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Eur J Cardiothorac Surg 1999;15:302-308
© 1999 Elsevier Science NL

Intermediate-term durability of bicuspid aortic valve repair for prolapsing leaflet¹

^a Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, OH, USA
^b Biostatistics and Epidemiology, The Cleveland Clinic Foundation, Cleveland, OH, USA

Received 21 September 1998; accepted 13 October 1998.

Corresponding author. Tel.: +1-216-445-6816; fax: +1-216-444-0777.

	Abstract

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Objective: To determine the durability of repair of a bicuspid aortic valve with leaflet prolapse, and to identify factors associated with repair failure. Methods: From November 1988 to January 1997, 94 patients with a bicuspid aortic valve and regurgitation from leaflet prolapse had aortic valve repair. In 66 patients, the repair employed triangular resection of the prolapsing leaflet. The remainder underwent mid-leaflet plication of the prolapsing leaflet. Mean age was 38±10 years and 93% were male. Median follow-up was 5.5 years (range 0.2–9 years). Factors associated with aortic valve competence and durability were identified by multivariable logistic and hazard function analyses. Results: Early valve competence was more difficult to achieve in patients with large, poor functioning ventricles (P=0.02). Aortic valve reoperation was necessary in 12 patients that included three re-repairs and nine aortic valve replacements. Freedom from reoperation was 95, 87 and 84% at 1, 5 and 7 years, respectively. The instantaneous risk of reoperation was highest immediately after operation, and fell rapidly to approximately 2% per year and less after 2 years. The only risk factor identified was the presence of residual aortic regurgitation (trace to mild in 35 cases) on immediate intraoperative post-repair transesophageal echocardiography. Late aortic regurgitation did not progress detectably across time (P=0.3). There were no deaths, early or late. Conclusion: Bicuspid aortic valve repair for prolapsing leaflet is a safe procedure with good intermediate-term outcome. However, any residual aortic regurgitation jeopardizes repair durability and initial repair achievement is more difficult in patients with dilated, poor functioning ventricles.

Key Words: Bicuspid • Aortic • Valve • Repair

	Introduction

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Advantages of aortic valve repair over aortic valve replacement include avoidance of anticoagulation and prosthetic valve-related complications. Aortic valve repair may be of particular benefit in young patients, who would be more likely to experience prosthetic valve-related morbidity over a long life-span.

Although early results of aortic valve repair are good [1] [2], intermediate and long-term results of aortic valve repair have not been reported. This study was primarily undertaken to assess the intermediate-term results of aortic valve repair for aortic regurgitation caused by prolapsing bicuspid aortic valve. A secondary goal was to identify factors associated with repair failure.

	Materials and methods

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Inclusion criteria
Between November 1988 and January 1997, 435 patients underwent an aortic valve reparative procedure at The Cleveland Clinic Foundation. This represents 9.7% of the total aortic valve procedures during the same period. A prolapsing leaflet was present in 136 aortic valves, of which 105 were bicuspid. Ninety-four of these patients were operated upon by the same surgeon (D.M.C.), which constitutes the patient cohort for this report.

Patient characteristics
Mean age was 38±10 (standard deviation, SD) years (range 16–67). Ninety-three percent was male. In 74 cases (78.7%), the fused leaflets in the bicuspid valves were the right and left; in 12 patients (12.8%), the fusion was between the right and the non-coronary cusp and in eight patients (8.5%) between the non-coronary and left cusp.

Preoperative New York Heart Association (NYHA) functional class was I in 37 (39.2%) patients, II in 49 (52.1%) patients, III in 7 (7.4%) patients and IV in 1 (1%) patient.

Isolated aortic valve repair was performed in 80 patients. Concomitant procedures included mitral valve repair in eight patients, coronary artery bypass grafting (CABG) in two, and ascending aortic aneurysm repair in four. Two patients had previously undergone coarctation repair, one patient CABG, and one patient congenital aortic balloon valvuloplasty.

