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Egyptian experience with aortic valve repair using Ozaki procedure in adult and pediatric patients

Journal of Cardiothoracic Surgery volume 20, Article number: 196 (2025) Cite this article

Abstract

Background and aim

to document the Egyptian experience with Ozaki procedure in adults and children and compare the clinical outcomes of the procedure to that of aortic valve replacement (AVRc) in adult patients.

Patients and methods

The study included adult and pediatric patients submitted to the Ozaki procedure with available 1-year follow up data. In addition, adult patients submitted to AVRc during the study period were also included for comparison. Recorded outcome parameters included intensive care unit stay, hospital stay and early and late postoperative complications and mortality.

Results

The present prospective study included 72 adult and 25 pediatric patients with aortic valve disease (AVD). Adult patients were submitted to Ozaki procedure (n = 31) or AVRc (n = 41) while all pediatric patients were submitted to Ozaki procedure. One year follow up demonstrated that patients submitted to the Ozaki procedure had significantly higher peak pressure gradient (28.6 ± 7.6 versus 21.0 ± 5.7 mmHg, p < 0.001) and higher mean pressure gradient (13.5 ± 4.4 versus 10.5 ± 3.2 mmHg, p = 0.002) when compared to patients in the AVRc group. In the Ozaki group, moderate aortic stenosis (AS) was identified in only 1 patient. In the pediatric group, at one year follow up, there were 8 patients (32.0%) with trivial aortic regurgitation (AR), 12 patients (48.0%) with mild AR and 4 patients (16.0%) with moderate AS.

Conclusions

Ozaki procedure appears to be a promising alternative to AVRc in adults and children with AVD with good efficacy and safety profile.

Peer Review reports

Introduction

Aortic valve disease (AVD) is considered the third leading cause of cardiovascular disease worldwide with significant associated morbidity and mortality. Degeneration, calcification, and congenital defects are the primary causes of AVD in developed countries, while post-rheumatic valvular disease is the main cause in developing countries [1]. Aortic valve replacement (AVRc) using mechanical or biological valves is regarded as the gold standard for management of AVD [2].

Alternatively, aortic valve repair (AVR) can be used in selected cases. The recent developments in understanding diseased valve pathology, aortic insufficiency classification systems and tissue engineering have paved the way for emergence of new effective and reproducible valve repair techniques [3].

Common repair techniques include leaflet extensions, neo-leaflet creation, resuspension or plication of prolapsing leaflets, and commissuroplasty [4]. Aortic valve neocuspidization using glutaraldehyde-treated autologous pericardium was first reported by Ozaki et al. [5]. Short and mid-term follow up studies showed that clinical outcomes are generally comparable to that of mechanical valve replacement without the need of long-term oral anticoagulation [6]. Utilization of autologous pericardium in the Ozaki procedure offers several benefits such as increased tissue durability and decreased likelihood of immune-mediated calcification. These factors enhance the durability and robustness of the reconstructed valve [7].

In children, AVR is particularly challenging. To achieve a successful repair, one must take into account the entire aortic valve complex, which includes the sino-tubular junction, ventriculo-aortic junction, annulus, and leaflets [8]. However, even in those patients, the Ozaki procedure proved to be a promising future alternative to other interventions e.g. Ross procedure [9].

While many studies reported the outcomes of Ozaki procedure worldwide, most of them are of retrospective design and lacks comparison to other interventions. The present prospective study aimed to document the Egyptian experience with Ozaki procedure in adult and pediatric patients over 1-year follow up period. In addition, we compared the clinical outcomes of the procedure to that of AVRc in adult patients.

Subjects and methods

The present prospective study was conducted at Assiut University Hospitals, Assiut, Egypt and Al-Nas Hospital, Cairo, Egypt from March, 2021 through June, 2024. The study protocol was approved by the institutional review board of Assiut University Faculty of Medicine (Ref. No. 17200559) and all patients or their legal guardians signed informed written consent before participation in the study. The study was also registered as a clinical trial at ClinicalTrials.gov with registration number NCT04816851.

