, inclusive of structural valve deterioration [1–3,6]. The documented factors include age, gender, pre-operative New York Heart Association (NYHA) class, indication for re-operation, type of prosthetic valve, position of prosthetic valve, number of previous operations and timing of re-operations [1,6–8].

The choice of prosthesis is determined by the influence of predominant valve-related complications of the prosthesis-type on valve-related mortality and morbidity. The utilization of bioprostheses for aortic valve replacement is determined by the risk of failure, that is, the risk of valve failure with time and the risk of re-operation with time [9]. The major consideration is the competing risks of death without re-replacement and re-replacement before death [9]. As stated, this study addresses the re-operative mortality and the risk assessment of that mortality for management of aortic bioprosthetic structural failure from biological tissue deterioration.

	2. Materials and methods

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
In the 25 years from 1975 to 1999 at the University of British Columbia, aortic valve replacement was performed with heterograft bioprostheses in 3356 patients in 3530 operations. Of the 3530 operations performed from 1975 to 1999 there were 2142 performed without concomitant coronary artery bypass (CAB) and 1388 with CAB. Of the total patients, there were 322 re-operations for structural valve deterioration in 312 patients, 286 without CAB and 36 with concomitant CAB. The incidence of concomitant CAB was unchanged throughout the observation – periods I and II – 14.6% (20/137) and period III – 21.6% (40/185) (P=0.15). The re-operation mortality for the total re-operative procedures extending through 2000 was 6.8%, or 22 patients.

Of the 3530 operations performed the age group distribution is detailed in Table 1, <40 years, 4.4% (154); 41–50 years, 4.8% (170); 51–60 years, 13.8% (489); 61–70 years, 30.0% (1059); and >70 years, 47.0% (1658). The prostheses utilized were previous generation porcine bioprostheses (Hancock I, 69; Carpentier-Edwards standard, 576; Medtronic Intact, 234; St Jude Medical Bioimplant, 10); pericardial bioprostheses (Carpentier-Edwards PERIMOUNT pericardial, 353; Mitroflow pericardial, 85); and current generation porcine bioprostheses (Carpentier-Edwards SAV, 1895; Hancock II, 15; Medtronic Mosaic, 248; Toronto SPV stentless, 1; Medtronic Freestyle stentless, 40; and Edwards Prima Plus stentless, 4). The Carpentier-Edwards standard and supra-annular (SAV) porcine and Carpentier-Edwards PERIMOUNT pericardial bioprostheses comprise 80% of the total patient population.

2.1. Statistical analysis
The project was conducted under the Society of Thoracic Surgeons, American Association for Thoracic Surgery and European Association of Cardio-Thoracic Surgery ‘Guidelines for reporting morbidity and mortality after cardiac valvular operations’ [10]. The predictive model for early mortality caused by structural valve deterioration was based on multiple logistic regression analysis. Interpretable odds ratios and 95% confidence intervals to determine significance were determined for the overall population and populations within the re-operating periods 1975–1986, 1987–1992 and 1993–2000. The univariate analysis was determined by Fisher's exact probability, t-tests and Chi-square and, as stated, multiple analysis as Cox logistic regression analysis.

	3. Results

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
The overall re-replacement mortality during the years 1979–2000, inclusive for implants performed from 1975 to 1999 inclusive, was 6.8% (22). The overall re-replacement mortality by year periods is shown in Fig. 1 – for the period 1975–1986, 6.1% (2); 1987–1992, 7.7% (8); and 1993–2000, 6.5% (12), (II versus III, P=0.8838). The mortality for the age periods, overall and with and without concomitant coronary bypass, are presented in Fig. 2 . The mortality for re-operation with concomitant CAB was for period I – 0.0% (0/1), for period II – 5.3% (1/19) and for period III – 5.0% (2/40) (II versus III, pNS). The mortality for re-operation without concomitant CAB was for period I – 6.3% (2/32), for period II – 8.2% (7/85) and for period III – 6.9% (10/145) (II versus III, P=0.9096).

