New systems of reimbursement are exerting enormous pressure on clinicians and hospitals to reduce costs. Using cheaper supplies or reducing the length of stay may be a satisfactory short-term solution, but the best strategy for long-term success is radical reduction of costs by reengineering the processes of care. However, few clinicians or institutions know the actual costs of medical care; nor do they understand, in detail, the activities involved in the delivery of care. Finally, there is no accepted method for linking the two.
Clinical process cost analysis begins with the construction of a detailed flow diagram incorporating each activity in the process of care. The cost of each activity is then calculated, and the two are linked. This technique was applied to Diagnosis Related Group 75 to analyze the real costs of the operative treatment of lung cancer at one institution.
Total costs varied between $6,400 and $7,700. The major driver of costs was personnel time, which accounted for 55% of the total. Forty percent of the total cost was incurred in the operating room. The cost of care decreased progressively during hospitalization.
Clinical process cost analysis provides detailed information about the costs and processes of care. The insights thus obtained may be used to reduce costs by reengineering the process.
Successful publication of a research study usually requires a small p value, typically p < 0.05. Many clinicians believe that a p value represents the probability that the null hypothesis is true, so that a small p value means the null hypothesis must be false. In fact, the p value provides very weak evidence against the null hypothesis, and the probability that the null hypothesis is true is usually much greater than the p value would suggest. Moreover, even considering "the probability that the null hypothesis is true" is not possible with the usual statistical setup and requires a different (Bayesian) statistical approach. We describe the Bayesian approach using a well-established diagnostic testing analogy. Then, as a practical example, we compare the p-value result of a study of aprotinin-associated operative mortality with the more illuminative interpretation of the same study data using a Bayesian approach.
The present study was designed to evaluate the effectiveness of intrapleural 0.25% bupivacaine delivered by intermittent infusions for post-thoracotomy pain relief.
Forty patients undergoing elective lobectomy were randomly, but equally, placed into two groups. An intrapleural catheter was inserted under direct vision during surgery. Group I received intrapleural 40 mL of 0.25% bupivacaine, group II was administered 40 mL of saline solution as a control group. Diclofenac sodium was administered as an additional analgesic, if required. Postoperative pain was evaluated using a visual analog scale (VAS), and Prince Henry pain scale. Arterial oxygen saturation, heart rate, and systemic arterial pressures were monitored. All observations were recorded 5, 10, 15, 20, 25, and 30 minutes after the injection, and thereafter at hourly intervals through the postoperative 24 hours.
The mean analgesia times were 5 hours and 2 hours in group I and group II, respectively. Therefore, bupivacaine administrations were repeated every 6 hours in group I, and saline with additional analgesic were administered every 4 hours in group II. The heart rate and arterial pressures did not show a significant difference. While the additional analgesic requirement was 180 +/- 10 mg/d in group II, there was no need for additional analgesic administration in the group I patients. Arterial oxygen was significantly higher in group I than in group II. Arterial carbon dioxide tension of group II was significantly higher than that of group I. While the postoperative atelectasis and pneumonia developed in four patients and one, respectively, in group II, no such complication was observed in group I.
The easy placement of an intrapleural catheter and better pain relief observed in the present study suggest that intermittent pleural infusion of 0.25% bupivacaine has proven to be a safe and effective method for relief of post-thoracotomy pain.
The purposes of this study are to determine whether patients with severe left ventricular dysfunction benefit from prophylactic insertion of an intraaortic balloon pump and to evaluate its cost-effectiveness.
Between January 1991 and December 1995, 163 consecutive patients with a left ventricular ejection fraction of 0.25 or less underwent isolated coronary artery bypass grafting. An intraaortic balloon pump was inserted before operation in 37 patients (group A). The remaining 126 patients underwent operation without preoperative insertion of the device (group B). Preoperatively, 91.9% (34/37) of group A patients and 54.8% (69/126) of group B patients were in New York Heart Association functional class III or IV (p < 0.001).
The 30-day mortality rate was 2.7% (1/37) and 11.9% (15/126) for groups A and B, respectively (p < 0.005). All deaths occurred in patients in functional class III or IV. In group B, 28 patients (22.2%) required an intraaortic balloon pump after cardiotomy for low cardiac output, 42.9% (12/28) of whom died. Median postoperative hospital stay was 9.9 days and 12.0 days, and mean hospital charges were $50,627 and $54,818 for survivors in groups A and B; respectively (p = not significant).
Our experience suggests that patients with severe left ventricular dysfunction undergoing coronary artery bypass grafting may benefit from preoperative intraaortic balloon pump insertion, especially patients in functional class III or IV. This approach improved survival significantly, reduced hospital stay, and was more cost-effective.
We evaluated the impact of ischemic mitral regurgitation (IMR) on long-term outcome of patients with an ejection fraction (EF) exceeding 0.30 undergoing isolated coronary artery bypass grafting (CABG).
From November 1994 to December 2002, 4226 patients (EF > 0.30) underwent a first isolated CABG. Preoperative IMR was present in 1421 (33.6%, group IMR), of which 1254 had mild (1/4) and 167 had moderate (2/4). The remaining 2805 patients (66.4%, group no-IMR) showed no IMR. A nonparsimonious regression model was built to determine the propensity score. Ten-year freedom from death from any cause, cardiac death, and cardiac events was evaluated by the Kaplan-Meier method. Results of Cox analysis were adjusted by entering the propensity score as an independent variable.
All patients had similar early mortality (2.1% no-IMR vs 2.5% IMR, p = 0.502) and morbidity (6.5% no-IMR vs 6.6% IMR, p = 0.840). In patients with EF of 0.31 to 0.40, but not in those ones with EF exceeding 0.40, IMR grade was an independent variable for worse long-term freedom from cardiac death (82.8 +/- 3.2 vs 91.4 +/- 2.4; Cox hazard ratio [HR], 2.1 [95% confidence interval (CI), 1.1 to 4.1]; p = 0.0324) and cardiac events (78.6 +/- 3.5 vs 88.5 +/- 2.7; Cox HR, 2.0 [95% CI, 1.1 to 3.7]; p = 0.0174).
Mild or moderate IMR in patients with an EF exceeding 0.30 undergoing first isolated CABG influences long-term outcome when EF is 0.31 to 0.40, but not when it exceeds 0.40.
Paravertebral block in combination to intravenous analgesics could be an alternative to epidural analgesia for postoperative pain control after thoracotomy, but it has been scarcely evaluated so far. We thus assessed the efficacy of paravertebral block using a continuous infusion of ropivacaine in a multimodal analgesic approach.
Forty patients were randomized to receive ketoprofen, paracetamol, and patient-controlled-analgesia (PCA) with intravenous morphine (control group) or the same treatment with a continuous 48-hour infusion of ropivacaine 0.5% (0.1 mL/kg(-1)/h(-1)) in a thoracic paravertebral catheter (thoracic paravertebral block [TPVB] group). Visual analog scale (VAS) at rest and when coughing, morphine consumption, and side effects were recorded during the first 48 hours after surgery. Venous blood was sampled at 24 and 48 hours for ropivacaine plasma concentration measurements.
Mean VAS scores at rest and when coughing were significantly decreased in the TPBV group (p < 0.005). Despite a decrease in the morphine-titrated dose given in the postanesthesia care unit, cumulated morphine consumption was not significantly different between the two groups (51 +/- 29 mg and 57 +/- 24 mg in the TPVB and control groups, respectively). Side effects (nausea, vomiting, urinary retention) were less frequent in the TPBV group (30% vs 75%; p < 0.005). Plasma ropivacaine concentrations remained below the toxic threshold.
