Sustained angina relief 5 years after transmyocardial laser revascularization with a CO(2) laser.

BACKGROUND: Although transmyocardial laser revascularization (TMR) has provided symptomatic relief of angina over the short term, the long-term efficacy of the procedure is unknown. Angina symptoms as assessed independently by angina class and the Seattle Angina Questionnaire (SAQ) were prospectively collected up to 7 years after TMR. METHODS: Seventy-eight patients with severe angina not amenable to conventional revascularization were treated with a CO(2) laser. Their mean age was 61+/-10 years at the time of treatment. Preoperatively, 66% had unstable angina, 73% had had >/=1 myocardial infarction, 93% had undergone >/=1 CABG, 42% had >/=1 PTCA, 76% were in angina class IV, and 24% were in angina class III. Their average pre-TMR angina class was 3.7+/-0.4. RESULTS: After an average of 5 years (and up to 7 years) of follow-up, the average angina class was significantly improved to 1.6+/-1 (P=0.0001). This was unchanged from the 1.5+/-1 average angina class at 1 year postoperatively (P=NS). There was a marked redistribution according to angina class, with 81% of the patients in class II or better, and 17% of the patients had no angina 5 years after TMR. A decrease of >/=2 angina classes was considered significant, and by this criterion, 68% of the patients had successful long-term angina relief. The angina class results were further confirmed with the SAQ; 5-year SAQ scores revealed an average improvement of 170% over the baseline results. CONCLUSIONS: The long-term efficacy of TMR persists for >/=5 years. TMR with CO(2) laser as sole therapy for severe disabling angina provides significant long-term angina relief.

Transmyocardial CO(2) laser revascularization improves symptoms, function, and quality of life: 12-month results from a randomized controlled trial.

PURPOSE: To describe differences in health status (symptoms, physical function, and quality of life) between continued medical management and transmyocardial revascularization with a carbon dioxide laser in patients with severe, symptomatic, inoperable coronary artery disease. SUBJECTS AND METHODS: This prospective, multicenter trial randomized 98 patients to transmyocardial revascularization and 99 to continued medical therapy. Health status was assessed with the Seattle Angina Questionnaire and the Short Form-36 at baseline and at 3, 6, and 12 months. A new analytic technique, the benefit statistic, was developed to facilitate interpretability of disease-specific health status assessments over time. RESULTS: Of the 99 patients assigned to medical therapy, 59 (60%) subsequently underwent transmyocardial revascularization. By an intention-to-treat analysis, patients initially randomized to transmyocardial revascularization had 44% of their angina eliminated versus 21% for the medical treatment group (difference = 23%; 95% confidence interval [CI], 11% to 34%). Differences in the benefits of transmyocardial revascularization on physical limitations (33% vs 11% in the medical arm [difference = 23%; 95% CI, 15% to 31%]) and quality of life (47% vs 20% in the medical arm [difference = 26%; 95% CI, 18% to 35%]) were similarly large. These benefits were apparent at 3 months and sustained throughout the 1 year of follow-up. An efficacy analysis that excluded patients who crossed over from the medical treatment to transmyocardial revascularization arm suggested greater treatment benefits. CONCLUSIONS: Transmyocardial revascularization may offer a valuable palliative alternative to patients with severe limitations in health status for whom no standard revascularization options exist.

Morbidity and duration of ICU stay after cardiac surgery. A model for preoperative risk assessment.

Although risk factors for mortality after cardiac surgery have been identified, there is no widely applicable method for readily determining risk of postoperative morbidity based on preoperative severity of illness. The goal of this study was to develop a model for stratifying the risk of serious morbidity after adult cardiac surgery using readily available and objective clinical data. After univariate analysis of risk factors in 3,156 operations, 11 variables were identified as important predictors by logistic regression (LR) analysis and used to construct an additive model to calculate the probability of serious morbidity. Reliable correlation was found between a simplified additive model for clinical use and the LR model. The clinical and logistic models were then tested prospectively in 394 patients and demonstrated a pattern of increasing morbidity with ascending scores similar to that predicted by the reference group. Increasing clinical risk score was also associated with a greater frequency of individual complications as well as prolongation of ICU stay. This study demonstrates that it is feasible to design a simple method to stratify the risk of serious morbidity after adult cardiac surgery. With further prospective multicenter refinement and testing, such a model is likely to be useful for adjusting severity of illness when reporting outcome statistics as well as planning resource utilization.

Transmyocardial laser revascularization in allograft coronary artery disease.

