Angiogenic Gene Therapy for Refractory Angina: Results of the EXACT Phase 2 Trial.

BACKGROUND: XC001 is a novel adenoviral-5 vector designed to express multiple isoforms of VEGF (vascular endothelial growth factor) and more safely and potently induce angiogenesis. The EXACT trial (Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment) assessed the safety and preliminary efficacy of XC001 in patients with no option refractory angina. METHODS: In this single-arm, multicenter, open-label trial, 32 patients with no option refractory angina received a single treatment of XC001 (1×1011 viral particles) via transepicardial delivery. RESULTS: There were no severe adverse events attributed to the study drug. Twenty expected severe adverse events in 13 patients were related to the surgical procedure. Total exercise duration increased from a mean±SD of 359.9±105.55 seconds at baseline to 448.2±168.45 (3 months), 449.2±175.9 (6 months), and 477.6±174.7 (12 months; +88.3 [95% CI, 37.1-139.5], +84.5 [95% CI, 34.1-134.9], and +115.5 [95% CI, 59.1-171.9]). Total myocardial perfusion deficit on positron emission tomography imaging decreased by 10.2% (95% CI, -3.1% to 23.5%), 14.3% (95% CI, 2.8%-25.7%), and 10.2% (95% CI, -0.8% to -21.2%). Angina frequency decreased from a mean±SD 12.2±12.5 episodes to 5.2±7.2 (3 months), 5.1±7.8 (6 months), and 2.7±4.8 (12 months), with an average decrease of 7.7 (95% CI, 4.1-11.3), 6.6 (95% CI, 3.5-9.7), and 8.8 (4.6-13.0) episodes at 3, 6, and 12 months. Angina class improved in 81% of participants at 6 months. CONCLUSIONS: XC001 administered via transepicardial delivery is safe and generally well tolerated. Exploratory improvements in total exercise duration, ischemic burden, and subjective measures support a biologic effect sustained to 12 months, warranting further investigation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04125732.

EXACT Trial: Results of the Phase 1 Dose-Escalation Study.

BACKGROUND: New therapies are needed for patients with refractory angina. Encoberminogene rezmadenovec (XC001), a novel adenoviral-5 vector coding for all 3 major isoforms of VEGF (vascular endothelial growth factor), demonstrated enhanced local angiogenesis in preclinical models; however, the maximal tolerated dose and safety of direct epicardial administration remain unknown. METHODS: In the phase 1 portion of this multicenter, open-label, single-arm, dose-escalation study, patients with refractory angina received increasing doses of encoberminogene rezmadenovec (1×109, 1×1010, 4×1010, and 1×1011 viral particles) to evaluate its safety, tolerability, and preliminary efficacy. Patients had class II to IV angina on maximally tolerated medical therapy, demonstrable ischemia on stress testing, and were angina-limited on exercise treadmill testing. Patients underwent minithoracotomy with epicardial delivery of 15 0.1-mL injections of encoberminogene rezmadenovec. The primary outcome was safety via adverse event monitoring over 6 months. Efficacy assessments included difference from baseline to months 3, 6 (primary), and 12 in total exercise duration, myocardial perfusion deficit using positron emission tomography, angina class, angina frequency, and quality of life. RESULTS: From June 2, 2020 to June 25, 2021, 12 patients were enrolled into 4 dosing cohorts with 1×1011 viral particle as the highest planned dose. Seventeen serious adverse events were reported in 7 patients; none were related to study drug. Six serious adverse events in 4 patients were related to the thoracotomy, 3 non-serious adverse events were possibly related to study drug. The 2 lowest doses did not demonstrate improvements in total exercise duration, myocardial perfusion deficit, or angina frequency; however, there appeared to be improvements in all parameters with the 2 higher doses. CONCLUSIONS: Epicardial delivery of encoberminogene rezmadenovec via minithoracotomy is feasible, and up to 1×1011 viral particle appears well tolerated. A dose response was observed across 4 dosing cohorts in total exercise duration, myocardial perfusion deficit, and angina class. The highest dose (1×1011 viral particle) was carried forward into phase 2. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04125732.