Continuous paravertebral ropivacaine 0.5% infusion improves pain control after thoracic surgery using a multimodal analgesic approach.
Severe aortic stenosis with a low transvalvular gradient and preserved left ventricular ejection fraction (LVEF) is often misdiagnosed, leading to undertreatment of such patients with no clear indication for surgical intervention. This study investigated the outcome of aortic valve replacement (AVR) in patients with severe aortic stenosis and a low transvalvular gradient despite normal LVEF.
Between 1985 and 2008, we evaluated 73 patients who underwent AVR compared with 29 patients who did not. Overall, aortic valve area was 1.0 cm2 or smaller, LVEF was 0.50 or higher, and transvalvular gradient was 30 mm Hg or less. Multivariate and Cox analyses were used to compare these two groups according to AVR.
Compared with controls, AVR patients were younger and with higher body mass index. Coronary artery bypass grafting was performed simultaneously in 38 AVR patients (52%). At follow-up (median, 42 months; interquartile range, 23 to 75 months), survival was longer in AVR patients. By Cox analysis, AVR remained a major predictor of lower mortality (hazard ratio, 0.237; 95% confidence interval, 0.119 to 0.470; p<0.0001).
In patients with severe aortic stenosis and low transvalvular gradient despite a normal LVEF, AVR was associated with significant improvement in long-term survival and functional status and with a low operative mortality.
As part of a compassionate-use study, a placebo-controlled study was undertaken to assess the efficacy of aprotinin in patients undergoing any procedure associated with cardiopulmonary bypass and at increased risk of perioperative bleeding. This article reviews results in 116 patients 16 years of age or less.
Patients were randomly assigned to four treatment groups: high dose, low dose, pump prime only, and placebo. Efficacy was measured by four parameters: requirement for units of donor blood, requirement for units of donor blood and blood product, thoracic drainage volumes, and rates of reoperation required primarily because of diffuse bleeding. Results were separately analyzed in all patients, patients undergoing primary procedures, patients undergoing repeat procedures, neonates and infants 1 year of age or less, and patients older than 1 year of age.
There was a trend toward reduced blood and blood product requirements with aprotinin use, least evident in neonates and infants and particularly evident in patients undergoing repeat procedures. Aprotinin did not reduce drainage volumes in this pediatric population.
There is a trend toward benefit with aprotinin use in a pediatric population, as measured by requirement for blood and blood product, in patients who are more than 1 year of age and in patients undergoing a repeat operation rather than a primary sternotomy operation.
The gastroepiploic artery (GEA) has been used as a graft in 1,000 patients in our institution, and the clinical outcome and the angiographic long-term results were reviewed.
Between June 1, 1991, and June 30, 2001, 1,000 consecutive isolated coronary artery bypass grafting procedures using the GEA were performed in the Shin-Tokyo Hospital Group. The perioperative data were retrospectively analyzed, and the late angiographic results, cardiac related events, and survival were examined. The end points of the follow-up study were death or the occurrence of a cardiac-related event.
The GEA was used in 767 men and 233 women (mean age, 63.8 +/- 9.4 years). The GEA was used as an in situ graft in 99.6% of patients and was anastomosed to the right coronary artery in 87.8% and the circumflex artery in 10.0%. In addition, the left internal mammary artery was used in 96.9% of patients, the right internal mammary artery in 28.5%, the radial artery in 41.7%, the inferior epigastric artery in 1.4%, and the saphenous vein in 40.1%. The hospital morbidity and mortality rates were 10.8% and 0.8%, respectively. No abdominal complications were observed. Postoperative myocardial infarction associated with GEA graft failure occurred in 2 patients. During the late follow-up of 4.0 +/- 2.3 years, cardiac-related events were observed in 155 patients. The actuarial 3- and 5-year event-free rates were 91.2% and 84.2%, respectively. There were 86 late deaths, 36 of which were cardiac related deaths. The actuarial 3- and 5-year survival rates were 96.6% and 92.6%, respectively. Angiography was performed on 437 patients within 1 year after operation and in 221 patients more than 1 year postoperatively (mean interval, 3.1 +/- 1.8 years). The actuarial 1-, 3-, and 5-year GEA graft patency rates were 98.7%, 91.1%, and 84.4%, respectively, and the actuarial 1-, 3-, and 5-year LIMA graft patency rates were 99.6%, 98.8%, and 97.0%, respectively (p < 0.0005).
The GEA was used for coronary artery bypass grafting with good perioperative results. However, the angiographic patency rate of the GEA was inferior to that of the internal mammary arteries. The late occurrence of angina attributed to GEA graft failure should be carefully monitored.
The prognostic implication of serum carcinoembryonic antigen (CEA) has yet to be comprehensively analyzed since the reports available so far have comprised small patient populations. We evaluated perioperative CEA values with regard to surgical results in a large number of patients to clarify its merit.
We measured serum CEA levels before and after surgery in 1,000 consecutive patients with clinical stage I non-small cell lung cancer who underwent resection of tumor. High CEA value was greater than 5.0 ng/mL.
Three hundred and sixty-eight patients (36.8%) had high preoperative CEA levels. The CEA levels after surgery were normalized in 242 patients (24.2%) and persistently elevated in 126 patients (12.6%). High CEA levels were seen more frequently in patients with older age, male gender, larger size of tumor, incomplete resection, and advanced pathologic stage. Patients with a high preoperative CEA level had a poor survival. Among these patients, even worse survival was seen for those with a high postoperative CEA level. These prognostic trends were still observed for patients with pathologic stage I disease. Multivariate analysis demonstrated that both preoperative and postoperative CEA levels were independent prognostic determinants (p = 0.0243 and p < 0.0001, respectively).
Perioperative measurement of serum CEA concentrations yields information valuable for detecting patients at high risk of poor survival. Normalization of CEA levels after surgery was a significant favorable prognostic sign in patients with an elevated CEA level before surgery. Even after apparently successful surgical therapy, patients with a high CEA level should be carefully followed up, and might represent a suitable target for neoadjuvant clinical trials.
Of the first 1,000 consecutive patients in our unit to receive aortocoronary bypass grafts, 108 have died: 32 at operation, 16 in hospital, and 60 late. Of 343 patients who had a normal ventricle, only 1 (0.29%) died at operation, and 2 of the 8 late deaths were noncardiac in cause. Most operative deaths resulted from low cardiac output, and most later deaths were caused by congestive heart failure. A study of the relation of various clinical and operative factors with mortality found that patients with congestive heart failure who underwent valve replacement and bypass grafting had the worst prognosis (73% mortality) while those undergoing bypass grafting with Class III or IV ventricular function (as we define it) and congestive heart failure were next (49% mortality).
One thousand consecutive cardiac reoperations for valve surgery in 897 patients were reviewed to determine in-hospital mortality and indicators of risk. Subgroups based on the number of previous cardiac procedures and the valve or valves replaced or repaired at reoperation (aortic valve, mitral valve, tricuspid valve, or multiple valves and mortality [deaths/number of procedures (% mortality)]) for those subgroups are as follows: (Table: see text) Predictors of increased risk for a first aortic valve reoperation were advanced age (p = .0002), endocarditis (p = .0018), female sex (p = .014), impaired left ventricular function (p = .039), and number of coronary vessels obstructed by 70% or more (p = .055). For a first mitral valve reoperation, the predictors were advanced age (p less than .0001), preoperative shock or cardiac arrest (p = .01), previous aortic or tricuspid valve operations (p = .02), type of mitral valve procedure (risk for repair of periprosthetic leak was greater than mitral valve replacement which was greater than mitral valve-conserving operation [p = .05]), and impaired left ventricular function (p = .059). For a first multiple valve reoperation, the predictors were diabetes (p = .04) and ascites (p = .02), whereas patients undergoing mitral valve replacement and tricuspid valve operations were at decreased risk (p = .01). Comparison of second reoperations with first reoperations indicates risk increases for multiple operations (p = .01) but not for aortic or mitral valve procedures. Rereplacement of a prosthesis (p = .007), coronary bypass grafting at reoperation (p = .006), and advanced age (p = .06) increased the risk for second reoperations. Age is the most consistent predictor of risk for patients undergoing valve reoperations.
