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Abstract: Temporary mechanical circulatory support (MCS) encompasses a wide array of invasive devices, which provide short-term hemodynamic support for multiple clinical indications. Although initially developed for the management of cardiogenic shock, indications for MCS have expanded to include prophylactic insertion prior to high-risk percutaneous coronary intervention, treatment of acute circulatory failure following cardiac surgery, and bridging of end-stage heart failure patients to more definitive therapies, such as left ventricular assist devices and cardiac transplantation. A wide variety of devices are available to provide left ventricular, right ventricular, or biventricular support. The choice of a temporary MCS device requires consideration of the clinical scenario, patient characteristics, institution protocols, and provider familiarity and training. In this review, the most common forms of left, right, and biventricular temporary MCS are discussed, along with their indications, contraindications, complications, cannulations, hemodynamic effects, and available clinical data

[Image: see text] Central Picture Legend: Ethical standards for global health initiatives.

The joint efforts in the fields of surgery, medicine and biomedical engineering, sponsored by both the government and the industry, have led to the development of mechanical support devices that can provide reliable circulatory support, which can temporarily support a patient's circulation until either the heart recovers or until a new heart can be transplanted or permanently replace a failed heart. Their development has been driven by the shortage of donor organs. Various systems have eventually evolved for short or long-term support of patients suffering from cardiogenic and/or advanced heart failure (HF). Over time, several have been withdrawn from the market due to high rate of thromboembolism and pump-related complications, but many others remained with modern principles of circulatory support proved to be durable and reliable. Hopefully, the ever-evolving technology will yield several devices aimed at their miniaturization, with an energy supply without risk of infection, a system which is simple to implant and to exchange, minimalization of thrombus formation by optimal interior pump design, new antithrombotic medications and a system with demand-based pump activity. It is important to remember that such devices are only implanted to keep a patient alive or in an immediate life-threatening stage. In such circumstances, attribution of aforementioned difficulties to pump limitations or to advanced disease states remains difficult. In the coming years, ventricular assist devices (VADs) could be the most common surgical preference for treating severe HF.

Although complete myocardial recovery after ventricular assist device (VAD) implantation is rather seldom, systematic search for recovery is worthwhile because for recovered patients weaning from VADs is feasible and can provide survival benefits with long-term freedom from heart failure (HF) recurrence, even if a chronic cardiomyopathy was the primary cause for the drug-refractory HF necessitating left ventricular (LVAD) or biventricular support (as bridge-to-transplantation or definitive therapy) and even if recovery remains incomplete. LVAD patients explanted for myoacardial recovery compared to those transplanted from LVAD support showed similar survival rates and a significant proportion of explanted patients can achieve cardiac and physical functional capacities that are within the normal range of healthy controls. In apparently sufficiently recovered patients, a major challenge remains still the pre-explant prediction of the weaning success which is meanwhile reliably possible for experienced clinicians. In weaning candidates, the combined use of certain echocardiography and right heart catheterization parameters recorded before VAD explantation can predict post-weaning cardiac stability with good accuracy. However, in the absence of standardization or binding recommendations, the protocols for assessment of native cardiac improvement and also the weaning criteria differ widely among centers. Currently there are still only few larger studies on myocardial recovery assessment after VAD implantation. Therefore, the weaning practice relies mostly on small case series, local practice patterns, and case reports, and the existing knowledge, as well as the partially differing recommendations which are based mainly on expert opinions, need to be periodically systematised. Addressing these shortcomings, our review aims to summarize the evidence and expert opinion on the evaluation of cardiac recovery during mechanical ventricular support by paying special attention to the reliability of the methods and parameters used for assessment of myocardial recovery and the challenges met in both evaluation of recovery and weaning decision making.

