Venous valve reconstruction in patients with secondary chronic venous insufficiency.

OBJECTIVES: To evaluate the durability of venous valve reconstruction (VVR) and its benefits in terms of symptom improvement, ulcer healing and symptom/ulcer recurrence among patients with secondary chronic venous insufficiency (SCVI) in whom superficial venous surgery and compression treatment had failed. METHODS: During a ten year period (1993-2004) 1800 patients with chronic venous insufficiency (CVI) were evaluated by colour duplex ultrasound (CDU) and ambulatory venous pressure measurement (AVP). Approximately two thirds of patients had SCVI. Initial treatment consisted of compression therapy for a 6 month period. In addition, superficial vein and perforator surgery was performed in those presenting with reflux in these venous systems. 121 patients who did not improve with this treatment were investigated by ascending venography, descending video venography, air plethysmography and measurement of post-ischaemic venous pressure gradient. Thirty two cases having venous reflux without obstruction were selected for VVR. RESULTS: The ulcer healing rate within three months was 68% (13/19 patients). VVR resulted in valvular competence and a clinical success rate of 47% and 40% after 3 and 7 years respectively. In 8/13 (54%) of patients with a healed leg ulcer, a median post-operative AVP reduction of 33 mm Hg (range 20-38) was recorded. The durability of clinical success was numerically longer in patients with haemodynamic improvement (n=10) median 24 months (12-108), when compared with that in those without haemodynamic improvement (n=22) median 18 months (6-108). Popliteal vein reconstruction was part of the VVR procedure in all patients with haemodynamic improvement (post-op. AVP reduction >or=20 mm Hg). VVR at the popliteal level alone or combined with inguinal reconstruction seemed to be the one significant factor associated with haemodynamic improvement (P=0.014, Chi squared). CONCLUSION: VVR may lead to ulcer healing, but when performed at the popliteal level, haemodynamic improvement can be obtained along with a longer recurrence-free period (durability). VVR should be considered in the treatment of patients with SCVI who do not respond to superficial venous surgery and compression treatment.

The Oslo balloon angioplasty versus conservative treatment study (OBACT)--the 2-years results of a single centre, prospective, randomised study in patients with intermittent claudication.

OBJECTIVES: To compare the effect of optimal medical treatment only (OMT) with OMT combined with percutaneous transluminal angioplasty (OMT+PTA) in patients with intermittent claudication (IC). DESIGN: A single centre prospective, randomised study. Quality of life (QoL) was the primary outcome measure. Secondary measures were ankle-brachial-index (ABI), treadmill walking distances and mortality. METHODS: From a total of 434 patients considered for inclusion into the trial, only 56 patients with disabling IC fulfilled the inclusion criteria. The patients were randomised into treatment groups consisting of 28 patients each and followed for 2 years. ABI and treadmill walking distances were measured in addition to the visual analogue scale (VAS) for pain evaluation, and QoL assessment using the Short Form (SF-36 and Claudication Scale (CLAU-S). RESULTS: The demographic data in the 2 groups were almost identical. After 2 years of follow-up the ABI, the treadmill walking distances and the VAS were significant improved in the group treated with OMT+PTA, compared to the group treated with OMT only (p<0.01 for all). Furthermore, some variables from the QoL assessment also showed a significant improvement in favour of the OMT+PTA group (p<0.05 for all). CONCLUSION: The advantage of conducting a single centre study and adhering to very strict inclusion criteria was illustrated by the homogenous demographic data of the two groups. This partly outweighed the disadvantage of having included a relatively small number of patients. Early intervention with PTA in addition to OMT seems to have a generally more positive effect compared to OMT only, on haemodynamic, functional as well as QoL aspects during the first 2 years in patients with IC.

External venous valve plasty (EVVP) in patients with primary chronic venous insufficiency (PCVI).