This study reviews a single institution experience with the Carpentier-Edwards pericardial aortic valve bioprosthesis, concentrating on late outcomes.
From December 1991 to June 2002, 1,000 patients underwent aortic valve replacement with the Carpentier-Edwards pericardial valve (mean follow-up 6.01 +/- 3.56 years). The institutional database was reviewed. Follow-up data were acquired through telephone interviews and mail-in questionnaires. Time-to-event analyses were performed by the Kaplan-Meier method. Mean age was 74.1 years; 545 patients (54.5%) were male. Mean preoperative ejection fraction was 52.5%. Isolated aortic valve replacement occurred in 372 cases (37.2%). Combined aortic valve replacement with coronary artery bypass grafting occurred in 443 cases (44.3%). The remaining 185 patients (18.5%) underwent complex procedures with concomitant mitral, tricuspid, or arch repair. One hundred forty patients (14.0%) had prior aortic valve surgery. Follow-up was 99.4% complete.
Overall operative mortality was 7.2% (72 of 1,000). There were 503 late deaths (50.3%). Age-stratified survival at 15 years was 43.7% for patients less than 65 years of age; 18.2% for patients aged 65 to 75; and 9.4% for patients aged more than 75 years. There were 26 failed bioprostheses (2.6%) requiring reoperation. Structural valve deterioration was the cause in 13 of 26 cases (50%), endocarditis in 11 of 26 (42%), and perivalvular leak in 2 of 26 (7.6%). Age-stratified freedom from reoperation due to structural valve deterioration at 15 years was 34.7% for patients less than 65 years of age; 89.4% for patients aged 65 to 75; and 99.5% for patients aged more than 75 years.
The Carpentier-Edwards pericardial bioprosthesis shows long-term durability with low rates of structural failure.
A retrospective study was conducted to evaluate the intermediate-term outcome in patients with the Carbomedics aortic valve prosthesis.
The study included 1,019 primary valve replacements between 1989 and 1997. Seventy-two percent of patients were men; mean (standard deviation) age was 61 (10) years. The preoperative New York Heart Association functional class was III or IV in 70% of patients. Follow-up at 9 years was 99.6% complete, comprising 2,730 patient-years (mean, 2.7 years).
Patient survival, including operative deaths, was 80% at 7 years. The linearized death rate was 2.9%/year. Statistically significant risk factors for mortality were diabetes, pure valve insufficiency, advanced age at operation, and advanced preoperative functional class. Linearized rates were thrombosis, 0.1%/year; thromboembolism, 1.0%/year; hemorrhage, 1.7%/year; endocarditis, 0.1%/year; paravalvular leak, 0.1%/year; reoperation, 0.1%/year; and all events, 3.0%/year. The 7-year estimates of freedom from complications were thrombosis, 99%; thromboembolism, 93%; hemorrhage, 89%; endocarditis, 99%; paravalvular leak, 99.7%; reoperation, 99%; and all events, 82%. No structural valve failure was observed.
The low incidence of valve-related complications favors the continued use of the Carbomedics valve in the aortic position.
Resection was carried out in 1,025 of 1,654 patients with cancer of the esophagus or esophagogastric junction at the Peking Medical College Hospitals in China from 1953 through 1973. All cancers of the esophagus were squamous cell carcinomas except for five adenocarcinomas. A lesion localized within the esophageal wall was found in 55% and lymph node metastasis in 41.3% of the patients undergoing resection. All cancers of the esophagogastric junction were adenocarcinomas. The tumor had invaded beyond the boundaries of the stomach in 76.7% of these patients, and positive nodes were found in 61% of the patients. The rate of resectability was 81.2% for esophageal cancer and 74% for cancer of the esophagogastric junction. Surgical mortality after resection was 4.9% (50/1,025). The 5-year survival after resection was 20.9% (214/1,025). Better results were found following complete resection: 24% (210/875) for all patients, 28.2% (162/575) for patients with cancer of the esophagus, and 16% (48/300) for patients with cancer of the esophagogastric junction. Late survival at 10, 15, and 20 years after resection of esophageal cancer was 20%, 12%, and 7.4%, respectively. The favorable prognostic factors after resection of esophageal cancer were tumor of the lower third of the esophagus, the absence of lymph node involvement, and the presence of a localized lesion. The 5-year survival for patients with cancer of the lower third of the esophagus was 32.7%. It was 64.2% for patients with a localized lesion with negative nodes in this subgroup.
The lack of valve rotatability, the structural deterioration, and the rate of valve-related complications with the standard mechanical bileaflet prosthesis led to the development of a new second-generation bileaflet valve in 1986.
Between January 1989 and March 1994, 1,049 CarboMedics valves were implanted in 859 patients. The rotatability was used in 109 mitral prostheses (21.5%) and in 61 aortic prostheses (11.6%). Follow-up was 97.1% complete, with 3,049 patient-years.
The hospital mortality was 6.9% for the mitral group, 3.4% for the aortic group, and 10.7% for the double-valve group (p < 0.005). The actuarial survival curve at 5 years was 77.3% +/- 3.6%, 90.1% +/- 2.5%, and 79.2% +/- 3.7% (p = 0.0003), freedom from thromboembolism was 89.1% +/- 3.6%, 87.1% +/- 3.8%, and 68.8% +/- 8.2%, freedom from reoperation was 95.9% +/- 1.4%, 98.9% +/- 0.6%, and 94.9% +/- 2.4%, and freedom from valve-related complications was 68.8% +/- 4.1%, 79.5% +/- 3.5%, and 55.3% +/- 5.9% after mitral, aortic, and mitral and aortic valve replacement, respectively. There were five episodes of valve thrombosis, but no structural deterioration occurred.
The clinical performance of the CarboMedics valve is quite satisfactory, with a low incidence of valve-related mortality and morbidity. The rotatability feature was useful when the native valve was preserved or for repeat valve replacement.
The porcine bioprosthetic valve was used in 440 patients having isolated mitral valve replacement (MVR), 522 patients having isolated aortic valve replacement (AVR), and 88 patients having MVR + AVR between 1974 and 1981. Patients with associated surgical procedures were excluded. Mean follow-up was 8.3 years. At 10 years, there was no difference in patient survival between those having AVR and those having MVR. Reoperations were performed on 192 patients. Endocarditis was the reason for reoperation in 3.7% of patients who had MVR and 10.6% of those who had AVR. Structural valve degeneration was the reason for reoperation in 89.7% of MVR patients and 78.8% of AVR patients (p = 0.04). Hospital mortality among patients having valve reoperations was 4.7%. At 10 years, the freedom from valve reoperation for all causes and from structural valve degeneration was significantly better for the AVR group than the MVR group (74% +/- 3% versus 61% +/- 4%, p = 0.004; and 79% +/- 3% versus 63% +/- 4%, p = 0.0006, respectively). For patients in their 60s, the 10-year freedom from reoperation was 92% +/- 2% for AVR and 80% +/- 6% for MVR (p = not significant). At 10 years, freedom from cardiac-related death and valve reoperation was best for both MVR and AVR patients in their 60s. Patients 70 years old or older rarely had reoperation but died before valve failure occurred. The 10-year freedom from all major valve-related events (cardiac-related death, reoperation, thromboembolism, endocarditis, and anticoagulant-related bleeding) was practically the same for both MVR and AVR patients (48% +/- 3% versus 49% +/- 3%, respectively). The porcine bioprosthetic valve is the valve of choice only for patients 60 years old or older. Patients in their 70s have an extremely low rate of reoperation but a high rate of cardiac-related death and do not outlive the prostheses.
