Comparison of Extracellular Matrix Patch and Standard Patch Material in the Pulmonary Arteries

Abstract

After pulmonary artery (PA) patch augmentation, surgical or catheterization reintervention to address PA stenosis is not uncommon. Multiple patch materials are available and the need for reintervention may be related to characteristics of the patch material. In this retrospective chart review of patients who underwent PA augmentation from 2004 through 2013, we compare outcomes after PA augmentation with standard patch (SP) material and extracellular matrix (ECM) patch material. The primary outcome was reintervention-free survival (surgery or catheterization) using Kaplan-Meier survival analysis with the log-rank test. Risk factors for reintervention were assessed with Cox proportional hazard analyses. Baseline characteristics between groups were similar, except single-ventricle (SV) patients were more likely to have SP, and duration of follow-up was longer in the SP group. Median time to reintervention for all patients was 1099 days (95 % CI 646-1552 days). There was no difference in reintervention-free survival between the patch groups (p = 0.12); however, in multivariable analysis controlling for surgeon and patch, longer reintervention-free survival was associated with SV physiology (HR 0.57 95 % CI 0.34-0.95, p = 0.03) and aortic cross-clamp (XC) use (HR 0.52, 95 % CI 0.32-0.84, p = 0.008). Since there is no difference in median time to reintervention following PA augmentation with SP or ECM, patch choice should be determined by other factors, such as surgeon preference and cost. Longer reintervention-free survival in SV patients may be related to the set schedule of staged palliation. XC use may allow more extensive PA augmentation, thus protecting against the need for reintervention.

Comparison of Patch Materials for Pulmonary Artery Reconstruction

“…To estimate the early quality of PAR, we reviewed predominantly discharge echocardiography reports, as few other modalities were used prior to discharge. While we included this data (Table 1), and controlled for it in the multivariable analysis, we wish to note some caveats which likely limit the accuracy of the data: (1) only 51 preoperative sites were evaluated by angiography, CT, or magnetic resonance imaging; (2) We could not assign preoperative or postoperative degree of stenosis in 13 patients in the earlier era of the cohort (missing study reports); and 3) several cardiologists, each with some degree of subjective variation in estimating severity (particularly branch PA), read and reported results of the various studies. We therefore estimated degree of stenosis by using the qualitative language provided in the study reports and categorized as none to trivial, mild, moderate, or severe.…”

“…Note that our most commonly used patch cost $5,100 more than our second most expensive patch. While clinical relevance may be questioned, a comparison of bovine pericardium to porcine submucosal patch, accounting for amount of patch material, yields costs of $28.4 per cm 2 for submucosal patch versus $20.3 per cm 2 for bovine pericardium.…”

“…A second study by Fraint et al compared extracellular matrix (ECM) patch to a composite group of "standard patches" (homograft, various types of pericardium). 2 The cohort included 48 patients with ECM patches and 173 with standard patches. There was no difference in reintervention-free survival between the groups, with reintervention occurring at a median follow-up of 3 years.…”

Patch Materials for Pulmonary Artery Arterioplasty and Right Ventricular Outflow Tract Augmentation: A Review

“…Numerous small studies with shorter follow-up periods have shown similar, if not more favorable, results [ 12 , 13 , 21 , 39 , 40 ]. When compared directly to standard patch materials, including autologous pericardium, homograft and xenograft pericardium, and synthetic materials, no significant difference has been reported in outcomes for patients receiving CorMatrix™ patches [ 21 , 41 ]. Fraint et al compared CorMatrix™ patch patients ( N = 48) to a standard patch material cohort ( N = 173) composed of autologous pericardium, native PA tissue, non-native pericardial tissue, pulmonary and aortic homografts, and ePTFE [ 41 ].…”

“…When compared directly to standard patch materials, including autologous pericardium, homograft and xenograft pericardium, and synthetic materials, no significant difference has been reported in outcomes for patients receiving CorMatrix™ patches [ 21 , 41 ]. Fraint et al compared CorMatrix™ patch patients ( N = 48) to a standard patch material cohort ( N = 173) composed of autologous pericardium, native PA tissue, non-native pericardial tissue, pulmonary and aortic homografts, and ePTFE [ 41 ]. This study demonstrated identical mortality rates of 6%, and total reintervention rates of 29% for CorMatrix™ as opposed to 39% for standard materials.…”