View larger version (10K): [in this window] [in a new window]   Fig. 1. Aortic valve replacement re-operative mortality overall (1975–2000) and by year periods (1975–1986, 1987–1992 and 1993–2000).

View larger version (20K): [in this window] [in a new window]   Fig. 2. Aortic valve replacement re-operative mortality by year periods overall, and with and without concomitant coronary artery bypass.

For the combined cumulative period 1975–1992 (1975–1986, and 1987–1992) there were 137 re-operations in 135 patients with a re-operative mortality of 7.4% (10). In the multivariate analysis only valve lesion (regurgitation>stenosis/mixed) at the original operation was predictive of re-operative mortality OR 6.19 (1.19–33.58) (P=0.0345). Urgency status was not predictive – elective/urgent 7.0% (9/128) and emergent 11.1% (1/9). Risk factors predictive by univariate analysis were NYHA class at re-operation – I/II 0.0% (0/11), III 4.5% (4/89) and IV 16.2% (6/37) (P=0.044); age at implant ‘No’ 49.2±13.1 years, ‘Yes’ 57.7±8.0 years (P=0.009); age at explant ‘No’ 58.2±13.4 years, ‘Yes’ 67.5±6.4 years (P=0.001); and age at explant <60 years 0.0% (0/64), 60–70 13.0% (6/46), and >70 14.8% (4/27) (P=0.0085). CAB pre-Re-op and CAB concomitant with Re-op were not different (pNS). The valve lesion at initial surgery was not different by univariate analysis – regurgitation 12.5% (4/32) and stenosis/mixed 5.7% (6/105) (pNS), but, as noted, significant by multivariate analysis.

To the latest re-operative period (III) 1993–2000, there were 185 re-operations in 177 patients. The predictors of re-operative mortality by multivariate analysis were gender (female>male) OR 6.0 (1.4–25.3) (P=0.0144), and NYHA class III at re-operation period III OR 0.69 (0.06–7.7) and class IV OR 3.67 (0.36–37.07) III versus I/II (negative co-efficient) (P=0.098). Urgency status was also not significant OR 0.9 (0.06–13.3) (P=0.94). The predictors by univariate analysis were gender – male 3.0% (4/135), female 16.0% (8/50) (P=0.0035); age at implant ‘No’ 53.4±11.3 years, ‘Yes’ 61.8±6.5 years (P=0.012); age at implant <60 years 3.7% (5/134), 60–70 years 15.9% (7/44) and >70 years 0.0% (0/7) (P=0.0135); age at explant ‘No’ 65.9±11.0 years and ‘Yes’ 73.1±5.3 years (P=0.001); age at explant <60 years 0.0% (0/46), 60–70 years 5.6% (4/71) and >70 years 11.8% (8/68) (P=0.041); NYHA class I/II 2.6% (1/39), III 3.9% (4/102) and IV 15.9% (7/44) (P=0.014). Urgency status was not significant – elective/urgent 5.8% (10/171) and emergent 14.3% (2/14) (pNS). CAB pre-Re-op and CAB with concomitant Re-op were not significant.

	4. Discussion

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
The predominant complication of bioprostheses is structural valve deterioration and the consequences of re-operative management. The major consideration, as stated by McGiffin and colleagues [9], is ‘the competing risks of death without re-replacement and re-replacement before death’. The documentation on risk assessment for valvular prosthesis dysfunction is limited and deals with prosthetic dysfunction for bioprostheses and mechanical prostheses and for all positions. The majority of publications document the risk assessment for re-replacement for aortic prosthetic dysfunction [6,9,11,13]. The publications addressing bioprosthetic valve failure are Akins [1], Bortolotti [2], Glower [7], McGiffin [9], O'Brien [14], Sundt [12], Vogt [6] and Jamieson [13] and colleagues. The publications by Tyers [3], McGrath [4] and Sener [5] and their colleagues assess both bioprostheses and mechanical prostheses.

