Biocompatibility of extracorporeal circulation. In vitro comparison of heparin-coated and uncoated oxygenator circuits.

Oxygenator/tubing sets coated with endpoint-attached heparin were compared to uncoated sets in a dynamic model of extracorporeal circulation. Biocompatibility was assessed by evaluations of complement activation and platelet loss. The median concentration of C3 activation products increased gradually from 12 AU/ml at baseline to 65 AU/ml after 120 minutes in the uncoated sets and from 12 AU/ml to 19 AU/ml after 120 minutes in the coated sets (p less than 0.002). The median concentration of the terminal complement complex in the uncoated sets increased gradually from 3.1 AU/ml at baseline to 18.2 AU/ml after 120 minutes. In the coated sets the terminal complement complex reached a peak of 12.0 AU/ml at 15 minutes and returned to baseline values at 60 minutes. Median platelet loss at 120 minutes was 166 x 10(9) in the uncoated and 21 x 10(9) in the coated sets (p less than 0.01). Heparin coating thus improved biocompatibility by reducing both complement activation and platelet loss.

Reduced complement activation with heparin-coated oxygenator and tubings in coronary bypass operations.

Complement activation after cardiopulmonary bypass is correlated with postoperative organ dysfunction. Heparin coating of the entire blood-contact surface of the cardiopulmonary bypass circuit has proved to reduce complement activation in vitro. A membrane oxygenator and tubing setup coated with functionally active heparin was compared with an uncoated, otherwise identical setup in 20 patients undergoing routine coronary bypass operations. The concentrations of C3 activation products and the terminal complement complex were measured in sensitive and specific enzyme immunoassays. Peak concentrations of C3 activation products were 90.1 (74.7 to 107.4) AU/ml (medians and 95% confidence intervals) and 52.4 (35.7 to 76.4) AU/ml with the uncoated and coated setups, respectively (p = 0.02). The corresponding concentrations of the terminal complement complex were 26.2 (20.1 to 37.5) AU/ml and 13.7 (11.1 to 25.1) AU/ml (p = 0.03). Blood loss from the mediastinal drains during the first 12 postoperative hours was 533 (416 to 975) ml in patients treated with the uncoated setup and 388 (313 to 579) ml in the coated treatment group (p = 0.06) and was significantly correlated with peak concentrations of the terminal complement complex (p = 0.01). There were no differences in neutrophil counts nor platelet numbers between the treatment groups. The approximate 45% reduction in complement activation with the heparin-coated cardiopulmonary bypass device indicates a substantial improvement of biocompatibility.

Complement activation during extracorporeal circulation. In vitro comparison of Duraflo II heparin-coated and uncoated oxygenator circuits.

The degree of complement activation during cardiopulmonary bypass is considered a valuable parameter of biocompatibility of the extracorporeal circuit. In an in vitro setting with a heart-lung machine primed with fresh whole blood and saline solution, the C3 activation products C3b, iC3b, and C3c and the terminal complement complex were measured in double-antibody enzyme immunosorbent assays. No differences were found between seven sets treated with Duraflo II heparin coating and seven uncoated sets after 2 hours of circulation. C3 activation products (expressed as median and 95% confidence intervals) increased from 4.5 AU (2.8 to 12.3 AU) to 16.5 AU (10.0 to 19.4 AU) in the uncoated sets (p = 0.02) and from 4.6 AU (2.2 to 5.8 AU) to 19.3 AU (3.5 to 27.1 AU) in the coated sets (p = 0.02). Terminal complement complex increased from 5.7 AU (2.7 to 11.3 AU) to 13.6 AU (8.2 to 17.8 AU) in the uncoated sets (p = 0.02) and from 7.9 AU (4.6 to 11.4 AU) to 17.3 AU (9.4 to 35.1 AU) in the coated sets (p = 0.02). A significant drop in thrombocyte levels was observed in both coated and uncoated sets. In a supplementary series, the sterilization process did not influence the results. Although Duraflo II heparin coating is considered highly effective in preventing coagulation, it did not prevent complement activation in the present in vitro study. We hypothesize that the mode by which the heparin molecule is bound to the surface may be essential to obtain effects on both coagulation and complement system.

