Interventional procedure overview of aortic valve reconstruction using glutaraldehyde-treated autologous pericardium for aortic valve disease

Akiyama S, Iida Y, Kazuma S et al. (2020) Midterm outcome of aortic valve neocuspidization for aortic valve stenosis with small annulus. General thoracic and cardiovascular surgery. 68(8): 762-767

Case series

n=34

Mean follow-up period: 28.0 ± 22.7 months

The midterm outcome of AVNeo for AS with a small annulus was excellent. The long-term outcome and reliability of this procedure must be fully clarified.

The number of patients is less than 50.

Studies with more patients or longer follow up are included.

Amabile A, Krane M, Dufendach K et al. (2022) Standardized Aortic Valve Neocuspidization for Treatment of Aortic Valve Diseases. The Annals of thoracic surgery. 114(4): 1108-1117

Literature review

n=1372 (10 studies)

Aortic valve neocuspidization is a versatile and standardized alternative to aortic valve replacement with a biological prosthesis. Early to midterm outcomes from a number of centers are excellent and demonstrate the safety and durability of the procedure. Long-term outcomes and clinical trial data are necessary to determine which patients benefit the most from this procedure

A more recent systematic review and meta-analysis is included.

Arutyunyan V, Chernov I, Komarov R et al. (2020) Immediate Outcomes of Aortic Valve Neocuspidization with Glutaraldehyde-treated Autologous Pericardium: a Multicenter Study.Brazilian journal of cardiovascular surgery.35:241-248

Prospective multicentre study

n= 170

Followed during hospital stay

AVNeo is feasible and reproducible with good clinical results. Hemodynamically, AVNeo produces immediate postoperative low-pressure gradients, large EOA, and minimal regurgitation of the aortic valve. Further studies are necessary to evaluate mid- and long-term evolution.

Studies with more patients or longer follow up are included.

Study is included in the meta-analysis by Mylonas et al. (2023)

Baird C, Cooney B, Chavez M et al. (2021) Congenital aortic and truncal valve reconstruction using the Ozaki technique: Short-term clinical results. The journal of thoracic and cardiovascular surgery.161: 1567-1577

Retrospective analysis

n=57

Median follow-up of 8.1 months

The aortic valve reconstruction procedure has acceptable short-term results and should be considered for valve reconstruction in pediatric patients with congenital aortic and truncal valve disease. Longer-term follow-up is necessary to determine the optimal patch material and late valve function and continued annular growth.

Studies with more patients or longer follow up are included.

Study is included in the meta-analysis by Mylonas et al. (2023)

Chan J, Basu A, Di Scenza G et al. (2022) Understanding aortic valve repair through Ozaki procedure: A review of literature evidence. Journal of Cardiac Surgery. 1-5

Literature review

n= 1342

(9 studies)

AVNeo can be a suitable alternative to surgical aortic valve replacement in

selected patients. The short‐ and midterm outcomes are comparable without the need for long‐term oral anticoagulation. Long‐term follow‐up data are required for

this novel approach to be widely adopted.

A more recent systematic review and meta-analysis is included.

Chan J, Rahman-Haley S, Mittal T et al. (2011) Truly stentless autologous pericardial aortic valve replacement: an alternative to standard aortic valve replacement. The journal of thoracic and cardiovascular surgery. 141(1):276-83

Case series

n=11

Mean follow-up was 6.5 years (range, 5.3−7.5 years).

Truly stentless aortic valve replacement using autologous pericardium sutured directly onto the aortic wall is safe and feasible and has excellent durability up to 7.5 years with no calcification.

The number of patients is less than 50.

Studies with more patients or longer follow up are included.

Chivers S, Pavy C, Vaja R et al (2019) The Ozaki Procedure With CardioCel Patch for Children and Young Adults With Aortic Valve Disease: Preliminary Experience - a Word of Caution. World journal for pediatric & congenital heart surgery;10(6):724-730

Case series

n=5

Mean follow-up: 29.6 months (range: 22-36 months)

Ozaki procedure with CardioCel in pediatric and young adult patients should be approached with caution. Further research with larger groups of pediatric patients, comparison of different graft materials, and longer follow-up is required to ascertain long-term success in children.