Jamieson and co-authors [15] reported, in 2000, on survival and actual (and actuarial) freedom from structural valve deterioration in 1582 mitral valve replacements and 2237 aortic valve replacements. For the aortic replacement 61–70 years age group, the survival at 15 years was 31.4% and the actual freedom from valve-related re-operation was 71%, while for greater than 70 years at 15 years survival was only 18.6% and actual freedom from valve-related re-operation was 93.3%. The predictors of freedom from structural valve deterioration for aortic prostheses were advancing age and patients older than 60 years [16].

The early mortality for aortic re-operation for bioprosthetic valve failure was 7.8% in the series reported by Akins and colleagues [1]. In this series, the early mortality over 25 years was 6.8%, 22 deaths in 322 patients. Bortolotti et al. [2] reported a re-operative mortality over 26 years for structural valve deterioration for all valve positions of 9%. Tyers and colleagues [3] reported on the University of British Columbia experience, a bioprosthetic early mortality for all positions of 10.6%, while McGrath et al. [4] identified an early mortality of 13.2% for failed bioprostheses re-operation. In the series by Sener and co-investigators [5], the early mortality for bioprosthetic failure was 6.8%. The remaining publications deal exclusively with aortic re-operative mortality, 3–5% [6,11]. The re-operative mortality rates are similar to the mortality for the initial surgery. Vogt and colleagues [6] reported overall re-operation mortality of 5.2%, 22.6% for emergent cases and 1.4% for elective cases.

Several authors have documented the predictors of re-operative mortality. Akins et al. [1] identified age greater than 65 years, male gender, renal insufficiency and non-elective surgery. This study showed that the best results occurred in elective surgery without concomitant cardiac procedures. Bortolotti et al. [2] confirmed that mortality was greatly influenced by pre-operative clinical status and reduction in operative risk must be attributed to increasing surgical experience, better myocardial protection and patient management. Tyers et al. [3] identified mortality higher for age greater than 75 years and trended higher with concomitant procedures and increasing numbers of re-operations. Lytle and co-investigators [8], reporting in 1986, identified advanced age as the most predominant predictor of risk, others being, concomitant coronary artery bypass and second multiple replacements, but not second replacements for aortic or mitral replacements.

O'Brien [14] and Bortolotti [2] and colleagues have recommended more accurate patient follow-up, closer patient-surgeon relationship and possibly earlier and more optimal timing for re-operation. O'Brien et al. [14] have recommended knowledge of the most important risk factors and adherence to specific technical steps at explant.

The cardiac valve database at the University of British Columbia incorporates the changing patterns of practice over the 25-year observation time in which longitudinal patient evaluation was conducted. It is for this reason that the 25-year time-frame was divided into three time periods. During the years 1975–1986 (first time period), essentially the overwhelming number of patients had bioprostheses implanted in both the aortic and mitral positions. Commencing in 1987 (second time period), the use of bioprostheses became more selective as to age indications for both aortic and mitral implantations. In the latter time period, bioprostheses have been recommended for patients greater than 65 years for aortic valve replacement and greater than 70 years of age for mitral valve replacement. These indications obviously would be altered based on co-morbidity factors that would potentially alter life expectancy in relation to the anticipated durability of the implanted prostheses.

In the overall 25-year time frame, only NYHA functional class and age at explant were predictive of mortality. The mortality for elective/urgent status was 6.4% while emergent status 13.0%. The mortality for NYHA class III was 4.2% and class IV, 16.0%. The odds ratio for NYHA class IV was 7.8. In the earlier time periods, the mortality was influenced by valve lesion, age at explant and NYHA class. The NYHA class mortality for the combined intermediate time intervals was 4.5% for class III and 16.0% for class IV. For 1993–2000, mortality was not reduced, 15.9% for NYHA class IV.

In the latest re-operative time period (1993–2000), the overall mortality decreased to 6.5%; 5.0% with concomitant coronary artery bypass and 6.9% without concomitant coronary artery bypass: urgency status was not a predictor of mortality. The risk of mortality by age at implant, 15.9% for age group 60–70 years and 0.0% for age group greater than 70 years, was predictive only by univariate analysis; the risk of mortality by age at explant, 5.6% for age group 60–70 years and 11.8% for age group greater than 70 years, was also predictive only by univariate analysis.