The study included adult and pediatric patients submitted to the Ozaki procedure with available 1-year follow up data. In addition, adult patients submitted to AVRc during the study period were also included for comparison. Patients were excluded from final analysis if they were lost to follow up for any cause before complete 1 year period.

Ozaki procedure was performed for patients with symptomatic AVD who refused to undergo aortic valve replacement and female patients seeking pregnancy without being exposed to the risks associated with anticoagulants.

Before surgery, all participants were submitted to careful history taking, thorough clinical examination and standard laboratory work up. In adult patients, the functional performance was evaluated using the New York Heart Association (NYHA) classification [10]. All patients had echocardiographic assessment (GE VIVID 7 PRO, VIVID 9, Norway) before and during surgery. Grades of AS and AR were determined according standard recommendations [11]. Repeat examinations were conducted at the time of hospital discharge and at 1,3,6 and 12 months after surgery.

Adult patients were either submitted to Ozaki technique described in detail elsewhere [5] (Fig. 1) or AVRc using mechanical valve (n = 38) or bioprosthetic valve (n = 3) via median sternotomy whereas pediatric patients were submitted to Ozaki technique.

Fig. 1
figure 1

Main steps of the Ozaki procedure: (a) Pericardial harvesting (b) Pericardial fixation (c) Pericardial preservation (d) Sizing leaflets (e) Cusp preparation (f) Reconstruction

Full size image

Postoperatively, patients were transmitted to cardiac intensive care unit while ventilated and on inotropic support and fully monitored. Hemodynamic stability was maintained by IV fluid daily, blood loss was compensated by blood and plasma infusions. Most patients in the pediatric and adult cohorts were maintained on postoperative lifelong low-dose aspirin. Only three adult patients were given warfarin due to concomitant mitral valve surgery. In the pediatric group, two patients were given warfarin due to temporary restriction of valve cusp movement.

Recorded outcome parameters included intensive care unit (ICU) stay, hospital stay, use of inotropic support, warfarin use, postoperative mean pressure gradient (MPG), postoperative peak pressure gradient (PPG) and postoperative echocardiographic parameters and early and late postoperative complications.

Data obtained from the present study were presented as number and percent, mean and standard deviation (SD). Categorical data were compared using Fisher’s exact test or chi-square test while numerical data were compared using t test. p value less than 0.05 was considered statistically significant. All statistical calculations were computed using SPSS 27.0 (IBM, USA).

Results

The present prospective study included 72 adult and 25 pediatric patients with AVD. Adult patients were submitted to AVR using Ozaki procedure (n = 31) or aortic valve replacement (AVRc) while all pediatric patients were submitted to AVR using Ozaki procedure.

In adult patients, preoperative assessment showed that both interventions were comparable regarding patients’ age, sex distribution, weight, body surface area (BSA), prevalence of concomitant hypertension, diabetes mellitus, arrhythmia and Marfan syndrome. However, patients submitted to AVRc had significantly higher frequency of rheumatic heart disease (RHD) (43.9% versus 6.5%, p < 0.001) and smoking (29.3% versus 3.2%, p = 0.005). In respect to the type of AVD in the studied groups, it was also noted that patients in the Ozaki procedure group had higher frequency of aortic stenosis without statistical significance (38.7% versus 17.1%, p = 0.063). It was also found that both groups were comparable regarding the associated structural cardiac conditions apart from dilated aortic root which was more prevalent in the AVRc group. NYHA classification revealed marginally higher frequency of grades I/II in the AVRc group. Comparison between echocardiographic data in both groups revealed that patients in the AVRc group had significantly higher LVEDD (5.9 ± 1.0 versus 5.4 ± 1.0 cm, p = 0.026) and LVESD (4.0 ± 1.1 versus 3.5 ± 0.8 cm, p = 0.03) in comparison to their counterparts in the Ozaki procedure group (Table 1).

Table 1 Baseline characteristics in the studied patients (n = 96)
Full size table

Patients in the pediatric group comprised 21 males and 4 females with an age of 9.1 ± 2.9 years and were affected by AR (36.0%), AS (24.0%) or combined AS and AR (40.0%) and 96.0% of patients had bicuspid valves (Table 1).

