Identifying Patterns of Adverse Events of Solid Organ Transplantation Through Departmental Case Reviews.

The best approach to adverse-event review in solid organ transplantation is unknown. We initiated a departmental case review (DCR) method based on root-cause analysis methods in a high-volume multiorgan transplant center. We aimed to describe this process and its contributions to process improvement. METHODS: Using our prospectively maintained transplant center quality portfolio, we performed a retrospective review of a 30-month period (October 26, 2015, to May 14, 2018) after DCR-process initiation at our center. We used univariate statistics to identify counts of adverse events, DCRs, death and graft-loss events, and quality improvement action-plan items identified during case review. We evaluated variation among organ groups in action-plan items, associated phase of transplant care, and quality improvement theme. RESULTS: Over 30 months, we performed 1449 transplant and living donor procedures with a total of 45 deaths and 31 graft losses; 91 DCRs were performed (kidney transplant n=43; liver transplant n=24; pancreas transplant n=10; heart transplant n=6; lung transplant n=3; living donor n=5). Seventy-nine action-plan items were identified across improvement domains, including errors in clinical decision making, communication, compliance, documentation, selection, waitlist management, and administrative processes. Median time to review was 83 days and varied significantly by program. Median time to action-plan item completion was 9 weeks. Clinical decision making in the pretransplant phase was identified as an improvement opportunity in all programs. CONCLUSIONS: DCRs provide a robust approach to transplant adverse-event review. Quality improvement targets and domains may vary based on adverse-event profiles.

Destination Therapy: Standardizing the Role of Palliative Medicine and Delineating the DT-LVAD Journey.

CONTEXT: Destination therapy (DT) patients face significant challenges as they transition from chronic left ventricular assist device (LVAD) support to comfort-oriented care. Integration of palliative medicine (PM) into the multidisciplinary team is important to facilitate advanced care planning (ACP) and improve quality of life (QoL). OBJECTIVES: We evaluated the impact of a structured programmatic approach to the end-of-life (EOL) process in DT patients as measured by QoL surveys and the utilization of ACP. METHODS: We instituted a four prong intervention approach: 1) delineated the path from implant to EOL by defining specific stages, including a transitional phase where care limits were agreed upon, 2) standardized the role of PM, 3) held transitional care meetings to support shared decision-making, and 4) held multidisciplinary team debriefings to facilitate communication. Preintervention and postintervention outcomes were measured for patients/caregivers by using the QUAL-E/QUAL-E (family) QoL instrument. Wilcoxon signed-ranks test compared nonparametric variables. RESULTS: All patients (n = 41)/caregivers (n = 28) reported improved QoL measures (patient P = 0.035/caregiver P = 0.046). Preparedness plans increased from 52% to 73% after implementation and advance directives increased from 71% to 83%. Fifty-nine percent of the patients completed an outpatient PM clinic visit; 51% completed/scheduled a second visit. Clinician outcomes improved including satisfaction with multidisciplinary team communication/expectations, ACP processes, and EOL management. CONCLUSION: A programmatic approach that standardizes the role of PM and delineates the patient's path from implant to EOL improved quality outcomes and increased implementation of ACP. A defined communication process allowed the multidisciplinary team to have a clear patient management approach.

Monster Lung Cavity in a Heart Transplant Recipient.

Invasive mucormycosis infections occur in less than 1% of recipients of orthotopic heart transplants. Given the angioinvasive nature of these infections, the mortality rate is high. Little literature exists regarding the presentation and management of these infections. We present a case of a patient who developed an infection after orthotopic heart transplant, describe the successful multidisciplinary management surrounding his care, and review the available literature regarding mucormycosis infections in heart transplant recipients.

Ethical Analysis of Withdrawing Total Artificial Heart Support.

