CT in Transcatheter-delivered Treatment of Valvular Heart Disease.

Minimally invasive strategies to treat valvular heart disease have emerged over the past 2 decades. The use of transcatheter aortic valve replacement in the treatment of severe aortic stenosis, for example, has recently expanded from high- to low-risk patients and became an alternative treatment for those with prohibitive surgical risk. With the increase in transcatheter strategies, multimodality imaging, including echocardiography, CT, fluoroscopy, and cardiac MRI, are used. Strategies for preprocedural imaging strategies vary depending on the targeted valve. Herein, an overview of preprocedural imaging strategies and their postprocessing approaches is provided, with a focus on CT. Transcatheter aortic valve replacement is reviewed, as well as less established minimally invasive treatments of the mitral and tricuspid valves. In addition, device-specific details and the goals of CT imaging are discussed. Future imaging developments, such as peri-procedural fusion imaging, machine learning for image processing, and mixed reality applications, are presented.

SCAI expert consensus statement update on best practices for transradial angiography and intervention.

Transradial angiography and intervention continues to become increasingly common as an access site for coronary procedures. Since the first "Best Practices" paper in 2013, ongoing trials have shed further light onto the safest and most efficient methods to perform these procedures. Specifically, this document comments on the use of ultrasound to facilitate radial access, the role of ulnar artery access, the utility of non-invasive testing of collateral flow, strategies to prevent radial artery occlusion, radial access for primary PCI and topics that require further study.

Coronary CT Angiography-derived Fractional Flow Reserve: Machine Learning Algorithm versus Computational Fluid Dynamics Modeling.

Purpose To compare two technical approaches for determination of coronary computed tomography (CT) angiography-derived fractional flow reserve (FFR)-FFR derived from coronary CT angiography based on computational fluid dynamics (hereafter, FFRCFD) and FFR derived from coronary CT angiography based on machine learning algorithm (hereafter, FFRML)-against coronary CT angiography and quantitative coronary angiography (QCA). Materials and Methods A total of 85 patients (mean age, 62 years ± 11 [standard deviation]; 62% men) who had undergone coronary CT angiography followed by invasive FFR were included in this single-center retrospective study. FFR values were derived on-site from coronary CT angiography data sets by using both FFRCFD and FFRML. The performance of both techniques for detecting lesion-specific ischemia was compared against visual stenosis grading at coronary CT angiography, QCA, and invasive FFR as the reference standard. Results On a per-lesion and per-patient level, FFRML showed a sensitivity of 79% and 90% and a specificity of 94% and 95%, respectively, for detecting lesion-specific ischemia. Meanwhile, FFRCFD resulted in a sensitivity of 79% and 89% and a specificity of 93% and 93%, respectively, on a per-lesion and per-patient basis (P = .86 and P = .92). On a per-lesion level, the area under the receiver operating characteristics curve (AUC) of 0.89 for FFRML and 0.89 for FFRCFD showed significantly higher discriminatory power for detecting lesion-specific ischemia compared with that of coronary CT angiography (AUC, 0.61) and QCA (AUC, 0.69) (all P < .0001). Also, on a per-patient level, FFRML (AUC, 0.91) and FFRCFD (AUC, 0.91) performed significantly better than did coronary CT angiography (AUC, 0.65) and QCA (AUC, 0.68) (all P < .0001). Processing time for FFRML was significantly shorter compared with that of FFRCFD (40.5 minutes ± 6.3 vs 43.4 minutes ± 7.1; P = .042). Conclusion The FFRML algorithm performs equally in detecting lesion-specific ischemia when compared with the FFRCFD approach. Both methods outperform accuracy of coronary CT angiography and QCA in the detection of flow-limiting stenosis.

Coronary CT Angiography-derived Fractional Flow Reserve.

