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Ann Thorac Surg 2001;71:1564-1571
© 2001 The Society of Thoracic Surgeons

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Original article: cardiovascular

Aortic valvotomy for congenital valvular aortic stenosis: a 37-year experience

^a Department of Cardiac Surgery, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany

Accepted for publication December 13, 2000.

Address reprint requests to Dr Detter, Department of Cardiac Surgery, Klinikum Grosshadern, Ludwig-Maximilians-University, D-81366 Munich, Germany
e-mail: cdetter{at}hch.med.uni-muenchen.de

	Abstract

Top Abstract Introduction Patients and methods Results Comment References

 
Background. The purpose of the study was to analyze the long-term results of aortic valvotomy and the risk factors associated with reoperation and survival.

Methods. From 1960 to 1977, 116 patients with congenital valvular aortic stenosis underwent isolated aortic valvotomy at a mean age of 13.7 ± 7.8 years with a mean aortic gradient of 78 ± 33 mm Hg. Fifteen patients had additional aortic regurgitation, and leaflet calcification was present in another 15 patients.

Results. Postoperatively the mean aortic gradient decreased to 19.4 ± 11.3 mm Hg (p < 0.0001). Early mortality was 2.6%. At a mean follow-up of 23.8 years, 26 late deaths (22.4%) occurred among the 113 early survivors. Actuarial 10-, 20-, 30-, and 37-year survival rates were 94.6%, 79.7%, 76.2%, and 72.5%, respectively. According to multivariate Cox regression analysis, survival was influenced by preoperative New York Heart Association class (p = 0.0418), leaflet calcification (p = 0.0339), date of operation (p = 0.0253), and postoperative endocarditis (p < 0.0001). At a mean interval of 18.3 years, 37 patients required reoperation (31.9%) mainly because of recurrent aortic stenosis. The reoperation rate increased significantly 15 years postoperatively from 0.73%/year to 2.31%/year (p < 0.0001). In a multivariate risk model, reoperation was influenced by older patient age (p = 0.0032) and the presence of leaflet calcification (p = 0.0289).

Conclusions. Aortic valvotomy is a simple and effective procedure for congenital aortic stenosis with excellent long-term results. However, the rate of reoperation increases 15 years postoperatively, and clinical follow-up should be intensified. Our results suggest that early repair should be performed and that adequate patient selection is the most important determinant of the long-term results.

	Introduction

Top Abstract Introduction Patients and methods Results Comment References

 
Valvular aortic stenosis occurs in 3% to 6% of patients with congenital heart disease [1]. Congenital aortic stenosis is caused by imperfect cusp development with leaflet thickening and fusion. The valve is in most cases bicuspid with an anterior and a posterior commissure or tricuspid with three thickened leaflets and fused commissures of varying degrees. Valvular aortic stenosis was one of the first congenital cardiac lesions treated surgically. Aortic valvotomy under direct vision was first reported in 1956 using hypothermia and inflow occlusion [2, 3]; shortly thereafter cardiopulmonary bypass (CPB) was routinely used during operation [4, 5]. Several groups reported good early and late results up to 20 years [6–8]. However, valvotomy is a palliative surgical treatment, and reoperation may occur [9–12]. Because ultralong-term follow-up data are lacking, opponents of valvotomy assumed that all patients would ultimately require reoperation [13]. However, it remains uncertain whether in selected patients aortic valvotomy may be more than a palliative procedure.

The purpose of the study was to review our historic (1960 to 1977) long-term experience with aortic valvotomy and to evaluate long-term survival rates, valve-related complications, and the risk factors associated with reoperation and survival.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment References

 
From January 1960 to March 1977, 116 patients with congenital valvular aortic stenosis underwent isolated aortic valvotomy at our institution as their first surgical procedure. The mean age at operation was 13.7 ± 7.8 years (median, 13.0 years; range, 0.1 to 30 years). Four patients were younger than 1 year of age; none of them had critical aortic stenosis. There were 85 male and 31 female patients. The majority of patients (73%) were in New York Heart Association (NYHA) functional class II or III. The preoperative clinical characteristics of the patients are summarized in Table 1.

Operative techniques
All operations were performed through a median sternotomy using CPB with moderate hypothermia (28°C to 32°C) and induced ventricular fibrillation; cardioplegia was not used. For additional myocardial protection, cold saline solution was applied topically. The aorta was cross-clamped and opened by a transverse incision. Fused aortic commissures were incised widely with attention to avoid valve regurgitation. The procedure was associated with debridement of calcium depositions in 12 patients with moderate leaflet calcification. The aortic valve was bicuspid in 84 patients (72.4%) and tricuspid in 32 patients (27.6%). The mean duration of CPB was 29 ± 13 minutes, and the aortic cross-clamp time was 15 ± 8 minutes. After the operation, the result was controlled by invasive measurements to confirm a successful relief of the pressure gradient across the aortic valve.

