No room for radiant dreams in the real world.
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Beta Particles↗
Biomedical subjects
C di Mario
Publications and source records attributed to C di Mario.
Value of coronary stenotic flow velocity acceleration in prediction of angiographic restenosis following balloon angioplasty.
INTRODUCTION: Quantitative angiographic assessment after balloon angioplasty is a poor predictor of immediate and long-term outcome. However, the measurement of blood flow velocity during angioplasty has been proved clinically useful. AIMS: To analyse the value of the maximal stenotic flow velocity and the presence of stenotic flow velocity acceleration (aSV) for the long-term outcome after balloon angioplasty. METHODS AND RESULTS: Patients undergoing single lesion angioplasty within the DEBATE trial were included. aSV was defined as acceleration in the stenotic coronary flow velocity >50% baseline velocity assessed at a reference site of the target vessel. After balloon angioplasty diameter stenosis, minimal lumen diameter (MLD) and coronary flow velocity reserve were similar between the aSV (n=54) and non-aSV group (n=125). At follow-up, the aSV group had a higher restenosis rate (52% vs 30%, P=0.006) The presence of aSV was the strongest independent predictor of restenosis (OR 3.08, 95% CI 1.35 to 7.05, P=0.008). The best predictive cut-off value of SV was 101cm.s(-1) (sensitivity of 46%, specificity of 81%, positive predictive value of 85% and a negative predictive value of 58%). CONCLUSION: Following angioplasty, SV appears to be exquisitely sensitive to the changes experienced at the treated area without depending on the status of the microcirculation.
Angioplasty, Balloon↗
Randomized comparison of coronary stent implantation under ultrasound or angiographic guidance to reduce stent restenosis (OPTICUS Study).
BACKGROUND: Observational studies in selected patients have shown remarkably low restenosis rates after ultrasound-guided stent implantation. However, it is unknown whether this implantation strategy improves long-term angiographic and clinical outcome in routine clinical practice. Methods and Results-- A total of 550 patients with a symptomatic coronary lesion or silent ischemia were randomly assigned to either ultrasound-guided or angiography-guided implantation of </=2 tubular stents. The primary end points were angiographic dichotomous restenosis rate, minimal lumen diameter, and percent diameter stenosis after 6 months as determined by quantitative coronary angiography. Secondary end points were the occurrence rates of major adverse cardiac events (death, myocardial infarction, coronary bypass surgery, and repeat percutaneous intervention) after 6 and 12 months of follow-up. At 6 months, repeat angiography revealed no significant differences between the groups with ultrasound- or angiography-guided stent implantation with respect to dichotomous restenosis rate (24.5% versus 22.8%, P=0.68), minimal lumen diameter (1.95+/-0.72 mm versus 1.91+/-0.68 mm, P=0.52), and percent diameter stenosis (34.8+/-20.6% versus 36.8+/-19.6%, P=0.29), respectively. At 12 months, neither major adverse cardiac events (relative risk, 1.07; 95% CI 0.75 to 1.52; P=0.71) nor repeat percutaneous interventions (relative risk 1.04; 95% CI 0.64 to 1.67; P=0.87) were reduced in the ultrasound-guided group. CONCLUSIONS: This study does not support the routine use of ultrasound guidance for coronary stenting. Angiography-guided optimization of tubular stents can be performed with comparable angiographic and clinical long-term results.
Blood Vessel Prosthesis Implantation↗
The immediate and long-term effect of optimal balloon angioplasty on the absolute coronary blood flow velocity reserve. A subanalysis of the DEBATE study. Doppler Endpoints Balloon Angioplasty Trial Europe.