The number of patients is less than 50.

Studies with more patients or longer follow up are included.

Study is included in the meta-analysis by Mylonas et al. (2023)

Duran C M, Gometza B, Kumar N et al. (1995) Aortic valve replacement with freehand autologous pericardium. The journal of thoracic and cardiovascular surgery. 110(2):511-6

Case series

n=51

Mean follow-up: 21.2 months

The results obtained so far encourage us to continue replacing the aortic valve with stentless autologous pericardium

Studies with more patients or longer follow up are included.

Iida Y, Fujii S, Akiyama S et al. (2018) Early and mid-term results of isolated aortic valve neocuspidization in patients with aortic stenosis. General thoracic and cardiovascular surgery. 66(11): 648-652

Case series

n=57

The mean follow-up period was 30.4 ± 20.8 months

AVNeo is suitable for patients with AS considering its early and mid-term outcomes. Verification of long-term outcomes and reliability is necessary

Studies with more patients or longer follow up are included.

Study is included in the meta-analysis by Mylonas et al. (2023) and Benedetto et al. (2021)

Iida Y, Sawa S, Fujii S et al. (2020) Aortic valve neocuspidization in patients under 65 years old. General thoracic and cardiovascular surgery. 68(8):780-784

Case series

n=36

The mean follow-up period was 47.8 ± 27.3 months

AVNeo in patients aged under 65 years appears to be suitable considering its early and midterm outcomes. Verification and follow-up of its long-term outcomes and reliability are indispensable.

The number of patients is less than 50.

Studies with more patients or longer follow up are included.

Study is included in the meta-analysis by Benedetto et al. (2021)

Kasimir M, Simon P, Seebacher G et al. (2004) Reconstructed bicuspid aortic valve after 10 years: clinical and echocardiographic follow-up. The heart surgery forum. 7(5):e485-9

Case series

n=13

Long-term follow-up (mean, 10.06 ± 1.01 years)

In contrast to early follow-up results of 5 reoperations, clinical and echocardiographic results were excellent for 10 patients who had undergone reconstruction of bicuspid incompetent aortic valves, and the patients were in stable condition after 10 years. However, the mode of early failure is unknown. Reconstruction of bicuspid valves is possible in selected patients.

The number of patients is less than 50.

Studies with more patients or longer follow up are included.

Kawase I, Ozaki S, Yamashita H et al (2013) Aortic valve reconstruction with autologous pericardium for dialysis patients. Interactive cardiovascular and thoracic surgery. 16(6):738-42

Case series

n=54

Mean follow up: 847 days

Medium-term results are excellent. Since warfarin for dialysis patients becomes problematic, a postoperative warfarin-free status is desirable. Aortic valve reconstruction can provide patients with a better quality of life without warfarin

Studies with more patients or longer follow up are included.

Study is included in the systematic review by Dilawar et al. (2022)

Kawase I, Ozaki S, Yamashita H et al. (2012) Aortic valve reconstruction of unicuspid aortic valve by tricuspidization using autologous pericardium. The Annals of thoracic surgery. 94(4):1180-4)

Case series

n=9

Mean follow up: 551.1 days

Diseased unicuspid aortic valves were treated by our original aortic valve reconstruction technique with excellent early results. We continue to study the long-term results.

The number of patients is less than 50.

Studies with more patients or longer follow up are included.

Study is included in the systematic review by Dilawar et al. (2022)

Koechlin L, Schurr U, Miazza J et al. (2020) Echocardiographic and Clinical Follow-up After Aortic Valve Neocuspidization Using Autologous Pericardium. World journal of surgery. 44(9):3175-3181

Case series

n=35

Median follow up: 645 (430-813) days

The Ozaki procedure is reliable and reoperation due to structural valve deterioration nil within a median 645 days follow-up period. The low rate of moderate aortic regurgitation will be surveilled very closely. Further studies are required to evaluate the significance of this procedure in aortic valve surgery.

The number of patients is less than 50.

Studies with more patients or longer follow up are included.

Study is included in the meta-analysis by Mylonas et al. (2023) and Benedetto et al. (2021).