Invasive coronary angiography (ICA) with measurement of fractional flow reserve (FFR) by means of a pressure wire technique is the established reference standard for the functional assessment of coronary artery disease (CAD) ( 1 , 2 ). Coronary computed tomographic (CT) angiography has emerged as a noninvasive method for direct assessment of CAD and plaque characterization with high diagnostic accuracy compared with ICA ( 3 , 4 ). However, the solely anatomic assessment provided with both coronary CT angiography and ICA has poor discriminatory power for ischemia-inducing lesions. FFR derived from standard coronary CT angiography (FFRCT) data sets by using any of several advanced computational analytic approaches enables combined anatomic and hemodynamic assessment of a coronary lesion by a single noninvasive test. Current technical approaches to the calculation of FFRCT include algorithms based on full- and reduced-order computational fluid dynamic modeling, as well as artificial intelligence deep machine learning ( 5 , 6 ). A growing body of evidence has validated the diagnostic accuracy of FFRCT techniques compared with invasive FFR. Improved therapeutic guidance has been demonstrated, showing the potential of FFRCT to streamline and rationalize the care of patients suspected of having CAD and improve outcomes while reducing overall health care costs ( 7 , 8 ). The purpose of this review is to describe the scientific principles, clinical validation, and implementation of various FFRCT approaches, their precursors, and related imaging tests. © RSNA, 2017.

Diagnostic accuracy of coronary CT angiography using 3rd-generation dual-source CT and automated tube voltage selection: Clinical application in a non-obese and obese patient population.

PURPOSE: To investigate diagnostic accuracy of 3rd-generation dual-source CT (DSCT) coronary angiography in obese and non-obese patients. METHODS: We retrospectively analyzed 76 patients who underwent coronary CT angiography (CCTA) and invasive coronary angiography. Prospectively ECG-triggered acquisition was performed with automated tube voltage selection (ATVS). Patients were dichotomized based on body mass index in groups A (<30 kg/m2, n = 37) and B (≥30 kg/m2, n = 39) and based on tube voltage in groups C (<120 kV, n = 46) and D (120 kV, n = 30). Coronary arteries were assessed for significant stenoses (≥50 % luminal narrowing) and diagnostic accuracy was calculated. RESULTS: Per-patient overall sensitivity, specificity, positive predictive value, negative predictive value (NPV) and accuracy were 96.9 %, 95.5 %, 93.9 %, 97.7 % and 96.1 %, respectively. Sensitivity and NPV were lower in groups B and D compared to groups A and C, but no statistically significant differences were observed (group A vs. B: sensitivity, 100.0 % vs. 93.3 %, p = 0.9493; NPV, 100 % vs. 95.5 %, p = 0.9812; group C vs. D: sensitivity, 100.0 % vs. 92.3 %, p = 0.8462; NPV, 100.0 % vs. 94.1 %, p = 0.8285). CONCLUSION: CCTA using 3rd-generation DSCT and (ATVS) provides high diagnostic accuracy in both non-obese and obese patients. KEY POINTS: • Coronary CTA provides high diagnostic accuracy in non-obese and obese patients. • Diagnostic accuracy between obese and non-obese patients showed no significant difference. • <120 kV studies were performed in 44 % of obese patients. • Current radiation dose-saving approaches can be applied independent of body habitus.

Correlation and predictive value of aortic root calcification markers with coronary artery calcification and obstructive coronary artery disease.

OBJECTIVE: To evaluate the correlation between aortic root calcification (ARC) markers and coronary artery calcification (CAC) derived from coronary artery calcium scoring (CACS) and their ability to predict obstructive coronary artery disease (CAD). METHODS: We retrospectively analyzed 189 patients (47% male, age 60.3 ± 11.1 years) with an intermediate probability of CAD who underwent clinically indicated CACS and coronary CT angiography (CCTA). ARC markers [aortic root calcium score (ARCS) and volume (ARCV)] were calculated and compared to CAC markers: coronary artery calcium score (CACS), volume (CACV), and mass (CACM). CCTA datasets were visually evaluated for significant CAD (stenosis ≥ 50%) and the ability of ARC markers to predict obstructive CAD was assessed. RESULTS: ARCS (mean 67.7 ± 189.5) and ARCV (mean 67.3 ± 184.7) showed significant differences between patients with and without CAC (109.4 ± 238.6 vs 9.42 ± 31.4, p < 0.0001; 108.5 ± 232.4 vs 9.9 ± 30.5, p < 0.0001). A strong correlation was found for ARCS and ARCV with CACS, CACM, and CACV (all p < 0.0001). In a multivariate analysis, ARCS (OR 1.09, p = 0.033) and ARCV (OR 1.12, p = 0.046) were independent markers for CAC. Using a receiver-operating characteristics analysis, the AUC to detect severe CAC was 0.71 (p < 0.0001) and 0.71 (p < 0.0001) for ARCS and ARCV, respectively. ARCS (0.67, p < 0.0001) and ARCV (0.68, p < 0.0001) showed discriminatory power for predicting obstructive CAD, yielding sensitivities 61 and 78% and specificities of 62 and 80%, respectively. CONCLUSION: ARC markers are associated with and independently predict the presence of CAC and obstructive CAD. Further testing is required in patients with severe ARC and significant CAD in order to reliably obtain these markers from thoracic-CT or X-ray for proper risk classification.

