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Biomedical subjects

L F Satler

Publications and source records attributed to L F Satler.

At least 55 records · Page 3Linked to original sources

Safety of intracoronary gamma-radiation on uninjured reference segments during the first 6 months after treatment of in-stent restenosis: a serial intravascular ultrasound study.

BACKGROUND: The effects of endovascular irradiation on uninjured reference segments during the treatment of in-stent restenosis are unknown. METHODS AND RESULTS: In the Washington Radiation for In-Stent restenosis Trial (WRIST), patients with in-stent restenosis were first treated with conventional catheter-based techniques and then randomized (blinded) to receive either gamma-irradiation ((192)Ir) or a placebo (dummy seeds). We identified all patients in whom the active (n=19) or dummy seeds (n=19) extended >10 mm proximal and distal to the in-stent restenosis lesion. Serial (postirradiation and follow-up) external elastic membrane (EEM), lumen, and plaque and media (EEM-lumen) areas were measured (using intravascular ultrasound) every 1 mm over 5-mm-long reference segments that were 6 to 10 mm proximal and distal to the in-stent restenosis lesion. During follow-up, a similar small increase occurred in the plaque and media area in the proximal and distal reference segments in both (192)Ir and placebo patients. However, in the (192)Ir patients, an increase in both proximal and distal EEM area occurred; as a result, no change in lumen area occurred. Conversely, in the placebo patients, the proximal reference EEM area decreased, and no change occurred in the distal reference EEM area; this contributed to a decrease in lumen area. CONCLUSIONS: There was no evidence of a deleterious effect of gamma-irradiation on angiographically normal uninjured reference segments in the first 6 months after the treatment of in-stent restenosis.

Coronary Disease↗

Intracoronary gamma-radiation therapy after angioplasty inhibits recurrence in patients with in-stent restenosis.

BACKGROUND: Treatment of in-stent restenosis presents a critical limitation of intracoronary stent implantation. Ionizing radiation has been shown to decrease neointimal formation within stents in animal models and in initial clinical trials. We studied the effects of intracoronary gamma-radiation therapy versus placebo on the clinical and angiographic outcomes of patients with in-stent restenosis. METHODS AND RESULTS: One hundred thirty patients with in-stent restenosis underwent successful coronary intervention and were then blindly randomized to receive either intracoronary gamma-radiation with (192)Ir (15 Gy) or placebo. Four independent core laboratories blinded to the treatment protocol analyzed the angiographic and intravascular ultrasound end points of restenosis. Procedural success and in-hospital and 30-day complications were similar among the groups. At 6 months, patients assigned to radiation therapy required less target lesion revascularization and target vessel revascularization (9 [13.8%] and 17 [26.2%], respectively) compared with patients assigned to placebo (41 [63.1%, P=0.0001] and 44 [67.7%, P=0.0001], respectively). Binary angiographic restenosis was lower in the irradiated group (19% versus 58% for placebo, P=0.001). Freedom from major cardiac events was lower in the radiation group (29.2% versus 67.7% for placebo, P<0.001). CONCLUSIONS: Intracoronary gamma-radiation used as adjunct therapy for patients with in-stent restenosis significantly reduces both angiographic and clinical restenosis.

Aged↗

Prognostic value of cardiac troponin-I levels following catheter-based coronary interventions.