Heparin-coated cardiopulmonary bypass equipment. I. Biocompatibility markers and development of complications in a high-risk population.

OBJECTIVES: 1. To study possible clinical benefits of heparin-coated cardiopulmonary bypass in patients with a broad range of preoperative risk factors. 2. To evaluate the correlation between the terminal complement complex and clinical outcome. 3. To identify clinical predictors of complement activation and correlates of granulocyte activation during cardiac surgery. METHODS: Blood samples from adults undergoing elective cardiac surgery with Duraflo II heparin-coated (n = 81) or uncoated (n = 75) cardiopulmonary bypass sets (Duraflo coating surface; Baxter International, Inc, Deerfield, Ill) were analyzed for activation of complement (C3 activation products, terminal complement complex), granulocytes (myeloperoxidase, lactoferrin), and platelets (beta-thromboglobulin) by enzyme immunoassays. Preoperative risk was assessed by means of the "Higgins' score." Complications (cardiac, renal, pulmonary, gastrointestinal, and central nervous system dysfunction, infections, death) were registered prospectively. Data were analyzed by analysis of variance, logistic regression, and linear regression. RESULTS AND CONCLUSIONS: Sixty-seven percent of the patients had predefined risk factors. Complications developed in 53 patients (34%), equivalently with and without heparin-coated bypass sets (P =. 44-.82), despite a significant reduction in complement and granulocyte activation by heparin coating. No clear-cut relationship between the terminal complement complex and outcome was found, even if it was significant in the models for renal and central nervous system dysfunction and infections (P =.006). The Higgins' score was significantly related to complement activation (P <.05). Approximately 50% of the variation in granulocyte activation was explained by complement (P

Heparin-coated cardiopulmonary bypass equipment. II. Mechanisms for reduced complement activation in vivo.

OBJECTIVE: Our objective was to study mechanisms for reduced complement activation by heparin coating of cardiopulmonary bypass equipment in clinical heart surgery. METHODS: Adults undergoing elective coronary artery bypass grafting were randomized to cardiopulmonary bypass with Duraflo II heparin-coated (n = 15) or uncoated (n = 14) sets (Duraflo coating surface; Baxter International, Inc, Deerfield, Ill). Blood samples were analyzed with the use of enzyme immunoassays for C1rs-C1 inhibitor complexes and the activation products Bb, C4bc, C3bc, C5a-desArg, and the terminal complement complex. Data were compared by repeated-measures analysis of variance. RESULTS: C1 was activated during bypass, and increases in C1rs-C1 inhibitor complexes were larger with heparin coating (P =.03). C4bc increased after administration of protamine, without intergroup differences (P =.69). Bb (P =.22) and C5a-desArg (P =.13) tended to increase less with heparin coating. Formation of C3bc (P =.03) and the terminal complement complex (P <.01) was significantly reduced with heparin coating. C5a-desArg increased 2-fold during bypass, whereas the terminal complement complex increased 10- to 20-fold. Maximal terminal complement complex concentrations were significantly correlated to maximal Bb and C3bc (R = 0.6, P <.001), but not to C1rs-C1 inhibitor complexes or C4bc (R < 0.05, P >.8). CONCLUSIONS: C1 activation during bypass was increased by heparin coating, but further classical pathway activation was held in check until administration of protamine. Heparin coating significantly inhibited C3bc and terminal complement complex formation. Terminal complement complex concentrations were related to alternative pathway activation and may be useful for evaluation of differences in bypass circuitry. Increases and intergroup differences in terminal complement complex concentrations were much larger than those in C5a-desArg.

Diagnosis and management of major trauma.

A regional trauma system involving trained hospital teams as well as physician-manned ambulances and helicopters has been established in Norway. Emphasis is on written guidelines and the continuous evaluation of the results. A grading system of injury severity is used. Despite major advances in the initial treatment of shock and major trauma, posttraumatic pulmonary insufficiency still represents a problem. Our results indicate a beneficial effect of the early prophylactic use of high-dose corticosteroids in major chest trauma. The use of three doses of methylprednisolone was not associated with any increased risk of infection.

