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1.
Ann Thorac Surg ; 72(6): 2026-32, 2001 Dec.
Article in English | MEDLINE | ID: mdl-11789788

ABSTRACT

BACKGROUND: There are limited data to help clinicians identify patients likely to have an improvement in quality of life following CABG surgery. We evaluated the relationship between preoperative health status and changes in quality of life following CABG surgery. METHODS: We evaluated 1,744 patients enrolled in the VA Cooperative Processes, Structures, and Outcomes in Cardiac Surgery study who completed preoperative and 6-month postoperative Short Form-36 (SF-36) surveys. The primary outcome was change in the Mental Component Summary (MCS) and Physical Component Summary (PCS) scores from the SF-36. RESULTS: On average, physical and mental health status improved following the operation. Preoperative health status was the major determinant of change in quality of life following surgery, independent of anginal burden and other clinical characteristics. Patients with MCS scores less than 44 or PCS scores less than 38 were most likely to have an improvement in quality of life. Patients with higher preoperative scores were unlikely to have an improvement in quality of life. CONCLUSIONS: Patients with preoperative health status deficits are likely to have an improvement in their quality of life following CABG surgery. Alternatively, patients with relatively good preoperative health status are unlikely to have a quality of life benefit from surgery and the operation should primarily be performed to improve survival.


Subject(s)
Angina Pectoris/surgery , Coronary Artery Bypass/psychology , Postoperative Complications/psychology , Quality of Life , Activities of Daily Living/psychology , Aged , Angina Pectoris/psychology , Female , Health Status , Humans , Male , Middle Aged , Sick Role , Treatment Outcome
2.
J Am Coll Cardiol ; 36(4): 1152-8, 2000 Oct.
Article in English | MEDLINE | ID: mdl-11028464

ABSTRACT

OBJECTIVES: The goal of this study was to compare long-term survival and valve-related complications between bioprosthetic and mechanical heart valves. BACKGROUND: Different heart valves may have different patient outcomes. METHODS: Five hundred seventy-five patients undergoing single aortic valve replacement (AVR) or mitral valve replacement (MVR) at 13 VA medical centers were randomized to receive a bioprosthetic or mechanical valve. RESULTS: By survival analysis at 15 years, all-cause mortality after AVR was lower with the mechanical valve versus bioprosthesis (66% vs. 79%, p = 0.02) but not after MVR. Primary valve failure occurred mainly in patients <65 years of age (bioprosthesis vs. mechanical, 26% vs. 0%, p < 0.001 for AVR and 44% vs. 4%, p = 0.0001 for MVR), and in patients > or =65 years after AVR, primary valve failure in bioprosthesis versus mechanical valve was 9 +/- 6% versus 0%, p = 0.16. Reoperation was significantly higher for bioprosthetic AVR (p = 0.004). Bleeding occurred more frequently in patients with mechanical valve. There were no statistically significant differences for other complications, including thromboembolism and all valve-related complications between the two randomized groups. CONCLUSIONS: At 15 years, patients undergoing AVR had a better survival with a mechanical valve than with a bioprosthetic valve, largely because primary valve failure was virtually absent with mechanical valve. Primary valve failure was greater with bioprosthesis, both for AVR and MVR, and occurred at a much higher rate in those aged <65 years; in those aged > or =65 years, primary valve failure after AVR was not significantly different between bioprosthesis and mechanical valve. Reoperation was more common for AVR with bioprosthesis. Thromboembolism rates were similar in the two valve prostheses, but bleeding was more common with a mechanical valve.


Subject(s)
Aortic Valve , Bioprosthesis , Heart Valve Prosthesis , Mitral Valve , United States Department of Veterans Affairs/statistics & numerical data , Aged , Cause of Death , Follow-Up Studies , Heart Valve Diseases/mortality , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation , Humans , Male , Middle Aged , Postoperative Complications , Surveys and Questionnaires , Survival Rate , United States/epidemiology
3.
Am J Kidney Dis ; 35(6): 1127-34, 2000 Jun.
Article in English | MEDLINE | ID: mdl-10845827