BACKGROUND: There are limited data regarding the immediate and long-term effect of balloon angioplasty on the coronary flow reserve evaluated in a multicentre setting. METHODS AND RESULTS: A total of 86 patients with one-vessel disease and normal left ventricular function were analysed before and after optimal balloon angioplasty (diameter stenosis <35%) and at 6-month follow-up. Coronary flow reserve was assessed with a Doppler guide wire. A low coronary flow reserve ( 2.5 (46% vs 23% and 36% vs 16%, respectively; P<0.05) due to a trend towards restenosis (29% vs 16%; P=0.15) or a low coronary flow reserve at follow-up due to persistent elevated baseline blood flow velocity. Patients without restenosis showed a decrease or increase of coronary flow reserve during follow-up, determined by alterations of hyperaemic blood flow velocity. CONCLUSIONS: Patients with an impaired coronary flow reserve directly after optimal balloon angioplasty showed a higher target lesion revascularization rate compared to patients with a coronary flow reserve >2.5. This patient group consists of patients prone to develop restenosis, while other patients are characterized by a persistently low coronary flow reserve, probably secondary to disturbed autoregulation and/or diffuse mild coronary atherosclerosis. Coronary flow reserve alterations in patients without restenosis were related to changes in hyperaemic blood flow velocity, suggesting that this phenomenon relates to epicardial remodelling.
Adult↗
Value of coronary stenotic flow velocity acceleration on the prediction of long-term improvement in functional status after angioplasty.
BACKGROUND: The coronary flow velocity acceleration at the stenotic site (SVA), defined as a > or = 50% increase in resting stenotic velocity when compared with the reference segment, has been shown to be highly sensitive and specific for the diagnosis of a hemodynamically significant stenosis. In this study, we describe the value of postprocedural SVA for the prediction of a lack of improvement in functional activity at long-term follow-up balloon angioplasty (BA). METHODS: We investigated the improvement in functional activity in patients undergoing single native vessel angioplasty and intracoronary Doppler (before BA, after BA, and again at 6-month follow-up) as part of the Doppler Endpoints Balloon Angioplasty Trial Europe (DEBATE) I trial. Lack of improvement was defined as no change in Duke Activity Status Index (DASI) at 6-month follow-up, whereas SVA was defined as > or = 50% elevation in resting velocity at the treated area compared with the distal measurement. RESULTS: SVA was found more frequently in patients without improvement in DASI (45% vs 31%, P =.03). Similar percent diameter stenosis and coronary flow velocity reserve were observed in patients with and those without improvement in DASI at follow-up. By multivariate regression analysis, the presence of SVA (P = .029; odds ratio, 1.97; 95% confidence interval, 1.07 to 3.63) and an elevated DASI at baseline (P < .001; odds ratio, 1.05; 95% confidence interval, 1.03 to 1.07) were associated with a lack of improvement at follow-up. CONCLUSIONS: The detection of SVA was associated with failure of improvement in functional activity at follow-up after coronary intervention.
Angioplasty, Balloon↗
Angiographical and Doppler flow-derived parameters for assessment of coronary lesion severity and its relation to the result of exercise electrocardiography. DEBATE study group. Doppler Endpoints Balloon Angioplasty Trial Europe.
AIMS: Evaluation of angiographical and intracoronary Doppler-derived parameters of coronary stenosis severity. METHODS AND RESULTS: A total of 225 patients with one-vessel disease were studied before PTCA and at 6 months follow-up. Exercise electrocardiography was performed to document presence (n = 157) or absence (n = 138) of an ST segment shift (> or =0.1 mV). Intracoronary blood flow velocity analysis was performed to determine the proximal/distal flow velocity ratio, the distal diastolic/systolic flow velocity ratio and coronary flow velocity reserve. Receiver operator characteristic curves were calculated to assess the predictive value of these variables compared with the exercise test. The distal coronary flow velocity reserve demonstrated the best linear correlation for both percentage diameter stenosis and minimum lumen diameter (r = 0.67 and r = 0.66; P<0.01), compared to the diastolic/systolic flow velocity ratio (r = 0.19 and r = 0.14; P<0.01) and the proximal/distal flow velocity ratio (r = 0.03 and r = 0.07; not significant). The areas under the curve were 0. 84+/-0.02; 0.82+/-0.03 and 0.83+/-0.03 for diameter stenosis, minimum lumen diameter and coronary flow velocity reserve, respectively. Logistic regression analysis revealed that the percentage diameter stenosis or minimum lumen diameter and coronary flow velocity reserve were independent predictors for the result of stress testing. CONCLUSIONS: The distal coronary flow velocity reserve is the best intracoronary Doppler parameter for evaluation of coronary narrowings. Angiographical estimates of coronary lesion severity and distal coronary flow velocity reserve are good and independent predictors for the assessment of functional severity of coronary stenosis, emphasizing the complementary role of these parameters for clinical decision making.