OBJECTIVES: To evaluate the patency of EVVP and its effect in symptom relief, ulcer healing and ulcer-free period in patients with PCVI. METHODS: Between 1993 and 2004, 1800 patients with CVI were evaluated and seventeen with PCVI were selected for EVVP. They were all investigated with ambulatory venous pressure measurement (AVP), colour duplex ultrasound (CDU), ascending venography and descending video venography. The CEAP classification was used to group the patients. Six patients were C4, four C5 and seven C6. All had deep reflux and high levels of AVP. RESULTS: All procedures were technically successful. The ulcer healing rate was 4/7 (57%) within 3 months. All C4 patients experienced symptom improvement postoperatively and had a median recurrence free period of 72 (range 60-122) months. The C5 group had an median ulcer free period of 61 months (12-72) and the C6 of median 48 (12-72) months. Single valve plasties (4) reached a median competence period of 48 months (12-72), 12 multiple valve plasties at the same level show a median 78 months (63-122) and 10 multilevel repairs median 54 months (12-96). Multiple valve plasties at the same level (multi-station plasties) performed on the C4 group seemed to yield the longest durability with a median of 103 months (84-122). CONCLUSION: EVVP with an ulcer healing rate of 57% and satisfactory symptom improvement seems to be an alternative of surgical treatment for selected patients with PCVI. The durability of this technique seems to be related to clinical severity and the multiplicity of repairs.

Duration of preoperative electrocardiographic QRS complex and the incidence of heart arrest after aorto coronary bypass surgery.

Sudden heart arrest (HA) in the early phase after aorto coronary bypass surgery represents a serious event necessitating resuscitation, and for those who survive usually also an extra stay in the coronary care unit. Since such episodes of heart standstill may be related to conduction defects, a study was conducted to determine whether the duration of the QRS complex on the preoperative ECG is a marker for this morbid event. A cohort of 1011 consecutive patients operated on between 1982 and 1986 and followed to January 1st, 1993 were included in the study. Incidence of lethal or non-lethal HA during the first 4 weeks after surgery was considered as the primary endpoint and total mortality as the secondary endpoint. The incidence of HA was 40/1011 = 4%, with the majority of events (60%) being lethal. Independent risk factors of HA using the multivariate logistic model were previous coronary artery bypass surgery, presence of mitral regurgitation, left ventricular ejection fraction and the intraoperative cross-clamp time of aorta. Adjusting for the effect of confounder variables showed that the gradient effect of QRS complex duration on the endpoint HA was still present (p = 0.012). The duration of the QRS complex taken from the preoperative ECG had a gradient effect on the incidence of HA. With a baseline level of QRS <70 ms, the following odds ratios (OR) for HA were found: OR = 1.38 (95% CI 0.60-3.31) for QRS 70-80 ms; OR = 2.27 (95% CI 0.87-5.90) for QRS >90-120 ms; and OR = 3.38 (95% CI 1.06-11.50) for QRS > 120 ms, when adjusting for the risk factors. Cumulative survival at 5 years after surgery was 28+/-7.1% for patients experiencing HA versus 87+/-1.2% for patients free from this event. Our results underline the importance of the QRS complex duration as a preoperative marker for HA after aorta coronary bypass surgery, when adjusting for other risk factors. Although the one-year survival is poor for patients experiencing HA, there is no increase in mortality during the late follow-up.

[Mortality, recurrent angina pectoris and late myocardial infarction in patients surgically treated for coronary heart disease]. / Dødelighet, tilbakefall av angina pectoris og seninfarkt hos pasienter operert for koronar hjertesykdom.

This cohort study includes 1,025 patients operated between 1982 and 1986 at Rikshospitalet, the National Hospital of Norway, 912 men and 113 women. The closing date was 1 January 1993. A total of 31 patients (3%) died within 30 days of operation. Independent risk factors were atrial fibrillation, previous heart surgery, mitral insufficiency, left main stem stenosis, unstable angina pectoris and elevated end-diastolic pressure. Among the 164 patients (16%) who died more than 30 days after operation, the independent risk factors of total mortality were atrial fibrillation, concomitant resection of left ventricular aneurysm, left main stem stenosis, NYHA functional class IV on admission, elevated end-diastolic pressure and prolonged cross-clamping time. Recurrent angina pectoris was experienced by 146 patients (14.2%) while 102 patients had non-fatal myocardial infarction. The cumulative incidence of these conditions was initially low, but began to increase four year after operation. The independent risk factor for these two end-points was hypertension. The study suggests that stratification of independent risk factors facilitates comparison of mortality in different centres and permits improved quality control.

[Mortality and morbidity after coronary bypass surgery in high-risk patients]. / Dødelighet og sykelighet etter koronar bypasskirurgi hos høyrisikopasienter.