ABSTRACT

The present study was performed to ascertain whether the presence of mild renal failure (defined as a serum creatinine concentration of 1. 5 to 3.0 mg/dL) is an independent risk factor for adverse outcome after cardiac valve surgery. An extensive set of preoperative and postoperative data was collected in 834 prospectively evaluated patients undergoing cardiac valve surgery at 14 Veterans Affairs Medical Centers. Univariate and multivariable analyses were performed to determine whether an independent association of mild renal dysfunction with adverse outcomes was present. Patients with mild renal failure had significantly greater 30-day mortality rates (P = 0.001; 16% versus 6%) and frequency of postoperative bleeding (P = 0.023; 16% versus 8%), respiratory complications (P = 0.02, 29% versus 16%), and cardiac complications (P = 0.002; 18% versus 7%) than patients with normal renal function (serum creatinine <1.5 mg/dL) when controlling for multiple other variables. The presence of a serum creatinine concentration of 1.5 to 3.0 mg/dL is significantly and independently associated with adverse outcomes after cardiac valve surgery.


Subject(s)
Heart Valves/surgery , Renal Insufficiency/complications , Age Factors , Aged , Analysis of Variance , Chi-Square Distribution , Coronary Artery Bypass , Creatinine/blood , Erythrocyte Transfusion , Female , Heart Diseases/etiology , Humans , Length of Stay , Logistic Models , Male , Middle Aged , Multivariate Analysis , Postoperative Hemorrhage/etiology , Prospective Studies , Renal Insufficiency/blood , Renal Insufficiency/classification , Respiratory Tract Diseases/etiology , Risk Factors , Survival Rate , Treatment Outcome
4.
Ann Thorac Surg ; 68(2): 391-7; discussion 397-8, 1999 Aug.
Article in English | MEDLINE | ID: mdl-10475402

ABSTRACT

BACKGROUND: Despite improving outcomes in cardiac surgical patients, stroke continues to remain a major complication. Few prospective studies are available on postoperative stroke. The present study was conducted to elucidate the incidence and predictors of stroke in a large group of cardiac surgical patients. METHODS AND RESULTS: Prospective data collected on 4,941 patients undergoing cardiac surgery were subjected to univariate and logistic regression analyses (98.4% men; 72% older than 60 years; 9.1% with history of prior stroke; 80.4% underwent isolated coronary artery bypass grafting). Stroke predictors include history of stroke and hypertension, older age, systolic hypertension, bronchodilator and diuretic use, high serum creatinine, surgical priority, great vessel repair, use of inotropic agents after cardiopulmonary bypass, and total cardiopulmonary bypass time (p < 0.05 for all comparisons). Median intensive care unit and hospital stays were longer, and hospital mortality and 6-month mortality were higher for patients with stroke (p < 0.001). CONCLUSIONS: Stroke after cardiac surgical procedures is a morbid event. Identification of predictors and development of strategies to modify these factors should lead to a lower incidence of stroke.


Subject(s)
Cerebrovascular Disorders/etiology , Coronary Artery Bypass , Heart Valve Prosthesis Implantation , Postoperative Complications/etiology , Adult , Aged , Aged, 80 and over , Cerebrovascular Disorders/mortality , Female , Hospital Mortality , Humans , Male , Middle Aged , Outcome and Process Assessment, Health Care , Postoperative Complications/mortality , Risk Factors , Survival Analysis
5.
Ann Thorac Surg ; 68(2): 756-60, 1999 Aug.
Article in English | MEDLINE | ID: mdl-10475483

ABSTRACT

BACKGROUND: We hypothesized that bridge to transplantation with the CardioWest Total Artificial Heart would succeed in a large percentage of patients. Further, we hypothesized that this success rate would not be significantly decreased by infection or thromboembolism. METHODS: From 1993 to March 1999, 24 patients received implants with the intention of bridge to transplantation. Data were collected prospectively. Heparin, coumadin, aspirin, ticlopidine, dipyridamole, and pentoxifylline were used for anticoagulation. RESULTS: Four patients died while on device support. Nineteen of 23 patients (83%) were transplanted. All 19 survived long term. One patient remains on CardioWest Total Artificial Heart support 6 weeks after implant. There was one stroke on the day of transplantation. There was a second stroke on the day of implantation. Neither stroke caused significant residual deficits. Both were in close relationship to an operative procedure. There were no serious device-related infections. CONCLUSIONS: The CardioWest Total Artificial Heart salvaged 20 of 24 critically ill patients. Neither infections nor neurologic problems were significant. We believe it is the device of choice for decompensating patients with biventricular failure who have adequate body and heart size.