Up to eight years' follow-up of 997 patients receiving the CarboMedics prosthetic heart valve.

BACKGROUND: The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis. METHODS: Nine hundred ninety-seven consecutive patients underwent mechanical valve implantation (aortic, 771; mitral, 169; double, 52; tricuspid, 5) with this prosthesis from September 1987 through December 1993. The mean age was 62.3+/-13.7 years (range, 0.4 to 84 years); 56.6% (564 patients) were men. Four hundred seventy patients (47.1%) underwent additional surgical procedures. Mean follow-up was 4.1+/-2.2 years (range, 0 to 8.3 years) with a total of 4,040 patient-years. RESULTS: Early mortality was 5.0% (50/997; aortic, 4.4%; mitral, 6.4%; double, 9.6%). Late mortality was 14.8% (140/947). Survival at 7 years was 75.9%+/-1.8% (aortic, 78.4%+/-2%; mitral, 70.7%+/-4.5%; double, 60.8%+/-7.4%). When matched for sex and age and compared with the normal Norwegian population, our patients had an increased standard mortality ratio in both men (1.9+/-0.4) and women (2.9+/-0.6). The linearized rate of major thromboembolism was 0.9% per patient-year, valve thrombosis 0.2% per patient-year, major bleeding event 0.6% per patient-year, paravalvular leak needing reoperation 0.5% per patient-year, prosthetic valve endocarditis 0.1% per patient-year, and of all reoperations 0.6% per patient-year. CONCLUSIONS: The CarboMedics Heart Valve Prosthesis has incidences of morbid events comparable with or better than reported for other mechanical valves.

Intraaortic balloon pump in open heart operations: 10-year follow-up with risk analysis.

BACKGROUND: The intraaortic balloon pump (IABP) is the primary mechanical device used for perioperative cardiac failure. METHODS: We analyzed the prognostic predictors and long-term survival of 344 patients undergoing cardiac operations who required the perioperative use of an IABP at our institution from January 1980 to December 1989. Hospital survivors (163 patients) were followed up for a mean of 7.45 years (range, 1 month to 15.3 years); cumulative follow-up included 1,167 patient-years. RESULTS: The early mortality rate was 52.6% (181 patients). From parameters available at the time of IABP insertion, logistic regression analysis identified preoperative serum creatinine level, left ventricular ejection fraction, perioperative myocardial infarction, timing of IABP insertion, and indication for operation as independent predictors of early (30-day) death (p < 0.05). Cox regression analysis of hospital survivors identified timing of IABP insertion, perfusion time, and preoperative serum creatinine level as independent prognostic factors for late death (p < 0.05), whereas patient age was only marginally significant (p < 0.06). There was no association between IABP-related complications and death. Survival analysis demonstrated a 10-year actual survival rate of 22.04% +/- 0.023%, with 57 patients still at risk and significantly improved survival among those who received an IABP before operation (p < 0.02). CONCLUSIONS: The early mortality rate in patients who received an IABP was high. Hospital survivors had a relatively good long-term prognosis. The significantly better short- and long-term survival of patients who received an IABP before operation may justify more liberal preoperative use of the IABP in high-risk patients.

Should the lungs be ventilated during cardiopulmonary bypass? Clinical, hemodynamic, and metabolic changes in patients undergoing elective coronary artery surgery.

No beneficial effects were achieved by ventilating the lungs of a group of 10 patients during total extracorporeal circulation for coronary artery bypass operation. Ventilation of nonperfused lungs, which was suggested to prevent postoperative atelectasis, may even have negative effects. Intrapulmonary shunting increased significantly (p less than 0.05), while the shunt fraction in the nonventilated lungs of another group of 10 patients remained unchanged. There were only minor differences between the two groups with respect to systemic and pulmonary hemodynamic changes.

Complement activation with bubble and membrane oxygenators in aortocoronary bypass grafting.

