Routine Pressure Wire Assessment Versus Conventional Angiography in the Management of Patients With Coronary Artery Disease: The RIPCORD 2 Trial.

BACKGROUND: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone. METHODS: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non-ST-segment-elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events. RESULTS: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3-5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613-£7015); and angiography+FFR, £4510 (£2721-£7415; P=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60-87); and angiography+FFR, 75 (interquartile range, 60-90; P=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (P=0.64). CONCLUSIONS: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01070771.

A randomised controlled trial to compare two coronary pressure wires using simultaneous measurements in human coronary arteries: the COMET trial.

AIMS: We aimed to examine the relative performance of the new COMET wire from Boston Scientific (BS), and the established technology from St. Jude/Abbott Vascular (SJ). METHODS AND RESULTS: We compared simultaneous readings from pairs of wires. Patients were randomised to one of three groups: BS/BS, SJ/SJ, or SJ/BS. The last group was sub-randomised to specify the type of wire that would be passed first. After pressure equalisation at the guide catheter, we recorded paired observations in sequence: (a) distal to proximal pressure ratio at baseline, (b) FFR at maximum hyperaemia, and (c) pressure on withdrawal into the guide catheter to quantify "drift". We randomised 106 patients, yielding 288 sets of paired recordings (BS/BS=90; SJ/SJ=90; SJ/BS=108). Drift was recorded from 208 vessels (BS=105; SJ=103). All wires were successfully advanced to their desired positions in the coronary vasculature. The mean (±SD) differences for the randomised pairs were similar: BS/BS=0.0016 (0.023); SJ/SJ=0.002 (0.03); SJ/BS=0.0013 (0.028). The primary outcome tested the hypothesis that the absolute magnitude of the difference (irrespective of sign) observed in the SJ/BS pairing would be similar to that in the SJ/SJ group. The median (IQR) values were SJ/BS=0.015 (0.01-0.03); SJ/SJ=0.01 (0.00-0.03); p=0.61. The drift, expressed as the median (IQR) difference in Pd/Pa from 1.0 (irrespective of sign), was similar: BS=0.02 (0.01-0.05); SJ=0.02 (0.01-0.04); p=0.14. CONCLUSIONS: We found no significant difference between these wires in terms of safety and performance.

Design and Rationale of the RIPCORD 2 Trial (Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?): A Randomized Controlled Trial to Compare Routine Pressure Wire Assessment With Conventional Angiography in the Management of Patients With Coronary Artery Disease.

BACKGROUND: Investigation of anginal chest pain has traditionally involved either assessment of the coronary anatomy by angiography or noninvasive testing for reversible ischemia. Invasive pressure wire assessment at the time of angiography offers information on both anatomy and physiology. Fractional flow reserve-guided percutaneous coronary intervention is associated with lower resource utilization and improved clinical outcome compared with angiographic guidance alone. However, the value of routine fractional flow reserve of all major coronary vessels at the time of diagnostic angiography has not been established in a randomized trial despite persuasive observational data. A change in practice to routine fractional flow reserve assessment of all major vessels during diagnostic angiography would require evidence not just of clinical benefit but also of cost effectiveness. This randomized trial aims to test that strategy. METHODS AND RESULTS: RIPCORD 2 (Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?) is an 1100 patient prospective, multicenter, randomized trial. Participants are randomized, after initial coronary angiography, and in equal proportion, to assessment and management according to (1) conventional angiography only or (2) additional routine pressure wire assessment in all epicardial vessels of sufficient size to be amenable to revascularization. The primary economic outcome measure will be a comparison of healthcare costs at 1 year. The primary quality-of-life outcome measure analysis will compare patient-reported quality-of-life scores at 1 year. Secondary outcome measures include clinical events at 1 year, management strategy (optimal medical therapy with or without revascularization), and angina status at 1 year according to Canadian Cardiovascular Society angina grade. CONCLUSIONS: The aim of the RIPCORD 2 trial is to assess whether a strategy of routine fractional flow reserve-guided assessment and management of all major coronary arteries will be associated with more effective resource utilization, improved quality of life, and better clinical outcome, compared with angiographic guidance alone. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02892903.