Single vs Serial Measurements of Cardiac Troponin Level in the Evaluation of Patients in the Emergency Department With Suspected Acute Myocardial Infarction.

Importance: Chest pain is among the most common reasons for emergency department (ED) presentations. However, most patients are at low risk for acute coronary syndrome (ACS), with low cardiac adverse outcomes rates. Biomarker testing with troponin levels is key in the initial assessment for ACS. Although serial troponin testing can improve the diagnosis of ACS in clinical practice, some patients deemed to be low risk are discharged after a single negative troponin test result. Objective: To report the clinical outcomes of patients discharged after a single negative troponin test result compared with patients discharged after serial troponin measurements. Design, Setting, and Participants: This is a retrospective cohort study of ED encounters from May 5, 2016, to December 1, 2017, across 15 community EDs within an integrated health care system in southern California. The study cohort includes 27 918 adult ED encounters in which patients were evaluated for suspected ACS with a HEART (history, electrocardiogram, age, risk factors, and troponin) score and an initial conventional troponin-I measurement below the level of detection (<0.02 ng/mL). Statistical analysis was performed from December 1, 2019, to December 1, 2020. Exposure: Single troponin test vs multiple troponin tests. Main Outcomes and Measures: The primary outcome was acute myocardial infarction or cardiac mortality; secondary outcomes included coronary artery bypass graft, percutaneous coronary intervention, invasive coronary angiography, and unstable angina within 30 days of discharge. A multivariable logistic regression model was performed to evaluate the association between testing strategies and clinical outcomes. Results: A total of 27 918 patient encounters (16 212 women [58.1%]; mean [SD] age, 58.7 [15.2] years) were included in the study. Of patients with an initial troponin measurement below the level of detection, 14 459 (51.8%) were discharged after a single troponin measurement, and 13 459 (48.2%) underwent serial troponin tests. After adjustment for cardiac risk factors and comorbidities, there was no statistically significant difference in the primary outcome of acute myocardial infarction or cardiac mortality within 30 days between the 2 groups (single troponin, 56 [0.4%] vs serial troponin, 52 [0.4%]; adjusted odds ratio, 1.41 [95% CI, 0.96-2.07]). Patients discharged after a single troponin test had lower rates of coronary artery bypass graft (adjusted odds ratio, 0.24 [95% CI, 0.11-0.48]) and invasive coronary angiography (adjusted odds ratio, 0.46 [95% CI, 0.38-0.56]). Conclusions and Relevance: This study suggests that patients are routinely discharged from the ED after a single negative troponin test result, and when compared with serial troponin testing, a single troponin test appears safe based on current physician decision-making, with no difference in rates of 30-day cardiac mortality and acute myocardial infarction, which are low in both groups.

Rate of Incomplete Revascularization Following Coronary Artery Bypass Grafting at a Single Institution Between 2007 and 2017.

Incomplete revascularization following coronary artery bypass grafting (CABG) is associated with increased repeat revascularization, myocardial infarction and death. Whether the rate of incomplete revascularization is increasing over time has not been previously described. All patients with multivessel coronary artery disease who underwent isolated and elective CABG at our Institution in 2007 (n = 291) were compared to patients who underwent CABG in 2017 (n = 290). A Revascularization Index Score was created to compare rates of incomplete revascularization between the 2 years based on the coronary anatomy and degree of stenosis. Comparison of the 2 years disclose that the rate of incomplete revascularization increased from 17.9% in 2007 to 28.3% in 2017 (p = 0.003) and was accompanied by a decline in the Revascularization Index Score from 0.73 to 0.67 (p = 0.005). Left ventricular function improved in both groups following CABG. Two-year cardiovascular mortality was significantly higher in the 2017 cohort compared to the 2007 cohort. These differences may be attributable to patient factors including more severe coronary artery disease associated with older age, greater incidence of smoking and previous percutaneous coronary intervention. In conclusion, the rate of incomplete revascularization following CABG significantly increased in 2017 compared to 2007 and was associated with higher cardiovascular mortality.

