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Biomedical subjects

J Brinker

Publications and source records attributed to J Brinker.

At least 19 recordsLinked to original sources

Predicting postoperative morbidity by clinical assessment.

BACKGROUND: The aim of this study was to determine the accuracy of prediction of the surgeon's 'gut-feeling' in estimating postoperative outcome. METHODS: A prospective series of 1077 consecutive patients undergoing major hepatobiliary or gastrointestinal surgery were studied. Patients having elective (n = 827) and emergency (n = 250) procedures were included. The surgeon predicted the development of postoperative complications immediately after completion of surgery on a scale from 0 to 100 percent. These predictions were compared with the actual outcome and with predictions made using the Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity (POSSUM). The Portsmouth predictor equation (P-POSSUM) was applied for the estimation of mortality. RESULTS: The observed morbidity and mortality rates were 29.5 and 3.4 percent respectively. POSSUM predicted a morbidity rate of 46.4 percent and P-POSSUM a mortality rate of 6.9 percent. The surgeon's gut-feeling was more accurate in the prediction of morbidity at 32.1 percent. On the basis of gut-feeling, surgeons overpredicted morbidity in elective surgery, but underestimated the risk of complications in the emergency setting. The (P)-POSSUM scoring system overpredicted morbidity and mortality for elective and emergency operations. CONCLUSION: The surgeon's gut-feeling is a good predictor of postoperative outcome, especially after elective surgery. (P)-POSSUM overpredicted morbidity and mortality in this series of major gastrointestinal and hepatobiliary operations.

Attitude of Health Personnel↗

Prospective randomized comparison of the safety and effectiveness of placement of endocardial pacemaker and defibrillator leads using the extrathoracic subclavian vein guided by contrast venography versus the cephalic approach.

The purpose of this prospective randomized study was to compare the safety and efficacy of the cephalic approach versus a contrast-guided extrathoracic approach for placement of endocardial leads. Despite an increased incidence of lead fracture, the intrathoracic subclavian approach remains the dominant approach for placement of pacemaker and implantable defibrillator leads. Although this complication can be prevented by lead placement in the cephalic vein or by lead placement in the extrathoracic subclavian or axillary vein, these approaches have not gained acceptance. A total of 200 patients were randomized to undergo placement of pacemaker or implantable defibrillator leads via the contrast-guided extrathoracic subclavian vein approach or the cephalic approach. Lead placement was accomplished in 99 of the 100 patients randomized to the extrathoracic subclavian vein approach as compared to 64 of 100 patients using the cephalic approach. In addition to a higher initial success rate, the extrathoracic subclavian vein medial approach was determined to be preferable as evidenced by a shorter procedure time and less blood loss. There was no difference in the incidence of complications. In conclusion, these results demonstrate that lead placement in the extrathoracic subclavian vein guided by contrast venography is effective and safe. It was also associated with no increased risk of complications as compared with the cephalic approach. These findings suggest that the contrast-guided approach to the extrathoracic portion of the subclavian vein should be considered as an alternative to the cephalic approach.

Aged↗

Wavelet analysis and time-frequency distributions of the body surface ECG before and after angioplasty.

In a pilot study, electrocardiographic (ECG) recordings of patients with left and right coronary stenosis taken before and after angioplasty were analyzed using the continuous wavelet transform. Time-frequency distributions were obtained for different leads in order to examine the dynamics of the QRS-spectrum and establish features specific of ischemia in the time-frequency domain. We found relevant changes in the mid-frequency range, reflecting the ECG's response to percutaneous transluminal coronary angioplasty (PTCA). The changes appeared in ECG leads close to ischemic zones of the myocardium. Time-frequency distributions of the ECG during the QRS may thus become another electrocardiographic indicator of ischemia, alternative to ST-level in standard ECG or body surface mapping. The paper demonstrates the ability of the continuous wavelet transform to detect short lasting events of low amplitude superimposed on large signal deflections.

Angioplasty, Balloon, Coronary↗

[Prostaglandin E1 for prevention of contrast medium-induced kidney dysfunction].

