The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial

Background Current guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting (CABG) in patients undergoing surgical aortic valve replacement. However there is no consensus as to how best to treat coronary disease in high-risk patients requiring transcatheter aortic valve implantation (TAVI). Methods/Design The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial is a randomized, controlled open-label trial of 310 patients randomized to treatment of significant coronary artery disease by percutaneous coronary intervention (PCI - test arm) or no PCI (control arm). Significant coronary disease is defined as ≥1 lesion of ≥70% severity in a major epicardial vessel or 50% in a vein graft or protected left main stem lesion. The trial tests the hypothesis that the strategy of performing pre-TAVI PCI is non-inferior to not treating such coronary stenoses with PCI prior to TAVI, with a composite primary outcome of 12-month mortality and rehospitalization. Secondary outcomes include efficacy end-points such as 30-day mortality, safety endpoints including bleeding, burden of symptoms, and quality of life (assessed using the Seattle Angina Questionnaire and the Kansas City Cardiomyopathy Questionnaire). In conclusion, we hope that using a definition of coronary artery disease severity closer to that used in everyday practice by interventional cardiologists - rather than the 50% severity used in surgical guidelines - will provide robust evidence to direct guidelines regarding TAVI therapy and improve its safety and efficacy profile of this developing technique. Trial registration ISRCTN75836930, http://www.controlled-trials.com/ISRCTN75836930 (registered 19 November 2011)

Triple-Vessel Percutaneous Coronary Revascularization In Situs Inversus Dextrocardia

Dextrocardia with situs inversus occurs in approximately one in 10,000 individuals of whom 20% have primary ciliary dyskinesia inherited as an autosomal recessive trait. These patients have a high incidence of congenital cardiac disease but their risk of coronary artery disease is similar to that of the general population. We report what is, to our knowledge, the first case of total triple-vessel coronary revascularization by percutaneous stent implantation in a 79-year-old woman with situs inversus dextrocardia. We describe the successful use of standard diagnostic and interventional guide catheters with counter rotation and transversely inversed image acquisition techniques. The case also highlights that the right precordial pain may represent cardiac ischemia in this population

Appearance of microvascular obstruction on high resolution first-pass perfusion, early and late gadolinium enhancement CMR in patients with acute myocardial infarction

<p>Abstract</p> <p>Background</p> <p>The presence and extent of microvascular obstruction (MO) after acute myocardial infarction can be measured by first-pass gadolinium-enhanced perfusion cardiovascular magnetic resonance (CMR) or after gadolinium injection with early or late enhancement (EGE/LGE) imaging. The volume of MO measured by these three methods may differ because contrast agent diffusion into the MO reduces its apparent extent over time. Theoretically, first-pass perfusion CMR should be the most accurate method to measure MO, but this technique has been limited by lower spatial resolution than EGE and LGE as well as incomplete cardiac coverage. These limitations of perfusion CMR can be overcome using spatio-temporal undersampling methods. The purpose of this study was to compare the extent of MO by high resolution first-pass <it>k-t </it>SENSE accelerated perfusion, EGE and LGE.</p> <p>Methods</p> <p>34 patients with acute ST elevation myocardial infarction, treated successfully with primary percutaneous coronary intervention (PPCI), underwent CMR within 72 hours of admission. <it>k-t </it>SENSE accelerated first-pass perfusion MR (7 fold acceleration, spatial resolution 1.5 mm × 1.5 mm × 10 mm, 8 slices acquired over 2 RR intervals, 0.1 mmol/kg Gd-DTPA), EGE (14 minutes after injection with a fixed TI of 440 ms) and LGE images (1012 minutes after injection, TI determined by a Look-Locker scout) were acquired. MO volume was determined for each technique by manual planimetry and summation of discs methodology.</p> <p>Results</p> <p><it>k-t </it>SENSE first-pass perfusion detected more cases of MO than EGE and LGE (22 vs. 20 vs. 14, respectively). The extent of MO imaged by first-pass perfusion (median mass 4.7 g, IQR 6.7) was greater than by EGE (median mass 2.3 g, IQR 7.1, p = 0.002) and LGE (median mass 0.2 g, IQR 2.4, p = 0.0003). The correlation coefficient between MO mass measured by first-pass perfusion and EGE was 0.91 (p < 0.001).</p> <p>Conclusion</p> <p>The extent of MO following acute myocardial infarction appears larger on high-resolution first-pass perfusion CMR than on EGE and LGE. Given the inevitable time delay between gadolinium administration and acquisition of either EGE or LGE images, high resolution first-pass perfusion imaging may be the most accurate method to quantify MO.</p

Automated quantification of mitral valve geometry on multi-slice computed tomography in patients with dilated cardiomyopathy: Implications for transcatheter mitral valve replacement

Objectives The primary aim of this study was to quantify the dimensions and geometry of the mitral valve complex in patients with dilated cardiomyopathy and significant mitral regurgitation. The secondary aim was to evaluate the validity of an automated segmentation algorithm for assessment of the mitral valve compared to manual assessment on computed tomography. Background Transcatheter mitral valve replacement (TMVR) is an evolving technique which relies heavily on the lengthy evaluation of cardiac computed tomography (CT) datasets. Limited data is available on the dimensions and geometry of the mitral valve in pathological states throughout the cardiac cycle, which may have implications for TMVR device design, screening of suitable candidates and annular sizing prior to TMVR. Methods A retrospective study of 15 of patients with dilated cardiomyopathy who had undergone full multiphase ECG gated cardiac CT. A comprehensive evaluation of mitral valve geometry was performed at 10 phases of the cardiac cycle using the recommended D-shaped mitral valve annulus (MA) segmentation model using manual and automated CT interpretation platforms. Mitral annular dimensions and geometries were compared between manual and automated methods. Results Mitral valve dimensions in patients with dilated cardiomyopathy were similar to previously reported values (MAarea Diastole: 12.22 ± 1.90 cm2), with dynamic changes in size and geometry between systole and diastole of up to 5%. The distance from the centre of the MA to the left ventricular apex demonstrated moderate agreement between automated and manual methods (ρc = 0.90) with other measurements demonstrating poor agreement between the two methods (ρc = 0.75–0.86). Conclusions Variability of mitral valve annulus measurements are small during the cardiac cycle. Novel automated algorithms to determine cardiac cycle variations in mitral valve geometry may offer improved segmentation accuracy as well as improved CT interpretation times