Variation in diagnostic testing for older patients with syncope in the emergency department.

BACKGROUND: Older adults presenting with syncope often undergo intensive diagnostic testing with unclear benefit. We determined the variation, frequency, yield, and costs of tests obtained to evaluate older persons with syncope. METHODS: We conducted a prospective, multicenter observational cohort study in 11 academic emergency departments in the United States of 3686 patients aged ≥60 years presenting with syncope or presyncope. We measured the frequency, variation, yield, and costs (based on Medicare payment tables) of diagnostic tests performed at the index visit. RESULTS: While most study rates were similar across sites, some were notably discordant (e.g., carotid ultrasound: mean 9.5%, range 1.1% to 49.3%). The most frequently-obtained diagnostic tests were initial troponin (88.6%), chest x-ray (75.1%), head CT (42.5%) and echocardiogram (35.5%). The yield or proportion of abnormal findings by diagnostic test ranged from 1.9% (electrocardiogram) to 42.0% (coronary angiography). Among the most common tests, echocardiogram had the highest proportion of abnormal results at 22.1%. Echocardiogram was an outlier in total cost at $672,648, and had a cost per abnormal test of $3129. CONCLUSION: Variation in diagnostic testing in older patients presenting with syncope exists. The yield and cost per abnormal result for common tests obtained to evaluate syncope are also highly variable. Selecting tests based on history and examination while also prioritizing less resource intensive and higher yield tests may ensure a more informed and cost-effective approach to evaluating older patients with syncope.

Correlates of Emergency Department Service Utilization Among U.S. Chinese Older Adults.

Older adults visit emergency departments (EDs) at a disproportionally higher rate than other age groups. Prior studies examining racial disparities in ED utilization focus on African Americans and Hispanics. There is a dearth of information on ED utilization patterns among older Asian Americans despite the evidence that ED expenditures in Asian Americans are comparable to that of Caucasians. To address this knowledge gap, we examined factors associated with ED service utilization in the largest Asian subgroup, U.S. Chinese older adults. Cross-sectional data from the Population Study of Chinese Elderly in Chicago (PINE) (N = 3,157) were used. Multivariate negative binomial regression analyses were conducted to examine significant factors associated with ED use. Higher education (rate ratio [RR] = 1.03, 95% confidence interval [CI] 1.00-1.05) and acculturation levels (RR = 1.02, CI 1.00-1.04), fewer people in the household (RR = 0.94, CI 0.88-0.99), health insurance coverage (RR = 1.34, CI 1.01-1.78), lower income (RR = 0.89, CI 0.80-0.99), poorer perceived health (RR = 0.67, CI 0.58-0.77), more functional limitations (RR = 1.09, CI 1.06-1.13) and depressive symptoms (RR = 1.04, CI 1.02-1.07), and a history of heart disease (RR = 2.28, CI 1.83-2.84), stroke (RR = 1.68, CI 1.20-2.35), cancer (RR = 1.86, CI 1.31-2.63), and hip fracture (RR = 1.42, CI 1.02-1.98) were associated with higher rates of ED visits. Our findings highlight several significant correlates of ED use in U.S. Chinese older adults. Culturally-appropriate interventions modifying these factors have the potential to decrease ED visits and improve care outcomes in this population.

Emergency Department Attending Physician Variation in Opioid Prescribing in Low Acuity Back Pain.