PURPOSE: Acute renal failure is a known complication of contrast media (CM) application in risk patients. Therefore an efficient prevention is highly desirable. The purpose of this pilot study was a) to demonstrate the efficacy and safety of prostaglandin E1 (PGE1 = alprostadil) in the prophylaxis against CM associated renal dysfunction in patients with renal disease, and b) to identify the adequate dose. METHODS: A total of 130 patients with renal dysfunction who were scheduled for intravascular CM administration were enrolled. They received PGE1 (10, 20, or 40 ng/kg/min) or placebo intravenously over a period of six hours (beginning one hour prior to exposure). Efficacy was determined by measuring serum creatinine and creatinine clearance. Safety was assessed by recording adverse experiences throughout the study and close monitoring of vital parameters especially during study drug administration. RESULTS: PGE1 proved to be superior to placebo in all doses. The dose of 20 ng/kg/min was most promising due to the lowest increase of serum creatinine 48 hours after CM administration. With respect to creatinine clearance, no relevant differences between study and control groups were observed. CONCLUSION: Our results suggest that intravenously administered PGE1 may be efficient in preventing CM-induced renal dysfunction in patients with renal impairment.

Acute Kidney Injury↗

Evaluation of a weight-adjusted single-bolus plasminogen activator in patients with myocardial infarction: a double-blind, randomized angiographic trial of lanoteplase versus alteplase.

BACKGROUND: Lanoteplase (nPA) is a rationally designed variant of tissue plasminogen activator with greater fibrinolytic potency and slower plasma clearance than alteplase. METHODS AND RESULTS: InTIME (Intravenous nPA for Treatment of Infarcting Myocardium Early), a multicenter, double-blind, randomized, double-placebo angiographic trial, evaluated the dose-response relationship and safety of single-bolus, weight-adjusted lanoteplase. Patients (n=602) presenting within 6 hours of acute myocardial infarction were randomized and treated with either a single-bolus injection of lanoteplase (15, 30, 60, or 120 kU/kg) or accelerated alteplase. The primary objective was to determine TIMI grade flow at 60 minutes. Angiographic assessments were also performed at 90 minutes and on days 3 to 5. Follow-up was continued for 30 days. Lanoteplase achieved its primary objective, demonstrating a dose-response in TIMI grade 3 flow at 60 minutes (23.6% to 47.1% of subjects, P<0. 001). Similar results were observed at 90 minutes (26.1% to 57.1%, P<0.001). At 90 minutes, coronary patency (TIMI 2 or 3) increased across the dose range up to 83% of subjects at 120 kU/kg lanoteplase compared with 71.4% with alteplase. Thus, at this dose, lanoteplase was superior to alteplase in restoring coronary patency (difference, 12%; 95% CI, 1% to 23%). The early safety experience in this study suggests that lanoteplase was well tolerated at all doses with safety comparable to that of alteplase. CONCLUSIONS: Lanoteplase, a single-bolus, weight-adjusted agent, increased coronary patency at 60 and 90 minutes in a dose-dependent fashion. Coronary patency at 90 minutes was achieved more frequently with 120 kU/kg lanoteplase than alteplase. In this study, safety with lanoteplase and alteplase was comparable. InTIME-II, a worldwide mortality trial, will evaluate efficacy and safety with this promising new agent.

Adolescent↗

Laser wire for crossing chronic total occlusions: "learning phase" results from the U.S. TOTAL trial. Total Occlusion Trial With Angioplasty by Using a Laser Wire.

The Prima laser guidewire system (Spectranectics Corp., Colorado Springs, CO) consists of an 0.018" hypotube containing a bundle of 45-microm optical fibers coupled to a pulsed excimer laser operating at a tip fluence of 60 ml/mm2 and a repetition rate ranging from 25-40 Hz. This laser guidewire was specifically designed to cross total occlusions refractory to passage with conventional wires. The Prima wire was evaluated in a feasibility study at 15 U.S. centers. Following failure to cross a total occlusion with approved guidewires, the Prima wire was utilized in 179 patients. Average age of subjects was 61 yr. Lesion locations included left anterior descending (36%), right (45%), and circumflex (19%) coronary arteries. Mean angiographic age of total occlusions was 70 wk (range, 2-1,020 wk, median, 14 wk). The use of the Prima wire either solely or in combination with conventional guidewires resulted in successful crossing in 61% of these previously impenetrable occlusions. Failure of the device was commonly related to length of the occlusion and tortuosity along the occluded pathway. Major complications included myocardial infarction in 7 patients (3.9%), tamponade in 3 (1.7%), and death in 2 (1.1%). This "learning phase" pilot study confirmed the feasibility of a laser guidewire in chronic total occlusions that are resistant to passage of conventional guidewires. An extended registry at these investigative sites is planned.

Adult↗

Efficacy of coronary stenting versus balloon angioplasty in small coronary arteries. Stent Restenosis Study (STRESS) Investigators.