Solid organ transplant (SOT) recipients are at high risk for severe disease with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Emerging variants of concern have disproportionately affected this population. Data on severity and outcomes with the Omicron variant in SOT recipients are limited. Thus we conducted this single-center, retrospective cohort study of SOT recipients diagnosed with SARS-CoV-2 infection from December 18, 2021 to January 18, 2022, when prevalence of the Omicron variant was more than 80%-95% in the community. Univariate and multivariate logistic regression analysis was performed to identify risk factors for hospital admission. We identified 166 SOT patients: 112 (67.5%) kidney, 22 (13.3%) liver, 10 (6.0%) lung, seven (4.2%) heart, and 15 (9.0%) combined transplants. SARS-CoV-2 vaccine series was completed in 59 (35.5%) recipients. Ninety-nine (59.6%) and 13 (7.8%) recipients received casirivimab/imdevimab and sotrovimab, respectively. Fifty-three (32%) recipients required hospital admission, of which 19 (35.8%) required intensive care unit level of care. Median follow-up was 50 (interquartile range, 25-59) days, with mortality reported in six (3.6%) patients. Risk factors identified for hospital admission were African American race (p.001, odds ratio [OR] 4.00, 95% confidence interval [CI] 1.84-8.70), history of coronary artery disease (p = .031, OR 3.50, 95% CI 1.12-10.87), and maintenance immunosuppression with corticosteroids (p = .048, OR 2.00, 95% CI 1.01-4.00). In conclusion, contrary to that in the general population, we found a higher hospital admission rate in SOT recipients with omicron variant infection. Further studies to investigate the efficacy of newer treatments are necessary, even as outcomes continue to improve.

The use of left ventricular assist devices (LVADs) is increasingly more common as the availability of donor organs in relation to failing hearts is outstandingly limited. Infections are the most common complications in LVAD recipients, particularly those caused by Staphylococcus spp. Refractory LVAD-related infections are not uncommon as achieving adequate source control is often not feasible before heart transplantation. Evidence suggest that cefazolin plus ertapenem is effective in refractory methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia, but this approach has not been described in LVAD recipients. In this article, we report two cases of refractory MSSA bacteremia in LVAD recipients that were successfully treated with salvage therapy with cefazolin plus ertapenem and subsequent heart transplantation. This treatment strategy should be considered in patients with refractory LVAD-associated infection due to MSSA that are not responding to standard treatment.

A 26-year-old pregnant woman, with multiple metastatic Ewing sarcoma, presented with a sternal mass that began enlarging during pregnancy. Due to high-risk pregnancy, the patient was discussed in a multidisciplinary meeting and intubation was considered too risky without cardiopulmonary support. Computed tomography showed extrinsic tumor compression of the right ventricle outflow tract. Veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) was initiated before general anesthesia, followed by Cesarean section (C-section). VA ECMO was initiated with the patient in the awake position, ECMO support was discontinued when the patient had stable ventilation and hemodynamics. This case represents a unique indication of VA ECMO, during C-section, with maternal and fetal survival.

BACKGROUND Human immunodeficiency virus (HIV) infection affects nearly 38 million people worldwide. Patients living with HIV (PLHIV) on modern highly active antiretroviral therapy face significant morbidity and mortality related to the progression of chronic diseases, which lead to an increase in the burden of end-stage organ disease and organ failure. PLHIV present a two fold increased risk of heart failure as compared with the general population, with a prevalence of clinical heart failure of 6.5 %. Orthotopic heart transplantation (OHT) is rarely performed in HIV-positive patients despite the fact that HIV-associated cardiomyopathy is a major long-term complication of HIV infection. MATERIAL AND METHODS We present a case of PLHIV presenting with decompensated heart failure, requiring initial therapy with left ventricular assist device, followed by heart transplantation, accompanied by an update on current concepts, and experience in the field. DISCUSSION AND CONCLUSION HIV-associated cardiomyopathy is a major long-term complication of HIV infection. LVAD support or OHT should also be encouraged among HIV-positive patients as current data indicates that AHFT is safe in carefully selected HIV-positive patients and outcomes are similar to those of HIV-negative patients.