A total of 113 women and 912 men were submitted to coronary artery bypass surgery at Surgical Department A, Rikshospitalet between August 1982 and December 1986 and followed till January 1993. We found no difference in early mortality, recurrent angina pectoris or non-fatal myocardial infarction in diabetic patients compared to nondiabetic patients. However, total mortality was 1.87 times higher in the diabetic group. For patients with ejection fraction < or = 40%, early mortality was 10.2 times higher than for the reference group. For total mortality we found a practically linear relationship between increased mortality and falling ejection fraction values. We found no relationship between ejection fraction and recurrent angina and non-fatal myocardial infarction, neither did we find any difference in mortality and morbidity between women and men. Although a somewhat higher mortality and morbidity rate must be expected for high-risk patients, they seem to profit to the same extent from the favourable effects of coronary bypass surgery as other patients.

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.

Mortality and morbidity after coronary artery bypass surgery related to pre-operative left ventricular ejection fraction: a follow-up study.

OBJECTIVE: To study the pre-operative level of left ventricular ejection fraction that may be indicative of an increased risk of early and late mortality and of recurrent angina pectoris and late non-fatal myocardial infarction. MATERIAL AND METHODS: A total of 934 patients with known left ventricular ejection fraction, 80 women and 854 men, were submitted to coronary artery bypass grafting at the Cardiovascular Unit of Rikshospitalet, Oslo, between August 1982 and December 1986. The closing date was the 1st of January 1993, with a mean follow-up of time of 7.4 years. The patients were divided in to four subgroups according to their level of left ventricular ejection fraction: < or = 40%, 41-60%, 61-80% and > 80%. The left ventricular ejection fraction varied from 13-98%. A chi-square test of linear trend was used to calculate the relative risk between the different subgroups. Cumulative survival was determined using survival curves. RESULTS: Early mortality. Twenty-five patients (2.7%) died within 30 days of operation. Patients with left ventricular ejection fraction < or = 40% had a relative risk of 10.2 (1.9-17.2), for left ventricular ejection fraction 41-60% the relative risk was 0.9 (0.1-8.9) and for left ventricular ejection fraction 61-80% the relative risk was 2.8 (0.6-17.2). Left ventricular ejection fraction > 80% was defined as relative risk = 1. Late mortality. Altogether, 174 patients died in the late phase (18.6%). For patients with left ventricular ejection fraction < or = 40% the relative risk was 3.6 (2.8-10.9), for left ventricular ejection fraction 41-60% the relative risk was 1.8 (1.1-3.6), and for left ventricular ejection fraction 61-80% the relative risk was 1.5 (0.9-2.8). Recurrent angina pectoris. A total of 138 patients developed recurrent angina pectoris during the follow-up period, giving an incidence of 14.8%. Here, for left ventricular ejection fraction < or = 40% the relative risk was 0.5 (0.2-1.3), for left ventricular ejection fraction 41-60% the relative risk was 1.0 (0.5-1.8) and for left ventricular ejection fraction 61-80% the relative risk was 1.2 (0.7-2.0). Late non-fatal myocardial infarction. Altogether, 90 patients (9.6%) experienced non-fatal myocardial infarction in the late phase. For left ventricular ejection fraction < or = 40% the relative risk was 0.6 (1.2-1.8), for left ventricular ejection fraction 41-60% the relative risk was 1.0 (0.5-2.0) and for left ventricular ejection fraction 61-80% the relative risk was 0.7 (0.41-1.3). Cumulative survival. When pooled together, the cumulative survival for patients with left ventricular ejection fraction > 40% was 95.9, 91.9 and 79% after 1, 5 and 10 years, respectively. For the patients with left ventricular ejection fraction < or = 40% cumulative survival was 87.5, 73.1 and 55.2%, respectively. CONCLUSION: When the left ventricular ejection fraction was 40% or lower, there was a substantial increase in the risk of early mortality in patients submitted to coronary artery bypass grafting. As for the risk of late mortality, there was a practically linear increase in risk with falling values of left ventricular ejection fraction. We found no difference in risk of developing recurrent angina pectoris or of late non-fatal myocardial infarction related to values of left ventricular ejection fraction.

Diabetes mellitus and morbidity and mortality risks after coronary artery bypass surgery.

Of 1025 patients (912 men, 113 women) who underwent coronary artery bypass grafting and were followed up for a mean of 7.4 years, 45 (4.4%) had diabetes mellitus. Norwegian population is 1.8-2%). Early mortality was not significantly greater among diabetics than in non-diabetics (2.2 vs. 3.1%, odds ratio--OR-0.44, confidence interval--CI- 0.05-3.56). Diabetic patients had no increased risk of perioperative myocardial infarction (OR = 0.87, CI 0.36-2.10) or of low-output syndrome necessitating intraortic balloon pumping (OR = 0.42, CI 0.55-3.05), and no excess incidence of late non-fatal myocardial infarction (relative risk = 0.69, CI 0.10-1.28) or late chronic heart failure (OR = 2.50, CI 0.5-11.0). Long-term mortality was increased in the diabetic patients (relative risk 1.87, CI 1.60-2.14). Thus diabetes did not entail heightened risk of early mortality, perioperative myocardial infarction or low-output syndrome. Nor was there excess risk of recurrent angina pectoris, late non-fatal myocardial infarction or chronic heart failure among the diabetic patients, but the late mortality risk was increased.