OBJECTIVES: The goal of this study was to compare the efficacy of elective stent implantation and balloon angioplasty for new lesions in small coronary arteries. BACKGROUND: Palmaz-Schatz stents have been designed and approved by the Food and Drug Administration for use in coronary arteries with diameters > or = 3.0 mm. The efficacy of elective stent placement in smaller vessels has not been determined. METHODS: By quantitative coronary angiography, 331 patients in the Stent Restenosis Study (STRESS) I-II were determined to have a reference vessel < 3.0 mm in diameter. Of these, 163 patients were randomly assigned to stenting (mean diameter 2.69 +/- 0.21 mm), and 168 patients were assigned to angioplasty (mean diameter 2.64 +/- 0.24 mm). The primary end point was restenosis, defined as > or = 50% diameter stenosis at 6-month follow-up angiography. Clinical event rates at 1 year were assessed. RESULTS: Baseline clinical and angiographic characteristics were similar in the two groups. Procedural success was achieved in 100% of patients assigned to stenting and in 92% of patients assigned to angioplasty (p < 0.001). Abrupt closure within 30 days occurred in 3.6% of patients in both groups. Compared with angioplasty, stenting conferred a significantly larger postprocedural lumen diameter (2.26 vs. 1.80 mm, p < 0.001) and a larger lumen at 6 months (1.54 vs. 1.27 mm, p < 0.001). Restenosis (> or = 50% diameter stenosis at follow-up) occurred in 34% of patients assigned to stenting and in 55% of patients assigned to angioplasty (p < 0.001). At 1 year, event-free survival was achieved in 78% of the stent group and in 67% of the angioplasty group (p = 0.019). CONCLUSIONS: These findings suggest that elective stent placement provides superior angiographic and clinical outcomes than balloon angioplasty in vessels slightly smaller than 3 mm.

Angioplasty, Balloon, Coronary↗

Safety and effectiveness of placement of pacemaker and defibrillator leads in the axillary vein guided by contrast venography.

Despite evidence of an increased incidence of lead fracture, the infraclavicular subclavian approach remains the dominant approach for placement of pacemaker and implantable defibrillator leads. Although this complication can be prevented by lead placement in the cephalic vein or by recently described approaches for lead placement in the axillary vein, these approaches have not gained widespread acceptance. The purpose of this study was to evaluate the safety and efficacy of an alternative technique for lead placement that uses contrast-guided venipuncture of the axillary vein with a 5Fr micropuncture introducer set. A total of 50 patients underwent an attempt at placement of pacemaker or implantable defibrillator leads via the axillary vein using this new technique. Patients were randomized into 2 groups based on whether the initial attempt at axillary vein access was performed medial or lateral to the rib cage margin. Lead placement was successfully accomplished in 49 of the 50 patients using this technique. Initial success was achieved in each of 25 patients randomized to the medial approach compared with 18 of 24 patients randomized to the lateral approach to the axillary vein (75%). In each of the 6 patients in whom the initial technique failed, lead placement was subsequently achieved with the medial approach. In addition to a higher initial success rate, the medial approach was determined to be preferable as evidenced by a shorter lead placement time, a smaller number of contrast injections, and a reduced requirement for additional micropuncture guidewires. There were no major complications associated with either approach. Contrast-guided venipuncture of the axillary vein is a safe and effective approach to placement of endocardial leads.

Aged↗

Health after coronary stenting or balloon angioplasty: results from the Stent Restenosis Study.

This study was designed to compare health-related quality of life (HRQOL) in patients undergoing coronary stenting or balloon angioplasty in the randomized Stent Restenosis Study. The study sample was drawn from patients at nine U.S. clinical sites of the Stent Restenosis Study, a randomized trial comparing Palmaz-Schatz coronary stent implantation with conventional balloon angioplasty. One hundred ninety-nine consecutive patients were sent surveys 6 to 18 months after enrollment and 160 (80%) were returned. The survey sent to the patients included the Medical Outcomes Study 36-Item Short-Form Health Survey, the Canadian Cardiovascular Society Classification, and the Duke Activity Status Index. Although patients who underwent stenting had less angiographic restenosis and a tendency for fewer ischemic events, there were few differences in HRQOL after a mean of 456 days after randomization. The group that underwent stenting reported significantly less bodily pain than the group that underwent angioplasty (p = 0.02). Otherwise, there were no significant differences in generic or disease-specific measures. In a rating of their overall health, 47% of the group that underwent stenting and 45% of the group that underwent percutaneous transluminal coronary angioplasty reported very good or excellent health. In each group, 60% of the patients reported being symptom free from a cardiovascular perspective. This survey revealed no marked differences in long-term HRQOL between patients who underwent Palmaz-Schatz coronary stenting compared with those who underwent conventional angioplasty.

