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Biomedical subjects

Michael K Banbury

Publications and source records attributed to Michael K Banbury.

At least 19 recordsLinked to original sources

Ventricular assist devices and aggressive immunosuppression: looking beyond overall survival.

BACKGROUND: Patients bridged to heart transplantation with a ventricular assist device (VAD) developed coronary vasculopathy at the same rate as non-bridged patients despite having higher levels of pre-formed antibodies. We hypothesized that allosensitized VAD patients have higher levels of immunosuppression and thus different morbidity and causes of mortality. METHODS: Patients who received a transplant between January 1996 and May 2002 were separated into 2 groups based on the need for VAD support as a bridge to transplantation. Transplant and Inpatient Pharmacy Databases and charts were queried for date of transplantation, degree of allosensitization, use of desensitization therapy, immunosuppressive strategies, number of treated rejection episodes, and specific causes of death. RESULTS: This study investigated 238 patients (125 VAD patients, 113 non-VAD patients). VAD patients were more likely to be allosensitized than non-VAD patients (20% vs 5%, p < 0.01). OKT3 was given to 22% of VAD patients as anti-rejection prophylaxis and 14% received pre-transplant plasmapheresis. Non-VAD patients rarely were desensitized (2.6% of non-VAD patients). After transplantation, 68 VAD patients (54%) and 44 non-VAD patients (39%) had episodes of severe rejection requiring therapy. Episodes of rejection in VAD patients were commonly treated with steroids (90%), plasmapheresis (10%), and OKT3 (7%), and episodes of rejection in non-VAD patients were treated with steroids (76%) and OKT3 (8%). The 5-year survival for both groups was similar (90% and 86% respectively, p = 0.31). VAD patients commonly died of sepsis (75%), and non-VAD patients died of rejection (39%) and ischemic transplant cardiomyopathy (30%). CONCLUSION: When short-term outcomes between bridged and non-bridged heart transplant recipients were compared, overall survival was similar but causes of death differed. Findings in this study might aid in the post-operative management of patients bridged to transplantation with a VAD.

Aged↗

Safety of targeted perioperative mupirocin treatment for preventing infections after cardiac surgery.

BACKGROUND: Indiscriminate antibiotic use may lead to development of antibiotic resistance. Preoperative mupirocin treatment decreases Staphylococcus aureus carriage and may reduce subsequent surgical site infection, but is unlikely to benefit noncarriers. This study was undertaken to evaluate whether avoiding mupirocin in noncarriers places them at increased risk for subsequent postoperative infection. METHODS: We conducted a retrospective cohort study examining incidence of postoperative infection in patients undergoing cardiac surgery at the Cleveland Clinic after introduction of a protocol of polymerase chain reaction screening for nasal S aureus carriage, and avoiding mupirocin treatment of noncarriers. RESULTS: Between August 1, 2002, and May 31, 2004, 6,334 patients were screened for nasal carriage of S aureus before undergoing cardiac surgery. There was no significant difference in infection rates between carriers and noncarriers when examining the incidence of all infections (5.6% and 5.0%; relative risk [RR] 1.11 [95% confidence interval (CI): 0.86 to 1.43]), infections caused specifically by S aureus (1.04% and 0.80%; RR 1.30 [95% CI: 0.71 to 2.39]), any surgical site infection (3.1% and 3.2%; RR 0.97 [95% CI: 0.69 to 1.36]), S aureus surgical site infection (0.82% and 0.58%; RR 1.41 [95% CI: 0.71 to 2.82]), any bloodstream infection (3.1% and 2.5%; RR 1.21 [95% CI: 0.86 to 1.71]), and S aureus bloodstream infection (0.37% and 0.48%; RR 0.77 [95% CI: 0.30 to 2.03]). Mupirocin use declined substantially after introduction of the protocol. CONCLUSIONS: A strategy of targeting perioperative mupirocin treatment to carriers leads to significant reduction in mupirocin use without increasing early postoperative infectious complications in noncarriers.

Aged↗

Does use of a right internal thoracic artery increase deep wound infection and risk after previous use of a left internal thoracic artery?

