Original article
The Ross Operation in Young Patients
A single-center, long-term follow-up study
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Background: The standard aortic valve replacement operations in young patients are bioprosthetic or mechanical aortic valve replacement. In this study, we present the long-term results of the Ross operation in young patients.
Methods: The Ross operation with root replacement was performed on 795 patients between 1995 and 2020. The endpoints were overall survival, re-operation/reintervention rates on the autograft and homograft/RV-PA conduit (RV, right ventricle; PA, pulmonary artery), and the occurrence of serious adverse events.
Results: 795 patients (75% male, 25% female; mean age 43 ± 14 years) underwent the Ross operation with root replacement. The 30-day mortality was 1% (8 patients) with a 95% confidence interval of [0.48; 1.9]. The follow-up was 96 % complete and covered 9540 patient-years, with a mean follow-up time of 12 ± 7 years. The survival rates at 5, 10, 15 and 20 years were 97% [96; 98], 96% [93; 96], 92% [89; 94] and 86% [83; 90]. The rate of autograft survival without reoperation was 94% [92; 96] at 10 years and 80% [76; 85] at 20 years. The rate of homograft/RV-PA conduit survival without reoperation was 95% [93; 97] at 10 years and 85% [81; 90] at 20 years. There were 5 cases of hemorrhage, 14 of thromboembolic complications or apoplexy, and 19 of endocarditis.
Conclusion: The Ross operation with root replacement was associated with high survival rates over 25 years of follow-up. The rates of reoperation and reintervention, the morbidity and mortality, and the rate of endocarditis are low. The Ross operation is thus an effective surgical treatment option for young patients with aortic valve disease.
Severe aortic valve disease in patients between the ages of 18 and 55 (defined as young patients) usually requires surgical treatment with aortic valve replacement (1). This subgroup of patients with severe aortic valve disease is treated using either bioprosthetic or mechanical aortic valve replacement (AVR) (2). Continuous technical improvements to the implants have reduced the anticoagulation regimen needed with mechanical grafts, while with bioprostheses, novel integrity preservation technology ensures longer durability (3, 4). The bioprosthetic AVR can essentially be performed with or without a stent as well as with or without sutures (sutureless valves) using rapid deployment or, very rarely, by means of transcatheter techniques (5, 6, 7, 8). Over the last decade, a clear trend has been observed at the national and international level towards bioprosthetic AVR (9, 10). Both types of heart valve—mechanical and bioprosthetic—are associated with an immense improvement from a hemodynamic perspective and a reduction in symptoms from a clinical perspective. However, they are characterized by prosthesis-related complications as a result of lifelong anticoagulation with coumarin derivatives and the consequently higher risk of bleeding (0.15%/patient year), thromboembolic complications (0.13%/patient year), and reduced life expectancy compared to the age- and sex-matched general population, as well as by a greater risk of reoperation due to high rates of structural degeneration of bioprosthetic valves (0.36%/patient year) (11, 12, 13). The ideal valve substitute does not appear to exist for young patients (14). In order to overcome these shortcomings, alternatives are available, such as the recently introduced Ozaki procedure (aortic valve neocuspidization by inserting autologous or xenogenic pericardial patches following resection of the patient’s own diseased aortic valve), tissue-engineered (TE) homografts, and the long-established Ross procedure (15, 16, 17). The original Ross operation involves the transfer of the autologous pulmonary valve to the position of the aorta and the reconstruction of the right ventricular outflow tract (RVOT) using a human donor valve (homograft) (18). Due to the complexity of the Ross operation and highly heterogeneous results from various institutions over the past decade—mostly a handful of high-volume centers (> 20/year and surgeon) and numerous low-volume centers (< 5/year and surgeon), the technique has been downgraded in European as well as in US American guidelines (19, 20, 21, 22). In theory, however, the pulmonary autograft offers all the properties of an ideal valve substitute: It is made of autologous material with living cells and has morphological, histological, and geometric as well as ontogenetic aspects in common with the aortic valve (23, 24). Once the pulmonary valve (pulmonary autograft) has been transplanted to the position of the aorta, it transforms morphologically into a “neo-aortic valve” due to the increased pressure conditions (systemic pressure). The decision-making process, from the time of patient referral to the point of actually performing the Ross operation or other treatment options, is presented in a flow diagram (Figure 1). In this study, we analyze and present the results of the Ross operation as performed in young patients at the Herzzentrum Stuttgart, Germany and collected retrospectively from 1995 onwards and prospectively between 2002 and 2020.