Thirty-three patients admitted for coronary bypass grafting were randomized to cardiopulmonary bypass with a bubble oxygenator (Cobe or Polystan) or a membrane oxygenator (SciMed). Plasma concentrations of C3 activation products and the terminal complement complex were measured using enzyme immunoassays. Both variables increased almost linearly after onset of cardiopulmonary bypass, with maximal concentrations at closure of the sternum. From a baseline of 7.5 to 12.0 arbitrary units (AU)/mL (medians), the concentrations of C3 activation products increased by 117.5 AU/mL (Cobe), 120.5 AU/mL (Polystan), and 213.3 AU/mL (SciMed). The increase in the membrane group was significantly higher than in the two bubble oxygenator groups (p less than 0.01). From a baseline of 0.9 to 1.3 AU/mL, the concentrations of terminal complement complex increased by 5.4 AU/mL (Cobe), 6.6 AU/mL (Polystan), and 7.7 AU/mL (SciMed) (differences not significant). The higher C3 activation caused by the membrane oxygenator may be explained by differences in flow profile and surface area in contact with blood. The study cannot confirm the general assumption that membrane oxygenators lead to lower complement activation than do bubble oxygenators.

Time for new concepts about measurement of complement activation by cardiopulmonary bypass?

Fifty-one patients admitted for routine coronary bypass operations were randomized to cardiopulmonary bypass with a membrane oxygenator (Capiox) or a bubbler (Polystan or William Harvey). Complement activation was measured using enzyme immunoassays for concentrations of C3 activation products and the terminal complement complex. From 5.8 to 8.1 arbitrary units (AU)/mL (medians), the plasma concentrations of C3 activation products increased by 119.9 AU/mL (Capiox), 124.6 AU/mL (Polystan), and 79.5 AU/mL (William Harvey) to a peak at closure of the sternum (not significant when related to baseline concentrations). The increase in C3 activation products and baseline C3 activation were linearly correlated (R2 = 0.30; p less than 0.0001). From 5.5 to 6.1 AU/mL, the plasma terminal complement complex concentrations increased by 45.2 AU/mL (Capiox), 15.4 AU/mL (Polystan), and 17.4 AU/mL (William Harvey) to a peak before termination of cardiopulmonary bypass. Maximal terminal (C5-C9) activation was significantly higher in the membrane oxygenator group (p less than 0.0001) and showed no relationship to C3 activation. Measurement of C3 activation only gives no information about C5-C9 activation. At present, terminal complement complex quantitation is probably the best index of C5-C9 activation during cardiopulmonary bypass.

The CarboMedics valve: midterm follow-up with analysis of risk factors.

BACKGROUND: This study examined the midterm results with the CarboMedics prosthetic valve. METHODS: From 1987 through 1991 a total of 569 patients received the CarboMedics prosthesis. RESULTS: Early mortality was 4.9% and related to emergency operation, presence of diabetes mellitus, coronary artery disease, preoperative New York Heart Association class, duration of cardiopulmonary bypass, and aortic cross-clamp time. Midterm follow-up with respect to mortality was 100% complete. All patients were followed up in the hospital after 1 year. In addition 86% of the patients responded to a questionnaire. Mean follow-up was 3 years (range, 0 to 5.6 years). Cumulative survival at 1 and 4 years was 91.2% +/- 1.2% and 83.7% +/- 1.8%, respectively. Five patients experienced obstructive valve thrombosis (0.3%/patient-year), 16 patients had major thromboembolic events (0.9%/patient-year), and 10 patients had major warfarin-related bleeding (0.6%/patient-year) requiring hospitalization or blood transfusions. Eight patients were reoperated on for paraprosthetic leak (0.4%/patient-year). Prosthetic valve endocarditis developed in 4 patients (0.2%/patient-year). No structural valve failure was observed. CONCLUSIONS: Midterm follow-up demonstrates that the CarboMedics mechanical prosthesis is reliable and has an acceptable rate of valve-related complications.

Intraaortic balloon pumping for predominantly right ventricular failure after heart transplantation.