Preoperative assessment
All patients had a preoperative Doppler echocardiogram to assess aortic valve pathology, according to previously described criteria [3] [4] [5], to determine left ventricular function [6] and left ventricular end-diastolic diameter. Preoperative aortic regurgitation distribution was 2+ in five patients, 3+ in 28 patients and 4+ in 61 patients. While 80 patients had no aortic stenosis on the preoperative echocardiography, 12 patients had mild aortic stenosis and two moderate. There were only two patients whose left ventricle was not dilated preoperatively, and the mean left ventricular end-diastolic diameter was 7.0±0.8 cm. Preoperative left ventricular function was normal in 46 patients, mildly impaired in 30, moderately impaired in 13, moderately to severely impaired in three, and severely impaired in two. Coronary catheterization was performed in patients with significant risk factors or who were older than 45 years of age.

Repair technique
Initially, full mid-line sternotomy was used; however, since January 1996 all isolated valve procedures have been performed via minimally invasive approach (n=13). After the patient was placed on cardiopulmonary bypass, the aortic valve repair and any concomitant procedure was performed under single aortic cross-clamp. The heart was protected by a variety of techniques throughout the years. The mean aortic cross-clamp and cardiopulmonary bypass times were 47±17 and 60±28 min, respectively.

All patients had a commissuroplasty. In addition, further elimination of the prolapsing area was by triangular resection and linear closure in 66 (70%) cases or leaflet plication opposite the raphe in 28 (30%) cases. During the study period, the use of triangular resection decreased in favor of plication (P<0.0001, Table 1). Other interventions on the aortic valve are listed in Table 2. Details of the aortic valve repair are described in earlier publications [7] [8].

Postoperative follow-up
Re-exploration for bleeding was necessary in five patients. One patient had a perioperative myocardial infarction and one patient required prolonged ventilatory support for respiratory failure. The mean length of postoperative hospital stay was 6.3±1.9 days.

Follow-up was achieved either by out-patient visit or by telephone interview with the patient or referring physician and a questionnaire completed with current status, medication and information on morbidity and mortality. The data of the most recent echocardiogram were recorded and detailed information obtained for patients who underwent an aortic valve reoperation during follow-up.

Mean duration of follow-up was 5.1±2.4 (SD) years (median 5.5 years, range 0.2–9 years) and was complete in all patients. There were no deaths, early or late, or episodes of thromboembolism or endocarditis. At follow-up, 84 patients were in NYHA functional class I and ten patients were in class II (P<0.001 versus preoperative status).

Reoperations other than aortic valve reoperations were mitral valve repair in one patient, mitral valve replacement in two, and thoracic aneurysm repair in one. One patient underwent an aortic valve replacement after a Ross procedure (patient No. 3 of Table 5).

Overall freedom from aortic valve reoperation
Non-parametric estimates of freedom from reoperation (whether by re-repair or aortic valve replacement) were obtained by the method of Kaplan and Meier [9]. A parametric method was used to resolve the number of hazard phases, identify the shape of the hazard function, and estimate its parameters [10].

Multivariable analysis of aortic reoperation
Variables
Potential risk factors (variables) were organized for entry into the analysis: demography (age at original aortic repair; sex); aortic valve pathology and function (degree of aortic valve regurgitation; degree of aortic valve stenosis; leaflet fusion); left ventricular function (presence of left ventricular dilatation; degree of left ventricular dysfunction (normal, mild, moderate, moderate-to-severe and severe); left ventricular end diastolic diameter); aortic valve procedure (triangular resection (n=66); debridement (n=41); leaflet plication (n=28); resection of raphe (n=15); leaflet patching (n=5); commissurotomy (n=1); leaflet shaving (n=7); repair of perforation (n=4)); concomitant operations (coronary artery bypass grafting (n=2); mitral valve repair (n=8); repair of ascending aortic aneurysm (n=4)); and echocardiographic assessment (degree of immediate intraoperative post-repair residual aortic incompetence (none, trace, 1+, 2+, 3+, 4+)).

