Edward A. Lefrak

A clinicopathologic analysis of adriamycin cardiotoxicity

The cardiotoxic effects of adriamycin were studied in 399 patients treated for far‐advanced carcimma. Forty‐five patients (11%) exhibited transient electrocardiographs changes. Eleven others developed severe congestive heart failure. Eight of these latter patients died within 3 weeks of the onset of the cardiac decompensation. The diffuse nature of this myocardiopathy was suggested by: 1. a conspicuous decrease in the QRS voltage on the electrocardiograms; 2. rapidly occurring cardiac dilatation and ventricular failure, and 3. refractoriness to inoiropic drugs and mechanical ventricular assistance. Postmortem examination of the hearts in two cases showed a striking decrease in the number of cardiac: muscle cells present, degeneration of the remaining myocardial cells, loss o contractile substance, mitochondrial swelling, and intramitochondrial dense inclusion bodies. Congestive heart failure occurred only once in the 366 patients who were treated with less than 550 mg/m2 of adriamycin (0.27%), but there were 10 cases of cardiac failure in the 33 patients who received more than 550 mg/m2 of this drug (30%). Therefore, until more direct means are established to prevent adriamycin‐induced congestive heart failure, it is suggested that the total dose of adriamycin should be limited to less than 550 mg/m2 to permit safer use of this efficacious cancer chemotherapeutic agent.

Multicenter clinical evaluation of the HeartMate 1000 IP left ventricular assist device

The Thermo Cardiosystems Inc (Woburn, MA) HeartMate 1000 IP left ventricular assist device (LVAD) has been evaluated as a bridge to transplantation in 34 patients for up to 324 days at seven clinical centers in the United States. Sixty-five percent of the patients underwent transplantation, 80% of whom were discharged from the hospital. Six additional control patients, transplant candidates who met the entrance criteria but who did not receive the device, were also included in the study. Although 3 (50%) of the control patients received transplants, all 6 died within 77 days of having met the LVAD inclusion criteria (100% mortality). Complications resulting from use of the device were comparable with those previously reported for all ventricular assist devices, except for thromboembolic events: bleeding, 39%; infection, 25%; and right heart failure, 21%. No device-related thromboembolic events occurred, although 1 patient experienced an event related to a mechanical aortic valve in the native heart. None of the complications had a significant negative association with outcome of the patient except for right heart failure. All survivors had a significant improvement in hepatic function before transplantation. Total bilirubin values were reduced by 60% during LVAD support. No significant differences were observed when total bilirubin values were compared at 30 and 60 days after LVAD support and at 30 and 60 days after transplantation in a cohort of 15 patients (p greater than 0.05). The improvement in renal function was less predictable than that of hepatic function. Creatinine values decreased significantly before transplantation; however, the values measured at 30 and 60 days after transplantation were higher than those measured at the same intervals after LVAD support had been initiated, and this increase is presumably related to the immunosuppressive drugs. In conclusion, the HeartMate 1000 IP LVAD has been shown to be effective in supporting end-stage cardiomyopathy patients to transplantation. Thromboembolism, previously regarded as a serious complication with such devices, has not been a problem with this device. Additional patients are being enrolled into the study to further document the safety and effectiveness of this technology.

In Situ Preservation of Cadaver Kidneys for Transplantation: Laboratory Observations and Clinical Application

Many kidneys obtained from cadaver donors undergoing sudden cardiac arrest cannot be transplanted due to the long periods of warm ischemia from the moment of arrest to nephrectomy. A double-balloon-triple-lumen catheter for the rapid in situ preservation of cadaver kidneys has been designed. Used in combination with equipment routinely found in any hospital, it can cool human kidneys in situ to 10–15 C and maintain this temperature until nephrectomy can be performed. Kidneys preserved with this catheter have functioned after transplantation into suitable recipients. This report describes the design and laboratory evaluation of this new device, its clinical effectiveness and technique of insertion.