A non-contrast self-navigated 3-dimensional MR technique for aortic root and vascular access route assessment in the context of transcatheter aortic valve replacement: proof of concept.

OBJECTIVES: Due to the high prevalence of renal failure in transcatheter aortic valve replacement (TAVR) candidates, a non-contrast MR technique is desirable for pre-procedural planning. We sought to evaluate the feasibility of a novel, non-contrast, free-breathing, self-navigated three-dimensional (SN3D) MR sequence for imaging the aorta from its root to the iliofemoral run-off in comparison to non-contrast two-dimensional-balanced steady-state free-precession (2D-bSSFP) imaging. METHODS: SN3D [field of view (FOV), 220-370 mm(3); slice thickness, 1.15 mm; repetition/echo time (TR/TE), 3.1/1.5 ms; and flip angle, 115°] and 2D-bSSFP acquisitions (FOV, 340 mm; slice thickness, 6 mm; TR/TE, 2.3/1.1 ms; flip angle, 77°) were performed in 10 healthy subjects (all male; mean age, 30.3 ± 4.3 yrs) using a 1.5-T MRI system. Aortic root measurements and qualitative image ratings (four-point Likert-scale) were compared. RESULTS: The mean effective aortic annulus diameter was similar for 2D-bSSFP and SN3D (26.7 ± 0.7 vs. 26.1 ± 0.9 mm, p = 0.23). The mean image quality of 2D-bSSFP (4; IQR 3-4) was rated slightly higher (p = 0.03) than SN3D (3; IQR 2-4). The mean total acquisition time for SN3D imaging was 12.8 ± 2.4 min. CONCLUSIONS: Our results suggest that a novel SN3D sequence allows rapid, free-breathing assessment of the aortic root and the aortoiliofemoral system without administration of contrast medium. KEY POINTS: • The prevalence of renal failure is high among TAVR candidates. • Non-contrast 3D MR angiography allows for TAVR procedure planning. • The self-navigated sequence provides a significantly reduced scanning time.

Vascular Imaging Before Transcatheter Aortic Valve Replacement (TAVR): Why and How?

Transcatheter aortic valve replacement (TAVR) has become an alternative to surgical intervention for symptomatic or severe aortic valve stenosis in patients with high surgical risk. Successful TAVR requires a multimodality imaging approach for appropriate patient selection and prosthesis sizing. Here, we describe individual imaging modalities and report their respective roles in this emerging field. To date, echocardiography remains the traditional test for determining patient candidacy and prosthesis selection, but computed tomography (CT) has been taking on an increasingly important role in the evaluation of both the aortic root anatomy and aortoiliofemoral vessels as a single examination. Cardiac magnetic resonance (CMR) is useful in grading the severity of aortic stenosis and should be considered a reasonable alternative to CT for the evaluation of the aortic annulus, e.g., when the administration of contrast media is contraindicated.

Dual-source CT imaging to plan transcatheter aortic valve replacement: accuracy for diagnosis of obstructive coronary artery disease.

