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Eur J Cardiothorac Surg 2002;22:70-77
© 2002 Elsevier Science NL
a Department of Cardio-Thoracic Surgery, Erasmus Medical Center, Rotterdam, The Netherlands
b Department of Cardio-Thoracic Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands
c Department of Cardio-Thoracic Surgery, University Medical Center Leiden/Academic Medical Center, Amsterdam, The Netherlands
d Department of Cardio-Thoracic Surgery, University Medical Center Nijmegen, Nijmegen, The Netherlands
e Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands
f Department of Cardio-Thoracic Surgery, University Medical Center Groningen, Groningen, The Netherlands
Received 18 December 2001; received in revised form 22 February 2002; accepted 22 March 2002.
* Corresponding author. Tel.: +31-10-463-5413; fax: +31-10-463-3993
e-mail: takkenberg{at}thch.azr.nl
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Abstract |
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 Top Abstract 1. Introduction2. Methods3. Results4. DiscussionAppendix AReferences |
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Key Words: Ross procedure • Autograft • Allograft • Multicenter study • Clinical outcome
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1. Introduction |
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TopAbstract1. Introduction2. Methods3. Results4. DiscussionAppendix AReferences |
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The Ross procedure was introduced in the Netherlands by Dr Donald Ross himself in 1988 in Rotterdam, but to date the outcome of the Ross procedures that were performed in the Netherlands is unknown. In the light of recent concern regarding progressive dilatation of the pulmonary autograft in aortic position [5] and growing evidence on the limited durability of the allograft in the right ventricular outflow tract [6], a retrospective analysis of all patients who underwent a Ross procedure in the Netherlands was performed.
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2. Methods |
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TopAbstract1. Introduction2. Methods3. Results4. DiscussionAppendix AReferences |
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The combined results of the collected data were analyzed using SPSS 10.0 for Windows. Means were compared by the unpaired t-test. The 
2-test or Fisher's exact test was used to compare categorical variables. All tests were two-sided, with an 
-level of 0.05. Univariate logistic regression was used to study potential determinants of early mortality (death during hospitalization or within 1 month after operation). The following parameters were considered: patient age (continuous variable); prior cardiac surgery (yes/no); pre-operative serum creatinin (continuous variable); New York Heart Association (NYHA) class IV/V (versus NYHA class I–III); extended Ross procedure (autograft aortic root replacement with additional enlargement of the left ventricular outflow tract); concomitant procedures (yes/no); perfusion time (continuous variable); pre-operative left ventricular function. Cumulative survival and freedom from reoperation or reintervention were analyzed using the Kaplan–Meier method. The survival of a patient started at the time of surgery and ended at death (event) or at last follow-up (censoring). The analysis of autograft and pulmonary allograft survival started at the time of implantation and ended with reoperation or reintervention (event) or last follow-up or patient death (censoring). The differences between Kaplan–Meier curves were evaluated using the log-rank test. For overall survival, the parameters that were also considered for operative mortality were analyzed. The following parameters were considered for freedom from reoperation or reintervention: patient age (continuous variable); aortic regurgitation versus stenosis; type of valve disease (bicuspid, tricuspid or prosthesis); prior cardiac surgery (yes/no); extended Ross procedure; concomitant procedures (yes/no); size of donor valve (mm); type of donor valve (pulmonary versus aortic); type of donor (heart beating, domino or non-heart beating); preservation technique (cryopreserved versus fresh); origin (Rotterdam, London, Berlin, Barcelona, other) and quality code of donor valve (ranging from 1 to 5). Multivariate analysis of time-related events (death, reoperation, and reoperation for structural valve deterioration) was done using the Cox proportional hazard regression model. Backward stepwise selection of potential predictors (criteria for entering variables: log-rank 2-test P<0.05) was employed. Covariables were examined by complete case analysis.
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3. Results |
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TopAbstract1. Introduction2. Methods3. Results4. DiscussionAppendix AReferences |
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16 years (N=245) and <16 years (N=98) separately. The right ventricular outflow tract was reconstructed with an allograft in 341 patients; a bioprosthesis was used in two patients (bovine pericardium mounted xenograft). Allograft characteristics are displayed in Table 3. Nine patients died during or shortly after operation (2.6% hospital mortality). Of these patients, five were children aged 0.02–5.1 years with complex congenital heart defects. In eight patients, death was operative and not valve-related. In one patient who underwent an autograft aortic root replacement with reimplantation of the coronary arteries, intraoperative malperfusion of the reinserted right coronary artery occurred, necessitating coronary artery bypass grafting. However, the patient had already developed a major acute myocardial infarction causing massive heart failure and died shortly after operation. Therefore, this death is considered to be valve-related.