INTRODUCTION: Despite treatment guidelines suggesting alternatives, as well as evidence of a lack of benefit and evidence of poor long-term outcomes, opioid analgesics are commonly prescribed for back pain from the emergency department (ED). Variability in opioid prescribing suggests a lack of consensus and an opportunity to standardize and improve care. We evaluated the variation in attending emergency physician (EP) opioid prescribing for patients with uncomplicated, low acuity back pain (LABP). METHODS: This retrospective study evaluated the provider-specific proportion of LABP patients discharged from an urban academic ED over a seven-month period with a prescription for opioids. LABP was strictly defined as (1) back pain chief complaint, (2) discharged from ED with no interventions, and (3) predefined discharge diagnosis of back pain. We excluded providers if they had less than 25 LABP patients in the study period. The primary outcome was the physician-specific proportion of LABP patients discharged with an opioid analgesic prescription. We performed a descriptive analysis and then risk standardized prescribing proportion by adjusting for patient and clinical characteristics using hierarchical logistic regression. RESULTS: During the seven-month study period, 23 EPs treated and discharged at least 25 LABP patients and were included. Eight (34.8%) were female, and six (26.1%) were junior attendings (≤ 5 years after residency graduation). There were 943 LABP patients included in the analysis. Provider-specific proportions ranged from 3.7% to 88.1% (mean 58.4% [SD +/- 22.2]), and we found a 22-fold variation in prescribing proportions. There was a six-fold variation in the adjusted, risk-standardized prescribing proportion with a range from 12.0% to 78.2% [mean 50.4% (SD +/-16.4)]. CONCLUSION: We found large variability in opioid prescribing practices for LABP that persisted after adjustment for patient and clinical characteristics. Our findings support the need to further standardize and improve adherence to treatment guidelines and evidence suggesting alternatives to opioids.

The Unintended Consequences of Over-Reducing Cardiopulmonary Bypass Circuit Prime Volume.

BACKGROUND: The Society of Thoracic Surgeon blood conservation guidelines recommend minimizing cardiopulmonary bypass circuit prime volume (PV) as an integral, evidence-based (Class I, Level A) blood conservation strategy. We used a large, multiinstitutional registry to evaluate the effectiveness of restricting cardiopulmonary bypass PV on intraoperative red blood cell (RBC) transfusion. METHODS: We reviewed 47,273 isolated coronary artery bypass graft procedures performed among 189 institutions between April 2012 and May 2015. The primary outcome was intraoperative transfusion of at least 1 unit RBC; the secondary outcome was intraoperative transfusion of 4 or more units RBC. We estimated the adjusted odds of each transfusion type using separate multivariable logistic regression models that controlled for 13 confounding factors. The effect of PV on odds of transfusion was modeled using restricted cubic splines to assess possible nonlinearity. RESULTS: We found a statistically significant nonlinear pattern in the relation between PV and odds of transfusion of both 1 or more units RBC (χ2 = 116.3, df = 4, p < 0.001) and 4 or more units RBC (χ2 = 25.9, df = 4, p < 0.001). The lowest probability of transfusion of 1 or more units RBC was estimated at a ratio of PV to estimated blood volume of 0.152 (p < 0.001). CONCLUSIONS: Efforts to minimize PV below 15% of a patient's estimated blood volume do not protect patients from intraoperative RBC transfusion, and may increase exposure. Prime volume can affect both patient morbidity and the economic impact associated with blood utilization. Further studies on the effect of PV on blood transfusion are warranted.

Design, Challenges, and Implications of Quality Improvement Projects Using the Electronic Medical Record: Case Study: A Protocol to Reduce the Burden of Postoperative Atrial Fibrillation.