BACKGROUND: Right ventricular failure from elevated pulmonary vascular resistance in the recipient is a main cause of early mortality after heart transplantation. When pharmacologic treatment is insufficient, mechanical circulatory assistance has been used to support the failing right ventricle. Considering right and left ventricular interdependence, we investigated whether intraaortic balloon counterpulsation (IABP) might also alleviate predominantly right ventricular dysfunction after heart transplantation. METHODS: Among 278 cardiac recipients, 12 adult patients underwent mechanical circulatory support for cardiac allograft dysfunction. Five patients were treated with percutaneous IABP for early postoperative low cardiac output syndrome characterized by predominantly right ventricular failure. Clinical data and hemodynamic variables were recorded before and during IABP treatment. RESULTS: Cardiac index (CI) and mean arterial pressure (MAP) increased (CI 1.7 +/- 0.1 to 2.5 +/- 0.2, MAP 53 +/- 12 to 71 +/- 7, p < 0.05) within 1 hour after IABP, whereas central venous pressure (CVP) and pulmonary artery wedge pressure (PAWP) decreased (CVP 21.6 +/- 1.7 to 13.8 +/- 3.1, p < .05; PAWP 14.8 +/- 4.9 to 12.4 +/- 3.7, nonsignificant). Within the next 12 hours, CI and mixed venous oxygen saturation increased (p < 0.05) and pulmonary artery pressure decreased (p < 0.05). All 5 patients were weaned successfully and 4 are long-term survivors with adequate cardiac performance at 1 year follow-up. CONCLUSIONS: Intraaortic balloon pumping is a minimally invasive circulatory assist device with proved efficiency in low cardiac output syndromes. This report shows that low output syndrome caused by predominantly right ventricular allograft failure may be an additional indication for IABP.

Sternal wound infections in patients undergoing open heart surgery: randomized study comparing intracutaneous and transcutaneous suture techniques.

BACKGROUND: Intracutaneous suture technique has been our standard method for closing sternal wounds in cardiac surgery, mainly for cosmetic reasons. However, an increased rate of postoperative infections has been reported in cosmetic surgery with this method compared with the percutanous or transcutaneous closure technique. A comparison of these two techniques in cardiac surgery is presented. METHODS: In a randomized study, 300 patients were selected to intracutaneous suture (n = 150) or percutanous suture (n = 150). The endpoints were superficial and deep sternal wound infections within 6 weeks postoperatively. RESULTS: The total infection rate was lower in the percutanous group compared with the intracutaneous group (3% versus 8%) (p = 0.007). The superficial infection rate was lower in the percutaneous group (2.3% versus 6.7%) (p = 0.01), whereas there was no statistically significant difference in the deep infection rate between the groups. CONCLUSIONS: The percutaneous suture technique reduces the incidence of superficial wound infections, but not the deep infection rate in open heart surgery. There was no difference in the cosmetic results on a visual scale, assessed by the patients.

Vascular complications of the intraaortic balloon pump in patients undergoing open heart operations: 15-year experience.

BACKGROUND: The beneficial effects of the intraaortic balloon pump (IABP) in providing circulatory support must be weighed against its complications, particularly its vascular trauma. METHODS: Five hundred nine patients who underwent open heart operations at our institution and who were treated with the IABP from January 1980 through December 1994 were studied retrospectively to assess IABP-related vascular complications and their independent preoperative predictors and the implications of IABP-related vascular complications on the patients' mortality, morbidity (clinical sepsis and organ failure), and long-term survival. RESULTS: Early vascular complications occurred in 56 patients (11%) and major complications occurred in 41 patients (8%). The latter consisted of aortic perforation in 1 patient, aortoiliac dissection in 2 patients, and limb ischemia in 38 patients. Logistic regression analysis identified concomitant peripheral vascular disease (p<0.001), elevated preoperative end-diastolic pressure, small body surface area, and large catheter size (p<0.05) as independent risk factors for IABP-related major vascular complications in patients who survived the day of operation. Late IABP-related sequelae occurred in 10 patients, 9 of whom had had early vascular complications. The presence of vascular complications per se was not a significant independent factor among other risk factors for mortality, morbidity, or long-term survival. CONCLUSIONS: Careful clinical assessment of the aortofemoral vascular tree is a cornerstone of early diagnosis and early intervention and usually prevents limb loss. The significant decrease in major vascular complications that has occurred over the last 5 years can be explained by the increased use of catheters with smaller diameters. The timing of IABP insertion in relation to operation and the duration of IABP use were the only device-related risk factors identified for morbidity and survival.