OBJECTIVES: To describe the characteristics of patients who undergo withdrawal of total artificial heart support and to explore the ethical aspects of withdrawing this life-sustaining treatment. PATIENTS AND METHODS: We retrospectively reviewed the medical records of all adult recipients of a total artificial heart at Mayo Clinic from the program's inception in 2007 through June 30, 2015. Management of other life-sustaining therapies, approach to end-of-life decision making, engagement of ethics and palliative care consultation, and causes of death were analyzed. RESULTS: Of 47 total artificial heart recipients, 14 patients or their surrogates (30%) requested withdrawal of total artificial heart support. No request was denied by treatment teams. All 14 patients were supported with at least 1 other life-sustaining therapy. Only 1 patient was able to participate in decision making. CONCLUSION: It is widely held to be ethically permissible to withdraw a life-sustaining treatment when the treatment no longer meets the patient's health care-related goals (ie, the burdens outweigh the benefits). These data suggest that some patients, surrogates, physicians, and other care providers believe that this principle extends to the withdrawal of total artificial heart support.

Unexplained Obstruction of an Integrated Cardiotomy Filter During Cardiopulmonary Bypass.

Cardiopulmonary bypass (CPB) is considered relatively safe in most cases, yet is not complication free. We present a case of an integrated cardiotomy filter obstruction during CPB, requiring circuit reconfiguration. Approximately an hour after uneventful initiation of CPB the integrated cardiotomy filter became obstructed over several minutes, requiring circuit reconfiguration using an external cardiotomy filter to maintain functionality. Following reconfiguration, CPB was maintained with a fully functional circuit allowing safe patient support throughout the remainder of CPB. Postoperatively, there was no sign of thrombus or mechanical obstruction of the filter, which was sent to the manufacturer for analysis. The cause of the obstruction was unclear even after chemical analysis, visual inspection, and a review of all techniques and products to which the patient was exposed. The patient had a generally routine hospital stay, with no signs or symptoms related to the incident. To our knowledge, this is the first report describing an obstructed integrated cardiotomy filter. An appropriate readiness plan for such an incident includes proper venting of the filter chamber, a method for detecting an obstruction, and a plan for circuit reconfiguration. This case illustrates the need for a formal reporting structure for incidents or "near miss" incidents during CPB.

Mechanical circulatory assist devices: a primer for critical care and emergency physicians.

Mechanical circulatory assist devices are now commonly used in the treatment of severe heart failure as bridges to cardiac transplant, as destination therapy for patients who are not transplant candidates, and as bridges to recovery and "decision-making". These devices, which can be used to support the left or right ventricles or both, restore circulation to the tissues, thereby improving organ function. Left ventricular assist devices (LVADs) are the most common support devices. To care for patients with these devices, health care providers in emergency departments (EDs) and intensive care units (ICUs) need to understand the physiology of the devices, the vocabulary of mechanical support, the types of complications patients may have, diagnostic techniques, and decision-making regarding treatment. Patients with LVADs who come to the ED or are admitted to the ICU usually have nonspecific clinical symptoms, most commonly shortness of breath, hypotension, anemia, chest pain, syncope, hemoptysis, gastrointestinal bleeding, jaundice, fever, oliguria and hematuria, altered mental status, headache, seizure, and back pain. Other patients are seen for cardiac arrest, psychiatric issues, sequelae of noncardiac surgery, and trauma. Although most patients have LVADs, some may have biventricular support devices or total artificial hearts. Involving a team of cardiac surgeons, perfusion experts, and heart-failure physicians, as well as ED and ICU physicians and nurses, is critical for managing treatment for these patients and for successful outcomes. This review is designed for critical care providers who may be the first to see these patients in the ED or ICU.

Effect of Continued Cardiac Resynchronization Therapy on Ventricular Arrhythmias After Left Ventricular Assist Device Implantation.

