Med Biol Eng Comput. 2012; 50(1):53-59

Capelli C, Bosi GM, Cerri E, Nordmeyer J, Odenwald T, Bonhoeffer P, Migliavacca F, Taylor AM, Schievano S

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) enables treatment of aortic stenosis with no need for open heart surgery. According to current guidelines, only patients considered at high surgical risk can be treated with TAVI. In this study, patient-specific analyses were performed to explore the feasibility of TAVI in morphologies, which are currently borderline cases for a percutaneous approach.

METHODS: Five patients were recruited: four patients with failed bioprosthetic aortic valves (stenosis) and one patient with an incompetent, native aortic valve. Three-dimensional models of the implantation sites were reconstructed from computed tomography images. Within these realistic geometries, TAVI with an Edwards Sapien stent was simulated using finite element (FE) modelling. Engineering and clinical outcomes were assessed.

RESULTS: In all patients, FE analysis proved that TAVI was morphologically feasible. After the implantation, stress distribution showed no risks of immediate device failure and geometric orifice areas increased with low risk of obstruction of the coronary arteries. Maximum principal stresses in the arterial walls were higher in the model with native outflow tract.

CONCLUSIONS: FE analyses can both refine patient selection and characterise device mechanical performance in TAVI, overall impacting on procedural safety in the early introduction of percutaneous heart valve devices in new patient populations.

PMID: 22286953

J Am Coll Cardiol. 2012; 59(2):192-193

Kahlert P, Parohl N, Albert J, Schäfer L, Reinhardt R, Kaiser GM, McDougall I, Decker B, Plicht B, Erbel R, Eggebrecht H, Ladd ME, Quick HH

Real-time magnetic resonance imaging (rtMRI) is considered attractive for guiding transarterial aortic valve implantation (TAVI). Compared with X-ray fluoroscopy, rtMRI offers unrestricted scan plane orientation and an unsurpassed soft-tissue contrast with simultaneous device visualization, potentially allowing enhanced positioning accuracy together with online monitoring of cardiac function and immediate detection of complications. Additionally, MRI offers noninvasive assessment of cardiovascular anatomy and function for preinterventional screening as well as immediate morphologic and functional assessment of the implanted prothesis and may, thus, be envisioned as a single comprehensive imaging modality for TAVI. We, therefore, sought to assess the preclinical feasibility of entirely rtMRI-guided TAVI in a swine model (female domestic pigs weighing 70.5 to 86.5 kg) using the original CoreValve (Medtronic, Minneapolis, Minnesota) prosthesis without alterations in conjunction with a modified, MRI-compatible delivery device (1).

rtMRI-guided transfemoral (n = 2) and transsubclavian (n = 6) TAVI was performed in a 1.5-T whole-body MRI scanner (Magnetom Avanto, Siemens Healthcare Sector, Erlangen, Germany). Conventional x-ray fluoroscopy and angiography were performed for comparison. After pre-interventional evaluation using standard steady-state free-precession imaging with electrocardiographic gating and time-resolved retrospective image reconstruction (cine-TrueFISP retro) (TR, 40 ms; TE, 1.1 ms; flip angle, 62°; FOV, 380 x 330 mm2; matrix, 192 x 168; slice thickness, 6 mm; bandwidth, 930 Hz/pixel; image acquisition time, 15 s for a single slice acquired over 20 phases of the cardiac R-R interval) and electrocardiography-triggered, flow-sensitive, phase-contrast sequences (TR, 62 ms; TE, 3.5 ms; flip angle, 30°; FOV, 320 x 220 mm2; matrix, 192 x 132; bandwidth, 555 Hz/pixel; acquisition time, 1 min 52 s; velocity encoding value, 100 cm/s), TAVI was performed using rtMRI fluoroscopy based on a commercially available interactive real-time projection reconstruction TrueFISP sequence with radial k-space filling during free breathing and without cardiac triggering that was modified to achieve a frame rate of 7 frames per second (TR, 3.0 ms; TE, 1.5 ms; flip angle, 70°; FOV, 360 x 360 mm2; matrix, 192 x 192; bandwidth, 1530 Hz/pixel; slice thickness, 6 mm). Images were displayed without delay inside the scanner room and could be adapted interactively according to the operator’s (P.K.) needs while the sequence was running. After TAVI, real-time TrueFISP, cine-TrueFISP retro, and flow-sensitive phase-contrast sequences were used to verify procedural success. Autopsies were performed to validate MRI findings.