Introduction Most studies of solid organ transplant (SOT) recipients with COVID-19 focus on outcomes within one month of illness onset. Delayed mortality in SOT recipients hospitalized for COVID-19 has not been fully examined. Methods We used data from a multicenter registry to calculate mortality by 90 days following initial SARS-CoV-2 detection in SOT recipients hospitalized for COVID-19 and developed multivariable Cox proportional-hazards models to compare risk factors for death by days 28 and 90. Results Vital status at day 90 was available for 936 of 1117 (84%) SOT recipients hospitalized for COVID-19: 190 of 936 (20%) died by 28 days and an additional 56 of 246 deaths (23%) occurred between days 29 and 90. Factors associated with mortality by day 90 included: age > 65 years [aHR 1.8 (1.3-2.4), p = Conclusions In SOT recipients hospitalized for COVID-19, >20% of deaths occurred between 28 and 90 days following SARS-CoV-2 diagnosis. Future investigations should consider extending follow-up duration to 90 days for more complete mortality assessment

long-term survival after lung transplantation has increased over recent years, but still fall short of providing extensive life expectancy for more than 10 years.

Combined heart lung transplant has become a rare procedure. However, there is a significant number of patients potentially benefitting from replacement of both heart and lungs. This represents a quite diverse patient population. Decisions in patient selection have to be adjusted to individual needs and distinct constellation of the patient. Age may be a risk factor, but should be carefully integrated into the evaluation of perioperative and long term risks.

Lung transplant recipients (LTR) with Covid-19 may have higher mortality than non-lung solid organ transplant recipients (SOTR), but direct comparisons are limited. Risk factors for mortality specifically in LTR have not been explored. We performed a multicenter cohort study of adult SOTR with Covid-19 to compare mortality by 28-days between hospitalized LTR and non-lung SOTR. Multivariable logistic regression models were used to assess comorbidity-adjusted mortality among LTR vs. non-lung SOTR and to determine risk factors for death in LTR. Of 1,616 SOTR with Covid-19, 1,051 (65%) were hospitalized including 117/159 (74%) LTR and 934/1457 (64%) non-lung SOTR (p=0.02). Mortality was higher among LTR compared to non-lung SOTR (24% vs. 16%, respectively, p=0.035) and lung transplant was independently associated with death after adjusting for age and comorbidities (aOR 1.7, 95% CI 1.0-2.6, p=0.05). Among LTR, independent risk factors for mortality included single lung transplant (aOR 2.8, 95% CI 1.0-7.7, p=0.04) and chronic lung allograft dysfunction (aOR 3.6, 95% CI 1.0-12.4, p=0.05), but not age >65 years, heart failure, or obesity. Among SOTR hospitalized for Covid-19, LTR had higher mortality than non-lung SOTR. In LTR, single lung transplant and chronic allograft dysfunction were independently associated with mortality.

Objetives ECMO is progressively being adopted as a last resort to stabilize patients receiving cardiopulmonary resuscitation (ECMO CPR). A significant number of these patients will present recovery of end-organ function, but evolve with brain death, accounting for only 30% of patients discharged from the hospital alive. Harvesting organs from donors on VA ECMO has recently been proposed as a strategy to expand the pool of available organs for transplantation. Methods We present a case of combined heart and kidney transplantation from a brain death donor with recent out of hospital cardiac arrest rescued with eCPR. Results A 31 year old male patient was admitted to local hospital with diagnosis of drowning after seizure episode. Patient received two rounds of CPR for 8 and 30 minutes respectively, and required emergency insertion of VA ECMO. Patient developed compartment syndrome of right lower extremity (RLE) with CPK = 30,720, prompting discontinuation of ECMO support within 48 hours as cardiac function had recovered, reflected on echocardiographic and enzymatic parameters. Patient was declared brain death and became organ donor. Multiple organ procurement was performed. Combined heart and right kidney transplant was then performed on a 61-year-old male with uneventful course, and with normal function of all implanted allografts at 3 months follow up. Conclusion Our experience supports the concept that VA ECMO is not a contraindication for solid organ donation. Individual evaluation of organ function can lead to successful transplantation of multiple organs from donors with recent history of VA ECMO support.

