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This phase I open label, dose-escalating study shows that gene transfer of vascular endothelial growth factor-2 naked deoxyribonucleic acid by direct myocardial injection by way of thoracotomy in patients with Canadian Cardiovascular Society class 3 or 4 angina is feasible and safe. The procedure is well tolerated, with few major adverse cardiac events at 1 year, and without complications directly related to gene expression. In this prospective, nonblinded study, the procedure is associated with clinical improvement; however, there was no angiographic evidence of angiogenesis and there is a great potential for a sham or placebo effect in the study patients. A randomized phase III trial is underway that will help determine the efficacy of vascular endothelial growth factor-2 gene transfer in “no-option” patients.

Purpose: A prosthetic venous valve must be biocompatible and nonthrombogenic and function in the venous circulation. Biocompatibility and thrombogenicity of our prosthesis have been examined in prior animal experiments, and 91% of valve conduits including early prototypes are patent at 3 weeks. However, evaluation of valve function is much more difficult in animals; therefore in this study the function of excised valves was evaluated ex vivo. Methods: Nine bovine jugular vein conduits, each with one bileaflet venous valve, were harvested and placed in a venous flow simulator. Flows and pressures were adjusted to mimic human respiratory and hydrostatic variations. Each valve and conduit was tested for variations in valve diameter and sinus expansion in response to flow. Valve opening and closing times and valve competence were measured in response to pressure changes. After testing, each specimen was glutaraldehyde fixed and assessed a second time. Results: Valve orifice area increased in response to flow in both fresh and fixed tissues. Maximum valve orifice area was reduced by fixation (27.7%) at full flows ( p p p Conclusions: Size and availability make the bovine jugular vein valve an ideal venous valve substitute. Glutaraldehyde fixation renders the tissue biocompatible and nonthrombogenic while preserving anatomic integrity and leaflet strength and flexibility. Mounted and stented in a sewing sleeve, this prosthesis could represent the first generally applicable clinical solution to chronic venous insufficiency and venous hypertension. (J VASC SURG 1993;18:577-86.)

We reviewed the cases of 10,638 cardiac surgical patients to determine the incidence of deep vein thrombosis (DVT) after open heart surgery (OHS). Seventy-seven patients (0.7 percent) had DVT. Group 1 included 36 patients who had DVT without pulmonary embolism (PE). Occurrence was equal in either leg. Anticoagulation with heparin and warfarin sodium (Coumadin) was employed as treatment. Extension of hospital stay was 10.8 days. Group 2 consisted of 41 patients who experienced PE 9.9 days after OHS. Sixteen patients had known DVT and were receiving heparin. In 25 patients, PE was the first event. Risk factors for PE included perioperative myocardial infarction (16 percent), atrial fibrillation (41 percent), blood type A (70 percent) (p

Intra-aortic balloon counterpulsation (IABC) was developed to assist the circulation in pump failure. Its use has recently been suggested to decrease or retard the extent of ischemia in normotensive patients with acute myocardial infarction. In dogs, the combination of IABC and phenylephrine decreased the extent of ischemia after acute coronary occlusion by 76 per cent, far more than IABC alone. The data suggest that increasing coronary perfusion is a more important factor than decreasing left ventricular afterload in this effect of IABC.

The surgical management of 18 patients diagnosed as having malignant mesothelioma is reviewed. Of these patients, 7 received limited treatment—pleurectomy or biopsy. The mean survival was 10 months, and no patient was disease-free at time of death. The other 11 patients were treated by radical extrapleural pneumonectomy. There were 2 long-term, disease-free survivors at 2 and 4 years. Mean survival for the entire group was 15 months, but most patients received good palliation following tumor removal. Surgical procedures for removal of malignant mesothelioma can be accomplished safely and without major morbidity. When possible, radical extrapleural pneumonectomy affords the best palliation and the only opportunity for cure.

With the use of an epicardial ST mapping technique, left ventricular bypass (LVB) was shown to reduce effectively the myocardial ischemia associated with coronary artery occlusion in dogs in proportion to the extent of bypass. Pulsatile flow was equally, but not more, effective. A reduction in cardiac work is proposed as the basis for these benefits.

Over a period of 18 years, 191 consecutive patients had interruption of the inferior vena cava with the Hunter-Sessions balloon for complications of deep venous thrombosis and pulmonary embolism. Causes of deep venous thrombosis and pulmonary embolism included the postoperative state (33%), cancer (32%), and stroke (11%). There were 93 females and 98 males; ages ranged from 17 to 90 years (average, 57 years). Indications for placement of the Hunter-Sessions balloon were as follows: contraindication to anticoagulants (33%), anticoagulant complications (24%), pulmonary embolism despite anticoagulants (45%), and others including inferior vena cava thrombus (12%). Sixty-eight percent had clinical phlebitis and 36% had positive venography results. Pulmonary embolism had occurred in 165 patients (86%). It was diagnosed by ventilation-perfusion scanning (75%), angiography (23%), or on clinical grounds (2%) in patients with confirmed deep venous thrombosis. At the time of the procedure 52% were in significant cardiopulmonary distress, and 10% were intubated and on respirators. Transjugular placement was done in 188 patients, and transfemoral placement was performed in three. All tolerated inferior vena cava interruption. Thirty patients (15%) died while in the hospital an average of 21 days after balloon placement, which was unrelated to the deaths. Followup was 45 months. Ninety-four patients are dead, 95 are alive, and the status of two patients is unknown. Twenty-nine of 64 patients (45%) who died after they left the hospital died of cancer. At last follow-up, 75% of patients had legs free of edema and 25% had need for elastic stockings. No malfunction or migration has occurred with the device. No patient had a pulmonary embolism while in the hospital after insertion of the Hunter-Sessions balloon, and no patient died of pulmonary embolism. Late minor pulmonary embolism occurred in three patients. (J Vasc Surg 1989;10:450–6.)

