The initial United States experience with the ATS mechanical cardiac valve prosthesis.

From January 1, 1997 through June 30, 2000, 224 patients underwent valve replacement with the ATS Medical cardiac valve prosthesis under a USFDA-approved investigational device exemption study. Aortic valve replacement (AVR) was conducted in 152 patients (39 with coronary bypass) and mitral replacement (MVR) in 72 patients (18 with coronary bypass). Overall operative mortality was 1.8% (AVR = 2.8%, MVR = 0%), with only one valve-related death. In 372 patient-years of follow-up, there were an additional four patient deaths, two of which were valve related following a stroke. Valve-related complications included: thromboembolism (linearized rate = 3.8% per patient year), of which 3/11 had chronic deficits (0.8% per patient year); thrombosis (1 MVR = 0.8% per patient year); paravalvular leak (1 AVR = 0.4% per patient year); anticoagulant-related hemorrhage (1 AVR and 5 MVR = 1.6% per patient year) with no patient mortality; prosthetic valve endocarditis (1 MVR = 0.8% per patient year); and valve dysfunction (0%). Echocardiographic gradients were proportional to valve size and did not significantly change over the follow-up period. This study documented the ATS Medical prosthesis to be a valuable addition to the surgeon's armamentarium in the treatment of cardiac valvular disease.

Complications of rotator cuff repair.

Complications are reported in 10.5% of shoulders undergoing rotator cuff repair, but little attention has been directed toward this aspect of the procedure. A total of 116 shoulders undergoing rotator cuff repair were studied carefully relative to complications and risk factors. Complications occurred in 44 of these shoulders (38%). A major surgical complication affecting the final result occurred in 19 shoulders (16%). In order of frequency, the complications of tendon healing were frozen shoulder, deep infection, and dislocation. Many risk factors were also identified.

Ten-year follow-up study of patients who had double valve replacement with the St. Jude Medical prosthesis.

Records of 100 consecutive patients who had received double valve replacement were reviewed (41 men, 59 women, mean age, 60.86 +/- 13.0 years). The early death rate was 6% (six patients). A completed follow-up rate of 93% was accomplished in these 94 patients who left the hospital (mean, 309.8 patient-years). Twenty-three of these patients died. The late death rate was 26.4%. Four patients experienced thromboembolic episodes (one transient and three permanent; all were minor). One patient had a paravalvular leak (mitral), and another had thrombosis of the tricuspid valve. There was no clinical evidence of hemolysis, infective endocarditis, or structural failure or anticoagulant-related bleeding. One of those 23 patients who died was the patient who had thrombosis of the tricuspid valve. Another three patients died of sudden and unknown causes, 15 of cardiac-related problems and four of noncardiac problems. Of those patients who survived, New York Heart Association functional class improved significantly (from 66% class III before to 85% class I after). Linearized rates for thromboembolism and thrombosis were 1.29 +/- 0.65 and 0.32 +/- 0.32 per 100 patient-years, respectively. The actuarial estimates of incidence free of all complications and valve-related deaths were 77.9% +/- 10.6%. Despite the advanced heart disease involving two native valves, the patients who had double valve replacement with the St. Jude Medical prosthesis had very good results over a 10-year period.

Mechanical circulatory support as a bridge to transplantation.

From December 1985 through April 1988, 11 patients (three female and eight males), 33.1 +/- 3.9 (+/- SEM) years of age (range, 15 to 50 years), underwent heart transplantation preceded by the use of mechanical circulatory support. The causes of cardiac failure were ischemic (four), viral cardiomyopathy (three), idiopathic cardiomyopathy (two), congenital heart disease (one), and valvular heart disease (one). All patients were preterminal. Mechanical circulatory support consisted of intra-aortic balloon pump (eight), the total artificial heart (seven), biventricular assist (three), and left ventricular assist (two). Seven patients had more than one form of support. The duration of mechanical circulatory support was 12.2 +/- 4.1 days (range, 1 to 44 days). Once listed for transplantation, patients waited for 8.1 +/- 2.4 days for a donor. Seven patients received OKT3 monoclonal antibody as prophylaxis, in addition to triple-drug immunosuppression. There were four rejection episodes and 12 serious infections. In addition, eight patients suffered a major posttransplant complication of a distant organ system: central nervous system (three), renal (two), and respiratory (three). Post transplant hospitalization was 48 +/- 22 days (range, 15 to 248 days). Two patients (18%) died after transplant, one of severe acute rejection (29 days) and one of multisystem failure (248 days). All patients surviving transplant hospitalization are alive 6 to 34 months after the transplant procedure. Eight patients are in functional class I and 1 patient class II. This patient attends school full-time but has a premechanical support system neurologic defect. In follow-up of 163 patient-months except for yearly catheterization, these nine patients required only 5 hospital days. Although the use of the mechanical circulatory support as a bridge to transplantation can result in a prolonged, complicated hospitalization after transplant, the long-term results are gratifying.

