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Patient-Specific Simulations of Transcatheter Aortic Valve Stent Implantation

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

Real-Time Magnetic Resonance Imaging-Guided Transarterial Aortic Valve Implantation In-Vivo Evaluation in Swine

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

Multicenter Assessment of the Reproducibility of Volumetric Radiofrequency-Based Intravascular Ultrasound Measurements in Coronary Lesions that Were Consecutively Stented

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

Resting Coronary Flow Velocity in the Functional Evaluation of Coronary Artery Stenosis: Study on Sequential Use of Computed Tomography Angiography and Transthoracic Doppler Echocardiography

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

Long-Term Follow-Up After Fractional Flow Reserve-Guided Treatment Strategy in Patients With an Isolated Proximal Left Anterior Descending Coronary Artery Stenosis

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

Clinical Outcome in Asymptomatic Severe Aortic Stenosis

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:

Computed Tomography Stress Myocardial Perfusion Imaging in Patients Considered for Revascularization: A Comparison With Fractional Flow Reserve

OBJECTIVES:  Adenosine stress computed tomography myocardial perfusion imaging (CTP) is an emerging non-invasive method for detecting myocardialischaemia. Its value when compared with fractional flow reserve (FFR), a highly accurate index of ischaemia, is unknown. Our aim was to determine the diagnostic accuracy of CTP and its incremental value when used with computed tomography coronary angiography (CTA) for detecting ischaemia compared with FFR.

METHODS: Forty-two patients (126 vessel territories), who had at least one ≥50% angiographic stenosis on invasive angiography considered for non-urgent revascularization, were included and underwent FFR and CT assessment, including CTP, delayed contrast enhancement scan and CTA all acquired using 320-detector row CT, and prospective ECG gating.

RESULTS: Fractional flow reserve was determined in 86 territories subtended by vessels with ≥50% stenosis upon visual assessment. Fractional flow reserve ≤0.8 was considered to indicate significant ischaemia. Computed tomography myocardial perfusion imaging correctly identified 31/41 (76%) ischaemic territories and 38/45 (84%) non-ischaemic territories. Per-vessel territory sensitivity, specificity, positive, and negative predictive values of CTP were 76, 84, 82, and 79%, respectively. The combination of a ≥50% stenosis on CTA and perfusion defect on CTP was 98% specific for ischaemia, while the presence of <50% stenosis on CTA and normal perfusion on CTP was 100% specific for exclusion of ischaemia. Mean radiation for CTP and combined CT was 5.3 and 11.3 mSv, respectively.

CONCLUSIONS: Computed tomography myocardial perfusion imaging is moderately accurate in identifying perfusiondefects associated with ischaemia as assessed by FFR in patients considered for revascularization. In territories, where CTA and CTP are concordant, CTA/CTP is highly accurate in the detection and exclusion of ischaemia. This is achievable with acceptable radiation exposure using 320-detector row CT and prospective ECG gating.

PMID: 21810860

Thin-Cap Fibroatheroma and Microchannel Findings in Optical Coherence Tomography Correlate With Subsequent Progression of Coronary Atheromatous Plaques

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

Iterative Reconstruction of Dual-Source Coronary CT Angiography: Assessment of Image Quality and Radiation Dose

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

Anomalous Origin of the Right Coronary Artery from the Left Coronary Sinus With an Interarterial Course: Subtypes and Clinical Importance

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

Cardiovascular Magnetic Resonance and Single-Photon Emission Computed Tomography for Diagnosis of Coronary Heart Disease (CE-MARC): A Prospective Trial

OBJECTIVES: In patients with suspected coronary heart disease, single-photon emission computed tomography (SPECT) is the most widely used test for the assessment of myocardial ischaemia, but its diagnostic accuracy is reported to be variable and it exposes patients to ionising radiation. The aim of this study was to establish the diagnostic accuracy of a multiparametric cardiovascular magnetic resonance (CMR) protocol with x-ray coronary angiography as the reference standard, and to compare CMR with SPECT, in patients with suspected coronary heart disease.

METHODS: In this prospective trial patients with suspected angina pectoris and at least one cardiovascular risk factor were scheduled for CMR, SPECT, and invasive x-ray coronary angiography. CMR consisted of rest and adenosine stress perfusion, cine imaging, late gadolinium enhancement, and MR coronary angiography. Gated adenosine stress and rest SPECT used 99mTc tetrofosmin. The primary outcome was diagnostic accuracy of CMR.