Subject(s)
Heart Failure/surgery , Heart Transplantation , Heart, Artificial , Adult , Cause of Death , Female , Follow-Up Studies , Heart Failure/etiology , Heart Failure/mortality , Hospital Mortality , Humans , Male , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/mortality , Prosthesis-Related Infections/etiology , Prosthesis-Related Infections/mortality , Survival Rate , Thromboembolism/etiology , Thromboembolism/mortality
6.
JAMA ; 281(14): 1298-303, 1999 Apr 14.
Article in English | MEDLINE | ID: mdl-10208145

ABSTRACT

CONTEXT: Health-related quality of life has not been evaluated as a predictor of mortality following coronary artery bypass graft (CABG) surgery. Evaluation of health status as a mortality predictor may be useful for preoperative risk stratification. OBJECTIVE: To determine whether the Physical and Mental Component Summary scores from the preoperative Short-Form 36 (SF-36) health status survey predict mortality following CABG surgery after adjustment for known clinical risk variables. DESIGN: Prospective cohort study conducted between September 1992 and December 1996. SETTING: Fourteen Veterans Affairs hospitals. PATIENTS: Of the 3956 patients undergoing CABG surgery only and who were enrolled in the Processes, Structures, and Outcomes of Care in Cardiac Surgery study, the 2480 who completed a preoperative SF-36. MAIN OUTCOME MEASURE: All-cause mortality within 180 days after surgery. RESULTS: A total of 117 deaths (4.7%) occurred within 180 days of CABG surgery. The Physical Component Summary of the preoperative SF-36 was a statistically significant risk factor for 6-month mortality after adjustment for known clinical risk factors for mortality following CABG surgery. In multivariate analysis, a 10-point lower SF-36 Physical Component Summary score had an odds ratio (OR) of 1.39 (95% confidence interval [CI], 1.11-1.77; P=.006) for predicting mortality. The SF-36 Mental Component Summary score was not associated with 6-month mortality in multivariate analyses (OR, 1.09; 95% CI, 0.92-1.29; P=.31). CONCLUSIONS: The Physical Component Summary score from the preoperative SF-36 is an independent risk factor for mortality following CABG surgery. The baseline Mental Component Summary score does not appear to be predictive of mortality. Preoperative patient self-report of the physical component of health status may be helpful for risk stratification and clinical decision making for patients undergoing CABG surgery.


Subject(s)
Coronary Artery Bypass/mortality , Outcome Assessment, Health Care , Quality of Life , Sickness Impact Profile , Female , Hospitals, Veterans , Humans , Likelihood Functions , Male , Middle Aged , Multivariate Analysis , Prospective Studies , Risk Assessment , Statistics, Nonparametric , United States
7.
Kidney Int ; 55(3): 1057-62, 1999 Mar.
Article in English | MEDLINE | ID: mdl-10027944

ABSTRACT

BACKGROUND: More than 600,000 coronary artery bypass graft (CABG) procedures are done annually in the United States. Some data indicate that 10 to 20% of patients who are undergoing a CABG procedure have a serum creatinine of more than 1.5 mg/dl. There are few data on the impact of a mild increase in serum creatinine concentration on CABG outcome. METHODS: We analyzed a Veterans Affairs database obtained prospectively from 1992 through 1996 at 14 of 43 centers performing heart surgery. We compared the outcome after CABG in patients with a baseline serum creatinine of less than 1.5 mg/dl (median 1.1 mg/dl, N = 3271) to patients with a baseline serum creatinine of 1.5 to 3.0 mg/dl (median 1.7, N = 631). RESULTS: Univariate analysis revealed that patients with a serum creatinine of 1.5 to 3.0 mg/dl had a higher 30-day mortality (7% vs. 3%, P < 0.001) requirement for prolonged mechanical ventilation (15% vs. 8%, P = 0.001), stroke (7% vs. 2%, P < 0.001), renal failure requiring dialysis at discharge (3% vs. 1%, P < 0.001), and bleeding complications (8% vs. 3%, P < 0.001) than patients with a baseline serum creatinine of less than 1.5 mg/dl. Multiple logistic regression analyses found that patients with a baseline serum creatinine of less than 1.5 mg/dl had significantly lower (P < 0.02) 30-day mortality and postoperative bleeding and ventilatory complications than patients with a serum creatinine of 1.5 to 3.0 mg/dl when controlling for all other variables. CONCLUSION: These results demonstrate that mild renal failure is an independent risk factor for adverse outcome after CABG.