OBJECTIVE: To determine whether adding right internal thoracic artery to previous left internal thoracic artery bypass at reoperation increases deep sternal wound infection and hospital mortality, particularly in diabetic patients. METHODS: Reoperations (n = 2875; 2381 men) in patients with previous left internal thoracic artery bypass were performed between January 1990 and January 2003; 1939 (67%) had no repeat internal thoracic artery grafting, 923 (32%) received an additional right internal thoracic artery graft, and 13 (0.5%) had bilateral internal thoracic artery grafting with reuse of the left internal thoracic artery. Of the patients, 352 (12%) were insulin-treated and 590 (21%) non-insulin-treated diabetics. Multivariable logistic regression analysis was used to identify preoperative variables associated with right versus non-right internal thoracic artery use in diabetics and nondiabetics and to formulate propensity models. Propensity scores were used for matching and adjusted multivariable analyses of deep wound infection and hospital mortality. RESULTS: Deep wound infection occurred in 3.0% (7/230) of diabetics receiving right internal thoracic artery grafts, 2.2% (5/230) of propensity-matched diabetics receiving non-right internal thoracic artery grafts (P = .6), in 1.1% (6/538) of nondiabetics receiving right internal thoracic artery grafts, and in 1.0% (5/538) of matched non-diabetic patients receiving non-right internal thoracic artery grafts (P = .8). Corresponding hospital mortality in these matched groups was 1.7% (4/230) versus 6.1% (14/230) for diabetics (P = .02) and 2.6% (14/538) versus 3.5% (19/538) for nondiabetics (P = .4). Risk factors for deep wound infection included higher weight (P = .0003), higher New York Heart Association functional class (P = .03), and less severe left anterior descending disease (P = .03). Risk factors for death were (P < .02) emergency operation, mitral valve replacement, and greater number of saphenous vein grafts. CONCLUSIONS: Use of the right internal thoracic artery for reoperations does not increase the risk of deep wound infections in diabetics or nondiabetics and does not increase mortality.

Aged↗

Influence of patient characteristics and arterial grafts on freedom from coronary reoperation.

OBJECTIVE: Arteriosclerosis is a progressive disease, and many patients require repeat coronary intervention after coronary artery bypass grafting. We sought to identify patient characteristics and operative factors that predict the need for or bias toward reoperative coronary artery bypass grafting. METHODS: From 1971 to 1998, 48,758 patients underwent primary isolated coronary artery bypass grafting, and 1000 per year were followed every 5 years (n = 26,927). A multivariable time-related analysis was performed to model freedom from coronary reoperation and to identify patient and operative variables associated with occurrence of coronary reoperation. RESULTS: Freedoms from reoperative coronary artery bypass grafting were 99.6%, 98.4%, 93%, 82%, 72%, and 65% at 1, 5, 10, 15, 20, and 25 years, respectively. Risk of reoperation (hazard function) demonstrated a short, rapidly declining early phase, followed by a long, slow-rising late phase. Patient variables that increased the likelihood of coronary reoperation included younger age (P < .0001), higher total cholesterol (P = .0004) and triglyceride levels (P = .0005), lower high-density lipoprotein (P = .0002) level, diabetes mellitus (P < .0001), and more extensive coronary artery disease (P = .01). Increasing extent of arterial grafting performed at primary coronary artery bypass grafting decreased occurrence of coronary reoperation (P < .0001). CONCLUSION: Patient factors associated with arteriosclerosis progression and type of bypass conduit influence the need for or bias toward repeat coronary artery bypass grafting. Aggressive patient risk-factor reduction and extensive arterial coronary revascularization at primary coronary artery bypass grafting should result in fewer coronary reoperations.

Coronary Artery Bypass↗

Transfusion increases the risk of postoperative infection after cardiovascular surgery.