This study has examined the prognostic significance of troponin-I (Tn-I) levels after catheter-based coronary interventions in coronary arteries and saphenous vein grafts lesions. Tn-I and creatine kinase-MB (CK-MB) fraction levels were measured at 6 and 18 to 24 hours after catheter-based coronary intervention in 1,129 consecutive patients with normal preintervention plasma levels of Tn-I, and CK-MB levels below the cutoff for myocardial infarction. Patients were stratified according to maximal postangioplasty Tn-I levels. Group I (n = 784) had no elevated Tn-I (<0.15 ng/ml), group II (n = 170) had Tn-I at 0.15 to 0.45 ng/ml, and group III (n = 175) had Tn-I elevation >0.45 ng/ml. Major in-hospital complications (death, 0-wave infarction, and emergent coronary bypass grafting) and out-of-hospital intermediate-term (8 months) outcomes were compared between the 3 groups. Tn-I elevation >0.45 ng/ml was associated with increased risk of mortality (group III, 1.6%; group II, 0.6%; and group I, 0.1%; p = 0.019) and major in-hospital complications (3.2%, 1.7%, and 0.5%; p = 0.004). There was no difference in death (1.8%, 3.2%, and 2.4%; p = 0.74), Q-wave infarction (0.6%, 0%, and 0.3%; p = 0.66), or target lesion revascularization (10.1%, 9.0%, and 9.3%; p = 0.86) between the 3 groups at follow-up. Cardiac event-free survival was similar between groups (p = 0.3). By multivariate analysis, Tn-I >0.45 ng/ml was an independent predictor for major in-hospital complications (odds ratio 2.1, 95% confidence interval 1.2 to 3.9, p = 0.01). The degree of risk was also associated with the conjoint elevation of Tn-I and CK-MB levels (odds ratio 1.1, 95% confidence interval 1.02 to 1.2, p = 0.01). We conclude that Tn-I levels >3 times the normal limit and conjoint elevation of Tn-I and CK-MB levels after coronary angioplasty are associated with increased risk of major in-hospital complications, but have no incremental risk of adverse intermediate-term (8 months) clinical outcomes.

Aged↗

Intracoronary beta-radiation therapy inhibits recurrence of in-stent restenosis.

BACKGROUND: Intracoronary gamma-radiation therapy reduces recurrent in-stent restenosis (ISR). This study, BETA WRIST (Washington Radiation for In-Stent restenosis Trial) was designed to examine the efficacy and safety of the beta-emitter 90-yttrium for the prevention of recurrent ISR. METHODS AND RESULTS: A total of 50 consecutive patients with ISR in native coronaries underwent percutaneous transluminal coronary angioplasty, laser angioplasty, rotational atherectomy, and/or stent implantation. Afterward, a segmented balloon catheter was positioned and automatically loaded with a 90-yttrium, 0.014-inch source wire that was 29 mm in length to deliver a dose of 20.6 Gy at 1.0 mm from the balloon surface. In 17 patients, manual stepping of the radiation catheter was necessary for lesions >25 mm in length. The radiation was delivered successfully to all patients, with a mean dwell time of 3.0+/-0.4 minutes. Fractionation of the dose due to ischemia was required in 11 patients. At 6 months, the binary angiographic restenosis rate was 22%, the target lesion revascularization rate was 26%, and the target vessel revascularization rate was 34%; all rates were significantly lower than those of the placebo group of gamma-WRIST. CONCLUSIONS: beta-Radiation with a 90-yttrium source used as adjunct therapy for patients with ISR results in a lower-than-expected rate of angiographic and clinical restenosis.

Adult↗

Percutaneous revascularization of the internal mammary artery graft: short- and long-term outcomes.

OBJECTIVES: We evaluated the short- and long-term clinical outcomes after percutaneous revascularization of the internal mammary artery (IMA) graft. BACKGROUND: Previous reports in a relatively small number of patients have indicated the safety of balloon angioplasty for the treatment of stenoses in the IMA graft. However, the use of alternative interventional techniques and their long-term results have not yet been evaluated. METHODS: We analyzed the in-hospital and one-year clinical outcomes of 174 consecutive patients who underwent percutaneous revascularization of 202 lesions located in the IMA graft, by either balloon angioplasty or stenting. RESULTS: Anastomotic lesions were evident in 128 cases (63%), and they were more commonly treated with balloon angioplasty (116/128, 91%), whereas lesions located at the ostium (n = 16, 8%) were more frequently treated with stents (11/16, 69%). Procedural success was 97% with excellent in-hospital outcome: 0.6% mortality rate, no Q-wave myocardial infarction (MI) and 0.6% rate of urgent bypass surgery. Cumulative one-year rates were: mortality 4.4%, MI 2.9% and target lesion revascularization (TLR) 7.4%. CONCLUSIONS: Revascularization of the IMA graft can be performed safely, with high procedural success and a low rate of in-hospital complications. Long-term follow-up showed very low TLR rate.