Heart transplantation is the most accepted treatment for end-stage heart disease. A review of 1,083 consecutive transplants (1984 to 2001) was undertaken.
Adult recipients were divided into quartiles. The last 540 transplants were combined. Three eras were created from these, 1984 to 1991, 1991 to 1995, and 1995 to 2001, with three age groups: 0 to 18 years, 19 to 61 years, and 62 to 74 years. All patients have at least 1 year of follow-up time. End points were survival, rejection, and graft coronary artery disease.
There were 1,012 patients. Donor age, graft ischemic time, and the proportion of elderly recipients and nonstandard donor hearts have increased in the current era. Actuarial 60-month survivals of recipients after 1995 were 80.7% (0 to 18 years); 75.3% (19 to 61 years); and 76.2% (>62 years). The current era children and younger adult groups demonstrated improved results when compared with previous eras (p = 0.003 and p = 0.05). Rejection episodes equal to or greater than ISHLT grade 3A per person per year improved to 0.15 in the current era (p < 0.001). During the three eras, older recipients (>62 years) demonstrated fewer episodes of rejection when compared with other adults (0.13 versus 0.58, p = 0.03). Deaths attributed to graft coronary artery disease decreased from 11% to 5% from era 2 to era 3. Regression analysis revealed a mild effect of donor age on survival and graft coronary artery disease (hazard ratio = 1.02, p = 0.001; hazard ratio = 1.039, p < 0.001, respectively). Recipient predictors of graft coronary artery disease were diagnosis of ischemic cardiomyopathy (hazard ratio = 1.6, p = 0.014) and congenital heart disease (hazard ratio = 3.41, p = 0.02).
Improved survival in the current era may be attributed to better organ preservation, improved immunosuppression and control of infection, and less life-threatening graft coronary artery disease.
The thymus or thymoma plays a role in the pathogenesis of myasthenia gravis (MG). Although previous studies have reported that the presence of MG in thymoma patients is an indicator of poor prognosis, recent reports have shown that the presence of MG no longer influences the prognosis or indicates a more favorable prognosis in thymoma patients.
To clarify the difference in tumor behavior between thymoma with MG and that without MG, we compiled 1,089 thymomas treated between 1990 and 1994 from 115 institutes in Japan and analyzed the clinical characteristics of thymoma with MG compared with thymoma without MG.
MG was associated with 270 cases (24.8%) of thymoma. The total resection cases comprised 94.6% and 91.4%, and the recurrent cases comprised 6.4% and 8.3% in the groups with and without MG, respectively. The 5-year survival rates for thymoma with and without MG in stage III were 85.7% and 89.3%, respectively; and those in stage IV were 85.1% and 63.9%, respectively. The prognosis of thymoma with MG in stage IV tended to be better than that of thymoma without MG (p = 0.0523). The thymoma with MG group had fewer stage IVb thymomas than did the thymoma without MG group (15% vs 34%). The resectability rate in the thymoma with MG group was higher than that in the thymoma without MG group (60% vs 38%).
Thymoma with MG is equally or less malignant than that without MG. The infrequency of stage IVb thymomas and the high resectability rate had an influence on the favorable prognosis of stage IV thymoma with MG.
Although many video-assisted thoracic surgery (VATS) lobectomies have been performed over the 12 years since the first VATS lobectomy, controversies about the procedure remain regarding the safety and associated morbidity and mortality of that procedure. This series is reviewed to assess these issues.
Between 1992 and 2004, we performed 1,100 VATS lobectomies in 595 women (54.1%) and 505 men (45.9%), with a mean age of 71.2 years. Diagnoses were as follows: benign disease (53), pulmonary metastases (27), lymphoma (5), and lung cancer (1,015). Of the primary lung cancers, 641 (63.1%) were adenocarcinoma. With visualization on a monitor, anatomic hilar dissection and lymph node sampling or dissection were performed, primarily through a 5-cm incision without spreading the ribs.
There were 9 deaths (0.8%), and none was intraoperative or due to bleeding; 932 patients had no postoperative complications (84.7%). Blood transfusion was required in 45 of 1,100 patients (4.1%). Length of stay was median 3 days (mean, 4.78). One hundred eighty patients (20%) were discharged on postoperative day 1 or 2. Conversion to a thoracotomy occurred in 28 patients (2.5%). Recurrence developed in the incisions in 5 patients (0.57%). In 2003, 89% of 224 lobectomies were performed with VATS.
VATS lobectomy with anatomic dissection can be performed with low morbidity and mortality rates. The risk of intraoperative bleeding or recurrence in an incision seems minimal.
Automated coronary anastomotic devices could be the key to limited or port access procedures. To evaluate their clinical performance to date, 33 studies that included systematic elective angiographic imaging were reviewed, reporting on five proximal and seven distal devices. Marked outcome differences between the technologies were uncorrelated to study type and demographic, operative, and follow-up variables. Significant issues included graft thrombosis, graft kinking, and stenosing intimal hyperplasia inside the connector, limiting clinical applicability of at least three devices. Substantial equivalence to 1-year conventional anastomotic patency standards was found for selected anastomotic devices, which holds the promise of expanded applicability.
Off-pump coronary artery bypass grafting (OPCAB) has gained wide acceptance in tandem with the development of the stabilizer and associated operative techniques. However bypass grafting to the small branches of a beating heart is technically demanding and remains controversial. In the present study we evaluated the graft patency and quality of anastomoses to small coronary arteries by early postoperative angiography.
Between March 2000 and December 2002 a total of 1,328 anastomosed sites to coronary branches were studied angiographically in 404 patients representing 88.6% of all cases who underwent OPCAB in this period. The coronary artery branches were categorized as large (>1.5 mm, group L: 1,028 anastomoses sites) or small (< 1.5 mm, group S: 300 sites) by intraoperative measurement. As in situ grafts the internal thoracic artery (ITA) and the gastroepiploic artery (GEA) were used at 504 and 28 distal anastomosis sites respectively. The radial artery (RA) was used as a composite graft for 739 distal anastomosis sites. Sequential bypass grafting was performed at 388 anastomosis sites in side-to-side fashion. Arterial grafts were used in 96.1% of total bypass grafting.
The percentage of male gender was 78.3% in group S and 87.2% in group L (p = 0.025). The ITA was used in 43.7% of group L and 18.3% of group S (p < 0.0001). The RA was used in 49.4% of group L and 77% of group S (p < 0.0001). The overall patency and stenosis free rates (FitzGibbon Type A) were 97.2% and 96.2%. Graft patency and stenosis free rates in group S (96.7% and 93.3%) were as good as those in group L (97.5% and 97.1%). In group S, the patency and stenosis free rates of SV grafts were 71.4% and 57.1%. On the other hand, those of ITA grafts were 100% and 98.3% (p = 0.53 vs. saphenous vein graft [SVG]) and RA grafts were 95.8% and 92.1% (p = 0.61 vs. SVG) respectively. In group S, the graft patency and stenosis free rates of bypass to the obtuse marginal (OM) (93.7% and 87.5%) were slightly lower than those to other implantation sites left anterior descending (LAD: 100% and 97.3%; PL: 96.5% and 92.3%; DI: 98.0% and 96%; PDA: 97.0% and 97.0%; right coronary artery [RCA]: 100% and 100%) although there was no statistical significance. The graft patency and stenosis free rates were slightly better with side-to-side anastomosis than with end-to-side anastomosis (side-to-side: 98.1% and 95.8% vs. end-to-side 96.3% and 86.3%) in group S.