Three-point localizer sequences allowed for rapid detection (11 ± 3 min) of all scan planes required for preinterventional evaluation, procedural guidance, and post-procedural validation. High-resolution TrueFISP retro sequences enabled detailed visualization of all procedurally relevant anatomic landmarks and allowed precise measurements (aortic annulus diameter in long axis, 17 ± 3 mm; aortic arch diameter, 21 ± 4 mm; distance from aortic annulus to left and right coronary ostium, 9 ± 3 and 10 ± 2 mm; access vessel diameter, 6.9 ± 1.2 mm) in good accordance with measurements on previous angiographic images (mean error, 0.4 ± 0.3 mm; p = NS) and during autopsy (mean error, 0.5 ± 0.2 mm; p = NS).

Passive device visualization using real-time TrueFISP sequences provided reliable imaging guidance during TAVI superior to fluoroscopy. Mild susceptibility artifacts confined to the loaded stent valve enabled adequate determination of the position of stent valve and delivery system in relation to the surrounding anatomy without undue image distortion, allowing a precise, real-time anatomic orientation during device navigation through the vasculature, aortic valve passage, positioning and deployment of the prosthesis, and catheter withdrawal.

In 6 of 8 animals, an oversized 26-mm CoreValve prosthesis was successfully placed across the aortic annulus without dislocation, coronary artery obstruction, or impairment of the mitral valve, as confirmed by autopsy (rtMRI acquisition time, 4 ± 2 min) (Fig. 1). However, 2 implant failures occurred. The first was a result of unsuccessful aortic arch passage due to insufficient support by the initially used MRI-compatible, soft polymer guidewire and led to a controlled deployment of the stent valve in the thoracic aorta, which is sometimes required in clinical application when the prosthesis dislocates into the ascending aorta during deployment. As a consequence, we continued our experiments without guidewire support and focused on the straighter transsubclavian access route. The second implant failure occurred due to perforation of the left ventricular apex caused by the delivery device, which was inadvertently pushed with too much force, this complication being immediately detected by rtMRI. Both cases indicate that rtMRI might improve both precision and safety of the TAVI procedure.

Postprocedural TrueFISP retro sequences allowed precise structural evaluation of the procedural result in good accordance with autopsy findings. Flow-sensitive, electrocardiography-triggered, phase-contrast sequences with imaging planes placed approximately 1 cm below and above the nitinol stent frame confirmed good systolic transvalvular blood flow without diastolic regurgitation. The current study demonstrates the preclinical feasibility of entirely MRI-guided TAVI. As a single imaging modality, MRI offered comprehensive diagnostic evaluation of the relevant cardiac and vascular anatomy for adequate interventional planning, real-time procedural guidance with excellent anatomic orientation, immediate evaluation of procedure-related complications, and post-interventional validation of treatment success with a total procedure time of 61 ± 13 min. Complementary to reduction of radiation exposure and nephrotoxic contrast media, rtMRI guidance, therefore, provides clinically relevant advantages over conventional X-ray-fluoroscopy and warrants further attention. These advantages should encourage future efforts to translate rtMRI-guided TAVI into clinical application using commercial but modified or entirely novel devices (2,3) and to overcome remaining obstacles such as the development of suitable, MRI-compatible guidewires.

PMID: 22222083

Int J Cardiovasc Imaging. 2012; 27(8):1123-1132

Huisman J, Egede R, Rdzanek A, Böse D, Erbel R, Kochman J, Jensen LO, van der Palen J, Hartmann M, Mintz GS, von Birgelen C

OBJECTIVES: To assess in a multicenter design the between-center reproducibility of volumetric virtual histology intravascular ultrasound (VH-IVUS) measurements with a semi-automated, computer-assisted contour detection system in coronary lesions that were consecutively stented.

METHODS: 4 European IVUS centers performed independent analyses (in total 8,052 cross-sectional analyses) to obtain volumetric data of 40 coronarysegments (length 20.0 ± 0.3 mm) from target lesions prior to percutaneous intervention that were performed in the setting of stable (65%) or unstable angina pectoris (35%).