Krane M, Boehm J, Prinzing A et al. (2021) Excellent Hemodynamic Performance After Aortic Valve Neocuspidization Using Autologous Pericardium. The Annals of thoracic surgery. 111(1):126-133

Case series

n=102

Mean follow-up was 426 ± 270 days.

AVNeo shows low reoperation rates after surgery within the first 2 years. The hemodynamic performance is excellent, and the effective orifice area and MPG remain stable within the first year.

Studies with more patients or longer follow up are included.

Study is included in the meta-analysis by Mylonas et al. (2023) and Benedetto et al. (2021) and in the systematic review by Dilarwar et al. (2022).

Liu X, Han L, Song Z et al. (2013) Aortic valve replacement with autologous pericardium: long-term follow-up of 15 patients and in vivo histopathological changes of autologous pericardium. Interactive cardiovascular and thoracic surgery. 16(2) 123-8

Case series

n=15

The mean clinical follow-up was 11.43 ± 4.50 years.

Autologous pericardial aortic valve (APAV) replacement is a procedure with a low mortality. APAVs adapt to new environmental demands by producing an elastic band and by endothelialization, whereas myofibroblast/osteoblast transdifferentiation seems to be responsible for the fibrocalcification of APAVs.

The number of patients is less than 50.

Studies with more patients or longer follow up are included.

Marathe S P, Chavez M, Sleeper L A et al. (2021) Single-Leaflet Aortic Valve Reconstruction Utilizing the Ozaki Technique in Patients With Congenital Aortic Valve Disease. Seminars in Thoracic and Cardiovascular Surgery.

Case series

n=33

The median follow-up was 1.1 year

Single-leaflet aortic valve leaflet reconstruction utilizing the Ozaki technique has promising early results and can be considered in patients when there are acceptable native leaflets.

The number of patients is less than 50.

Studies with more patients or longer follow up are included.

Marathe S P, Chavez M, Sleeper L et al. Modified Ozaki Procedure Including Annular Enlargement for Small Aortic Annuli in Young Patients.The Annals of thoracic surgery. 110(4):1364-1371

Case series

n=51

Mean follow-up of 11.9 months

The Ozaki procedure has acceptable short-term results in young patients with small aortic annuli. A larger aortic annulus can be achieved with surgical annular enlargement. Long-term follow-up is necessary to determine late valve function and potential continued annular growth

Studies with more patients or longer follow up are included.

Makino M, Yamamoto H, Ishibashi-Ueda H et al. (2019),A case of aortic valve leaflet tear and perforations

after neocuspidization. ESC Heart Failure. 6: 446-448

Case report

n=1

27 months after AVNeo

Encountered a first case of AV

leaflet tear and perforations 27 months after AVNeo using autologous pericardium

Studies with more patients or longer follow up are included.

Mittal C, Sachin T, Velayoudham D et al. (2009) Early results of aortic valve reconstruction with stentless

glutaraldehyde treated autologous pericardial valve. Indian J Thorac Cardiovasc Surg 25: 178–182

Retrospective

n=34

Mean follow up: 16.3 ± 8.6 months

Aortic Valve reconstruction using glutaraldehyde treated autologous pericardium is feasible in young patients with acceptable results.

The number of patients is less than 50.

Studies with more patients or longer follow up are included. Study is included in the systematic review by Dilawar et al. (2022).

Mourad F, Shehada S, Lubarski J et al. (2019) Aortic valve construction using pericardial tissue: short-term single-centre outcomes. nteractive cardiovascular and thoracic surgery. 28(2) 183-190

Prospective single-centre study

n=52

Mean follow-up: 11.2 ± 4.8 month

Aortic valve construction using pericardial tissue could be an alternative in middle-age patients presenting with aortic valve disease in whom valve repair was not possible. The newly designed templates allow exact sizing of the neo-cusps and optimal commissure implantation; however, long-term follow-up in a larger cohort is warranted to assess the durability of the neo-valves.

Studies with more patients or longer follow up are included.

Study is included in the meta-analysis by Mylonas et al. (2023) and Benedetto et al. (2021).