BACKGROUND: Because of the immunomodulatory effects of transfusion, we attempted to identify factors associated with blood product use and determine the association of transfusion quantity with postoperative infection. STUDY DESIGN: We studied total perioperative transfusion of blood products for 15,592 cardiovascular operations performed from July 1998 to May 2003. Infection end points were septicemia/bacteremia (n=351, 2.2%) and superficial (n=353, 2.3%) and deep (n=212, 1.4%) sternal wound infections. Factors associated with blood product administration were used to form balancing scores to adjust for differences in patient characteristics among those receiving and not receiving blood products. RESULTS: Fifty-five percent of patients received packed red blood cells (RBC), 21% received platelets, 13% got fresh frozen plasma (FFP), and 3% got cryoprecipitate. Factors associated with RBC use included older age, female gender, higher New York Heart Association class, lower hematocrit, reoperation, and longer cardiopulmonary bypass time--all indicative of higher-risk patients. The more RBC units transfused, the higher was the occurrence of septicemia/bacteremia (p < 0.0001) and superficial (p=0.0007) and deep (p < 0.0001) sternal wound infection. Use of FFP (septicemia/bacteremia) and platelets (septicemia/bacteremia and deep sternal wound infection) mitigated against this association only slightly. CONCLUSIONS: Blood products tended to be used in the sickest patients. But after accounting for this, risk of infection increased incrementally with each unit of blood transfused. Although cause and effect cannot be established, results suggested that blood product transfusion is an independent risk factor for postoperative infection in cardiac surgical patients, blood products are more likely to be used in the sickest patients, and no amount of blood loss treated by transfusion is innocuous.

Aged↗

Does the arterial cannulation site for circulatory arrest influence stroke risk?

BACKGROUND: We investigated whether axillary/subclavian artery inflow with a side graft decreases the risk of stroke versus cannulation at other sites during hypothermic circulatory arrest. METHODS: Between January 1993 and May 2003, 1,352 operations with circulatory arrest were performed for complex adult cardiac problems. A single arterial inflow cannulation site was used in 1,336 operations, and these formed the basis for comparative analyses. Cannulation sites were axillary plus graft in 299 operations, direct cannulation of the aorta in 471, femoral in 375, innominate in 24, and axillary or subclavian without a side graft in 167. Retrograde brain perfusion was used in 933 (69%). A total of 272 (20%) were for emergencies, 432 (32%) were reoperations, and 439 (32%) were for dissections. A total of 617 (46%) had aortic valve replacement and 1,160 (87%) ascending, 415 arch (31%), and 248 descending (18%) aortic replacements. Indications also included arteriosclerosis (n = 301) and calcified aorta (n = 278). Primary comparisons were made by using propensity matching, and, secondarily, risk factors for stroke or hospital mortality were identified by multivariable logistic regression. RESULTS: Stroke occurred in 6.1% of patients (81/1,336): 4.0% (12/299) of those had axillary plus graft and 6.7% who had direct cannulation (69/1,037; p = 0.09; p = 0.05 among propensity-matched pairs). Operative variables associated with stroke included direct aortic cannulation, aortic arteriosclerosis, descending aorta repair, and mitral valve replacement. The risk of hospital mortality was higher (11%; 42/375) for patients who had femoral cannulation than axillary plus graft (7.0%; 21/299; p = 0.06; p = 0.02 among propensity-matched pairs). CONCLUSIONS: Axillary inflow plus graft reduces stroke and is our method of choice for complex cardiac and cardioaortic operations that necessitate circulatory arrest. Retrograde or antegrade perfusion is used selectively.

Aged↗

Contemporary outcomes of outpatients referred for cardiac transplantation evaluation to a tertiary heart failure center: impact of surgical alternatives.

BACKGROUND: The growing epidemic of congestive heart failure in the setting of limited donor-organ availability has mandated continued development and increased utilization of medical and surgical alternatives to cardiac transplantation. We sought to assess current disposition and outcomes of patients recently referred for transplant evaluation to a single high-throughput tertiary referral center. METHODS AND RESULTS: We performed a retrospective observational review of consecutive patients with advanced heart failure who were assessed initially in an outpatient setting by a heart failure cardiologist, with a view to transplant or nontransplant surgical alternatives between 1995 and 2000. Of 1174 consecutive referrals (mean age 55.1 [+/-12.7], 74% male), 588 (50%) were recommended for medical treatment (mean age 55.3 [+/-12.4], 72% male) and 200 (17%) for nontransplant surgery, principally coronary artery bypass grafting, mitral valve repair, infarct exclusion, partial left ventriculectomy, or combinations thereof (mean age 57.8 [+/-10.6], 76% male). A minority, 418 (36%), were initially listed for cardiac transplantation (mean age 53.5 [+/-13.9], 80% male). Of these, 74 (18% of listed) died waiting (34 on left ventricular assist device support), 45 were delisted (27 for improved clinical status), and 217 (18% of referred group) have been transplanted. The 3-year survival (Kaplan-Meier) was equivalent (82%) in the transplanted and nontransplant surgery groups (excluding partial left ventriculectomy patients). CONCLUSION: In current clinical practice less than one fifth of transplant referrals are ultimately transplanted, reflecting both a limited donor supply and the application of alternative, nontransplant strategies. Medium-term survival in patients suitable for alternative surgical strategies equals that of cardiac transplantation.

