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Biomedical subjects

R R Heuser

Publications and source records attributed to R R Heuser.

At least 37 records · Page 2Linked to original sources

Outpatient coronary angiography: indications, safety, and complication rates.

In the years since the introduction of outpatient cardiac catheterization and coronary angiography, the indications for the use of these procedures have expanded rapidly with advancements in surgical and endovascular procedures. The safety of outpatient coronary angiography has been well established, comparing very favorably with that of inpatient procedures. At present, a variety of different outpatient facilities exist. Catheterization laboratories may adjoin a hospital or be free-standing; the safety and success of procedures performed in mobile cardiac catheterization laboratories has also been described. There are a variety of access techniques for cardiac catheterization in use today, and there are many types and sizes of catheters available. Miniaturization of equipment has reduced complications and allowed early ambulation and discharge from outpatient laboratories. In addition, the development and refinement of catheters and techniques for achieving hemostasis may allow further reductions in patient stay and complications. The complication rates of outpatient cardiac catheterization and coronary angiography are, in fact, quite low--in some cases, lower complication rates are seen in the outpatient population than in the inpatient population. Although this is certainly related in part to the fact that outpatients generally have more stable disease, it is clear that careful equipment choices, proper technique, and adequate monitoring have contributed to the success of these important outpatient procedures.

Ambulatory Care↗

Embolization of IMA side branch for post-CABG ischemia.

The existence of a chest wall "steal" of blood away from the myocardium through patent internal mammary artery branches has been hypothesized as a cause of recurrent angina pectoris after coronary artery bypass grafting. Although some authors believe that such a steal is physiologically impossible because coronary flow occurs in diastole and chest wall flow in systole, we recently documented ischemia in the left anterior descending coronary artery distribution before embolization of a large left internal mammary artery first intercostal branch that had been left intact at the time of operation. After embolization of the branch, clinical and objective evidence of ischemia resolved.

Coronary Artery Bypass↗

Coronary thrombi increase PTCA risk. Angioscopy as a clinical tool.

BACKGROUND: The presence of angiographically identified intracoronary thrombus has been variably associated with complications after coronary angioplasty. Angiography has been shown to be less sensitive than angioscopy for detecting subtle details of intracoronary morphology, such as intracoronary thrombi. The clinical importance of thrombi detectable by angioscopy but not by angiography is not known. METHODS AND RESULTS: Percutaneous coronary angioscopy was performed in 122 patients undergoing conventional coronary balloon angioplasty (PTCA) at six medical centers. Unstable angina was present in 95 patients (78%) and stable angina in 27 (22%). Therapy was not guided by angioscopic findings, and no patient received thrombolytic therapy as an adjunct to angioplasty. Coronary thrombi were identified in 74 target lesions (61%) by angioscopy versus only 24 (20%) by angiography. A major in-hospital complication (death, myocardial infarction, or emergency bypass surgery) occurred in 10 of 74 patients (14%) with angioscopic intracoronary thrombus, compared with only 1 of 48 patients (2%) without thrombi (P = .03). In-hospital recurrent ischemia (recurrent angina, repeat PTCA, or abrupt occlusion) occurred in 19 of 74 patients (26%) with angioscopic intracoronary thrombi versus only 5 of 48 (10%) without thrombi (P = .03). Relative risk analysis demonstrated that angioscopic thrombus was strongly associated with adverse outcomes (either a major complication or a recurrent ischemic event) after PTCA (relative risk, 3.11; 95% CI, 1.28 to 7.60; P = .01) and that angiographic thrombi were not associated with these complications (relative risk, 0.85; 95% CI, 0.36 to 2.00; P = .91). CONCLUSIONS: The presence of intracoronary thrombus associated with coronary stenoses is significantly underestimated by angiography. Angioscopic intracoronary thrombi, the majority of which were not detected by angiography, are associated with an increased incidence of adverse outcomes after coronary angioplasty.

Adult↗

Femoral artery hemostasis using an implantable device (Angio-Seal) after coronary angioplasty.