Introduction Complexity of combined heart-liver transplantation has resulted in low adoption rates. We report a case series of adult patients receiving en-bloc heart-liver transplantation (HLTx), describe technical aspects, and discuss benefits of the technique. Methods Retrospective review of patients receiving en-bloc HLTx over 18 months, with clinical follow up to 1 year. Primary outcomes included postoperative mortality and major complications. Secondary outcomes included 1-year survival, cardiac or hepatic allograft rejection, and infection. Results Five patients received en-bloc HLTx. Mean recipient age was 43 years (26-63), and 3 patients were male. Total operative time was 430 minutes (393-480), cold and warm ischemic times of 85 (32-136) and 37.5 (31-47) minutes. Hospital survival was 80%. One patient died on postoperative day 55 due to fungal sepsis. Major postoperative complications included prolonged mechanical ventilation in 2 of 5 patients (40%), and renal insufficiency requiring hemodialysis in 2 of 5 patients (40%). Among patients discharged from hospital 1-year survival was 100%, with no evidence of rejection or infectious complications. Conclusion En-bloc HLTx technique is a safe and effective strategy, decreasing operative times, and allograft ischemic times, whereas offering protection of implanted allografts during early stages of reperfusion while patient is hemodynamically supported on cardiopulmonary bypass.

Complications of the bronchial anastomosis in lung transplantation, once the Achilles heel of the procedure, have become quite rare. The surgical technique is well established and safe. Risks contributing to anastomotic complications are primarily related to patients pre-existing conditions. The key factor is good blood flow to the bronchial stump. Postoperative infection can also contribute to the breakdown of the anastomosis. This may be the reason why different immunosuppressive regimes lead to differences in the incidence of bronchial dehiscence.

Objectives To test the feasibility of a novel method of heart donation under circulatory death criteria that allows precardiectomy donor heart assessment. Materials and methods This is a translational study utilizing 16 female Yorkshire pigs in a series of eight heart transplant procedures under a circulatory death model. Results Successful resuscitation of the donor hearts occurred in seven out of eight animals. All seven of these hearts were deemed to have good function and were successfully transplanted. In the animal in which donor heart resuscitation was not successful, the transplant was aborted, and a left ventricular assist device (LVAD) was placed in the recipient's heart. Conclusion This animal study demonstrates the feasibility of using this novel technique for resuscitation and precardiectomy evaluation of donated after circulatory death hearts. For those donor hearts without adequate function, an LVAD can be safely implanted as a "bail-out" option. The limitations of this technique are the patient population to which it can be applied (only those patients eligible and consented for LVAD).

Cardiac disease is a leading cause of early mortality for patients undergoing liver transplantation (LT), and severe coronary artery disease (CAD) is usually considered a contraindication for LT in patients with cirrhosis. Incidence of CAD in LT candidates has increased in recent years. While stable patients might be candidates for percutaneous interventions, patients with decompensated liver failure, or critical coronary lesions present a therapeutic challenge, and are often not considered candidates for LT. We present the case of a 60 year old male patient with decompensated liver failure, and critical CAD, who received successful combined off-pump coronary bypass grafting without heparin and LT using ex vivo normothermic liver perfusion machine. This approach represents a novel strategy to offer LT to this very selective group of patients.

