Multicentre randomized clinical trial to investigate the cost-effectiveness of an allogeneic single-donor fibrin sealant after coronary artery bypass grafting (FIBER Study).

BACKGROUND: Reduction of blood transfusion in cardiac surgery is an important target. The aim of this study was to investigate the cost-effectiveness of the use of CryoSeal®, an allogeneic single-donor fibrin sealant, in patients undergoing coronary artery bypass grafting (CABG). METHODS: This randomized clinical study involved seven cardiac surgery centres in the Netherlands. Patients undergoing elective isolated CABG with the use of at least one internal thoracic artery (ITA) graft were assigned randomly to receive either CryoSeal® (5 ml per ITA bed) or no CryoSeal®. Primary efficacy endpoints were units of transfused red blood cells, fresh frozen plasma and platelet concentrates, and duration of intensive care unit stay. Secondary efficacy endpoints were 48-h blood loss, reoperation for bleeding, mediastinitis, 30-day mortality and duration of hospital stay. RESULTS: Between March 2009 and January 2012, 1445 patients were randomized. The intention-to-treat (ITT) population comprised 1436 patients; the per-protocol (PP) population 1292. In both the ITT and the PP analysis, no significant difference between the treatment groups was observed for any of the primary and secondary efficacy endpoints. In addition, no significant difference between the groups was seen in the proportion of transfused patients. Estimated CryoSeal® costs were €822 (95 per cent c.i. €808 to €836) per patient, which translated to €72,000 per avoided transfusion (unbounded 95 per cent c.i.). CONCLUSION: The use of the fibrin sealant CryoSeal® did not result in health benefits. Combined with the high cost per avoided transfusion, this study does not support the implementation of routine CryoSeal® use in elective isolated CABG. REGISTRATION NUMBER: NTR1386 ( http://www.trialregister.nl).

Noninvasive assessment of coronary flow reserve in the right gastroepiploic artery graft.

BACKGROUND: To investigate the functional capacity of the right gastroepiploic artery graft (GEA) and its ability to adapt to provide adequate flow at peak myocardial demand, we investigated the feasibility of determining coronary flow reserve (CFR) provided by this vessel using transabdominal color Doppler echocardiography and the correlation between this noninvasive determination of flow reserve and nuclear stress scintigraphy. METHODS: In 40 selected patients, who underwent complete arterial myocardial revascularization using the GEA and the internal thoracic arteries (ITAs), CFR of the GEA was measured at maximum coronary hyperemia induced by intravenous adenosine infusion, 7 months (range 3 to 20) after surgery. In the same period, in 31 of this group of patients, exercise thallium scintigraphy was performed. RESULTS: We succeeded in measuring CFR in 37 of 40 patients with values ranging from 1.1 to 3.6 with an average of 2.1 +/- 0.7. During adenosine infusion, mean velocity in the GEA significantly increased from 48 +/- 20 to 89 +/- 41 cm/sec (p < 0.001), mean arterial blood pressure significantly decreased from 96 +/- 11 to 87 +/- 11 mm Hg (p < 0.001), and heart rate significantly increased from 74 +/- 11 to 87 +/- 15 beats/min (p < 0.001). In 8 of these 37 patients, the nuclear exercise test was positive (compatible with reversible ischemia in the distribution area of the GEA). Average CFR in these 8 patients with positive nuclear stress test was 1.46 +/- 0.28 versus 2.27 +/- 0.70 in those patients with a negative test (p < 0.001). CONCLUSIONS: Noninvasive determination of CFR of GEAs is feasible, using transabdominal Doppler echocardiography. The present study shows that coronary vasodilator reserve and autoregulation is maintained in myocardium supplied by the GEA and that the CFR has a significant correlation with the results of noninvasive nuclear exercise testing. Therefore, noninvasive determination of CFR by transabdominal Doppler echocardiography might be a valuable contribution to functional assessment of GEAs.

Noninvasive assessment of right gastroepiploic artery graft patency using transcutaneous color Doppler echocardiography.