RESULTS: Geometric and compositional VH-IVUS measurements were highly correlated for the different comparisons. Overall intraclass correlation for vessel, lumen, plaque volume and plaque burden was 0.99, 0.92, 0.96, and 0.83, respectively; for fibrous, fibro-lipidic, necrotic core and calcified volumes overall intraclass correlation was 0.96, 0.94, 0.98, and 0.99, respectively. Nevertheless, significant differences for both geometrical and compositional measurements were seen. Of the plaque components, fibrous tissue and necrotic core showed on average the highest measurement reproducibility.

CONCLUSIONS: A central analysis for VH-IVUS multicenter studies of lesions prior to PCI should be pursued. Moreover, it may be problematical to pool VH-IVUS data of individual trials analyzed by independent centers.

PMID: 22246064

Circ J. 2012; 125(3):474-481

Kume T, Okura H, Miyamoto Y, Yamada R, Saito K, Tamada T, Koyama T, Neishi Y, Hayashida A, Kawamoto T, Yoshida K

OBJECTIVES: The clinical impact of stent edge dissection, tissue protrusion, and incomplete stent apposition (ISA) after stent implantation, detectable only on optical coherence tomography (OCT), is still unknown because the natural course has not been investigated.

METHODS: All consecutive patients with angina pectoris in whom both intravascular ultrasound (IVUS) and OCT were performed immediately after stenting and at follow-up were included in the present study. The natural history of OCT-detected stent edge dissection, tissue protrusion, and ISA during follow-up was investigated.

RESULTS: A total of 36 patients with 39 lesions was analyzed. At baseline, OCT showed 12 stent edge dissections, 25 tissue protrusions, and 8 ISAs, whereas IVUS demonstrated 6 stent edge dissections, 5 tissue protrusions, and 3 ISAs. All IVUS findings were clearly visualized on OCT. The maximum length of dissection flap and depth of ISA visualized on OCT were significantly shorter than those visualized on IVUS. Maximum length of tissue protrusion tended to be smaller on OCT than on IVUS. At follow-up (median 188 days), all findings noted on OCT were healed or resolved without any restenosis or thrombus formation.

CONCLUSIONS: Acute findings after stenting, such as edge dissection, tissue protrusion, and ISA, detectable only on OCT, tended to be smaller than those seen on both OCT and IVUS. The majority of OCT-detected acute findings resolved completely at follow-up.

PMID: 22251751

J Am Coll Cardiol. 2012; 59(2):119-127

Hamdan A, Guetta V, Konen E, Goitein O, Segev A, Raanani E, Spiegelstein D, Hay I, Di Segni E, Eldar M, Schwammenthal E

OBJECTIVES: The purpose of this study was to assess deformation dynamics and in vivo mechanical properties of the aortic annulus throughout the cardiac cycle. Understanding dynamic aspects of functional aortic valve anatomy is important for beating-heart transcatheter aortic valve implantation.

METHODS: Thirty-five patients with aortic stenosis and 11 normal subjects underwent 256-slice computed tomography. The aortic annulus plane was reconstructed in 10% increments over the cardiac cycle. For each phase, minimum diameter, ellipticity index, cross-sectional area (CSA), and perimeter (Perim) were measured. In a subset of 10 patients, Young’s elastic module was calculated from the stress-strain relationship of the annulus.

RESULTS: In both subjects with normal and with calcified aortic valves, minimum diameter increased in systole (12.3 ± 7.3% and 9.8 ± 3.4%, respectively; p < 0.001), and ellipticity index decreased (12.7 ± 8.8% and 10.3 ± 2.7%, respectively; p < 0.001). The CSA increased by 11.2 ± 5.4% and 6.2 ± 4.8%, respectively (p < 0.001). Perim increase was negligible in patients with calcified valves (0.56 ± 0.85%; p < 0.001) and small even in normal subjects (2.2 ± 2.2%; p = 0.01). Accordingly, relative percentage differences between maximum and minimum values were significantly smallest for Perim compared with all other parameters. Young’s modulus was calculated as 22.6 ± 9.2 MPa in patients and 13.8 ± 6.4 MPa in normal subjects.

CONCLUSIONS: The aortic annulus, generally elliptic, assumes a more round shape in systole, thus increasing CSA without substantial change in perimeter. Perimeter changes are negligible in patients with calcified valves, because tissue properties allow very little expansion. Aortic annulus perimeter appears therefore ideally suited for accurate sizing in transcatheter aortic valve implantation.

