Inflammation and infection in nine surgically explanted Medtronic Freestyle® stentless aortic valves

Butany, Jagdish; Zhou, Taylor; Leong, Shaun W.; Cunningham, Kristopher S.; Thangaroopan, Molly; Jeggatheeswaran, Anusha; Feindel, Christopher M.; David, Tirone E.

doi:10.1016/j.carpath.2007.01.009

Cited by 42 publications

(26 citation statements)

References 17 publications

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“…Nevertheless, a slow but steady increase in prosthetic calcification was measured by electron-beam computed tomography up to 8 years after implantation (26). In a recent study of 9 cases of Freestyle reoperation, Butany et al (27) reported 3 cases of significant calcification (grade 3 or 4) and 3 cases of cusp tear at a median time of 5 years after surgery, further emphasizing the importance of close patient follow-up. Interestingly, these 6 cases had all undergone subcoronary or root inclusion Freestyle implantation at initial surgery.…”

Section: Discussionmentioning

confidence: 97%

Late Outcomes Following Freestyle Versus Homograft Aortic Root Replacement

El-Hamamsy

Clark

Stevens

et al. 2010

Journal of the American College of Cardiology

112

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Section: Discussionmentioning

confidence: 97%

Late Outcomes Following Freestyle Versus Homograft Aortic Root Replacement

El-Hamamsy

Clark

Stevens

et al. 2010

Journal of the American College of Cardiology

112

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“…Butany et al [14] have reported that in one model of stentless valve with no fabric covering the adventitial surface of the device, there was a significant cellular infiltrate composed of mononuclear cells and macrophages to the porcine aorta and the porcine aorta showed significant damage related to this. Some of these BHVs failed due to aortic root dilation and BHV incompetence.…”

Section: Cellular Reaction and Damagementioning

confidence: 99%

Bioprosthetic Heart Valves: Impact of Implantation on Biomaterials

2013

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Prosthetic heart valves are commonly used in the treatment of valvular heart disease. Mechanical valves are more durable than the bioprosthetic valves; however, the need for long-term anticoagulant therapy renders them unsuitable for some patient groups. In this paper we discuss the different types and models of bioprosthesis, and in particular, pericardial bioprosthesis. We also discuss the preimplantation preparation processes, as well as their postimplantation changes and modes of failure.

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“…In a comprehensive examination of this complication, data from MFB implantations at the University of Toronto were detailed in a series of articles describing the clinical, imaging, and pathology results of explanted specimens [7, 8, 10]. These studies noted 3 specimens with aneurysmal deterioration without infective endocarditis etiology.…”

Section: Commentmentioning

confidence: 99%

“…Several studies have reported immune cell infiltrates within the porcine root [7, 8, 10], raising concerns of a host immune reaction to the foreign porcine material and leading to structural deficits in the root wall.…”

mentioning

confidence: 99%

Pseudoaneurysm Formation After Medtronic Freestyle Porcine Aortic Bioprosthesis Implantation: A Word of Caution

Englum¹,

Pavlisko²,

Mack³

et al. 2014

The Annals of Thoracic Surgery

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Background A growing literature describes aneurysmal deterioration after implantation of the stentless porcine aortic Medtronic Freestyle bioprosthesis (MFB; Medtronic Inc, Minneapolis, MN), with some suggesting inadequate tissue fixation with immune response as a cause. However, disjointed reports make the significance of these findings difficult to interpret. We address this concern by aggregating available data. Methods We reviewed institutional data, the Food and Drug Administration’s Manufacturer and User Facility Device Experience registry, and the medical literature for mention of aneurysm or pseudoaneurysm after MFB. Case details were aggregated, and the rate of aneurysmal deterioration was estimated. Immunohistopathologic examination of institutional explanted specimens was performed to elucidate a cause. Results We found 42 cases of aneurysmal deterioration with adequate detail for analysis; all occurred with full root replacement and valve sizes ranging from 23 to 29 mm. The rate of aneurysmal deterioration considering all data sources was 1.1% (9 of 851; 95% confidence interval, 0.5% to 2.0%) vs 4.7% (4 of 86; 95% confidence interval, 1.3% to 11.5%) at our institution, where yearly surveillance imaging is performed. Rate of aneurysmal deterioration appeared constant until 5 years after the operation; however, events are reported out to 10 years. Consistent with previous reports, histopathology demonstrated an immune cell infiltrate in areas of MFB wall breakdown. Conclusions Aneurysmal deterioration is an increasingly described complication of MFB implantation as a full root, with an incidence as high as 4.7%. Given the observed immune reaction and lack of occurrence in smaller (19-mm and 21-mm) valve sizes, inadequate pressure fixation of larger valves is a potential etiology. Patients with MFB require annual surveillance imaging, and consideration of this complication should factor into preoperative decision making because treatment mandates redo root replacement, which may not be feasible in high-risk patients.

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Inflammation and infection in nine surgically explanted Medtronic Freestyle® stentless aortic valves

Cited by 42 publications

References 17 publications

Late Outcomes Following Freestyle Versus Homograft Aortic Root Replacement

Late Outcomes Following Freestyle Versus Homograft Aortic Root Replacement

Bioprosthetic Heart Valves: Impact of Implantation on Biomaterials

Pseudoaneurysm Formation After Medtronic Freestyle Porcine Aortic Bioprosthesis Implantation: A Word of Caution

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