Adult↗

Stapled explant of the Jarvik 2000 left ventricular assist device.

Currently the most common indication for placement of a left ventricular assist device is as a bridge to heart transplantation. One of the new generation axial flow left ventricular assist devices is the Jarvik 2000. This device is placed in the apex of the left ventricle and the outflow graft passes through the left pleural space and is anastomosed to the descending thoracic aorta. The course of the outflow graft presents technical challenges during explant for heart transplantation. Opening the posterior pericardium and use of a vascular stapler to control the outflow graft at the level of the descending thoracic aorta facilitates easy explantation.

Aorta, Thoracic↗

Emboli capture using the Embol-X intraaortic filter in cardiac surgery: a multicentered randomized trial of 1,289 patients.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Aged↗

Vacuum-assisted venous return reduces blood usage.

OBJECTIVE: To determine whether vacuum-assisted venous return has clinical advantages over conventional gravity drainage apart from allowing the use of smaller cannulas and shorter tubing. METHODS: A total of 150 valve operations were performed at our institution between February and July 1999 using vacuum-assisted venous return with small venous cannulas connected to short tubing. These were compared with (1) 83 valve operations performed between April 1997 and January 1998 using the initial version of vacuum-assisted venous return, and (2) 124 valve operations performed between January and April of 1997 using conventional gravity drainage. Priming volume, hematocrit value, red blood cell usage, and total blood product usage were compared multivariably. These comparisons were covariate and propensity adjusted for dissimilarities between the groups and confirmed by propensity-matched pairs analysis. RESULTS: Priming volume was 1.4 +/- 0.4 L for small-cannula vacuum-assisted venous return, 1.7 +/- 0.4 L for initial vacuum-assisted venous return, and 2.0 +/- 0.4 L for gravity drainage (P <.0001). Smaller priming resulted in higher hematocrit values both at the beginning of cardiopulmonary bypass (27% +/- 5% compared with 26% +/- 4% and 25% +/- 4%, respectively, P <.0001) and at the end (30% +/- 4% compared with 28% +/- 4% and 27% +/- 4%, respectively, P <.0001). Red cell transfusions were used in 17% of the patients having small-cannula vacuum-assisted venous return, 27% of the initial patients having vacuum-assisted venous return, and 37% of the patients having gravity drainage (P =.001); total blood product usage was 19%, 27%, and 39%, respectively (P =.002). Although ministernotomy also was associated with reduced blood product usage (P <.004), propensity matching on type of sternotomy confirmed the association of vacuum-assisted venous return with lowered blood product usage. CONCLUSIONS: Vacuum-assisted venous return results in (1) higher hematocrit values during cardiopulmonary bypass and (2) decreased red cell and total blood product usage.

Blood Circulation↗

Experience in prevention of sternal wound infections in nasal carriers of Staphylococcus aureus.

Nosocomial and surgical-site infections are significant burdens to the health care system that account for $5 billion and $1.6 billion each year in the United States, respectively. These infections are associated with significant morbidity and mortality rates, increased length of hospitalization, and increased treatment costs that are often not reimbursed by third-party payers. Approximately 40% of sternal wound infections in cardiac surgery patients are caused by Staphylococcus aureus and the prevalence of methicillin-resistant S aureus (MRSA) has risen dramatically in the past 2 to 3 decades. The economic burden that is associated with MRSA is significant; infections caused by MRSA cost approximately $3700 more to treat than infections caused by methicillin-sensitive S aureus, and the death rate for MRSA infection is nearly 3 times that of methicillin-sensitive S aureus. Thus, interventions to prevent nosocomial infection in patients who undergo cardiac surgery may improve outcomes and decrease costs. Advances in diagnostic testing may help to target intranasal antibiotic therapy to those patients who are most likely to receive a benefit. The LightCycler System is a fast and effective polymerase chain reaction-based diagnostic test that may be used to identify patients with nasal colonization of S aureus. Carrier status can be determined in a matter of hours rather than days as is the case with traditional culture techniques.