Subject(s)
Coronary Artery Bypass/adverse effects , Kidney Failure, Chronic/complications , Aged , Coronary Artery Bypass/mortality , Creatinine/blood , Databases, Factual , Female , Humans , Kidney Failure, Chronic/blood , Male , Middle Aged , Postoperative Hemorrhage/etiology , Prospective Studies , Respiratory Tract Diseases/etiology , Risk Factors , Treatment Outcome , United States/epidemiology
8.
ASAIO J ; 44(5): M336-9, 1998.
Article in English | MEDLINE | ID: mdl-9804448

ABSTRACT

The CardioWest total artificial heart is a pneumatically driven device that totally replaces the failing ventricles. It is currently used as a bridge to heart transplantation in selected centers in the United States under a study by the Food and Drug Administration. Twenty-seven patients have undergone placement of the total artificial heart since 1993 with the intention to bridge to transplantation. Inclusion criteria included candidacy for heart transplantation, cardiac index (CI) < 2.0 L/min/m2, and maximal inotropic support. The population consisted of 25 men and 2 women of mean +/- SD age 46.5 +/- 10.3 years, body surface area 2.01 +/- 0.17 m2, and duration of implant 52 +/- 42 days. Initial diagnosis included ischemic cardiomyopathy (n = 10), idiopathic (n = 10), viral (n = 4), valvular (n = 2), and graft failure (n = 1). Infectious complications were defined as systemic (evidence of leukocytosis or fever) or local. The population experienced 64 infections (range, 0-9 per patient): 45 systemic and 19 local. Three patients did not experience any infection. Twenty-five patients reached transplantation, and were discharged home for a survival rate of 92.6%. Two patients died during the bridge, one because of mechanical failure, and one because of infection (mediastinitis). Therefore, death attributable to infections occurred in 3.7%. Previous reports of the total artificial heart experience in the late 1980s described death rates as high as 40%. Although infectious complications are common in patients who are bridged to heart transplantation with the total artificial heart, mortality from infections is 10 times less than previously reported. This may be the result of a better strategy for bridging to transplantation that includes patient selection, mobilization, early central line removal, and waiting until all possible infections are resolved before proceeding to transplantation.


Subject(s)
Heart, Artificial/adverse effects , Prosthesis-Related Infections/epidemiology , Female , Humans , Male , Middle Aged , Prosthesis Design , Prosthesis-Related Infections/microbiology
9.
ASAIO J ; 44(5): M634-7, 1998.
Article in English | MEDLINE | ID: mdl-9804512

ABSTRACT

Patients who are bridged-to-transplantation with mechanical support have a high incidence of pretransplant sensitization defined by panel reactive antibody (PRA) titers greater than 10. Risk factors for positive PRA in patients with assist devices were investigated. From 1993 to 1997, 17 patients underwent implant surgery with CardioWest C-70 total artificial hearts (TAHs; CardioWest Technologies, Inc., Tucson, AZ), and 13 with Novacor left ventricular assist systems (LVASs; Baxter Healthcare, Novacor Division, Oakland, CA) for bridge-to-transplantation at this institution. Two patients died during implantation of the assist devices. Of the remaining 28 patients, four (14%) were women (3 with TAHs and 1 with an LVAS). All four women (100%) had a positive PRA, whereas only two of the 24 men (8%) had positive PRA (p < 0.0001). The transfusion histories of these patients were reviewed. Using chi-squared analysis (alpha = 0.05), the PRA levels were independent of transfusion of packed red blood cells and fresh frozen plasma. There was an association, however, between platelet transfusions and PRA levels. The times on device awaiting cardiac transplantation were also compared between the PRA positive and PRA negative groups. The average time to transplantation for PRA positive patients was 116 days, whereas the average waiting time for the PRA negative patients was 55 days (p = 0.05). Based on these data, a female patient with consistently positive PRA (93%) after TAH implantation underwent a transplant on post implant day 25 despite a positive lymphocytotoxic crossmatch with the donor. She was treated with plasmapheresis during cardiopulmonary bypass at the time of transplantation, and with four further treatments post transplant. As of this writing, she is alive and well on our standard triple immunotherapy. Therefore, women who are bridged-to-transplantation with assist devices are at risk for positive PRA. It is recommended that patients who are bridged-to-transplantation with assist devices and have high PRA levels be treated with perioperative plasmapheresis. With this aggressive approach, it may no longer be necessary to keep patients on mechanical support for prolonged periods, but possible to perform transplants as soon as suitable donors become available.


