Prospective clinical trial of robotically assisted endoscopic coronary grafting with 1-year follow-up.

OBJECTIVE: To follow up in prospective fashion patients with coronary artery anastomoses completed endoscopically with robotic assistance. The robotic system was evaluated for safety and its effectiveness in completing microsurgical coronary anastomoses. SUMMARY BACKGROUND DATA: Recently there has been an interest in using robotics and computers to enhance the surgeon's ability to perform endoscopic cardiac surgery. This interest has stemmed from the rapid advancement of technology and the desire to make cardiac surgery less invasive. Using traditional endoscopic instruments, it has not been possible to perform coronary surgery. METHODS: Nineteen patients underwent robotically assisted endoscopic coronary artery bypass grafting of the left internal thoracic artery (LITA) to the left anterior descending artery (LAD). Two robotic instruments and one endoscopic camera were placed through three 5-mm ports. A robotic system was used to construct the LITA-LAD anastomosis. All other required grafts were completed by conventional techniques. RESULTS: Seventeen LITA-LAD grafts (89%) had adequate intraoperative flow. The mean LITA-LAD graft flow was 38.5 +/- 5 mL/min. At 8 weeks, LITA-LAD grafts were assessed by angiography and showed 100% patency with thrombolysis in myocardial infarction (TIMI) I flow. At a mean follow-up of 17 +/- 4.2 months, all patients were NYHA class I and there were no adverse cardiac events. CONCLUSIONS: The results from the first prospective clinical trial of robotically assisted endoscopic coronary bypass surgery in the United States showed favorable short-term outcomes with no adverse events. Robotic assistance is an enabling technology allowing the performance of endoscopic coronary anastomoses.

Advances in interventional cardiology: beyond the balloon.

The world of interventional cardiology has changed dramatically since the advent of balloon angioplasty. New therapies have evolved over the past decade as knowledge of the pathophysiology of heart disease has increased. Nurses who have an understanding of this pathophysiology will be better equipped to manage and educate their patients, teaching them about current and future interventional therapies. This article reviews the pathophysiology of heart disease, current interventional therapies, and the future directions for interventional cardiology nursing practice.

Ad hoc coronary intervention.

Ad hoc coronary intervention is a percutaneous revascularization procedure performed at the same sitting as diagnostic cardiac catheterization. While this appears to be an efficient strategy, the safety and cost of ad hoc coronary intervention compared with delayed coronary intervention have not been clearly documented. Special preparation and precautions are necessary for patients in whom ad hoc coronary intervention is anticipated. Ad hoc coronary intervention is not appropriate if informed consent has not been previously obtained or if it would pose greater risks than delayed intervention. While ad hoc coronary intervention is often efficient and effective, its use should be individualized. Cathet. Cardiovasc. Intervent. 49:130-134, 2000.

Robotically assisted coronary artery bypass grafting: a prospective single center clinical trial.

AIM: This prospective study was performed as a Phase 1 Food and Drug Administration clinical trial to assess the safety and feasibility of robotically assisted coronary artery bypass grafting (CABG). METHODS: Eighteen patients undergoing elective CABG were enrolled in this study. Full sternotomy was performed in 17 of 18 patients, while cardiopulmonary bypass and cardioplegic arrest was used in all cases. Robotically assisted CABG of the left internal thoracic artery (LITA) to the left anterior descending artery (LAD) was performed through three ports using a robotically assisted microsurgical system. Conventional techniques were used to perform all other grafts. Blood flow in the LITA graft was measured in the operating room, and when necessary, angiography was performed. Six weeks after the operation, all patients underwent selective coronary angiography of the LITA graft. RESULTS: Robotically assisted coronary artery anastomoses were successfully completed in all patients. Blood flow through the LITA graft was adequate in 16 of 18 patients (89%). The two inadequate grafts were revised successfully by hand. Six weeks after the operation, angiography demonstrated a graft patency of 100% (13 of 13). Mean follow-up has been over 190 days. All patients remain New York Heart Association Angina Class I. CONCLUSION: Robotic assistance represents an enabling technology that may allow the surgeon to perform endoscopic coronary artery anastomoses. Further clinical trials are needed to explore the clinical potential and value of robotically assisted CABG.

Initial United States clinical trial of robotically assisted endoscopic coronary artery bypass grafting.

OBJECTIVES: With traditional instruments, endoscopic coronary artery bypass grafting has not been possible. This study was designed to determine the clinical feasibility of using a robotically assisted microsurgical system to create endoscopic coronary anastomoses. METHODS AND RESULTS: Ten patients underwent endoscopic coronary artery bypass grafting of the left internal thoracic artery to the left anterior descending artery. Subxiphoid endoscopic ports (2 for instruments, 1 for a camera) were placed, and a robotic system was used to perform the left internal thoracic artery-left anterior descending artery bypass graft. Conventional techniques were used to perform the other grafts. Blood flow through the left internal thoracic artery graft was measured in the operating room and was adequate in 8 of 10 patients. The 2 inadequate grafts were revised successfully by hand. Six weeks after the operation, selective coronary angiography demonstrated a graft patency of 100% (8/8). There were no technical failures of the robotic system. The only postoperative complication was mediastinal hemorrhage in 1 patient. CONCLUSIONS: This pilot study demonstrates the feasibility of robotically assisted endoscopic coronary artery bypass grafting.