BACKGROUND: Because the right gastroepiploic artery graft (GEA), when routed antegastrically, is situated just behind the abdominal wall, we investigated the possibility of evaluating graft patency and flow characteristics using transabdominal color Doppler echocardiography. METHODS: The right GEA graft was evaluated in 71 patients who underwent complete arterial revascularization, 4 months (range, 2 to 17 months) postoperatively. Selective angiography of the right GEA was performed in the patients in whom the graft could not be visualized using color Doppler echocardiography. RESULTS: Flow in the right GEA graft was detected in 65 (91.5%) of 71 patients using color Doppler echocardiography. In all visualized right GEAs, a biphasic flow pattern was observed, with higher peak velocity during systole. Mean (+/- standard deviation) peak systolic velocity was 76+/-16 cm/s. Mean (+/- standard deviation) velocity was 41+/-14 cm/s. Selective angiography of the right GEA in 5 patients in whom the graft could not be visualized using echocardiography showed four patent and functional grafts and one graft that was open but not functional ("slender sign"). One patient died before angiography could be performed. The sensitivity of noninvasive ultrasound assessment of the patency of the right GEA graft was 94% (65 of 69 patients). In this group of patients, an overall right GEA graft patency rate of 97% (69 of 71 patients) was found at mean follow-up of 4 months (range, 2 to 17 months). CONCLUSIONS: The right GEA graft is an adequate coronary artery graft with a good short-term patency rate, and transcutaneous color Doppler echocardiography is a useful tool for evaluating its patency and flow characteristics. Selective angiography of the right GEA can be avoided in most cases and is indicated only when the graft cannot be detected using Doppler echocardiography.

Damage to the circumflex coronary artery during mitral valve repair with sliding leaflet technique.

We report a case of damage to the circumflex coronary artery during mitral valve repair using sliding leaflet technique in a patient with a posterior mitral leaflet prolapse and coronary artery disease who underwent mitral valve reconstruction using Carpentier's technique and coronary artery bypass grafting. This case underscores the risk of circumflex coronary artery injury during mitral valve reconstruction, especially in patients with left coronary dominance or codominance, and therefore emphasizes the importance of knowing the coronary artery anatomy preoperatively. The use of intraoperative transesophageal echocardiography is mandatory for the evaluation of mitral valvuloplasty.

Intraoperative blood flow measurement of the right gastroepiploic artery using pulsed Doppler echocardiography.

BACKGROUND: In coronary artery revascularization, the right gastroepiploic artery (GEA) has become the third arterial conduit of choice after both internal thoracic arteries. To evaluate the function of the right GEA, we used intraoperative ultrasonographic Doppler measurement of the blood flow of this artery. METHODS: From November 1992 to December 1993, in 41 consecutive patients, graft flow velocity, diameter, and blood flow were measured in the proximal part of the GEA before takedown and after completion of the anastomosis just before sternal closure. We also analyzed the predictors of postoperative ischemia. RESULTS: Flow volume of the GEA after anastomosis with the coronary artery has a significant correlation with the diameter of the target coronary artery (p = 0.0011). Two patients had development of ischemia postoperatively. In both, volume flow of the GEA was less than 25 mL/min before takedown compared with an average flow of 55.78 mL/min in the patients without ischemia postoperatively. This was found to be a prognostic indicator of poor graft performance with consequent ischemia. CONCLUSIONS: When the GEA blood flow volume before takedown is less than 25 mL/min, we suggest that this artery not be used as a bypass graft for myocardial revascularization.

Right gastroepiploic artery for coronary bypass reoperation without cardiopulmonary bypass.

Reoperative coronary artery bypass grafting procedure presents a particularly challenging situation for cardiac surgeons. Technical obstacles and operative risks still exceed those of primary procedures. We report a case of a reoperative myocardial revascularization in a 61-year-old woman, in whom the pedicled right gastroepiploic artery was used to bypass the right coronary artery without cardiopulmonary bypass. Postoperative angiographic study before discharge of the patient and transcutaneous Doppler echocardiography controls at two and eleven months showed a good patency of the right gastroepiploic artery graft.

Efficacy and safety of a blood conservation program including low-dose aprotinin in routine myocardial revascularization.

