Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry.

OBJECTIVES: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population. METHODS AND RESULTS: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates. CONCLUSION: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy.

Magnetic resonance assessment of myocardial perfusion via catheter-based ventricle-coronary vein bypass in porcine myocardial infarction model.

OBJECTIVE: The goal of this study was to investigate the efficacy of VPASS with physiological measurements, magnetic resonance imaging (MRI), and histology in a porcine model of myocardial infarction. BACKGROUND: A catheter-based ventricle-to-coronary vein bypass (VPASS) has been proposed as a potential treatment strategy for refractory coronary artery disease patients. METHODS: In an acute setting, the VPASS implant was deployed percutaneously in three swine. The partial pressure of oxygen (PO(2)) in the anterior interventricular vein (AIV) and left ventricle (LV) were measured before and after VPASS implant with various combinations of balloon occlusion in the AIV and left anterior descending artery (LAD). In a separate chronic study, the VPASS procedure was completed on three swine with a mid-LAD occlusion. Thirty days post-VPASS procedure, angiography, contrast-enhanced MRI, and histology were performed to assess myocardial viability. Perfusion was analyzed using the average percent signal intensity change (APSIC) in the anterior walls (AW) and inferior walls (IW). RESULTS: The VPASS implant was performed without complication. Post-VPASS implantation, the distal AIV PO(2) increased up to the LV PO(2) level during simultaneous AIV and LAD blockage (432 +/- 24 mmHg). At day 30, quantitative perfusion analysis demonstrated no difference in APSIC between AW and IW (125 +/- 26% vs. 137 +/- 38%, P = 0.46). Delayed enhancement and histology showed focal subendomyocardial infarction. CONCLUSIONS: VPASS implant with simultaneous AIV and LAD occlusion allows perfusion of oxygenated blood to the distal AIV, which in the setting of an acute myocardial infarction model was capable of rescuing most of the myocardium at risk.

CT measurement of coronary calcium mass: impact on global cardiac risk assessment.

Coronary calcium mass percentiles can be derived from electron beam CT as well as from multidetector-row CT of all manufacturers. Coronary calcium mass may serve as a more individualized substitute for age for cardiac risk stratification. The aim was to investigate the potential impact of CT coronary calcium mass quantification on cardiac risk stratification using an adjusted Framingham score. Standardized coronary calcium mass was determined by multidetector-row CT in a total of 1,473 patients (1,038 male, 435 female). The impact on risk stratification of replacing the traditional Framingham age point score by a point score based on calcium mass relative to age was tested. Any coronary calcium found in males in the age group of 20-34 years and females in the age group of 20-59 years results in an increase of the Framingham score by 9 and 4-7 points, respectively. Only in males 65 years of age and older, none or minimal amounts of coronary calcium decrease the Framingham score by three points. The coronary calcium mass and age-related scoring system may have impact on the reassignment of patients with an intermediate Framingham risk to a lower or higher risk group.

Assessment of myocardial infarctions using multidetector-row computed tomography.

OBJECTIVE: To evaluate the diagnostic power of contrast-enhanced multidetector-row computed tomography (MDCT) in assessing the presence, age, and size of myocardial infarctions. METHODS: One hundred six patients underwent standard MDCT coronary angiography without additional changes in the protocol. In all patients, a complete patient history and left heart catheterization with biplane contrast ventriculography were available. The MDCT images were reviewed for the presence and age of myocardial infarctions in a blinded fashion. Infarct areas were detected as regions of reduced uptake of contrast in the early arterial phase and/or regional wall thinning. Reviewing the computed tomography (CT) images, CT density values (Hounsfield units [HU]) were measured at the site of infarcted and noninfarcted myocardium, and a volumetric assessment of the infarct size was performed. RESULTS: In 27 of 106 patients, myocardial infarctions were present. Multidetector-row computed tomography detected 23 of 27 infarctions (sensitivity of 85%, specificity of 91%, and accuracy of 90%). Comparing the HU of infarcted versus noninfarcted myocardium, the mean HU of infarcted areas was 54 +/- 19 HU versus 117 +/- 28 HU for noninfarcted myocardium (P < 0.01). Multidetector-row computed tomography was able to differentiate between recent and chronic infarctions. The infarct volumes of recent infarctions (6.3 +/- 3.6 cm) showed a negative correlation to the ejection fraction (EF) according to contrast ventriculography (ie, the larger the infarct volumes as measured using MDCT, the worse was the EF [r = -0.72, P < 0.01]). CONCLUSIONS: Performing standard MDCT coronary angiography, areas of infarcted myocardium can be identified with moderate to high sensitivity, without additional scanning or contrast administration. Infarct localization can be assessed accurately as compared with cineventriculography. To some degree, infarct age and infarct volume can be estimated.

Direct stenting with the Bx VELOCITY balloon-expandable stent mounted on the Raptor rapid exchange delivery system versus predilatation in a European randomized Trial: the VELVET trial.

AIMS: This study examined the six-month angiographic results of direct coronary stenting, and compared the nine-month safety, efficacy and cost of this strategy versus stenting after balloon predilatation. METHODS: In phase I of VELVET, 122 patients (mean age = 62.3 +/- 10.1 years, 77% male, 11% with diabetes) with angina pectoris or myocardial ischemia resulting from a single de novo 51% to 95% coronary stenosis underwent direct stenting. The endpoints of phase I included angiographic findings and rates of major adverse cardiac events up to six months of follow-up. In phase II, 401 patients (mean age = 61.3 +/- 10.8 years, 79% male, 16% with diabetes) with angina pectoris or documented myocardial ischemia resulting from single or multiple, de novo or restenotic, coronary lesions were randomized between direct stenting and stenting after predilatation. The immediate angiographic results, and clinical outcomes and costs associated with the two treatment strategies up to nine months of follow-up were compared. RESULTS: In phase I the mean diameter stenosis immediately before and after the procedure, and at six months was 61.7+/-9.4%, 13.5+/-6.3%, and 33.6+/-16.2%, respectively. The six-month binary restenosis rate was 11%. The overall rate of major adverse cardiac events, including two non-cardiac deaths, was 9.8%. In phase II, the success rates of the intended delivery strategies were 87.9% and 97.9% for direct stenting and predilatation, respectively (p < 0.001), while the procedural success rates were similar (93.9% vs 96.5%). Over a follow-up period of nine months, major adverse cardiac events rates were 12.0% and 10.9% in patients randomized to direct stenting and predilatation, respectively (non-significant). Analyses of the costs incurred up to nine months in each treatment group revealed a mean saving of e362 per patient in favor of the direct stenting strategy (non-significant). CONCLUSIONS: Compared with a strategy of stenting preceded by balloon dilatation, direct stenting was associated with an equivalent procedural success rate, equivalent clinical results up to nine months of follow-up, and a reduction in procedural and in-hospital costs (p < 0.0001 and p < 0.001, respectively), that was no longer significant after nine months.