RESULTS: In the 752 recruited patients, 39% had significant CHD as identified by x-ray angiography. For multiparametric CMR the sensitivity was 86·5% (95% CI 81·8—90·1), specificity 83·4% (79·5—86·7), positive predictive value 77·2%, (72·1—81·6) and negative predictive value 90·5% (87·1—93·0). The sensitivity of SPECT was 66·5% (95% CI 60·4—72·1), specificity 82·6% (78·5—86·1), positive predictive value 71·4% (65·3—76·9), and negative predictive value 79·1% (74·8—82·8). The sensitivity and negative predictive value of CMR and SPECT differed significantly (p<0·0001 for both) but specificity and positive predictive value did not (p=0·916 and p=0·061, respectively).

CONCLUSIONS: CE-MARC is the largest, prospective, real world evaluation of CMR and has established CMR’s high diagnostic accuracy in coronary heart disease and CMR’s superiority over SPECT. It should be adopted more widely than at present for the investigation of coronary heart disease.

PMID:

Survival After Open Versus Endovascular Thoracic Aortic Aneurysm Repair in an Observational Study of the Medicare Population

OBJECTIVES: The goal of this study was to describe short- and long-term survival of patients with descending thoracic aortic aneurysms (TAAs) after open and endovascular repair (TEVAR).

METHODS: Using Medicare claims from 1998 to 2007, we analyzed patients who underwent repair of intact and ruptured TAA, identified from a combination of procedural and diagnostic International Classification of Disease, ninth revision, codes. Our main outcome measure was mortality, defined as perioperative mortality (death occurring before hospital discharge or within 30 days), and 5-year survival, from life-table analysis. We examined outcomes across repair type (open repair or TEVAR) in crude, adjusted (for age, sex, race, procedure year, and Charlson comorbidity score), and propensity-matched cohorts.

RESULTS: Overall, we studied 12 573 Medicare patients who underwent open repair and 2732 patients who underwent TEVAR. Perioperative mortality was lower in patients undergoing TEVAR compared with open repair for both intact (6.1% versus 7.1%; P=0.07) and ruptured (28% versus 46%; P<0.0001) TAA. However, patients with intact TAA selected for TEVAR had significantly worse survival than open patients at 1 year (87% for open, 82% for TEVAR; P=0.001) and 5 years (72% for open; 62% for TEVAR; P=0.001). Furthermore, in adjusted and propensity-matched cohorts, patients selected for TEVAR had worse 5-year survival than patients selected for open repair.

CONCLUSIONS: Although perioperative mortality is lower with TEVAR, Medicare patients selected for TEVAR have worse long-term survival than patients selected for open repair. The results of this observational study suggest that higher-risk patients are being offered TEVAR and that some do not benefit on the basis of long-term survival. Future work is needed to identify TEVAR candidates unlikely to benefit from repair.

PMID: 22104552

Percutaneous Transvenous Melody Valve-in-Ring Procedure for Mitral Valve Replacement

OBJECTIVES: The purpose of this study was to demonstrate the feasibility of percutaneous transvenous mitral valve-in-ring (VIR) implantation using the Melody valve in an ovine model. The recurrence of mitral regurgitation following surgical mitral valve (MV) repair in both adult and pediatric patients remains a significant clinical problem. Mitral annuloplasty rings are commonly used in MV repair procedures and may serve as secure landing zones for percutaneous valves.

METHODS: Five sheep underwent surgical MV annuloplasty (24 mm, n = 2; 26 mm, n = 2; 28 mm, n = 1). Animals underwent cardiac catheterization with VIR implantation via a transfemoral venous, transatrial septal approach 1 week following surgery. Hemodynamic, angiographic, and echocardiographic data were recorded before and after VIR.

RESULTS: VIR was technically successful and required <1 h of procedure time in all animals. Fluoroscopy demonstrated securely positioned Melody valves within the annuloplasty ring in all animals. Angiography revealed no significant MV regurgitation in 4 and moderate central MV regurgitation in the animal with the 28-mm annuloplasty. All animals demonstrated vigorous left ventricular function, no outflow tract obstruction, and no aortic valve insufficiency.

CONCLUSIONS: This study demonstrated the feasibility of a purely percutaneous approach to MV replacement in patients with preexisting annuloplasty rings. This novel approach may be of particular benefit to patients with failed repair of ischemic mitral regurgitation and in pediatric patients with complex structural heart disease.

