CorMatrix

CorMatrix

Results

RVOT stenosis requiring treatment was present in two ToF patients, one in association with signs of persistent inflammation and pulmonary haemorrhage requiring pneumonectomy. Absent or trivial pulmonary regurgitation was recorded in two ToF, mild in two, moderate in four, in one associated with moderate stenosis, the last four with RV dilatation. One patient each in the group of PV reconstruction and PAs augmentation presented severe recurrent stenosis, requiring haemodynamic manoeuvres.

Conclusion

On short-term follow up, the performance of the CormatrixR ECM patch seemed suboptimal. Further clinical experience and longer follow up are needed to judge the adequacy of this material.

Authors chose to use CorMatrix for several reasons:

1) The injury occurred at an area of high pressure, and they felt that the inherent tensile strength and burst pressure of CorMatrix was well suited to the location.

2) CorMatrix is a biologic vs synthetic material (ie, woven Dacron or polytetrafluoroethylene) and will hopefully resist infection better in a traumatic setting. They did not used autologous pericardium because of the urgent nature of the case, and simply could not predict the exact injury and type of repair needed.

3) CorMatrix is more resistant to calcification and breakdown than pericardium or homograft material.

They have also found that suture lines involving CorMatrix are markedly hemostatic.

First successful case of innominate artery (or brachiocephalic trunk) disruption and repair using CorMatrix

A 12-year-old boy sustained a crush injury to the chest during an all-terrain vehicle accident.

Visually, there was no dissection but there was a clean, circumferential intimal disruption of the entire innominate artery from the aorta with intact adventitia.

Posterior wall of innominate artery was sutured to aorta and anterior wall was reconstructed with Cormatrix

EXTRACELLULAR MATRIX GRAFT FOR CARDIAC AND VASCULAR RECONSTRUCTIVE SURGERY: PRELIMINARY CLINICAL RESULTS

O Milanesi, M Padalino, G Torin, VL Vida, R Biffanti, A Cerutti, B Castaldi, N Maschietto, E Reffo, G Stellin; University of Padova, Italy

FU since December 2009, months (2–24)

Retrospective review fourteen patients:

• ToF 10 cases;
• DORV (double outflow right ventricle) sub-pulmonary VSD + subAoS (aortic stenosis)

+ AoCo (coarctation of aorta),

• complete A-V septal defect,
• PS (pulmonary artery stenosis) and
• RV hypoplasia, asplenia syndrome + single RV + PS, one case each.

Median age at operation was 4.8 months (1–66). CormatrixR ECM patch was used for RVOT reconstruction in ToF patients, PV reconstruction in two cases, PAs patch augmentation in two.

Retrospective review of 37 patients <18 years who had SIS-ECM implanted from

July 2009 to September 2011

• Follow up 6-757 days
• Implanted in 48 cardiac locations:
• 13 septal defects
• 26 vascular augmentations
• 7 outflow tract augmentations
• 3 valve reconstructions

SIS-ECM is suitable for the closure of septal defects. Use of SIS-ECM for the reconstructions of outflow tracts and great vessels carries a small risk of stenosis.

Two patients needed explantation due to RVOT obstruction (Two institutional studies not employing the SIS-ECM have shown that reintervention specifically for RVOT obstruction occurs at a rate between 18 and 31% within 5 years)

The majority of SIS-ECM patches performed well in paediatric cardiovascular reconstructions, particularly those with septal defects or vascular patch augmentation remote from the outflow tract.

New 2013... 2014

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SOUTHAMPTON PRELIMINARY EXPERIENCE IN THE USE OF AN EXTRACELLULAR MATRIX TO REPAIR CONGENITAL AND ACQUIRED HEART DEFECTS

Michael J Lavrsen, Nicola Viola, Joseph Vettukattil, Markku Kaarne; University of Southampton, Southampton, UK

Retrospective studies from April 2011 to June 2012, FU 1-15 months

109 CorMatrix patches were used in 89 operations on 82 patients aged 1 day to 81 years.

ECM was used for:

• cardiac or great vessel repair 82 cases:
• pulmonary arterioplasty in 34,
• intracardiac tissue repair in 16,
• pulmonary monocusp valve creation in 10,
• ascending aortoplasty 5,
• aortic arch augmentation in 5,
• right ventricular outflow tract patch in 5,
• superior vena cava patch in 4
• valve leaflet augmentation in 4 patients,
• 27 cases for pericardial closure.

A novel surgical technique to reconstruct the entire tricuspid valve using CorMatrix extracellular matrix

Yoshiya Toyoda  Mohammed A. Kashem, Akira Shiose, T. Sloane Guy

In Press, Accepted Manuscript, Available online 2 January 2014

Histology of CorMatrix Bioscaffold 5 Years After Pericardial Closure

Meghan Stellya, Terry C. Stelly, MDb,      ,      

a Clemson University, Clemson, South Carolinab Department of Cardiothoracic Surgery, Providence Hospital, Mobile, Alabama, 2013

Constructive Remodeling of CorMatrix ECM Following Aortic Root Repair in a 90 Year-old Female.