Intraoperative angiography in minimally invasive direct coronary artery bypass grafting.

Intraoperative angiography in minimally invasive direct coronary artery bypass grafting without cardiopulmonary bypass and in hybrid procedures is reported. Twelve procedures were performed in a specially designed surgical-radiologic suite with a cross-disciplinary organization. In 2 patients the anastomosis was successfully revised on the basis of angiographic findings. In 4 of the 12 patients anastomosis of the left internal mammary artery to the left anterior descending coronary artery performed as a minimally invasive direct coronary artery bypass grafting procedure was combined with percutaneous transluminal coronary angioplasty of lesions in other coronary vessels in the same session. Intraoperative angiography allows a reliable diagnosis of an anastomosis or graft failure and prompt and reliable correction, and it allows the combination of minimally invasive direct coronary artery bypass grafting and angioplasty in one session.

Extracorporeal membrane oxygenation using a centrifugal pump and a servo regulator to prevent negative inlet pressure.

BACKGROUND: We studied whether negative inlet pressure created by a centrifugal pump during extracorporeal membrane oxygenation damages blood. METHODS: Fresh, whole human blood and primer were circulated through a test circuit, applying an inlet pressure of 0, -50, or -100 mm Hg. Thereafter, hemolysis and kidney function were compared between 6 patients treated before and 14 patients treated after inclusion in our setup of extracorporeal membrane oxygenation with a servo inlet pressure regulator. RESULTS: In vitro, negative inlet pressure caused substantial hemolysis, leukocyte and platelet destruction, and complement activation. Maximal plasma free hemoglobin concentrations were 199 mg/100 mL before use of the servo inlet pressure regulator and 40 mg/100 mL afterward (p = 0.06), and serum creatinine peaked at 330 and 115 mumol/L, respectively (p = 0.03). The minimal 24-hour diuresis normalized for weight was 4.8 mL/kg before use of the servo inlet pressure regulator and 45.6 mL/kg afterward (p = 0.03). Three of 5 evaluable patients before use of the servo inlet pressure regulator and 1 of 14 patients after inclusion in this setup experienced anuria (p = 0.04). CONCLUSIONS: There were strong indications that reduction of negative pump inlet pressure with the servo regulator prevented hemolysis and kidney damage.

Hemodynamic characterization of the CarboMedics mitral valve prosthesis.

BACKGROUND AND AIMS OF THE STUDY: The hemodynamic function of the CarboMedics bileaflet mitral valve prosthesis was evaluated by Doppler echocardiography and by heart catheterization. The clinical state of the invasively examined patients was evaluated before and after surgery. METHODS: Doppler echocardiography was performed in 54 patients at six months after surgery. Further, combined right and left heart catheterization was performed in 22 of these patients before surgery and at six months thereafter. RESULTS: The Doppler mean gradients were small (3.6 +/- 1.2 mmHg), and corresponded well with Doppler mean gradients in the subgroup examined with both methods (3.5 +/- 1.1 mmHg) and with the invasive gradients (3.4 +/- 1.9 mmHg); there was also no difference between the different valve sizes. Clinically, pressure recovery distal to the valve is probably so small that no systematic difference between the two techniques of measurement is present. Only physiological regurgitation was found, and no case of valve dysfunction. The patients improved from functional NYHA class 3.1 +/- 0.4 to 1.4 +/- 0.6, regardless of preoperative diagnosis, with most pronounced improvement in those with mitral stenosis. Pulmonary artery pressure was normalized. Pulmonary vascular resistance and cardiac index improved slightly. CONCLUSIONS: In conclusion, the valvular prostheses demonstrated excellent hemodynamic function. There was striking agreement between the small invasive and non-invasive gradients. Finally, the functional status of the patients improved considerably, most distinctly in those patients with prior mitral stenosis.

Mechanical valve replacement in congenital heart disease.