Methods
Surgical technique
Due to its better reproducibility, the Ross operation has been performed in Stuttgart from the outset not with the original subcoronary technique involving intra-aortic implantation of the pulmonary autograft below both coronary artery ostia, but rather with the root replacement technique. Figure 2 shows the Ross operation with root replacement as performed at the Herzzentrum Stuttgart.
Patient population
Between February 1995 and September 2020, 795 patients (n = 593, 75% male; n = 202, 25% female) underwent the Ross operation with root replacement at the Herzzentrum Stuttgart, and those that gave their consent were included in the study. This time period was chosen in order to investigate the long-term results of the Ross operation at the authors’ institution well into the third decade following the procedure. A total of 782 Ross operations (98%) were performed electively. The demographic and preoperative data of the patients can be found in eTable 1. The Herzzentrum Stuttgart and the office-based cardiologists providing treatment were responsible for the collection of postoperative clinical and echocardiographic data. Furthermore, all data were made available to the German Ross registry with patient consent.
Ethics Committee and follow-up
The study was approved by the Ethics Committee at the Medical Faculty of the Eberhard-Karls University Tübingen, Germany (484/2020BO). The mean follow-up time was 12 ± 7 years, with an overall follow-up period of 9540 patient years (between 0.1 and 24.9 years) and a 96% rate of complete follow-up. Reasons for incomplete follow-up included loss of contact (name change/change of address/change of contact details) as well as results missing from the cardiological follow-up. A total of 56 patients died during the follow-up period (32 from cardiac causes, 21 from non-cardiac causes of death). The cause of death was unknown in three patients.
Statistical analysis
The primary endpoints of the study were death during follow-up and reoperation. Survival and time to event were calculated and plotted graphically using the Kaplan-Meier method. For the descriptive analysis, proportions and relative frequencies were used. Survival time was given at 5, 10, 15, and 20 years and the 95% confidence intervals calculated. The Log-rank test was used to compare freedom from reoperation between the patients groups. Data were statistically calculated and analyzed using R 4.4.1 and SPSS Statistics 27.0.
Results
Intraoperative and perioperative data
A total of 104 patients (13%) underwent the Ross operation with root replacement as a reoperation. Of these, 32 patients (31%) had undergone multiple cardiac surgeries. In terms of valve morphology, 492 participants (62%) had a bicuspid aortic valve, 156 (20%) a unicuspid, and 147 (18%) a tricuspid aortic valve. In 17 participants (2%), a prosthetic aortic valve replacement was found rather than a native aortic valve. In 731 of those operated (92%), a homograft was used for RVOT reconstruction (n = 720, 98% of pulmonary origin; n = 676, 92% using a cryopreserved aortic allograft). Due to a shortage of homografts in 2007 and 2008, 64 patients were implanted with a stentless porcine aortic root bioprosthesis (Freestyle bioprosthesis, Medtronic Inc, Minneapolis, USA) as the right ventricular–pulmonary artery (RV-PA) conduit to reconstruct the RVOT. Additional intraoperative data are given in Table 1. Perioperativen data can be found in Table 2.
Survival
The 30-day mortality rate was 1% (n = 8; [0.48; 1.9]). The long-term survival rate at 5, 10, 15, and 20 years was 97% [96; 98], 95% [93; 96], 92% [89; 94], and 86% [83; 90], respectively (Figure 3). During the follow-up period, 32 cardiac causes of death and 21 deaths of non-cardiac cause were documented. The cause of death was unknown in three patients.