PURPOSE: To assess the accuracy of computed tomographic (CT) examinations performed for the purpose of transcatheter aortic valve replacement (TAVR) planning to diagnose obstructive coronary artery disease (CAD). MATERIALS AND METHODS: With institutional review board approval, waivers of informed consent, and in compliance with HIPAA, 100 consecutive TAVR candidates (61 men, mean age 79.6 years ± 9.9) who underwent both TAVR planning CT (with a dual-source CT system) and coronary catheter (CC) angiographic imaging were retrospectively analyzed. At both modalities, the presence of stenosis in the native coronary arteries was assessed. Additionally, all coronary bypass grafts were rated as patent or occluded. With CC angiographic imaging as the reference standard, the accuracy of CT for lesion detection on a per-vessel and per-patient basis was calculated. The accuracy of CT for the assessment of graft patency was also analyzed. RESULTS: For per-vessel and per-patient analysis for the detection of stenosis that was 50% or more in the native coronary arteries, CT imaging had, respectively, 94.4% and 98.6% sensitivity, 68.4% and 55.6% specificity, 94.7% and 93.8% negative predictive value (NPV), and 67.0% and 85.7% positive predictive value. Per-patient sensitivity of stenosis 50% or greater with CT for greater than 70% stenosis at CC angiographic imaging was 100%. All 12 vessels in which percutaneous coronary intervention was performed were correctly identified as demonstrating stenosis 50% or greater with CT. There was agreement between CT and CC angiographic imaging regarding graft patency in 114 of 115 grafts identified with CC angiographic imaging. CONCLUSION: TAVR planning CT has high sensitivity and NPV in excluding obstructive CAD. An additional preprocedural CC angiographic examination may not be required in TAVR candidates with a CT examination that does not show obstructive CAD.

Initial experience with the novel patent foramen ovale occlusion device Nit-Occlud® in patients with stroke or transient ischemic attack.

BACKGROUND: Patent foramen ovale (PFO) is associated with cryptogenic strokes and transient ischemic attacks (TIAs). This study examined the initial experience with a new PFO occluder, the Nit-Occlud® PFO Occlusion Device. METHODS: Sixty-three patients with history of cryptogenic stroke or TIA and PFO underwent percutaneous closure of the defect with the Nit-Occlud® PFO Occlusion Device. The primary endpoint was successful implantation without recurrent event, device malfunction, embolization, or the need for a replacement device over 6 ± 2 weeks. All patients underwent transesophageal echocardiography (TEE) at 6-weeks, and 42 patients had repeat TEE at 6-months. Clinical follow-up at 18.7 ± 7.4 months was also performed. RESULTS: The device was successfully implanted in 62 (98.4%) patients with no relevant procedural complications. At 6-week follow-up, 60 (95.2%) patients met the primary endpoint. A residual shunt at rest and with Valsalva was noted in 8 (12.7%) and 31 (49.2%) patients respectively at 6-week TEE. At 6-months, 1 of 42 (2.4%) and 9 of 42 (21.4%) patients had a residual shunt at rest and with Valsava, respectively. At 18 months, 5/63 patients had recurrent events (3 TIAs, 2 strokes). No device-related complications occurred. One patient developed atrial fibrillation. CONCLUSION: In patients with cryptogenic stroke or TIA and a PFO, the Nit-Occlud® PFO Occlusion Device appears to be both a safe and effective means to occlude the PFO. It is associated with high procedural success and favorable rates of complete closure.

Coronary CT angiography-derived fractional flow reserve correlated with invasive fractional flow reserve measurements--initial experience with a novel physician-driven algorithm.

OBJECTIVES: The present study aimed to determine the feasibility of a novel fractional flow reserve (FFR) algorithm based on coronary CT angiography (cCTA) that permits point-of-care assessment, without data transfer to core laboratories, for the evaluation of potentially ischemia-causing stenoses. METHODS: To obtain CT-based FFR, anatomical coronary information and ventricular mass extracted from cCTA datasets were integrated with haemodynamic parameters. CT-based FFR was assessed for 36 coronary artery stenoses in 28 patients in a blinded fashion and compared to catheter-based FFR. Haemodynamically relevant stenoses were defined by an invasive FFR ≤0.80. Time was measured for the processing of each cCTA dataset and CT-based FFR computation. Assessment of cCTA image quality was performed using a 5-point scale. RESULTS: Mean total time for CT-based FFR determination was 51.9 ± 9.0 min. Per-vessel analysis for the identification of lesion-specific myocardial ischemia demonstrated good correlation (Pearson's product-moment r = 0.74, p < 0.0001) between the prototype CT-based FFR algorithm and invasive FFR. Subjective image quality analysis resulted in a median score of 4 (interquartile ranges, 3-4). CONCLUSIONS: Our initial data suggest that the CT-based FFR method for the detection of haemodynamically significant stenoses evaluated in the selected population correlates well with invasive FFR and renders time-efficient point-of-care assessment possible. KEY POINTS: • CT-based FFR computation is a promising novel non-invasive application. • A novel prototype algorithm permits time-efficient point-of-care CT-based FFR assessment. • Initial results of the CT-based FFR prototype algorithm compare favourably with FFR.