Complications after placement of an intracoronary stent: nursing implications.

BACKGROUND: Care of patients after stent placement has evolved with the goal of reducing thrombosis and bleeding. Initially, all patients received full antithrombotic therapy; now most receive antiplatelet therapy only. Despite this evolution, no description of the differences in complications and nursing care with these two treatments has been published. OBJECTIVES: To determine the differences in complications and nursing care for patients receiving different pharmacological therapies after placement of an intracoronary stent. METHODS: A nonrandomized, noncontrolled, retrospective, comparative design was used with 176 sequential patients assigned to treatment groups on the basis of the adjunctive pharmacological therapy the patient received after placement of a stent. The equivalency of baseline characteristics and risk of complications, as well as the differences in length of stay, intensity of nursing care, and frequencies of bleeding and ischemic or thrombotic events were determined for the two groups: 65 patients who received anticoagulant therapy and 111 patients who received antiplatelet therapy. RESULTS: The two groups were equivalent with respect to baseline characteristics of sex, concomitant illness, and cardiac condition before stent placement. The two groups differed with respect to predisposing risks for bleeding and ischemic or thrombotic events. Patients receiving antiplatelet therapy alone had significantly shorter lengths of stay, less use of intensive care, fewer requirements for nursing care, and fewer bleeding complications, with no increase in ischemic or thrombotic events. CONCLUSIONS: Patients receiving anticoagulant therapy had more complications and required a higher intensity of nursing care than did patients who received antiplatelet therapy alone.

Guidelines for internal peer review in the cardiac catheterization laboratory. Laboratory Performance Standards Committee, Society for Cardiac Angiography and Interventions.

The Laboratory Performance Standards Committee of the Society for Cardiac Angiography and Interventions has proposed guidelines for establishing an internal peer review program in the cardiac catheterization laboratory. The first step is to establish a committee and a data base. This data base should include quality indicators that reflect: physician qualifications, outcomes of procedures, and processes of care. The outcomes must be risk-adjusted to account for the variable severity of illness. Data should be collected by catheterization laboratory personnel and entered into a laboratory-specific computerized data base. These data must be analyzed and organized into profiles that reflect the quality of care. Based on this information, the Committee would institute the following interventions to improve physician performance: education, clinical practice standardization, feedback and benchmarking, professional interaction, incentives, decision-support systems, and administrative interventions. The legal aspects of peer review are reviewed briefly.

Physical and structural characterization of yersiniophore, a siderophore produced by clinical isolates of Yersinia enterocolitica.

Clinical isolates of Yersinia enterocolitca, which belong to mouse-lethal serotypes, produce the siderophore yersiniophore. Siderophore production was shown to be iron regulated and to reach maximum production in late log phase. Yersiniophore is a fluorescent siderophore with maximum excitation at 270 nm and a major emission peak at 428 nm. Absorption maxima were seen at 210 and 250 nm with a low broad peak from 280 to 320 nm. Purification of unchelated yersiniophore for structural analysis was made difficult by low yields (1-2 mg mg-1), and susceptibility to acid hydrolysis, oxidation and possibly polymerization. Yersinophore was therefore purified as an Al3+ chelate, which was found to be stable in solution for several weeks. To purify Al(3+)-yersinophore, unchelated yersiniophore was first extracted from culture supernatants with dichloromethane, concentrated by rotary evaporation and adsorbed to a DEAE-sephacel column. Al(3+)-yersiniophore was eluted with 0.01 M AlCl3 and further purified by HPLC. The structure was established by a combination of elemental analysis, high resolution mass spectrometry and two-dimensional NMR experiments. Yersiniophore is a phenolate-thiazole siderophore with the formula C21H24N3O4S3Al and a molecular weight of 505.07404 when chelated to Al3+. The structure of yersiniophore was determined to be closely related to the structures of pyochelin, produced by Pseudomonas aeruginosa, and anguibactin, produced by Vibrio anguillarum.

The "dented bladder": diagnosis of a retroperitoneal hematoma.

Retroperitoneal hemorrhage and associated hematoma is a rare but potentially life threatening complication of cardiac catheterization and coronary artery interventions. This case presents the potential diagnostic utility of a supine film of the abdomen for early identification of a retroperitoneal hematoma in a patient following acute infarction PTCA.

Systemic anaphylactoid reactions to iodinated contrast media during cardiac catheterization procedures: guidelines for prevention, diagnosis, and treatment. Laboratory Performance Standards Committee of the Society for Cardiac Angiography and Interventions.