BACKGROUND AND AIMS OF THE STUDY: Mechanical valves are the prosthesis of choice in valve replacement in children. However, the problem of somatic growth leading to patient-valve mismatch remains present, and the appropriate anticoagulation regimen remains controversial. We present our experience of valve replacement in a young population over 20 years. MATERIALS AND METHODS: Between 1972 and 1992, 48 patients (34 males and 14 females), mean age 11.2 years (range 0.4-27.4 years), underwent mechanical valve replacement at our institution. Aortic valve replacement was performed in 28 patients (58.3%), mitral valve replacement in 13 (27.1%), tricuspid valve replacement in six (12.5%) and pulmonary valve replacement in one patient (2.1%). The prostheses used were: St. Jude Medical (n = 2), Björk-Shiley (n = 14), Medtronic Hall (n = 16), Duromedics (n = 2) and CarboMedics (n = 14). Early mortality was 14.3%, 10.7% for aortic valve replacement and 30.8% for mitral valve replacement. Mean follow up for all patients was 8.3 years (range 0-22 years), with a total of 398 patient-years. RESULTS: Seven patients died during the follow up (17.1%). Survival after 10 years, including operative mortality, was 81% for aortic valve replacement, 33% for mitral valve replacement, 83% for tricuspid valve replacement and 100% for pulmonary valve replacement. All patients were anticoagulated with warfarin. In eight patients (16.7%) an antiplatelet drug (aspirin or dipyridamole) was added. Major events included paravalvular leak in six patients (1.5%/pty), valve thrombosis in five (mitral position in two, tricuspid in three) (1.3%/pty) and endocarditis in one patient (0.3%/pty). Minor thromboembolic events occurred in three patients (0.8%/pty) and minor hemorrhagic events in three (0.8%/pty). No patients developed hemolytic anemia and there was no case of structural failure. CONCLUSIONS: In our experience, mechanical prostheses in congenital heart disease were associated with significant morbidity and mortality, however long term survival after aortic valve replacement was good (81% at 10 years). Thromboembolic and hemorrhagic events were of minor significance. Atrio-ventricular valve replacement carried the highest risk of valve thrombosis and we now give warfarin and an antiplatelet drug to children undergoing mechanical valve implantation in this position.

Coronary artery bypass surgery in women and in men; early and long-term results. A study of the Norwegian population adjusted by age and sex.

OBJECTIVE: We wished to analyse early mortality, postoperative low-output syndrome needing intra-aortic balloon pumping support (IABP), total mortality, recurrent angina pectoris and total non-fatal myocardial infarction in women compared with men. Also, the standard mortality ratio (SMR) was estimated to compare the mortality data to the general Norwegian population of comparable sex and age. METHODS: A total of 1025 patients; 113 women and 912 men, were submitted to coronary artery bypass surgery at Rikshospitalet, Oslo between August 1982 and December 1986. The patients were followed up until the 1st of January 1993, representing a mean follow-up time of 7.4 years. An exposed/non-exposed cohort study design was used. A power study was carried out. The standardized mortality ratios for women and men were calculated after adjusting for age and sex. RESULTS: Crude odds ratio (ORC) of early mortality was 2.0 with a 95% confidence limit (CL95%) of 0.7-5.4. Odds ratio of low output syndrome needing intra-aortic balloon support was 1.7 (CL95% = 0.8-4.2). Statistical significance was not achieved for these end-points. Women did not run an increased hazard of total mortality (ORC = 0.9; CL95% = 0.5-1.5), recurrent angina pectoris (ORC = 1.4; CL95% = 0.8-2.4) or of total non-fatal myocardial infarction (ORC = 0.8; CL95% = 0.4-1.6) when compared with men. Adjusting for confounders did not significantly alter the results. When matched on sex and age and compared to the normal Norwegian population, we found an increased SMR in both men (2.5; CL95% = 2.2-2.9) and women (4.1; CL95% = 2.2-4.9). CONCLUSION: The risk of early mortality and low-output syndrome needing intra-aortic balloon support tended to be higher in women compared with men. Women did not run an increased risk of total mortality, recurrent angina or of total non-fatal myocardial infarction. The standard mortality ratio was increased in both men and women, but in particular higher in women, suggesting a more aggressive course of coronary artery disease in operated women than in operated men. However, this difference did not show in the long term follow-up, due to the beneficial effect of coronary artery bypass surgery in both men and women.