Intraoperatively, it was shown that adult patients submitted to the Ozaki procedure had significantly longer CBP time (151.4 ± 44.2 versus 131.0 ± 38.5 min., p = 0.043) and cross-clamping time (125.0 ± 36.5 versus 97.8 ± 31.1 min., p = 0.001) and significantly higher frequency of reoperation for bleeding (12.9% versus 0%, p = 0.031) as compared to their counterparts submitted to AVRc (Table 2).

Table 2 Operative characteristics in the studied patients (n = 96)
Full size table

In the pediatric group, the reported CBP time was 123.2 ± 20.6 min. and cross-clamping time was 101.0 ± 20.3 min. One patient was converted to ROSS/Kono operation due to high peak pressure gradient post Ozaki (100 mmHg) and mean pressure gradient (70 mmHg). One patient was reoperated for bleeding, three patients required twice bypass and two patients needed revision of surgery (Table 2).

Postoperative outcome assessment revealed that adult patients submitted to the Ozaki procedure had significantly shorter ICU stay (3.4 ± 1.7 versus 4.6 ± 2.4 days, p = 0.026), shorter hospital stay (10.2 ± 3.4 versus 14.2 ± 5.8 days, p < 0.001), lower warfarin use (9.7% versus 92.7%, p < 0.001), lower frequency of pericardial effusion (3.2% versus 22.0%, p = 0.036). One year follow up demonstrated that patients in the Ozaki procedure had significantly lower LVESD (3.4 ± 0.7 versus 3.8 ± 0.9 cm, p = 0.034), higher LVEF (60.5 ± 6.1 versus 55.6 ± 8.6%, p = 0.010), higher PPG (28.6 ± 7.6 versus 21.0 ± 5.7 mmHg, p < 0.001) and higher MPG (13.5 ± 4.4 versus 10.5 ± 3.2 mmHg, p = 0.002) when compared to patients in the AVRc group. In the Ozaki group, moderate AS was identified in only 1 patient (Table 3).

Table 3 Postoperative outcome in the studied patients (n = 96)
Full size table

In the pediatric group, the reported ICU and hospital stays were 3.1 ± 1.8 and 9.5 ± 5.8 days respectively. At one year follow up, there were 8 patients (32.0%) with trivial AR, 12 patients (48.0%) with mild AR and 4 patients (16.0%) with moderate AS. Patients’ PPG and MPG were 33.8 ± 14.6 and 16.6 ± 7.1 mmHg respectively which significantly decreased from the baseline values (Table 3).

Discussion

The present study aimed to document our experience with AVR using the Ozaki procedure in adult and pediatric Egyptian patients after one-year follow up. In addition, we compared the clinical outcomes of the procedure in adult patients to that of AVRc.

At the end of follow up, only one patient in the Ozaki group had moderate AS and two cases of early infective endocarditis (6.5%) were encountered. These findings are consistent with that reported by the study of Benedetto et al. [12] who noted that after a follow up duration of 12.5 ± 0.9 months, only 3 patients had endocarditis and 1 required reintervention while other patients had no or mild AV insufficiency with very low peak and mean transvalvular gradients. Likewise, in the study of Mourad et al. [13] during follow-up (mean 11.2 ± 4.8 months), trace AR was observed in 4 patients and 5 patients needed reoperation due to endocarditis.

Regarding surgery complications, no aortic valve-related deaths were reported. However, as expected, our results are different from other studies with different follow up durations. In the study of Bazylev et al. [14], the prevalence of AV insufficiency over a maximum follow-up duration of 65 months was 12.9%. In another study, Iida et al. [15] reported that of 57 patients, 2 patients underwent reoperation owing to infective endocarditis 2 months postoperatively and recurrent aortic AR 22 months postoperatively over a follow up duration of 30.4 ± 20.8 months.