Ngo H T, Nguyen H C, Thinh D et al. (2022) Aortic valve reconstruction surgery using autologous pericardium: The experience in Vietnam. Journal of cardiac surgery. 37(5): 1233-1239

Case series

n=72

The mean follow-up time was 26.4 months (12-42 months)

This procedure was safe and effective, with favorable valvular hemodynamics and a low rate of valvular degeneration. However, more long-term follow-up data are needed

Studies with more patients or longer follow up are included.

Ngo H T, Nguyen H C, Nguyen T T et al. Reconstruction of aortic valve by autologous pericardium (Ozaki's procedure): Single center experience in Vietnam. Asian cardiovascular & thoracic annalsAsian cardiovascular & thoracic annals. 29(5):394-399

Case series

n=61

The mean follow-up period was 18.5 ± 5.7 months

Aortic valve reconstruction with autologous pericardium provided good outcomes in our study.

Studies with more patients or longer follow up are included.

Study is included in the meta-analysis by Mylonas et al. (2023), and in the systematic review by Dilarwar et al. (2022).

Nguyen D H, Vo A T, Le K et al. (2018) Minimally Invasive Ozaki Procedure in Aortic Valve Disease: The Preliminary Results. Innovations (Philadelphia, Pa.). 13(5) 332-337

Case series

n=9

NA

Ministernotomy combined with Ozaki procedure might be feasible, as well as an alternative to conventional sternotomy. This approach is associated with low mortality and morbidity and may be beneficial in younger populations.

The number of patients is less than 50.

Studies with more patients or longer follow up are included. Study is included in the meta-analysis by Mylonas et al. (2023).

Nguyen T, Vo A, Nguyen D et al. (2020). Progressive Left Ventricular Hypertrophy After Ozaki Procedure: A Case Report. The Heart Surgury Forum. 23(6)

Case report

n=1

NA

A 57-year-old man with symptomatic severe

aortic stenosis who underwent Ozaki technique Ozaki procedure. Seven months later,

he rapidly developed progressive left ventricular hypertrophy with a left ventricular outflow tract obstruction. This

required a reoperation for septal myectomy.

Studies with more patients or longer follow up are included.

Ozaki S, Kawase I, Yamashita H et al. (2018) Midterm outcomes after aortic valve neocuspidization with glutaraldehyde-treated autologous pericardium. The Journal of thoracic and cardiovascular surgery. 155(6) 2379-2387

Case series

n=850

he mean follow-up period was 53.7 ± 28.2 months

The midterm outcomes of AVNeo using autologous pericardium were satisfactory in 850 patients with various aortic valve diseases. However, further randomized, multicenter prospective studies are needed to confirm the results of the current study

Study is included in the meta-analysis by Mylonas et al. (2023) and Benedetto et al. (2021) and in the systematic review by Dilarwar et al. (2022).

Ozaki S, Kawase I, Yamashita H et al. (2014) Reconstruction of bicuspid aortic valve with autologous pericardium--usefulness of tricuspidization. Circulation journal: official journal of the Japanese Circulation Society. 78(5) 1144-51

Case series

n=34

Mean follow-up was 733 days

Medium-term results were excellent. Tricuspidization gave good opening and closure of aortic valve with excellent hemodynamics.

The number of patients is less than 50.

Studies with more patients or longer follow up are included. Study is included in the systematic review by Dilawar et al. (2022).

Ozaki S, Kawase I, Yamashita H et al. (2014) A total of 404 cases of aortic valve reconstruction with glutaraldehyde-treated autologous pericardium. The Journal of thoracic and cardiovascular surgery. 147(1) 301-6

Retrospective study

n=404

The mean follow-up period was 23.7 ± 13.1 months.

Original aortic valve reconstruction was feasible in patients with various aortic valve diseases. Long-term data will be disclosed in the future.

Study is included in the systematic review by Dilawar et al. (2022).

Ozaki S, Kawase I, Yamashita H et al. (2011) Aortic valve reconstruction using self-developed aortic valve plasty system in aortic valve disease. Interactive cardiovascular and thoracic surgery. 12(4) 550-3

Case series

n=88

One year follow-up echocardiography

AVP provides good short- and mid-term results with good hemodynamics and good quality-of-life without anticoagulation. This procedure is effective especially for calcified AS with small aortic annulus in elderly patients. Assessment of long-term data especially regarding valve durability will be examined in the future.