Adult↗
Multicenter evaluation of the XT modular coronary stent: clinical and angiographic results.
BACKGROUND: In the past few years, the indications for stent implantation have broadened, along with a larger number of available designs. The Bard XT stent is a new modular stent with an original structure and design. METHODS: To evaluate the new Bard XT stent, we studied its use in a multicenter experience in 163 patients, with a total of 168 lesions and 180 implanted units. RESULTS: Despite the predominance of complex lesions, the procedural success rate was 98%, with only a 2% failure of stent implantation. There was only one death (no-reflow phenomenon in a rescue primary PTCA in a patient in cardiogenic shock) without other major periprocedural complications. Centralized QCA showed a statistically significant increase of MLD (from 0.73 +/- 0.43 mm to 2.71 +/- 0.40 mm, p < 0.0001) and DS reduction (from 73.8 +/- 15.1% pre-treatment to 7.8 +/- 0.4% after stent implantation; p < 0.0001). Aspirin and ticlopidine were routinely administered after the procedure. Thirty-day follow-up reported only one case of subacute stent thrombosis (in the first day), treated with re-PTCA. CONCLUSIONS: In a group of patients with complex lesions, we obtained a high rate of success with a low incidence of complications. The Bard XT stent had a high-performance profile with normalization of vessel diameter and angiographic results similar to the ones obtained with the "slotted tube" stents.
Aged↗
Atherectomy for ostial LAD stenosis: "a cut above".
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Atherectomy, Coronary↗
Modified "T" stenting: a technique for kissing stents in bifurcational coronary lesion.
The kissing stenting using a new technique in two patients is reported. A stent was positioned at the ostium of the side branch. Another stent was advanced into the main vessel until the center of the stent was positioned near the origin of the side branch. The stent at the ostium of the side branch was deployed and the balloon and the guidewire were removed from the side branch. Thereafter, the stent in the main vessel was deployed. The follow-up angiogram of those patients showed no restenosis in both the vessels.
Aged↗
Procedural and follow up results with a new balloon expandable stent in unselected lesions.
OBJECTIVE: To assess the clinical and angiographic results of the first clinical application of a new balloon expandable stent, the NIR stent, characterised by high longitudinal flexibility and low profile before expansion, and by high radial support and minimal recoil and shortening after expansion. DESIGN: Single centre survey of unselected lesions in consecutive patients. SETTING: Tertiary referral centre. PATIENTS AND LESIONS: 93 stents of various length (9, 16, and 32 mm) were implanted in 64 lesions in 41 patients. Twenty lesions (31%) were longer than 15 mm, and 17 lesions (27%) were located in vessels with a diameter smaller than 2.5 mm. Extreme tortuosity of the proximal vessel was present in 15 lesions (23%). All patients were treated with aspirin and ticlopidine. All lesions were evaluated before and after treatment by quantitative angiography, and in 47 lesions (75%) the stent expansion was also controlled by intracoronary ultrasound. Clinical follow up was available in all patients and angiographic follow up was performed in 53 lesions (84%), at a mean (SD) interval of 5.4 (1.7) months. RESULTS: Deployment of the stent failed in two lesions (3%). Minimum lumen diameter increased from 1.01 (0.54) mm to 2.94 (0.49) mm, and diameter stenosis decreased from 66(15)% to 7(11)%. There was one in-hospital non-Q wave myocardial infarction, one sudden death after 40 days, and 17 target lesion revascularisations (27%). Angiographic restenosis (> or = 50% diameter stenosis) was documented in 19 lesions (36% of all lesions with angiographic follow up), with an average residual diameter stenosis of 43(21)% and minimum lumen diameter of 1.63 (0.74) mm. Restenosis was more common in vessels with a reference diameter < 2.5 mm (45%) and for lesions longer than 15 mm (46%). CONCLUSIONS: The NIR stent could be used successfully in most lesions, achieving optimal angiographic results with very few in-hospital or subacute cardiac events. The angiographic restenosis rate and need for target lesion revascularisation remained high in this unfavourable lesion subset, especially in small vessels and long lesions.