PMID: 22133846

Post-Mortem Imaging as an Alternative to Autopsy in the Diagnosis of Adult Deaths: A Validation Study

OBJECTIVES: Public objection to autopsy has led to a search for minimally invasive alternatives. Imaging has potential, but its accuracy is unknown. We aimed to identify the accuracy of post-mortem CT and MRI compared with full autopsy in a large series of adult deaths.

METHODS: This study was undertaken at two UK centres in Manchester and Oxford between April, 2006, and November, 2008. We used whole-body CT and MRI followed by full autopsy to investigate a series of adult deaths that were reported to the coroner. CT and MRI scans were reported independently, each by two radiologists who were masked to the autopsy findings. All four radiologists then produced a consensus report based on both techniques, recorded their confidence in cause of death, and identified whether autopsy was needed.

RESULTS: We assessed 182 unselected cases. The major discrepancy rate between cause of death identified by radiology and autopsy was 32% (95% CI 26-40) for CT, 43% (36-50) for MRI, and 30% (24-37) for the consensus radiology report; 10% (3-17) lower for CT than for MRI. Radiologists indicated that autopsy was not needed in 62 (34%; 95% CI 28-41) of 182 cases for CT reports, 76 (42%; 35-49) of 182 cases for MRI reports, and 88 (48%; 41-56) of 182 cases for consensus reports. Of these cases, the major discrepancy rate compared with autopsy was 16% (95% CI 9-27), 21% (13-32), and 16% (10-25), respectively, which is significantly lower (p<0·0001) than for cases with no definite cause of death. The most common imaging errors in identification of cause of death were ischaemic heart disease (n=27), pulmonary embolism (11), pneumonia (13), and intra-abdominal lesions (16).

CONCLUSIONS: We found that, compared with traditional autopsy, CT was a more accurate imaging technique than MRI for providing a cause of death. The error rate when radiologists provided a confident cause of death was similar to that for clinical death certificates, and could therefore be acceptable for medicolegal purposes. However, common causes of sudden death are frequently missed on CT and MRI, and, unless these weaknesses are addressed, systematic errors in mortality statistics would result if imaging were to replace conventional autopsy.

PMID: 22112684

Association of Coronary CT Angiography or Stress Testing With Subsequent Utilization and Spending Among Medicare Beneficiaries

OBJECTIVES: Coronary computed tomography angiography (CCTA) is a new noninvasive diagnostic test for coronary artery disease (CAD), but its association with subsequent clinical management has not been established. The objective here is to compare utilization and spending associated with functional (stress testing) and anatomical (CCTA) noninvasive cardiac testing in a Medicare population.

METHODS: Retrospective, observational cohort study using claims data from a 20% random sample of 2005-2008 Medicare fee-for-service beneficiaries 66 years or older with no claims for CAD in the preceding year, who received nonemergent, noninvasive testing for CAD (n = 282 830).The main outcome measure was cardiac catheterization, coronary revascularization, acute myocardial infarction, all-cause mortality, and total and CAD-related Medicare spending over 180 days of follow-up.

RESULTS: Compared with stress myocardial perfusion scintigraphy (MPS), CCTA was associated with an increased likelihood of subsequent cardiac catheterization (22.9% vs 12.1%; adjusted odds ratio [AOR], 2.19 [95% CI, 2.08 to 2.32]; P < .001), percutaneous coronary intervention (7.8% vs 3.4%; AOR, 2.49 [2.28 to 2.72]; P < .001), and coronary artery bypass graft surgery (3.7% vs 1.3%; AOR, 3.00 [2.63 to 3.41]; P < .001). CCTA was also associated with higher total health care spending ($4200 [$3193 to $5267]; P < .001), which was almost entirely attributable to payments for any claims for CAD ($4007 [$3256 to $4835]; P < .001). Compared with MPS, there was lower associated spending with stress echocardiography (−$4981 [−$4991 to −$4969]; P < .001) and exercise electrocardiography (−$7449 [−$7452 to −$7444]; P < .001). At 180 days, CCTA was associated with a similar likelihood of all-cause mortality (1.05% vs 1.28%; AOR, 1.11 [0.88 to 1.38]; P = .32) and a slightly lower likelihood of hospitalization for acute myocardial infarction (0.19% vs 0.43%; AOR, 0.60 [0.37 to 0.98]; P = .04).

CONCLUSIONS: Medicare beneficiaries who underwent CCTA in a nonacute setting were more likely to undergo subsequent invasive cardiac procedures and have higher CAD-related spending than patients who underwent stress testing.

PMID: