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Thoracic organ recovery and implantation is increasing in complexity. Simultaneously the logistic burden and associated cost is rising. An electronic survey distributed to the surgical directors of thoracic transplant programs in the United States indicated dissatisfaction amongst 72% of respondents with current procurement training and 85% of respondents favored a process for certification in thoracic organ transplantation. These responses highlight concerns for the current paradigm of training in thoracic transplantation. We discuss the implications of advancements in organ retrieval and implant for surgical training and propose that the thoracic transplant community might address the need through formalized training in procurement and certification in thoracic transplantation. [ABSTRACT FROM AUTHOR]

Introduction: The impact of Impella and ECMO (ECPELLA) in cardiogenic shock (CS) remains to be defined. The aim of this meta-analysis is to evaluate the benefit of ECPELLA compared to VA-ECMO in patients with non post-pericardiotomy CS.Methods: All studies reporting short term outcomes of ECpella or VA ECMO in non post-pericardiotomy CS were included. The primary endpoint was 30-day mortality. Vascular and bleeding complications and LVAD implantation/heart transplant within 30-days were assessed as secondary outcomes.Results: Of 407 studies identified, 13 observational studies (13,682 patients, 13,270 with ECMO and 412 with ECpella) were included in this analysis. 30-day mortality was 55.8% (51.6-59.9) in the VA-ECMO group and 58.3% (53.5-63.0) in the ECpella group. At meta-regression analysis the implantation of IABP did not affect mortality in the ECMO group. The rate of major bleeding in patients on VA-ECMO and ECpella support were 21.3% (16.9-26.5) and 33.1% (25.9-41.2) respectively, while the rates of the composite outcome of LVAD implantation and heart transplantation within 30-days in patients on VA-ECMO and ECpella support were 14.4% (9.0-22.2) and 10.8%. When directly compared in 3 studies, ECpella showed a positive effect on 30-day mortality compared to ECMO (OR: 1.81: 1.039-3.159).Conclusion: Our data suggest that ECpella may reduce 30-day mortality and increase left ventricle recovery, despite increased of bleeding rates. [ABSTRACT FROM AUTHOR]

Intra-aortic balloon pump (IABP) has been used more recently as a bridge to cardiac transplantation in hospitalized patients. Femoral IABP limits mobility and rehabilitation; thus, transaxillary approach has been described. However, a transaxillary IABP may migrate, causing significant vascular injury, potential death, or disqualification from transplantation. We describe a case of a 67-year-old male with transaxillary IABP inserted to allow for pre-transplant physical rehabilitation. Due to the unfolded nature of his aorta, the IABP coiled onto itself and migrated several times. We employed a novel technique to mitigate IABP migration using a long 25-cm introducer sheath. [ABSTRACT FROM AUTHOR]

Post-cardiotomy extracorporeal life support (PC-ECLS) in adult patients has been used only rarely but recent data have shown a remarkable increase in its use, almost certainly due to improved technology, ease of management, growing familiarity with its capability and decreased costs. Trends in worldwide in-hospital survival, however, rather than improving, have shown a decline in some experiences, likely due to increased use in more complex, critically ill patients rather than to suboptimal management. Nevertheless, PC-ECLS is proving to be a valuable resource for temporary cardiocirculatory and respiratory support in patients who would otherwise most likely die. Because a comprehensive review of PC-ECLS might be of use for the practitioner, and possibly improve patient management in this setting, the authors have attempted to create a concise, comprehensive and relevant analysis of all aspects related to PC-ECLS, with a particular emphasis on indications, technique, management, and avoidance of complications, appraisal of new approaches and ethics, education, and training. [ABSTRACT FROM AUTHOR]

We sought to assess the outcomes after heart transplantation (HT) of patients supported with a temporary total artificial heart (t-TAH) as a bridge to transplantation in high-volume centers. A retrospective analysis of 217 consecutive patients who underwent t-TAH (SynCardia Systems, Tucson, Arizona) implantation between January 2014 and May 2019 in 6 high-volume North American centers was performed. End points included survival and adverse events after t-TAH and HT. The mean age of patients was 49 ± 12 years, and heart failure etiologies were non-ischemic dilated cardiomyopathy (36%), ischemic (25%), restrictive (12%), and cardiac graft failure (9%). A total of 101 (48%) patients had Interagency Registry for Mechanically Assisted Circulatory Support patient profile 1, and 65 (31%) had Interagency Registry for Mechanically Assisted Circulatory Support patient profile 2. At the end of the study period, 138 of 217 (63.5%) patients had undergone HT, and 75 (34.5%) patients died before HT. The mean time between t-TAH implantation and HT averaged 181 ± 179 days (range: 0–849) and the mean follow-up after HT was 35 ± 25 months. The overall survival in the entire cohort was 75%, 64%, and 58% at 1, 2, and 5 years, respectively. Post-transplant survival was 88%, 84%, 79%, and 74% at 6 months, 1 year, 2 years, and 5 years, respectively. Among the 32 patients (23%) who died after HT, the main causes of death were chronic allograft vasculopathy (25%), multiorgan failure (21.8%), sepsis (15.6%), and stroke (9%). In this multicenter study, almost two thirds of patients implanted with a t-TAH could be transplanted. The overall and post-transplantation survival after t-TAH was satisfactory in these critically ill patients. [ABSTRACT FROM AUTHOR]

Patients with ccTGA or d-TGA managed via atrial switch (Mustard or Senning operations) have biventricular circulations with a sub-aortic right ventricle (2V-RV). Other than in a tiny percentage of ccTGA patients, premature heart failure (HF) is common, driven by chronic RV dilatation and dysfunction and/or tricuspid regurgitation. These patients are different from the general HF population in that they are younger, more heterogeneous, are predisposed to pulmonary hypertension and present unique and complex surgical challenges. Despite their young age, they experience disproportionately poor access to advanced therapies and are often disqualified for transplant by pulmonary hypertension, HLA sensitization, program risk-tolerance and psychosocial issues. Mechanical support of the subaortic RV with ventricular assist device (subaortic RVAD, also known as SVAD), although technically challenging, can be an effective alternative to palliative care and offers high likelihood of bridging patients to heart transplant candidacy. In addition, temporary trans-catheter SVAD Impella support has been advantageous for stabilization of decompensated 2V-RV patients or as bridge to durable SVAD support. Improved awareness of and access to specialist ACHD-HF teams offering mechanical support (and transplantation) for 2V-RV patients is increasingly urgent for this aging population, and will improve options and outcomes for these patients as HF emerges. [ABSTRACT FROM AUTHOR]

To determine the presence of and periprocedural changes caused by aortic regurgitation (AR) in patients supported with an Impella (Abiomed, Danvers, MA) left ventricular assist device. Retrospective. Tertiary academic medical center. Patients who underwent insertion of an Impella device at Allegheny General Hospital from January 2015 to December 2018. Analysis of patient electronic medical records. Demographic information; comorbidities; duration of support; and the presence and severity of AR pre-procedure and post-procedure, as reported by echocardiography, were analyzed. The electronic medical records of 69 patients were included in the present study. Before placement of the Impella device, 25 (35%) patients showed detectable AR, with 18 (26%) showing mild AR and 7 (10%) showing moderate AR. After the removal of the Impella device, AR remained steady or increased in 61 patients. Fifteen patients (22%) demonstrated mild AR, 6 (8.7%) demonstrated moderate AR, and 2 (2.9%) demonstrated severe AR. An increase in severity of AR was noted in 9 patients (14.7%), and 52 patients (85%) had no change in the severity of AR. The duration of support with the Impella device, demographic variables, and comorbidities were not associated with a statistically significant risk for increased severity of post-procedural AR in multiple multivariable logistic regression analyses. The presented data suggest that after Impella device support, a significant proportion of patients may show evidence of increased AR. Additional studies are needed to understand the etiology and significance of this observation. [ABSTRACT FROM AUTHOR]

Extracorporeal life support has traditionally been used as a supportive platform for patients with cardiopulmonary failure. Many of these patients require endovascular access for the performance of diagnostic or therapeutic procedures, and obtaining vascular access in these patients can be problematic. We sought to develop a novel system that allows the extracorporeal life support circuit to serve as an access point to the cardiovascular system. By using computer-aided design, modeling, and 3-dimensional printing, a novel adaptor that can be easily inserted and removed from an extracorporeal life support circuit was developed. A mock loop was used to measure flow and pressure at various pump speeds with insertion of guidewires and catheters through the adaptor. The ability of the system to enable performance of endovascular procedures in vivo was then tested in a porcine extracorporeal life support model. By using a small arterial cannula (15F) at 3500 RPM and 3.2 LPM, 15% and 24% decrements in circuit flow were observed when a 0.035" guidewire and 5F angiography catheter, respectively, were passed through the adaptor (P <.001). However, when using a larger arterial cannula (23F) at 3500 RPM and 4.7 LPM, only 3% and 5% decrements in flow were observed (P <.001), respectively, with intermediate changes when using 17F to 21F cannulas. In vivo testing confirmed that this system enables the performance of a variety of endovascular procedures, including left ventriculography, aortic root and coronary angiography, and descending aortography. This novel system successfully enables endovascular access through an extracorporeal life support circuit. This technology may transform extracorporeal life support from a purely supportive strategy to a platform for endovascular intervention. [ABSTRACT FROM AUTHOR]

The purpose of this study was to examine outcomes and survival with mechanical ventilation (MV) and extracorporeal membrane oxygenation (ECMO) as a bridge to lung transplantation (LT) using a national registry. The United Network for Organ Sharing database was analyzed for recipients in the period 2005 to 2017. Recipients were categorized into 3 groups based on pre-transplant bridging. Multivariable regression analyses examined the effect of bridging on post-LT outcomes adjusting for clinical characteristics, including era (early = 2005–2011, late = 2012–2017) and center volume. There were 21,576 LT recipients: no bridge (n = 19,783), MV (n = 1,129), and ECMO (n = 664). Mean age was 54 ± 15 years (41% female). Use of ECMO increased significantly in the late era (1% vs 5%, p < 0.001). Compared with no bridge, patients with MV and ECMO had greater odds for peri-operative outcomes including ventilator support >48 hours, acute rejection, and dialysis. Patients with MV had reduced odds for ventilator support >48 hours (p = 0.003), dialysis (p = 0.003), post-operative ECMO (p = 0.006), and greater odds for reintubation (p = 0.005) compared with ECMO. Patients in both MV (hazard raio [HR] 1.45, p < 0.001) and ECMO (HR 1.48, p < 0.001) groups had greater risk for 5-year mortality, but MV and ECMO groups did not differ (HR 0.98, p = 0.817). Risk for mortality in the ECMO group decreased in the later era (HR 0.54, p = 0.006). ECMO as a bridge to LT has increased 271%, while MV has decreased 38% over the past decade. Survival with ECMO has significantly improved and is now equivalent to survival in recipients bridged on MV. These results suggest gains in use, outcomes, and safety of ECMO in this patient cohort. [ABSTRACT FROM AUTHOR]

BACKGROUND Right ventricular failure (RVF) after myocardial infarction, cardiotomy, or left ventricular assist device (LVAD) implantation increases morbidity and mortality. RVF also contributes to prolonged length of hospital stay and higher costs of care. The aim of this study was to evaluate the efficacy and safety of the Impella RP (Abiomed, Danvers, MA) in patients with severe RVF in these clinical settings. METHODS This is a prospective cohort study of patients with severe RVF treated with a percutaneous right ventricular assist device (RVAD). Sixty patients with RVF refractory to medical treatment received the Impella RP device at 14 United States institutions as part of the Impella RP pre‒ and post‒market approval studies. The study population included 2 cohorts: Cohort A, patients with RVF post-(LVAD) implantation (n = 31); and Cohort B, patients with RVF post-cardiotomy, heart transplant, or myocardial infarction (n = 29). The primary end-point was survival at 30 days or hospital discharge (whichever was longer). RESULTS Mean age of patients was 59 ± 15 years; 68% were males, 84% had a history of congestive heart failure, 44% had valvular disease, and 35% had pre-operative renal dysfunction. Patients received an average of 3.4 inotropes/vasopressors before the Impella RP implant. Patients were supported with the Impella RP for 4.0 ± 1.5 (0.5 to 14) days. Hemodynamics improved immediately after initiation of device support, with an increase in cardiac index from 1.9 ± 0.1 to 3.1 ± 0.2 liters/min/m2 (p < 0.001) and a decrease in central venous pressure from 19.0 ± 1 to 13 ± 1 mm Hg (p < 0.001). The overall survival at 30 days (or discharge) was 72%. CONCLUSIONS To the best of our knowledge, this study represents the largest prospective study of patients with life-threatening RVF. Mechanical support with the Impella RP device in patients with RVF resulted in rapid hemodynamic improvement with reversal of shock and favorable survival. [ABSTRACT FROM AUTHOR]

Mechanical support of the heart can be offered to patients who are refractory to pharmacological treatment, therapy for coronary or valvular disease or resynchronization therapy. Ventricular assist devices enable end-organ perfusion in the setting of heart failure. This can be temporary (as a bridge to recovery or transplantation) or permanent (destination therapy). Devices can be extracorporeal or implanted, and generated flows can be pulsatile or non-pulsatile. Implantation usually requires sternotomy with or without cardiopulmonary bypass, but percutaneous devices exist. Cardiostable anaesthesia with inotropic support is vital. Problems include bleeding versus thrombosis, right heart failure and late infections. Transoesophageal echocardiography can be used to detect potential right-to-left atrial shunts, aortic regurgitation and cannula malposition, and to monitor filling and right ventricular function after implantation. In the future, total implantability of the devices, including the power source, is likely to occur. Eventually, they are likely to become a widespread alternative to transplantation. [ABSTRACT FROM AUTHOR]

Background Expanded use of pediatric ventricular assist devices (VADs) has decreased mortality in children awaiting heart transplantation. Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), a National Heart, Lung, and Blood Institute–sponsored North American database, provides a platform to understand this emerging population. Methods Between September 2012 and September 2016, patients aged younger than 19 years who underwent VAD implantation were enrolled in Pedimacs. FDA approved durable devices as well as temporary support devices were included. The second annual report updates the current Pedimacs data. Patients implanted with temporary devices are included in Pedimacs and this analysis includes this group of paracorporeal continuous flow VADs. Results Over the 4 years, 42 hospitals implanted 432 devices in 364 patients less than 19 yrs of age. Diagnoses included cardiomyopathy in 223 (61%), myocarditis in 41 (11%), and congenital heart disease in 77 (21%), of which 48 had single-ventricle physiology. At implant, 87% were at Intermacs patient profile 1 or 2. The age distribution of children (59% male) supported on VAD included 69 (19%) aged younger than 1 year, 66 (18%) aged 1 to 6 years, 56 (15%) aged 6 to 10 years, and 173 (48%) aged 11 to 19 years. Median follow-up was 2.2 months (range, 1 day to 41.5 months). Median (interquartile) age at implant was 1.7 (0.3–10.0) years for paracorporeal continuous-flow pumps ( n = 60), 1.7 (0.4–5.3) years for paracorporeal pulsatile pumps ( n = 105), and 15.0 (11.3–16.9) years for implantable continuous-flow pumps ( n = 174). Support strategies included LVAD in 293 (80%), biventricular device in 55 (15%), and total artificial heart in 8 (2%). Nearly 50% of patients underwent transplantation within 6 months, with overall mortality of 19%. Adverse event burden continues to be high. Conclusions Pedimacs constitutes the largest longitudinal pediatric VAD registry. Preimplant data across centers will be helpful at creating shared protocols with which to improve outcomes. Adverse events continue to be the major challenge, especially among the young critically ill children with complex congenital disease. [ABSTRACT FROM AUTHOR]

Background The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database now includes >20,000 patients from >180 hospitals. Methods The eighth annual report of INTERMACS updates the first decade of patient enrollment. Results In the current era, >95% of implants are continuous flow devices. Overall survival continues to remain >80% at 1 year and 70% at 2 years. Review of major adverse events shows minimal advantage for patients with ambulatory heart failure pre-implant. Stroke, major infection, and continued inotrope requirement during the first 3 months have a major effect on subsequent survival. Conclusions Greater application of durable devices to patients with ambulatory heart failure will mandate more effective neutralization or prevention of major adverse events. [ABSTRACT FROM AUTHOR]

Intramyocardial biomaterial injection therapy for myocardial infarction has made significant progress since concept initiation more than 10 years ago. The interim successes and progress in the first 5 years have been extensively reviewed. During the last 5 years, two phase II clinical trials have reported their long term follow up results and many additional biomaterial candidates have reached preclinical and clinical testing. Also in recent years deeper investigations into the mechanisms behind the beneficial effects associated with biomaterial injection therapy have been pursued, and a variety of process and material parameters have been evaluated for their impact on therapeutic outcomes. This review explores the advances made in this biomaterial-centered approach to ischemic cardiomyopathy and discusses potential future research directions as this therapy seeks to positively impact patients suffering from one of the world's most common sources of mortality. [ABSTRACT FROM AUTHOR]

Background Serum lactate dehydrogenase (LDH) is the standard measure for detection of hemolysis and thus surveillance for device thrombosis in patients on continuous-flow left ventricular assist device (CF-LVAD) support. Significant hemolysis has been defined as LDH ≥600 IU/L. However, LDH testing requires phlebotomy, precluding frequent home monitoring. Simple dipstick urinalysis (UA) for urine hemoglobin (U-Hb) overcomes this limitation. This study correlated U-Hb and LDH levels and evaluated the performance of UA for detection of significant hemolysis in patients with CF-LVADs. Methods U-Hb and LDH were measured concurrently 956 times in 221 patients with CF-LVADs. Statistics were computed to determine accuracy of UA in detecting LDH ≥600 IU/L, with a positive result being any detected U-Hb. All analyses were performed with and without excluding for 1) conditions associated with tissue damage, which are known to increase LDH, and 2) suspected or confirmed urinary tract infections or hematuria, which are known to cause hemoglobinuria for reasons other than hemolysis. Results Mean LDH for absent/mild/severe U-Hb was 360 IU/L/467 IU/L IU/L/777 IU/L without exclusions, 354 IU/L/444 IU/L IU/L/651 IU/L after excluding non-hemolytic LDH elevations, 370 IU/L/513 IU/L IU/L/1,357 IU/L after excluding urinary tract infections and hematuria, and 367 IU/L/470 IU/L IU/L/1,217 IU/L when both exclusions applied (all p < 0.001). Absent U-Hb had a negative predictive value for LDH ≥600 IU/L of >90% for all analyses. Conclusions Serum LDH is significantly associated with U-Hb levels. Absence of U-Hb appears to efficiently exclude significant hemolysis in patients with CF-LVADs. Because it can be performed by patients at home, hemoglobinuria monitoring may enable more intense surveillance and earlier diagnosis of device thrombosis. [ABSTRACT FROM AUTHOR]

Data regarding the influence of intraoperative residual lesions on extracorporeal membrane oxygenation (ECMO) following the Norwood procedure are limited. Moreover, the significance of postoperative ECMO timing on in-hospital outcomes remains incompletely characterized. This was a single-center, retrospective review of consecutive patients who underwent the Norwood operation from January 1997 to November 2017. Patients with at least minor residual lesions based on the intraoperative postcardiopulmonary bypass echocardiogram were identified. The association between residual lesions and postoperative ECMO was assessed with logistic regression, adjusting for age, weight, prematurity, various preoperative system-specific and procedural risk factors, shunt type, and era. Among patients receiving ECMO, associations between late ECMO (≥3 days post-Norwood) and in-hospital mortality or transplant, postoperative hospital length-of-stay, and cost of hospitalization were evaluated using logistic regression or generalized linear models with a gamma distribution and logarithmic link. Among 500 patients, 78 (15.6%) received ECMO postoperatively. On multivariable analysis, the presence of at least minor residual lesions (odds ratio, 4.4; 95% CI, 2.1-9.3; P <.001) was associated with postoperative ECMO. In the ECMO subpopulation, there were 44 (56.4%) deaths or transplants. Late ECMO was associated with increased risk of in-hospital mortality or transplant (adjusted odds ratio, 6.2; 95% CI, 1.5-26.0), longer postoperative hospital length of stay (regression coefficient, 0.7; 95% CI, 0.3-1.1), and greater cost (regression coefficient, 0.6; 95%, CI 0.4-0.7), versus early ECMO (all P values <.05). The presence of even minor intraoperative residua significantly increases the risk of ECMO following the Norwood operation. Among patients receiving ECMO postoperatively, early institution of ECMO is associated with lower mortality and resource utilization. [Display omitted] [ABSTRACT FROM AUTHOR]

Background The prognosis of ambulatory patients with advanced heart failure (HF) who are not yet inotrope dependent and implications for evaluation and timing for transplant or destination therapy with a left ventricular assist device (DT-LVAD) are unknown. We hypothesized that the characteristics defining eligibility for advanced HF therapies would be a primary determinant of outcomes in these patients. Methods Ambulatory patients with advanced HF (New York Heart Association class III–IV, Interagency Registry for Mechanically Assisted Circulatory Support profiles 4–7) were enrolled across 11 centers from May 2013 to February 2015. Patients were stratified into 3 groups: likely transplant eligible, DT-LVAD eligible, and ineligible for both transplant and DT-LVAD. Clinical characteristics were collected, and patients were prospectively followed for death, transplant, and left ventricular assist device implantation. Results The study enrolled 144 patients with a mean follow-up of 10 ± 6 months. Patients in the ineligible cohort ( n = 43) had worse congestion, renal function, and anemia compared with transplant ( n = 51) and DT-LVAD (n = 50) eligible patients. Ineligible patients had higher mortality (23.3% vs 8.0% in DT-LVAD group and 5.9% in transplant group, p = 0.02). The differences in mortality were related to lower rates of transplantation (11.8% in transplant group vs 2.0% in DT-LVAD group and 0% in ineligible group, p = 0.02) and left ventricular assist device implantation (15.7% in transplant group vs 2.0% in DT-LVAD group and 0% in ineligible group, p < 0.01). Conclusions Ambulatory patients with advanced HF who were deemed ineligible for transplant and DT-LVAD had markers of greater HF severity and a higher rate of mortality compared with patients eligible for transplant or DT-LVAD. The high early event rate in this group emphasizes the need for timely evaluation and decision making regarding lifesaving therapies. [ABSTRACT FROM AUTHOR]

Despite greatly improved survival in pediatric patients with end-stage heart failure through the use of ventricular assist devices (VADs), heart failure ultimately remains a life-threatening disease with a significant symptom burden. With increased demand for donor organs, liberalizing the boundaries of case complexity, and the introduction of destination therapy in children, more children can be expected to die while on mechanical support. Despite this trend, guidelines on the ethical and pragmatic issues of compassionate deactivation of VAD support in children are strikingly absent. As VAD support for pediatric patients increases in frequency, the pediatric heart failure and palliative care communities must work toward establishing guidelines to clarify the complex issues surrounding compassionate deactivation. Patient, family and clinician attitudes must be ascertained and education regarding the psychological, legal and ethical issues should be provided. Furthermore, pediatric-specific planning documents for use before VAD implantation as well as deactivation checklists should be developed to assist with decision-making at critical points during the illness trajectory. Herein we review the relevant literature regarding compassionate deactivation with a specific focus on issues related to children. [ABSTRACT FROM AUTHOR]

Background In the registry of the International Society for Heart and Lung Transplantation (ISHLT), cerebrovascular accidents are the fifth most common cause for mortality after pediatric heart transplantation (PHTx), but details are lacking in the literature. The purpose of this analysis of the ISHLT registry was to determine the prevalence, risk factors and outcomes of stroke after PHTx. Methods Data from the ISHLT registry (1998 to 2010) were used to identify all patients whose primary transplantation was performed at <18 years of age. Of the 10,441 transplants reviewed, 9,837 primary transplants and 604 retransplants were analyzed. Results Three hundred thirty-three (3%) patients had a stroke after PHTx; 54% were male, median age at PHTx was 6 years (0 to 17 years), and 44% had a diagnosis of congenital heart disease (CHD). Freedom from stroke was 99% at 1 month, 97% at 5 years, 95% at 10 years and 91% at 20 years post-PHTx. After a stroke, survival at 1 month, 1 year and 5 years was 83%, 69% and 55%, respectively. Multivariable independent risk factors for stroke included a primary diagnosis of congenital heart disease [hazard ratio (HR) 1.4 (1.1 to 1.7), p = 0.01], previous stroke [HR 4.5 (3.2 to 6.2), p < 0.001], history of aborted sudden death [HR 1.5 (1.1 to 2), p = 0.01], ventricular assist device [HR 1.5 (1.1 to 2.2), p = 0.03] or extracorporeal membrane oxygenation [HR 1.7 (1.2 to 2.2), p = 0.01], post-operative dialysis [HR 3.3 (2.3 to 4.7), p < 0.001], infection requiring antibiotics before discharge [HR 1.9 (1.4 to 2.5), p < 0.001], pacemaker implantation [HR 1.6 (1 to 2.5), p = 0.04] or drug-treated hypertension [HR 1.4 (1.1 to 1.8), p = 0.003] during follow-up. Conclusions Stroke after pediatric heart transplantation is associated with increased mortality. Congenital heart disease and mechanical support both portend greater risk, in addition to markers of increased pre- and post-transplant medical acuity. [ABSTRACT FROM AUTHOR]

Mechanical circulatory support represents an evolving field of clinical research and practice. Currently, several cardiac assist devices have been developed but, among different institutions and countries, a large variation in indications for use and device selection exists. The Impella platform is an easy to use percutaneous circulatory support device which is increasingly used worldwide. During 2014, we established a working group of European physicians who have collected considerable experience with the Impella device in recent years. By critically comparing the individual experiences and the operative protocols, this working group attempted to establish the best clinical practice with the technology. The present paper reviews the main theoretical principles of Impella and provides an up-to-date summary of the best practical aspects of device use which may help others gain the maximal advantage with Impella technology in a variety of clinical settings. [ABSTRACT FROM AUTHOR]

Background Right heart failure (RHF) is a serious post-operative complication of left ventricular assist device (LVAD) implantation, with significant morbidity and mortality. Many clinical, hemodynamic and laboratory variables have been shown to have prognostic value for appearance of RHF. We sought to investigate the incidence of new-onset right ventricular dysfunction (RVD) complicating the long-term use of LVADs. Methods We retrospectively examined all patients supported with a continuous-flow LVAD for >1 year at our center. Results Twenty patients (mean age 54 ± 10 years, 95% men, 60% with ischemic cardiomyopathy, left ventricular ejection fraction 22 ± 6%, pulmonary capillary wedge pressure 23.5 ± 7.5 mm Hg, brain natriuretic peptide [BNP] 1,566 ± 1,536 pg/ml, serum creatinine 1.6 ± 0.64 mg/dl, furosemide dose 643 ± 410 mg/day) underwent long-term mechanical support as destination therapy support with a continuous-flow LVAD (HeartMate II) at our center. During follow-up (1,219 ± 692 days), 9 patients (45%) manifested symptoms and signs of RVD (increase in right atrial pressure [RAP], BNP and daily furosemide dose compared with the early post-operative period). In these patients, RAP was increased by 6.6 ± 2.6 mm Hg and BNP by 526 ± 477 pg/ml, whereas furosemide dose increased by 145 ± 119 mg. The mean and median times of RVD onset were 2.3 ± 1.5 and 2.1 years, respectively, after LVAD implantation (range 0.4 to 4.8 years). Four of these patients (44.4%) demonstrated further deterioration of RV function and died 73 ± 106 days (median 25 days, range 9 to 231 days) after first manifestation of RVD. Comparisons of baseline variables regarding medical history and clinical status did not demonstrate significant differences between the patients with or without RVD, including parameters related to RV function at the time of implantation. Conclusions Late-onset RVD is a complication of LVAD support, which can manifest several months to years from device implantation. This complication has significant adverse implications with regard to patient outcome. Prognostic factors need to be identified to follow and treat high-risk patients more efficiently. [ABSTRACT FROM AUTHOR]

The seventh annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes the first 9 years of patient enrollment. The Registry includes >15,000 patients from 158 participating hospitals. Trends in device strategy, patient profile at implant and survival are presented. Risk factors for mortality with continuous-flow pumps are updated, and the major causes/modes of death are presented. The adverse event burden is compared between eras, and health-related quality of life is reviewed. A detailed analysis of outcomes after mechanical circulatory support for ambulatory heart failure is presented. Recent summary data from PediMACS and MedaMACS is included. With the current continuous-flow devices, survival at 1 and 2 years is 80% and 70%, respectively. [ABSTRACT FROM AUTHOR]

Mechanical support of the heart can be offered to patients who are refractory to pharmacological treatment, therapy for coronary or valvular disease or resynchronization therapy. Ventricular assist devices enable end-organ perfusion in the setting of heart failure. This can be temporary (as a bridge to recovery or transplantation) or permanent (destination therapy). Devices can be extracorporeal or implanted, and generated flows can be pulsatile or non-pulsatile. Implantation usually requires sternotomy with or without cardiopulmonary bypass, but percutaneous devices exist. Cardiostable anaesthesia with inotropic support is vital. Problems include bleeding versus thrombosis, high pulmonary vascular resistance, right heart failure and late infections. Transoesophageal echocardiography can be used to detect potential right-to-left atrial shunts, aortic regurgitation and cannula malposition, and to monitor filling and right ventricular function after implantation. In the future, total implantability of the devices, including the power source, is likely to occur. Eventually, they are likely to become a widespread alternative to transplantation. [ABSTRACT FROM AUTHOR]

Background Mitral valve regurgitation (MR) is prevalent in patients with heart failure. Because very few data exist examining the influence of significant pre-operative MR on outcomes after left ventricular assist device (LVAD) implantation, we evaluate our experience. Methods Between October 1996 and August 2013, 756 patients underwent primary LVAD implantation at our institutions. Of these, 508 patients received a continuous-flow LVAD and represent the contemporary cohort for this analysis. Devices implanted included the HeartMate II in 410 patients (81%) and HeartWare HVAD in 98 patients (19%). Based on availability of pre-operative echocardiography, 491 patients were divided into 2 study groups according to degree of pre-operative MR; 189 patients (39%) had moderate to severe or greater MR (MR group), and 302 (61%) had less than moderate to severe MR (less MR group). Median age at operation (60 years in MR group vs 58 years in less MR group, p = 0.19), male sex (78% in MR group vs 81% in less MR group, p = 0.42), and ischemic etiology (46% in MR group vs 51% in less MR group, p = 0.35) were similar between groups. Results There were 40 early deaths (7.9%), and follow-up was available in all 468 early survivors for 641 patient-years of support. Patients in the MR group had higher late survival (2 years, 75%; 4 years, 65%) compared with patients in the less MR group (2 years, 66%; 4 years, 48%; p < 0.04). Cox proportional hazards model confirmed the independent interaction between MR and late survival (hazard ratio 0.62, p = 0.04). Conclusions There was improved survival in patients with severe pre-operative MR after continuous-flow LVAD implantation in our cohort. These findings may lend insight into the possible lack of value of addressing significant MR at the time of LVAD implantation. [ABSTRACT FROM AUTHOR]

With significant improvements in the medical and surgical management of patients with congenital heart disease, prognosis has improved substantially in the last several decades. However, many lesions are still associated with the eventual development of progressive heart failure, resulting in an increasing number of adults with congenital heart disease potentially requiring heart transplant. This presents many challenges, ranging from difficulty in determining the appropriate timing of transplant and organ allocation, to technical challenges in the operating room and problems with postoperative anti-rejection medication management. While recent studies have attempted to clarify many of these issues, questions remain. [ABSTRACT FROM AUTHOR]

Background Drive-line infections and sepsis lead to significant morbidity and even mortality in patients with ventricular assist devices (VADs). The HeartWare HVAD system is unique compared with other VAD systems in that it has a thin, flexible drive-line and is implanted directly into the pericardial space without the need for a pump pocket. We reviewed 332 patients receiving the HVAD in the pivotal ADVANCE Bridge to Transplant (BTT) trial and Continued Access Protocol (CAP) to determine the incidence of drive-line infections and sepsis. Methods Summary statistics of outcomes and Kaplan–Meier freedom-from-event analyses were performed. The Cochran–Mantel–Haenszel test for homogeneity was used to determine whether there was any site effect on rates of either drive-line exit-site or sepsis infections. Results Drive-line exit-site infections occurred in 16.9% (56 of 332) of patients (0.25 event per patient-year [EPPY]). These infections were primarily treated with antibiotics and most occurred >30 days post-implant (88%, or 66 of 75 drive-line infections). Sepsis occurred in 17.2% (57 of 332) of patients (0.23 EPPY), and sepsis events occurred more frequently >30 days post-implant (86%, or 60 of 70 sepsis events). Of patients with sepsis, 17.5% (10 of 57) died due to sepsis-related neurologic events (7 of 10) and multisystem organ failure (2 of 10) and cardiopulmonary failure (1 of 10), whereas there were no deaths related to drive-line infections. In addition, 17.5% (10 of 57) of patients had a stroke event while under treatment for sepsis (7 hemorrhagic and 3 ischemic strokes), and 3.5% (2 of 57 patients with sepsis) had a device exchange for VAD thrombus (4 days before and 1 day after sepsis diagnosis). Patients with drive-line infections or sepsis had a larger body mass index compared to those without infection (29.4 vs 27.6 kg/m 2 , p = 0.015), and were more frequently diabetic (43.7% vs 31.2%, p = 0.034). Although there was no negative impact on survival in patients with drive-line exit-site infections, there was a trend for reduced survival in patients with sepsis events when compared to those patients without sepsis. Conclusions The incidence of drive-line infection and sepsis was low in patients receiving the HVAD pump. Despite a trend toward reduced survival in patients with sepsis events, the overall survival of patients with either drive-line infections or sepsis was excellent. [ABSTRACT FROM AUTHOR]

The sixth annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes the first 8 years of patient enrollment. The analysis is based on data from >10,000 patients and updates demographics, survival, adverse events and risk factors. Among patients with continuous-flow pumps, actuarial survival continues to be 80% at 1 year and 70% at 2 years. The report features a comparison of two eras of continuous-flow durable devices in the USA in terms of device strategy, patient profiles, adverse event burden, survival and quality of life. [Copyright &y& Elsevier]

Abstract: The Extracorporeal Life Support Organization Registry has collected outcome data of almost 56,000 patients receiving extracorporeal life support (ECLS) over the last 24 years. The use of neonatal respiratory ECLS declined from a peak of 1516 cases in 1992 to 750–865 cases from 2008 to 2012. The 26,583 cases of neonatal respiratory ECLS (75% survival) represent the largest patient population in the registry. Indicating the rapid growth in other patient populations, 2013 marks the first year where the number of neonatal respiratory ECLS cases is less than 50% of the registry. Stagnant at ~200 cases/year from 1993 to 2004, growth is occurring in the use of pediatric respiratory ECLS with 331–448 cases/year from 2008 to 2012 (58% survival). Similarly, adult respiratory ECLS use increases have been seen from ~100 cases/year from 1996 to 2007 to 480–846 cases/year from 2009 to 2012 (58% survival). Just over 15,000 cardiac ECLS patients have survival rates of 40%, 49%, and 40% for neonates, pediatric, and adults, respectively. [Copyright &y& Elsevier]

Background: Comorbidities complicate recovery and contribute to mortality after implant of a left ventricular assist device (LVAD). Coexistent cardiac and renal dysfunction (so-called cardiorenal syndrome) increases the risk of death, both with advanced heart failure and after LVAD implantation. We analyzed patients from the Interagency Registry for Mechanically Assist Circulatory Support to better estimate postimplant mortality according to the severity of renal dysfunction. Methods: Patients with a continuous-flow LVAD were grouped according to their pre-implant level of renal dysfunction: severe was defined as dialysis and/or estimated glomerular filtration rate (eGFR) < 30 ml/min; moderate if eGFR was 30 to 59 ml/min or blood urea nitrogen (BUN) was > 60 mg/dl; and mild or no renal dysfunction if eGFR was ≥ 60 ml/min and BUN was < 60 mg/dl. Results: Of the 4,917 patients with a continuous-flow LVAD implanted between June 2006 and March 2012, 3,160 (64%) were identified with mild or no renal dysfunction, 1,475 (30%) with moderate dysfunction, and 282 (6%) with severe dysfunction. Worsening renal dysfunction correlated with decreased survival, with nearly a 20% reduction in the 2-year survival going from low to severe dysfunction. The major negative survival effect occurred during the first 3 months. Combination of severe renal dysfunction and cardiogenic shock predicted the highest early mortality. Conclusions: Pre-implant renal dysfunction predicts higher mortality after LVAD implant. The progressive reduction in survival with higher grades of renal dysfunction supports consideration of LVAD implant before cardiorenal syndrome is advanced. For patients with severe renal dysfunction and other major comorbidities, initial support with a temporary device while awaiting organ recovery before implanting a durable pump could be considered. [Copyright &y& Elsevier]

The 5th annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes and analyzes the first 6 years of patient and data collection. The current analysis includes more than 6000 patients and updated risk factors for continuous flow pumps. Among continuous flow pumps, actuarial survival is 80% at 1 year and 70% at 2 years. Quality of life indicators are generally favorable and adverse event burden will likely influence patient selections of advanced heart failure therapies. [ABSTRACT FROM AUTHOR]

Abstract: Mechanical support of the heart can be offered to patients who are refractory to pharmacological treatment, therapy for coronary or valvular disease or resynchronization therapy. Ventricular assist devices enable end-organ perfusion in the setting of heart failure. This can be temporary (as a bridge to recovery or transplantation) or permanent (destination therapy). Devices can be extracorporeal or implanted, and generated flows can be pulsatile or non-pulsatile. Implantation usually requires sternotomy with or without cardiopulmonary bypass, but percutaneous devices exist. Cardiostable anaesthesia with inotropic support is vital. Problems include bleeding versus thrombosis, high pulmonary vascular resistance, right heart failure and late infections. Transoesophageal echocardiography can be used to detect potential right-to-left atrial shunts, aortic regurgitation and cannula malposition, and to monitor filling and right ventricular function after implantation. In the future, total implantability of the devices, including the power source, is likely to occur. Eventually, they are likely to become a widespread alternative to transplantation. [Copyright &y& Elsevier]

Background: Patients bridged to heart transplantation with left ventricular assist devices (LVADs) have been reported to have higher post-transplant mortality compared with those without LVADs. Our aim was to determine the impact of the type of LVAD and implant era on post-transplant survival. Methods: In this study we included 8,557 patients from the registry of the International Society for Heart and Lung Transplantation. We examined post-transplant outcomes in 1,100 patients bridged to transplant with pulsatile-flow LVADs between January 2000 and June 2004 (first era), 880 patients bridged with pulsatile-flow LVADs between July 2004 and May 2008 (second era), and 417 patients bridged with continuous-flow LVADs in the second era. Patients who required intravenous inotropes but not LVAD support (n = 2,728) and patients who did not require either LVAD or inotropes (n = 3,432) served as controls. Results: Post-transplant survival of patients bridged with pulsatile LVADs improved significantly between the first and the second era (p = 0.03). In the second era, there was no significant difference in post-transplant survival of patients bridged with pulsatile- vs continuous-flow LVADs (p = 0.26), and survival rates in the 2 groups were not statistically different from that of the non-LVAD group. Graft rejection was similar in patients bridged with LVADs compared to those without LVADs. Conclusions: In the most recent era, the use of either pulsatile- or continuous-flow LVADs did not result in increased post-transplant mortality. This finding is important as the proportion of patients with LVADs at the time of transplant has been rising. [ABSTRACT FROM AUTHOR]

Abstract: Building on the success of the current KEKB Flavour Factory and the Belle experiment, which helped to firmly establish the CKM picture of quark mixing and CP violation in the Standard Model, a luminosity upgrade of the asymmetric e+e− machine is planned. This new Super Flavour Factory, SuperKEKB, will deliver a luminosity of 8×1035 cm−2 s−1, a factor 40 of increase over the present luminosity world record. It is foreseen to begin its operation in 2013. With these increased statistics, a new silicon vertex detector is needed in order to obtain precise decay vertex resolution measurements; these new precise measurements in the flavour sector can probe new physics well beyond the scales accessible to direct observations. [ABSTRACT FROM AUTHOR]

Background: Rejection is a major cause of morbidity and mortality after pediatric heart transplantation (HTx). Survival after pediatric HTx has improved over time, but whether there has been an era-related improvement in the occurrence of allograft rejection is unknown. Methods: The Pediatric Heart Transplant Study (PHTS) database was queried for patients who underwent HTx from January 1993 to December 2005 to determine the incidence of rejection and identify factors associated with the first episode of rejection in the first year after HTx. Results: Data were reviewed in 1,852 patients from 36 centers. The incidence of rejection declined over 13 years at a rate of −2.58 ± 0.41 (p < 0.001) from approximately 60% to 40% (p < 0.001). The mean number of episodes of rejection also significantly fell at a rate of −0.05 ± 0.01 per patient/year from 1.19 to 0.66 (p < 0.001). The incidence of rejection with hemodynamic compromise and death from rejection did not change. Multivariate analysis for the risk of a first rejection episode demonstrated decreased risk of rejection with later year of HTx (odds ratio [OR], 0.88; 95% confidence interval [CI], 0.85–0.91; p < 0.001) and use of mechanical support (OR, 0.65; 95% CI, 0.42–0.99; p = 0.046). Increased risk of rejection was associated with positive donor-specific crossmatch (OR, 1.85; 95% CI, 1.18–2.88; p = 0.007) and older recipient age (OR, 1.05; 95% CI, 1.02–1.07; p < 0.001). Conclusions: Although the overall incidence and prevalence of rejection has substantially decreased over time in pediatric HTx recipients in the first year after HTx, the rate of rejection with hemodynamic compromise or death from rejection remains unchanged. [Copyright &y& Elsevier]

Cardiac cachexia, associated with excessive activation of the sympathetic nervous system together with immune activation, is an important prognostic indicator in heart failure. Anecdotally, the prevalence of cardiac cachexia appears to be falling, perhaps due to the increased use of beta-blockers. However, chronic heart failure is so common that many patients continue to lose weight and continue to deteriorate to a point where transplantation or mechanical support is considered. The origin of cachexia remains elusive and further research is needed to explore the relation between weight, sympathetic activation, and the response to cardiac surgery or transplantation. [Copyright &y& Elsevier]