Subject(s)
Antibodies/blood , Blood Transfusion , Heart-Assist Devices , Adult , Female , Heart Transplantation , Humans , Male , Middle Aged , Risk Factors
10.
Infect Control Hosp Epidemiol ; 19(7): 513-5, 1998 Jul.
Article in English | MEDLINE | ID: mdl-9702577

ABSTRACT

Vancomycin prophylaxis for coronary artery bypass graft surgery without prosthetic valve implantation voluntarily decreased from 94% to 18% in one medical center. Median hospital stay (10 vs 9 days, P = .30) and number of postoperative infections (17.0% vs 14.3%, P = .60) did not differ among patients who received vancomycin and those who did not.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis , Coronary Artery Bypass , Vancomycin/therapeutic use , Adult , Aged , Animals , Arizona , Hospitals, Veterans , Humans , Middle Aged
11.
Ann Thorac Surg ; 65(3): 857-8, 1998 Mar.
Article in English | MEDLINE | ID: mdl-9527239

ABSTRACT

We present a technique for rapid and easy endomyocardial biopsy of the heterotopic transplanted heart. With a recent resurgence in heterotopic heart transplantation, we believe that ours is a sound technique in obtaining both routine surveillance biopsies as well as evaluating "right-sided pressures" in the "piggy-back" heart.


Subject(s)
Biopsy/methods , Endocardium/pathology , Heart Transplantation , Transplantation, Heterotopic , Humans , Monitoring, Physiologic/methods
12.
Ann Thorac Surg ; 66(6): 2119-20, 1998 Dec.
Article in English | MEDLINE | ID: mdl-9930514

ABSTRACT

The Thoratec biventricular assist device has been used extensively as a bridge to heart transplantation. Right atrial cannulation has always been used during right ventricular support, however diminished filling and output of the right ventricular assist device have been noticed when compared with filling and output of the left ventricular assist device. We describe a technique to directly cannulate the right ventricle to maximize filling and output of the right ventricular assist device.


Subject(s)
Cardiac Catheterization/methods , Heart-Assist Devices , Equipment Design , Humans
13.
Ann Thorac Surg ; 66(5): 1662-9, 1998 Nov.
Article in English | MEDLINE | ID: mdl-9875768

ABSTRACT

BACKGROUND: We performed a controlled study of a total artificial heart in bridge to transplantation. We hypothesized that the CardioWest total artificial heart used in a selected population of decompensating cardiac transplantation candidates would result in improved survival compared with matched controls. METHODS: The CardioWest trial started in 1993 in six United States institutions under an investigational device exemption from the Food and Drug Administration. Four centers contributed 27 implant and 18 matched retrospective control patients. RESULTS: Of the implant patients, 25 (93%) received a transplant, 24 (89% of the total, 96% of those transplanted) were discharged and are currently surviving. In the control group, 10 patients died awaiting transplantation, 8 received a transplant, and 7 were discharged with 6 surviving (p = 0.00001). All adverse events were documented with respect to time. Thirteen serious adverse events occurred, 11 of which occurred in the 2 patients that died during implant. CONCLUSIONS: In a selected group of patients with endstage heart disease, use of the CardioWest total artificial heart is lifesaving. When compared with the series of matched retrospective controls, a significant improvement in survival was found in the CardioWest implant group.


Subject(s)
Heart Transplantation , Heart, Artificial , Adolescent , Adult , Female , Heart Transplantation/adverse effects , Heart Transplantation/mortality , Humans , Male , Middle Aged , Postoperative Complications , Reoperation , Survival Rate , Treatment Outcome
15.
Ann Surg ; 226(4): 501-11; discussion 511-3, 1997 Oct.
Article in English | MEDLINE | ID: mdl-9351718