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Follow-up was obtained for all patients until at least discharge. Long-term follow-up was complete until at least January 1, 1999 for 307 patients (92% of all hospital survivors). The 27 patients whose follow-up was incomplete (last information from before January 1999) were censored at the time of their last follow-up. Mean follow-up duration was 4.0 years (median 3.9 years, SD 2.8, range 0–12.5 years) with a total follow-up of 1387 patient years. During follow-up, another eight patients died. Cause of death was non-valve-related in five patients: one patient died 6 months post-operative of recurrent rheumatic fever; three patients died of cardiac causes at 1.8, 4.2 and 4.7 years post-operative; and one patient died of sepsis 7 weeks post-operative. Cause of death was valve-related in three patients. One patient died of unknown causes 6 months post-operative (valve-related by definition). One patient who underwent an autograft aortic root replacement had coronary artery bypass grafting 6 months post-operative after an acute myocardial infarction caused by stenosis of the reimplanted left coronary artery ostium, and finally died of heart failure 1 year post-operative. Finally, one patient died of a stroke 2.9 years after operation. Cumulative overall survival is displayed in Fig. 1A , and was 97% at 1 month post-operative (95% CI 96–99%), 96% at 1 year (95% CI 94–98%) and 94% at 5 and 7 years post-operative (95% CI 91–97%). NYHA class at last follow-up was available in 320 patients (99% of patients still alive). Two-hundred-and-seventy-eight patients (87%) were in NYHA class I, 40 (13%) in NYHA class II, and 2 (<1%) in NYHA class III. Table 4 displays the hazard ratios for those parameters that univariately had a significant effect on overall survival, and the results of the full multivariate Cox regression model. The only two factors that independently predicted overall mortality were pre-operative NYHA class IV/V and longer perfusion time.
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Freedom from reoperation on the autograft (Fig. 1B) was 99% at 1 year (95% CI 98–100%), 95% at 5 years (95% CI 92–98%), and 91% at 7 years (95% CI 85–97%). No risk factors for reoperation on the autograft could be identified, in particular no relation was seen with pre-operative hemodynamic diagnosis (aortic regurgitation versus stenosis) and bicuspid valve disease. Freedom from reintervention (reoperation or catheter intervention) on the allograft in the right ventricular outflow tract (Fig. 1C) was 99% at 1 year (95% CI 98–100%), 97% at 5 years (95% CI 95–99%), and 96% at 7 years (95% CI 93–99%). The only two parameters that were univariately associated with an increased hazard for reintervention on the allograft in the right ventricular outflow tract was younger patient age (heart rate (HR) 0.94, 95% CI 0.88–0.99) and smaller size of donor valve (HR 0.80, 95% CI 0.69–0.93). None of the other allograft characteristics (pulmonary versus aortic allograft, type of donor, preservation technique, origin and quality code of the donor valve) were associated with an increased hazard. Freedom from any autograft or allograft-related reintervention (Fig. 1D) was 98% at 1 year (95% CI 96–100%), 92% at 5 years (95% CI 88–96%), and 88% at 7 years (95% CI 81–94%). No risk factors for any autograft- or allograft-related reintervention could be identified.
Echocardiographic follow-up studies were available in 309 patients who were alive at last clinical follow-up and did not undergo a replacement of the aortic or pulmonary valve. The majority of patients (96%; N=296) had no to mild aortic regurgitation. Moderate to severe aortic regurgitation was present in 4% (N=13) of patients, reversed descending aorta diastolic flow in 3% (N=8). Of the 281 patients with echocardiographic data on the right ventricular outflow tract, 10% (N=29) had a peak gradient over the right ventricular outflow tract >30 mmHg. Ninety-nine percent of patients (N=277) had no to mild pulmonary regurgitation, while 1% (N=4) had moderate to severe pulmonary regurgitation.
Other non-fatal valve-related events occurred in four patients: two patients who received cumarin therapy for non-cardiac reasons had a major bleeding (0.14%/patient year), one patient had a cardiovascular accident (CVA) (0.07%/patient year), and one patient developed endocarditis of a degenerated pulmonary autograft after surgical treatment of an axillary abscess (0.07%/patient year). No other valve-related events were reported.