OPCAB to small coronary artery branches with arterial grafts provided satisfactory graft patency and stenosis free rates.
The clinical experience gained by performing aorta-to-coronary artery bypass grafts on 1,287 patients over the past four years is analyzed. Multiple procedures such as valve replacement and left ventricular aneurysmectomy were performed in 65 of these patients. In the remaining 1,222 patients, modifications in technique are demonstrated by comparing the recent group of 759 patients operated upon in 1971 to 463 patients operated upon previously. Both groups were similar with regard to the severity of disease. The recent group of 759 patients had more multiple graft procedures and a greater incidence of left circumflex coronary artery bypass. The mortality in that group was decreased to 4.5%. In the entire group the mortality rate was 6.4%, including operative and late mortality. Postoperative complications decreased with regard to ventricular arrhythmias and postoperative myocardial infarctions. Emergency coronary artery bypass was done in 20 of the patients over the past year, with a mortality of 35%. Postoperative assessment revealed marked to moderate improvement in all but 13% of the patients. Late results in patients with congestive heart failure and angina or with intractable Functional Class IV angina are compared with results in the remainder of the patients. A standard surgical approach for the treatment of coronary artery disease has resulted from review of these data.
Particulate emboli are thought to play a significant role in the development of cardiac surgical complications. Intraaortic filtration of particulate emboli may reduce the burden of this morbidity in cardiac patients.
A multiinstitutional randomized trial was designed and enrolled 1,289 patients at 22 centers. Six hundred forty-five patients were assigned to the treatment arm and received the Embol-X intraaortic filter, whereas 644 patients were assigned to the control arm. The endpoints examined were mortality, stroke, transient ischemic attack, renal insufficiency/failure, myocardial infarction, gastrointestinal complications, and limb-threatening ischemia. All filters were examined for histologic evidence of particulate emboli.
Particulate emboli were identified in 598 (96.8%) of 618 filters successfully deployed. Composite event rates for the clinical endpoints were similar in both the filtered and nonfiltered arm (110/645 = 17% vs 122/644 = 19%, respectively). Individual event rates were also similar in both arms. A post hoc comparison of patients with moderate or greater preoperative risk scores demonstrated event reduction favoring the filtered group for renal complications (17/124 = 14% vs 28/117 = 24%, p = 0.04) and for the composite endpoint (30/124 = 24% vs 42/117 = 36%, p = 0.047). No clinically evident complications attributed to the use of the filter were identified.
The use of the Embol-X intraaortic filter is both safe and effective, as demonstrated by the emboli capture rate of 97%. In addition, post hoc analysis indicates a reduction in postoperative renal complications for patients with moderate or greater preoperative risk. Further study of high-risk patients is warranted.
Video-assisted thoracoscopic surgery (VATS) has been shown to be a safe and effective method of closing patent ductus arteriosus (PDA). We retrospectively studied our series of patients with PDA who underwent VATS closure with new modifications.
From June 1997 to December 2004, 1,300 consecutive patients diagnosed with PDA (mean age, 6 years) were referred to us, and all of them met our inclusion criteria for the VATS procedure. Recently, we made some minor alterations to our routine methodology. After complete closure of PDA by two titanium clips, the extubated patient leaves the operating room without a chest tube.
There were 3 cases of chylothorax, which were successfully treated by thoracotomy and ligation of the small lymphatic ducts after 1 week of close observation. The procedure was changed to thoracotomy in 7 patients. Meanwhile, 5 additional patients had transient recurrent laryngeal nerve dysfunction. All cases were reassessed immediately after the procedure, and followed for more than 7 years by control echocardiography. No significant complication or residual shunt was recorded during the follow-up period. Mean procedure time was about 10 +/- 2 minutes. All patients were discharged shortly after the procedure (about 20 hours).
Based on this experience, VATS appears to be safer and more effective as well as having other advantages such as being simple to perform, quick, and comfortable for the patients. Furthermore, the cosmetic benefits also make it appropriate as an outpatient procedure.
Surgery remains the mainstay of treatment for thymic epithelial tumors, and radiation and chemotherapy also have been applied widely as adjuvant and palliative procedures.
We compiled records of 1,320 patients with thymic epithelial tumors who were treated from 1990 to 1994 in 115 institutes certified as special institutes for general thoracic surgery by The Japanese Association for Chest Surgery.
Patients with stage I thymoma were treated with only surgery, and patients with stage II and III thymoma and thymic carcinoid underwent surgery and additional radiotherapy. Patients with stage IV thymoma and thymic carcinoma were treated with radiation or chemotherapy. The Masaoka clinical stage is an excellent predictor of the prognosis of thymoma and thymic carcinoma, but not thymic carcinoid. In stage III and IV thymoma, the 5-year survival rates of total resection, subtotal resection, and inoperable groups were 93%, 64%, and 36%, respectively. On the other hand, in thymic carcinoma, the 5-year survival rates of total resection, subtotal resection, and inoperable groups were 67%, 30%, and 24%, respectively. Prophylactic mediastinal radiotherapy could not prevent local recurrences effectively in patients with totally resected stage II and III thymoma. Adjuvant therapy including radiation or chemotherapy did not improve the prognosis in patients with totally resected III and VI thymoma and thymic carcinoma.
Total resection is the most important factor in the treatment of thymic epithelial tumors. There is value in debulking surgery in invasive thymoma, but not in thymic carcinoma. We doubt that adjuvant therapy is valuable for patients with totally resected invasive thymoma and thymic carcinoma.
The CarboMedics bileaflet prosthetic heart valve was introduced in 1986. We first implanted it in March 1991. The purpose of this study was to analyze our clinical experience with this valve.
Between March 1991 and December 1997, 1,378 valves were implanted in 1,247 patients, 705 men (56.5%) and 542 (43.5%) women with a mean age of 62 +/- 11.9 years (+/- the standard deviation). Follow-up is 99% complete and totals 3,978 patient-years.
The early mortality rate was 4.4% (55/1,247). The survival rates at 1 year and 5 years were 91.8% +/- 0.8% (+/- the standard error of mean) (n = 1,062) and 79.2% +/- 1.4% (n = 281), respectively. Freedom from valve-related complications (linearized rate, 4.9% per patient-year) at 1 year and 5 years was 90.6% +/- 0.8% (+/- the standard error of the mean) (n = 996) and 80.6% +/- 1.4% (n = 243), respectively. Linearized rates for various complications were as follows: bleeding events, 1.73% per patient-year; embolic events, 1.76% per patient-year; operated valvular endocarditis, 0.18% per patient-year; valve thrombosis, 0.10% per patient year; and nonstructural dysfunction, 1.21% per patient-year. Freedom from reoperation at 1 year and 5 years was 98.6% +/- 0.3% (+/- the standard error of the mean) (n = 1,070) and 97.7% +/- 0.5% (n = 285), respectively.
Midterm results demonstrate that the CarboMedics prosthetic heart valve exhibits a low incidence of valve-related complications.
Atherosclerotic disease of the ascending aorta during coronary artery bypass graft surgery (CABG) increases the risk for postoperative stroke. The objective of this study was to examine the incidence of postoperative stroke in CABG utilizing the Heartstring (Maquet Cardiovascular, San Jose, CA) proximal anastomotic device.