PMID: 22222074

Circ Cardiovasc Imaging. 2012; 5(1):12-20

White JA, Fine NM, Gula L, Yee R, Skanes A, Klein G, Leong-Sit P, Warren H, Thompson T, Drangova M, Krahn A

OBJECTIVES: Sudden cardiac death (SCD) and sustained monomorphic ventricular tachycardia (SMVT) are frequently associated with prior or acute myocardial injury. Cardiovascular magnetic resonance (CMR) provides morphological, functional, and tissue characterization in a single setting. We sought to evaluate the diagnostic yield of CMR-based imaging versus non-CMR-based imaging in patients with resuscitated SCD or SMVT.

METHODS: Eighty-two patients with resuscitated SCD or SMVT underwent routine non-CMR imaging, followed by a CMR protocol with comprehensive tissue characterization. Clinical reports of non-CMR imaging studies were blindly adjudicated and used to assign each patient to 1 of 7 diagnostic categories. CMR imaging was blindly interpreted using a standardized algorithm used to assign a patient diagnosis category in a similar fashion. The diagnostic yield of CMR-based and non-CMR-based imaging, as well as the impact of the former on diagnosis reclassification, was established.

RESULTS: Relevant myocardial disease was identified in 51% of patients using non-CMR-based imaging and in 74% using CMR-based imaging (P=0.002). Forty-one patients (50%) were reassigned to a new or alternate diagnosis using CMR-based imaging, including 15 (18%) with unsuspected acute myocardial injury. Twenty patients (24%) had no abnormality by non-CMR imaging but showed clinically relevant myocardial disease by CMR imaging.

CONCLUSIONS: CMR-based imaging provides a robust diagnostic yield in patients presenting with resuscitated SCD or SMVT and incrementally identifies clinically unsuspected acute myocardial injury. When compared with non-CMR-based imaging, a new or alternate myocardial disease process may be identified in half of these patients.

PMID: 22038987

Eur J Echocardiogr. 2012; 13(1):79-85

Joutsiniemi E, Saraste A, Pietilä M, Ukkonen H, Kajander S, Mäki M, Koskenvuo J, Airaksinen J, Hartiala J, Saraste M, Knuuti J

OBJECTIVES: Accelerated flow at the site of flow-limiting stenosis can be detected by transthoracic Doppler echocardiography (TTDE). We studied feasibility and accuracy of sequential coronary computed tomography angiography (CTA) and TTDE in detection of haemodynamically significant coronary artery disease (CAD).

METHODS: We prospectively enrolled 107 patients with intermediate (30-70%) pre-test likelihood of CAD. All patients underwent CTA using a 64-slice scanner. Using TTDE, the ratio of maximal diastolic flow velocity to pre-stenotic flow velocity (M/P ratio) was measured in the coronary segments with stenosis in CTA. In all patients, the results were compared with invasive coronary angiography, including measurement of fractional flow reserve when appropriate. All analyses were done blinded.

RESULTS: TTDE was feasible in 276 of 285 evaluated coronary segments. Significant coronary stenoses were associated with a higher M/P ratio than non-significant stenoses (3.59 ± 1.82 vs. 1.28 ± 0.60, P < 0.001). The optimal M/P ratio for detection of significant stenosis was 2.2 (area under receiver operating characteristic curve 0.92, P < 0.001). Compared with the strategy of CTA alone, sequential CTA and focused TTDE had a better positive predictive value (PPV; 61 vs. 78%) and diagnostic accuracy (93 vs. 96%, P = 0.006) without impairment of the negative predictive value (97 vs. 97%).

CONCLUSIONS: Sequential use of CTA and TTDE is feasible for combined anatomic and functional evaluation of coronary stenoses. Compared with coronary CTA alone, addition of TTDE improved PPV for detection of significant CAD.

PMID: 21880607

J Am Coll Cardiol. 2012; 59(5):462-474

Rory Hachamovitch, Benjamin Nutter, Mark A. Hlatky, Leslee J. Shaw, Michael L. Ridner, Sharmila Dorbala, Rob S.B. Beanlands, Benjamin J.W. Chow, Elizabeth Branscomb, Panithaya Chareonthaitawee, W. Guy Weigold, Szilard Voros, Suhny Abbara, Tsunehiro Yasuda, Jill E. Jacobs, John Lesser, Daniel S. Berman, Louise E.J. Thomson, Subha Raman, Gary V. Heller, Adam Schussheim, Richard Brunken, Kim A. Williams, Susan Farkas, Dominique Delbeke, Uwe J. Schoepf, Nathaniel Reichek, Stuart Rabinowitz, Steven R. Sigman, Randall Patterson, Carolyn R. Corn, Richard White, Ella Kazerooni, James Corbett, Sabahat Bokhari, Josef Machac, Erminia Guarneri, Salvador Borges-Neto, John W. Millstine, James Caldwell, James Arrighi, Udo Hoffmann, Matthew Budoff, Joao Lima, James R. Johnson, Barbara Johnson, Mariya Gaber, Julie A. Williams, Courtney Foster, Jon Hainer, Marcelo F. Di Carli SPARC Investigators