Adult↗

Procedural results and late clinical outcomes after percutaneous interventions using long (> or = 25 mm) versus short (< 20 mm) stents.

OBJECTIVES: To evaluate clinical outcomes after the use of long coronary stents. BACKGROUND: The use of long slotted-tube stents has been recently approved in the U.S. to treat long lesions or dissections. Procedural success and long-term outcomes of long versus short stents have not been established. METHODS: We evaluated procedural success, major in-hospital complications, target lesion revascularization and long-term (one year) clinical outcomes in 1,226 consecutive patients (1,259 native coronary lesions) who underwent a single vessel intervention using a single long (> or =25 mm, 116 patients) or short (<20 mm, 1,110 patients) tubular-slotted stent. RESULTS: Patients treated with long stents had more diffuse (>10 mm length) lesions (63% vs. 28%, p = 0.001). The mean stent length was 28 +/- 5 mm versus 15 +/- 2 mm for long versus short stent groups (p = 0.001). Overall procedural success was similar in the long versus short stent groups (96% vs. 98%, p = 0.08). However, major in-hospital complications tended to occur more frequently in patients treated with longer stents (3.4% vs. 1.0%, p = 0.04). The rate of periprocedural non-Q-wave myocardial infarction (MI) (creatine kinase-MB > or =5 times normal) was notably higher after long stent implantation (23% vs. 11%, p = 0.001). Target lesion revascularization at one year was 14.5% vs. 13.8% (p = 0.69), and target vessel revascularization rate was 19.6% vs. 17.3% (p = 0.41) in the long versus short stent group, respectively. There was no difference in one year mortality (2.5% vs. 3.5%, p = 0.49) or Q-wave MI (2.7% vs. 1.2%, p = 0.48), and the overall cardiac event-free survival was similar for the two groups (81%). CONCLUSIONS: The use of single coronary long (> or =25 mm) versus short (<20 mm) stents is associated with: 1) somewhat increased major procedural complications, 2) significantly higher frequency of periprocedural non-Q-wave MIs, and 3) equivalent repeat revascularization risk and cardiac event-free survival out-of-hospital up to one year.

Blood Vessel Prosthesis Implantation↗

Atherosclerotic plaque burden and CK-MB enzyme elevation after coronary interventions : intravascular ultrasound study of 2256 patients.

BACKGROUND: Elevation of serum creatine kinase MB fraction (CK-MB) after percutaneous coronary interventions has been associated with early and late mortality; however, the pathogenesis of CK-MB elevation is still unknown. We hypothesized that CK-MB elevation was related to atherosclerotic plaque burden as assessed by preintervention intravascular ultrasound (IVUS). METHODS AND RESULTS: We studied 2256 consecutive patients who underwent intervention of 2780 native coronary lesions and had complete high-quality preintervention IVUS imaging in the era before routine use of platelet glycoprotein IIb/IIIa inhibitors. Patients were divided into 3 groups: CK-MB within normal range (1675 patients; 2061 lesions); CK-MB elevation 1 to 5 times upper limit of normal (292 patients; 355 lesions); and CK-MB elevation > or = 5 times upper limit of normal (289 patients; 364 lesions). Qualitative angiographic lesion morphology and quantitative analysis were similar among the 3 groups. On preintervention IVUS, progressively more reference segment and lesion site plaque burden and lesion site calcium occurred in the groups with CK-MB elevation. Positive remodeling was more common in lesions with CK-MB elevation. As levels of CK-MB increased, cross-sectional narrowing (percentage plaque burden) increased, both at the reference site (mean cross-sectional narrowing values were 45.1%, <49.3%, and <52.2% for normal CK-MB, 1 to 5 times upper limit of normal, and > or =5 times upper limit of normal groups, respectively; P=0.03) and at the lesion site (81.9%, <85.4%, and <87.1%, respectively; P=0.04). Multivariate analysis indicated that de novo lesions, atheroablative technique, plaque burden at the lesion and reference segments, and final minimal lumen diameter were independent predictors of CK-MB elevation. CONCLUSIONS: CK-MB elevation correlates with a greater atherosclerotic plaque burden. CK-MB elevation after intervention may be a marker of diffuse atherosclerotic disease or a consequence of catheter-based intervention in more diseased arteries or both.