Carrier State↗

Predictive value and cost-effectiveness analysis of a rapid polymerase chain reaction for preoperative detection of nasal carriage of Staphylococcus aureus.

OBJECTIVE: To determine the accuracy and cost-effectiveness of a polymerase chain reaction (PCR) for detecting nasal carriage of Staphylococcus aureus directly from clinical specimens. CROSS-SECTIONAL STUDY: This occurred in a tertiary-care hospital in Cleveland, Ohio, and included 239 consecutive patients who were scheduled for a cardiothoracic surgical procedure. Conventional cultures and a PCR for S. aureus from nasal swabs were used as measurements. COST-EFFECTIVENESS ANALYSIS: Data sources were market prices and Bureau of Labor Statistics. The time horizon was the maximum period for availability of culture results (3 days). Interventions included universal mupirocin therapy without testing; initial therapy, with termination if PCR negative (treat-PCR); initial therapy, with termination if culture negative (treat-culture); treat PCR-positive carriers (PCR-guided treatment); and treat culture-positive carriers (culture-guided treatment). The perspective was institutional and costs and the length of time to treatment were outcome measures. RESULTS: Sixty-seven (28%) of the 239 swabs grew S. aureus. Rapid PCR was 97.0% sensitive and 97.1% specific for the detection of S. aureus. For populations with prevalences of nasal S. aureus carriage of up to 50%, the PCR assay had negative predictive values of greater than 97%. PCR-guided treatment had the lowest incremental cost-effectiveness ratio (1.93 dollars per additional day compared with the culture strategy). Among immediate treatment strategies, treat-PCR was most cost-effective. The universal therapy strategy cost 38.19 dollars more per additional day gained with carrier identification compared with the PCR strategy. CONCLUSION: Rapid real-time PCR is an accurate, rapid, and cost-effective method for identifying S. aureus carriers for preoperative intervention.

Algorithms↗

Prospective assessment of the predictive value of alpha-glutathione S-transferase for intestinal ischemia.

Nonspecific investigations resulting in treatment delays contribute to the 30 per cent mortality associated with acute mesenteric ischemia (AMI). As preliminary studies indicate that alpha-glutathione S-transferase (alpha-GST) is elevated in AMI we compare the ability of alpha-GST against conventional biochemical tests to predict AMI. There were 58 patients prospectively evaluated for AMI. Samples for alpha-GST (Biotrin International, Dublin, Ireland), lactate, pH, amylase, base excess, and white blood cell count (WBC) were evaluated. Intestinal ischemia was confirmed by colonoscopy, angiography, or laparotomy. Ischemia was present in 35 (60%) patients: small bowel (n = 14), colonic (n = 17), and global (n = 4). Four patients without autopsy were excluded. Alpha-GST was elevated in those with AMI [22.2 (7-126) ng/mL vs 2.2 (1-3) (P = 0.001)]. Alpha-GST was more accurate at predicting intestinal ischemia (74%) than conventional tests (47-69% accuracy). Accuracy was increased to 80 per cent by combination with lactate or WBC, which increased sensitivity to 97 to 100 per cent. Alpha-GST monitoring is a useful tool for the diagnosis of intestinal ischemia. A normal alpha-GST and WBC may exclude the presence of AMI.

Acute Disease↗

Predictors of severe right ventricular failure after implantable left ventricular assist device insertion: analysis of 245 patients.

