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

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

JACC Cardiovasc Interv. 2011; 4(11):1175-1182

Muller O, Mangiacapra F, Ntalianis A, Verhamme KM, Trana C, Hamilos M, Bartunek J, Vanderheyden M, Wyffels E, Heyndrickx GR, van Rooij FJ, Witteman JC, Hofman A, Wijns W, Barbato E, De Bruyne B

OBJECTIVES: This study sought to evaluate the long-term clinical outcome of patients with an angiographically intermediate left anterior descending coronary artery (LAD) stenosis in whom the revascularization strategy was based on fractional flow reserve (FFR). When revascularization is based mainly on angiographic guidance, a number of hemodynamically nonsignificant stenoses will be revascularized.

METHODS: In 730 patients with a 30% to 70% isolated stenosis in the proximal LAD and no significant valvular disease, FFR measurements were obtained to guide treatment strategy. When FFR was ≥ 0.80, the patients (n = 564) were treated medically (medical group); when FFR was <0.80, the patients (n = 166) underwent a revascularization procedure (revascularization group; 13% coronary artery bypass graft surgery and 87% percutaneous coronary intervention). A 100% long-term clinical follow-up (median follow-up: 40 months) was obtained. The 5-year survival of the medical group was compared with that of a reference population. For each patient, 4 controls were selected from an age- and sex-matched control population.

RESULTS: The 5-year survival estimate was 92.9% in the medical group versus 89.6% in the controls (p = 0.74). The mean diameter stenosis was significantly smaller in the medical than in the revascularization group (39 ± 14% vs. 54 ± 13%, p < 0.0001), but there was a large overlap between both groups. The 5-year event-free survival estimates (death, myocardial infarction, and target vessel revascularization) were 89.7% and 68.5%, respectively (p < 0.0001).

CONCLUSIONS: Medical treatment of patients with a hemodynamically nonsignificant stenosis (FFR ≥ 0.80) in the proximal LAD is associated with an excellent long-term clinical outcome with survival at 5 years similar to an age- and sex-matched control population.

PMID: 22035875

J Am Coll Cardiol . 2012; 59(3):235-243

Lancellotti P, Magne J, Donal E, Davin L, O'Connor K, Rosca M, Catherine Szymanski, Cosyns B, Piérard LA

OBJECTIVES: This study examined the clinical course of patients with asymptomatic severe aortic stenosis (AS) according to the new proposed aortic valve stenosis grading classification. The management of patients with asymptomatic severe AS remains controversial. Moreover, under the same denomination of severe AS, several entities might be identified according to transvalvular flow rates and pressure gradients, resulting in 4 flow-gradient patterns.

METHODS: Transthoracic echocardiography and measurement of B-type natriuretic peptide level from venous blood sample were performed in 150 consecutive patients with asymptomatic severe AS and normal exercise test. Patients were classified in 4 groups, depending on left ventricular flow state (normal flow [NF] vs. low flow [LF]: 35 ml/m2) and pressure gradient levels (low gradient [LG] vs. high gradient [HG]: 40 mm Hg).

RESULTS: Patients with NF/LG had significantly lower B-type natriuretic peptide than those with LF/HG and LF/LG. The mean follow-up was 27 ± 12 months. At 2 years, cardiac event-free survival was 83 ± 6%, 44 ± 6%, 30 ± 12%, and 27 ± 13% in NF/LG, NF/HG, LF/HG, and LF/LG groups, respectively (p < 0.0001). On multivariable analysis, LF/LG (hazard ratio [HR]: 5.26, 95% confidence interval [CI]: 2.04 to 14.3, p = 0.045) and LF/HG (HR: 2.38, 95% CI: 1.02 to 5.55, p = 0.001) were identified as strong independent determinants of poor prognosis as compared with NF/HG. By limiting the multivariable analysis to patients with LF, LF/LG was an independent predictor of markedly reduced cardiac event-free survival when compared with LF/HG (HR: 5.4, 95% CI: 1.03 to 28.6, p = 0.046).

CONCLUSIONS: The use of the new proposed AS grading classification integrating valve area and flow-gradient patterns allows a better characterization of the clinical outcome of patients with asymptomatic severe AS.

PMID:

Eur Heart J. 2011; 33(1):15-23

Ko BS, Cameron JD, Meredith IT, Leung M, Antonis PR, Nasis A, Crossett M, Hope SA, Lehman SJ, Troupis J, Defrance T, Seneviratne SK

PMID: 21810860

Eur Heart J. 2011; 33(1):26-35

Uemura S, Ishigami KI, Soeda T, Okayama S, Sung JH, Nakagawa H, Somekawa S, Takeda Y, Kawata H, Horii M, Saito Y

OBJECTIVES:  Morphological characteristics of non-significant coronary plaques (NSCPs) that develop rapid progression have not been fully elucidated. The aim of this study was to clarify the morphological characteristics of NSCPs in patients with coronary artery disease (CAD) using intravascular optical coherence tomography (OCT).