OBJECTIVES: We attempted to analyze the efficacy and safety of an extensive blood saving program applied in a large cohort of patients. MEASURES: Blood saving included reinfusion of intraoperative predonated blood, aprotinin (2 million KIU) in the prime solution, reinfusion of any residual volume, postoperative acceptance of normovolemic anemia (hematocrit > or = 25%) and autotransfusion of shed blood. SETTING, EXPERIMENTAL DESIGN AND PATIENTS: In our general hospital with a heart surgery service (1150 cases/year), we studied the records of 527 non-selected consecutive patients, who were prospectively treated with this program being applied in primary myocardial revascularization between. RESULTS: We avoided the use of donor blood in 86.9% of the patients requiring a mean of 0.2+/-0.01 unit of donor blood per patient. No repeat thoracotomy for bleeding was needed in any patient. Univariate analysis revealed that female gender, a low level of hematocrit, high age, a small stature, weight, body surface area, and red cell volume prebypass significantly (p<0.001) were correlated to treatment with donor blood. Multiple regression showed that a small red cell volume and a low prebypass hematocrit were the most (p<0.0001) significant predictors for the use of donor blood. Observing a low incidence of morbidity (myocardial infarction, gastrointestinal, neurological thromboembolic, renal and wound complications), the safety of this program seems to be emphasized. CONCLUSIONS: Extensive blood saving including low-dose aprotinin reduced effectively and safely the need for donor blood in a large cohort of patients.

Information processing during cardiac surgery: an event related potential study.

The aim of this study was to investigate whether information processing persists during general anesthesia, and if so, to determine the relationship between the degree of cognitive processing measured during anesthesia and the presence or absence of intraoperative memories measured after anesthesia. Subjects were 12 patients, undergoing cardiac surgery with propofol/alfentanil anesthesia. During several periods of the operation, event related potentials (ERPs) to frequent and infrequent tones of different pitch were analyzed. After the operation, a word recognition task with ERP recording was administered to determine whether intraoperatively presented words would elicit a (covert) recognition reaction in the brain. ERP wave forms could be obtained during the intraoperative recording periods but differed substantially from those in the awake state. The presence of ERP components up to 500 msec after stimulus presentation suggests that auditory information processing continued during anesthesia up to a certain level of cognition. Intraoperative ERPs to frequent and infrequent tones were not different from each other implying that differences in pitch could not be detected. The postoperative results demonstrated evidence for intraoperative memories in 3 patients. For 2 of these 3 patients, low propofol levels as well as reliable ERPs with large amplitudes were found close to the moment of information presentation. The results emphasize the importance of combining intra- and postoperative measurements and suggest that late ERP components might be used as indicators of an increased risk of auditory perception.

Complete arterial myocardial revascularization using the right gastroepiploic artery and both internal thoracic arteries as pedicled grafts.

To achieve complete arterial myocardial revascularization without vein grafts, the right gastroepiploic artery and both internal thoracic arteries were used as pedicled grafts in 105 patients from March 1989 to July 1994. There were 101 male and 4 female patients, with a mean age of 51 years (range 32 to 65 years). Three-vessels disease was present in all patients. Six patients underwent previous bypass procedures with the use of vein grafts. A total of 363 distal anastomosis (108 with the right gastroepiploic artery, 255 with both internal thoracic arteries) were constructed. The mean number of distal anastomoses was 3.4. There was no hospital mortality. Seven patients required a rethoracotomy: 5 because of post-operative signs of ischemia, 2 because of bleeding. In one patient a splenectomy had to be performed because of bleeding. A new Q wave was noted in 2 patients. Follow-up averaged 21 months (range 1 to 67 months). Ninety nine (95%) of the patients were in NYHA class I, 6 (5%) in class II. No late complications were noted. We conclude that, complete myocardial revascularization using the right gastroepiploic artery in combination with both internal thoracic arteries as pedicled grafts can be achieved in selected patients with excellent mid term results.

Multiple primary lung cancers.