BACKGROUND: Insertion of an implantable left ventricular assist device (LVAD) complicated by early right ventricular (RV) failure has a poor prognosis and is largely unpredictable. Prediction of RV failure after LVAD placement would lead to more precise patient selection and optimal device selection. METHODS AND RESULTS: We reviewed data from 245 patients (mean age, 54+/-11 years; 85% male) with 189 HeartMate (77%) and 56 Novacor (23%) LVADs. Ischemic cardiomyopathy predominated (65%), and 29% had dilated cardiomyopathy. Overall, RV assist device (RVAD) support was required after LVAD insertion for 23 patients (9%). We compared clinical and hemodynamic parameters before LVAD insertion between RVAD (n=23) and No-RVAD patients (n=222) to determine preoperative risk factors for severe RV failure. By univariate analysis, female gender, small body surface area, nonischemic etiology, preoperative mechanical ventilation, circulatory support before LVAD insertion, low mean and diastolic pulmonary artery pressures (PAPs), low RV stroke work (RVSW), and low RVSW index (RVSWI) were significantly associated with RVAD use. Elevated PAP and pulmonary vascular resistance were not risk factors. Risk factors by multivariable logistic regression were preoperative circulatory support (odds ratio [OR], 5.3), female gender (OR, 4.5), and nonischemic etiology (OR, 3.3). CONCLUSIONS: The need for circulatory support, female gender, and nonischemic etiology were the most significant predictors for RVAD use after LVAD insertion. Regarding hemodynamics, low PAP and low RVSWI, reflecting low RV contractility, were important parameters. This information may lead to better patient selection for isolated LVAD implantation.

Adolescent↗

Hemodynamic stability during 17 years of the Carpentier-Edwards aortic pericardial bioprosthesis.

BACKGROUND: Long-term stability of the hemodynamic performance of commercially available Carpentier-Edwards stented bovine pericardial aortic bioprostheses (Perimount RSR) is unknown. To anticipate the fate of this bioprosthesis, we examined its hemodynamic performance up to 17 years using echocardiographic studies in a Premarket Approval cohort. METHODS: Of 267 patients at four institutions in the Premarket Approval cohort, 85 had a total of 168 echocardiographic studies during a 17-year period of yearly follow-up examinations. These were reviewed and quantified in a core echocardiographic facility. Longitudinal data analysis was used to account for repeated, censored data. RESULTS: Mean transvalvular gradient was inversely related to prosthesis size (p = 0.01), and possibly (p = 0.06) increased somewhat during the first 10 years of follow-up, then stabilized. Effective orifice area was larger in larger valve sizes (p = 0.01), declined somewhat during the first 10 years, and then began to increase again. Ejection fraction declined minimally (p = 0.2). In contrast to the rather stable hemodynamics, aortic regurgitation steadily increased from none to 1 to 2+ (p = 0.005), but rarely (< 10% at 17 years) progressed to 3+ or 4+. CONCLUSIONS: The Carpentier-Edwards aortic pericardial bioprosthesis can be anticipated to have an acceptable long-term transvalvular gradient and effective orifice size that will change trivially up to 17 years after implantation. Mild aortic regurgitation will develop progressively. This anticipated hemodynamic resilience supports continued clinical use of the Perimount Carpentier-Edwards bovine pericardial stented bioprosthesis.

Adult↗

Do left ventricular assist device (LVAD) bridge-to-transplantation outcomes predict the results of permanent LVAD implantation?

BACKGROUND: Implantable left ventricular assist devices (LVADs) were designed for permanent implant, but we began their use for bridge-to-transplant (BTTx) to study their safety and effectiveness. We review our experience in order to compare the BTTx lessons learned with the outcomes and goals of permanent implants. METHODS: From December 1991 until January 2002, 264 patients received 277 LVADs for BTTx. We analyzed temporal trends in pre-LVAD patient factors and device-specific time-related complications. RESULTS: Survival to transplant was 69%. Adverse event analysis demonstrated a high risk of infections (0.56, 1.28, and 1.88 per patient at 30 days and 3 and 6 months). HeartMate devices were more prone to infection than Novacor devices (p < 0.0001). Cerebral infarctions occurred less commonly than infections (0.15, 0.25, 0.30 at 30 days and 3 and 6 months), were more common in Novacor than HeartMate (p = 0.0001), and were decreased by the new Novacor Vascutek conduit (p = 0.07), but these were still slightly higher than the HeartMate (p = 0.04). Device failures occurred in 21 instances (all but one were in HeartMate devices [p = 0.04 vs Novacor]), but have significantly decreased (p < 0.0001) in HeartMate since 1998. CONCLUSIONS: Infections and device durability limit the chronic use of the HeartMate device, but device failures are decreasing. Novacor has fewer problems with infection and durability, and the new Vascutek conduit will reduce, but not eliminate, strokes.

Cerebral Infarction↗