Studies with more patients or longer follow up are included.

Pirola S, Mastroiacovo G, Arlati F et al. (2020) Single center 5-years' experience of Ozaki procedure: mid-term follow-up. The Annals of thoracic surgery. 111(6):1937-1943

Retrospective study

n=71

The median follow-up period was 20.7 months (range, 2 to 47)

Midterm outcome follow-up of the Ozaki procedure showed optimal results in terms of mortality, transaortic valve gradients, freedom from major adverse valve-related events, and recurrence of aortic valve insufficiency.

Visual Abstract

Studies with more patients or longer follow up are included.

Study is included in the meta-analysis by Mylonas et al. (2023) and Benedetto et al. (2021).

Pirola S, Mastroiacovo G, Giorgio A et al. (2021) Single Center Five Years' Experience of Ozaki Procedure: Midterm Follow-up. The Annals of thoracic surgery. 111(6):1937-1943

Retrospective study

n=71

The median follow-up period was 20.7 months (range, 2 to 47)

Midterm outcome follow-up of the Ozaki procedure showed optimal results in terms of mortality, transaortic valve gradients, freedom from major adverse valve-related events, and recurrence of aortic valve insufficiency.

Studies with more patients or longer follow up are included.

Polito A, Albanese S B, Cetrano E et al. (2021) Aortic valve neocuspidalization in paediatric patients with isolated aortic valve disease: early experience. Interactive cardiovascular and thoracic surgery. 32(1):111-117

Case series

n=22

Median follow-up of 11.3 (4.7-21) months

The Ozaki procedure is safe and effective in paediatric patients with aortic valve disease. The use of heterologous pericardium should probably be minimized. Moreover, preoperative small aortic annuli should probably be promptly treated by means of an associated ring enlargement procedure

The number of patients is less than 50.

Study is included in the meta-analysis by Mylonas et al. (2023).

Polito A, Albanese S, Cetrano E et al. (2021) Aortic Valve Neocuspidalization May Be a Viable Alternative to Ross Operation in Pediatric Patients. Pediatric cardiology. 42(3):668-675

Comparative study

n=38

Median follow-up of 18.2 (5-32) months

The medium-term outcome of Ozaki and Ross in paediatric patients is similar, despite an increased tendency of the former to develop aortic transvalvular gradient in the follow-up. Future larger multicenter studies with longer follow-up are warranted to confirm these results.

The number of patients is less than 50.

Prinzing A, Bohm J, Sideris K et al. (2022) AVNeo Improves Early Hemodynamics In Regurgitant Bicuspid Aortic Valves Compared To Aortic Valve Repair. Interactive cardiovascular and thoracic surgery. 35(5)

Retrospective study

n=22

NA

Compared to AV-repair, patients AVNeo showed lower MPGs and larger orifice areas at discharge. The functional result was not different.

The number of patients is less than 50.

Reuthebuch O, Koechlin L, Schurr U et al. (2018) Aortic valve replacement using autologous pericardium: single centre experience with the Ozaki technique. Swiss medical weekly. 148:

Retrospective study

n=30

Mean follow-up: 3 months

In our experience, it can be mastered after a relatively short training period, and has become part of our routine clinical toolbox. The use of autologous pericardium in combination with excellent haemodynamics may have the potential to overcome the structural disadvantages of biological aortic valves, to be beneficial in infective endocarditis, and to represent an alternative for patients with small annuli.

The number of patients is less than 50.

Study is included in the systematic review by Dilawar et al. (2022).

Rosseikin E V, Kobzev E E, Bazylev V V. (2019) Minimally invasive Ozaki technique. Angiology and vascular surgery. 25(3) 142-155

Retrospective study

n=30

NA

Minimally invasive approach apart from a good cosmetic effect has a series of advantages over full sternotomy by the in-hospital and remote outcomes

The number of patients is less than 50.

Study is included in the meta-analysis by Mylonas et al. (2023).

Secinaro A, Milano E G, Ciancarella P et al. (2022) Blood flow characteristics after aortic valve neocuspidization in paediatric patients: a comparison with the Ross procedure. European heart journal. Cardiovascular Imaging. 23(2):275-282

Prospective cohort

n=20

NA

Proximal aorta flow dynamics of children treated with the Ozaki and the Ross procedure are comparable. Similarly to the Ross, Ozaki technique restores a physiological laminar flow pattern in the short-term follow-up, with the advantage of not inducing a bivalvular disease, although further studies are warranted to evaluate its long-term results.