Of 4,124 patients undergoing median sternotomy for cardiac operations, 1.8% had sternal wound complications. These included wound drainage, skin separation, unstable sternum, and sternal dehiscence with or without infection. Septicemia and mediastinal abscess were found in all 19 patients who died. Incision and drainage of skin and subcutaneous tissue with frequent changes of dressing or irrigation (Method A) is recommended for those patients with (I) serosanguineous drainage only or (2) a stable sternum and superficial infection without systemic reaction. Surgical debridement of the sternum and mediastinum with reclosure followed by mediastinal irrigation via drainage tubes with 0.5% povidone-iodine solution (Method B) is recommended for patients with (1) a draining, unstable sternum, (2) infection involving the retrosternal space, or (3) infection causing a systemic reaction unresponsive to Method A. None of the eight patients in the latter group with more serious infections died when managed by Method B, and only one had recurrent infection. In contrast, of 28 patients of the latter group not treated with Method B, 11 died of infection-related causes and 13 returned with recurrent infection.

Despite a 15 year experience with the aorta-coronary bypass operation, indications for its use remain unsettled, especially in the elderly. Between January, 1974, and June, 1980, 2,667 patients underwent coronary artery revascularization with an overall mortality of 3.8% (101/2,667). During the last 12 months the mortality has decreased to 1%. There were 2,562 patients below the age of 70, with a mortality of 3.5% (90/2,562), in contrast to 105 patients over the age of 70, with a mortality of 10.5% (11/105) (p = 0.002). In patients less than 70 years of age there was a significant difference between the mortality of men, 3.12% (67/2,146). and that of women, 5.53% (23/416) (p = 0.015). This disparity of operative risk was far more pronounced in patients over 70 years of age: men 6 % (5/84) and women 28.6% (6/21) (p = 0.002). The overall operative mortality of women, 6.6% (29/437), was significantly different from the overall mortality of men, 3.2% (72/2,230) (p = 0.001). An in depth analysis of past medical history, risk factors, and catheterization data is presented in those patients over the age of 70. The average number of vessels bypassed was 2.40: men 2.47 and women 2.09 (p = NS). The ages varied from 70 to 81 years with a mean of 72.5. Smoking (p = 0.012) and diabetes (p = 0.0078) were significant risk factors for coronary disease. Smoking (p = 0.032) and abnormal pulmonary artery pressures (p = 0.0429) were significant variables affecting mortality. A 97.1% follow-up was obtained up to 78 months. Coronary artery revascularization can be performed in men below the age of 70 with acceptable mortality, but there is a twofold increase above the age of 70. Women can undergo revascularization below the age of 70 with a significantly higher risk than males. Those above the age of 70 are at severe risk and should undergo revascularization only after careful selection.

Between 1970 and 1982, 126 inferior vena cava (IVC) balloon occlusions were performed for complications of venous thromboembolism (VTE). Forty, or 32%, were in patients with cancer. There were 20 men and 20 women. The average age was 60.8 +/- 2 years. Cancers of the brain, lung, and breast, along with diffuse metastatic disease with unknown primary disease, were equally common and represented 50% of our cases. Indications for IVC occlusion included pulmonary embolus despite anticoagulation (AC); 50% VTE and contraindication to AC, 38%; and complications of AC, 12%. Three patients died from ongoing complications of previous AC. Eight additional patients died of cancer, for a hospital mortality rate of 28%. Twenty-nine patients were discharged an average of 28.4 +/- 4.3 days after IVC balloon occlusion. Twenty of these patients subsequently died of cancer an average of 13 +/- 4.7 months after hospital discharge. Eight patients remain alive, four for more than 4 years. Pulmonary emboli did not occur after balloon occlusion, and there were no balloon complications. Only 4 of 29 discharged patients had mild leg edema. Hunter balloon occlusion of the IVC represents a safe and effective method for managing complications of VTE in patients with cancer. Early hospital discharge is possible, treatment is permanent, and future chemotherapy is not compromised by the need for long-term anticoagulation.

The production of prosthetic valve incompetence during atriotomy closure is among the operative maneuvers utilized to prevent air embolism in mitral valve replacement. The leaflets of a porcine bioprosthesis may be retracted safely and effectively, thereby producing temporary valve incompetence, by placing three polypropylene sutures through the valve orifice and around the sewing ring to encircle the leaflets. These traction sutures are easily pulled out through the atriotomy suture line after all air has been displaced from the heart. The technique has been effective, easily accomplished, and without complications.