Randomized, Controlled Trial Comparing Mitral Valve Repair With Leaflet Resection Versus Leaflet Preservation on Functional Mitral Stenosis: The CAMRA CardioLink-2 Study.

BACKGROUND: Equipoise exists between the use of leaflet resection and preservation for surgical repair of mitral regurgitation caused by prolapse. We therefore performed a randomized, controlled trial comparing these 2 techniques, particularly in regard to functional mitral stenosis. METHODS: One hundred four patients with degenerative mitral regurgitation surgically amenable to either leaflet resection or preservation were randomized at 7 specialized cardiac surgical centers. Exclusion criteria included anterior leaflet or commissural prolapse, as well as a mixed cause for mitral valve disease. Using previous data, we determined that a sample size of 88 subjects would provide 90% power to detect a 5-mm Hg difference in mean mitral valve gradient at peak exercise, assuming an SD of 6.7 mm with a 2-sided test with α=5% and 10% patient attrition. The primary end point was the mean mitral gradient at peak exercise 12 months after repair. RESULTS: Patient age, proportion who were female, and Society of Thoracic Surgeons risk score were 63.9±10.4 years, 19%, and 1.4±2.8% for those who were assigned to leaflet resection (n=54), and 66.3±10.8 years, 16%, and 1.9±2.6% for those who underwent leaflet preservation (n=50). There were no perioperative deaths or conversions to replacement. At 12 months, moderate mitral regurgitation was observed in 3 subjects in the leaflet resection group and 2 in the leaflet preservation group. The mean transmitral gradient at 12 months during peak exercise was 9.1±5.2 mm Hg after leaflet resection and 8.3±3.3 mm Hg after leaflet preservation (P=0.43). The participants had similar resting peak (8.3±4.4 mm Hg versus 8.4±2.6 mm Hg; P=0.96) and mean resting (3.2±1.9 mm Hg versus 3.1±1.1 mm Hg; P=0.67) mitral gradients after leaflet resection and leaflet preservation, respectively. The 6-minute walking distance was 451±147 m for those in the leaflet resection versus 481±95 m for the leaflet preservation group (P=0.27). CONCLUSIONS: In this adequately powered randomized trial, repair of mitral prolapse with either leaflet resection or leaflet preservation was associated with similar transmitral gradients at peak exercise at 12 months postoperatively. These data do not support the hypothesis that a strategy of leaflet resection (versus preservation) is associated with a risk of functional mitral stenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT02552771.

Predictors of contrast induced nephropathy and the applicability of the Mehran risk score in high risk patients undergoing coronary angioplasty-A study from a tertiary care center in South India.

OBJECTIVE: To study the incidence and predictors of Contrast induced nephropathy (CIN) in high risk patients undergoing coronary angioplasty. To study the applicability of the Mehran Risk Score (MRS) in the prediction of CIN in our population. METHODS: This was a prospective observational study where patients with an estimated glomerular filtration rate (eGFR) between 30 and 60ml/mt undergoing elective percutaneous coronary intervention (PCI) over a period of 15 months were evaluated prospectively for the development of CIN. The patients who developed CIN were then analysed for the presence of specific risk factors. The patients were categorized into the 4 risk groups based on the MRS. RESULTS: 100 high risk patients underwent PCI during the study period. The incidence of CIN was 29%. On multivariate analysis, the presence of anemia (p=0.007), increased contrast volume usage (as defined by >5* B.Wt/S.cr) (p=0.012) and usage of loop diuretics (p=0.033) were independently found to confer a significant risk of CIN. In patients belonging to the high Mehran risk group (MRS10- 15) and very high risk group (MRS >15) the risk of CIN was 3 fold (OR: 3.055, 95% CI: 1.18-7.94, p=0.022) and 24 fold (OR: 24, 95% CI: 2.53-228.28, p=0.006) higher respectively when compared to intermediate and low risk patients (MRS <10). CONCLUSION: The incidence of CIN in high risk patients undergoing PCI is substantially higher in our population compared to similar studies in the west. The MRS risk prediction is pertinent even in an Indian population.