Multimodality direct coronary imaging with combined near-infrared spectroscopy and intravascular ultrasound: initial US experience.

Recent studies emphasize the importance of direct intracoronary imaging techniques that provide insights regarding not only lesion architecture but also plaque composition, particularly the presence or absence of lipid-core plaque (LCP). Intracoronary near-infrared spectroscopy (NIRS) is the only validated FDA approved device for in vivo detection of LCP. A recently introduced catheter provides simultaneous NIRS spectral data coregistered with standard intravascular ultrasound (IVUS) images in a single intracoronary pullback. The present series of cases illustrates the unique data obtained by this combined NIRS-IVUS device and highlights its potential clinical applications. © 2012 Wiley Periodicals, Inc.

Renal sympathetic denervation as second-line therapy in mild resistant hypertension: a pilot study.

BACKGROUND: Catheter-based renal sympathetic denervation (CRD) is associated with significant blood pressure (BP) reductions in patients with severe therapy-resistant hypertension (office systolic BP ≥ 160 mm Hg or ≥ 150 mm Hg in diabetic patients). Effects of renal denervation on BP in patients with milder forms of therapy-resistant hypertension have not been examined. We sought to investigate the feasibility, safety, and effectiveness of CRD in patients with longstanding mild hypertension despite treatment with ≥ 3 antihypertensive drugs. METHODS: Consecutive patients with office systolic BPs of 140-160 mm Hg despite ≥ 3 antihypertensive medications treated with CRD were included in this prospective study. Procedural safety and adverse events during follow-up were assessed. Clinical evaluations were performed at baseline, 3, and 6 months to determine changes in office systolic BPs, 24-hr ambulatory BPs, and medication doses. RESULTS: Twenty patients (mean age 60.6 ± 10.8 years; 45% female) treated with an average of 5.4 ± 1.5 antihypertensive drugs were treated with CRD. The procedure was successful in all patients. There were no procedure- or device-related complications. BP at baseline was 148.4/83.0 ± 6.6/11.0 mm Hg and decreased by 5.7/0.6 ± 20.0/8.3 mm Hg (P = 0.2) and 13.1/5.0 ± 13.6/8.3 mm Hg (P < 0.01) at 3 and 6 months, respectively. Comparing baseline and 6-month follow-up, mean ambulatory 24 hr-BP was reduced by 11.3/4.1 ± 8.6/7.3 mm Hg (P < 0.01). Four patients were able to reduce antihypertensive medications prior to their 3-month visit. CONCLUSION: As in patients with severe treatment-resistant hypertension, CRD is a safe and effective treatment for patients with milder drug-resistant hypertension.

Recurrent events after percutaneous closure of patent foramen ovale.

OBJECTIVES: To determine the incidence of symptomatic recurrent embolic events after patent foramen ovale (PFO) closure and potential causes for these events. BACKGROUND: It is well-known that cerebral or other embolic events may occur after PFO closure. METHODS: This is a retrospective analysis of consecutive patients who underwent PFO closure for secondary prevention of embolic events at a single institution. RESULTS: 1,930 patients (mean age of 50 ± 13.3 years) underwent transcatheter PFO closure. Complete closure occurred in 92%. The annual recurrence rate of embolic events before PFO closure was 22.4% (785 events in 3,497 patient-years). During follow-up (mean 39 months), 63 recurrent events were documented: 25 strokes, 36 transient ischemic attacks (TIAs), and 2 peripheral embolic events. The overall annual recurrence rate after the procedure was 1% per year (63 events in 6,211 patient-years). The majority of events occurred in patients without residual shunts (54/63). There was no significant association between the presence of a residual shunt and recurrent events [hazard ratio (HR) 1.7; 95% confidence interval (CI) 0.8-3.6, P = 0.16]. The most common cause for recurrent events was atherosclerosis. Nine out of 63 events were considered likely or possible paradoxical embolism due to residual shunt [stroke (2), TIA (5), and peripheral embolism (2)]. After PFO closure, the annual rate of events potentially related to paradoxical embolism was 0.14% (9 events in 6,211 patient-years). CONCLUSION: The incidence of symptomatic embolic events after PFO closure is low. Most recurrent events are related to coexistent conditions associated with thromboembolic risk rather than residual shunts.

Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: results from the prospective multicenter German TAVI registry.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis. BACKGROUND: Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated. METHODS: We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild (n = 67), moderate (n = 392), and severe (n = 906) valve calcification, determined by visual estimation by the operator. RESULTS: Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak-to-peak gradient before the intervention (P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification (P < 0.01 for procedure and P < 0.05 for fluoroscopy). During the periprocedural period there were no differences among the groups regarding in-hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35). During 30-day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions. CONCLUSIONS: Our results of a real-world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly.

Alcohol septal ablation for obstructive hypertrophic cardiomyopathy: outcomes in young, middle-aged, and elderly patients.

OBJECTIVES: We compared the efficacy and safety of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) in young, middle-aged, and elderly patients. BACKGROUND: Intersociety guidelines suggest based on limited evidence that young patients with medically refractory symptoms of obstructive HCM should undergo surgical myectomy while elderly patients may be more appropriate for ASA. METHODS: Data for 360 patients undergoing 389 ASAs were prospectively collected and retrospectively analyzed according to age. RESULTS: Young (<45 years), middle-aged (45-64 years), and elderly (≥65 years) patients comprised 28, 40, and 32% of the study population, respectively. Young patients had thicker left ventricular septal walls at baseline, and elderly patients had more comorbidity and dyspnea. Resting, mean left ventricular outflow tract gradients (LVOTGs) were similar across the age groups at baseline (62, 66, and 68 mm Hg, respectively; P = NS for all comparisons). LVOTGs and dyspnea were significantly and similarly improved in all age groups immediately after ASA and through 12 months of follow-up (P < 0.001 for before and after comparisons; P = NS for intergroup comparisons). Complication rates were similar for young and middle-aged patients but higher for elderly patients (9.1 and 6.3% vs. 20.8%, respectively; P ≤ 0.016 for elderly vs. others). Mortality rates for young and middle-aged patients were lower than for elderly patients, but the differences were not statistically significant. CONCLUSIONS: Patients undergoing ASA had significant and similar improvements in LVOTGs and symptoms regardless of age. Procedural complications were increased in elderly patients, who had numerically but not statistically significantly higher mortality rates.

Coronary CT angiography versus conventional cardiac angiography for therapeutic decision making in patients with high likelihood of coronary artery disease.

PURPOSE: To assess the efficacy of coronary computed tomographic (CT) angiography for therapeutic decision making in patients with high likelihood of coronary artery disease (CAD)-specifically the ability of coronary CT angiography to help differentiate patients without and patients with a need for revascularization and determine the appropriate revascularization procedure. MATERIALS AND METHODS: The study protocol was approved by institutional review board, with written informed consent from all patients. The study was conducted in compliance with HIPAA. One hundred eighty-five consecutive symptomatic patients (121 men; mean age, 59.4 years±9.7) with a positive single photon emission computed tomography (SPECT) myocardial perfusion study underwent coronary CT angiography and conventional cardiac angiography (hereafter, cardiac catheterization). The management strategy (conservative treatment vs revascularization) and revascularization procedure (percutaneous coronary intervention [PCI] vs coronary artery bypass graft surgery [CABG]) were prospectively selected on the basis of a combination of coronary CT angiography and SPECT. In addition, the authors calculated the accuracy, sensitivity, specificity, and negative and positive predictive values of coronary CT angiography in the detection of obstructive CAD and the selection of a revascularization strategy. Cardiac catheterization was used as the standard of reference. RESULTS: Of the 185 patients, 113 (61%) did not undergo revascularization and 42 (23%) were free of CAD. In 178 patients (96%), the same therapeutic strategy (conservative treatment vs revascularization) was chosen on the basis of coronary CT angiography and catheterization. All patients in need of revascularization were identified with coronary CT angiography. When revascularization was indicated, the same procedure (PCI vs CABG) was chosen in 66 of 72 patients (92%). CONCLUSION: In patients with high likelihood of CAD, the performance of coronary CT angiography in the differentiation of patients without and patients with a need for revascularization and the selection of a revascularization strategy was similar to that of cardiac catheterization; accordingly, coronary CT angiography has the potential to limit the number of patients without obstructive CAD who undergo cardiac catheterization and to inform decision making regarding revascularization.