Postoperative atrial fibrillation (POAF) is a frequent complication of cardiac surgery, which results in increased morbidity, mortality, length of stay, and hospital costs. We developed and followed a process map to implement a protocol to decrease POAF: (1) identify stakeholders and form a working committee, (2) formal literature and guideline review, (3) retrospective analysis of current institutional data, (4) data modeling to determine expected effects of change, (4) protocol development and implementation into the electronic medical record, and (5) ongoing review of data and protocol adjustment. Retrospective analysis demonstrated that POAF occurred in 29.8% of all cardiovascular surgery cases. Median length of stay was 2 days longer (P<0.001), and median total variable costs $2495 higher (P<0.001) in POAF patients. Modeling predicted that up to 60 cases of POAF and >$200 000 annually could be saved. A clinically based electronic medical record tool was implemented into the electronic medical record to aid preoperative clinic providers in identifying patients eligible for prophylactic amiodarone. Initial results during the 9-month period after implementation demonstrated a reduction in POAF in patients using the protocol, compared with those who qualified but did not receive amiodarone and those not evaluated (11.1% versus 38.7% and 38.8%; P=0.022); however, only 17.3% of patients used the protocol. A standardized methodological approach to quality improvement and electronic medical record integration has potential to significantly decrease the incidence of POAF, length of stay, and total variable cost in patients undergoing elective coronary artery bypass graft and valve surgeries. This framework for quality improvement interventions may be adapted to similar clinical problems beyond POAF.

Impact of a kiosk educational module on HIV screening rates and patient knowledge.

We assessed the effect of a kiosk educational module on HIV screening rates and patient knowledge about HIV testing. The evaluation was performed in a walk-in clinic offering routine HIV screening. During alternating two-week periods, patients were referred either to view a kiosk-based, educational module prior to receiving usual care, or the kiosk module was turned off and no alterations to care processes were made. The primary outcome was HIV testing rate. The secondary outcome was knowledge about HIV rapid screening, as measured with a questionnaire. There were 71 patients in the kiosk periods and 79 patients in the usual-care periods. The overall HIV testing rate was 41%. The kiosk period was not associated with greater odds of HIV testing (OR 0.7; 95% CI: 0.4-1.4). In 44 patients who completed the knowledge survey, the kiosk group was strongly associated with increased knowledge (predicted increase in knowledge score: 1.3; 95% CI: 036-2.1). The brief kiosk educational module did not improve HIV screening rates, but it increased overall patient knowledge about HIV testing.

Abdominal only CPR during cardiac arrest for a patient with an LVAD during resternotomy: a case report.

We present a case in which a patient with a previous sternotomy and left ventricular assist device (LVAD) implantation developed cardiac arrest during resternotomy for LVAD exchange. The surgeon refused chest compressions for fear of potential damage to the inflow cannula directly beneath the sternum. The perioperative team had no alternatives to external cardiac massage other than rapid deployment of extra-corporeal membrane oxygenation for mechanical support, so the anesthesiologist advised the nursing personnel to perform abdominal only cardiopulmonary resuscitation while the surgeon performed a femoral bypass to cannulate the groin for extra-corporeal membrane oxygenation support.

Outcomes of a multicenter trial of the Levitronix CentriMag ventricular assist system for short-term circulatory support.

OBJECTIVE: The Levitronix CentriMag (Levitronix LLC, Waltham, Mass) ventricular assist system is designed for temporary left, right, or biventricular support. Advantages include ease of use, excellent reliability, and low thrombosis risk,. which may allow wider application of short-term support and improved outcomes in patients with cardiogenic shock. This multi-institutional study evaluated safety, effectiveness, and outcomes of the CentriMag in patients with cardiogenic shock. METHODS: Thirty-eight patients were supported at 7 centers. Patients included 12 after cardiotomy, 14 after myocardial infarction, and 12 with right ventricular failure after implantable left ventricular assist device placement. Devices were implanted in left (n = 8), right (n = 12), or biventricular (n = 18) configuration. Support was continued until recovery, transplantation, or implantation of long-term ventricular assist device. RESULTS: Mean support duration for the entire cohort (n = 38) was 13 days (1-60 days), with 47% of patients (18/38) surviving 30 days after device removal. Mean CentriMag biventricular support (n = 18) duration was 15 days (1-60 days), with 44% (8/18) surviving at 30 days. Mean CentriMag right ventricular support with a commercially available left ventricular assist device (n = 12) duration was 14 days (1-29 days), with 58% (7/12) surviving at 30 days. Complications included bleeding (21%), infection (5%), respiratory failure (3%), hemolysis (5%), and neurologic dysfunction (11%). There were no CentriMag or pump failures. CONCLUSIONS: In this preliminary study, the CentriMag provided short-term support for patients with cardiogenic shock with a low incidence of device-related complications and no device failures.

