Retroinfusion‐supported stenting in high‐risk patients for percutaneous intervention and bypass surgery: Results of the prospective randomized myoprotect I study

Abstract

The objective of this study was to assess event-free survival and total treatment costs of retroinfusion-supported stenting in high-risk patients compared to bypass surgery. An increasing number of patients with main-stem and main-stem-equivalent stenosis are treated by stent implantation, which appears to be safe in the short-term follow-up. However, there is a lack of randomized studies comparing conventional bypass surgery with stent implantation, particularly in patients with high risk for both treatments. We here report on the 1-year results of a prospective randomized single-center study in patients with symptomatic main-stem and main-stem-equivalent lesions with substantially increased risk for bypass surgery. Patients where randomized to undergo either percutaneous transluminal coronary angioplasty/stent procedure (n = 23) or bypass surgery (n = 21). Patients randomized to stent implantation were supported by selective pressure-regulated retroinfusion of the anterior cardiac vein during ischemia. Patients of the stent group and the bypass group did not differ in baseline characteristics, including Parsonnet score and quality-of-life score. Twenty-eight-day mortality and 1-year mortality rate as well as quality-of-life scores were similar in both groups. Event-free survival after 1 year was higher in the bypass group (71.4% vs. 52.3%; P = 0.02) due to a lower target lesion revascularization rate. With regard to total treatment costs, however, the stent group compared favorably to the bypass group (9,346 +/- 807 vs. 26,874 +/- 3,985 euro), predominantly as a result of a shorter intensive care and hospital stay. In this first randomized study in high-risk patients for stent implantation and bypass surgery, patients with retroinfusion-supported stent implantation had a similar 1-year outcome and quality of life compared to patients with bypass surgery. Though in the stent group event-free survival was lower and target lesion revascularization rate was higher, retroinfusion-supported stent implantation was associated with substantially lower costs and might be considered as an alternative treatment option in this selected group of high-risk patients.

2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery

“…149 The latter document was updated in 2010. 139 Because of the use of different grading methodologies in the American Society of Anesthesiologists/Society of Cardiovascular Anesthesiologists guideline relative to that of the ACCF/AHA, precise comparisons are difficult. However, it is noted that TEE "should be considered" in subjects undergoing CABG, to confirm and refine the preoperative diagnosis, detect new or unsuspected pathology, adjust the anesthetic and surgical plan accordingly, and assess the results of surgery.…”

Cardio-specific long-term gene expression in a porcine model after selective pressure-regulated retroinfusion of adeno-associated viral (AAV) vectors

“…[1][2][3][4][5][6][7][8][9][10][11][12][13][14] We have chosen pressure-regulated retroinfusion of the coronary veins, as a catheterbased delivery system, which has been previously proven to be safe for human application. 15,16 Recently, it has been shown to provide efficient gene transfer to ischemic and nonischemic myocardium. This was demonstrated in case of cDNA transfer of vascular endothelial growth factor (VEGF) and heat shock protein 90 in a chronic porcine ischemia/reperfusion model.…”

Myocardial gene transfer by selective pressure-regulated retroinfusion of coronary veins

“…With regard to the well-known safety of selective retroinfusion in patients with coronary artery disease (13,26), this is a promising percutaneous delivery technique for genes that might require a more homogenous transmural myocardial distribution. To the best of our knowledge, no data are available so far concerning whether biological activity is greater when a small area has high levels of gene expression or whether a larger area has lower or equal levels of gene expression.…”