Single Center Five Years’ Experience of Ozaki Procedure: Midterm Follow-up

Pirola, Sergio; Mastroiacovo, Giorgio; Arlati, Francesco; Mostardini, G; Bonomi, Alice; Penza, Eleonora; Polvani, Gianluca

doi:10.1016/j.athoracsur.2020.08.039

Cited by 33 publications

(29 citation statements)

References 23 publications

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“…In patients with isolated aortic stenosis, Iida and colleagues report a mean peak pressure gradient of 22 ± 10.7 mmHg one week after the procedure and 19.2 ± 9.7 mmHg after 20 months [8]. In our cohort, after median 21 months of followup, median (IQR) mean and peak gradients were 6 (5,9) mmHg and 12 (8, 17) mmHg, respectively; these results are similar to recently published data from a US center [12].…”

Section: Hemodynamicsupporting

confidence: 90%

“…Even if several new study groups have recently confirmed AVNeo to be a safe and reproducible technique, the key question is durability. Data regarding this are limited to date [12][13]14•].…”

Section: Durabilitymentioning

confidence: 99%

“…Notwithstanding, the aortic valve replacement (AVR) technique with autologous glutaraldehyde-treated pericardium to rebuild the aortic valve, the so called "OZAKI" procedure (also referred to as "aortic valve neocuspidization, AVNeo"), has gained popularity within the past years [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17]. The concept of using (autologous) pericardium to reconstruct/rebuild the aortic valve is well known in pediatric cardiac surgery.…”

Section: Introductionmentioning

confidence: 99%

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Aortic Valve Neocuspidization Using Autologous Pericardium (Ozaki Procedure): an Alternative to Aortic Valve Replacement in Adult Cardiac Surgery?

Koechlin

Eckstein

2021

Curr Anesthesiol Rep

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Purpose of the Review The aim of this article is to describe the technique of aortic valve neocuspidization using autologous pericardium (AVNeo, “OZAKI procedure”) in adult cardiac surgery, to analyze recent findings, and to discuss benefits and limitations of this technique. Recent Findings Potential benefits of this technique include excellent hemodynamic performances, minimal use of foreign material, low rates of permanent pacemaker implantation, and omission of oral anticoagulation. However, data regarding the durability of the procedure are hitherto limited, and the procedure is associated with a higher complexity compared to aortic valve replacement. Summary AVNeo using autologous pericardium in adult cardiac surgery is a promising technique providing several benefits. However, there is a major unmet need for more data, especially regarding long-term durability. Thus, based on currently available data, we recommend careful patient selection within the heart team and shared decision-making with the informed patient.

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Section: Hemodynamicsupporting

confidence: 90%

Section: Durabilitymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Aortic Valve Neocuspidization Using Autologous Pericardium (Ozaki Procedure): an Alternative to Aortic Valve Replacement in Adult Cardiac Surgery?

Koechlin

Eckstein

2021

Curr Anesthesiol Rep

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“…Similar results have been observed in other series. 10,18,[21][22][23] This excellent hemodynamic performance is the result of preserving the natural motion of the aortic valve annulus and the coordination of the left ventricle, aortic annulus, sinus of Valsalva, and aorta. This is particularly important in patients with a small AV annulus.…”

Section: Hemodynamic Performancementioning

confidence: 99%

Aortic valve reconstruction surgery. Operative results from a Peruvian Cohort Running tittle: AVrec Surgery

Ríos-Ortega

Aranda-Pretell

Talledo-Paredes

et al. 2022

Preprint

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Background Aortic valve replacement is the gold standard treatment for severe symptomatic aortic valve disease. Recently, aortic valve reconstruction surgery (Ozaki procedure) emerges as a surgical alternative with good results in the medium term. Methods We retrospectively analyzed 38 patients who underwent aortic valve reconstruction surgery between January 2018 and June 2020 in a national reference center in Lima, Peru. The median age was 62 years, interquartile range 25. The main indication for surgery was aortic valve stenosis (63.1%), in most cases due to bicuspid valve (19 patients, 50%). Twenty-two (58%) patients had another pathology with surgical indication associated to AV disease, 8(21%) had dilatation of the ascending aorta with indication for replacement. Results One in-hospital death occurred (1/38, 2.6%) due to perioperative myocardial infarction. There was a significant reduction in the medians of the peak (66mmHg, CI95%=52.5-81.3 vs 15mmHg, CI95%=12.1-17.5, p<0.0001) and mean (41mmHg CI95%=31.8-50.1 vs 8mmHg, CI95%=6.0-9.6, p<0.0001) aortic valve gradients when we compared baseline characteristics with first 30-days results. In an average of 19 (±8.9) months of follow-up, survival, reoperation-free survival for valve dysfunction, and survival free of AV insufficiency> II were 94.6%, 94.6% y 91.7%, respectively. Significant reduction in the medians of the peak (66mmHg, CI95%=52.5-81.3 vs 14mmHg, CI95%=10.9-17.6, p<0.0001) and mean (41mmHg CI95%=31.8-50.1 vs 7mmHg, CI95%=5.2-9.1, p<0.0001) aortic valve gradients were maintained. Conclusions Mid-term outcome follow-up of aortic valve reconstruction surgery showed optimal results in term of mortality, reoperation free survival and hemodynamic characteristics of the neo-aortic valve.

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“…In cardiac surgery, for example the technique inclusive of Ozaky procedure, the aortic valve repair using neocuspidalization, require intraoperative taken fresh autologous pericardium patch before implant. Usually, the pericardium is immersed in aqueous solution with GA concentration up to 600 ppm, and then it is washed [13,14]. After that, the treated pericardium is anchored to the patient's aortic tissues as a function of the new apparatus valvular.…”

Section: Ga Use For Autologous Pericardial Patchmentioning

confidence: 99%

The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery

Noera¹

2021

IJCTS

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Glutaraldehyde is classified as a biocide-pesticide under the hazard class for toxic substance and control laws for the human health and environmental worldwide. The regulatory bodies restrict the intended use to disinfectant or laboratory application in hospital. The parenteral pathway in human is not considered and then not allowed, for the high-risk profile, so the constraints are an integral part of the Classification Labeling and Packaging for exposure of occupational health. Contextually, there are no preclinical-safety data as Risk Related Reference (DMEL probability of occurrence and severity of adverse effect (s)/event (s) in a given population under defined exposure conditions), or Chemical Safety Reports that justify any authorization for patient consumer uses. In the context of cardiac surgery, the biomechanical stability in treating the autologous pericardium with glutaraldehyde in solution, results as a hand-built biotech for a patient valve device. Theoretically, the surgeon is a manufacturer that uses a toxic chemical compound for the own product that does not comply to the law and regulations. Contrary to pharmaceutical definition for marketing authorized drugs, the off-label not allowed use of toxic chemical derived manufacture, expose the physicians to legal vulnerability of which it is inclusive the malpractice for thepatient's informed consent.

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Single Center Five Years’ Experience of Ozaki Procedure: Midterm Follow-up

Cited by 33 publications

References 23 publications

Aortic Valve Neocuspidization Using Autologous Pericardium (Ozaki Procedure): an Alternative to Aortic Valve Replacement in Adult Cardiac Surgery?

Aortic Valve Neocuspidization Using Autologous Pericardium (Ozaki Procedure): an Alternative to Aortic Valve Replacement in Adult Cardiac Surgery?

Aortic valve reconstruction surgery. Operative results from a Peruvian Cohort Running tittle: AVrec Surgery

The Gordian Knot of Glutaraldehyde-Treated Autologous Pericardium in Open Cardiac Surgery

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