General conduct of the multivariable analyses
Exploratory analysis included correlation analysis, stratified life table analyses and decile risk analysis of ordinal and continuous variables to determine possible transformations of scale. A directed technique of stepwise entry of variables into the multivariable risk factor model was then used [11]. The P-value criterion for retention of variables in the final model was 0.1. Regression coefficients are presented plus or minus one standard error.

Nature and influence of risk factors
Exploration of the influence of risk factors in the parametric multivariable analysis was performed by constructing a nomogram representing the solution of the parametric equation for specific values of each factor.

Immediate assessment of aortic valve competence
Immediate competence of the aortic valve was assessed by TEE in the operating room. When a second pump run was needed to achieve satisfactory repair, the grade of aortic regurgitation prior to the second pump run was used in the analysis. Factors associated with initial grade aortic regurgitation were identified using both multivariable ordinal logistic regression and binary logistic regression analyses, on both the presence of trace or more regurgitation and more than mild regurgitation [12]. The variables were those previously listed except for echocardiographic assessment.

Late aortic valve competence
Factors associated with possible progression of aortic regurgitation were identified by multivariable ordinal logistic regression analysis, incorporating time of late echocardiographic assessment after operation and variables as listed above. When aortic valve reoperation was performed, the grade of regurgitation prior to that reoperation was used in the analysis.

	Results

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Immediate assessment of the aortic valve
During the same time period, no patient of the same surgeon underwent immediate aortic valve replacement in the same operative session for failure of repair. In eight of the 94 patients, a second pump run was required to improve the repair due to residual aortic regurgitation of more than 1+. In one patient, the suture line after triangular resection was partially dehisced; two patients had residual central regurgitation which required adjustment of the commissuroplasty; two patients had their leaflet plication redone; two patients required a more extensive triangular resection due to residual leaflet prolapse, and one patient underwent additional leaflet debridement. One patient had 1+ aortic regurgitation after the first pump run, but the jet of regurgitation was considered due to a nodule on one of the aortic valve leaflets and this was debrided on a second pump run.

Degree of aortic competence, immediately after repair and before any second pump run, are shown in Table 3. One risk factor was identified for immediate intraoperative post-repair aortic regurgitation exceeding 1+ after the first pump: increasing left ventricular dysfunction (correlated with increasing left ventricular size, r=0.3, P=0.002), Table 4. Triangular resection versus plication was not identified as a risk factor. After any secondary repair, the degree of aortic regurgitation was 1+ or less in all patients (Table 3). Five (8%) patients of the 66 who underwent triangular resection versus three (11%) of 28 patients who underwent plication, had more than 1+ aortic regurgitation after the first pump run (P=0.6).

Durability of repair
A late follow-up TTE prior to any reoperation (mean interval 3.5±2.4 years after surgery) was available in 86 patients. Late aortic regurgitation was not demonstrated to progress with time (P=0.3, Table 5). No risk factors for late aortic regurgitation were identified. In particular, triangular resection versus plication as technique to eliminate the prolapsing area did not correlate with late aortic regurgitation (P=0.7). Twenty-two (37%) patients of 60 who underwent triangular resection had 2+ or more aortic regurgitation at follow-up, versus ten (38%) of 26 who underwent plication (P=0.7).

During follow-up, 12 patients underwent aortic valve reoperation after the initial valve repair and are outlined in Table 6. Seven of the 12 reoperations were due to dehiscence of the suture line at the level of the triangular resection. There were no deaths at reoperation.

Freedom from aortic valve reoperation was 95, 87 and 84% at 1, 5 and 7 years after aortic valve repair, respectively ( Fig. 1 ). The instantaneous risk (hazard function) for reoperation was highest immediately after reoperation, falling rapidly to approximately 2% per year, or less after 2 years ( Fig. 2 ). Multivariable hazard function analysis revealed the presence of residual aortic regurgitation on immediate intraoperative post-repair TEE as the single risk factor for reoperation ( Fig. 3 ). The methods of repair were not demonstrably associated with reoperation.