Coronary catheter interventional procedures are associated with risk of access site complications. We report our experience with Angio-Seal, an implantable hemostasis device, when used in the femoral artery after coronary angioplasty procedures. Sixty-eight patients were studied. Their average age was 63 years; 84% of the patients were male. All had 8 French access sheaths and received bolus heparin (mean dose 12,690 U). The arterial sheaths were removed an average of 455 min after the conclusion of the procedure, when the activated clotting time was 220 +/- 94 sec (range 97-503 sec). The hemostasis device was successfully deployed in 63 patients (93%). The average time to achieve complete arterial hemostasis was 4.4 +/- 8.9 min (range 0-45). Immediate, total hemostasis without requiring any form of external pressure was obtained in 37 of these patients (54%). the incidence of complications was as follows: significant bleeding occurred in 9 patients (13%); there were 2 hematomas (3%); there were no vascular or infectious complications. One device embolization occurred when the connecting suture broke and the intravascular anchor was lost; no clinical sequelae resulted, and manual hemostasis was successful. In four other patients, the device did not deploy and was removed entirely, followed by uneventful manual hemostasis. Follow-up for 2 months revealed no late sequelae in any patient, and complete absorption of the device was documented by ultrasound study in all cases. We conclude that this implantable device can achieve arterial hemostasis quickly and safety when used in anticoagulated patients after coronary interventional procedures.

Aged↗

Use of c7E3 Fab in conjunction with primary coronary stenting for acute myocardial infarctions complicated by cardiogenic shock.

Although use of thrombolytic therapy during primary angioplasty is controversial, the development of a monoclonal antibody (c7E3 Fab) to the platelet glycoprotein IIb/IIIa receptor has been a tremendous breakthrough in the field of interventional cardiology. Use of the antibody during high-risk angioplasty or atherectomy procedures has been shown to significantly reduce the incidence of death, MI, or emergent repeat revascularization. We describe four cases in which c7E3 Fab was used as an adjunct to coronary stenting in the peri-infarct period in patients with cardiogenic shock. To our knowledge, no other reports have addressed the use of glycoprotein IIb/IIIa receptor inhibitors with coronary stent implantation. Our experience in this small population suggests that coronary stenting for myocardial infarctions may be a feasible option in selected patients to allow maximal luminal dilation and successful reperfusion. We emphasize that our results are preliminary, and we eagerly await the results of the EPILOG study which will provide more definitive data on the safety and efficacy of c7E3 Fab and coronary stenting from the perspective of a large, randomized trial.

Abciximab↗

In-hospital and one-year economic outcomes after coronary stenting or balloon angioplasty. Results from a randomized clinical trial. Stent Restenosis Study Investigators.

BACKGROUND: Coronary stenting has been shown to improve initial success, reduce angiographic restenosis, and reduce the need for repeat revascularization compared with conventional balloon angioplasty (PTCA). Although previous studies have demonstrated that initial hospital costs for stenting are considerably higher than those for conventional PTCA, the impact of coronary stenting on long-term medical care costs remains unknown. METHODS AND RESULTS: Between January 1991 and June 1993, 207 consecutive patients with symptomatic coronary disease requiring revascularization of a single coronary lesion were randomized to receive initial treatment by either PTCA (n = 105) or Palmaz-Schatz coronary stent implantation (n = 102) in the multicenter STRESS trial. Detailed resource utilization and cost data were collected for each patient's initial hospitalization and for any subsequent hospital visits for 1 year after randomization. Compared with conventional angioplasty, coronary stenting resulted in additional catheterization laboratory costs, increased vascular complications, and longer length of stay. Initial hospital costs were thus approximately $2200 higher for stenting than for PTCA ($9738 +/- 3248 versus $7505 +/- 5015; P < .001). Over the first year of follow-up, however, patients assigned to initial stenting were less likely to require rehospitalization for a cardiac condition and underwent fewer subsequent revascularization procedures. Follow-up medical care costs thus tended to be lower for stenting than for conventional angioplasty ($1918 +/- 4841 versus $3359 +/- 7100, P = .21). Nonetheless, cumulative 1-year medical care costs remained higher for patients undergoing initial stenting ($11,656 +/- 5674 versus $10,865 +/- 9073, P < .001). Even after adjustment for the higher incidence of vascular complications in the stent group, total 1-year costs were $300 higher for stenting than for balloon angioplasty. CONCLUSIONS: Elective coronary stenting, as performed in the randomized STRESS trial, increased total 1-year medical care costs by approximately $800 per patient compared with conventional angioplasty. Future studies will be necessary to determine whether ongoing refinements in stent design, implantation techniques, and anticoagulation regimens can narrow this cost difference further by reducing stent-related vascular complications or length of stay.