Introduction A refractory bronchopleural fistula leading to respiratory failure in a trauma patient is one of the most challenging pathologies to manage in one of the most challenging patient populations. Modern equipment and techniques have decreased and perhaps even eliminated the need for anticoagulation with ECMO, and it is finding an important niche in saving this patient population from refractory hypoxia. We review here our experience with three refractory traumatic bronchopleural fistulae utilizing venovenous ECMO as the primary treatment modality. Material and methods Retrospective chart review of three cases of refractory traumatic bronchopleural fistula treated primarily with ECMO and an ultra-lung protective strategy. Results The use of an ultra-lung protective strategy with ECMO allowed sealing of all three bronchopleural fistula. Conclusions Traumatic bronchopleural fistulae require careful thought and early utilization of lung protective strategies to facilitate healing of the injured lung.

Cardiac xenotransplantation is believed to have approached clinical application. However, this approach to advanced heart failure is burdened with a multitude of ethical issues. These issues need to be addressed openly and be broadly discussed in public. Only through an honest and transparent approach, it will be possible to engage the lay audience in the evaluation of pig to human transplant.

CA extern

Background A central goal among researchers and policy makers seeking to implement clinical interventions is to identify key facilitators and barriers that contribute to implementation success. Despite calls from a number of scholars, empirical insights into the complex structural and cultural predictors of why decision aids (DAs) become routinely embedded in health care settings remains limited and highly variable across implementation contexts. Methods We examined associations between “reach”, a widely used indicator (from the RE-AIM model) of implementation success, and multi-level site characteristics of nine LVAD clinics engaged over 18 months in implementation and dissemination of a decision aid for left ventricular assist device (LVAD) treatment. Based on data collected from nurse coordinators, we explored factors at the level of the organization (e.g. patient volume), patient population (e.g. health literacy; average sickness level), clinician characteristics (e.g. attitudes towards decision aid; readiness for change) and process (how the aid was administered). We generated descriptive statistics for each site and calculated zero-order correlations (Pearson’s r) between all multi-level site variables including cumulative reach at 12 months and 18 months for all sites. We used principal components analysis (PCA) to examine any latent factors governing relationships between and among all site characteristics, including reach. Results We observed strongest inclines in reach of our decision aid across the first year, with uptake fluctuating over the second year. Average reach across sites was 63% (s.d. = 19.56) at 12 months and 66% (s.d. = 19.39) at 18 months. Our PCA revealed that site characteristics positively associated with reach on two distinct dimensions, including a first dimension reflecting greater organizational infrastructure and standardization (characteristic of larger, more established clinics) and a second dimension reflecting positive attitudinal orientations, specifically, openness and capacity to give and receive decision support among coordinators and patients. Conclusions Successful implementation plans should incorporate specific efforts to promote supportive and mutually informative interactions between clinical staff members and to institute systematic and standardized protocols to enhance the availability, convenience and salience of intervention tool in routine practice. Further research is needed to understand whether “core predictors” of success vary across different intervention types.

Over time, various surgical treatment strategies have evolved to manage advanced heart failure (HF). Scientific and technological breakthroughs through the last 50 years have put forward various surgical alternatives to patients with advanced HF encompassing surgical ventricular restoration to surgical gene therapy and stem cell replacement of the diseased ventricles. Organ-saving surgical options which used to be promising included dynamic cardiomyoplasty, partial resection of ventricle and cardiac wrapping with Acorn CorCap cardiac support device. These procedures were eventually abandoned due to negative outcomes and without proven disadvantages. Another organ-saving surgical option currently being considered but still make little sense is cardiac regeneration by stem cell therapy, i.e., cardiomyocyte restoration and replacement. Presently, the organ-saving surgical alternatives to treat end-stage HF are revascularization for ischemic cardiomyopathy, mitral valve surgery (repair or replacement) for ischemic mitral incompetence (IMI), left ventricular (LV) aneurysmectomy (surgical ventricular restoration) and mitral valve repair for IMI. These aforementioned procedures have become quite established approaches and with increasing experience are continuously being modified to improve outcome. Various mechanical circulatory support systems have emerged over time to improve functional status of patients with advanced HF, either as a bridge to heart transplantation or as a bridge to myocardial recovery. Likewise offered in those with contraindications to transplantation. Ventricular assist devices (VAD) can keep patients alive until an eventual transplantation. This article reviews the variety of the myriad of alternative organ-saving surgical alternatives that have been available or are currently available provided to patients with end-stage HF, their advantages and deficiencies, as well as prospects in HF therapy.