Ten years' experience with the St. Jude Medical valve prosthesis.

Records of 1,298 consecutive patients who had received the St. Jude Medical prosthesis were reviewed (713 male and 585 female patients; mean age, 61.79 +/- 13.4 years). Early mortality was 5.7% (74 patients). Ninety-three percent complete follow-up was accomplished for the 1,224 patients who left the hospital (4,306.50 patient-years). One hundred ninety-two of these patients died, a late mortality of 16.9%. Sixty-four patients experienced thromboembolic episodes (17 major and 35 permanent). Twenty-four patients had anticoagulant-related bleeding, 4 had valve thrombosis, 7 had prosthetic valve endocarditis, 9 had paravalvular leak, and 10 underwent reoperation. There was no structural valve failure in this series. Twenty-two of the 118 patients who had valve-related complications died; another 15 patients died of sudden and unknown causes. Therefore, the total number of valve-related deaths was 37. Of those patients who survived, New York Heart Association functional class improved significantly (98% in classes II and III preoperatively and 96% in classes I and II postoperatively). Linearized rates for thromboembolism, valve thrombosis, and anticoagulant-related bleeding were 1.49% +/- 0.19%, 0.09% +/- 0.05%, and 0.56% +/- 0.11%/100 patient-years, respectively. The actuarial estimate of incidence free from all complications, operative death, and valve-related death was 66.9% +/- 8.2% at the end of 9 years. In spite of old age and advanced heart disease, the patients who received the St. Jude Medical prosthesis had very good results over a 10-year period.

St. Jude Medical prosthesis: valve-related deaths and complications.

Despite the hemodynamic improvement in cardiac valve prostheses, valve-related deaths and complications have remained a substantial source of morbidity and mortality. This follow-up study was carried out in April, 1986, in a group of 816 patients who received 876 St. Jude Medical prostheses between October, 1977, and October, 1984. One hundred fifty-five patients (37%) of the 422 having aortic valve replacement (AVR) and 88 (29%) of the 300 having mitral valve replacement (MVR) had concomitant coronary artery bypass grafting, and 94 patients (12%) had miscellaneous procedures performed in addition to valve replacement. Sixty-three patients died within the operative period, an operative mortality of 7.7%. Follow-up was complete for 98% of the patients; the mean follow-up was 42 months. At that time, 87 more patients had died, a late mortality of 11.9%. There were 13 valve-related deaths (4 in the AVR group, 7 in the MVR group, and 2 in the miscellaneous group); the causes of death were thromboembolism (7), anticoagulant-related hemorrhage (2), valve thrombosis (2), prosthetic valve endocarditis (1), and perivalvular leak (1). There were 37 thromboembolic episodes (1.78/100 patient-years) and 67 anticoagulant-related hemorrhages (3.22/100 patient-years), 46% of which necessitated transfusion. The incidence of valve thrombosis was 0.6% (4 patients). Perivalvular leak and prosthetic valve endocarditis occurred in 7 patients (1.0%) and 5 patients (0.7%), respectively. Reoperation was carried out in 6 patients (0.8%), but only for perivalvular leak. There were no deaths, no complications, and no clinical evidence of malfunction of the prosthetic valve.(ABSTRACT TRUNCATED AT 250 WORDS)

Use of the mini Jarvik-7 total artificial heart as a bridge to transplantation.

A 40-year-old woman was maintained on a mini Jarvik-7 total artificial heart for 45 days, during which time she recovered from a viral cardiomyopathy and multiple organ failure. The total artificial heart and driver were free of mechanical dysfunction, and there was no evidence of thromboembolic complications. The patient was maintained on hemodialysis for 26 days, at which time kidney function returned to near normal. The patient underwent an uneventful heart transplant and is now alive at 4 months after transplantation.

Six years of experience with the St. Jude Medical valvular prosthesis.