Follow-up
The patients’ operative records were reviewed retrospectively. Survival and follow-up data were acquired by written questionnaires. In cases in which the patient did not answer, repeated letters and telephone interviews were used. If a patient died, a relative or the primary care physician was contacted. A clinical examination including echocardiography and electrocardiogram was performed at our institution on identified, not reoperated survivors. Valve function, valve morphology, transvalvular gradients, myocardial function, myocardial thickness, and the diameter of the left ventricle were determined. The functional status was assigned according to the NYHA. Mean follow-up was 23.8 ± 10.3 years (median, 26.4 years; range, 0.1 to 37.2 years). Follow-up was complete in 95.7% of the patients, representing a total of 2,761 patient-years.

The results of the operations performed are reported in accordance with the recommendations of the Ad Hoc Liaison Committee in "Guidelines for Reporting Morbidity and Mortality After Cardiac Valvular Operations" [14].

Statistical analysis
Continuous data were analyzed using the Mann-Whitney U test, categorical data using the ² test. Values were expressed as mean ± standard deviation. Long-term survival and freedom from reoperation were estimated using the Kaplan-Meier method. These data were expressed as mean ± standard error of the mean. Differences between groups were calculated by the log-rank test. The association of variables to long-term survival and reoperation was first tested in a univariate model. The tested variables included in the model were age, sex, preoperative NYHA class, emergency operation, history of decompensation, preoperative cardiac medication, preoperative thromboembolism, preoperative left ventricular enlargement, preoperative and postoperative aortic valve gradient and aortic regurgitation, valve morphology (bicuspid versus tricuspid), leaflet calcification, date of operation, aortic cross-clamp and CPB time, and all valve-related complications. Every univariate variable reaching significance (p < 0.05) was then tested in a multivariate analysis using the Cox regression model and removed stepwise if no significant influence was calculated. Statistical analyses were performed using the SPSS statistical software package 9.0 for Windows (SPSS, Inc, Chicago, IL).

	Results

Top Abstract Introduction Patients and methods Results Comment References

 
Postoperative results
The mean preoperative aortic pressure gradient decreased from 77.6 ± 32.5 mm Hg (range, 40 to 200 mm Hg) to 19.4 ± 11.3 mm Hg (range, 0 to 60 mm Hg) postoperatively (p < 0.0001). Twelve patients (10.3%) had postoperative gradients between 30 and 40 mm Hg and 1 patient (0.9%) still had a significant aortic gradient of 60 mm Hg. He died 3 months after the operation because of severe anticoagulant-related cerebral hemorrhage. There was no significant difference in preoperative (p = 0.976) and postoperative (p = 0.53) aortic gradients between bicuspid and tricuspid aortic valves. Postoperatively, 21 patients (18.1%) had mild aortic incompetence; no moderate or severe aortic regurgitation was recorded. There was no correlation between preoperative and postoperative aortic regurgitation (p = 0.366). In 12 patients, valvotomy caused no change in the degree of aortic regurgitation. Three patients with preoperative moderate aortic regurgitation had a postoperative improvement to mild degree, and mild aortic regurgitation developed in 6 patients with no regurgitation. The presence of leaflet calcification did not have any influence on postoperative aortic gradient (p = 0.73) or postoperative aortic regurgitation (p = 0.88).

Survival
Three patients (2.6%) died within the first 30 days after aortic valvotomy; all of them were older than 1 year. Causes of early death were acute cardiac failure in all 3 patients.

During the long-term follow-up, 26 late deaths (22.4%, 0.94% per patient-year) occurred among the 113 operative survivors, most of cardiac causes (n = 19). Table 2 describes the causes of late death in detail. Actuarial 10-, 20-, 30-, and 37-year survival rates were 94.6%, 79.7%, 76.2%, and 72.5%, respectively (Fig 1). Median survival of all patients was 26.4 years.

View larger version (10K): [in this window] [in a new window]   Fig 1. Actuarial long-term survival of the 113 early survivors after aortic valvotomy. Numbers below the curve indicate the numbers of patients at risk.

View larger version (15K): [in this window] [in a new window]   Fig 2. Actuarial survival curves according to log-rank univariate analysis of significant variables. (A) The effect of preoperative New York Heart Association (NYHA) functional class (p = 0.0067); (B) presence of leaflet calcification (p = 0.0039); and (C) occurrence of postoperative endocarditis (p < 0.0001) on survival rate. Numbers below the curves indicate the numbers of patients at risk.