The mortality for age at explant was higher for the earlier time periods for the age group 60–70 years, 13.0% for combined periods 1975–1992. For the patients who were greater than 70 years at explant, mortality was 14.8% for the period 1975–1992 and 11.8% for 1993–2000. For the age at implant 60–70 years, the mortality increased to 15.9% for 1993–2000 from 6.5% for the combined periods 1975–1992.

The above findings related to mortality at age of implant and at age of explant are related to the overall experience during the 25 years. In the first half of the experience, nearly all patients receiving aortic valve replacements at the University of British Columbia had bioprostheses. During the latter half of the observation period, bioprostheses were utilized in aortic valve replacement primarily for patients who were age 65 to 70 years and greater.

The mortality for re-operative surgery for aortic structural failure can be reduced significantly by optimizing timing of surgery before development of advanced functional class. The opportunity exists for clinical and echocardiographic heightened surveillance of patients starting 7–8 years after implantation to achieve the opportunity for re-replacement surgery before advanced ventricular and functional disease. O'Brien and colleagues [14] have recommended that the optimal timing for re-operation can be achieved by closer patient-surgeon-cardiologist relationship. Re-operative mortality can be lowered by performing surgery low/medium NYHA functional class by the detection of valve deterioration utilizing routine clinical and echocardiographic follow-up evaluation.

	Acknowledgments

 
The author acknowledges the support of Florence Chan for management of the data and development of the illustrations, Eva Germann for statistical support, and Jenny Lovegrove for contribution in preparation of the manuscript.

	Footnotes

 
Presented at the 16th Annual Meeting of the European Association for Cardio-thoracic Surgery, Monte Carlo, Monaco, September 22–25, 2002.

	Appendix A. Conference discussion

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 
Dr A. Carpentier (Paris, France): I will be very kind, the more so that we know that always from Eric we can get some important messages, and I think it would be sad to miss the messages. The only question I have, and I have not heard about it, is whether you have been able throughout the years to decrease the operative mortality in reoperation, because the reoperation today has nothing to do with the reoperation even 10 years ago. And this is a very important factor when taking into consideration the choice of a biological valve.

In the past we were afraid to reoperate. Today I think we should not be afraid to reoperate, and it is a price to pay for the advantage of a bioprosthesis versus a mechanical valve. So can you elaborate a little bit, Eric, on this diminishing risk of reoperation, whether you have tricks or indications or different approaches, or whatever?

Dr Jamieson: You have seen we have reduced mortality for isolated aortic valve re-replacement only marginally. I will share with you some data we will be presenting at the American Heart Association meeting which is very dramatic. In mitral valve replacement in the years 1993–2000, we have brought our re-operative mortality for isolated replacement to 2.8%, and valve re-replacement with revascularization to 3.5%. To achieve these results, patients must be evaluated and operated upon early in the course of structural failure. Dr Mark O'Brien has documented that there must be appropriate assessment and patients must have surgery in a timely fashion. As far as tricks at re-operation, there isn't anything really absolutely particular. Aortic valve replacement re-operation is relatively simple; sternotomy is the major risk factor. But even with re-operation in the mitral position, we have been able to re-operate on these patients relatively safely, and are now identifying the factors that contribute to mortality. We have been able to operate on NYHA class I/II patients without mortality for mitral valve re-replacement, and 2% for aortic valve re-replacement.