OBJECTIVES: This study examined short-term cardiac catheterization rates and medication changes after cardiac imaging. Noninvasive cardiac imaging is widely used in coronary artery disease, but its effects on subsequent patient management are unclear.

METHODS: We assessed the 90-day post-test rates of catheterization and medication changes in a prospective registry of 1,703 patients without a documented history of coronary artery disease and an intermediate to high likelihood of coronary artery disease undergoing cardiac single-photon emission computed tomography, positron emission tomography, or 64-slice coronary computed tomography angiography.

RESULTS: Baseline medication use was relatively infrequent. At 90 days, 9.6% of patients underwent catheterization. The rates of catheterization and medication changes increased in proportion to test abnormality findings. Among patients with the most severe test result findings, 38% to 61% were not referred to catheterization, 20% to 30% were not receiving aspirin, 35% to 44% were not receiving a beta-blocker, and 20% to 25% were not receiving a lipid-lowering agent at 90 days after the index test. Risk-adjusted analyses revealed that compared with stress single-photon emission computed tomography or positron emission tomography, changes in aspirin and lipid-lowering agent use was greater after computed tomography angiography, as was the 90-day catheterization referral rate in the setting of normal/nonobstructive and mildly abnormal test results.

CONCLUSIONS: Overall, noninvasive testing had only a modest impact on clinical management of patients referred for clinical testing. Although post-imaging use of cardiac catheterization and medical therapy increased in proportion to the degree of abnormality findings, the frequency of catheterization and medication change suggests possible undertreatment of higher risk patients. Patients were more likely to undergo cardiac catheterization after computed tomography angiography than after single-photon emission computed tomography or positron emission tomography after normal/nonobstructive and mildly abnormal study findings.

PMID:

JACC: Cardiovascular Imaging. 2012; 5(1):15-24

Thavendiranathan P, Verhaert D, Walls MC, Bender JA, Rajagopalan S, Chung Y-C, Simonetti OP, Raman SV

PMID: 22239888

Circ Cardiovasc Imaging. 2012; 5(1):147-154

Truong QA, Massaro JM, Rogers IS, Mahabadi AA, Kriegel MF, Fox CS, O'Donnell CJ, Hoffmann U

OBJECTIVES: Main pulmonary artery diameter (mPA) and ratio of mPA to ascending aorta diameter (ratio PA) derived from chest CT are commonly reported in clinical practice. We determined the age- and sex-specific distribution and normal reference values for mPA and ratio PA by CT in an asymptomatic community-based population.

METHODS: In 3171 men and women (mean age, 51±10 years; 51% men) from the Framingham Heart Study, a noncontrast, ECG-gated, 8-slice cardiac multidetector CT was performed. We measured the mPA and transverse axial diameter of the ascending aorta at the level of the bifurcation of the right pulmonary artery and calculated the ratio PA. We defined the healthy referent cohort (n=706) as those without obesity, hypertension, current and past smokers, chronic obstructive pulmonary disease, history of pulmonary embolism, diabetics, cardiovascular disease, and heart valve surgery.

RESULTS: The mean mPA diameter in the overall cohort was 25.1±2.8 mm and mean ratio PA was 0.77±0.09. The sex-specific 90th percentile cutoff value for mPA diameter was 28.9 mm in men and 26.9 mm in women and was associated with increase risk for self-reported dyspnea (adjusted odds ratio, 1.31; P=0.02). The 90th percentile cutoff value for ratio PA of the healthy referent group was 0.91, similar between sexes but decreased with increasing age (range, 0.82-0.94), though not associated with dyspnea.

CONCLUSIONS: For simplicity, we established 29 mm in men and 27 mm in women as sex-specific normative reference values for mPA and 0.9 for ratio PA.

PMID: 22178898