Intraoperative epiaortic ultrasonography was used to grade atherosclerosis in CABG patients at Emory University from April 2003 to December 2012. The Heartstring device was utilized in 1,380 patients: 407 (29.5%) grade I (minimal atherosclerosis), 367 (26.6%) grade II, 437 (31.7%) grade III, 110 (8.0%) grade IV, and 59 (4.3%) grade V (severe atherosclerosis). Logistic regression analysis was used to estimate the effect of aortic grade on outcomes adjusted for Society of Thoracic Surgeons predicted risk of mortality and predicted risk of stroke scores.
The mean age of all patients was 66.7 ± 10.5 years, and 31.9% were female. An increasing risk profile was apparent with rising aortic grade. Most CABG was done off pump (n = 1,277, 92.5%). There was no significant association between aortic grade and frequency of postoperative stroke (p = 0.83). In all patients, use of the Heartstring device reduced the predicted risk of stroke by 44% (O:E risk 0.56). The benefit for postoperative stroke was least apparent in the grade I aorta patients (O:E 0.8) compared with patients having grade II and greater. There were no strokes among patients with severe atherosclerosis using the Heartstring device.
Compared with the Society of Thoracic Surgeons predicted risk for stroke, the Heartstring proximal anastomotic device can be safely used with all aortic grades. The most prominent benefit appears to be for patients with grade II disease and greater.
To determine which preoperative variables were most predictive of long-term survival after coronary bypass surgery, the status of 1,448 consecutive patients was determined 10 to 14 years after operation. All patients were operated on at least 10 years ago and follow-up at 10 years was 93.8% complete. The overall 14-year survival probabilities were: for one-vessel disease, 73.3%; for two-vessel disease, 45.9%; for three-vessel disease, 34.2%; and for left main coronary artery disease, 41.9%. Patients with good left ventricular function had an overall survival rate of 53.3%, and patients with poor ventricular function had a survival rate of 31.9%. Preoperative variables predictive of greater risk of total mortality were: digoxin usage, multivessel disease, poor quality of left ventricular function, age at operation, electrocardiographic evidence of myocardial infarction, previous stroke, diabetes, heart failure, diuretic usage, cigarette smoking, and residual ungrafted coronary artery disease. The major determinants of long-term survival were variables associated with preoperative left ventricular function. Diabetes was the only important metabolic risk factor identified. This study suggests that unfavorable preoperative conventional risk factors should not be considered a contraindication to operation in patients with adequate coronary anatomy and left ventricular function.
After beginning our use of bilateral internal thoracic artery grafts in 1985, we found the pedicled right internal thoracic artery grafts limiting, and expanded the application of the right internal thoracic artery by elective use as a free graft. We evaluated the results of patients having a free right internal thoracic artery (FRITA)-to-coronary artery graft as part of their coronary revascularization.
From 1986 to 1995, 1,454 patients had a FRITA graft. Preoperative characteristics included mean age, 58.8 years (range 29 to 84 years); non-insulin-dependent diabetes, 116 (8%); insulin-dependent diabetes, 7 (0.5%); left ventricular ejection fraction from 0.30 to 0.40, 159 (11%); left ventricular ejection fraction less than 0.30, 14 (1%); and unstable angina, 144 (9.9%). In 11 patients the FRITA was the only graft, in 1,443 a left internal thoracic graft was also used and revascularization completed with additional arterial and vein grafts. There were 3.3 +/- 1.1 distal anastomoses per patient, the aortic clamp time was 49 +/- 12 minutes, and bypass time was 69 +/- 16 minutes. The FRITA was used to reach the circumflex marginal arteries in 718 patients (49.5%), posterior descending artery in 286 (19.7%), diagonal or intermediate in 172 (11.8%), left anterior descending artery in 119 (8.1%), right coronary artery in 115 (7.9%), and left ventricular branch of right coronary artery in 44 (3%). The proximal anastomosis was directly on the aorta in 1,441, other arterial graft in 8, and vein graft in 5.
Operative mortality was 13 patients (0.9%); stroke occurred in 14 patients (1%) and myocardial infarction in 19 (1.3%). The peak creatine kinase myocardial isoenzyme serum level was 20.6 +/- 13.6 IU/L. Complications included sternal infection in 18 patients (1.2%) and reoperation for hemorrhage in 23 (1.6%). Survival at 5 and 7 years, respectively, was 96% +/- 2.1% and 94% +/- 2.5%. In 71 patients with a FRITA studied at a mean of 41.5 +/- 14 months postoperatively for recurrent symptoms, 67 FRITA grafts were widely patent (94.5%), 3 displayed a string sign, and 1 was totally occluded.
Use of the right internal thoracic artery as a free graft is safe and effective and allows greater flexibility in arterial coronary revascularization.
Lung cancer is still the most common cause of death due to cancer. Although the 5-year survival rate of patients with lung cancer is reported to be increasing, whether the surgical results have actually been improving or not is controversial. We reviewed our experience to evaluate time trends of surgical outcomes in patients with nonsmall cell lung cancer.
We reviewed the clinical records of 1465 consecutive patients with proven primary nonsmall cell carcinoma who underwent complete removal of the primary tumor together with hilar and mediastinal lymph nodes from 1985 to 1995 (early era) and from 1996 to 2002 (late era). The clinical characteristics, surgical outcome, and overall survival of the patients were analyzed, and data from the two eras were compared.
There were 694 patients in the early era and 771 in the late era. As for their characteristics, elder age, female sex, adenocarcinoma, earlier stage of disease and smaller size of tumor were more frequently encountered in the late era. Lobectomy was the most common procedure performed during both periods, and in the late era, the rate of segmentectomy was doubled (11% to 25%) whereas that of pneumonectomy was much less (6% to 1%). Although the frequency of operative deaths in the two eras did not differ (0.3%), that of in-hospital deaths and of postoperative complications decreased significantly in the late era (2% to 0.5% and 28% to 12%, respectively). A significant improvement in survival probability was observed in patients with pathologic stage IA (p < 0.0001), IB (p = 0.0477), and III disease (p = 0.00120) but not in those with pathologic stage II disease (p = 0.5353). Also, the multivariate analysis of patients with pathologic stage I or III demonstrated that age, sex, and size of the tumor were significant prognostic determinants, and confirmed that the recent prolonged survivals remained significant even after simultaneous adjustment for other factors.
These data indicate a significant recent improvement in surgical outcomes after stratification of various prognostic variables although careful consideration should be given to the retrospective nature of this study.
During a 33-month period ending June, 1972, 1,492 patients underwent aortocoronary saphenous vein bypass (ACB). The early mortality with ACB alone was 7.1%, while mortality was more than double (14 of 86 patients died) when ACB was combined with resection or plication of a ventricular aneurysm. Twenty of 84 patients died in the early period following combined ACB and valve resection. One patient among 8 who had concomitant resection of an ascending aortic aneurysm died after operation. Factors that increased mortality in this series were advanced age, female sex, high coronary artery scores, left main coronary artery lesions, high left ventricular end-diastolic pressure, left ventricular dysfunction, congestive heart failure, the requirement for endarterectomy to perform the anastomosis, and recent acute myocardial infarction. Actuarial data from patients who underwent ACB without concomitant procedures show an annual attrition rate of 2.7% per year, which compares to rates of 4, 6, and 10% for patients with single, double, and triple coronary disease treated without operation. In 311 men and women under the age of 70 who had a coronary artery score below 13 and none of the other risk factors, the early mortality was 1.6% (5 patients) and the late mortality was 1.0% (3 patients).