In contrast, in the 35-patient study of Koechlin et al. [16], there were reoperation rate of 3% and moderate AR in 7% of patients over a median follow-up time of 645 days while in the study of Krane et al. [17], 4 patients out of 103 had reoperation over a follow up period of 426 ± 270 days and in the study of Mokryk et al. [18] with a follow up duration of 66.72 ± 12.77 months, there was 1 patient with moderate AR.

In the present study, two adjustments suggested by Ozaki et al. to the original technique were considered to reduce the rate of postoperative AR. First, a 5-mm “wing” extension to the cusps served to improve commissure fixation. Second, equal tricuspidization to create “new commissures” in patients with uni-cuspid and bicuspid valves was also used [16]. Notably, equal tricuspidization can be also useful to decrease the risk of endocarditis. In the present study, only twenty-one individuals (67%) had all three aortic cusps of the same size. At one-year post-operative echocardiography, those patients experienced less frequent mild AR as compared to patients with unequal cusps (38.1% versus 55.6%) in spite of the fact that the difference remains short of statistical significance.

In respect to surgical complications, no patient in the Ozaki group was converted to AVRc, no aortic valve-related deaths were reported. In another study including 61 patients with a mean follow-up period of 18.5 ± 5.7 months, one patient died in hospital due to cardiac tamponade and another patient underwent reoperation due to infective endocarditis 6 months after surgery. Other patients had no or mild aortic regurgitation at the last follow-up visits [19].

In the present study, comparative analysis between outcome parameters in Ozaki and AVRc groups revealed that adult patients submitted to the Ozaki procedure had significantly longer CBP time and cross-clamping time, higher frequency of reoperation for bleeding, shorter ICU stay, shorter hospital stay. One year follow up demonstrated that patients in the Ozaki procedure had significantly lower LVESD, higher PPG and higher MPG when compared to patients in the AVRc group. This could be related to thorough tricuspidization of all leaflets using large size which caused bulking and overcrowding. Probably, more optimal sizing would provide an appropriate technical adjustment to reduce these effects.

In comparison, the meta-analysis of Benedetto et al. [12] found no significant difference between AVNeo and all biological valves with regards to structural valve degeneration, reintervention and endocarditis. However, they showed that when compared Magna Ease valve, AVNeo and other valve substitutes showed an excess of valve-related events. At the AV Neo group, in our study, a case of neo aortic valve tear (3.2%) was encountered during follow up. Probably, the new AV leaflets themselves may have caused damage to one another because of physical contact or mechanical stress, thinner treated pericardium was used in constructing the leaflet causing tissue breakdown [20].

In another study, Boehm et al. [21] noted that AVNeo shows significantly larger effective orifice area and effective orifice area index compared to surgical aortic valve replacement using the Abbott/St. Jude Trifecta aortic valve biological prostheses. Moreover, the comparative study of Ogami et al. [22], showed comparable survival and freedom from at least moderate AR at 5 years in patients submitted to Ozaki and surgical AVRc groups while the study of Unai et al. [23] found that patients undergoing the Ozaki procedure had lower gradients but more recurrent AR than those receiving PERIMOUNT bioprostheses.

Noteworthy, in the present study, there were 2 patients with infective endocarditis encountered during the postoperative follow up period of Ozaki procedure. While one patient was submitted to tooth extraction, no specific risk factors could be identified in the other patient. Both patients were managed through Bentall operation. Prevention of such events in future cases may be achieved through strict implementation of international guidelines for prevention and management of infective endocarditis [24].

Moreover, it was found that adult patients submitted to the Ozaki procedure had significantly higher rate of reoperation for bleeding in comparison to those with AVRc. The four patients requiring this intervention had concomitant mitral valve surgery with prolonged bypass and cross clamp times. According to the study of Iino et al. [25] prolonged aortic cross clamping is an independent risk factor for reoperation for bleeding.