Catheterization↗
Prognostic value of intracoronary flow velocity and diameter stenosis in assessing the short- and long-term outcomes of coronary balloon angioplasty: the DEBATE Study (Doppler Endpoints Balloon Angioplasty Trial Europe).
BACKGROUND: The aim of this prospective, multicenter study was the identification of Doppler flow velocity measurements predictive of clinical outcome of patients undergoing single-vessel balloon angioplasty with no previous Q-wave myocardial infarction. METHODS AND RESULTS: In 297 patients, a Doppler guidewire was used to measure basal and maximal hyperemic flow velocities proximal and distal to the stenosis before and after angioplasty. In 225 patients with an angiographically successful percutaneous transluminal coronary angioplasty (PTCA), postprocedural distal coronary flow reserve (CFR) and percent diameter stenosis (DS%) were correlated with symptoms and/or ischemia at 1 and 6 months, with the need for target lesion revascularization, and with angiographic restenosis (defined as DS > or = 50% at follow-up). Logistic regression and receiver operator characteristic curve analyses were applied to determine the prognostic cutoff value of CFR and DS separately and in combination. Optimal cutoff criteria for predictors of these clinical events were DS, 35%; CFR, 2.5. A distal CFR after angioplasty > 2.5 with a residual DS < or = 35% identified lesions with a low incidence of recurrence of symptoms at 1 month (10% versus 19%, P=.149) and at 6 months (23% versus 47%, P=.005), a low need for reintervention (16% versus 34%, P=.024), and a low restenosis rate (16% versus 41%, P=.002) compared with patients who did not meet these criteria. CONCLUSIONS: Measurements of distal CFR after PTCA, in combination with DS%, have a predictive value, albeit modest for the short- and long-term outcomes after PTCA, and thus may be used to identify patients who will or will not benefit from additional therapy such as stent implantation.
Aged↗
Composition of human thrombus assessed by quantitative colorimetric angioscopic analysis.
BACKGROUND: Angioscopy surpasses other diagnostic tools, such as angiography and intravascular ultrasound, in detecting arterial thrombus. This capability arises in part from the unique ability of angioscopy to assess true color during imaging. In practice, hardware-induced chromatic distortions and the subjectivity of human color perception substantially limit the theoretic potential of angioscopic color. We used a novel application of tristimulus colorimetry to quantify thrombus color to both aid in its detection and assess its composition. METHODS AND RESULTS: A series of human thrombus models were constructed in vitro. Spatial homogeneity was ensured by light and electron microscopy. Quantitative colorimetric angioscopic analysis demonstrated excellent measurement reproducibility (mean difference, 0.07% to 0.17%), unaffected by illuminating light intensity (coefficient of variation, 0.21% to 3.67%). Colorimetric parameters C1 and C2 were strongly correlated (r=.99, P<.0001) with thrombus erythrocyte concentration. Principal components analysis transformed these parameters into a single value, the thrombus erythrocyte index, with little (0.06%) loss of content. Measured and predicted concentrations were similar (mean difference, 0.16 erythrocytes per 1 ng). Randomly ordered images were also subjected to visual analysis by three experienced angioscopists, with suboptimal levels of both intraobserver (mean kappa=0.63) and interobserver (mean kappa=0.48) agreement. In addition, visual ranking resulted in a Kendall rank coefficient of 0.72 to 0.76 versus a perfect 1.00 from quantitative measurement. CONCLUSIONS: Quantitative colorimetric angioscopic analysis provides a new, objective, and reproducible analytic tool for assessing angioscopic images of human thrombus. Even under ideal circumstances, experienced angioscopists do a poor job of assessing color (and therefore composition) of human thrombi. This technique can, for the first time, provide quantitative information of thrombus composition during routine diagnostic imaging.
