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Ann Thorac Surg 1997;63:1608-1612
© 1997 The Society of Thoracic Surgeons


Original Article: Cardiovascular

Aortic Valve Replacement With Patch Enlargement of the Aortic Annulus

K. Eric Sommers, MD, Tirone E. David, MD

Division of Cardiovascular Surgery, The Toronto Hospital and the University of Toronto, Toronto, Ontario, Canada


    Abstract
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Background. Aortic annulus enlargement has long been advocated for the placement of valve prostheses larger than otherwise would have been possible. Little information exists, however, on the short- and long-term outcome of this surgical procedure.

Methods. We performed a retrospective review of 530 patients enrolled in a registry for patients who underwent aortic valve replacement using the Hancock II bioprosthesis and were followed up prospectively over the course of 11 years at a single institution. In an effort to avoid prosthetic valve–patient mismatch, the aortic annulus was enlarged in 98 patients (18%). Short- and long-term outcome was analyzed.

Results. Enlargement of the aortic annulus during aortic valve replacement increased the operative mortality rate from 3.5% to 7.1%, but this difference did not reach statistical significance (p = 0.10). The long-term survival of patients who had annulus enlargement was similar to that of patients who did not. Because there were differences in the clinical profile of patients who had annulus enlargement and those who did not, a case–control study was carried out. This study showed similar long-term survival, freedom from valve-related and cardiac death, and combined end points in the two groups of patients.

Conclusion. Aortic annulus enlargement increased the operative mortality of aortic valve replacement. However, patients who underwent enlargement of a small aortic annulus had long-term survival and freedom from cardiac and valve-related death comparable to those of patients who received larger aortic prostheses.


    Introduction
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
See also page 1612.

Aortic valve replacement (AVR) with a small prosthetic aortic valve may result in prosthesis–patient mismatch, with consequent deleterious effects [1, 2]. To prevent this problem, enlargement of the aortic annulus for placement of an aortic valve prosthesis larger than otherwise would be possible has long been advocated and performed [3, 4]. However, there is little information on which to base an assessment of the efficacy and utility of this procedure. We reviewed the experience of one institution with AVR using a single prosthetic valve, and attempted to characterize the impact of aortic annulus enlargement on the early and late outcome of these patients.


    Patients and Methods
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
All patients who received a Hancock II bioprosthesis for AVR from 1982 to 1993 at The Toronto Hospital were entered into a registry and followed up prospectively at annual intervals. Follow-up was accomplished by mailed questionnaire and telephone interviews. When patients could not be contacted, follow-up was obtained from the family doctor. Postoperative complications were prospectively monitored and analyzed according to the guidelines of The Society of Thoracic Surgeons [5].

Operations were performed under cardiopulmonary bypass, moderate hypothermia, and continuous antegrade blood cardioplegia. An effort was made to match the size of the aortic valve prosthesis to the size of the patient using guidelines based on the hemodynamic performance of the Hancock II bioprosthesis (Table 1Go) [6]. Enlargement of the aortic annulus was performed by extending the aortotomy into the noncoronary aortic sinus, through the aortic annulus, and into the fibrous curtain that connects the aortic to the mitral valve. The incision was directed toward the midmitral line (an imaginary line that divides the anterior leaflet into two equal halves), down to the level where the roof of the left atrium is attached to the fibrous curtain. A teardrop-shaped pericardial patch (fresh autologous or glutaraldehyde-fixed bovine pericardium) was sutured to this extended aortotomy with a continuous 4-0 polypropylene suture. The width of the patch was 2 to 3 times the length of the cut into the fibrous curtain below the aortic annulus. This technique allowed for the implantation of a bioprosthetic valve one or two sizes larger than the original size of the aortic annulus. In patients in whom the aortic annulus along the noncoronary sinus lay in a lower level than along the right and left aortic sinuses, the bioprosthesis was secured in a supraannular position as previously described [7].


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Table 1. . The Toronto Hospital Guidelines for Matching the Size of the Prosthetic Aortic Valve With the Size of the Patient
 
Until 1989, patients were given warfarin sodium for the first 3 postoperative months; since then, they have been given only aspirin (325 mg daily). All patients had at least one Doppler echocardiographic study during the first year after operation and at any time that a cardiac or valve-related complication developed.

Of 530 patients who had AVR with the Hancock II bioprosthesis, 98 underwent patch enlargement of the aortic annulus. The follow-up of all patients was 98.6% complete and averaged 50 ± 34 months. Table 2Go shows selected variables of patients who had AVR with and without patch enlargement of the aortic annulus. The effective valve orifice of the Hancock II bioprosthesis was determined by echocardiography in a cohort of 152 patients and has been reported previously [6].