Postoperative complications among octogenarians after cardiovascular surgery

BACKGROUND The octogenarian patient is often perceived as too fragile to undergo cardiothoracic surgery. Our study aimed to compare postoperative complications in patients aged less than 80 versus elderly patients (80 years or more) after surgical cardiac intervention (coronary artery bypass or valve replacement). METHODS Subjects were all patients (n = 8,361) who had an open-heart procedure, either coronary artery bypass or valve implantation or replacement, at two medical centers located in northern Virginia using the same surgical group. A computerized medical record database was reviewed to determine preoperative risk factors and postoperative outcomes. Predictors of complications were identified by univariate and multivariate logistic regression. RESULTS A total of 3,214 complications were recorded. The most prevalent complications were prolonged ventilation time in the intensive care unit, reoperation for bleeding, and pneumonia. The overall mortality rate was 2.4% (204 of 8,361). Persons aged over 80 years had nearly double the mortality rate compared with younger patients (4.1% [18 of 444] to 2.3% [186 of 7,917]). Age greater than 80 years (odds ratio = 2.65, 95% confidence interval = 2.18 to 3.22) and male gender (odds ratio = 0.62, 95% confidence interval = 0.56 to 0.69) were the best univariate predictors of a single postoperative complication. CONCLUSIONS Octogenarian patients manifested twice the risk of death from a cardiac intervention with an average 2-day longer hospital stay compared with their younger counterparts. Furthermore, octogenarians were at markedly higher risk of nonfatal postoperative complications.

A reliable bridge to cardiac transplantation: The TCI left ventricular assist device

The Thermo Cardiosystems (TCI) HeartMate, a pneumatically driven, implantable left ventricular assist device, was designed for long-term support of the failing heart. Between February 1990 and August 1992, the HeartMate was implanted in 11 heart transplant candidates because of profound deterioration of left ventricular function. Patients had a mean cardiac index of 1.6 L.min-1 x m-2 and a mean pulmonary capillary wedge pressure of 33 mm Hg despite maximal pharmacologic support with at least three inotropic medications. In addition, 5 patients were being supported with an intraaortic balloon pump. Nine patients were bridged successfully to cardiac transplantation. The mean cardiac index after implantation of the left ventricular assist device was 3.2 L.min-1 x m-2. Support ranged from 2 to 143 days (mean duration, 60 days). One patient died early of low output secondary to right heart failure, and a second died of air embolism, which occurred intraoperatively. All surviving patients became fully ambulatory. There were no thromboembolic complications during a total of 658 patient-days of support on a regimen of only 80 mg of aspirin daily. The 9 bridged patients are currently alive 4 to 34 months after transplantation. The TCI HeartMate provides safe and effective hemodynamic support with low risk of complications and virtual freedom from thromboembolism on a regimen of minimal anticoagulation.

Paediatric perfusion practice in North America: an update

In August 1994, an updated survey questionnaire was mailed to each paediatric open-heart surgery programme in North America as a follow-up to the 1989 paediatric survey. The survey requested demographic data, equipment selection criteria and specific perfusion techniques for paediatric patients. The earlier survey revealed a wide range of clinical practice. Data from the recent survey were compared with the 1989 survey to identify current programme demographics and trends in equipment use and techniques. Responses were received from 125 hospitals (110 active programmes and 15 programmes that do not perform paediatric open-heart surgery) for a response rate of 74%. Of the 110 active centres, 77 perform both adult and paediatric cardiac surgery, and 33 perform paediatric surgery exclusively. Forty-three centres reported that they perform paediatric cardiac transplantation, an increase from 35 centres in 1989. Total caseload increased by more than 8% per year from 1988 to 1994. In 1994, 18% of the patients were operated upon during the first month of life (versus 15% in 1989), and 46% were operated on during the first year of life (versus 45% in 1989) While the 1989 survey was characterized by a high degree of heterogeneity in equipment and techniques, the recent survey reveals a trend toward homogeneity among respondents. The use of membrane oxygenation and arterial line filtration has become universal, and there was an increase in the use of all types of safety devices in the cardiopulmonary bypass circuit.