Cardiac resynchronization therapy (CRT) reduces ventricular arrhythmia (VA) burden in some patients with heart failure, but its effect after left ventricular assist device (LVAD) implantation is unknown. We compared VA burden in patients with CRT devices in situ who underwent LVAD implantation and continued CRT (n = 39) to those who had CRT turned off before discharge (n = 26). Implantable cardioverter-defibrillator (ICD) shocks were significantly reduced in patients with continued CRT (1.5 ± 2.7 shocks per patient vs 5.5 ± 9.3 with CRT off, p = 0.014). There was a nonsignificant reduction in cumulative VA episodes per patient with CRT continued at discharge (42 ± 105 VA per patient vs 82 ± 198 with CRT off, p = 0.29). On-treatment analysis by whether CRT was on or off identified a significantly lower burden of VA (17 ± 1 per patient-year CRT on vs 37 ± 1 per patient-year CRT off, p <0.0001) and ICD shocks (1.2 ± 0.3 per patient-year CRT on vs 1.7 ± 0.3 per patient-year CRT off, p = 0.018). In conclusion, continued CRT is associated with significantly reduced ICD shocks and VA burden after LVAD implantation.

Performance and Safety of an Integrated Portable Extracorporeal Life Support System for Adults.

Extracorporeal membrane oxygenation (ECMO) is indicated when conventional measures fail to support a patient during cardiac or respiratory failure. Due to the complicated nature of ECMO, patients often require transport to a tertiary care center. This study retrospectively compared the performance of the Cardiohelp™ (Maquet) life support system with a previously used ECMO circuit when transporting adult patients on venoarterial ECMO between facilities. Two ECMO circuits were compared for performance: 1) the Cardiohelp™ (Maquet) life support system and 2) the "standard" circuit consisting of a Thoratec CentriMag centrifugal pump, Maquet Quadrox-D oxygenator, and a Terumo CDI-500 in-line blood gas analyzer. After analyzing data from 16 patients (eight patients supported with each ECMO system), no differences in patient demographics, percentage of patients successfully weaned from ECMO, percentage of patients surviving to discharge, duration supported on the initial ECMO system, or total duration of ECMO were noted. No patient deaths were related to circuit failure or circuit disruptions in either group. Analysis of the performance of the ECMO circuits and the resulting patient status showed few significant differences between ECMO groups (Cardiohelp™ vs. standard circuit) and time points (the first 8 hours vs. a 24-hour time point). The statistically significant differences were not concerning in terms of appropriate medical support or patient safety. Of interest, the transmembrane pressure was significantly lower for the Cardiohelp™ module vs. the standard oxygenator during the first 8 hours (20.1 [5.3] vs. 37.1 [7.1] mmHg; p < .001) and at 24 hours (21.3 [3.8] vs. 34.8 [7.9] mmHg; p = .001). The Cardiohelp™ portable life support system provides safe and reliable support for adult patients on ECMO during interhospital patient transport as compared to the standard circuit.

SynCardia Portable Freedom Driver: A Single-Center Experience With 11 Patients.

OBJECTIVE: The portable Freedom Drive (SynCardia Inc, Tucson, AZ USA) for total artificial heart (TAH-t) support was approved for an investigational device exemption study in March 2010. We review our center's experience with the portable driver. METHODS: A retrospective review was conducted of patients who underwent TAH-t implantation and transfer to portable driver from September 2008 to June 2012, with follow-up through December 2012. RESULTS: A total of 30 patients underwent TAH-t implantation during this time period, with 11 patients successfully transferred to the Freedom Driver. Transfer to Freedom Driver after TAH-t implant was a median of 46 days (range, 225-86 days). Ninety-one percent (10) of 11 patients transferred to Freedom Driver were bridged to transplantation. One patient died on support. Five (45.5%) of 11 patients were discharged home and 5 (45.5%) remained in-patient on the portable driver before transplantation. Four patients (80%) successfully discharged home required at least 1 hospital readmission (range, 1-5 admissions per patient). Six patients (55%) transferred to the portable driver required a return to a main driver console. Two patients were temporarily maintained on the main driver then returned to the Freedom Driver for bridge to transplantation. CONCLUSIONS: Patients with TAH-t can be considered for transfer to the portable Freedom Driver while awaiting transplantation. Issues that complicated this patient population included inadequate social support, hemodynamic instability, and concurrent morbidities. The potential benefits of the portable driver are currently undergoing assessment. These may include increased mobility and improved quality of life, opportunity for discharge home, and decreased overall medical costs.