Ross-related reoperations and reinterventions
Rates of freedom from reoperation on the auto- and homograft/RV-PA conduit are presented in Figure 4. At 5, 10, 15, and 20 years postoperatively, freedom from reoperation on the auto- and homograft/RV-PA conduit was 96% [94; 98], 91% [89; 93], 81% [77; 85], and 70% [65; 76]. Freedom from reoperation on the autograft was 97% [95; 98], 94% [92; 96], 88% [84; 91], and 80% [76; 85] at 5, 10, 15, and 20 years, while freedom from reoperation on the homograft was 97% [96; 99], 95% [93; 97], 92% [89; 94], and 85% [81; 90] for the respective periods (eFigure 1a and 1b). In total, 132 Ross-related reoperations were required in 112 participants (14%). Of these, 56 patients needed to be reoperated only on the autograft, 33 on the homograft/RV-PA conduit alone, and 23 patients on both autograft and homograft/RV-PA conduit. Reoperation was required more than once in 16 patients. The autograft could be preserved by means of isolated reconstruction in 44 of those operated (51%). Further details regarding the autograft reoperations are presented in eTable 2. The homograft/RV-PA conduit could be preserved in only two patients (3%) and was replaced in 56 (97%). The patient collective that received an RV-PA conduit instead of a homograft for the reconstruction of the RVOT showed lower freedom from reoperation (eFigure 1c). A total of two patients died from multiorgan failure following reoperation. eFigure 1d shows the cumulative incidences for re-operation and death.
Bleeding complications, apoplexy, and endocarditis in the long term
Bleeding occurred in five operated patients. There were 11 cases of transient ischemic attack (TIA), and apoplexy/thromboembolic events were observed in 14 patients. Late endocarditis developed in 19 of the operated patients. Of the 13 patients with autograft endocarditis, 12 required reoperation. In contrast, reoperation was required in only half of the patients (three out of six) with homograft endocarditis. None of the participants that were initially treated with a Ross operation for endocarditis experienced a recurrence of endocarditis.
Discussion
General
This study reports on long-term survival, reoperation and reintervention rates as well as serious adverse events following the Ross operation with root replacement. The follow-up period extended as far as the third decade following the index procedure. This is the largest single-center database of its kind worldwide. The main findings of the study can be summarized as follows: at 86% [83; 90], long-term survival at 20 years is very good and comparable with the findings of other Ross working groups, registry results, and the normal population (16, 25, 28, 29). Freedom from reoperation on the auto- and homograft/RV-PA conduit is high. Likewise, patients have a very low risk of developing bleeding, apoplexy, or endocarditiis as a complication after the Ross procedure (25, 26, 27, 28, 29). A total of 13% of the patients in this study had previously undergone cardiac surgery. Thus, the Ross operation is not contraindicated in this patient collective—on the contrary, it offers a second treatment option for patients that have previously undergone aortic valve surgery, most of whom were treated with aortic valve reconstruction at primary surgery (30, 31).
Survival
Long-term survival following AVR is a central criterion of any surgical procedure on the aortic valve. The Ross operation is characterized by a higher level of technical complexity compared to a genuine AVR. The increased perioperative risk due to this complexity is reduced when the Ross operation is performed at specialized centers by appropriately trained surgeons (technical expertise and adequate case number) (32). In the present analysis, 30-day mortality was 1% and is thus in agreement with the results of other working groups (33, 34, 35, 36). The mortality rate for conventional bioprosthetic or mechanical AVR for the patient subgroup in the age category investigated in this study is reported to be more than 3% in two different meta-analyses (3.15% and 3.3%, respectively) (11, 13). Thus, our data demonstrate that the Ross operation, despite its complexity, has a very low mortality rate that even falls below the rate for conventional AVR (8). Long-term survival in the investigated patient cohort is 85% at 25 years. To the best of our knowledge, no other valve replacement procedure has been demonstrated to have a long-term survival rate of this kind. This confirms the hypothesis that a “living valve substitute” in the aortic position translates into better clinical patient outcomes (37, 38, 39, 40, e1, e2). A graphic representation of the Ross operation and its alternatives, including the characteristics and specific limitations of each procedure, can be found in eFigure 2a.
Ross-related reoperations and reinterventions
Autograft
Alongside long-term survival, the durability of any aortic valve replacement procedure represents a second key point, primarily among young and middle-aged patients. Since a clear trend has been seen in recent years towards the implantation of bioprosthetic aortic valves even in young patients, the risk of reoperation due to accelerated degeneration poses a challenge especially in this age range, despite modern bioprosthetic xenografts that are supposed to have longer durability (semilunar valves made from bovine material and tissue-engineered to reduce the calcification that develops over time) (e3, e4, e5). Nevertheless, these studies show a lower risk of reoperation for patients with mechanical aortic valve replacement compared to those that undergo the Ross procedure—however, at the cost of significantly higher complication rates in terms of bleeding, apoplexy, and endocarditis (e6, e7). Freedom from reoperation on the autograft was comparable in the investigated patient collective to that in other studies; in addition, more than half of the autografts could be preserved by means of reconstructive surgical techniques (in particular, the David procedure), in keeping with the principle of a living valve (e8). The neo-aortic root dilation that can potentially develop postoperatively and lead to relevant aortic regurgitation over time is considered to be the main reason for autograft reoperation (19, 32). Various techniques are aimed at preventing neo-aortic root dilation, including reinforcement: annuloplasty with an external Dacron band to stabilize the neo-aortic annulus. In this study, no reoperation risk-reducing effect could be demonstrated for reinforcement.