BackgroundThere is an ongoing critical need to improve therapeutic strategies for COVID-19 pneumonia, particularly in the most severely affected patients. Adult mesenchymal stem cell (MSC) infusions have the potential to benefit critically ill patients with acute respiratory syndrome SARS-COV-2 infection, but clinical data supporting efficacy are lacking.MethodsWe conducted a case-control study of critically ill patients with laboratory-confirmed COVID-19, severe acute respiratory distress syndrome (ARDS). To evaluate clinical responsiveness in the most critically ill patient we examined outcomes in a sub-group of those requiring extracorporeal membrane oxygenation (ECMO) support. Patients (n=9) were administered with up to 3 infusions of intravenous (IV) MSCs and compared to a local ECMO control group (n=31). The primary outcome was safety, and the secondary outcomes were all-cause mortality (or rate of hospital discharge), cytokine levels, and viral clearance.FindingsMSC infusions (12 patients) were well tolerated and no side effects occurred. Of ECMO patients receiving MSC infusions, 2 out of 9 died (22.2%; 95%CI: 2.8%, 60.0%) compared with a mortality of 15 of 31 (48.4%; 95%CI: 30.2%, 66.9%; p = 0.25) in the ECMO control group. Isolated plasma exosomes containing the SARS-COV-2 Spike protein decreased after MSC infusions between day 14 or 21 after administration (p=0.003 and p=0.005, respectively) and was associated with a decrease in COVID-19 IgG Spike protein titer at same time points (p = 0.006 and p=0.007, respectively). Control ECMO patients receiving convalescent plasma did not clear COVID-19 IgG over the same time frame.InterpretationTogether these findings suggest that MSC IV infusion is well tolerated in patients with a broad range of severity including the most severe COVID-19 ARDS requiring ECMO. These data also raise the possibility that MSCs, in addition to exerting an immunomodulatory effect, contribute to viral clearance and strongly support the conduct of randomized placebo-controlled trial.

Background The complexity of extracorporeal membrane oxygenation (ECMO) techniques continues to evolve. Different cannulation methods and configurations have been proposed as a response to a challenging cardiovascular and pulmonary physiology of the patients. The use of parallel ECMO circuits represents a unique and novel approach for patients with refractory respiratory failure and cardiovascular collapse with very large body surface areas. Case presentation We present the case of a 25-year-old morbidly obese male patient admitted for severe acute respiratory distress syndrome (ARDS) and refractory hypoxemia, requiring institution of double cannulation for veno-venous ECMO. Since his hypoxemia persisted, likely due to insufficient flows given his large body surface area, an additional drainage venous cannula was implemented to provide higher flows, temporarily addressing his oxygenation status. Unfortunately, the patient developed concomitant cardiogenic shock refractory to inotropic support and extracorporeal fluid removal, further worsening his oxygenation status, thus the decision was to institute four-cannulation/parallel-circuits veno-venous and veno-arterial ECMO, successfully controlling both refractory hypoxemia and cardiogenic shock. Conclusions Our case illustrates a novel and complex approach for combined severe ARDS and cardiovascular collapse through the use of parallel veno-venous and veno-arterial ECMO circuits, and exemplifies the expansion of ECMO techniques and its life-saving capabilities when conservative approaches are futile.