Aged↗

Current spectrum of cardiogenic shock and effect of early revascularization on mortality. Results of an International Registry. SHOCK Registry Investigators.

BACKGROUND: Cardiogenic shock remains the leading cause of death of patients hospitalized with acute myocardial infarction (MI). This study was conducted to examine (1) the current spectrum of cardiogenic shock, (2) the proportion of patients who are potential candidates for a trial of early revascularization, and (3) the apparent impact of early revascularization on mortality. METHODS AND RESULTS: Nineteen participating centers in the United States and Belgium prospectively registered all patients diagnosed with cardiogenic shock. Two hundred fifty-one patients were registered. The mean age was 67.5 +/- 11.7 years, and 43% were women. Acute mitral regurgitation or ventricular septal rupture was the cause of shock in 8%. Concurrent conditions contributing to the development of shock were noted in 5%, and 2% had isolated right ventricular shock. Among the remaining 214 patients, nonspecific findings on the ECG associated with "nontransmural" MI were seen in 14%. The median time to shock diagnosis after MI was 8 hours. The overall in-hospital mortality was 66%. Patients clinically selected to undergo cardiac catheterization were significantly younger and had a lower mortality than those not selected (51% versus 85%, P < .0001) even if they were not revascularized (58%). Mortality for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) was 60% (n = 55) and 19% (n = 16) for coronary artery bypass graft surgery (CABG). Sixty percent (n = 150) of registered patients were judged eligible for a trial of early revascularization. Trial-eligible patients were significantly younger (65.4 +/- 11.0 versus 70.6 +/- 11.9 years, P < .001), had an earlier median time to shock onset after MI (6.5 versus 17.5 hours, P = .003), and had lower mortality (62% versus 73%, P = .077) than ineligible patients. CONCLUSIONS: Patients diagnosed with cardiogenic shock complicating acute MI are a heterogeneous group. Those eligible for a trial of early revascularization tended to have lower mortality. Patients selected to undergo cardiac catheterization had lower mortality whether or not they were revascularized. Emergent PTCA and CABG are promising treatment modalities for cardiogenic shock, but biased case selection for treatment may confound the data. Whether PTCA and CABG reduce mortality and which patient subgroups benefit most remain to be determined in a randomized clinical trial.

Aged↗

Early coronary artery stent restenosis: utility of percutaneous coronary angioscopy.

Restenosis of an endovascular stent may be caused by thrombus, intimal hyperplasia, or extrinsic compression. Angiography may not adequately define the etiology of restenosis. We describe a patient in whom angioscopy proved important in diagnosing intimal hyperplasia obviating the need for thrombolytic therapy and prolonged anti-coagulation.

Aged↗

The interaction of antiarrhythmic drugs and the energy for cardioversion of chronic atrial fibrillation.

Antiarrhythmic drugs may alter the energy for cardioversion of ventricular arrhythmias. This study compares the energy necessary for cardioverting chronic atrial fibrillation in 57 patients taking type Ia, Ic, or type III antiarrhythmic drugs. Patients taking Ia (n = 22) or III (n = 14) drugs had a median energy for cardioversion of 100 joules, while the patients taking Ic (n = 17) drugs had a median energy of 200 joules (P = 0.03). There were no differences in the frequency of unsuccessful cardioversion. There were no serious adverse events in any of the three groups, although three patients in the Ic group had greater than 3 second pauses after the shock. The data suggest that the use of Ic antiarrhythmic drugs results in a higher energy for cardioversion of atrial fibrillation. However with higher energies, conversion is as successful as for type Ia and type III.

Amiodarone↗

Clinical interactions between pacemakers and automatic implantable cardioverter-defibrillators.

Concomitant use of a pacemaker and an automatic implantable cardioverter-defibrillator (AICD) is common. Seventeen percent of patients receiving an AICD at The Johns Hopkins Hospital also had a permanent pacemaker implanted before (16 patients), at the same time as (2 patients) or after (12 patients) AICD implantation. Four types of interactions were noted: 1) transient failure to sense or capture immediately after AICD discharge (seven patients); 2) oversensing of the pacemaker stimulus by the AICD, leading to double counting (one patient); 3) AICD failure to sense ventricular fibrillation resulting from pacemaker stimulus oversensing (three patients, one only at high asynchronous output); and 4) pacemaker reprogramming caused by AICD discharge (three patients). No clinical sequelae of these interactions were noted during follow-up study. Thus, potentially adverse clinical interactions are common and routine screening is recommended. With proper attention to lead placements and programming of the devices, clinical consequences of these interactions can be avoided.