View larger version (13K): [in this window] [in a new window]   Fig 3. Actuarial survival curve according to the date of operation. Guided by experience, patient selection changed after 1970. The mean age decreased from 15.3 to 10.3 years, only 1 patient with calcified leaflets and no patients with aortic regurgitation underwent operation, and aortic cross-clamp and CPB times were significantly lower. In this subgroup, long-term survival improved significantly (p = 0.0037). Numbers below the curves indicate the numbers of patients at risk.

Thromboembolism
One patient had a stroke 6 years after initial aortic valvotomy; the patient was in sinus rhythm when the event occurred. A thromboembolic event occurred in 3 patients after implantation of a mechanical heart valve.

Anticoagulant-related hemorrhage
Severe anticoagulant-related hemorrhage was observed in 1 patient. The hemorrhage occurred within 3 months after aortic valvotomy under phenprocoumon treatment. In 2 other patients, anticoagulant-related hemorrhage occurred after implantation of a mechanical heart valve.

Reoperations
Thirty-seven patients (31.9%) required reoperation of the aortic valve, corresponding to a linearized rate of 1.34% per patient-year. The mean interval between the first and second procedure was 18.3 ± 7.3 years (median, 19.2 years; range, 1.9 to 33.5 years). The most common cause of reoperation was a recurrent valvular aortic stenosis in 25 patients, followed by a severe aortic regurgitation in 12 patients. One of the 25 patients had postoperative residual aortic stenosis (p = 0.559), and 4 of the 12 patients had postoperative aortic regurgitation (p = 0.121). In 34 patients, an aortic valve replacement was performed with a mechanical prosthesis in 28 patients, a porcine bioprosthesis in 4 patients, and an aortic homograft in 2 patients. A repeat aortic valvotomy was performed in 2 patients, and 1 patient underwent balloon valvuloplasty. The freedom from reoperation at 10, 20, 30, and 35 years was 94.2%, 80.1%, 57.1%, and 44.8%, respectively. The reoperation rate was linear in the first 15 years after the operation and equaled 0.73% per year. Thereafter, it increased significantly to 2.31% per year (p < 0.0001; Fig 4). Two patients (5.4%) died at reoperation. Six patients underwent a second reoperation after degeneration of a bioprosthesis (n = 3) or a homograft (n = 1), endocarditis of a bioprosthetic valve (n = 1), and severe recurrent stenosis after repeat aortic valvotomy (n = 1).

View larger version (18K): [in this window] [in a new window]   Fig 4. Actuarial freedom from reoperation after aortic valvotomy. The curve shows two different phases that are distinct. The early, low-risk phase lasts 15 years; thereafter, the risk increases significantly. Risk of reoperation (R) per year, as a linearized number, is calculated for each phase. Numbers below the curves indicate the numbers of patients at risk. (p.o. = postoperatively.)

View larger version (12K): [in this window] [in a new window]   Fig 5. Actuarial freedom from reoperation according to log-rank univariate analysis of significant variables showing the effect of older patient age (A; p = 0.0001) and presence of leaflet calcification (B; p = 0.0023) on reoperation rate. Numbers below the curves indicate the numbers of patients at risk.

Echocardiographic results
Echocardiographic evaluations were performed in 44 of 50 surviving patients with no subsequent reoperation. The peak pressure gradients ranged between 6 and 122 mm Hg with a mean of 44.4 ± 23.4 mm Hg. The mean pressure gradient was 28.6 ± 18.1 mm Hg. A severe aortic stenosis (peak gradient > 80 mm Hg, mean gradient > 50 mm Hg) was seen in 3 patients (6.8%), and severe aortic regurgitation (grade III) was present in 2 patients (4.5%) who were scheduled for reoperation. Left ventricular myocardial function was measured as a function of fractional shortening and was normal in all patients. Significant left ventricular hypertrophy (wall thickness > 12 mm) and ventricular dilation (left ventricular end-diastolic diameter > 56 mm) was seen in 18 (40.9%) and 12 patients (27.3%), respectively. The valve leaflets were slightly calcified in 18.2% and severe in 22.7% of patients. Valve thickening was present in 34.1% of patients. All echocardiographic results are summarized in Table 5.

	Comment

Top Abstract Introduction Patients and methods Results Comment References

The early mortality rate was low and comparable to other investigators [6–8, 15, 16] even in the early years of cardiac operations, when cardioplegic solutions were not used. This is because of the fact that this technique is simple and easy to perform, which is well supported by the short aortic cross-clamp and CPB times. Nevertheless, all early deaths were caused by acute cardiac failure and not by technical faults, and may have been preventable by proper myocardial protection. The direct inspection of the valve allows careful incision of the aortic commissures and, if necessary, debridement of calcium depositions. In fact, the preoperative aortic pressure gradients could be substantially decreased, and except for 1 patient with a postoperative gradient of 60 mm Hg, no severe residual stenosis or severe aortic regurgitation was postoperatively recorded leading to early reoperation.

