Pulmonary Valve Replacement With Small Intestine Submucosa-Extracellular Matrix in a Porcine Model

Miller, Jacob R.; Henn, Matthew C.; Lancaster, Timothy S.; Lawrance, Christopher P.; Schuessler, Richard B.; Shepard, Mark; Anderson, Mark; Kovacs, Attila; Matheny, Robert G.; Eghtesady, Pirooz; Damiano, Ralph J.; Boston, Umar S.

doi:10.1177/2150135116651113

Cited by 16 publications

(28 citation statements)

References 31 publications

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“…Initial research showed good valve function and progressive endothelialization and constructive remodeling in the short-term in porcine, ovine, and human atrioventricular and pulmonary valves. 5,19,20 Miller and colleagues 6 showed advanced remodeling in the pig pulmonary position with myofibroblast infiltration, endothelialization, and conduit growth. Despite this remodeling, all animals eventually developed significant valve dysfunction within 6 months.…”

Section: Discussionmentioning

confidence: 99%

“…Despite this remodeling, all animals eventually developed significant valve dysfunction within 6 months. 6 Incomplete resorption and disorganized degradation of pSIS-ECM accompanied by chronic inflammation, fibrosis, and calcification led to progressive mechanical and remodeling failure at 4 to 6 months in small preclinical studies in pig aortic valve. 21,22 In line with these findings, the largest recent clinical studies on valve repair using CorMatrix have shown functional failure at short-and midterm follow-up with high reoperation rates.…”

Section: Discussionmentioning

confidence: 99%

“…4 In the pulmonary position, a small number of animal studies have shown tissue remodeling; however, these studies were performed in a homogeneic setting (porcine), whereas pSIS-ECM used in human patients is xenogeneic. 5,6 Although not extensively and independently studied in preclinical trials, pSIS-ECM is used off-label for valve reconstructions in human beings. Recently, surgeons experienced early failures after valve reconstruction using CorMatrix (CorMatrix Cardiovascular, Inc, Roswell, Ga) and a word of caution was raised regarding the use of pSIS-ECM in heart valve repair.…”

Section: Perspectivementioning

confidence: 99%

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Failure of decellularized porcine small intestinal submucosa as a heart valved conduit

Rijswijk

Talacua

Mulder

et al. 2020

The Journal of Thoracic and Cardiovascular Surgery

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Perspectivementioning

confidence: 99%

See 1 more Smart Citation

Failure of decellularized porcine small intestinal submucosa as a heart valved conduit

Rijswijk

Talacua

Mulder

et al. 2020

The Journal of Thoracic and Cardiovascular Surgery

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“…31 SIS grat has been successfully used in human medicine for urinary, 32 orthopaedic, 33 and abdominal wall surgery 34 and in veterinary patients for vascular grating, 35 esophageal reconstruction, 36 tendon reconstruction 37 38 and cardiac valve replacement. 39 In veterinary ophthalmology, the use of SIS is reported for corneal reconstruction ater limbal melanocytoma excision in a dog, 19 in diferent corneal disease in cats, 20 combined with conjunctival lap in cat, dog and horse, 21 in deep melting ulcers combined with nictitating membrane lap, 22 and with the use of one or more discs stacked depending on the depth of the lesion. 23 SIS scafolds have an acellular collagen composition, they are not immunogenic and act as an inductive substrate which induces tissue healing by stimulating migration, diferentiation and proliferation of sitespeciic cells, while conferring mechanical resistance to the tissue.…”