Initial experience with off-pump left ventricular assist device implantation in single center: retrospective analysis.

BACKGROUND: We hypothesize that implantation of left ventricular assist device through off-pump technique is feasible and has a comparable result to implantation on cardiopulmonary bypass and could improve one-year survival. METHODS: This retrospective, observational, single-center study was conducted on 29 consecutive patients at our institution who underwent off-pump left ventricular assist device implantation by a single surgeon. RESULTS: Twenty-seven procedures were performed successfully using the off-pump technique. The survival rate was 92% at 30 days, 76% at 90 days, and 67% at one year. We compared the one-year survival of different implantation periods, and divided our study into three time intervals (2004-2005, 2006, and 2007). There was a trend in reduction in number of deaths over one year that demonstrated a decrease in death rate from 50% to 17%, as well as improvement in our experience over time. However, this trend is not statistically significant (p = 0.08) due to limited sample size. CONCLUSIONS: Based upon our findings, off-pump left ventricular assist device implantation is a feasible surgical technique, and combining this technique with improved device technology in the future may provide even greater improvement in patient outcomes.

Effect of body mass index and device type on infection in left ventricular assist device support beyond 30 days.

Infection as a complication of long-term left ventricular assist device (LVAD) support leads to significant morbidity and mortality. Obesity, a possible risk factor for other postoperative cardiovascular surgical site infections, is an increasingly prevalent condition among recipients of LVAD devices. We retrospectively analyzed 145 LVADs that remained in place beyond 30 days over a nine-year period at a single medical institution. Statistical analysis was carried out using univariate and multivariable logistic regression and chi(2)-testing where indicated. Body mass index (BMI) had no effect on the incidence of infectious outcomes regardless of age, gender, underlying pathogen or device type. This included the morbidly obese population as well (BMI >or=40). Independent of BMI, device type did have an effect, with the HeartMate XVE increasing the risk for infections [odds ratio (OR) 4.3 with 95% confidence interval (CI) 2.1-8.8, P=0.0001] and the HeartMate II reducing the risk (OR 0.21 with 95% CI 0.09-0.50, P=0.0001). The risk for infection after LVAD placement for long-term support is likely to be a multi-factorial phenomenon. BMI, including morbid obesity, does not appear to be a statistically significant relevant factor in determining that risk. Device type may have an effect, however, on risk of infection in long-term support.

Effect of an education kiosk on patient knowledge about rapid HIV screening.

Patient education is an important part of routine HIV screening. In a pilot study, we assessed the effect of a computer kiosk education module on patient knowledge about routine HIV screening. A systematic sample of walk-in clinic patients completed a questionnaire before and after using the education module. The primary outcome was a composite nine-point knowledge score. Secondary outcomes included willingness to undergo HIV screening and patient satisfaction. Of 185 patients who were eligible to participate, 100 completed the study. The median duration of kiosk interaction was 3.9 min. The median knowledge score increased from 7 to 8 (P < 0.0001) after viewing the module. There was no significant change in the proportion of patients who were interested in HIV screening. The majority of patients expressed excellent (38%) or very good (39%) satisfaction with the kiosk module. The results suggest that a computer kiosk can deliver brief and targeted education to improve knowledge about HIV screening.

Pharmacological preconditioning of mesenchymal stem cells with trimetazidine (1-[2,3,4-trimethoxybenzyl]piperazine) protects hypoxic cells against oxidative stress and enhances recovery of myocardial function in infarcted heart through Bcl-2 expression.