ABSTRACT

OBJECTIVE: The purpose of the study was to investigate the incidence, predictors, morbidity, and mortality associated with postoperative atrial fibrillation (AF) and its impact on intensive care unit (ICU) and postoperative hospital stay in patients undergoing cardiac surgery in the Department of Veterans Affairs (VA). SUMMARY BACKGROUND DATA: Postoperative AF after open cardiac surgery is rather common. The etiology of this arrhythmia and factors responsible for its genesis are unclear, and its impact on postoperative surgical outcomes remains controversial. The purpose of this special substudy was to elucidate the incidence of postoperative AF and the factors associated with its development, as well as the impact of AF on surgical outcome. METHODS: The study population consisted of 3855 patients who underwent open cardiac surgery between September 1993 and December 1996 at 14 VA Medical Centers. Three hundred twenty-nine additional patients were excluded because of lack of complete data or presence of AF before surgery, and 3794 (98.4%) were male with a mean age of 63.7+/-9.6 years. Operations included coronary artery bypass grafting (CABG) (3126, 81%), CABG + AVR (aortic valve replacement) (228, 5.9%), CABG + MVR (mitral valve replacement) (35, 0.9%), AVR (231, 6%), MVR (41, 1.06%), CABG + others (95, 2.46%), and others (99, 2.5%). The incidence of postoperative AF was 29.6%. Multivariate logistic regression analysis of factors found significant on univariate analysis showed the following predictors of postoperative AF: preoperative patient risk predictors: advancing age (odds ratio [OR] 1.61, 95% confidence interval [CI] 1.48-1.75, p < 0.001), chronic obstructive pulmonary disease (OR 1.37, 95% CI 1.12-1.66, p < 0.001), use of digoxin within 2 weeks before surgery (OR 1.37, 95% CI 1.10-1.70, p < 0.003), low resting pulse rate <80 (OR 1.26, 95% CI 1.06-1.51, p < 0.009), high resting systolic blood pressure >120 (OR 1.19, 95% CI 1.02-1.40, p < 0.026), intraoperative process of care predictors: cardiac venting via right superior pulmonary vein (OR 1.42, 95% CI 1.21-1.67, p < 0.0001), mitral valve repair (OR 2.86, 95% CI 1.72-4.73, p < 0.0001) and replacement (OR 2.33, 95% CI 1.55-3.55, p < 0.0001), no use of topical ice slush (OR 1.29, 95% CI 1.10-1.49, p < 0.0009), and use of inotropic agents for greater than 30 minutes after termination of cardiopulmonary bypass (OR 1.36, 95% CI 1.16-1.59, p < 0.0001). Postoperative median ICU stay (3.6 days AF vs. 2 days no AF, p < 0.001) and hospital stay (10 days AF vs. 7 days no AF, p < 0.001) were higher in AF. Morbid events, hospital mortality, and 6-month mortality were significantly higher in AF (p < 0.001): ICU readmission 13% AF vs. 3.9% no AF, perioperative myocardial infarction 7.41 % AF vs. 3.36% no AF, persistent congestive heart failure 4.57% AF vs. 1.4% no AF, reintubation 10.59% AF vs. 2.47% no AF, stroke 5.26% AF vs. 2.44% no AF, hospital mortality 5.95% AF vs. 2.95% no AF, 6-month mortality 9.36% AF vs. 4.17% no AF. CONCLUSIONS: Atrial fibrillation after cardiac surgery occurs in approximately one third of patients and is associated with an increase in adverse events in all measurable outcomes of care and increases the use of hospital resources and, therefore, the cost of care. Strategies to reduce the incidence of AF after cardiac surgery should favorably affect surgical outcomes and reduce utilization of resources and thus lower cost of care.


Subject(s)
Atrial Fibrillation/etiology , Cardiac Surgical Procedures/adverse effects , Aged , Coronary Artery Bypass/adverse effects , Female , Heart Valve Prosthesis Implantation/adverse effects , Hospitals, Veterans , Humans , Incidence , Intensive Care Units , Length of Stay , Logistic Models , Male , Middle Aged , Odds Ratio , Risk Factors
16.
Eur J Cardiothorac Surg ; 11 Suppl: S5-10, 1997 Apr.
Article in English | MEDLINE | ID: mdl-9271174