The excellent long-term survival after aortic valvotomy is well recognized [7, 17–19] and is better if compared with valve replacement in our institution during the same period [20]. However, it remained uncertain which factors may influence long-term survival and the recurrence of aortic valve disease leading to reoperation. In our study, many preoperative and postoperative factors were tested for whether they influenced early or late survival. There were no significant risk factors for early mortality. However, the operative mortality for the surgical treatment of congenital valvular aortic stenosis is close to zero [6, 15, 18], and therefore risk factors are difficult to isolate. Among the various analyzed predicting factors for late survival, advanced preoperative NYHA class, the presence of leaflet calcification, patient selection, and a postoperative endocarditis were independent risk factors. Thus, earlier surgical intervention in this patient group should be performed to avoid worsened clinical status and leaflet calcification. In fact, after 1970 patient selection changed. The mean age decreased from 15.3 to 10.3 years, and only 1 patient with calcified leaflets and no patients with aortic regurgitation underwent operation. In addition, the experience of the surgeon increased after 1970, which is well documented by patient selection and significant shorter aortic cross-clamp and CPB times. In this subgroup, long-term survival improved remarkably to a 25-year survival of 94.6% (Fig 3). However, improved perioperative and postoperative management may have added to better long-term outcome. These results demonstrate that aortic valvotomy is an excellent long-term treatment in selected patients in the hands of experienced surgeons.

Aortic valvotomy was considered only a palliative surgical treatment in earlier studies [9–13, 15, 16]. In our study, 31.9% of the patients required reoperation, and the mean interval between the initial valvotomy and reoperation was 18.3 years. This compares well with the 39% at a mean of 17.7 years postoperatively reported by DeBoer and colleagues [17] and reflects the effectiveness of aortic valvotomy with the excellent relief of aortic stenosis. However, our results showed a significant increase of the reoperation rate 15 years postoperatively. DeBoer and coworkers [17] were also able to demonstrate that the need of reoperation was unlikely during the first decade and increased linearly at 3.3% per year thereafter. Then, reoperation will be more likely, and clinical examinations should be intensified. Previous reports have predicted that restenosis would be a major long-term complication [13, 17, 18]. In fact, the major cause of reoperation was a recurrent valvular aortic stenosis. Supported by multivariate analysis, reoperation was more likely to occur in older patients with calcified aortic leaflets. No correlation among the preoperative aortic valve gradient, bicuspid valves, and restenosis could be demonstrated. Thus, indications for aortic valvotomy include young patients without leaflet calcification; bicuspid valves and severe aortic stenosis are not contraindications. In patients with severe leaflet calcification, valve replacement may be the better choice. Aortic regurgitation was less likely to occur after open valvotomy [18, 19] and was mild in all patients. This appears to be well tolerated and did not influence long-term survival and reoperation rate.

Valvotomy, however, has several advantages. It preserves the native valve and offers 15 years with low reoperation rates. Thus, congenital aortic stenosis can be surgically well controlled in children until adulthood [18]. During this time, the aortic annulus may grow sufficiently to accommodate a prosthesis of proper size. If reoperation is necessary, valve replacement is frequently needed and can be performed with low mortality. Because the native valve is preserved, valve-related complications were low and no anticoagulation treatment was necessary; they are significantly lower when compared with those of aortic valve replacements in the same period [20]. The fact that almost all (94%) surviving patients not requiring reoperation are in NYHA functional class I or II and only 2% were unable to work demonstrates that these patients still enjoy a good quality of life after a follow-up time of up to 37 years. Only 20% of patients were taking cardiac medication. Correspondingly in the majority of patients, the echocardiographic evaluations showed excellent results with a mean aortic gradient of 29 mm Hg. Severe aortic stenosis occurred in 6.8% and severe aortic regurgitation in only 4.5%. All patients had a good left ventricular myocardial function, which highlights the excellent hemodynamic performance of the native valve. Thus, the excellent functional classification and cardiac performance persisted in the majority of the patients.

In conclusion, aortic valvotomy for congenital aortic stenosis is a safe, simple, and effective surgical intervention with excellent early and long-term results. However, our results showed a significant increase of the reoperation rate 15 years postoperatively. At this time, reoperation becomes more likely, and clinical follow-up should be intensified. According to multivariate analysis, preoperative NYHA class, leaflet calcification, date of operation, and postoperative endocarditis were significant predictors for late death, and reoperation was more likely to occur in older patients with calcified aortic leaflets. Therefore, early repair should be performed. Adequate patient selection is the most important determinant of the long-term results.

	References

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Christian Detter Teddy Fischlein Georg Nollert Bruno Reichart Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Detter, C. Articles by Reichart, B. Search for Related Content PubMed PubMed Citation Articles by Detter, C. Articles by Reichart, B. Related Collections Congenital - acyanotic