Rationale and design of the Prospective LongitudinAl Trial of FFRCT: Outcome and Resource IMpacts study.

BACKGROUND: Fractional flow reserve (FFR) measured by coronary computed tomography angiography (FFRCT) has been validated against invasive FFR. However, there are no data on how the use of FFRCT affects patient care and outcomes. The aim of this study is to compare standard practice guided by usual care testing to FFRCT-guided management in symptomatic subjects with suspected coronary artery disease (CAD). METHODS: In this prospective nonrandomized trial, symptomatic patients with suspected CAD will be enrolled in 2 consecutive cohorts: a usual care-guided pathway (cohort 1) and an FFRCT-guided pathway (cohort 2). Each cohort is divided into 2 groups according to whether noninvasive or invasive diagnostic testing was planned before enrollment. In all subjects, the patient's clinical team will review all diagnostic test results and determine a treatment strategy. A total sample size of 580 subjects will be enrolled and followed up for 12 months. RESULTS: The primary end point is the comparison of the percentage of patients with planned invasive testing who have a catheterization (invasive coronary angiography) within 90 days from initial assessment, which does not show a significant stenosis (defined as coronary artery stenosis >50% or invasive FFR ≤0.80). Secondary end points include the rate of invasive coronary angiography without obstructive CAD in those with planned noninvasive testing and, in all groups, noninferiority of resource use, quality of life, medical radiation exposure, and major adverse cardiac events up to 365 days of follow-up. CONCLUSIONS: The study compares clinical and economic outcomes based on diagnostic evaluation using FFRCT with that based on standard diagnostic strategies.

Persisting eustachian valve in adults: relation to patent foramen ovale and cerebrovascular events.

BACKGROUND: The eustachian valve (EV) (valvula venae cavae inferioris) is a remnant of the embryonic right valve of the sinus venosus. Embryologically, the EV directs oxygenated blood from the inferior vena cava across the patent foramen ovale (PFO) into the systemic circulation. Transthoracic echocardiography shows the EV in the majority of newborns, but the prevalence of EV in adults studied with transesophageal echocardiography is unknown. We studied whether the presence of an EV is associated with PFO or with cryptogenic stroke. METHODS: The frequency and size of the EV was studied in 211 consecutive patients undergoing transesophageal echocardiography after a cryptogenic stroke and in 95 consecutive patients without cerebrovascular events. In all 306 patients, the presence of a PFO was studied with 2-dimensional transesophageal echocardiographic, color Doppler, and contrast echocardiographic studies. RESULTS: An EV was seen in 174 of 306 patients overall (57%). The mean size was 1.0 +/- 0.4 cm (range: 0.5-2.0); 70% of patients with an EV had a PFO (Cohen's kappa = 0.75; P <.001). This relationship was not significantly influenced by a cryptogenic stroke. The prevalence of PFO was 30% in the control group and 61% for those with presumed paradoxical embolism (P <.001). Thus, an EV was more common for patients with presumed paradoxical embolism than in control patients (143 of 211 68% vs 31 of 95 33%, respectively, P <.001). There was no significant difference in the size of the EV between the 2 groups (1.1 vs 1.0 cm; P =.24). CONCLUSION: A persisting EV is a frequent finding in patients with a PFO. By directing the blood from the inferior cava to the interatrial septum, a persisting EV may prevent spontaneous closure of PFO after birth and may, therefore, indirectly predispose to paradoxical embolism.

Transesophageal echocardiography for quantifying size of patent foramen ovale in patients with cryptogenic cerebrovascular events.

BACKGROUND AND PURPOSE: Patent foramen ovale (PFO) is a risk factor for paradoxical embolism, and severe shunting and wide opening of PFO are risk factors for severe and recurrent cerebrovascular events. Neither contrast echocardiography nor 2-dimensional (2D) measurement of PFO size have been validated or compared with invasive balloon sizing. METHODS: We performed transesophageal echocardiography (TEE) in 100 patients with cryptogenic stroke and catheter closure of PFO. The amount of contrast shunting through the PFO during cubital and femoral contrast delivery and the PFO size measured by 2D TEE were compared with balloon sizing. RESULTS: There was a significant correlation (r(2)=0.8; P<0.0001) between 2D TEE measurement and invasive balloon sizing. Mean balloon-sized PFO diameter was significantly larger than mean PFO diameter measured by 2D TEE (8.3+/-2.6 versus 5.2+/-1.7 mm). Semiquantitative contrast TEE correlated with PFO size (r(2)=0.7; P<0.0001) only if the contrast agent was administered through a femoral vein. Correlation was poor when the contrast agent was administered via a cubital vein. CONCLUSIONS: We conclude that 2D TEE measurement of a PFO size is more accurate than the traditionally used contrast technique.