The cases of 680 consecutive patients who underwent valve replacement with the St. Jude Medical prostheses by one group of surgeons from October 1977 through October 1983 were reviewed. The operative mortality for the entire group was 6.6% (3.7% for aortic valve replacement [AVR], 1.6% for AVR and coronary artery bypass [CAB], 14.3% for AVR and miscellaneous procedures; 7.9% for mitral valve replacement [MVR], 15.5% for MVR and CAB, 33% for MVR and miscellaneous procedures; 5% for double valve replacement [DVR], 8.3% for DVR and CAB, and 0% for DVR and miscellaneous procedures). Warfarin (Coumadin) anticoagulation was recommended for all the patients. The mean follow-up of 24 months was completed in 95% of the patients (14,737 patient-months). The overall late mortality was 7.7% (6.2% for AVR, 6.3% for AVR and CAB, 8.3% for AVR and miscellaneous procedures; 7.9% for MVR, 6.7% for MVR and CAB, 33% for MVR and miscellaneous procedures; 15.8% for DVR, 18.2% for DVR and CAB, and 0% for DVR and miscellaneous procedures). There were no cases of mechanical prosthetic failure. Clinically significant hemolysis occurred in only five patients (less than 1%) with paravalvular leak after MVR. Only three patients (less than 0.5%) experienced prosthetic infection. Incidence of embolization was 0.7 per 100 patient-years in the patients who underwent AVR and 2.2 per 100 patient-years in those who underwent MVR.(ABSTRACT TRUNCATED AT 250 WORDS)

Combined techniques for double valve replacement in the infant.

A 6-month-old female infant was seen with heart failure secondary to severe aortic and mitral regurgitation. As a neonate the infant had undergone an aortic valvotomy for congenital aortic stenosis. Subsequently the infant had aortic and mitral regurgitation with an infarcted papillary muscle. Double valve replacement was carried out with the St. Jude valve. The first approach was by the Manouguian procedure with extension of the aortotomy out between the left coronary cusp and the noncoronary cusp. The posterior mitral apparatus was resected, and a 19-mm St. Jude aortic valve was sewn into the mitral position. Because the enlarged aortic valve annulus was still inadequate to accommodate a 19-mm St. Jude valve, a Konno procedure was carried out to enlarge the aortic ring anteriorly. Atrial, septal, and aortic repair and right ventricular outflow tract reconstruction were carried out with bovine pericardium. Bypass was carried out with standard techniques of hypothermia, aortic cross-clamping, and cardioplegia. Postoperative anticoagulation therapy was initially with aspirin and dipyridamole (Persantine); however, clotting of the mitral prosthesis necessitated treatment with urokinase and heparin, which completely resolved the clot. Sodium warfarin (Coumadin) therapy was then begun. One year postoperatively, the child is developing normally.

Should valve replacement and related procedures be performed in elderly patients?

The cases of 135 consecutive elderly patients 70 years old or older who had valve replacement and related surgical procedures from October, 1977, through April, 1982, were reviewed. There were 75 men and 60 women. The mean left ventricular ejection fraction was 50.16 +/- 5%. The overall operative mortality was 8% (11 patients). The early operative deaths were related mainly to cardiac failure, low cardiac output, sepsis, and renal and multiorgan failure. To assess the operative risk, these 135 patients were compared with 312 younger patients (less than 70 years old) who had undergone similar procedures during the same period. The operative mortality in this group was 5.2% (16). In-hospital complications included arrhythmia (13%), psychosis (7.4%), respiratory failure (6.7%), renal failure (6.7%), cerebrovascular accident (5.2%), myocardial infarction (4.4%), and reoperation for bleeding (2.2%). Wound dehiscence occurred in 1.5% of the patients, and pulmonary emboli and sepsis developed in 0.7%. Of these complications, only the incidence of cerebrovascular accident appeared to be more common in the elderly group (5.2% versus 2.8%), but it had no statistical significance (p = 0.18). A follow-up of 3,892 patient-months was completed in 98.4% of the survivors. There were 8 late deaths (6.4%). Six were related to the valve or to ongoing cardiovascular disease. Thirty-four patients subsequently required medical attention: 4 had bleeding because of the anticoagulant; 3 required a blood transfusion; and 27 were hospitalized. Six were admitted for related cardiac conditions and 7, for observation of other conditions; 14 underwent surgical procedures not related to the cardiovascular system.(ABSTRACT TRUNCATED AT 250 WORDS)

The influence of prophylactic antibiotics on the warfarin anticoagulation response in the postoperative prosthetic cardiac valve patient. Cefamandole versus vancomycin.

The influence of cefamandole and vancomycin used for prophylaxis on the warfarin anticoagulation response in 60 cardiac valve replacement patients during the postoperative period is presented. Patients were divided into two groups, hyper-responders prothrombin time (PT) greater than or equal to 32 sec, 48 hr after the initial warfarin dose (GrIHR), or normal responders PT less than 32 sec (GrIINR). Fifteen patients (25%) were in GrIHR (PT 44.3 +/- 10.5) and 45 in GrIINR (21 +/- 5). Fourteen of the 15 GrIHR patients received cefamandole and 1 of the 15 GrIHR patients received vancomycin p less than 0.05, as prophylaxis. Warfarin sensitivity was assessed using a warfarin dose index (WDI) calculated in the initial postoperative period (WDIINT) and at discharge (WDIDIS). GrIHR patients had greater WDIINT and WDIDIS compared to GrIINR p less than 0.001. Baseline prothrombin time measured 8 hours prior to start of warfarin therapy (PTBL), was linearly correlated to the WDIINT with r = 0.8, p less than 0.001 in cefamandole patients only. The data suggests that cefamandole increases warfarin sensitivity early in the postoperative course of oral anticoagulation therapy, which may lead to excessively high prothrombin times with the possibility for serious bleeding.