Stem cell transplantation is a possible therapeutic option to repair ischemic damage to the heart. However, it is faced with a number of challenges including the survival of the transplanted cells in the ischemic region. The present study was designed to use stem cells preconditioned with trimetazidine (1-[2,3,4-trimethoxybenzyl]piperazine; TMZ), a widely used anti-ischemic drug for treating angina in cardiac patients, to increase the rate of their survival after transplantation. Bone marrow-derived rat mesenchymal stem cells (MSCs) were subjected to a simulated host tissue environment by culturing them under hypoxia (2% O(2)) and using hydrogen peroxide (H(2)O(2)) to induce oxidative stress. MSCs were preconditioned with 10 microM TMZ for 6 h followed by treatment with 100 microM H(2)O(2) for 1 h and characterized for their cellular viability and metabolic activity. The preconditioned cells showed a significant protection against H(2)O(2)-induced loss of cellular viability, membrane damage, and oxygen metabolism accompanied by a significant increase in HIF-1alpha, survivin, phosphorylated Akt (pAkt), and Bcl-2 protein levels and Bcl-2 gene expression. The therapeutic efficacy of the TMZ-preconditioned MSCs was evaluated in an in vivo rat model of myocardial infarction induced by permanent ligation of left anterior descending coronary artery. A significant increase in the recovery of myocardial function and up-regulation of pAkt and Bcl-2 levels were observed in hearts transplanted with TMZ-preconditioned cells. This study clearly demonstrated the potential benefits of pharmacological preconditioning of MSCs with TMZ for stem cell therapy for repairing myocardial ischemic damage.

Results of a multicenter clinical trial with the Thoratec Implantable Ventricular Assist Device.

OBJECTIVE: The Thoratec Implantable Ventricular Assist Device (Thoratec Corporation, Pleasanton, Calif) can be used for univentricular or biventricular support in patients with a body surface area as low as 1.3 m(2). Results of the multicenter clinical trial are reviewed. METHODS: Between October 2001 and June 2004, a total of 39 patients at 12 institutions were supported with the Thoratec Implantable Ventricular Assist Device. Twenty-four patients (62%) received left ventricular assist devices and 15 (38%) received biventricular assist devices. Indications included bridge to transplantation (n = 30) and postcardiotomy failure (n = 9). The control group included 100 patients from the Food and Drug Administration approval submissions for the paracorporeal version of the ventricular assist device. RESULTS: Twenty-eight male and 11 female patients, with mean age of 48 years (16-71 years) and body surface area of 1.9 m(2) (1.3-2.4 m2) were supported for 3938 patient-days (10.8 patient-years). Mean left ventricular assist device flow index on the first postoperative day was 2.5 +/- 0.5 L/(min x m2). Mean duration of support was 101 days (9-597 days). Eighteen patients were discharged after a mean duration of 96 days. There were no ventricular assist device failures. Complications included 13 cases of bleeding requiring reexploration (33.3%), 1 embolic and 2 hemorrhagic strokes (7.7%), 5 driveline infections (12.8%), and 2 pocket infections (5%). Support to successful outcomes was 70% for bridge to transplantation and 67% for postcardiotomy recovery, versus historical results for the paracorporeal ventricular assist device of 69% for bridge to transplantation and 48% for postcardiotomy recovery. CONCLUSION: The Thoratec Implantable Ventricular Assist Device is a new implantable pulsatile ventricular assist device that allows hospital discharge for patients as a bridge to transplantation or for postcardiotomy failure. It is the first Food and Drug Administration-approved implantable ventricular assist device with biventricular capability.

An unexpected surgical complication of ventricular assist device implantation identified by transesophageal echocardiography: a case report.

Ventricular assist devices are used for circulatory support for patients with cardiogenic shock and refractory heart failure. Although early and late complications of left ventricular assist devices have been reported, we report a rare surgical complication of a left ventricular assist device implantation. This unexpected surgical complication was accurately identified by transesophageal echocardiography.