Intermittent Occlusion of the Superior Vena Cava to Improve Hemodynamics in Patients With Acutely Decompensated Heart Failure: The VENUS-HF Early Feasibility Study.

BACKGROUND: Reducing congestion remains a primary target of therapy for acutely decompensated heart failure. The VENUS-HF EFS (VENUS-Heart Failure Early Feasibility Study) is the first clinical trial testing intermittent occlusion of the superior vena cava with the preCARDIA system, a catheter mounted balloon and pump console, to improve decongestion in acutely decompensated heart failure. METHODS: In a multicenter, prospective, single-arm exploratory safety and feasibility trial, 30 patients with acutely decompensated heart failure were assigned to preCARDIA therapy for 12 or 24 hours. The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events through 30 days. Secondary end points included technical success defined as successful preCARDIA placement, treatment, and removal and reduction in right atrial and pulmonary capillary wedge pressure. Other efficacy measures included urine output and patient-reported symptoms. RESULTS: Thirty patients were enrolled and assigned to receive the preCARDIA system. Freedom from device- or procedure-related major adverse events was observed in 100% (n=30/30) of patients. The system was successfully placed, activated and removed after 12 (n=6) or 24 hours (n=23) in 97% (n=29/30) of patients. Compared with baseline values, right atrial pressure decreased by 34% (17±4 versus 11±5 mm Hg, P<0.001) and pulmonary capillary wedge pressure decreased by 27% (31±8 versus 22±9 mm Hg, P<0.001). Compared with pretreatment values, urine output and net fluid balance increased by 130% and 156%, respectively, with up to 24 hours of treatment (P<0.01). CONCLUSIONS: We report the first-in-human experience of intermittent superior vena cava occlusion using the preCARDIA system to reduce congestion in acutely decompensated heart failure. PreCARDIA treatment for up to 24 hours was well tolerated without device- or procedure-related serious or major adverse events and associated with reduced filling pressures and increased urine output. These results support future studies characterizing the clinical utility of the preCARDIA system. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03836079.

Decline in platelet count in patients treated by percutaneous coronary intervention: definition, incidence, prognostic importance, and predictive factors.

AIMS: We investigated the incidence, predictors, and prognostic impact of a decline in platelet count (DPC) in patients treated by percutaneous coronary intervention (PCI). METHODS AND RESULTS: A total of 10 146 consecutive patients treated by PCI from 2003 to 2006 were included. According to the magnitude of the DPC, the population was divided into four groups: no DPC (<10%), minor DPC (10-24%), moderate DPC (25-49%), and severe DPC (>or=50%). The primary haemorrhagic endpoint was a composite of post-procedure surgical repair major bleeding. The primary ischaemic endpoint was 30-day all-cause mortality-non-fatal myocardial infarction. Among the total population, 36% had a DPC <10%, 47.7% had a DPC of 10-24%, 14% had a DPC of 25-49%, and 2.3% had a DPC >or=50%. On multivariate analysis, moderate and severe DPC were independent predictive factors of the ischaemic outcome. Two procedural practices were identified that, if modified, might reduce the incidence of acquired thrombocytopaenia. Both the intraprocedural use of heparin (as opposed to bivalirudin) and of low molecular weight contrast material were independently associated with severe acquired thrombocytopaenia. CONCLUSION: Moderate and severe DPC are independent predictors of adverse bleeding and ischaemic outcomes in PCI. Adoption of intraprocedural anticoagulant other than heparin and avoidance of a low molecular weight contrast agent could potentially decrease the occurrence of severe acquired thrombocytopaenia.