ABSTRACT

As the number of potential heart donors remains constant and the number of potential recipients continuous to increase, the need for circulatory devices to bridge patients becomes more important. The CardioWest total artificial heart (TAH) is a pneumatic, implantable system that totally replaces the failing ventricles. It has been utilized worldwide as a bridge to heart transplantation in 79 patients. There were 73 males and six females who received the TAH. Currently three patients remain on the device waiting for transplantation. A total of 55 patients (70%) were transplanted of which 50 survived (91% of patients transplanted) and were discharged home. Idiopathic/dilated cardiomyopathy was the most common etiology followed by ischemic cardiomyopathy. The mean duration of implant was 34 days (range 0-186 days) and the mean age of the group was 45 years (range 16-62 years). Twenty-one patients died while on the device. Multiple organ failure was the major cause of death. There were a total of 255 complications in this group that included reoperation, bleeding, hepatic failure, renal failure, respiratory failure, neurologic events, thromboembolic events, infections, device malfunction, and fit complications. This represented a mean complication rate of three events per patient. The survival rate for the CardioWest TAH of 91% of the patients who reached transplantation is an improvement over that of the Symbion registry (55% of those transplanted) probably as a result of a better patient selection and better control of the coagulation system. These results are also comparable to those survival results obtained with other biventricular and left ventricular assist devices currently available.


Subject(s)
Heart Diseases/surgery , Heart Transplantation , Heart, Artificial , Adolescent , Adult , Female , Heart Diseases/mortality , Heart Diseases/physiopathology , Heart, Artificial/adverse effects , Hemodynamics , Humans , Male , Middle Aged , Patient Selection , Prosthesis Design , Treatment Outcome
17.
J Heart Lung Transplant ; 15(9): 936-47, 1996 Sep.
Article in English | MEDLINE | ID: mdl-8889990

ABSTRACT

BACKGROUND: Advances in myocardial preservation techniques and immunosuppressive drug therapy have resulted in heart transplantation as an acceptable treatment for end-stage heart failure. However, excessive periods of global myocardial ischemia followed by reperfusion can progress to irreversible graft injury. It has been reported that cyclosporine A (in addition to its well-characterized immunosuppressive actions) can blunt certain features of ischemia and reperfusion injury. This study was performed to examine the ability of cyclosporine A to attenuate such injury in a model of heart transplantation. METHODS: Twenty rabbit heterotopic transplants were divided into four study groups: (1) 30-minute ischemic control hearts; (2) 30-minute ischemic cyclosporine A-treated hearts; (3) 4-hour ischemic control hearts; and (4) 4-hour ischemic cyclosporine A-treated hearts. A single dose of cyclosporine A (10 mg/kg intravenously) or vehicle was administered to both the donor and recipient rabbits 45 minutes before heart explantation and heart transplantation, respectively. RESULTS: After transplantation and 30 minutes of reperfusion, the 4-hour ischemic control hearts showed a significant (p < 0.01) leftward shift in the left ventricular end-diastolic pressure versus left ventricular volume curve compared with the 30-minute ischemic control hearts. This finding represents higher end-diastolic pressures and incomplete diastolic relaxation caused by ischemia and reperfusion. Cyclosporine A administration to the donor and recipient rabbits resulted in a significant improvement (p < 0.01) in diastolic relaxation (shift in the left ventricular end-diastolic pressure versus left ventricular volume curve back to the right) compared with 4-hour ischemic control hearts. Cyclosporine A-treated hearts also showed significant improvements in the rate of diastolic pressure fall (p < 0.05) and tau (the isovolumetric pressure decay constant) (p < 0.01) compared with ischemic control hearts. CONCLUSIONS: These results indicate that single doses of cyclosporine A to both the donor and recipient inhibit the dysfunction in extent and rate of left ventricular relaxation caused by prolonged global ischemia and reperfusion. Possible mechanisms for cyclosporine A's myocardial protective actions are presented in the discussion.


Subject(s)
Cardiovascular Agents/pharmacology , Cyclosporine/pharmacology , Heart Transplantation/adverse effects , Myocardial Ischemia/prevention & control , Myocardial Reperfusion Injury/prevention & control , Animals , Blood Pressure/drug effects , Body Fluids/metabolism , Cardiovascular Agents/therapeutic use , Cyclosporine/therapeutic use , Disease Models, Animal , Heart Transplantation/physiology , Male , Myocardial Ischemia/etiology , Myocardial Ischemia/physiopathology , Myocardial Reperfusion Injury/etiology , Myocardial Reperfusion Injury/physiopathology , Myocardium/metabolism , Rabbits , Time Factors , Transplantation, Heterotopic , Ventricular Function, Left/drug effects
18.
ASAIO J ; 42(5): M542-6, 1996.
Article in English | MEDLINE | ID: mdl-8944938