Background: Pulmonary hypertension associated with chronic congestive heart failure posses a significant risk of morbidity and death after heart transplantation. Isolated observations suggest that chronic ventricular unloading may lead to normalization of pulmonary pressures and thus render a patient likely to be a heart transplant candidate. Methods: This study is a retrospective analysis of 9 heart failure patients with secondary pulmonary hypertension (transpulmonary gradient [TPG] > 15 mm/Hg). Two were treated with a pulsatile left ventricular assist device (LVAD) and 7 with an axial-flow LVAD. Results: After LVAD support, mean pulmonary artery pressure decreased from 39 ± 7 to 31 ± 5 mm Hg, and the TPG decreased from 19 ± 3 to 13 ± 4 mm Hg (p < 0.01). The 1-year Kaplan–Meier survival curve for patients with pre-LVAD TPG > 15 mm Hg vs those with TPG < 15 mm Hg showed no difference in survival (p = 0.6). This finding was supported by analysis of a large multi-institutional cohort obtained from the Organ Procurement and Transplantation Network database, where no differences in survival were found in the same groups. Conclusions: Pulmonary hypertension that is secondary to congestive heart failure, as defined by a TPG > 15 mm Hg can be reversed by the use of pulsatile and axial-flow LVADs; furthermore, post-transplant survival for patients with secondary pulmonary hypertension treated with an LVAD was no different than for those without pulmonary hypertension who received LVAD support. [Copyright &y& Elsevier]

Abstract: Mechanical support of the heart can be offered to patients who are refractory to pharmacological treatment, therapy for coronary or valvular disease or resynchronization therapy. Ventricular assist devices enable end-organ perfusion in the setting of heart failure. This can be temporary (as a bridge to recovery or transplantation) or permanent (destination therapy). Devices can be extracorporeal or implanted, and generated flows can be pulsatile or non-pulsatile. Implantation usually requires sternotomy with or without cardiopulmonary bypass, but percutaneous devices exist. Cardiostable anaesthesia with inotropic support is vital. Problems include bleeding versus thrombosis, high pulmonary vascular resistance, right heart failure and late infections. Transoesophageal echocardiography can be used to detect potential right-to-left atrial shunts, aortic regurgitation and cannula malposition, and to monitor filling and right ventricular function after implantation. In the future, total implantability of the devices, including the power source, is likely to occur. Eventually, they are likely to become a widespread alternative to transplantation. [Copyright &y& Elsevier]

Abstract: Heart transplantation not only enables children with end-stage heart failure to live longer, but also improves their quality of life. Peritransplant survival has improved with advances in intensive care and better mechanical support systems for the failing heart. Heart–lung transplantation is the only option for some children near the end of life from disease affecting both organs and remains a challenge, with much poorer outcomes than heart transplantation alone. All thoracic transplants require scrupulous attention to follow-up care and, despite improving outcomes, can be regarded only as palliative solutions. The medical and surgical management of heart failure and congenital heart disease has also improved in recent years, and these options are thoroughly explored before considering listing for heart transplantation. [Copyright &y& Elsevier]

Advanced revascularization strategies continue to uncover a growing number of patients with symptomatic diffuse coronary artery disease. Transmyocardial laser revascularization (TMR) provides significant benefit in terms of improved quality of life and more complete revascularization for these difficult to treat patients when TMR is used as sole therapy or in combination with coronary artery bypass grafting. The safe clinical application of this important procedure relies on diligent perioperative management with appropriate patient selection, intraoperative care that avoids myocardial ischemia, and postoperative pain control along with expeditious reinstitution of antianginal medications. The treatment paradigms learned with the safe application of TMR should prove useful as new therapies to extend our revascularization options are developed. [Copyright &y& Elsevier]

Abstract: The pixel vertex detector is critical to the success of the BTeV experiment. It will provide very high-precision space points along charged particle trajectories with a readout fast enough so that this information can be used by the lowest level trigger. The detector will be placed in a 1.6T dipole magnet, inside the beam vacuum, and with the innermost region as close as 6mm from the colliding beams. The status of the technical design of this unique vertex detector is presented in this paper. [Copyright &y& Elsevier]

With the increasing availability of pigs genetically engineered to protect their tissues from the human immune response, research into xenotransplantation is progressing steadily. One potential route to the clinic would be the use of a pig heart as a bridge to allotransplantation. This would only be ethical if the outcome was realistically estimated to be as good as, or better than, bridging with a mechanical device. The experimental results that would be required to warrant consideration of a clinical trial and the patients in whom bridging with a xenograft might be considered preferable to a mechanical device are discussed. [ABSTRACT FROM AUTHOR]

Abstract: We report the successful use of extracorporeal membranous oxygenation in a previously healthy parturient with fulminant peripartum cardiomyopathy. Native cardiac function recovered rapidly, with weaning from extracorporeal membranous oxygenation after only 68h. This case highlights the potential of this lifesaving treatment, in appropriately selected patients, where death seems inevitable. No major complications of extracorporeal membranous oxygenation occurred in this patient. [Copyright &y& Elsevier]

Objectives The value of intraoperative extracorporeal membrane oxygenation (ECMO) in lung transplantation remains controversial. In our department, ECMO has been used routinely for intraoperatively unstable patients for more than 15 years. Recently, we have extended its indication to a preemptive application in almost all cases. In addition, we prolong ECMO into the early postoperative period whenever graft function does not meet certain quality criteria or in patients with primary pulmonary hypertension. The objective of this study was to review the results of this strategy. Methods All standard bilateral lung transplantations performed between January 2010 and June 2016 were included in this single-center, retrospective analysis. Patients were divided into 3 groups: group I—no ECMO (n = 116), group II—intraoperative ECMO (n = 343), and group III—intraoperative and prolonged postoperative ECMO (n = 123). The impact of different ECMO strategies on primary graft function, short-term outcomes, and patient survival were analyzed. Results The use of intraoperative ECMO was associated with improved 1-, 3-, and 5-year survival compared with non-ECMO patients (91% vs 82%, 85% vs 76%, and 80% vs 74%; log-rank P = .041). This effect was still evident after propensity score matching of both cohorts. Despite the high number of complex patients in group III, outcome was excellent with higher survival rates than in the non-ECMO group at all time points. Conclusions Intraoperative ECMO results in superior survival when compared with transplantation without any extracorporeal support. The concept of prophylactic postoperative ECMO prolongation is associated with excellent outcomes in recipients with pulmonary hypertension and in patients with questionable graft function at the end of implantation. [ABSTRACT FROM AUTHOR]