We used transmyocardial laser revascularization to treat accelerated cardiac allograft atherosclerosis in 2 patients. One patient received transmyocardial laser revascularization as sole therapy, the other as an adjunct to coronary artery bypass grafting. The systolic function improved in both patients, although the patient who had adjunctive transmyocardial laser revascularization died of systemic infection and renal failure on postoperative day 55. The second patient is alive and well 1 1/2 years after the laser procedure. We discuss 4 other patients who received transmyocardial laser revascularization treatment elsewhere in the United States. Transmyocardial laser revascularization has the potential to become important in the treatment of transplant atherosclerosis. Randomized clinical trials are warranted to assess the efficacy of transmyocardial laser revascularization in this setting.

Transmyocardial laser revascularization with the CO2 laser: one year results of a randomized, controlled trial.

Transmyocardial laser revascularization (TMR) was compared to continued medical management in 198 patients with symptomatic end-stage coronary artery disease in a 1:1 randomized prospective study. Angina class, quality of life, and myocardial perfusion significantly improved following TMR over a 12-month period of follow-up. Continued medical management was associated with a higher incidence of unstable anginal episodes, repeat hospitalizations, worsening anginal class and myocardial perfusion. This study demonstrates the superiority of TMR over medical management in the treatment of chronic stable angina. With appropriate patient selection and perioperative management, TMR with the CO2 laser is associated with a very low operative risk.

Transmyocardial laser revascularization: current experience and future direction.

Transmyocardial laser revascularization (TMR) with the CO2 laser (PLC Medical Systems, Inc., Franklin, MA) appears to improve the quality of life and event-free survival of end-stage coronary artery disease patients. Application of this technology prior to clinical instability, along with diligent anesthetic support, careful patient selection, and perioperative management, are essential to a successful outcome. Rush-Presbyterian-St. Luke's Medical Center became the fifth clinical site to investigate TMR under Phase II and Phase III U.S. Food and Drug Administration (FDA) protocols. This clinical experience includes a total of seventy-nine patients, of whom sixty-three had sole TMR utilizing a minimally invasive approach on the beating heart. Lessons learned, to optimize patient selection and operative- and postoperative management, will be delineated and the future direction of TMR will be discussed.

Transmyocardial revascularization with a carbon dioxide laser in patients with end-stage coronary artery disease.

BACKGROUND: The construction of subendocardial channels to perfuse ischemic areas of the myocardium has been investigated since the 1950s. We assessed the safety and efficacy of transmyocardial revascularization with a carbon dioxide laser in patients with refractory angina and left ventricular free-wall ischemia that was not amenable to direct coronary revascularization. METHODS: In a prospective, controlled, multicenter trial, we randomly assigned 91 patients to undergo transmyocardial revascularization and 101 patients to receive continued medical treatment. The severity of angina (according to the Canadian Cardiovascular Society [CCS] classification), quality of life, and cardiac perfusion (as assessed by thallium-201 scanning) were evaluated at base line and 3, 6, and 12 months after randomization. RESULTS: At 12 months, angina had improved by at least two CCS classes in 72 percent of the patients assigned to transmyocardial revascularization, as compared with 13 percent of the patients assigned to medical treatment who continued medical treatment (P<0.001). Patients in the transmyocardial-revascularization group also had a significantly improved quality of life as compared with the medical-treatment group. Myocardial perfusion improved by 20 percent in the transmyocardial-revascularization group and worsened by 27 percent in the medical-treatment group (P=0.002). In the first year of follow-up, 2 percent of patients assigned to undergo transmyocardial revascularization were hospitalized because of unstable angina, as compared with 69 percent of patients assigned to medical treatment (P<0.001). The perioperative mortality rate associated with transmyocardial revascularization was 3 percent. The rate of survival at 12 months was 85 percent in the transmyocardial-revascularization group and 79 percent in the medical-treatment group (P=0.50). CONCLUSIONS: In patients with angina refractory to medical treatment and coronary artery disease that precluded coronary-artery bypass surgery or percutaneous transluminal coronary angioplasty, transmyocardial revascularization improved cardiac perfusion and clinical status over a 12-month period.

Epidural anaesthesia and analgesia do not affect energy expenditure after major abdominal surgery.