View larger version (18K): [in this window] [in a new window]   Fig. 1. Freedom from aortic valve reoperation during follow-up.

View larger version (16K): [in this window] [in a new window]   Fig. 2. Instantaneous risk for aortic valve reoperation during follow-up.

View larger version (30K): [in this window] [in a new window]   Fig. 3. Freedom from aortic valve reoperation during follow-up according to the amount of aortic regurgitation on immediate post-repair intraoperative transesophageal echocardiogram.

	Discussion

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Aortic regurgitation
Guidelines to maximize repair durability are necessary to optimize results of repair of bicuspid prolapsing aortic valve. The result of the repair is assessed in the operating room by TEE which has proved to be reliable [16]. In this series, residual regurgitation greater than 1+ resulted in a second pump run in order to improve the repair. However, analysis indicates that this relatively strict policy should be more strict since patients with any residual aortic regurgitation after the repair have an increased risk of late repair failure. In order to reduce the risk of reoperation, the surgeon should aim to eliminate residual aortic regurgitation at operation; however, this is difficult in patients with large, poor functioning ventricles.

The overall 13% prevalence of reoperation at 5 years is higher than reported by Duran et al. [17] [18] [19]. However, the maximum follow-up in his series was only 4 years. Carpentier [20] reported a similar 13% reoperation prevalence but the duration of follow-up is not quoted in his report. Haydar et al. [21] reported a reoperation prevalence of 18% after a mean follow-up of 2.6 years in a heterogeneous group of patients. In contrast, we investigated only patients who had a bicuspid valve with leaflet prolapse causing aortic regurgitation. Patients with rheumatic valve disease were excluded.

Haydar et al. [21] state that the reoperation prevalence is 11% if immediate failures due to technical errors are excluded. Seven of the 12 reoperations in our series were performed within 16 months of the initial repair. Whether or not these are all attributable to technical failures is doubtful. However, the repair is certainly more stable after the first 18 months.

Another consideration was the technique for eliminating the prolapsing area, triangular resection versus central plication. We gradually changed our technique in favor of plication of the central area. The advantage of plication is the preservation of the thicker, central tissue opposite the raphe, which presumably holds the plication suture better. There is also more coapting surface area of the leaflet when no resection is performed. To date, we have not demonstrated that this change has improved results. Longer follow-up and larger numbers should reveal whether plication is more durable than triangular resection.

Another measure of durability is the stability of the repair on follow-up TTE. Carpentier [20] reported that 15% of patients had moderate aortic regurgitation at echocardiographic follow-up, while aortic regurgitation of 2+ or greater was present in 26% of all patients in the present series who still had their native aortic valve. Although all of these patients are asymptomatic, some of them may require late reoperation. Therefore, close echocardiographic follow-up is imperative in these patients.

Aortic stenosis
This study confirms that the repair technique does not create aortic stenosis [1] [2] [7]. However, the technique does not necessarily protect the valve from developing late aortic stenosis. Two patients with mild aortic stenosis required reoperation predominantly for combined aortic stenosis and aortic regurgitation (Table 5). It is therefore essential to keep patients with a history of aortic stenosis in regular echocardiographic follow-up.

Current strategy
All patients with aortic regurgitation from a prolapsing bicuspid aortic valve who require intervention are considered candidates for valve repair. Patients with mild aortic stenosis are also considered candidates for repair; however, the feasibility of repair will have to be evaluated intraoperatively.

Morbidity and mortality is minimal. The native aortic valve is preserved and anticoagulation is unnecessary.

Currently, we accept 1+ residual aortic regurgitation as a satisfactory repair. However, since those patients with any residual aortic regurgitation have an increased risk of reoperation, the benefits and risks of a second pump-run must be carefully and individually considered. Plication is the preferred technique for elimination of the prolapsing area.