Results of a prospective multicenter study on port-access coronary bypass grafting.

BACKGROUND We reviewed the initial patient series of three institutions performing large volume port-access (PA) coronary artery bypass grafting (CABG) to evaluate the efficacy of this new procedure. METHODS From October 1996 until June 1998, 302 consecutive patients underwent isolated CABG using the PA approach. Patients (mean age 60.7 years) were predominantly male (77.5%) and received a mean of 2.3 distal anastomoses; few were New York Heart Association class III or IV (15.9%). The distribution of the number of grafts was: 76 (25.2%) single, 110 (36.4%) double, 73 (24.2%) triple, and 43 (14.2%) four or more bypass grafts. The Society of Thoracic Surgeons (STS) Database data collection form was used prospectively by all three institutions to define patient risk factors and record outcomes. RESULTS Total 30-day hospital mortality was 0.99% compared to the STS-database-model-predicted risk of 1.2%. Complication rates for the PA CABG patients compared with risk-matched morbidity rates from the STS data for CABG alone were: reoperation for bleeding, 3.3% versus 1.9%; ventilatory support more than 1 day, 1.7% versus 3.8%; stroke, 1.7% versus 1.2%; and perioperative transmural myocardial infarction 0% versus 1.3%. CONCLUSIONS The STS CABG risk-adjusted model demonstrates that the 30-day mortality for patients undergoing PA CABG is lower than predicted for traditional CABG patients (confidence intervals not available). Likewise, the morbidity was low, with minimal ventilatory support, pulmonary complications, and atrial fibrillation. The port-access technique is an acceptable strategy for multivessel bypass grafting.

Aortic cannula velocimetry

Robert C Groom, Aaron G Hill The Virginia Heart Center at Fairfax Hospital, Falls Church, Virginia, Barry Kuban The Ohio State University Department of Biomedical Engineering, Columbus, Ohio, William Oneill 3M Cardiovascular, Incorporated, Ann Arbor, Michigan, Bechara F Akl, Alan M Speir, James Koningsberg, Gregory T Sprissler, Mohamed Shakoor, Paul S Massimiano, Nelson A Burton, Robert A Albus, Quentin Macmanus and Edward A Lefrak The Virginia Heart Center

Alternative Method of Ultrafiltration After Cardiopulmonary Bypass

A revised circuit design for modified ultrafiltration is presented rendering the technique more convenient for use after cardiopulmonary bypass when blood cardioplegia is used. The procedure employs a hollow-fiber ultrafiltration device attached to the cardioplegia circuit. A bubble trap, heat exchanger, and a pressure monitor are incorporated as safety features. The technique has been used in 80 patients (30 pediatric and 50 adult) and has been associated with relevant increases in colloid osmotic pressure and hematocrit.

An Improved Mitral Valve Prosthesis

Abstract A Dacron velour–covered, Teflon-disc mitral valve prosthesis was developed in an effort to reduce thromboembolic complications of mitral valve replacement. A 12- to 28-month follow-up of 202 patients receiving these prostheses demonstrated only a 4.5% total incidence of such complications. However, a continuing search has been made for more durable materials. The most promising of these has been Pyrolite carbon, which now has been used for both the disc and the struts. Sacrifice of calves at intervals up to 12 months with scanning electron microscopical studies has demonstrated a disc and strut wear curve projecting 140 years prior to penetration of the Pyrolite carbon coating. Orifice and frustum areas of all sizes have been enlarged without change in mounting diameter. Clinical investigations of this prosthesis in several centers have been associated with as low an incidence of thromboembolic complications as that achieved with the Teflon-disc prosthesis. This improved prosthesis now has been released for general use.