This report represents the first guidelines for prevention, diagnosis, and treatment of anaphylactoid reactions to contrast media occurring specifically during cardiac catheterization. The incidence of contrast media complications in the catheterization laboratory is 0.23% with 1 death per 55,000. Anaphylactoid reactions are nonimmune mediated, but histamine release and other mediators produce a clinical presentation indistinguishable from anaphylaxis. In patients with known previous reactions, pretreatment with steroids and diphenhydramine and the use of nonionic contrast media have significantly reduced the potential of recurrent reaction. Minor reactions such as limited urticaria may be watched for progression or treatment with diphenhydramine, whereas more serious reactions such as angioedema or laryngeal edema require airway stability and ephinephrine administration. Shock should be vigorously treated simultaneously with intravenous epinephrine and large volumes of normal saline. If the patient can be stabilized, the study should be completed as histamine, leukotrienes, and other vasoactive products should be relatively depleted.

Pyrazinoylguanidine downregulates the glucose fatty-acid cycle in hypertensive, hyperinsulinemic diabetic patients.

Eight hypertensive patients with noninsulin dependent diabetes mellitus (NIDDM) were administered the experimental drug pyrazinoylguanidine (PZG) either alone or in combination with calcium-channel or beta-blockers. This treatment appeared to "downregulate" the glucose fatty acid cycle and reduced both systolic and diastolic blood pressures and mean body weight. Patients served as their own controls in this dose-escalation study, which included placebo treatment (baseline) 3 weeks, 300 mg PZG for 3 weeks and 600 mg for 3 weeks. PZG reduced increased serum concentrations of free fatty acids (FFA), glucose, and triglycerides (TG). TG concentrations correlated inversely with serum HDL-cholesterol concentrations. The beta-blockers used by several patients increased their FFA, glucose, insulin and TG concentrations, as well as blunting their response to PZG. The calcium-channel blockers exerted these effects to a much lesser extent. PZG reduced or abolished glycosuria, related to PZG's capacity to decrease hyperglycemia. Withdrawal of PZG restored glycosuria, as blood sugar increased. PZG was well tolerated. No patient reported any adverse effect or missed a weekly clinic visit (12 weeks). PZG deserves further study as supplementary and/or replacement therapy in NIDDM patients who are hypertensive and hyperlipidemic.

Marked ST elevation after successful PTCA for acute myocardial infarction.

Prompt reperfusion of acutely ischemic myocardium appears to be the rational way of reversing ischemic injury and limiting the extent of eventual necrosis. Recent advances in emergency coronary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA) and thrombolytic therapy have provided methods for effective treatment of acute myocardial infarction. However, several observations indicate this issue is more complex. Although blood flow must be restored to ischemic myocardium if it is to survive, animal experiments suggest potential deleterious effects associated with this reperfusion. These deleterious effects may be associated with unstable ST segments reported early after acute infarct thrombolysis. Though recurrent coronary occlusion cannot be excluded, reperfusion injury in this setting of coronary artery patency must be considered. This case illustrates this proposed reperfusion injury reflected as "tombstone" ST segment elevation in a patient following successful acute infarct PTCA.

Comparison of siderophore production and utilization in pathogenic and environmental isolates of Yersinia enterocolitica.

Yersinia enterocolitica strains of serotypes lethal to mice have been reported previously to produce an endogenous siderophore. In this study, an ethyl acetate-extractable siderophore was characterized and given the name yersiniophore. Yersiniophore was produced by 16 of 16 human isolates of serotypes O:4, O:4,32, O:8, O:21, and one nonhuman isolate of serotype O:21. It was not produced by isolates of serotype O:3, O:5, or O:9. One strain of Yersinia pseudotuberculosis produced yersiniophore, but strains of Yersinia kristensenii, Yersinia frederiksenii, and Yersinia intermedia did not produce or utilize yersiniophore. Food and water isolates of Y. enterocolitica produced a water-soluble siderophore but not yersiniophore. Sixty-two strains of Y. enterocolitica including 42 isolates from human infections, 2 animal isolates, and 18 water and food isolates were examined for utilization of yersiniophore, the water-soluble siderophore, and ferrioxamine. Yersiniophore promoted growth rate, iron binding, and uptake in 17 of 62 strains, all of which produced yersiniophore. Ten of 17 food and water isolates and one human isolate were capable of utilizing the water-soluble siderophore. Utilization studies suggest that at least one additional water-soluble siderophore may be produced. Ferrioxamine promoted the growth of 60 of 62 strains examined; however, only the 17 strains which produced yersiniophore actively accumulated [59Fe]ferrioxamine. Yersiniophore production and utilization may be important in clinical infections since all human strains belonging to serotype O:8 produced yersinophore. The water-soluble siderophore was not detected in human isolates.

Effects of pyrazinoylguanidine on the glucose-fatty acid cycle in normal subjects and patients with non-insulin-dependent diabetes mellitus.

Pyrazinoylguanidine (PZG) reduced the hyperglycemia, hyperinsulinemia, and hyperlipidemia of patients with non-insulin-dependent diabetes mellitus (NIDDM) as well as of normal subjects receiving hydrochlorothiazide (HCTZ). Mechanisms are proposed by which PZG downregulated the elevated glucose-fatty acid cycle toward a more normal level in NIDDM patients and in non-diabetic subjects maintained on HCTZ. Despite maintenance of these NIDDM patients on their current antihypertensive medication, PZG reduced further their systolic and diastolic pressures. PZG was well tolerated by both normal and NIDDM patients.