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Table 2. . Patients' Clinical Profiles
 
Table 2Go shows that the clinical profile of the two groups of patients was different in many aspects. For this reason, we performed a case–control analysis. For this analysis, we used risk factors that affected the long-term survival of all patients after AVR (Table 3Go). Left ventricular function was not entered into the analysis because it was unknown in almost 20% of the patients. Of note, valve size and valve area index were included in this analysis and were not found to be significant by either univariate or multivariate analysis. We used the following variables for the case-matching study: age, sex, New York Heart Association functional class, coronary artery disease, and mitral valve disease.


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Table 3. . Predictors of Late Mortality
 
Comparisons of patient characteristics were performed by Student's t test for continuous variables and by chi square analysis for discrete data. In-hospital outcomes were compared using {chi}2 analysis. Univariate and multivariate Cox proportional hazard models were used to assess risk factors for long-term outcomes and to aid in the selection of case–control patient matching. The adequacy of case–control matching was confirmed by Student's t test or {chi}2 analysis where appropriate. Comparison of the two study groups for long-term outcome was performed by Kaplan-Meier analysis, with differences between groups assessed by Wilcoxon (Gehan's) or Mantel-Cox methods.


    Results
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Table 4Go shows the operative mortality and morbidity. The operative mortality for AVR with patch enlargement was twice as high as for AVR without patch enlargement, but the difference did not reach statistical significance (p = 0.10). Two deaths in the patch enlargement group could be attributed to complications of the procedure (excessive bleeding in one and prolonged aortic cross-clamping in the other). Table 5Go shows the operative mortality of each surgeon. Aortic valve replacement with patch enlargement of the aortic annulus was associated with a higher operative mortality than AVR alone for all the surgeons, although the differences were not statistically significant. The operative morbidity was similar in both groups of patients, but there was a slightly higher rate of reexploration of the mediastinum for bleeding in patients who had patch enlargement of the aortic annulus. Of the 10 patients who required reexploration of the mediastinum for bleeding, only in 2 was the bleeding related to the aortic patch.


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Table 4. . Operative Mortality and Morbidity
 

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Table 5. . Operative Mortality by Surgeon
 
Long-term survival was no different between the two groups of patients (Fig 1Go). The case–control study also showed no difference in actuarial survival between the two groups (Fig 2Go). Case–control analyses were performed for late death, cardiac-related death, valve-related death, and the combined end points, and none showed a difference between the two groups. The postoperative functional classes (New York Heart Association) were remarkedly similar among the two groups in the case–control study.



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Fig 1. . Actuarial overall survival in patients requiring aortic annulus enlargement for aortic valve replacement compared with those not requiring enlargement.

 


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Fig 2. . Actuarial survival of case–control matched groups of patients requiring annulus enlargement and those not requiring enlargement.

 
Patients who underwent annulus enlargement were left with smaller average valve sizes (23.8 ± 1.94 mm versus 25.2 ± 2.07 mm) and smaller effective valve orifice indices (0.953 ± 0.097 cm2/m2 versus 0.982 ± 0.098 cm2/m2), as shown in Table 2Go. Although these differences are statistically significant, they probably are of no physiologic importance.


    Comment
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Our study demonstrates that the operative mortality rate for AVR with patch enlargement of the aortic annulus was 7.1% and that for AVR without annulus enlargement was 3.5%. This difference in operative mortality did not reach statistical significance, but it is clinically evident that patch enlargement of the aortic annulus increases the operative mortality of AVR. We could not identify specific causes for this increase in operative mortality, but the experience of the surgeon played an important role, even though annulus enlargement increased the operative mortality of AVR for all the surgeons at our institution (see Table 5Go). In addition to the surgeon's experience, there must be other factors responsible for the increased operative mortality, but these could not be identified, probably because of the relatively small size of our series.

The long-term survival of patients who had patch enlargement of the aortic annulus was similar to that of patients who did not. Does this imply that the natural history of these patients was improved by the annular enlargement, or that these patients would have done as well if they had not undergone the enlargement? The rationale behind annulus enlargement is the avoidance of prosthetic valve–patient mismatch [1, 2]. Examination of the valve area index between the two groups of patients shows very little difference, and both values are well above physiologically significant ones [1, 8]. Thus, in this series, it appears that the potential for valve–patient mismatch was largely negated by aggressive annular enlargement, and this may explain the identical survivorship of the two groups. We believe that annulus enlargement is most useful in patients who otherwise would be expected to live longer, and that the value of complete resolution of outflow tract obstruction is more likely to be manifested over time in patients without severe left ventricular dysfunction or coronary artery disease. Table 6Go shows selected series of patients who underwent AVR, including the percentage of patients who underwent annulus enlargement and the percentage who received a prosthesis size of 21 mm or smaller. Our series of patients have the lowest rate of small prosthetic valves and the highest rate of aortic annulus enlargement among these series.


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Table 6. . Comparison of Reported Series by Valve Size and Annulus Enlargement
 
Several questions remain unanswered: To what degree is valve–patient mismatch a clinically significant problem? What are the options for dealing with a small aortic root and what guidelines should be followed to avoid this problem?