Anti-Arrhythmia Agents↗

Influence of coronary occlusion during PTCA on end-systolic and end-diastolic pressure-volume relations in humans.

The influence of acute coronary occlusion on systolic and diastolic left ventricular pressure-volume relations was studied in 10 patients undergoing percutaneous transluminal coronary angioplasty (PTCA). Pressure-volume relations were obtained by conductance catheter and micromanometer techniques and with volume load altered by transient inferior vena caval occlusion. End-systolic and end-diastolic pressure-volume relations were obtained at baseline, during 60-90 seconds of ischemia, and at return to baseline after angioplasty balloon deflation. Coronary occlusion significantly altered systolic and diastolic chamber function. Systolic dysfunction was characterized by a reproducible rightward shift of the end-systolic pressure-volume relation (+25.4 +/- 18.4 ml) that was greater for proximal left anterior descending and circumflex coronary artery occlusions (+41 ml) than for distal or right coronary artery occlusions (+15.4 ml, p less than 0.05). Occlusion also lowered chamber systolic function indexes, such as the end-systolic pressure-volume relation slope (from 4.2 to 2.8 mm Hg/ml) and preload recruitable stroke work (from 97 to 78.6 mm Hg). All systolic (and diastolic) changes were resolved with successful angioplasty. Diastolic abnormalities during angioplasty were characterized by prolonged pressure relaxation and an upward shift of the resting diastolic pressure-volume data and by an apparent increase in chamber elastic stiffness. However, when end-diastolic data from multiple beats during inferior vena caval occlusion were compared, control and ischemic end-diastolic pressure-volume relations displayed little or no difference. Thus, elevations in resting diastolic pressure-volume relations and apparent increase in chamber elastic stiffness during coronary occlusion in humans appear dominated by altered right ventricular or pericardial loading. These data indicate that pressure-volume analysis is useful in assessing the functional significance of coronary lesions and reperfusion.

Angioplasty, Balloon, Coronary↗

Return to work after percutaneous transluminal coronary angioplasty.

A prospective study of 82 patients employed in the 6-month period before percutaneous transluminal coronary angioplasty (PTCA) was performed to determine the patterns of lag time in work resumption and the factors associated with early return to work. One month after PTCA, 59% of patients had resumed work whereas 87% were employed 6 months after PTCA. Patients who had a myocardial infarction in the month before PTCA, as well as those with less than 12 years of education, blue collar jobs and low levels of self-efficacy (self-confidence) for return to work had a lower probability of work resumption at every point in the 24 weeks of follow-up. Cox proportional hazards analysis revealed the psychosocial construct, self-efficacy, to be the strongest predictor of return to work 1 month after PTCA, independent of having a recent myocardial infarction, disease severity, age, job classification, gender and physician advice (p = 0.0006). Kaplan-Meier analysis for return to work after PTCA confirmed that patients with high self-efficacy estimates obtained just before hospital discharge after PTCA resumed employment earlier than those with low self-efficacy levels (p = 0.0001). The same relation was observed in those patients with and without a myocardial infarction in the month before PTCA, p = 0.0022 and 0.0012 respectively. These findings suggest that although PTCA is considered relatively safe and minimally invasive by physicians, patients may still lack confidence in their ability to return to work even when physically capable of doing so.

Absenteeism↗

Subclavian-coronary steal through a LIMA-to-LAD bypass graft.

Eighteen months after coronary artery bypass grafting with a left internal mammary artery (LIMA) graft, a 58-year-old woman had a change in the character of her angina to include pain in the left arm, especially with upper extremity work, culminating in an episode of prolonged rest pain. Cardiac catheterization revealed retrograde flow through the LIMA graft to the subclavian artery and stenosis of the left subclavian artery at its origin from the aorta. Restoration of antegrade flow through the LIMA graft to the coronary arteries was achieved by a carotid-subclavian bypass resulting in a resolution of symptoms. The evaluation of recurrent angina after LIMA bypass grafting should exclude the possibility of subclavian artery stenosis as well as disease of the native and graft coronary anatomy.

Angina Pectoris↗