Slachman FN. Ann Thorac Surg. 2013;In Press.

WORLDWIDE EXPERIENCE WITH PORCINE SMALL INTESTINE SUB-MUCOSAL EXTRACELLULARMATRIX GRAFT (CORMATRIX) IN CONGENITAL HEART SURGERY: A SINGLE-INSTITUTIONAL EXPERIENCE

Christian Gilbert, Robert Matheny, Sanjay Kaushal, John Iguidbashian, Kathleen Fenton, Jorge Ochoa, William Novick; International Children’s Heart Foundation, Memphis, Tennessee, USA

Report is a retrospective review of International Children Health Foundation database.

The patients were from Iraq, India, Egypt, Ukraine, Honduras and Ecuador.

Results:

174 patients who received 176 implants, including:

33 pulmonary valved conduit procedures

(14 Ross, 6 tetralogy with absent pulmonary valve, 6 truncus arteriosus, 4 Rastelli, 3 DORV with RV to PA conduit, 2 TOF redo RV to PA conduit),

39 primary tetralogy repairs,

34 valve leaflet repairs(included with primary repair),

65 septal patches,

7 arterial switch repairs,

5 AVSD repairs

5 Glenn procedures with pericardial closure

Thank You

What's new

Anna Sucharska

2013

CorMatrix® Cardiovascular, Inc. Receives Three U.S. Patents

for Biomaterial Heart Valve

Patent is called “Prosthetic Tissue Valve.”

• For replacement heart valves that utilize unique biomaterial called extracellular matrix (ECM®).
• The patents cover a flat valve configuration that can be employed in several cardiovascular applications.
• CorMatrix® plans to use this technology to rapidly accelerate its research and development of further medical devices.

Results:

Overall mortality was 19/174 or 10.9%.

There was no mortality, which could be directly attributed to the ECM.

Two patients required early replacement of an ECM pulmonary valved conduit for obstruction distal to the conduit.

Two patients receiving aortic leaflet augmentation required aortic valve replacement.

All patients having the Ross procedure have had excellent early and midterm results with no mortality or re-operations.

Conclusions:

The SIS-ECM (Cormatrix) is an easy-to-use haemostatic alternative to traditional materials.

It can be used to fashion valve conduits for right-sided reconstructions and establish competent pulmonary valves in tetralogy repairs needing trans-annular patch.

The valve constructs demonstrate excellent results in short and mid-term follow up. Complete freedom from calcification is an added benefit.

Clinical experience with CorMatrix extracellular matrix in the surgical treatment of mitral valve disease 

Marc W. Gerdisch, Richard J. Shea, Michael D. Barron Cardiac Surgery Associates, Franciscan St Francis Heart Center, Indianapolis, Ind Published December 2013

Retrospective study of patients undergoing partial or subtotal leaflet replacement and/or leaflet extension to treat mitral regurgitation or acute endocarditis and/or reconstruction of atrial–ventricular continuity after annular decalcification. The material used for repair was a bioresorbable extracellular matrix (ECM) material indicated for cardiac tissue repair (CorMatrix Cardiovascular, Inc, Roswell, Ga). After the necessary debridement, the ECM bioscaffold was tailored and sewn to the native mitral valve tissue. Intraoperative photographs and serial, follow-up echocardiograms were used for evaluation.

Results

• No evidence of ECM-related intracardiac or intravascular thrombosis.
• Two patients had pericardial effusions due to bleeding from the anastomosis.
• Six patients who underwent pulmonary arterioplasty had some element of re-stenosis but later had successful balloon dilatation in the catheterisation laboratory.
• Eight of the 10 monocusp valves were competent and none were stenotic.

Conclusions:

• Repair of congenital and acquired heart defects using CorMatrix ECM is feasible and safe.
• Authors like this product due to the way it curves and conforms to the native tissue.
• It is also amenable to balloon angioplasty.

Results

From September 2008 to February 2013, MVr requiring the addition of patch material was performed in 19 patients. The median echocardiographic follow-up was 10.9 months (range, 4 days to 48 months). One early and 2 late deaths were unrelated to MVr. No perioperative or late strokes occurred. Two patients with a history of cancer, chemotherapy, and radiotherapy experienced failure of the initial MVr, necessitating reintervention. The other MVrs continued to show good valvular function and no calcification on echocardiographic follow-up of 4 days to 48 months.

Conclusions

The ECM bioscaffold is a satisfactory material for MVr in a variety of surgical situations, including endocarditis. It appears to resist calcification and infection. Additional studies are warranted to determine the long-term durability of repairs made with ECM, and its appropriate use in patients who have previously undergone radiotherapy or chemotherapy.

1. In Your opinion the results are rather positive or negative?

2. What is the used material?

3. What is the most common used reconstructive material in congenital heart diseases?