The incidence of pulmonary hypertension resulting from chronic thrombotic occlusion of the pulmonary arteries is significantly underestimated. Although medical therapy for the condition is supportive only, surgical therapy is curative. Our pulmonary endarterectomy program was begun in 1970, and 188 patients were operated on in the subsequent 20 years. With the increased recognition of the disease and the success of operative therapy, however, more than 1,400 operations have been done since 1990 at our center.
The safety and efficacy of the operation was assessed with changes made through increased experience. We examined in detail the results of our last 500 consecutive patients.
Median sternotomy, cardiopulmonary bypass, profound hypothermia, and circulatory arrest were found to be essential to the success of the operation. All occluding material could be removed at operation. We currently believe that there is no degree of embolic occlusion within the pulmonary vascular tree that is inaccessible and no degree of right ventricular impairment or any level of pulmonary vascular resistance that is inoperable. With shorter cardiac arrest periods and the use of a cooling jacket to the head, cerebral impairment has been eliminated. The pulmonary artery pressures and pulmonary vascular resistance in a recent cohort of 500 patients is examined. The mortality rate for the operation has been reduced steadily, and was 22 of the last 500 patients operated on (4.4%).
The operation is considered curative and therefore greatly superior to transplantation for this condition. Current techniques of operation make the procedure relatively safe.
Pericardial prostheses have been used as valvular substitutes since 1975. They combine excellent hemodynamic characteristics with a low risk of valve failure during long-term observation. The aim of this article is to describe the clinical long-term performance of the Mitroflow Synergy pericardial valve (Sorin Group Inc, Mitroflow Division, Vancouver, Canada) in the aortic position for as long as 19 years.
Data were obtained between February 1985 and April 2004 from patients with aortic heart valve replacements (n = 1,464) or from patients with replacements of existing prosthetic aortic valves (n = 52). The age group distributions are less than 70 years (n = 175); 70 to 74 years (n = 462); 75 to 79 years (n = 532); 80 to 84 years (n = 273); and greater than or equal to 85 years (n = 74). The cause of the aortic valve lesions was combined (insufficiency and stenosis) in the majority of patients (62.4%). Concomitant procedures were performed in 897 patients (59.2%) and coronary artery bypass grafting was the most common (53.5%). Mean follow-up was 5.5 +/- 0.09 years. Total follow-up was 8,408 patient-years.
The early mortality (30 days) was 6.6% (n = 99) and late deaths were 60.8% (n = 921). Actuarial event-free rates at 5, 10, and 15 years of follow-up are given as mean +/- standard error for endocarditis: 96.9 +/- 0.5, 92.8 +/- 1.2, and 92.0 +/- 1.4, respectively; embolism: 96.7 +/- 0.6, 88.8 +/- 1.7, and 82.9 +/- 3.5, respectively; bleeding: 98.5 +/- 0.4, 97.2 +/- 0.6, and 94.4 +/- 1.7, respectively; structural valve deterioration: 99.0 +/- 0.3, 82.8 +/- 2.2, and 62.8 +/- 5.8, respectively; and reoperation: 98.2 +/- 0.4, 79.2 +/- 2.4, and 63.4 +/- 5.3, respectively. The rate of endocarditis, structural valve degeneration, and reoperation was lower in patients 75 years of age and older compared with younger patients, whereas embolism occurred more frequently in elderly than in younger patients.
Adverse events after implantation of Mitroflow aortic bioprosthesis rarely occurred during the first 5 years after valve replacement. The results of the prosthesis indicates reliable long-term morbidity rates and good durability in patients 75 years of age and older.
Off-pump coronary bypass may provide a safer form of surgical revascularization by avoiding the unwanted complications of cardiopulmonary bypass, particularly in the increasingly complex patients being referred for operation. This study reviews the entire experience of the Medtronic Octopus System (Medtronic, Minneapolis, MN) for beating heart bypass from 7 surgeons. Demographics, operative procedures, early outcomes, and trends in usage were examined.
Patients were selected for off-pump procedures by the individual surgeons. Data were entered prospectively into locally maintained databases and then collected for collation and analysis.
A total of 1,582 consecutive Octopus patients were entered, representing the entire Octopus experience of each surgeon. Proportions of off-pump procedures relative to standard bypass increased over time, as did the percentage of patients receiving three or more grafts, 24.6% in 1997 and 55.9% in 1999. A total of 3,653 anastomoses were performed, 1,905 to the left anterior descending system, 837 to the circumflex distribution, and 911 to the right coronary territory. Morbidity was low. Few patients required conversion to cardiopulmonary bypass (2.6%; 0.2% urgently). Permanent stroke occurred in 0.6% and myocardial infarction in 1.2%. Operative mortality was 1%.
Octopus off-pump bypass was demonstrated to be a safe procedure with widening applicability. With experience surgeons tend to apply the system to increasing proportions of their patients and are able to revascularize all coronary territories.
From 1976 to 1988, 1,593 patients underwent valve replacement with a porcine (878 patients) or a pericardial bioprosthesis (715 patients). There were 701 aortic, 678 mitral, and 214 multiple-valve replacements. Follow-up was obtained for 1,559 patients (98%). Early mortality was 9% (79 patients) in the porcine valve group and 5% (37 patients) among patients with a pericardial valve (p less than 0.01). Late survival after replacement with porcine valves was 80% +/- 1% and 62% +/- 3% at 5 and 10 years, respectively. With pericardial valves, 5-year survival was 79% +/- 2%. Among valve-related complications, rates of freedom from thromboembolism, endocarditis, and hemorrhage after 6 years were similar for both valve groups. Freedom from reoperation at 6 years was also similar after aortic (96% versus 91%) or multiple-valve replacement (95% versus 88%). However, for mitral valve replacement, freedom from reoperation was significantly better with porcine valves than with pericardial valves at 6 years (92% versus 68%; p less than 0.001). This difference was mainly due to the Ionescu-Shiley valve, which accounted for 83% of primary tissue failures among pericardial bioprostheses implanted in the mitral position (10/12 patients). After 6 years, freedom from primary tissue failure of mitral valves was 92% +/- 2% with porcine and 70% +/- 11% with pericardial bioprostheses (p less than 0.0001). The degree of clinical improvement among survivors was similar with both valve types. Thus, in the aortic position, pericardial valves compare with porcine valves up to 6 years, whereas in the mitral position, the durability of the former is significantly less, mainly because of the suboptimal performance of the Ionescu-Shiley pericardial bioprosthesis.
This study, developed for the purpose of establishing an appropriate protocol for general follow-up of the paced patient, is based on clinical experience with patients derived from diverse specialties, geographical locations and protocol preferences. The analysis represents a four-year study of the transtelephonic follow-up of 1,705 implanted cardiac pacers, which represents 44,616 pacer-months of experience. There were 340 system malfunctions, 41% (141) due to battery exhaustion and 59% (199) due to other causes. Of all observed system failures 9.7% (33) occurred within 1 month of implantation, with the rate declining sharply thereafter until battery failures began to occur at approximately the twenty-fourth month. Only 10.9% (37) of all system failures were accompanied by clinical symptoms. Of the clinical failures, 62% (23) occurred in patients who were tested at intervals greater than 10 weeks. Our analysis indicates that testing should be performed weekly for the first month following lead manipulation. Thereafter, tests should be performed at 8- to 10-week intervals for the first 24 months of pacemaker life. During the third postimplant year tests should be conducted more frequently, depending on the energy source of the generator.