Our objective was to determine the effect of perioperative epidural anaesthesia and analgesia on the increase in energy expenditure which accompanies major elective abdominal surgery in a prospective, randomized study. Eight patients undergoing elective resections of the colon and/or rectum received general anaesthesia alone (nitrous oxide, oxygen, and isoflurane, supplemented with intravenous fentanyl to a maximum of 10 micrograms.kg-1), and 12 patients received perioperative epidural anaesthesia and analgesia using lidocaine (carbonated lidocaine 2% with epinephrine 1:200,000, 20 ml over 30 min) and morphine (preservative-free morphine 0.10 mg.kg-1 after catheter insertion and 0.05 to 0.10 mg.kg-1 every 12 hr as needed until the morning following surgery) via a lower lumbar catheter in addition to general anaesthesia. Respiratory gas exchange was measured using a metabolic cart and canopy system early on the morning of surgery, six hours postoperatively, and on the first and second postoperative mornings. Parenteral analgesic administration (P < 0.001) and visual analogue pain scores (P < 0.05) were lower in the patients receiving epidural anaesthesia and time to first parenteral analgesia was longer (P < 0.005). Oxygen consumption, carbon dioxide production, and energy expenditure increased after surgery (all P < 0.001) but were very similar in the two groups (all P > or = 0.8) before and after surgery. Despite substantial effects on postoperative pain, we conclude that oxygen consumption and energy expenditure following major abdominal surgery are not diminished by perioperative epidural anaesthesia and analgesia.

Effects of age and body composition on the metabolic responses to elective colon resection.

Advancing age tends to be accompanied by predictable changes in organ-system function and body composition, as well as an increased prevalence of various diseases. Our knowledge of the metabolic responses to surgical stress is derived largely from studies of young and middle-aged individuals. Whether these responses are altered in the elderly is not well established; the characteristic changes in metabolic function and body composition that occur in the elderly may limit their ability to respond adequately and to survive severe or complicated surgical procedures. To evaluate the effects of age and differences in body composition on the metabolic responses to surgery, we studied 20 active and otherwise healthy men aged 43 to 77 years, before and after elective colon resection. Age was not related to weight or total body water (TBW) in the patients studied. Resting preoperative energy expenditure was strongly dependent on TBW (reflecting lean body mass) and age (r2 = 0.80, p less than 0.001), and to TBW and creatinine excretion (reflecting muscle mass) (r2 = 0.85, p less than 0.001). Energy expenditure increased 18 +/- 2% (range, 4% to 40%) after operation but this response was unrelated to age. Postoperative urine nitrogen was related to body weight or TBW, but not to age. Serum glucose, cortisol, white blood cell count count, and C-reactive protein responses were also independent of patient age. The metabolic responses of generally healthy men to a moderate surgical stress do not vary with age in the range studied. The metabolic responses to more severe or prolonged stress may be altered with advancing age and changes in body composition, and in patients with concomitant diseases.

Surface expression of a protective recombinant pertussis toxin S1 subunit fragment in Streptococcus gordonii.

In this study, the expression of the Bordetella pertussis S1 subunit was tested in Streptococcus gordonii, a commensal oral bacterium which has the potential to be a live oral vaccine vehicle. The DNA fragment encoding the N-terminal 179 amino acids of the S1 subunit was ligated into the middle part of spaP, the surface protein antigen P1 gene originating from Streptococcus mutans. The resulting construct, carried on the Escherichia coli-Streptococcus shuttle vector pDL276, was introduced into S. gordonii DL-1 by natural transformation. One of the transformants (RJMIII) produced a 187-kDa protein (the predicted size of the SpaP-S1 fusion protein) which was recognized by both the anti-pertussis toxin (anti-PT) and anti-SpaP antibodies, suggesting that an in-frame fusion had been made. Results from immunogold-electron microscopic studies and cellular fractionation studies showed that the fusion protein was surface localized and was mainly associated with the cell wall of RJMIII, indicating that SpaP was able to direct the fusion protein to the cell surface. A rabbit antiserum raised against heat-killed S. gordonii RJMIII recognized the native S1 subunit of PT in Western blotting and showed a weak neutralization titer to PT by the Chinese hamster ovary cell-clustering assay. BALB/c mice immunized with the heat-killed S. gordonii RJMIII were protected from the toxic effect of PT in the leukocytosis-promoting and histamine sensitization assays. In conclusion, a fragment of the S1 subunit of PT was successfully surface expressed in S. gordonii; the recombinant S1 fragment was found to be immunogenic and could induce protection against the toxic effect of PT in mice.

The influence of age on the severity of peritonitis.

