Mitral annuloplasty in patients with ischemic versus dilated cardiomyopathy

Objective: Mitral regurgitation is a frequent finding in patients with end-stage cardiomyopathy predicting poor survival. Conventional treatment consists medical treatment or cardiac transplantation. However, despite severely decreased left ventricular function, mitral annuloplasty may improve survival and reduce the need for allografts. Methods: From January 1996 to July 2002, 121 patients with severe end-stage dilated (DCM) or ischemic cardiomyopathy (ICM), mitral regurgitation ≥2, and left ventricular ejection fraction ≤30% underwent mitral valve annuloplasty using a flexible posterior ring. DCM was diagnosed in 30 patients (25%), whereas ICM was found in 91 patients (75%). Concomitant tricuspid valve repair was performed in 14 (46.6%) patients in the DCM, and in 11 (12%) in the ICM group (P=0.0001), coronary artery bypass grafting in three (10%) in the DCM, and in 78 patients (86%) in the ICM group (P<0.00001). The mean follow-up time was 567±74 days in the DCM and 793±63 days in the ICM group (ns). Results: Early mortality was 6.6% (8/121), and was equal for both groups. Improvement in NYHA class (DCM 3.3+0.1-1.8±0.16; ICM from 3.2+0.04 to 1.7±0.07) were equal between groups after 1 year. Seventeen (15%) late deaths occurred during the follow-up period. There was no difference in the 2-year actuarial survival between groups (DCM/ICM 0.93/0.85). Risk factors for mitral reconstruction failure, defined as regurgitation ≥2 after 1 year, were preoperative NYHA IV in the DCM group (P=0.03), a preoperative posterior infarction (P=0.025), decreased left ventricular function (P=0.043), larger ring size (P=0.026) and preoperative renal failure (P=0.05) in the ICM group. Risk factors for death were larger ring size (P=0.02) and an increased LVEDD (P=0.027) in the DCM group and the postoperative use of IABP (P=0.002), renal failure (P=0.001), and a larger preoperative LVESD (P=0.035) in the ICM group. Conclusion: Mitral reconstruction with a posterior annuloplasty using a flexible ring is effective in patients with severely depressed left ventricle function and has an acceptable operative mortality. Mid-term results are superior to medical treatment alone and comparable to cardiac transplantatio

Mitral annuloplasty in patients with ischemic versus dilated cardiomyopathy

Objective: Mitral regurgitation is a frequent finding in patients with end-stage cardiomyopathy predicting poor survival. Conventional treatment consists medical treatment or cardiac transplantation. However, despite severely decreased left ventricular function, mitral annuloplasty may improve survival and reduce the need for allografts. Methods: From January 1996 to July 2002, 121 patients with severe end-stage dilated (DCM) or ischemic cardiomyopathy (ICM), mitral regurgitation ≥2, and left ventricular ejection fraction ≤30% underwent mitral valve annuloplasty using a flexible posterior ring. DCM was diagnosed in 30 patients (25%), whereas ICM was found in 91 patients (75%). Concomitant tricuspid valve repair was performed in 14 (46.6%) patients in the DCM, and in 11 (12%) in the ICM group (P=0.0001), coronary artery bypass grafting in three (10%) in the DCM, and in 78 patients (86%) in the ICM group (P<0.00001). The mean follow-up time was 567±74 days in the DCM and 793±63 days in the ICM group (ns). Results: Early mortality was 6.6% (8/121), and was equal for both groups. Improvement in NYHA class (DCM 3.3+0.1-1.8±0.16; ICM from 3.2+0.04 to 1.7±0.07) were equal between groups after 1 year. Seventeen (15%) late deaths occurred during the follow-up period. There was no difference in the 2-year actuarial survival between groups (DCM/ICM 0.93/0.85). Risk factors for mitral reconstruction failure, defined as regurgitation ≥2 after 1 year, were preoperative NYHA IV in the DCM group (P=0.03), a preoperative posterior infarction (P=0.025), decreased left ventricular function (P=0.043), larger ring size (P=0.026) and preoperative renal failure (P=0.05) in the ICM group. Risk factors for death were larger ring size (P=0.02) and an increased LVEDD (P=0.027) in the DCM group and the postoperative use of IABP (P=0.002), renal failure (P=0.001), and a larger preoperative LVESD (P=0.035) in the ICM group. Conclusion: Mitral reconstruction with a posterior annuloplasty using a flexible ring is effective in patients with severely depressed left ventricle function and has an acceptable operative mortality. Mid-term results are superior to medical treatment alone and comparable to cardiac transplantatio

Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo

Background  Photodynamic therapy (PDT) with 5-aminolaevulinic acid (ALA) or its methylester [methyl-5-aminolaevulinate (MAL) or 5-amino-4-oxopentanoate] was recently ranked as first-line therapy for the treatment of actinic keratosis (AK) and is an accepted therapeutic option for the treatment of neoplastic skin diseases. BF-200 ALA (Biofrontera Bioscience GmbH, Leverkusen, Germany) is a gel formulation of ALA with nanoemulsion for the treatment of AK which overcomes previous problems of ALA instability and improves skin penetration. Objectives  To evaluate the efficacy and safety of PDT of AKs with BF-200 ALA in comparison with a registered MAL cream and with placebo. Methods  The study was performed as a randomized, multicentre, observer-blind, placebo-controlled, interindividual trial with BF-200 ALA, a registered MAL cream and placebo in a ratio of 3 : 3 : 1. Six hundred patients, each with four to eight mild to moderate AK lesions on the face and/or the bald scalp, were enrolled in 26 study centres in Germany, Austria and Switzerland. Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated. Results  PDT with BF-200 ALA was superior to placebo PDT with respect to patient complete clearance rate (78·2% vs. 17·1%; P < 0·0001) and lesion complete clearance rate (90·4% vs. 37·1%) at 3 months after the last PDT. Moreover, superiority was demonstrated over the MAL cream regarding the primary endpoint patient complete clearance (78·2% vs. 64·2%; P < 0·05). Significant differences in the patient and lesion complete clearance rates and severity of treatment-related adverse events were observed for the narrow- and broad-spectrum light sources. Conclusions  BF-200 ALA is a very effective, well-tolerated new formulation for AK treatment with PDT and is superior to a registered MAL medication. Efficacies and adverse events vary greatly with the different light sources used

Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo

Background  Photodynamic therapy (PDT) with 5-aminolaevulinic acid (ALA) or its methylester [methyl-5-aminolaevulinate (MAL) or 5-amino-4-oxopentanoate] was recently ranked as first-line therapy for the treatment of actinic keratosis (AK) and is an accepted therapeutic option for the treatment of neoplastic skin diseases. BF-200 ALA (Biofrontera Bioscience GmbH, Leverkusen, Germany) is a gel formulation of ALA with nanoemulsion for the treatment of AK which overcomes previous problems of ALA instability and improves skin penetration. Objectives  To evaluate the efficacy and safety of PDT of AKs with BF-200 ALA in comparison with a registered MAL cream and with placebo. Methods  The study was performed as a randomized, multicentre, observer-blind, placebo-controlled, interindividual trial with BF-200 ALA, a registered MAL cream and placebo in a ratio of 3 : 3 : 1. Six hundred patients, each with four to eight mild to moderate AK lesions on the face and/or the bald scalp, were enrolled in 26 study centres in Germany, Austria and Switzerland. Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated. Results  PDT with BF-200 ALA was superior to placebo PDT with respect to patient complete clearance rate (78·2% vs. 17·1%; P < 0·0001) and lesion complete clearance rate (90·4% vs. 37·1%) at 3 months after the last PDT. Moreover, superiority was demonstrated over the MAL cream regarding the primary endpoint patient complete clearance (78·2% vs. 64·2%; P < 0·05). Significant differences in the patient and lesion complete clearance rates and severity of treatment-related adverse events were observed for the narrow- and broad-spectrum light sources. Conclusions  BF-200 ALA is a very effective, well-tolerated new formulation for AK treatment with PDT and is superior to a registered MAL medication. Efficacies and adverse events vary greatly with the different light sources used