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Background: While the process of informed consent is designed to transfer knowledge of the risks and benefits of treatment and to engage patients in shared medical decision-making, this is poorly done in routine clinical care. We assessed the impact of a novel informed consent form for percutaneous coronary intervention (PCI) that is more simply written, includes images of the procedure, and embeds individualized estimates of outcomes on multiple domains of successful informed consent and shared decision-making., Methods: We interviewed 590 PCI patients receiving traditional consent documents and 527 patients receiving novel ePRISM consents at 9 US centers and compared patients' perceptions, knowledge transfer, and engagement in medical decision-making. Heterogeneity across sites was assessed and adjusted for using hierarchical models., Results: Site-adjusted analyses revealed more frequent review (72% for ePRISM vs 45% for original consents) and better understanding of the ePRISM consents (ORs=1.8-3.0, depending upon the outcome) with marked heterogeneity across sites (median relative difference [MRD] in the ORs of ePRISM's effect =2-3.2). Patients receiving ePRISM consents better understood the purposes and risks of the procedure (ORs=1.9-3.9, MRDs=1.1-6.2), engaged more in shared decision-making (proportional OR=2.1 [95% CI=1.02-4.4], MRD=2.2) and discussed stent options with their physicians (58% vs. 31%; site-adjusted odds ratio=2.7 [95% CI=1.2, 6.3], MRD=2.6) more often., Conclusions: A personalized consent document improved the process of informed consent and shared decision-making. Marked heterogeneity across hospitals highlights that consent documents are but one aspect of engaging patients in understanding and participating in treatment., (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: To test whether later intra-aortic balloon pump (IABP) deflation approaching or simultaneous with left ventricular ejection would improve hemodynamics and myocardial efficiency with the use of new balloon deflation methods, 4 IABP timing techniques were evaluated in 43 patients., Methods and Results: Later balloon deflation produced significantly greater percentage changes in mean aortic pressure (6% vs 1%), systolic pressure time index (-27% vs -20%), diastolic pressure time index (35% vs 19%), and the systolic pressure-time index/diastolic pressure-time index ratio (97% vs 51%), respectively. However, these changes increased peak systolic pressure (-15% vs -11%). Cardiac output and stroke volume indexes were not significantly altered over the 4 settings., Conclusions: These data suggest that systemic hemodynamics and myocardial efficiency may be improved by later balloon deflation approaching left ventricular ejection in comparison to conventional IABP timing.

The functional importance and protective nature of the coronary collateral circulation has been well established. There are few data, however, regarding the phasic nature and absolute velocities of collateral flow in patients. The aim of this study was to characterize and quantify ipsilateral coronary collateral blood flow velocity in patients during coronary angioplasty. Coronary collateral flow velocity was measured in 49 patients during coronary angioplasty. Angiographic collateral filling was categorized by the Rentrop grading scale (0 to 3) and by anatomic pathway (epicardial, intramyocardial, or unknown [acutely recruited]). Collateral blood flow velocity was measured with a Doppler-tipped guide wire placed distal to the balloon occlusion in the collateralized vessel. Collateral flow velocity was characterized as predominantly systolic or diastolic, and phasic flow patterns were defined as biphasic (both systolic and diastolic), monophasic (only systolic or diastolic), or bidirectional (antegrade and retrograde velocity). Twenty-three (47%) patients had biphasic flow; 17 (35%) patients had monophasic flow; and 9 (18%) patients had bidirectional flow. Thirty-six (73%) of 49 patients had predominantly systolic flow signals. Epicardial collateral pathways had the highest total flow velocity integral, at 15.0 +/- 7.0 (vs intramyocardial [8.4 +/- 5.7] and acutely recruitable [5.4 +/- 2.1]; p < 0.05). There were no differences in flow velocity integrals among the Rentrop angiographic grades of collateral filling. These data establish three patterns of coronary collateral blood flow and demonstrate that the majority of collateral flow in the ipsllateral receiving vessel occurs during systole. The measurement of coronary collateral flow velocity provides a unique means to study the effects of pharmacologic or mechanical interventions on human collateral blood flow.