OBJECTIVE: To evaluate the influence of age on the evolution and severity of peritonitis. DESIGN: A chart review. SETTING: An adult university hospital. PATIENTS: One hundred and twenty-two patients with acute appendicitis and 100 patients with acute colonic diverticulitis requiring operation or percutaneous drainage. MAIN OUTCOME MEASURES: Patient age and sex, presence of perforation or gangrene (appendicitis), extent of peritonitis (diverticulitis); duration of symptoms prior to admission; admission leukocyte count; duration of hospitalization before surgery; length of hospital stay; and death rate. RESULTS: Patients with acute appendicitis who were aged 65 years or older were three times more likely than younger patients to have a gangrenous or perforated appendix (odds ratio 3.1, 95% confidence interval 1.1 to 8.4, p < 0.05); older patients with perforated diverticulitis were three times more likely than younger patients to have generalized peritonitis than localized (pericolic or pelvic) peritonitis (odds ratio 2.9, 95% confidence interval 1.2 to 7.5, p < 0.05). CONCLUSION: These findings are consistent with the hypothesis that the biologic features of peritonitis differ in the elderly, who are more likely to present with an advanced or severe process than young patients.

Effects of phenylephrine or volume loading on right ventricular function in patients undergoing myocardial revascularization.

The acute effects of phenylephrine (PHE) administration or intravascular volume loading on right ventricular (RV) function were examined in 34 patients undergoing elective coronary artery surgery. After anesthetic induction with sufentanil and midazolam, 20 patients received PHE to treat hypotension and increase systemic arterial pressure 20% above baseline values. PHE effectively restored arterial pressure without changing stroke index (SI), although RV ejection fraction (RVEF) declined (41.3% to 37.6%) with concomitant increases in RV end-diastolic volume index (RVEDVI) (86.3 to 97.5 mL/m2) and RV end-systolic volume index (51.8 to 63.4 mL/m2). In the first 6 to 8 hours after surgery, 18 patients received intravascular volume expansion with 5% albumin when the clinical perfusion state was inadequate and accompanied by pulmonary artery occlusion pressure (PAOP) less than 15 mmHg and a hemoglobin level greater than 8 g/dL. Volume loading with 500 mL of albumin increased SI(27.0 to 31.8mL/m2), PAOP (12.2 to 15.4 mmHg) and RVEDVI (69.0 to 86.5 mL/m2), although RVEF declined (39.3% to 37.6%). Baseline values of RVEF and SI (but not PAOP or right atrial pressure [RAP]) were lower in 9 of 18 patients who exhibited declines in RVEF after volume loading, and RAP was a poor indicator of RVEDVI (r = 0.17). RVEDVI (but not RAP or PAOP) had significant correlation with SI during volume loading. There was no relationship between the presence of hemodynamically significant right coronary artery stenoses requiring revascularization or other perioperative factors with the response to PHE before revascularization or to volume loading after revascularization.(ABSTRACT TRUNCATED AT 250 WORDS)

Effects of epidural anesthesia and analgesia on coagulation and outcome after major vascular surgery.

To examine the interaction of epidural anesthesia, coagulation status, and outcome after lower extremity revascularization, 80 patients with atherosclerotic vascular disease were prospectively randomized to receive general anesthesia combined with postoperative epidural analgesia (GEN-EPI) or general anesthesia with on-demand narcotic analgesia (GEN). Demographics did not differ between groups except that the GEN-EPI group had a higher incidence of diabetes mellitus and of previous myocardial infarction. Coagulation status was monitored using thromboelastography. An additional 40 randomly selected patients without atherosclerotic vascular disease undergoing noncardiovascular procedures served as controls for coagulation status. Vascular surgical patients were hypercoagulable compared with control patients before operation and on the first postoperative day. Postoperatively, this hypercoagulability was attenuated in the GEN-EPI group and was associated with a lower incidence of thrombotic events (peripheral arterial graft coronary artery or deep vein thromboses). The rates of cardiovascular, infectious, and overall postoperative complications, as well as duration of intensive care unit stay, were significantly reduced in the GEN-EPI group. Stepwise logistic regression demonstrated that the only significant predictors of postoperative cardiovascular complications were preoperative congestive heart failure and general anesthesia without epidural analgesia. We conclude that in patients with atherosclerotic vascular disease undergoing arterial reconstructive surgery (a) thromboelastographic evidence of increased platelet-fibrinogen interaction is associated with early postoperative thrombotic events, and (b) epidural anesthesia and analgesia is associated with beneficial effects on coagulation status and postoperative outcome compared with intermittent on-demand opioid analgesia.

Placement of a PTFE-covered Wallstent through a 12 Fr sheath for the exclusion of a common iliac artery aneurysm.

We describe a technique for transfemoral endovascular exclusion of an iliac artery aneurysm with a reconstrained polytetrafluoroethylene (PTFE)-covered Wallstent inserted through a 12 Fr sheath after right femoral artery cutdown. The procedure was successfully performed, with evidence of complete aneurysm exclusion at 4-month follow-up. This technique reduces the caliber of the introducer needed to deploy the covered Wallstent. It should be noted that because of a leak, an additional covered Palmaz stent was also deployed.