Effects of transfusion of emboli and aged plasma on pulmonary capillary permeability.

The effects of transfusion of whole blood clot emboli and aged citrated platelet-poor plasma on pulmonary capillary permeability were investigated in anesthetized sheep by continuous collection of pulmonary lymph. Changes in lymph flow and lymph-to-plasma ratios (CL/CP) for albumin and globulin were utilized to detect changes in permeability. Infusion of 0.5 cc/kg of finely (less than or equal to 1 mm) diced autologous whole blood clot resulted in a 170% increase in lymph flow over control with no change in CL/CP for albumin or globulin. Infusion of 1 cc/kg of autologous clot increased lymph flow 180% over control and increased CL/CP for albumin and globulin. Infusion of homologous platelet-poor plasma caused greater increases in lymph flow without changes in CL/CP. Changes in each of these three groups were consistent with increased permeability. Balloon occlusion of one main pulmonary artery was induced without a fall in cardiac output and resulted in no change in lymph flow of CL/CP despite a rise in pulmonary vascular resistance (PVR). Femoral arteriovenous fistulas were created to increase cardiac output, but no change in lymph flow or CL/CP occurred. The results in these latter two experiments suggest that increased perfusion per unit lung capillary bed or increased PVR were not primarily responsible for the changes observed in the emboli-treated and plasma-infused animals. Since both emboli and aged platelet-poor plasma increased pulmonary capillary permeability, the permeability increasing factor appears to be humoral in origin. Similar humoral factors may be important in the pathogenesis of the adult respiratory distress syndrome in man.

The production of malignant tumors of the lung and pleura in dogs from intratracheal asbestos instillation and cigarette smoking.

Nine dogs were given early intratracheal instillations of crocidolite asbestos for periods up to three years. The maximum dose totalled 66 mg/kg. In addition, seven of these dogs smoked nine cigarettes per day, five days per week for six years. A malignant pleural and/or peritoneal mesothelioma developed in six of these dogs, and adenocarcinoma of the lung developed in four, one of which had areas of squamous differentiation. The first animal died of a malignant tumor six years after the onset of exposure, and the last animal died eight years after the onset.

The nature of failure of pulmonary adaptation to atelectasis.

The ability of the lung to decrease blood flow to an atelectatic lobe and to increase flow to normal after reinflation was investigated with a model using left lower lobe atelectasis (LLLA) in the dog. The change in the shunt fraction QS/Qt with continuing LLLA was assumed to represent a change in blood flow to the LLL. With LLLA the Qs/Qt rose from 0.112 to 0.172 and then decreased to 0.119 by the end of 2 hours at the rate of -17%/hour. Reversal of atelectasis for varying times demonstrated that the pulmonary vasoconstrictive response persisted for at least 4 hours after reinflation of LLLA. With LLL ischemia for 1 and 2 hours followed by LLLA, Qs/Qt decreased, but at a rate less than the controls, whereas after hemorrhagic shock with venous reinfusion and LLLA, the Qs/Qt did not decrease. When hemorrhagic shock was followed by arterial reinfusion, 60% had a normal response to LLLA; 40% did not. There was no difference in PVR in these two groups. Pulmonary extravascular water in both groups was the same as in controls. Infusion of NE after 3 hours of LLLA caused Qs/Qt to rise from 0.125 to 0.248, comparable to the value immediately after onset of LLLA. EPi had similar results. Catecholamines may restore blood flow to the atelectatic lobe by causing a maximum generalized pulmonary vasocontriction or by overexpansion of the pulmonary blood volume secondary to peripheral vasoconstriction and thereby abolish any differential in pulmonary vascular resistance across the lung. The early hypoxemia of adult respiratory distress syndrome may arise not on the basis of any intrinsic lung pathology but rather as the result of a normal response of the lung to increased catecholamines.

Surgical management of shotgun injuries of the face.

The surgical reconstruction of patients with self-inflicted gun blast injuries to the face requires the most efficient management. There was a uniform pattern of tissue loss in the patients studied. The repair sequence was subjected to a retrospective analysis to indicate the most efficient co-ordination and return to a functional state. Emphasis must be upon the principle of initial salvage of as much bony structure as possible. Primary flap transfer or early mobilization of flaps for soft tissue repair are desirable in speeding restoration.