There has been a decrease in the use of whole blood and red cell transfusions during and after open-heart operations in the greater Kansas City area from an average of slightly more than 9 units per patient from 1969 through 1971, to just over 3 units per patient from 1975 through 1977. In 1977, 1,256 patients, or 71% of 1,769 patients, underwent coronary artery bypass exclusively and had an average transfusion utilization of 2.6 units. All other open-heart operations averaged 4.7 units per patient. Hemodilution and the acceptance of hematocrits between 25 and 30% in open-heart operations are probably the main factors responsible for lower transfusion use per patient, while the increased proportion of patients undergoing coronary artery bypass accounts for a further decrease in the average amount of blood used per patient. It is of note that blood transfused to patients having an open-heart operation was not significantly fresher than blood for routine use, yet hemostasis was not a problem as evidenced by the small use of fresh-frozen plasma in 67 patients (3.8%) and platelet concentrates in 42 patients (2.4%).
Venoarterial extracorporeal membrane oxygenation (ECMO) has been used successfully for treatment of cardiogenic shock or cardiac arrest. The exact complication rate is not well understood, in part because of small study sizes. In the absence of large clinical trials, performance of pooled analysis represents the best method for ascertaining complication rates for ECMO.
A systematic PubMed search was conducted on ECMO for treatment of cardiogenic shock or cardiac arrest in adult patients only, updated to November 2012. Studies with more than 10 patients published in the year 2000 or later that reported complication rates for ECMO were included. Specific complications analyzed included lower extremity ischemia, fasciotomy or compartment syndrome, amputation, stroke, neurologic complications, acute kidney injury, renal replacement therapy, major or significant bleeding, rethoracotomy for bleeding or tamponade, and significant infection. For studies that included overlapping patients, the largest study was included and the others excluded. Cochran's Q and I-squared were calculated. A more conservative random-effects model was chosen for all analyses.
Twenty studies were included in the analyses encompassing 1,866 patients. Seventeen studies reported survival to hospital discharge, with a cumulative survival rate of 534 of 1,529, and a range of 20.8% to 65.4%. Analyses encompassed 192 to 1,452 patients depending on the specific complication analyzed. The pooled estimate rates of complications with 95% confidence intervals were as follows: lower extremity ischemia, 16.9% (12.5% to 22.6%); fasciotomy or compartment syndrome, 10.3% (7.3% to 14.5%); lower extremity amputation, 4.7% (2.3% to 9.3%); stroke, 5.9% (4.2% to 8.3%); neurologic complications, 13.3% (9.9% to 17.7%); acute kidney injury, 55.6% (35.5% to 74.0%); renal replacement therapy, 46.0% (36.7% to 55.5%); major or significant bleeding, 40.8% (26.8% to 56.6%); rethoracotomy for bleeding or tamponade in postcardiotomy patients, 41.9% (24.3% to 61.8%); and significant infection, 30.4% (19.5% to 44.0%).
Although ECMO can improve survival of patients with advanced heart disease, there is significant associated morbidity with performance of this intervention. These findings should be incorporated in the risk-benefit analysis when initiation of ECMO for cardiogenic shock is being considered.
Surgical resection, combined therapies, and lymphadenectomy are extensively utilized in the treatment of patients with lung cancer. In the present study, we summarized the clinical data of patients with primary lung cancer after surgical resection alone or combined with adjuvant therapy, and evaluate the main factors influencing long-term survival.
A retrospective review of 1,905 consecutive patients with primary lung cancer treated at the Cancer Institute of the Chinese Academy of Medical Sciences from March 1961 through December 1995 was performed. Statistical analysis was done using STATA software. The survival rate was estimated using the life-table method. Survival differences were performed using the log-rank test. The modified 1997 TNM staging system was used.
There was a 12.28% morbidity rate and a 1.31% hospital mortality in our series. The 5-year survival rate for the complete resection was 49.5% and for the palliative resection 18.8% (p < 0.01). The 5-year survival rate was 72.0% in stage IA and 61.0% in stage IB (p < 0.05), 32.9% in stage IIA and 34.5% in stage IIB, 22.6% in stage IIIA and 15.9% in stage IIIB (p < 0.05), and 7.1% in stage IV.
Multiple factors influence the long-term survival of patients with primary lung cancer after surgery. They include TNM staging, the extent of surgical resection (complete or palliative), resection margin (positive or negative), pathologic type of tumors, and type of resection.
The effectiveness of aggressive resuscitation and early surgical intervention is evaluated in 1,992 casualties with thoracic battle wounds in Lebanon. The mechanism of injury was mainly high-velocity missiles and shelling in city battles. Ninety-seven percent of the wounds were penetrating. The mean age of the wounded was 20 years and the average transport, 4.2 km (3 miles). Logistics and newly equipped thoracic centers aided uniform therapy. For decompensating patients or those in critical condition, initial shock was treated with rapid volume expansion, cardiopulmonary support, and urgent thoracotomy. Thoracotomy was required in 1,422 casualties (71%) and definitive tube thoracostomy in 29%. Three hundred ten patients had pulmonary resections: 36 pneumonectomies, 112 lobectomies, and 162 segmental resections. In 627 patients following primary thoracotomy survival was 98.4%. For 456 casualties with additional systemic procedures, survival was 96.9%. For 285 casualties with cardiac injuries, a significant 14% incidence, overall survival was 73%. Survival was best for those with pericardial and coronary vessel wounds and dropped to 46% for those with left ventricular injuries. Survival was 87% among 54 patients with great vessel wounds. Life salvage in 726 (36%) patients was documented to result from early open procedures. Other benefits of this approach are presented in this broad-based study.
A premature twin of 1.9 kg had mitral valve endocarditis develop during neonatal intensive care. Vegetation involving the entire anterior mitral valve leaflet was identified. Reconstruction was achieved by near complete resection of the anterior mitral valve leaflet and retention of the peripheral margin of coaptation including primary and secondary chordae. The body of the anterior mitral valve leaflet was reconstructed using fresh autologous pericardium, a technique not previously reported in an infant of this size. Three and a half years later, the child is well and has required no further intervention.
Whether center volume influences outcomes in lung transplantation is unknown. We reviewed United Network for Organ Sharing data to examine the effect of center volume on short-term mortality.
We reviewed United Network for Organ Sharing data (1998 through 2007) to identify 10,496 first-time adult lung transplantation recipients at 79 centers. Centers were stratified by quartiles of mean annual volume. Risk of 30-day mortality and 1- and 5-year mortality (censored for 30-day death) were assessed by multivariable Cox proportional hazards regression.
Mean center volume ranged from less than 1 to 58.2 (median, 9.4 cases/year; volume quartiles: 0 to 2.1, 2.2 to 9.4, 9.5 to 19.9, and 20 to 58.2 cases). Each 1 case/year decrease led to a 2% increase in 30-day mortality (hazard ratio, 1.02; 95% confidence interval, 1.01 to 1.02; p < 0.001). Centers of lowest quartile (performing <or=2.1 lung transplantations/year) had a 30-day cumulative mortality of 9.6% or 89% increase in the risk of death (hazard ratio, 1.89; 95% confidence interval, 1.01 to 3.44; p = 0.05) compared with the highest quartile centers despite fewer idiopathic pulmonary fibrosis patients (15.6% versus 25.8%; p < 0.001) and younger age (40.9 versus 51.5 years; p < 0.001). Low-volume centers had double the risk of 30-day censored 1-year mortality (hazard ratio, 1.95; 95% confidence interval, 1.30 to 2.92; p = 0.001). High-volume centers (>or=20 lung transplantations/year) had the lowest 30-day mortality (4.1%).
We provide an initial examination of the relationship of volume and lung allocation score to outcomes for lung transplantation. Low center volume is associated with increased short-term and cumulative mortality despite fewer idiopathic pulmonary fibrosis patients and younger patients.