	References

Top Abstract 1. Introduction 2. Materials and methods 3. Results 4. Discussion Appendix A. Conference... References

 

1. Akins C.W., Buckley M.J., Daggett W.M., Hilgenberg A.D., Vlahakes G.J., Torchiana D.F., Madsen J.C. Risk of re-operative valve replacement for failed mitral and aortic bioprostheses. Ann Thorac Surg 1998;65:1545-1552.[Abstract/Free Full Text]
2. Bortolotti U., Milano A., Mossuto E., Mazzaro E., Theine G., Casarotto D. Early and late outcome after re-operation for prosthetic valve dysfunction: analysis of 549 patients during a 26-year period. J Heart Valve Dis 1994;3:81-87.[Medline]
3. Tyers G.F.O., Jamieson W.R.E., Munro A.I., Germann E., Burr L.H., Miyagishima R.T., Ling H. Re-operation in biological and mechanical valve populations: fate of the re-operative patient. Ann Thorac Surg 1995;60(2 Suppl.):S464-S469.
4. McGrath L.B., Fernandez J., Laub G.W., Anderson W.A., Bailey B.M., Chen C. Perioperative events in patients with failed mechanical and bioprosthetic valves. Ann Thorac Surg 1995;60(2 Suppl.):S475-S478.
5. Sener E., Yamak B., Katircioglu S.F., Ozerdem G., Karagoz H., Tasdemir O., Bayazit K. Risk factors of re-operations for prosthetic heart valve dysfunction in the ten years 1984–1993. Thorac Cardiovasc Surg 1995;43:148-152.[Medline]
6. Vogt P.R., Brunner-LaRocca H., Sidler P., Zund G., Truniger K., Lachat M., Turina J., Turina M.I. Re-operative surgery for degenerated aortic bioprostheses: predictors for emergency surgery and re-operative mortality. Eur J Cardiothorac Surg 2000;17:134-139.[Abstract/Free Full Text]
7. Glower D.D., Landolfo K.P., Cheruvu S., Cen Y.Y., Harrison J.K., Bashore T.M., Smith P.K., Jones R.H., Wolfe W.G., Lowe J.E. Determinants of 15-year outcome with 1119 standard Carpentier-Edwards porcine valves. Ann Thorac Surg 1998;66(6 Suppl.):S44-S48.
8. Lytle B.W., Cosgrove D.M., Taylor P.C., Gill C.C., Goormastic M., Golding L.R., Stewart R.W., Loop F.D. Re-operations for valve surgery: perioperative mortality and determinants of risk for 1000 patients, 1958–1984. Ann Thorac Surg 1986;42:632-643.[Abstract]
9. McGiffin D.C., Galbraith A.J., O'Brien M.F., McLachlan G.J., Naftel D.C., Adams P., Reddy S., Early L. An analysis of valve re-replacement after aortic valve replacement with biologic devices. J Thorac Cardiovasc Surg 1997;113:311-318.[Abstract/Free Full Text]
10. Edmunds L.H., Jr, Clark R.E., Cohn L.H., Grunkemeier G.L., Miller D.C., Weisel R.D. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Eur J Cardiothorac Surg 1996;10(9):812-816.[Abstract]
11. O'Brien M.F., Harrocks S., Stafford E.G., Gardner M.A.H., Pohlner P.G., Tesar P.J., Stephens F. The homograft aortic valve: a 29-year, 99.3% follow up of 1022 valve replacements. J Heart Valve Dis 2001;10:334-344.[Medline]
12. Sundt T.M., 3rd, Rasmi N., Wong K., Radley-Smith R., Khaghani A., Yacoub M.H. Re-operative aortic valve operation after homograft root replacement: surgical options and results. Ann Thorac Surg 1995;60(2):S95-S100.
13. Jamieson W.R.E., Miyagishima R.T., Fradet G.J., Ling H., Burr L.H., Janusz M.T., Lichtenstein S.V. Re-operation for bioprosthetic mitral structural failure – risk assessment. Circ Cardiovasc Surg Suppl 2003;?:?.
14. O'Brien M.F., Harrocks S., Clarke A., Garlick B., Barnett A.G. Experiences with redo aortic valve surgery. J Card Surg 2002;17:35-39.[Medline]
15. Jamieson W.R.E., Miyagishima R.T., Burr L.H., Lichtenstein S.V., Fradet G.J., Janusz M.T. Carpentier-Edwards porcine bioprostheses: clinical performance assessed by actual analysis. J Heart Valve Dis 2000;9:530-535.[Medline]
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