In the pediatric group, the present study found only 4 patients (16.0%) with moderate AS at the end of one year follow up. In line with these findings, the study of Baird et al. [26], reported that at median follow-up of 8.1 months, 96% and 91% of patients had less than moderate regurgitation and stenosis, respectively. Regarding postoperative peak pressure gradient and mean pressure gradient follows up among studied patients, we did report statistically significant increase in the mean of PPG and MPG. Such rise is most likely attributable to the failure of growth of the aortic ring over time, which had been observed by Polito et al. [27]. Also, bulking or oversizing of Ozaki leaflets, no aortic root augmentation procedure was performed, fixation of pericardium for 10 min, using only acetylsalicylic acid in contrast with Baird et al. [26].

In comparison, Chivers et al. [28] found that out of five patients included, at a mean follow-up of 29.6 months, 4 patients had no evidence of stenosis and 3 patients had trivial or no regurgitation from the neoaortic valve and Cicek and Ozdemir [29] noted that over a median follow-up time of 8.5 months, one patient underwent valve replacement while in the retrospective study of Kalezi et al. [30], all of the 10 children included in that study had either none or trivial AR immediately after surgery. None of them had redone operations throughout the follow-up period.

The present study is not without limitations. Patients in the pediatric group weren’t compared to other interventions for aortic valve diseases. Also, patients were followed for a relatively short time. In conclusion, the present study suggests that Ozaki procedure appears to be a promising alternative to AVRc in adults and children with AVD with good efficacy and safety profile. Further studies are recommended to document the midterm and long-term outcomes of the adult and pediatric cohorts. Detailed cost-effectiveness analysis is also necessary to assess the value of the procedure in comparison to other alternatives.

Data availability

No datasets were generated or analysed during the current study.

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Acknowledgements

Heartful thanks and gratitude to all patients and their family members.All methods were performed in accordance with relevant guidelines and regulations.

Funding

Not applicable.

Author information

Authors and Affiliations

  1. Cardiothoracic Surgery Department, Assiut University, Assiut, Egypt

    Mohammed Emad Eldin Omar, Ali M. Abd Elwahab, Ahmed M.T. Ismail & Mohamed A. Nady

  2. Cardiothoracic Surgery Department, Beni Suef University, Beni Suef, Egypt

    Gehad M. Mahmoud

  3. Cardiothoracic Surgery Department, Zagazig University, Zagazig, Egypt

    Ahmed Fadaly

  4. Cardiothoracic Surgery Department, Cairo University, Cairo, Egypt

    Mohamed Azzam

  5. Cardiothoracic Surgery Department, AL Nas Hospital, Cairo, Egypt

    Gehad M. Mahmoud, Ahmed Fadaly & Mohamed Azzam

Authors
  1. Mohammed Emad Eldin Omar
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  2. Gehad M. Mahmoud
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  3. Ahmed Fadaly
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  4. Mohamed Azzam
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  5. Ali M. Abd Elwahab
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  6. Ahmed M.T. Ismail
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  7. Mohamed A. Nady
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Contributions

Conceptualization and design: MEO, GMM, AF, MA, AMA, AMTI, MAN; Patients recruitment: MEO, GMM, AF, MA, AMA, AMTI, MAN; Data retrieval and analysis: MEO, GMM, AF, MA, AMA, AMTI, MAN, Manuscript writing: All authors approved the final manuscript.

Corresponding author

Correspondence to Mohammed Emad Eldin Omar.

Ethics declarations

Ethics approval and consent to participate

Ethical approval was obtained from the ethical committee of Assiut University Faculty of Medicine (Ref. No. 17200559).

Consent for publication

Not applicable.

Consent to participate

All patients or their legal guardians signed informed written consent before participation in the study.

Clinical trial number

The study was also registered as a clinical trial at ClinicalTrials.gov with registration number NCT04816851.

Competing interests

The authors declare no competing interests.

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Omar, M., Mahmoud, G.M., Fadaly, A. et al. Egyptian experience with aortic valve repair using Ozaki procedure in adult and pediatric patients. J Cardiothorac Surg 20, 196 (2025). https://doi.org/10.1186/s13019-025-03351-8

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  • DOI: https://doi.org/10.1186/s13019-025-03351-8

Keywords

Journal of Cardiothoracic Surgery

ISSN: 1749-8090

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