The purpose of this study was to examine the influence of sequential percutaneous transluminal coronary rotational atherectomy (PTCRA) and coronary angioplasty on coronary blood flow reserve in patients. Rotational coronary atherectomy restores lumen patency by partially ablating fibrocalcific plaque, releasing microparticulate debris into the distal coronary circulation. Adjunctive balloon angioplasty is usually performed to optimize the angiographic luminal dimensions. Serial alterations in coronary physiology have not been reported. Fourteen lesions in 13 patients were treated by sequential rotational atherectomy followed by adjunctive balloon angioplasty. Poststenotic baseline coronary blood flow velocity was measured by using a Doppler flow wire (FloWire, Cardiometrics, Inc., Mountain View, Calif.), and coronary blood flow was calculated by using the distal vessel cross-sectional area obtained by quantitative coronary angiography. Data were acquired at baseline and during hyperemia (12 to 18 microg of intracoronary adenosine), before and after PTCRA, and again after balloon angioplasty. The mean stenosis decreased from 76 percent +/- 12 percent at baseline to 21 percent +/- 11 percent at the completion of the procedure (p<0.01). The minimal luminal diameter (by quantitative coronary angiography) was 0.7 +/- 0.4 mm at baseline, increased to 1.9 +/- 0.4 mm after rotational atherectomy (p<0.01), and increased to 2.4 +/- 0.5 mm after balloon angioplasty (p<0.01 versus baseline and PTCRA). Distal (poststenotic) coronary blood flow at baseline was 47 +/- 23 ml/min and 57 +/- 38 ml/min during hyperemia. After PTCRA, coronary blood flow increased to 104 +/- 59 ml/min and to 132 +/- 73 ml/min with hyperemia. After adjunctive angioplasty, coronary blood flow was 84 +/- 40 ml/min (p=not significant [NS] vs PTCRA) and increased to 143 +/- 81 ml/min with hyperemia (p=NS vs PTCRA). The poststenotic coronary flow reserve increased from an initial value of 1.1 +/- 0.2 ml/min to 1.3 +/- 0.3 ml/min after PTCRA (p=NS vs baseline) and to 1.6 +/- 0.3 ml/min after adjunctive balloon angioplasty (p<0.01 vs p=NS vs PTCRA). PTCRA significantly increased resting coronary blood flow. Adjunctive balloon angioplasty did not significantly augment resting or hyperemic coronary blood flow more than that achieved by rotational atherectomy alone. These data demonstrate that PTCRA alone improves baseline coronary blood flow with minimal additional physiologic change after adjunctive balloon angioplasty.

The physiologic importance of coronary stenoses can be assessed indirectly by stress myocardial perfusion imaging or directly by translesional pressure and flow measurements. The aims of this study were to compare myocardial fractional flow reserve (FFRmyo), a recently proposed index of lesion significance derived from hyperemic translesional pressure gradients, with directly measured poststenotic flow velocity reserve for the prediction of myocardial perfusion stress imaging results in corresponding vascular beds. Poststenotic coronary flow velocity (0.018-inch guide wire) and translesional pressure gradients (2.7F fluid-filled catheter) were measured at baseline and after intracoronary adenosine (12 to 18 micrograms) in 70 arteries (diameter stenosis: mean 56% +/- 15%, range 14% to 94% by quantitative angiography). Coronary flow reserve was calculated as the ratio of hyperemic to basal mean flow velocity. FFRmyo was calculated during maximal hyperemia as equal to 1-(hyperemic gradient [mean aortic pressure-5]), where 5 is the assumed central venous pressure. Positive and negative predictive values and predictive accuracy for reversible stress myocardial perfusion abnormalities were computed. There was a significant correlation between pressure-derived FFRmyo and distal coronary flow reserve (r = 0.46; p < 0.0001). The strongest predictor of stress myocardial perfusion imaging results was the poststenotic coronary flow reserve (chi square = 33.2; p < 0.0001). The correlation between stress myocardial perfusion imaging and FFRmyo was also significant (chi square = 8.3; p < 0.005). There was no correlation between stress myocardial perfusion imaging and percentage diameter stenosis (chi square = 2.9; p = 0.10) or minimal lumen diameter (chi square = 0.47; p = 0.73). A poststenotic coronary flow reserve of < or = 2 had a positive predictive value of 89% for regionally abnormal myocardial perfusion imaging abnormalities, whereas the positive predictive values of FFRmyo and angiographic percentage diameter stenosis were only 71% and 67% respectively. In conclusion, the predictive value of poststenotic coronary flow velocity reserve for stress-induced myocardial perfusion abnormalities exceeds that of the translesional FFRmyo. These findings should be considered when applying these techniques for clinical decision making in the assessment of coronary stenosis severity.

To characterize coronary blood flow velocity parameters and to determine the relation among velocity, volumetric flow, and vascular resistance in awake human beings, we performed paired proximal and distal velocity measurements in 28 angiographically normal coronary arteries. Mean velocity, peak velocity, diastolic-to-systolic velocity ratio, and diameter and cross-sectional area of proximal and distal arteries were determined and coronary flow and vascular resistance computed. Mean velocity and coronary vasodilator reserve were similar for all three native arteries and were preserved from proximal to distal segments. Volumetric flow decreased from proximal to distal segments. The demonstrated inverse and curvilinear (polynomial) relation between volumetric flow and vascular resistance agrees with theoretical and animal models of coronary physiologic characteristics and suggests a nadir of coronary vascular resistance below which coronary flow no longer increases.