Homograft/RV-PA conduit
Risk factors for reoperation on the RVOT in the investigated patient collective included the use of an RV-PA conduit (porcine aortic root replacement), non-cryopreserved homograft, and young patient age at the time of the index operation. Thus, homograft implantation is the gold standard for the reconstruction of the RVOT—especially since transplantation-related factors such as blood group, implantation technique, age, or sex mismatch had no effect on reoperation or reintervention on the RVOT in this study. Based on the collected data, it is possible that freedom from reoperation or reintervention on the RVOT in this study could be higher with consistent implantation of a cryopreserved homograft to reconstruct the RVOT. For the treatment of degenerated homografts, transcatheter techniques were used only as a bail-out strategy in inoperable patients (e9). To what extent decellularized or tissue-engineered human postmortem donor valves show better durability currently remains to be seen (e10, e11).
Long-term morbidity and mortality
The rates of bleeding (five operated patients), apoplexy (14 cases), and endocarditis (19 cases) were low in the investigated collective and is in line with previously published Ross studies in which a propensity score matching analysis was also carried out (16, 36, 39). The occurrence rate of these complications was significantly lower than in young patients that received a mechanical or bioprosthetic aortic valve replacement (11, 12, 13). Therefore, the Ross operation is the treatment method of choice for physically and professionally active people as well as for women wishing to start a family (30, e12).
The Ross operation in the light of current guidelines and lifetime management
In view of these long-term results, the Ross operation with root replacement should be given a higher grade of recommendation, particularly for the treatment of young patients, both in the US American and in the European guidelines, based on the principle that guidelines follow the evidence (20, 21, e13). In terms of potential strategies for the effective lifetime management of aortic valve disease in young patients, the Ross operation represents the long-term solution with the lowest rate of reoperations and comorbidities (eFigure 2b).
Limitations
The retrospective analysis of prospectively collected data represents a limitation. Patient allocation for this study was also carried out in subgroups and was not randomized, being based instead on surgical indication. For this reason, it is not possible to rule out confounding effects, nor can structural equality be guaranteed. A further limiting factor is the fact that the Ross operation is performed by individual surgeons at very few cardiac surgical centers. Moreover, the lack of a control group that received different treatment is an additional limitation.
Conclusion
The data in this study on the Ross operation with root replacement in young patients show that this procedure lives up to the promise of very good survival as well as very low valve-related morbidity and mortality even in the third postoperative decade.
Acknowledgments
The results of, and patient well-being during, this study would not have been possible without the many years of passion and tireless dedication of the entire team at the Cardiac Surgery Department of the Herzzentrum Stuttgart, Klinikum Stuttgart (formerly Sana Herzchirurgie Stuttgart).
Special thanks go to Cornelius Botha, FCS SA (cardio), who originally established the basis of the surgical technique for the Ross Operation with root replacement performed in Stuttgart and presented here.
Conflict of interest statement
The authors declare that no conflict of interest exists.
Manuscript submitted on 10 May 2024, revised version accepted on 19 September 2024.
Translated from the original German by Christine Rye.
Corresponding author
Dr. med. Markus Liebrich
Klinik für Herzchirurgie, Herzzentrum Stuttgart
Klinikum Stuttgart, Herdweg 2
70174 Stuttgart
M.Liebrich@klinikum-stuttgart.de
Cite this as
Liebrich M, Dingemann C, Roser D, Schrimm H, Feng YS, Hemmer W, Seeburger J, Voth V: The Ross operation in young patients—a single-center, long-term follow-up study.
Dtsch Arztebl Int 2024; 121: 766–72. DOI: 10.3238/arztebl.m2024.0195
Institute for Clinical Epidemiology and Applied Biometrics, Medical University of Tübingen, Tübingen, Germany: You-Shan Feng, PhD
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