Anesthetic pharmacology and perioperative considerations for heart transplantation.

From uncertain beginnings over four decades ago, heart transplantation is now the definitive therapy for end-stage heart failure. This review will attempt to comprehensively cover the broad gamut of anesthetic, hemodynamic, antimicrobial, immunosuppressive and hemostatic agents used by the cardiothoracic anesthesiologist in the perioperative management of patients with endstage heart disease.

Lung transplantation: perioperative pharmacology and anesthetic considerations.

In the past two decades, lung transplantation has become an increasingly important surgical option for the patient with end stage lung disease. Compared with the other solid organ transplants (heart, liver and kidney), lung transplantation carries immense clinical and logistic challenges; long-term organ viability is particularly problematic, with an expected five-year mortality of 40-50%. The number of lung transplants performed in the U.S. has been increasing steadily since 1988, when UNOS (United Network for Organ Sharing) started recording statistical data. In that year, 33 cases of lung transplantation were performed. As of today, a total of 23,815 lung transplants have been performed, and the largest number of yearly lung transplants (n=1,822) was performed in 2009. From appropriate patient selection, to optimal organ selection, surgical procedure, and immediate and long-term postoperative care, the medical process involves multiple healthcare providers and requires a very well-organized and committed healthcare system to achieve optimal surgical results. Understanding the pharmacology involved in the care of the lung transplant patient is of utmost importance to achieve appropriate organ preservation, immunosuppression, hemodynamic stability, and adequate anesthetic depth, while avoiding drug toxicity and side effects. The purpose of this review is to summarize the pharmacokinetics and pharmacodynamics of the medications most commonly administered to this patient population, throughout the perioperative period.

Role of total artificial heart in the management of heart transplant rejection and retransplantation: case report and review.

Cardiac allograft rejection and failure may require mechanical circulatory support as bridge-to-retransplantation. Prognosis in this patient group is poor and implantable ventricular assist devices have had limited success due to organ failure associated with the high dose immunosuppression required to treat ongoing rejection. We present a case from our institution and the world-wide experience utilizing the SynCardia CardioWest Total Artificial Heart (TAH-t; SynCardia Systems, Inc., Tucson, AZ, USA) for replacement of the failing graft, recovery of patient and end-organ failure with ultimate bridge to retransplantation. We present our experience and review of world-wide experience for use of TAH-t in this type patient.

Antibody-mediated rejection in heart transplantation: case presentation with a review of current international guidelines.

Antibody-mediated rejection (AMR) (humoral rejection) of cardiac allografts remains difficult to diagnose and treat. Interest in AMR of cardiac allografts has increased over the last decade as it has become apparent that untreated humoral rejection threatens graft and patient survival. An international and multidisciplinary consensus group has formulated guidelines for the diagnosis and treatment of AMR and established that identification of circulating or donor-specific antibodies is not required and that asymptomatic AMR, that is, biopsy-proven AMR without cardiac dysfunction is a real entity with worsened prognosis. Strict criteria for the diagnosis of cardiac AMR have not been firmly established, although the diagnosis relies heavily on tissue pathological findings. Therapy remains largely empirical. We review an unfortunate experience with one of our patients and summarize recommended criteria for the diagnosis of AMR and potential treatment schemes with a focus on current limitations and the need for future research and innovation.

Total lymphoid irradiation in heart transplantation: long-term efficacy and survival--an 18-year experience.