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4. Discussion |
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TopAbstract1. Introduction2. Methods3. Results4. DiscussionAppendix AReferences |
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Both operative mortality and mid-term mortality in this series are low, and functional mid-term results are good when considering the pre-operative functional status of patients. Most operative deaths were in young patients with complicated and lengthy procedures. However, one patient died due to a peri-operative myocardial infarction caused by malperfusion of a reinserted right coronary artery. This is a serious potential complication when using the root replacement technique with reimplantation of the coronary arteries. Another example of this technical problem is the patient who required coronary artery bypass grafting during the Ross procedure because of surgical damage to a coronary artery. Finally, a third patient had a major myocardial infarction 6 months post-operative caused by stenosis of the ostium of the reimplanted left coronary artery possibly due to dilatation of the autograft root, required coronary artery bypass grafting and died of heart failure at 1 year post-operative. Therefore, when using the root replacement technique, reimplantation of the coronary arteries should be done carefully using sufficiently large buttons of aortic wall tissue around the coronary ostia and paying close attention to possible kinking of the coronary arteries.
Autograft failure necessitating reoperation occurred in 14 patients, of which 13 had dilatation of the autograft root causing severe aortic valve regurgitation. There was no autograft stenosis. Another 13 patients have echocardiographic evidence of moderate to severe aortic regurgitation and will probably require replacement of the autograft relatively soon. Progressive dilatation of the neo-aortic root after autograft aortic root replacement is of great concern, and may possibly be related to bicuspid valve disease [5,8–10]. However, it may also be related to the way the autograft root is implanted in the aortic annulus. When the autograft root is implanted inside of the aortic annulus instead of on top, the occurrence of dilatation may be prevented [11]. Prosthetic or pericardial tissue strip support is also being applied to prevent dilatation. Unfortunately, details on annular support were not available from the Dutch experience study. No evident risk factors for autograft valve failure, including surgical technique and bicuspid valve disease, emerged from this study.
Structural valve failure of the allograft in pulmonary position required reintervention in 10 patients. Another 29 patients currently have considerable peak gradients over the right ventricular outflow tract. Unlike the autograft failure, structural valve failure of the allograft in pulmonary position is characterized by degenerative changes, calcification and stenosis. There are several possible explanations for the limited durability of allografts in the right ventricular outflow tract. First of all, young children will outgrow their allograft after a few years. This is supported by the association found between patient age and size of the allograft with freedom from allograft-related reintervention. Previous reports confirm this relationship [6,12–14]. Another explanation for limited allograft survival may be accelerated immunologic-mediated degeneration. The finding that young patient age is associated with structural allograft valve failure is supportive of this hypothesis, but may also be merely a reflection of somatic outgrowth of the allograft valve in young children. Although allograft valves have been shown to be immunogenic, no clinical relevance has been proven with regard to allograft failure [15–20]. The clinical impact of structural valve failure of the allograft in the right ventricular outflow tract on valve-related mortality and morbidity is yet unclear. In our experience, no major difficulties with the replacement and repair of the degenerated allograft were encountered.
Other valve-related events were rare in this retrospective study. For example, there was only one major thrombo-embolic event during a follow-up of 1387 patient years. This reflects one of the major advantages of the Ross procedure over the use of mechanical prostheses for aortic valve replacement. Other authors report similar low incidences of thrombo-embolic events [21–25]. Also, a high-intensity transient Doppler signal (HITS) study comparing patients after Ross procedure with patients after aortic valve replacement with a mechanical prosthesis confirms that pulmonary autografts, unlike mechanical valves, rarely cause microemboli [26]. It should be noted that this study was retrospective and follow-up was 92% complete, which may have resulted in an underestimation of the true occurrence of valve-related events.
Also of note is that the Ross procedure is used relatively infrequent for the replacement of the aortic valve. For example, in 1999 in the Netherlands, 1995 aortic valve operations (including concomitant procedures) were registered, of which 940 isolated aortic valve replacements (source: BHN database; 84.5% complete). In contrast, according to our study only 25 Ross procedures were done in the same year. In the pediatric population, the Ross procedure can be advised as a valuable surgical technique even in complex cardiac conditions. The same applies to adolescents. In adults who require aortic valve replacement, other valve alternatives are usually considered first, and the use of the Ross procedure should be limited to a highly selective group of mainly young adult patients.
In conclusion, the Dutch experience with the Ross procedure is satisfactory, with low operative mortality, good functional results, good midterm survival and few complications. Although both the autograft in aortic position and the allograft in the right ventricular outflow tract have a limited durability, this has not yet resulted in considerable morbidity and mortality.
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Footnotes |
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Appendix A |
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TopAbstract1. Introduction2. Methods3. Results4. DiscussionAppendix AReferences |
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Local investigators: University Medical Center Leiden: C. Wientjes; University Medical Center Nijmegen: T. Markou; BIS Foundation: J.J. van den Brand.
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References |
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TopAbstract1. Introduction2. Methods3. Results4. DiscussionAppendix AReferences |
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