METHODS:  Fifty-three consecutive CAD patients undergoing percutaneous coronary intervention were enrolled and 69 NSCPs (per cent diameter stenosis <50%) were identified on baseline angiogram. Baseline characteristics of NSCPs were evaluated by OCT, and patients were followed-up prospectively. At the second coronary angiography, the baseline OCT characteristics and plaque progression were correlated.

RESULTS: During the 7-month follow-up period, 13 NSCPs showed angiographic progression and 56 NSCPs did not. Baseline minimum lumen diameter and diametric stenosis were similar between NSCPs with and without progression. Compared with NSCPs without progression, those with progression showed a significantly higher incidence of intimal laceration (61.5 vs. 8.9%, P < 0.01), microchannel (76.9 vs. 14.3%, P < 0.01), lipid pools (100 vs. 60.7%, P = 0.02), thin-cap fibroatheroma (TCFA) (76.9 vs. 14.3%, P < 0.01), macrophage images (61.5 vs. 14.3%, P < 0.01), and intraluminal thrombi (30.8 vs. 1.8%, P < 0.01). Univariate regression analysis showed that TCFA and microchannel images showed high correlation with subsequent luminal progression [odds ratio (OR): 20.0, P < 0.01 and OR: 20.0, P < 0.01, respectively].

CONCLUSIONS: Optical coherence tomography-based complex characteristics of TCFA and microchannel were the potential predictors of subsequent progression of NSCPs in patients with CAD.

PMID: 21831910

Int J Cardiovasc Imaging. 2011; 27(8):1198-1205

Park EA, Lee W, Kim KW, Kim KG, Thomas A, Chung JW, Park JH

OBJECTIVES: To assess the image quality and radiation dose of low-dose dual-source CT (DSCT) coronary angiography reconstructed using iterativereconstruction in image space (IRIS), in comparison with routine-dose CT using filtered back projection (FBP).

METHODS: Eighty-one patients underwent low-dose coronary DSCT using IRIS with two protocols: (a)100 kVp and 200 mAs per rotation for body mass index (BMI) < 25 (group I), (b)100 kVp and 320 mAs for BMI ≥ 25 (II). For comparison, two sex-and BMI-matched groups using standard protocols with FBP were selected: (a)100 kVp and 320 mAs for BMI < 25 (III), (b)120 kVp and 320 mAs for BMI ≥ 25 (IV). Image noise, signal to noise ratio (SNR) and modulation transfer function (MTF) 50% were objectively calculated. Two blinded readers then subjectively graded the image quality. Radiation dose was also measured.

RESULTS: Image noise tended to be lower in IRIS of low-dose protocols: 22.0 ± 4.5 for group I versus 24.8 ± 4.0 for III (P < 0.001); 20.9 ± 4.5 for II versus 21.6 ± 4.9 for IV (P = 0.6). SNR was better with IRIS: 25.8 ± 4.4 for I versus 22.7 ± 4.6 for III (P < 0.001); 24.6 ± 5.4 for II versus 18.7 ± 4.5 for IV (P < 0.001). No differences in MTF 50% or image quality scores were seen between each two groups (P > 0.05). Radiation reduction was 40% for I and 51% for II, compared to standard protocols.

CONCLUSIONS: Compared with routine-dose CT using FBP, low-dose coronary angiography using IRIS provides significant radiation reduction without impairment to image quality.

PMID: 22187198

Radiology. 2012; 262(1):101-108

Lee HJ, Hong YJ, Kim HY, Lee J, Hur J, Choi BW, Chang HJ, Nam JE, Choe KO, Kim YJ

OBJECTIVES: To classify anomalous origins of the right coronary artery (RCA) from the left coronary sinus (AORL) with an interarterial course into two subtypes and to evaluate the clinical importance of each.

METHODS: Institutional review board approval was obtained for this retrospective study, and informed consent was waived. Through a retrospective review of 22 925 consecutive cardiac computed tomographic (CT) scans, 124 cases of AORL with an interarterial course were identified. These anomalies were classified into two subtypes according to the location of the anomalous RCA ostium: high interarterial course (between the aorta and the pulmonary artery) and low interarterial course (between the aorta and the right ventricular outflow tract). The clinical records were evaluated, and differences in prevalence of typical angina and major adverse cardiac events (MACEs) between the subtypes were analyzed through the χ(2) contingency tables or Fisher exact test.

RESULTS: After excluding patients with combined cardiac disease, 87 patients (51 [59%] men, 36 [41%] women; mean age, 56.0 years) were enrolled. Of the 87 patients, 53 had a high interarterial course and 34 had a low interarterial course. A significant difference in the prevalence of typical angina (high [43%] vs low [6%], P = .001) and MACE (high [28%] vs low [6%], P = .012) was observed between the two subtypes. For patients with a high interarterial course, the odds ratio for typical angina was 12.3 (95% confidence interval: 2.7, 56.6), and the odds ratio for MACE was 6.3 (95% confidence interval: 1.3, 29.7).

CONCLUSIONS: The prevalence of typical angina and that of MACE were significantly higher in patients with a high interarterial course than in those with a low interarterial course.

PMID: 22056684