Aged↗

Bleeding complications with the chimeric antibody to platelet glycoprotein IIb/IIIa integrin in patients undergoing percutaneous coronary intervention. EPIC Investigators.

BACKGROUND: The potential for novel antiplatelet and antithrombin agents to contribute to periprocedural bleeding complications of percutaneous coronary revascularization is poorly defined. In the Evaluation of c7E3 Fab in Preventing Ischemic Complications of High-Risk Angioplasty (EPIC) trial, the periprocedural use of aspirin, heparin, and a chimeric antibody to the platelet glycoprotein IIb/IIIa integrin c7E3 Fab in 2099 patients significantly reduced postprocedural ischemic complications and 6-month clinical restenosis but was associated with increased procedural bleeding complications. We review these complications and describe clinical and procedural variables associated with increased bleeding complications in the EPIC trial. METHODS AND RESULTS: Patients with high-risk clinical or lesion morphological characteristics were randomized to receive placebo bolus plus placebo infusion, c7E3 Fab bolus plus placebo infusion, or c7E3 Fab bolus plus c7E3 Fab infusion. Patients received periprocedural aspirin and intravenous heparin continued for a minimum of 12 hours after the procedure. Outcomes reflecting bleeding complications were measured: transfusions, decreased hemoglobin, and an index including both parameters. Major bleeding complications unrelated to bypass surgery occurred in 3.3%, 8.6%, and 10.6%, and blood product transfusions were used in 7.5%, 14.0%, and 16.8% of patients treated with placebo, bolus c7E3 Fab, and bolus plus infusion c7E3 Fab, respectively (both P < .001). Most major bleeding complications occurred at the femoral access site, regardless of treatment. Intracranial hemorrhage (0.3%) and death (0.09%) attributable to major bleeding complications were rare. Multivariable regression analyses identified several variables significantly and independently related to major bleeding complications or greater blood loss, including greater age, female sex, lower weight, c7E3 Fab therapy, and duration and complexity of the index procedure. Major bleeding complications and blood loss in patients receiving bolus plus infusion were not significantly greater than in those receiving bolus alone (P = .38 and P = .14, respectively). CONCLUSIONS: Bleeding complications unrelated to bypass surgery were two to three times more frequent in patients receiving c7E3 Fab than in those receiving placebo, but most were transient and well tolerated. Risk-factor analysis and modification of concomitant antithrombotic and antiplatelet treatment strategies may aid in reducing bleeding complications and enhancing clinical benefit in patients receiving c7E3 Fab during percutaneous coronary revascularization.

Aged↗

Rotational atherectomy in restenotic lesions at the distal saphenous vein graft anastomosis.

Restenotic lesions at distal saphenous vein graft (SVG) anastomoses have been notoriously difficult to treat with standard angioplasty techniques. We explored the potential of rotational atherectomy in three patients with nonthrombotic, focal restenoses at the SVG touch down. The Rotablator safely and successfully recanalized the lesions, allowing further treatment with dilation or stenting or both. Rotational atherectomy may warrant investigation as a treatment for nonthrombotic restenotic SVG lesions.

Aged↗

Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device.

OBJECTIVES: This study was performed to test the safety and efficacy of a novel bioabsorbable hemostatic puncture closure device deployed through an arterial sheath. BACKGROUND: Cardiac catheterization procedures are associated with a risk of complications at the arterial access site. Increasing numbers of interventional procedures requiring large sheaths or intense anticoagulation underline the need for secure, rapid methods of obtaining hemostasis at the time of sheath removal. METHODS: We conducted a randomized, multicenter trial in 435 patients undergoing cardiac catheterization or angioplasty at eight participating centers. In 218 patients, hemostasis was achieved using the device (group I); 217 patients were assigned to the manual pressure control group (group II). RESULTS: There were no significant differences in baseline characteristics. Time to hemostasis was considerably shorter in group I (2.5 +/- 15.2 vs. 15.3 +/- 11.7 min [mean +/- SD], p < 0.0001). The deployment success rate for the device was 96%, and 76% of group I patients experienced immediate (within 1 min) hemostasis. Complication rates were lower in group I for bleeding, hematoma and occurrence of any complication. There was no difference in the small incidence of pseudoaneurysm formation. There was no change in either group in the ankle/brachial systolic blood pressure index. Ultrasound follow-up studies 60 days after device deployment revealed complete absorption of the device in all cases. Subgroup analysis revealed particular benefit in patients undergoing interventional procedures. The administration of heparin was associated with a significantly higher complication rate in the manual pressure control group, whereas heparin had no effect on hemostasis time or complication rates in the device group. CONCLUSIONS: This sheath-deployed, bioabsorbable device provides a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterization procedures. It appears to be particularly useful in those patients most at risk for access site complications.