Angioscopy↗
One balloon approach for optimized Palmaz-Schatz stent implantation: the MUSCAT trial.
BACKGROUND: After stent deployment, larger balloons are frequently needed to optimize stent expansion according to angiographic and intravascular ultrasound (IVUS) criteria. The objective of this trial was to assess the feasibility and safety of a single-balloon approach for predilation, stent implantation, and optimization with a differential-compliant balloon allowing for focal overexpansion. We also evaluated the achieved degree of stent expansion according to IVUS criteria. METHODS AND RESULTS: Forty-seven consecutive patients with 50 lesions received single or multiple Palmaz-Schatz coronary stents. The final angiographic diameter stenosis was -2.6 +/- 12.6% (reference diameter, 2.89 +/- 0.44 mm), and the residual lumen area stenosis (IVUS) was 13.0 +/- 12.3% (reference area 10.8 +/- 3.0 mm2). This result was achieved in two steps (first angiographic, then IVUS-guided stent optimization). The balloon inflation pressure increased from 13.1 +/- 3.0 bar at step 1 to 16.1 +/- 3.0 bar at step 2, which resulted in a balloon to artery ratio of 0.97 +/- 0.12 and 1.10 +/- 0.15, respectively, at the low-compliant peripheral balloon segments. The more compliant central balloon segments showed a balloon to artery ratio of 1.09 +/- 0.17 and 1.28 +/- 0.17, respectively. The primary success rate for stent deployment was 94%. Acute complications included two type A and one type B dissection without clinical sequelae. CONCLUSIONS: The single-balloon approach for stenting is feasible and safe. The acute result is comparable to that of other studies with IVUS-guided stent optimization, the primary success rate, however, is slightly lower with the presently available catheter.
Adult↗
New stent delivery balloon: a technical note.
This study reports the first clinical application of a new noncompliant balloon composed of a middle polyurethane layer sandwiched between an inner layer of polyethylene terephtalate and an outer membrane that provides for consistent even expansion. With this balloon design, the very low compliance and high pressure resistance of polyethylene terephthalate are associated with the high elasticity of polyurethane, preventing balloon damage from stent crimping and expansion and allowing a firm embedding of the stent struts. Palmaz-Schatz stent implantation was successful in 33/35 stents (94%), and the two stents that could not be advanced up to the lesion were successfully withdrawn. High pressure expansion of the stent was obtained during deployment with no balloon ruptures at inflation pressures equal or lower than 16 atmospheres (atm). Accurate positioning of the stent was facilitated by the two markers at the balloon ends and by the optimal visualization after contrast injection, even with 6 Fr guiding catheters. This new delivery system maintains the advantages of hand-crimped stents on noncompliant balloons, reducing the risk of stent loss.
Angioplasty, Balloon↗
Impact of plaque morphology and composition on the mechanisms of lumen enlargement using intracoronary ultrasound and quantitative angiography after balloon angioplasty.
Limited information is provided by angiography on plaque morphology and composition before balloon angioplasty. Identification of plaques associated with reduced lumen gain or a high complication rate may provide the rationale for using alternative revascularization devices. We studied 60 patients with quantitative angiography and intracoronary ultrasound (ICUS) before and after balloon dilation. Angiography was used to measure transient wall stretch and elastic recoil. ICUS was used to investigate the mechanisms of lumen enlargement among different plaque compositions and in the presence of a disease-free wall (minimal thickness < or = 0.6 mm). Compared with ultrasound, angiography underestimated the presence of vessel calcification (13% vs 78%), lumen eccentricity (35% vs 62%), and wall dissection (32% vs 57%). ICUS measurements showed that balloon angioplasty increased lumen area from 1.82 +/- 0.51 to 4.81 +/- 1.43 mm2. Lumen enlargement was the result of the combined effect of an increase in the total cross-sectional area of the vessel (wall stretching, 43%) and of a reduction in the area occupied by the plaque (plaque compression or redistribution, 57%). Vessels with a disease-free wall had smaller lumen gain than other types of vessels (2.13 +/- 1.26 vs 3.59 +/- mm2, respectively, p < 0.01). Wall stretching was the most important mechanism of lumen enlargement in vessels with a disease-free wall (79% vs 37% in the other vessels). Angiography revealed a direct correlation between temporary stretch and elastic recoil that was responsible for 26% of the loss of the potential lumen gain. Thus, lumen enlargement after balloon angioplasty is the combined result of wall stretch and plaque compression or redistribution. ICUS indicates that vessels with a remnant arc of disease-free wall are dilated mainly by wall stretching compared with other types of vessels and are associated with a smaller lumen gain.