Risk factors of recurrent angina pectoris and of non-fatal myocardial infarction after coronary artery bypass surgery.

The long-term results of 1025 patients, 912 men and 113 women, undergoing coronary artery bypass grafting (CABG) at the Cardiovascular Unit of Rikshospitalet, Oslo, between 1982 and 1986, were analyzed on factors associated with the return of angina pectoris and of non-fatal post CABG myocardial infarction. The closing date was 1st January 1993, with a mean follow-up time of 7.4 years. Recurrent angina pectoris was experienced by 118 (11.6%) patients and 102 (10%) patients experienced non-fatal post CABG myocardial infarction during the observation period. Altogether 30 possible risk factors were analyzed. The cumulative incidence of recurrent angina was initially low after operation, followed by a rise after 4 years. One, 5 and 10 years after the operation, survival free from angina rates were 97.8%, 91.8% and 80.6%, respectively. The cumulative incidence of post CABG myocardial infarction was also low initially, followed by a rise after 4 years. The survival free of non-fatal post CABG myocardial infarction rate was 98.9%, 96% and 83.5%, at 1, 5 and 10 years after surgery, respectively. The incremental risk factor of recurrent angina pectoris was hypertension. The independent risk factors of non-fatal post CABG myocardial infarction were hypertension and preoperative stenosis of the left-sided, versus right-sided, coronary arteries. The study emphasizes the favorable effect of coronary bypass surgery on the functional outcome in patients with symptomatic coronary artery disease.

Risk factors for early and late mortality in surgical treatment of coronary artery disease.

A total of 1025 patients who had coronary bypass surgery at the Surgical Department A, Rikshospitalet, Oslo, between 1982 and 1986, were analysed for factors associated with early mortality and long-term survival. The cumulative follow-up time accounted for 6553 patient-years; the median follow-up was 6.45 years and ranged from the day of admission to 10 years. In total, 31 patients (3%) died within 30 days of surgery. Some 30 possible risk factors were analysed. Univariate analysis followed by a multivariate analysis defined six independent risk factors for early mortality. These were lack of sinus rhythm, previous heart surgery, mitral regurgitation, left main stem stenosis, unstable angina, and an elevated left ventricular end-diastolic pressure. Estimation of attributable risk showed that these factors could identify all patients who died early. Independent risk factors for late death were: lack of sinus rhythm, resection of a left ventricular aneurysm, left main stem stenosis, New York Heart Association (NYHA) class IV on admission, an elevated end-diastolic pressure, and prolonged cross-clamping time. The attributable risk analysis showed that independent risk factors for total mortality explained only about half of the patients who died. This appeared to be because of the competing effect of non-cardiac mortality. Results of the study show that risk factors for early mortality are good indicators for the outcome of coronary artery bypass surgery, identifying all deaths, whereas long-term mortality cannot be predicted. Stratification of independent risk factors allows a better comparison of mortality in different centres, and also better quality control of bypass surgery.

Morbidity in valvular heart replacement: risk factors of systemic emboli and thrombotic obstruction.

A study on a cohort of 839 patients with valvular heart replacement between June 1977 and May 1985 showed that the linearized rates of systemic emboli and thrombotic obstruction were 1.4/100 pts/year for Aortic Valve Replacement (AVR), 2.2/100 pts./year for Mitral Valve Replacement, and 3.00/100 pts./year for Double Valve Replacement (DVR). The 5-year free-from-thromboembolism (TE) survival was 95% for AVR and 92% for MVR. The hazard function (the instantaneous risk) for TE peaked in the first six months after operation for AVR and MVR. Another analysis using the Cox regression model to estimate risk factors of systemic emboli and thrombotic obstruction pinpointed two factors in the AVR group: presence of aortic regurgitation (AR) and age at operation. In the MVR group the sole predictor covariate was sex of the patients, with a higher hazard for females. Our results underline the importance of patient-related factors besides the type of prosthesis as predictors of morbidity from TE.