Patients should be evaluated by TTE at regular intervals, especially those with residual aortic regurgitation after initial repair.

If aortic valve reoperation becomes necessary, the aortic valve can be replaced using any of the available techniques and the risk of reoperation was very low in this series.

Limitations of the study
This is a single-institution, single-surgeon study. While this achieves homogeneity of repair strategy, it does so at the expense of study size and generalizability. Duration of follow-up is intermediate-term, which limits long-range inferences. As many of these patients were referred for aortic valve repair, only one post-repair echocardiogram is available on most of the patients. Serial echocardiograms would permit early detection of progressive aortic regurgitation and identify patients who require reoperation at an earlier stage. As a substitute for this, we have used a method of longitudinal analysis for aortic competence assessment that presumes that a group trend, reflecting individual trends, can be detected.

	Acknowledgments

 
The authors wish to thank Karen Mrazeck and Colleen Vahcic for research assistance.

	Footnotes

 
Presented at the 12th Annual Meeting of the European Association of Cardio-thoracic Surgery, Brussels, Belgium, September 20–23, 1998.

	Appendix A. Conference discussion

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Dr U. Althaus (Bern, Switzerland): You identified that residual aortic regurgitation is the only risk factor for re-operation. What is the practical clinical consequence of your study? If at the end of your repair, even after the second pump run, mild regurgitation is evident on intra-operative echocardiography, would you then usually envisage direct valve replacement or did you also observe that in some patients, a mild regurgitation turned out to be regressive in the post-operative course?

Dr Casselman: A second pump was indicated when the residual aortic regurgitation was two plus or more. If the residual aortic regurgitation was trace or one plus, this result was generally accepted. However, in the view of these results, the current strategy is, when patients have residual aortic regurgitation that is one plus, the transesophagael echocardiogram is studied to identify a correctable cause. If a cause is recognized on transesophageal echo, then the patient gets a second pump run to try to correct this cause. If no particular cause is detected, one plus aortic regurgitation is accepted as a satisfactory result.

Dr M. O'Brien (Brisbane, Australia): Many of these patients, at least in our hands, with congenital aortic incompetence and a bicuspid valve have quite a dilated annulus. You haven't really made reference to this. Do you consider that perhaps a circumferential plication suture to narrow the annulus when it is particularly dilated may enhance the coaption and consequently produce a better result?

Dr Casselman: This has not been performed in any of the patients. The only annuloplasty that has been performed is the commissural plasty which I described in the talk. Of course, this only decreases the annulus moderately and it would not be a suitable technique if there is a very dilated annulus.

Dr A. Moritz (Frankfurt, Germany); Especially in patients with bicuspid valves, there are indices that the aortic wall in itself is not completely normal, and it was our experience that some of the bicuspid valve repairs had a late dilatation of the aortic root and become incompetent by this mechanism. Do you have any similar experience or do you trust on the aortic wall in these patients?

Dr Casselman: We did particularly look at this also where we measured on the preoperative echocardiogram the aortic root and then compared it on the follow-up echo, and we did not see any statistical difference between pre- and post-repair results.

Dr Moritz: We published data where we found this dilatation in the sub-group of bicuspid valves, but not in tricuspid valves that we were able to repair.

Dr Casselman: We did not see this in this series.

Dr W. Northrup (Minneapolis, MN, USA): We have a much smaller series than the Cleveland Clinic. I think we have eight patients we have done in the last 3 years. We have no reoccurrences, but we have a slightly different suture technique than I believe you use. We use interrupted polyamide Cardionyl. We have not had any late failures or intermediate failures so far. I wonder if part of the trouble that you have had with the resection has to do with the suture material. I believe you used polypropylene.

Dr Casselman: Actually, currently 5–0 Ethibond is used and in the initial patients in the first half of the series, the triangular resection was closed with interrupted sutures. When Dr. Cosgrove became aware of the higher incidence of suture dehiscence, he changed his technique for the triangular suture, which he also uses for the plication.

	References

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