Aged↗
Cyclic flow variations after angioplasty: a rare phenomenon predictive of immediate complications. DEBATE Investigator's Group.
Experimental studies and studies in human beings have indicated that cyclic flow variation (CFV) is a reliable marker of the formation of platelet aggregates and thus may be predictive of immediate complications after coronary angioplasty. In this study, the incidence and clinical relevance of CFV in a large patient population after elective percutaneous transluminal coronary angioplasty (PTCA) was assessed. One hundred two patients with one-vessel disease and no previous Q-wave myocardial infarction underwent angiographically successful PTCA of a single lesion of a major coronary artery. A Doppler guide wire inserted distal to the stenosis was used to monitor flow velocity continuously after PTCA for 15 minutes. In 94 (92%) of 102 patients, a stable and reliable Doppler signal could be recorded for 15 minutes after the procedure. CFV, defined as gradual decline in flow over several minutes followed by a sudden restoration to higher values, was observed in 4 patients. In 3 of these 4 patients, the occurrence of CFV was predictive of immediate complications (2 intracoronary thrombosis and 1 acute closure), whereas none of the patients without CFV (n = 90) showed acute closure during hospital stay. In conclusion, CFVs in patients after angiographically successful elective PTCA are rare (4.3%) but highly sensitive for the prediction of abrupt occlusion.
Aged↗
Comparative validation of quantitative coronary angiography systems. Results and implications from a multicenter study using a standardized approach.
BACKGROUND: Computerized quantitative coronary angiography (QCA) has fundamentally altered our approach to the assessment of coronary interventional techniques and strategies aimed at the prevention of recurrence and progression of stenosis. It is essential, therefore, that the performance of QCA systems, upon which much of our scientific understanding has become integrally dependent, is evaluated in an objective and uniform manner. METHODS AND RESULTS: We validated 10 QCA systems at core laboratories in North America and Europe. Cine films were made of phantom stenoses of known diameter (0.5 to 1.9 mm) under four experimental conditions: in vivo (coronary arteries of pigs) calibrated at the isocenter or by use of the catheter as a scaling device and in vitro with 50% contrast and 100% contrast. The cine films were analyzed by each automated QCA system without observer interaction. Accuracy and precision were taken as the mean and SD of the signed differences between the phantom stenoses, and the measured minimal luminal diameters and the correlation coefficient (r), the SEE, the y intercept, and the slope were derived by their linear regression. Performance of the 10 QCA systems ranged widely: accuracy, +0.07 to +0.31 mm; precision, +/- 0.14 to +/- 0.24 mm; correlation (r), .96 to .89; SEE, +/- 0.11 to +/- 0.16 mm; intercept, +0.08 to +0.31 mm; and slope, 0.86 to 0.64. CONCLUSIONS: There is a marked variability in performance between systems when assessed over the range of 0.5 to 1.9 mm. The range of accuracy, intercept, and slope values of this report indicates that absolute measurements of luminal diameter from different multicenter angiographic trials may not be directly comparable and additionally suggests that such absolute measurements may not be directly applicable to clinical practice using an on-line QCA system with a different edge detection algorithm. Power calculations and study design of angiographic trials should be adjusted for the precision of the QCA system used to avoid the risk of failing to detect small differences in patient populations. This study may guide the fine-tuning of algorithms incorporated within each system and facilitate the maintenance of high standards of QCA for scientific studies.
Algorithms↗
Intracoronary two-dimensional ultrasound imaging in the assessment of plaque morphologic features and the planning of coronary interventions.
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Angioplasty, Balloon, Coronary↗