Purpose While there is much discussion about selection of patients for ECLS for acute respiratory distress syndrome (ARDS), little is said about the impact that ventilator management after cannulation might have on outcomes. We hypothesized that failure to properly protect the lungs after cannulation would lead to higher mortality. Methods A retrospective chart review was performed on all patients undergoing venovenous (VV) ECLS at a single center from Jan 2014 to July 2018. We evaluated the impact of ventilator management during ECLS on mortality by evaluating three variables obtained during ECLS support: the mean peak inspiratory pressure (PIP), FiO2, and respiratory rate. Results 54 patients underwent VV ECLS for ARDS . Bivariate analysis (Table) revealed a significant association with higher total bilirubin , lower mean arterial pressure & higher total days on ECLS in those who died vs. those who lived. During ECLS higher mean PIP & higher FiO2 were found in those who died. In multivariate analysis increasing age was predictive of mortality (OR 1.2; CI 1.04-1.39, p=0.02) while higher pre-cannulation serum hemoglobin was protective (OR = 0.42, CI 0.18-0.98, p=0.04). The mean PIP & the mean FiO2 during ECLS were both predictive of increased risk of mortality (PIP; OR 1.40, CI 1.03-1.89, p=0.03;FiO2; OR 1.16, CI 1.02-1.32, p =0.02). Conclusion The use of the EMPROVE protocol is significantly associated with survival in this study. As our patients’ PIP & FiO2 during ECLS more closely approximated the EMPROVE protocol criteria, survival increased. For every 1 mmHg increase in the mean peak pressure the risk of dying increased 1.4x, and for every 1% increase in the mean FiO2 during ECLS the risk of dying increased 1.16x. For lung rest to truly be effective, the lungs must be relieved of the burden of gas exchange. If gas exchange is not adequate with simple VV configuration, alternatives for gas exchange should be sought such as switching to venoarterial, rather than increasing the burden on the lungs.

Extracorporeal removal of carbon dioxide in patients experiencing severe hypercapnia due to lung protective mechanical ventilation was first described over four decades ago. There have been many devices developed and described in the interim, many of which require additional training, resources, and staff. This manuscript describes a readily available and relatively simple adjunct that can provide partial lung support in patients with acute respiratory distress syndrome complicated by severe hypercapnia and acute kidney injury requiring dialysis.

Background Studies indicate that decision making and informed consent among patients considering left ventricular assist device (LVAD) support for advanced heart failure could be improved. In the VADDA (Ventricular Assist Device Decision Aid) trial, we tested a patient-centered decision aid (DA) to enhance the quality of decision making about LVAD therapy. Methods After an extensive user-centered design process, we conducted a multisite randomized trial of the DA compared with standard education (SE) among inpatients considering LVAD treatment for advanced heart failure The main outcome was LVAD knowledge at 1 week and 1 month after administration of the DA versus the SE, according to a validated scale. Secondary measures included prespecified quality decision making measures recommended by the International Patient Decision Aid Standards collaboration. Results Of 105 eligible patients, 98 consented and were randomly assigned to the DA and SE arms. Patients receiving the VADDA exhibited significantly greater LVAD knowledge than the SE group at 1 week of follow-up (P = .01) but not at 1 month (P = .47). No differences were found between DA and SE patients in rates of acceptance versus decline of LVAD treatment (85% vs 78%; P = .74). Recipients in the DA arm reported greater satisfaction with life after implantation compared with nonrecipients (28 vs 23 out of 30; P = .008), although both arms reported high satisfaction. Patients rated the DA high in acceptability and usability. Conclusions The VADDA enhances LVAD knowledge, particularly in the short term (1 week) during the peak period of decision making. The DA does not encourage decision direction and reflects patient, caregiver, and physician preferences for content and format. Clinical Trial Registration https://clinicaltrials.gov/ct2/show/NCT02248974 . The trial is registered with clinicaltrials.gov (NCT02248974).

Although Chagas disease is a rare entity in North America, it is associated with significant cardiac morbidity. It is estimated that 20-30% of those who are infected will eventually develop cardiovascular disease secondary to Chagas disease. We review the literature and share our experience on the surgical management of this challenging patient population.