Aged↗

Optimally deployed stents in the treatment of restenotic versus de novo lesions.

Results from earlier trials performed before the implementation of optimal stent deployment techniques suggest that stenting for restenotic lesions may be associated with a higher risk of restenosis when compared with de novo lesions. The aim of this study was to compare the short- and long-term outcome of optimal stent deployment in restenotic versus de novo lesions. In all, 1,865 consecutive patients with 2,707 de novo lesions and 489 patients with 633 restenotic lesions underwent intravascular ultrasound-guided optimal stent deployment. In-hospital outcome was similar for both groups, except for a higher incidence of non-Q-wave myocardial infarction in the de novo group (14.6% vs 8.6%, p = 0.001). At 12-month follow-up, there was no statistical significant difference in the incidence of death or myocardial infarction, but event-free survival was better in the de novo lesion group of patients (74.5% vs 63.7%, p = 0.001). There was a higher incidence of target lesion revascularization in the restenosis group (25.1% vs 13.0%, p = 0.001). By multivariate analysis, restenotic lesions, vein graft lesions, and diabetes mellitus were strong determinants of repeat revascularization, whereas larger preprocedural reference vessel minimal lumen diameter and larger final minimal lumen diameter were associated with a reduced chance of restenosis and increased event-free survival. This study shows that optimal stent deployment for restenotic and de novo lesions has favorable short- and long-term outcome. However, the incidence of target lesion revascularization was significantly greater in restenotic lesions. Saphenous vein graft lesions and diabetes mellitus were confirmed as other independent risk factors for clinical restenosis.

Aged↗

Influence of patient age on acute and late clinical outcomes following Palmaz-Schatz coronary stent implantation.

Procedural success may be lower and complication rates higher after balloon angioplasty in older patients. Elective stent implantation improves procedural outcome in younger patients; however, few series have specifically analyzed the octogenarian population. Therefore, we studied 2,534 consecutive patients (3,965 native coronary artery stenoses) who were treated electively with Palmaz-Schatz stents and divided them into 3 groups: (1) < or = 70 years old (n = 1,805), (2) 71 to 80 years old (elderly, n = 607), and (3) > 80 years old (octogenarian, n = 122). Major in-hospital complications (death, myocardial infarction, and urgent bypass surgery) were significantly higher in the octogenarians than in the elderly and patients < or = 70 years of age (4.5% vs 2.0% and 1.5%; p = 0.001). At 1-year follow-up, cardiac events (death, nonfatal myocardial infarction, and need for any revascularization) did not differ among groups; however, there was a stepwise increase in late death in octogenarians (5%) compared with elderly patients (2%) and patients aged < or = 70 years (1%) (p = 0.001). Target lesion revascularization was similar among the groups (11% in octogenarian vs 14% in elderly and 15% in patients < or = 70 years, p = 0.791). By multivariate logistic regression analysis, age was an independent predictor of late mortality (odds ratio 1.05, p = 0.0001), but not a predictor of target lesion revascularization. Stent implantation in octogenarians is associated with (1) more acute complications, (2) a higher in-hospital mortality, (3) a higher late mortality, and (4) a target lesion revascularization similar to younger patients.

Age Factors↗

Comparison of time course of target lesion revascularization following successful saphenous vein graft angioplasty versus successful native coronary angioplasty.