Incremental Value of Live/Real Time Three-Dimensional over Two-Dimensional Transesophageal Echocardiography in the Assessment of Atrial Septal Pouch.

An atrial septal pouch (ASP) results from partial fusion of the septum primum and the septum secundum, and depending on the site of fusion, the pouch can be left-sided (LASP) or right-sided (RASP). LASPs have been described in association with thrombi found in patients admitted with acute strokes, raising awareness of its potential cardioembolic role, especially in those with no other clearly identifiable embolic source. We retrospectively studied 39 patients in whom the presence of an ASP had been identified by three-dimensional transesophageal echocardiography (3DTEE) and who had a two-dimensional transesophageal echocardiogram (2DTEE) performed during the same clinical encounter. The incremental value provided by 3DTEE over 2DTEE included the detection of six ASPs not found by 2DTEE; the detection of two ASPs in the same subject (in four patients) not identified by 2DTEE; larger ASP measurements of length and height in over 80% of the cases; and measurement of the ASP width (elevational axis) for the calculation of the area of the ASP opening, because of its unique capability to view the pouch en face. In addition, the volume of ASP and of the echogenic masses contained in the ASP (four of 39 patients) could be calculated by 3DTEE, which is a superior parameter of size characterization when compared to individual dimensions. One of these patients who presented with ischemic stroke diagnosed by magnetic resonance imaging had a large (>2 cm) mass in a LASP, with echolucencies similar to those seen in thrombi and associated with clot lysis and resolution. This mass completely disappeared on anticoagulant therapy lending credence that it was most likely a thrombus. There was no history of stroke or any other type of embolic event in the other three patients with masses in ASP. In conclusion, this retrospective study highlights the incremental value of 3DTEE over 2DTEE in the comprehensive assessment and characterization of ASPs, which can aid in the clarification of their role in cryptogenic stroke patients.

Usefulness of three-dimensional transesophageal echocardiography in retrieval of a dislodged vascular plug used to close paraprosthetic mitral regurgitation.

In this report, we describe a case of periprocedural dislodgement of an Amplatzer Vascular Plug II device during percutaneous closure of severe paraprosthetic mitral regurgitation. The free plug in the left atrium was successfully retrieved percutaneously using a snare inserted through a sheath under live/real time three-dimensional transesophageal echocardiographic guidance. This proved crucial not only in guiding device deployment but also in detecting and helping management of complications.

Incremental value of live/real time three-dimensional transthoracic echocardiography over two-dimensional echocardiography in hypertrophic cardiomyopathy with mid-ventricular obstruction and apical aneurysm.

We describe a case of hypertrophic cardiomyopathy with mid-left ventricular obstruction and apical aneurysm containing thrombi where live/real time three-dimensional transthoracic echocardiography provided incremental value over two-dimensional echocardiography in assessing the findings.

Incremental value of three-dimensional transesophageal echocardiography over the two-dimensional technique in percutaneous closure of aortic paraprosthetic regurgitation.

We describe 2 patients with significant aortic paraprosthetic regurgitation who underwent percutaneous closure where live/real time three-dimensional transesophageal echocardiography provided incremental value over two-dimensional transesophageal echocardiography.

Live/real time three-dimensional transesophageal echocardiographic assessment of the spinal cord.

We present an adult patient in whom live/real time three-dimensional transesophageal echocardiography (3DTEE) provided incremental value in the assessment of the spinal cord as compared to two-dimensional transesophageal echocardiographic (2DTEE) findings published in the literature. It improved accurate identification and assessment of the anterior radiculomedullary spinal arteries which may have an important clinical application in monitoring for spinal cord ischemia during thoracic aortic surgery. Because the spinal cord and spinal canal could be examined using not only transverse but also coronal (frontal), sagittal, and oblique planes, 3DTEE further allowed for three-dimensional measurements of the dimensions and volumetric analysis of the visualized spinal cord and spinal canal. These may have implications in the assessment of spinal cord edema due to trauma and other conditions which result in increase in the size and volume of the spinal cord.