Between 1970 and 1990, of 1287 patients undergoing resection for primary lung cancer, we considered 55 (4.3%) to have a second primary lung cancer, being synchronous in 15 cases (1.2%) and metachronous in 40 (3.1%). Two patients had a third primary lung cancer. The 15 patients with synchronous cancers were all treated surgically: ten underwent a two-stage procedure and 5 patients a one-stage. In 6 patients the cancers were located bilaterally and in 4 patients both synchronous cancers had a different histology. There were 3 postoperative deaths (20%). The 3- and 5-year actuarial survival rates were 26% and 15%. Of the 40 patients with metachronous cancers the mean interval between treatment of their first and second cancer was 5 years and 11 months. It was longer for the 21 patients having a contralateral second localization (7 years) than for those having an ipsilateral localization (4 years). There was no dependence of the intervals on whether or not the second cancer had the same histology as the first cancer. In 7 patients the second cancer was treated by chemo- and/or radiotherapy and in 33 patients by surgery. There were 5 postoperative deaths in this group (15.2%). The 3- and 5-year actuarial survival rates were 33% and 18%. For 25 patients with a stage I or II second cancer these rates were 42% and 27%; all 8 patients with a stage III second cancer died within 14 months. Survival was positively affected by: histological type differing between both cancers, an interval of more than 3 years, a bilateral localization, and a stage I or II second cancer.(ABSTRACT TRUNCATED AT 250 WORDS)

The Monostrut prosthetic valve. Predictors for valve-related events during an eight years' experience.

All postoperative complications, including transient ischaemic attacks (TIA) and cerebrovascular accidents (CVA) of 259 patients, in whom a total of 301 Monostrut tilting-disc valves were implanted between January 1985 and December 1991 were evaluated retrospectively. The follow-up was maximally 8 years, with a mean of 3.5 years, and totaled 914 patient-years. In this study we found no mechanical deterioration of the Monostrut valve and demonstrated the elimination of valve thrombosis in patients receiving adequate anticoagulation. The actuarial probability of being free of thrombo-embolism was 94.7% +/- 1.7% and free of anticoagulant related hemorrhage 95.4% +/- 1.5% at 8-years. In comparison with earlier reports by others, our findings show a lower ratio of thromboembolic and hemorrhagic events. We demonstrated a correlation (p < 0.05) between thrombo-embolic and hemorrhagic complications. In addition, a lower incidence of CVA's (0.22 per 100 patient-years), but a higher incidence of TIA's (0.66 per 100 patient-years) in comparison with the general Dutch population was found. At eight years follow-up, all patients were in Class I or II of the New York Heart Association Classification. Although the overall valve related event-free survival at eight years was only 47.9%, 93.5% of the patient were satisfied with their operative result. Predictive factors for late mortality were the occurrence of paravalvular leakage (p < 0.01), the age of the patient at the time of operation (p < 0.01) and the number of diseases coronary arteries (p < 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

An anatomical variation of the right gastroepiploic artery that excludes its use as a pedicled coronary bypass graft.

In an attempt to perform complete coronary revascularization with only arterial conduits in a 44 year-old male, both internal mammary arteries and the right gastroepiploic artery were harvested. The right gastroepiploic artery, however, showed an anatomical variation that excluded its use as a pedicled graft.

Histological study of the internal mammary artery with emphasis on its suitability as a coronary artery bypass graft.

The internal mammary, musculophrenic, and superior epigastric arteries were unilaterally harvested from 11 individuals (aged 49 to 83 years; mean age, 67 years) and were examined histologically at 1-cm intervals. In 2 individuals the media of the entire internal mammary artery was elastic, whereas in the other 9 individuals we observed an alternating histological pattern in the media of the internal mammary artery, that of the proximal and distal segments being elastomuscular and that of the mid segment being elastic. In 4 of the latter 9 individuals the distal 10% to 20% of the media of the internal mammary artery was muscular with rare elastic lamellae. The media of the first 1 to 2 cm of the musculophrenic and superior epigastric arteries was elastomuscular or muscular with rare elastic lamellae, whereas more distally the media was purely muscular. The degree of intimal hyperplasia was significantly greater in arterial segments with a purely muscular media (25.6%) than in those with elastic (16.7%), elastomuscular (15.3%), and muscular (with rare elastic lamellae) (17.5%) types of media (p < 0.01). The mean cross-sectional luminal area of the elastic segment (1.9 mm2) and proximal and distal elastomuscular segments (1.9 and 1.2 mm2, respectively) of the internal mammary artery was significantly greater than that of the muscular segments of the musculophrenic artery (0.9 mm2) and the superior epigastric artery (0.7 mm2) (p < 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

Detrimental sequelae on the wall of the internal mammary artery caused by hydrostatic dilation with diluted papaverine solution.