ABSTRACT

Circulatory assist devices as bridge to heart transplantation have become more important as the number of possible recipients has increased and the number of donors remains stable. The number of patients successfully bridged and discharged home after transplantation was determined for the Novacor Left Ventricular Assist System (Baxter Healthcare Corp., Oakland, CA) (LVAS), console and wearable; the TCI Left Ventricular Assist Device (Thermo Cardio Systems Inc., Woburn, MA) (LVAD), pneumatic and electric; the Thoratec LVAD and Biventricular Assist Device (Thoratec Lab Co., Berkeley, CA) (BIVAD); and the CardioWest total artificial heart (CardioWest Tech. Inc., Tuscon, AZ) (TAH). A total of 1,286 devices (14% Novacor console, 14% Novacor wearable, 35% TCI pneumatic, 4% TCI electric, 10% thoratec LVAD, 19% Thoratec BIVAD, and 4% CardioWest TAH) were implanted worldwide since 1984. A total of 776 (60%) patients reached heart transplantation and 687 patients (88.5% of those transplanted) were discharged home. The individual success rate for each device to bridge a patient to heart transplantation and be discharged home is as follows: Novacor LVAS console, 90%; Novacor LVAS wearable, 92%; TCI LVAD pneumatic, 89%; TCI LVAD electric, 89%; Thoratec LVAD, 93%; Thoratec BIVAD, 81%; and CardioWest TAH, 92%. The success rate with all the available systems to bridge a patient to heart transplantation and be discharged home is similar for all devices. The criteria used to determine which system to be used should be individualized for each patient. Some of the factors that should be considered in making a decision on which device to use should include anticoagulation, univentricular vs biventricular failure, mobility, protocol to discharge home, and size of the patient.


Subject(s)
Heart Transplantation , Heart-Assist Devices , Adult , Equipment Design , Female , Heart Failure/surgery , Heart Failure/therapy , Humans , Male , Middle Aged , Treatment Outcome
19.
ASAIO J ; 42(5): M546-9, 1996.
Article in English | MEDLINE | ID: mdl-8944939

ABSTRACT

Three patients were bridged to heart transplantation with the wearable Novacor Left Ventricular Assist System (Baxter Healthcare Corp., Oakland, CA) (LVAS). Two have been transplanted and discharged. The third patient remains at home. Hospitalization costs, which include the unit room charge, admission profile to the unit, and daily supply charge, were determined for all patients and compared. The patients were transferred from the surgical intensive care unit to a telemetry unit once they were hemodynamically stable. The projected hospitalization costs, if the patients had remained in the hospital, were calculated to determine probable savings for the third party payer. The average period from admission to placement of the Novacor LVAS was 15 days (range, 7-21 days). The average hospitalization cost from admission to time of Novacor left ventricular assist device implant was $2,240/day, and the average hospitalization cost after implant to discharge was $1,570/day. Hospitalization cost savings were $2,632 for the first patient, $5,922 for the second patient, and $132,124 for the third patient, who has not been transplanted. Although the number of patients is small, the daily hospitalization cost was higher before the Novacor LVAS was implanted. This is related to the severity of the disease and the length of stay in a surgical intensive care unit. There also is a significant cost savings for the third party payer, especially if the patient has to wait a significant amount of time before heart transplantation. These are important considerations in this time of managed care.


Subject(s)
Heart Transplantation , Heart-Assist Devices/economics , Ambulatory Care , Cardiomyopathies/economics , Cardiomyopathies/surgery , Cardiomyopathies/therapy , Costs and Cost Analysis , Equipment Design , Hospital Costs , Humans , Male , Middle Aged
20.
Ann Thorac Surg ; 62(1): 296-8, 1996 Jul.
Article in English | MEDLINE | ID: mdl-8678670

ABSTRACT

Reconstruction was accomplished in a 2 heart-lung recipients with situs inversus resulting in a left-sided systemic venous atrium. We created a large common atrium that was closed on the left side, leaving an atrial cuff on the inferior right quadrant. To this we anastomosed the donor right atrium, which had been opened laterally between the cavae. This resulted in some clockwise rotation of the ventricles and anterior positioning of the apex. The right pulmonary veins passed superior to the atrial anastomosis and posterior to the donor right atrium. Cardiopulmonary function was excellent in both cases.


Subject(s)
Heart-Lung Transplantation/methods , Kartagener Syndrome/surgery , Situs Inversus/surgery , Adolescent , Heart-Lung Transplantation/physiology , Humans , Male , Middle Aged
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