The number of patients is less than 50.

Study is included in the meta-analysis by Mylonas et al. (2023).

Shearn A I U, Ordonez M V, Rapetto F et al. (2020) Rapid Prototyping Flexible Aortic Models Aids Sizing of Valve Leaflets and Planning the Ozaki Repair. JACC: Case Reports. 2(8):1137-1140

Case report

n=2

NA

Two patients with bicuspid aortic valve were selected for aortic valve repair using the Ozaki procedure. Patient-specific models of their aortic roots were generated based on computed tomography data and were 3-dimensional printed using a flexible resin.

The number of patients is less than 50.

No important adverse events reported.

Sivalingam S, Haranal M, Pathan I, (2022) Aortic valve neocuspidization for aortic regurgitation associated with ventricular septal defect. Interactive cardiovascular and thoracic surgery. 34(2): 315-321

Restrospective review

n=7

mean follow-up period was 2.6±0.8 years

The aortic leaflet neocuspidization procedure for the aortic valve is a relatively new concept. Availability of a template makes it an easily reproducible valve repair in paediatric patients with a single-leaflet abnormality. This technique preserves the remaining 2 normal leaflets, thus promoting the growth potential while maintaining near normal aortic root complex dynamics.

The number of patients is less than 50.

Shi T, Gao Z, Li S et al. (2022) Single leaflet reconstruction in paediatric aortic regurgitation using the Ozaki procedure. Cardiology in the young. 32(5) 789-793

Case series

n=9

The median follow-up was 22 (14, 33) months

Single leaflet reconstruction using the Ozaki procedure was an effective surgical method for treating children with aortic regurgitation in our centre with satisfactory short-term results.

The number of patients is less than 50.

Study is included in the meta-analysis by Mylonas et al. (2023).

Vijayan J, Lachma R, Rao P et al. (2019) Autologous pericardial aortic valve reconstruction: early results

and comparison with mechanical valve replacement. Indian Journal of Thoracic and Cardiovascular Surgery. 36(3):186-192

Prospective cohort

n=20

NA

Autologous pericardial aortic valve reconstruction is a feasible alternative to prosthetic valve replacement with

several advantages.

The number of patients is less than 50.

Study is included in the meta-analysis by Mylonas et al. (2023).

Watanabe F, Go K, Kojima T (2021) Valvular changes after aortic valve neo-cuspidization in children: A case series. Pediatrics international : official journal of the Japan Pediatric Society. 63(11):1289-1296

Case series

n=7

Postoperative transthoracic echocardiography 3 months after the procedure

Most cases exhibited spontaneous improvement in AR, while one developed postoperative AS. Further prospective investigation is, therefore, needed to explore surgical outcomes following AVNeo among children.

The number of patients is less than 50.

Study is included in the meta-analysis by Mylonas et al. (2023).

Wiggins L M, Mimic B, Issitt R et al. (2020) The utility of aortic valve leaflet reconstruction techniques in children and young adults. The Journal of thoracic and cardiovascular surgery. 159(6):2369-2378

Case series

n=40

A median echocardiographic follow-up of 14.1 months (7.2-20.1 months)

Aortic leaflet reconstruction provides acceptable short-term hemodynamic outcomes and proves the utility of this technique as an adjunctive strategy for surgical treatment of aortic valve disease in children and young adults.

The number of patients is less than 50.

Study is included in the meta-analysis by Mylonas et al. (2023).

Yamamoto Y, Iino K, Shintani Y et al. (2017) Comparison of Aortic Annulus Dimension After Aortic Valve Neocuspidization With Valve Replacement and Normal Valve. Seminars in thoracic and cardiovascular surgery. 29(2):143-149

Retrospective cohort

n=8

NA

e results of the present study demonstrated that aortic annular dimensions after AVNeo are similar to the dimensions of normal aortic valves.

The number of patients is less than 50.

Study is included in the meta-analysis by Mylonas et al. (2023).