Section: Discussionmentioning

confidence: 99%

Use of four‐layer porcine small intestinal submucosa alone as a scaffold for the treatment of deep corneal defects in dogs and cats: preliminary results

et al. 2020

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BackgroundTo describe the efficacy of four-layer porcine small intestinal submucosa (Vetrix BioSIS plus+) as single scaffold for the treatment of deep corneal lesions in dogs and cats.Methods10 dogs and 3 cats with deep or full thickness corneal defects were treated surgically with BioSIS plus graft. Corneal transparency scores and vision were evaluated.ResultsLesions in dogs were four perforations, three descemetoceles, two limbal melanocytomas and one deep corneal ulcer. In cats, there were one limbal melanocytoma and two perforations. The average length of the follow-up was 86 days. In all, 12 out of 13 eyes treated were visual at last recheck (92.3 per cent). The scars were mild eight cases (66.7 per cent), but denser in four cases (33.4 per cent). Complication were partial collagenolysis in three cases (25 per cent), which resolved with medical therapy, mild corneal pigmentation in one case (8.4 per cent) and anterior synechia in one case (8.4 per cent). One case experienced severe collagenolysis and was enucleated 21 days postoperatively.ConclusionsFour-layer porcine SIS graft was successfully used for surgical treatment of deep corneal lesions in selected corneal diseases in a small series of dogs and cats, with good results in terms of mechanic support and corneal transparency.

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“…After experimental ( 6 – 8 ) and clinical ( 9 – 11 ) studies, the decellularized porcine small intestine sub-mucosa (DPSIS) patch has been introduced with the commercial name of CorMatrix® (CorMatrix Cardiovascular, Roswell, GA) for the surgical treatment of congenital heart defects, with implantations performed for closure of septal defects, valve repair, and as vascular patch in both the systemic and pulmonary circulations ( 12 – 16 ).…”

Section: Introductionmentioning

confidence: 99%

Is Decellularized Porcine Small Intestine Sub-mucosa Patch Suitable for Aortic Arch Repair?

et al. 2018

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Introduction: We reviewed our experience with decellularized porcine small intestine sub-mucosa (DPSIS) patch, recently introduced for congenital heart defects.Materials and Methods: Between 10/2011 and 04/2016 a DPSIS patch was used in 51 patients, median age 1.1 months (5 days to 14.5 years), for aortic arch reconstruction (45/51 = 88.2%) or aortic coarctation repair (6/51 = 11.8%). All medical records were retrospectively reviewed, with primary endpoints interventional procedure (balloon dilatation) or surgery (DPSIS patch replacement) due to patch-related complications.Results: In a median follow-up time of 1.5 ± 1.1 years (0.6–2.3years) in 13/51 patients (25.5%) a re-intervention, percutaneous interventional procedure (5/51 = 9.8%) or re-operation (8/51 = 15.7%) was required because of obstruction in the correspondence of the DPSIS patch used to enlarge the aortic arch/isthmus, with median max velocity flow at Doppler interrogation of 4.0 ± 0.51 m/s. Two patients required surgery after failed interventional cardiology. The mean interval between DPSIS patch implantation and re-intervention (percutaneous procedure or re-operation) was 6 months (1–17 months). While there were 3 hospital deaths (3/51 = 5.9%) not related to the patch implantation, no early or late mortality occurred for the subsequent procedure required for DPSIS patch interventional cardiology or surgery. The median max velocity flow at Doppler interrogation through the aortic arch/isthmus for the patients who did not require interventional procedure or surgery was 1.7 ± 0.57 m/s.Conclusions: High incidence of re-interventions with DPSIS patch for aortic arch and/or coarctation forced us to use alternative materials (homografts and decellularized gluteraldehyde preserved bovine pericardial matrix).

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Pulmonary Valve Replacement With Small Intestine Submucosa-Extracellular Matrix in a Porcine Model

Abstract: The SIS-ECM valved conduit implanted into a piglet demonstrated cellular infiltration with vascular remodeling and an increase in diameter. Conduit stenosis was a result of slower rates of size increase than native tissue. Suboptimal leaflet performance requires design modifications.

Cited by 16 publications

References 31 publications

Failure of decellularized porcine small intestinal submucosa as a heart valved conduit

Failure of decellularized porcine small intestinal submucosa as a heart valved conduit

Use of four‐layer porcine small intestinal submucosa alone as a scaffold for the treatment of deep corneal defects in dogs and cats: preliminary results

Is Decellularized Porcine Small Intestine Sub-mucosa Patch Suitable for Aortic Arch Repair?

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