BACKGROUND: Total lymphoid irradiation (TLI) has been used in transplantation for over 20 years and is currently used in a number of major heart transplant centers as a secondary therapy for recalcitrant recurrent rejection or rejection with hemodynamic compromise. The purpose of this study is to evaluate the long-term risks and efficacy of TLI in the treatment of rejection. METHODS: Between 1990 and 1996, 73 adult patients (from 211 adult transplant recipients) received TLI for recurrent rejection (71%), rejection with hemodynamic compromise (25%), and rejection with vasculitis (4%). The treatment consisted of 80 cGy twice per week for 5 weeks. Fifty-five patients received at least 80% of the full dose (>640 cGy). Follow-up ended December 31, 2007, comprising a total 18 year experience. RESULTS: Patients treated with TLI exhibited a short-term decrease in hazard for rejection in the first 12 months posttransplantation (relative risk, 0.36) but exhibited increased cumulative rejection over the long term. There were no differences in the rates of infection, allograft coronary disease, or malignancy, but seven patients developed myelodysplasia or acute myelogenous leukemia, four of those being the rare but uniformly fatal acute megakaryocytic leukemia type 7. CONCLUSIONS: Patients treated with TLI seemed to experience a reduction in the early hazard for rejection, but long-term outcomes indicate that such patients continued to accumulate more rejection and rejection-death events, likely because these patients were overall at much higher risk for rejection than the other patient groups. We observed minimal long-term complications, except for the unique occurrence of myelodysplasia and acute megakaryocytic leukemia type 7.

On solid-phase antibody assays.

There is considerable evidence that pre-operative and post-operative anti-human leukocyte antigen (anti-HLA) antibodies are deleterious in thoracic transplantation. While debate continues in heart and lung transplantation on the role of and the diagnosis and treatment of antibody-mediated rejection (AMR), central to the discussion is our ability to detect anti-HLA antibodies. This perspective outlines the concerns elicited by new technology for detection of anti-HLA antibodies using solid-phase assays, and highlights the need for functional assays to further understand the clinical significance of these antibodies.

Balancing rejection and infection with respect to age, race, and gender: clues acquired from 17 years of cardiac transplantation data.

BACKGROUND: Donor and recipient risk factors for rejection and infection have been well characterized. The contribution of demographic factors, especially age at the time of transplantation to morbidity and mortality due to rejection and infection, is much less well understood. METHODS: Using parametric hazard analysis and multivariate risk-factor equations for infection and rejection events, we quantitatively determined the relationship of fundamental demographic variables (age, race and gender) to infection and rejection. These analyses were conducted with respect to date of transplant and age at the time of transplantation. The patient group consisted of all primary heart transplants performed at the University of Alabama at Birmingham during the years 1990 to 2007 (n = 526). RESULTS: Risk factors for rejection within 12 months post-transplantation were date of transplant (p < 0.0001) and age at the time of transplantation (young adults 10 to 30 years of age, p < 0.0001). Risk factors for infection were date of transplant (p < 0.0001) and age at the time of transplantation (young children and older adults, p < 0.0001). There were three immunosuppressive eras in 1990 to 2007. Notably, although the proportion of patients experiencing rejection and infection events decreased during each successive immunosuppressive era, the relative relationship of infection to rejection, as well as age at the time of transplantation, remained similar into the most recent era. The maximal frequency of rejection events and rejection death occurred among patients transplanted at ages 10 to 30 years. Conversely, the frequency of infection events was minimal within the same group. In the oldest and youngest patients receiving transplants, infection was the predominant cause of death and rates of rejection events decreased. CONCLUSIONS: These data show that evolving immunosuppressive strategies have successfully reduced rejection and infection frequencies, and those patients transplanted at 30 to 60 years of age have the lowest frequency of rejection/infection events. However, individuals transplanted at younger or older ages, especially non-white recipients in the 10- to 30-year age group, experience significantly more infection or rejection. Therefore, programs should increase the level of surveillance in these patients and consider modification of immunosuppressive regimens in order to lower the frequency of infection and rejection events.