The objective of this study was to assess the use of coronary stenosis velocity in the determination of translesional pressure gradients. In the physiologic assessment of coronary stenosis, the accelerated intracoronary flow velocity within a narrowing has correlated with minimal lesion cross-sectional area according to the continuity equation. In large conduits the jet velocity can determine pressure gradients when used in the Bernouilli equation. However, the use of intralesional flow velocity for calculation of translesional pressure gradients by the simplified Bernouilli equation (delta P = 4V2) may be inaccurate in small (< 5 mm diameter) conduits. Translesional pressure (2.2F catheter) and flow velocity (0.018-inch guidewire) were measured in a single coronary artery in 23 patients undergoing diagnostic angiography or angioplasty. The electronically determined mean of phasic proximal and distal pressure and planimetry of the instantaneous phasic pressure gradient were used and compared with the instantaneous velocity calculations of pressure by the simplified Bernouilli formula with both maximal jet velocity and a modified formula including proximal velocity. The mean measured translesional pressure gradient was 18 +/- 13 mm Hg (range 0 to 50 mm Hg) and was equivalent to the instantaneous average pressure gradient by planimetry. The maximal jet velocity was 125 +/- 40 cm/sec (range 63 to 250 cm/sec), yielding a calculated pressure gradient of 3 +/- 3 mm Hg. The calculated pressure gradient by the simplified Bernouilli equation correlated poorly with the measured translesional gradient (r = 0.27, F = 1.63, p = 0.21).(ABSTRACT TRUNCATED AT 250 WORDS)

The purpose of this study was to evaluate the incidence of ventricular ectopy and catheter movement during left ventriculography with a new 5F halo angiographic catheter that has a unique helical-tip design unlike the design of standard 5F and 6F pigtail catheters. The pigtail catheter is presently preferred for left ventriculography, although its use is associated with a high incidence of ventricular ectopy, which often limits precise interpretation of data. In this study, 155 patients (in 145 unpaired and 10 paired studies) underwent left ventriculography during diagnostic cardiac catheterization. In the unpaired group, the 5F Halo catheter was used in 63 studies and standard 5F and 6F pigtail catheters in 40 and 42 studies, respectively. An additional 10 patients had two consecutive left ventriculograms with 5F Halo and pigtail catheters. Ventriculograms were performed with the same technique in the 30-degree right anterior oblique projection. The left ventricle was divided into a basal zone, midzone, and apical zone. Catheter movement within the ventricle was scored as significant if there was at least one zone change. Ventricular ectopy was quantified by a simultaneous electrocardiographic recording during contrast injection. There were no significant differences in the left ventricular systolic or end-diastolic pressures, left ventricular score, or diagnostic quality of the ventriculograms between the 5F Halo catheter group and the 5F and 6F pigtail catheter groups. Mean ventricular ectopy with the 5F Halo catheter was significantly less (0.9 +/- 1.4 ventricular premature beats [VPBs]) than with the 5F pigtail catheter (2.3 +/- 2.5 VPBs, p < 0.001) or the 6F pigtail catheter (2.9 +/- 2.9 VPBs, p < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

Continuous measurement of blood flow velocity during interventional procedures has the potential to provide an early warning of coronary flow instability, which can lead to abrupt closure or other adverse events before angiography. The magnitude and fluctuations of the average velocity over time (trend) was studied by using a 0.018-inch Doppler-tipped angioplasty guide wire in 32 patients after coronary angiography (n = 20), atherectomy (n = 2), urgent stent (n = 6), urgent vein graft thrombolysis (n = 4), or acute myocardial infarction (n = 2). The patients (mean age 60 +/- 11 years) had postprocedural in-laboratory flow monitoring for a mean of 19 +/- 11 (range 8 to 36) minutes. The coronary artery monitored was the left anterior descending in 13, circumflex in 6, right coronary artery in 9, and saphenous vein graft in 4. Seven patients had flow-related events during continuous flow velocity monitoring before serial angiographic study. These events included coronary vasospasm (abrupt flow acceleration), vasovagal flow cessation, cyclical flow variations resulting from accumulation of intraluminal thrombus, and rapid decline of flow velocity. The last two patterns were associated with abrupt vessel closure during angioplasty. Continuous flow velocity monitoring is easily incorporated into routine interventional procedures and provides an early indication of unstable flow and the potential for abrupt vessel closure and other adverse events.