We studied the effect of hydrostatic dilation of the internal mammary artery used for coronary revascularization in 10 patients (aged 45 to 79 years, median 63 years). Diluted papaverine solution was injected in the lumen of distal segments of the internal mammary artery, the musculophrenic artery, or the superior epigastric artery that had been obtained at operation; injection was followed by hydrostatic dilation not exceeding a sheer force of 50 gm. In 12 control patients (aged 42 to 76 years, median 64 years) in whom the internal mammary artery had also been harvested for elective myocardial revascularization, similar arterial segments were wrapped in sponges soaked in papaverine solution of the same dilution. In the nondilated group the median (with interquartile range) number of fenestrations in the internal elastic lamina increased from the elastic (21, 7) to the elastomuscular (41, 11) and muscular segments (89, 12) (elastic-elastomuscular: p = 0.006; elastic-muscular: p = 0.006; elastomuscular-muscular: p = 0.003) (Wilcoxon signed-rank test). In none of the three histologic segments were full-thickness disruptions of the intima and disruptions of the internal elastic lamina seen. Similarly, in the dilated group the number of fenestrations in the internal elastic lamina increased from the elastic (25, 18) to the elastomuscular (43, 9) and muscular (100, 13) segments (p values 0.01, 0.01, and 0.006, respectively). In addition, in 20% of the elastic sections, in 17% of the elastomuscular sections, and in 35% of the muscular sections of the dilated group, disruptions of the intima and internal elastic lamina were seen. Comparison of the number of fenestrations in internal elastic lamina in the three histologic segments between the nondilated and dilated groups revealed a significantly greater value in the muscular segments of the latter group (p = 0.01) (Mann-Whitney U test). We concluded that (1) hydrostatic dilation of the internal mammary, musculophrenic, and superior epigastric arteries may have detrimental effects on the histologic characteristics of the intima and the internal elastic lamina and (2) the number of fenestrations in the internal elastic lamina of these arteries is related to the presence or absence of elastic lamellae in the media.

Retrogastric versus antegastric routing and histology of the right gastroepiploic artery.

To maximize use of the right gastroepiploic artery in myocardial revascularization 11 cadavers were studied to determine the shortest route (retrogastric versus antegastric) of the right gastroepiploic artery from its origin to the recipient coronary artery. Any coronary artery could be reached with an in situ right gastroepiploic artery. There was no significant difference between the retrogastric and antegastric routes for any coronary artery, although the former generally is slightly shorter to the vessels on the posterior surface of the heart and the latter to vessels on the anterior surface of the heart. Histological examination of the right gastroepiploic artery in its proximal, mid, and distal segments showed a similar width of intima and media and invariably an almost purely muscular media. Based on the histological similarity of the right gastroepiploic artery to the coronary artery, some scepticism toward liberal use of the right gastroepiploic artery, especially if used as a free graft, is warranted until clinical studies on its long-term patency have been performed.

Modified Robicsek technique for complicated sternal closure.

A modification of the technique described by Robicsek and associates for treatment of sternum separation after open heart operation is described. The technique consists of placing four interlocking steel wires parasternally on both sides and then including them in the usual transverse peristernal wires.

Successful reoperation in a fractured convexo-concavo 70 degrees aortic Bjørk-Shiley valve.

A female patient was transferred to our unit with the suspicion of fracture of her 70 degrees Bjørk-Shiley valve. A successful replacement of the broken device confirmed the diagnosis. In steep Trendelenburg position, using femoral arterial inflow, the disc could be returned into the operative field by temporarily declamping the aorta.