Published data clearly support the conclusion that patients who undergo AVR with a small prosthesis may be at risk for late complications. Sim and associates [15] demonstrated faster resolution of left ventricular hypertrophy after AVR as a function of the relief of obstruction, and left ventricular hypertrophy is a well-known risk factor for sudden cardiac death and cardiovascular morbidity [16]. The measurement of postoperative gradients has long been used to assess the adequacy of AVR, and indexing valve areas with body surface area improves the correlation between valve area and gradient [8]. Valve size as a risk factor for long-term survival has been demonstrated by Jones and colleagues [9]. In our study, we were not able to identify valve size or valve area index as a risk factor for long-term survival, probably because only a few of our patients had valve–patient mismatch.

Kratz and colleagues [17] have identified a subset of patients with body surface area greater than 1.7 m2 who received small St. Jude valves and who were prone to late sudden death. Assuming an effective orifice area of 1.27 cm2 for the 19-mm St. Jude valve [18], the valve area index for high-risk patients (body surface area greater than 1.7 m2) is 0.75 cm2/m2, and the value for very high risk patients (body surface area greater than 1.9 m2) is 0.67 cm2/m2. These values are well below the 0.8- to 0.9-cm2/m2 transition point demonstrated by Dumesnil and associates [8] to be the point at which gradients become high.

Thus, there are several lines of evidence indicating that the implantation of small valves in large patients may predispose to an unfavorable outcome. However, the only way to answer this question definitively would be to perform a prospective, randomized trial.

What are the options for surgeons faced with a small aortic annulus? Annulus enlargement is an obvious solution, especially when faced with an unexpected intraoperative finding. Another alternative is to use a stentless biologic valve, because they have excellent hemodynamic features [19, 20]. There also are prosthetic valves that purport to have improved hemodynamic performance, including the "top hat" CarboMedics (Austin, TX) model and the HP series of St. Jude Medical (St. Paul, MN) valves.

We recommend that surgeons become familiar with the hemodynamic performance of the valves they use, and when the predicted valve area index for that valve is less than 0.8 cm2/m2, that they consider using one of the techniques outlined.


    Acknowledgments
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
We are indebted to Joan Ivanov, MSc, for her assistance with the statistical analyses.


    Footnotes
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Presented at the Forty-third Annual Meeting of the Southern Thoracic Surgical Association, Cancun, Mexico, Nov 7–9, 1996.

Address reprint requests to Dr David, 200 Elizabeth St, 13EN-219, Toronto, ON, Canada M5G 2C4.


    References
 Top
 Footnotes
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 

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  5. Edmunds LH, Clark RE, Cohn LH, Miller DC, Weisel RD. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ann Thorac Surg 1996;112:708–11.
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  7. David TE, Uden DE. Aortic valve replacement in adult patients with small aortic annuli. Ann Thorac Surg 1983;36:577–83.[Abstract]
  8. Dumesnil JG, Honos GN, Lemieux M, Beauchermin J. Validation and applications of indexed prosthetic valve areas calculated by Doppler echocardiography. J Am Coll Cardiol 1990;16:637–43.[Abstract]
  9. Jones EL, Craver JM, Morris DC, King SB, Morgan EA. Hemodynamic and clinical evaluation of the Hancock xenograft bioprosthesis for aortic valve replacement (with emphasis on management of the small aortic root). J Thorac Cardiovasc Surg 1978;75:300–8.[Abstract]
  10. Bove EL, Marvasti MA, Potts JL, et al. Rest and exercise hemodynamics following aortic valve replacement. J Thorac Cardiovasc Surg 1985;90:750–5.[Abstract]
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  13. Morris JJ, Schaff HV, Mullany CJ, et al. Determinants of survival and recovery of left ventricular function after aortic valve replacement. Ann Thorac Surg 1993;56:22–30.[Abstract]
  14. Cosgrove DM, Lytle BW, Taylor PC, et al. The Carpentier-Edwards pericardial aortic valve. Ten-year results. J Thorac Cardiovasc Surg 1995;110:651–62.[Abstract/Free Full Text]
  15. Sim EKW, Orszulak TA, Schaff HV, Shub C. Influence of prosthesis size on change in left ventricular mass following aortic valve replacement. Eur J Cardiothorac Surg 1994;8:293–7.[Abstract]
  16. Bikkina M, Larson MG, Levy D. Asymptomatic ventricular arrhythmias and mortality risk in subjects with left ventricular hypertrophy. J Am Coll Cardiol 193;22:1111–6.
  17. Kratz JM, Sade RM, Crawford FA, Crumbley AJ, Stroud MR. The risk of small St Jude aortic prosthesis. Ann Thorac Surg 1994;57:1114–9.[Abstract]
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  19. Jin XY, Gibson DG, Yacoub MH, Pepper JR. Perioperative assessment of aortic homograft, Toronto stentless valve, and stented valve in the aortic position. Ann Thorac Surg 1995;60:S395–S401.
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