Aneurysm, False↗

Immediate results and late outcomes after stent implantation in saphenous vein graft lesions: the multicenter U.S. Palmaz-Schatz stent experience. The Palmaz-Schatz Stent Study Group.

OBJECTIVES: This study reports the multicenter registry experience evaluating the safety and efficacy of the Palmaz-Schatz stent in the treatment of saphenous vein graft disease. BACKGROUND: Saphenous vein graft angioplasty is associated with frequent periprocedural complications and a high frequency of restenosis. Stent implantation has been shown to reduce restenosis, with improved long-term outcomes in the treatment of native coronary artery disease. Preliminary experience with stent placement in the treatment of saphenous vein graft lesions has been favorable. METHODS: Twenty U.S. investigator sites enrolled a total of 589 symptomatic patients (624 lesions) for treatment of focal vein graft stenoses between January 1990 and April 1992. Follow-up angiography was performed at 6 months, and the clinical course of all study patients was prospectively collected at regular intervals for up to 12 months. RESULTS: Stent delivery was successful in 98.8% of cases, and the procedural success rate was 97.1%. The lesion diameter stenosis decreased from 82 +/- 12% (mean +/- SD) before to 6.6 +/- 10.2% after treatment. Major in-hospital complications occurred in 17 patients (2.9%); stent thrombosis was found in 8 (1.4%); and major vascular or bleeding complications were noted in 83 (14.3%). Six-month angiographic follow-up revealed an overall restenosis rate (> or = 50% diameter stenosis) of 29.7%. Multivariate logistic regression analysis indicated that 1) restenotic lesions, 2) smaller reference vessel size, 3) history of diabetes mellitus, and 4) higher percent poststent diameter stenosis were independent predictors of restenosis. The 12-month actuarial event-free survival was 76.3%. CONCLUSIONS: Stent implantation in patients with focal saphenous vein graft lesions can be achieved with a high rate of procedural success, acceptable major complications, reduced angiographic restenosis and favorable late clinical outcome compared with historical balloon angioplasty control series. The rigorous anticoagulation regimen after stent placement results in more frequent vascular and other bleeding complications. Future randomized studies comparing standard balloon angioplasty with stent implantation are warranted to properly assess the full impact of stent placement in the treatment of saphenous vein graft lesions.

Aged↗

Endoluminal grafting for percutaneous aneurysm exclusion in an aortocoronary saphenous vein graft: the first clinical experience.

PURPOSE: Aneurysms develop only rarely in aortocoronary saphenous vein grafts (SVGs), and the usual treatment is surgical replacement of the diseased segment. However, in patients at appreciable risk for redo surgery, alternative therapies are desirable. We report the first compassionate use of a percutaneously delivered endoluminal graft (ELG) for internal exclusion of an SVG aneurysm. METHODS: A 47-year-old male with two coronary bypass procedures and SVG angioplasty presented with an 8-mm diameter aneurysm lying between 80% and 70% stenotic lesions in an SVG to the obtuse marginal branch. The risks of a third bypass operation were considerable, so the decision was made to attempt internal exclusion of the SVG aneurysm. RESULTS: An ELG composed of 2.0-mm diameter unexpanded PTFE graft material with Palmaz stents for fixation was delivered with a low-profile system, but a second ELG was necessary for complete exclusion of the aneurysmal sac. Both ELGs were dilated after initial deployment. The patient was discharged after 9 days without sequelae, and he remains asymptomatic with arteriographically documented ELG patency 5 months after treatment. CONCLUSIONS: In this patient with limited therapeutic options, percutaneous aneurysm exclusion in an SVG was effective in restoring a viable blood conduit. It remains to be seen if ELGs have a potential in aortocoronary SVGs.

Aneurysm↗