We studied 1,267 patients with 2,186 saphenous vein graft (SVG) lesions to determine the time course of target lesion revascularization (TLR) after successful SVG angioplasty. We found that the time course of TLR in SVG appears prolonged, with only 54% occurring within the first 6 months and continued TLR even after 1 year.

Aged↗

Prognostic value of recurrent episodes of creatine kinase-MB elevation following repeated catheter-based coronary interventions.

Creatine kinase-MB (CK-MB) enzyme elevations were shown to affect cardiac prognosis following percutaneous coronary interventions (PCIs). This study examined whether recurrent episodes of CK-MB elevation following repeated PCIs may be associated with a cumulative adverse prognostic risk. We studied 767 consecutive patients (age, 64 +/- 11 years; 69% male) who underwent two consecutive PCI procedures on two separate hospitalizations (mean interval, 121 +/- 110 days). Patients were stratified into four groups according to number of episodes of any (> 4 ng/ml) postinterventional CK-MB rise (no elevation, previously elevated, currently elevated, or elevated at the time of both procedures; n = 403, 107, 153, and 104 patients, respectively). In-hospital clinical outcomes (death, Q-MI, and repeat revascularization) and up to 1-year follow-up events were obtained. Recurrent episodes of CK-MB elevation were associated with increased in-hospital mortality (3.8% vs. 0.9% vs. 0% vs. 0%, P = 0.0003), increased cumulative mortality (18.9% vs. 5.9% vs. 4.3% vs. 4.3%, P = 0.0003) and cumulative Q wave MI (8.0% vs. 4.9% vs. 1.0% vs. 0.8%, P = 0.005) at 1 year, and lower overall cardiac event-free survival at follow-up (66.8% vs. 80.5% vs. 88.8% vs. 88.8%, P = 0.0001 for patients with twice, current, previous, and no CK-MB elevation, respectively). By multivariate analysis, CK-MB elevated at the time of both procedures, was the strongest independent predictor for cumulative mortality (OR 3.4, 95% CI 1.6-7.1, P = 0.001) or any adverse cardiac events (OR 2.6, 95% CI 1.6-4.3, P = 0.0002). We conclude that cumulative episodes of periprocedural CK-MB elevation are associated with an incremental adverse prognostic risk including mortality and Q-wave MI. Thus, measures aimed at reducing subsequent CK-MB rise may be warranted in particular among patients with a prior history of PCI related CK-MB elevation.

Aged↗

Lesion-to-lesion relationship of the restenosis process after placement of coronary stents.

The interrelation between multiple stented lesions within one patient in the restenosis process is only partially understood. From 492 patients with follow-up angiograms after coronary stent placement, 115 patients underwent multilesion procedures involving 233 lesions. In randomly chosen 39 patients with 79 lesions, additional intravascular ultrasound (IVUS) studies were performed to measure intimal hyperplasia cross-sectional area (CSA) and thickness. A general linear model with intraclass correlation was used to calculate the coefficient of correlation rho (rho = 1.0 indicates perfect correlation; rho = 0.0 indicates no correlation) of late loss, late loss index, intimal hyperplasia CSA, and intimal hyperplasia thickness. Multivariate analysis showed restenosis in the companion lesion (odds ratio 4.68, 95% confidence interval 1. 68-12.92, P = 0.003) and small minimal lumen diameter preintervention (odds ratio 0.28, 95% confidence interval 0.11-0.73, P = 0.009) to be predictors of restenosis. There was a weak correlation between multiple lesions within the same patient for late lumen loss rho = 0.28 (95% confidence interval 0.10-0.46, P < 0. 001) and late loss index. IVUS analysis demonstrated correlation of intimal hyperplasia CSA rho = 0.40 (95% confidence interval 0.06-0. 74, P = 0.009) and of intimal hyperplasia thickness. In conclusion, late loss and intimal hyperplasia demonstrate a correlation between multiple stented lesions within one patient. In addition to known lesion related factors, restenosis in a companion lesion is a predictor for restenosis. Cathet. Cardiovasc. Intervent. 51:266-272, 2000.

Aged↗