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The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), supported by the Society of Thoracic Surgeons, provides detailed information on pediatric patients supported with ventricular assist devices (VADs).From September 19, 2012, to December 31, 2021, there were 1,355 devices in 1,109 patients (19 years) from 42 North American Hospitals.Cardiomyopathy was the most common underlying etiology (58%), followed by congenital heart disease (CHD) (26%) and myocarditis (9%). Regarding device type, implantable continuous (IC) VADs were most common at 40%, followed by paracorporeal pulsatile (PP) (28%), and paracorporeal continuous (PC) (27%). Baseline demographics differed, with the PC cohort being younger, smaller, more complex (ie. CHD), and sicker at implant (P.0001). At six months post-VAD implantation, a favorable outcome (transplant, recovery, or alive on device) was achieved in 84% of patients, which was greatest among those on IC VADs (92%) and least for PC VADs (69%). Adverse events (AEs) were not uncommon, with non-gastrointestinal bleeding (incidence of 14%) and neurological dysfunction (11% [Stroke 4%]), within 2 weeks post implant being the most prevalent. Stroke and bleeding had negative impacts on overall survival (p=0.002 and p0.001, respectively).This Sixth Pedimacs Report demonstrates the continued evolution of the pediatric field. The complexity of cardiac physiologies and anatomical constraint mandates the need for multiple types of devices utilized (PC, PP, IC). Detailed analyses of each device type in this report provide valuable information to further advance the care of this challenging and vulnerable population.

The thirteenth annual report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) highlights outcomes for 27,314 patients receiving continuous flow durable left ventricular assist devices (LVAD) over the last decade (2012-2021). In 2021, 2,464 primary LVADs were implanted, representing a 23.5% reduction in the annual volume compared to peak implantation in 2019 and an ongoing trend from the prior year. This decline is likely a reflection of the untoward effects of the COVID-19 pandemic and the change in the US heart transplant allocation system in 2018. The last several years have been characterized by a shift in device indication and type with 81.1% of patients now implanted as destination therapy and 92.7% receiving an LVAD with full magnetic levitation in 2021. However, despite an older, more ill population being increasingly supported pre-implant with temporary circulatory devices in the recent (2017-2021) vs prior (2012-2016) eras, the 1- and 5-year survival continues to improve at 83.0% and 51.9%, respectively. The adverse events profile has also improved, with significant reduction in stroke, gastrointestinal bleeding, and hospital readmissions. Finally, we examined the impact of the change in heart transplant allocation system in 2018 on LVAD candidacy, implant strategy, and outcomes. In the competing outcomes analysis, the proportion of transplant eligible patients receiving a transplant has declined from 56.5% to 46.0% at 3 years, while the proportion remaining alive with ongoing support has improved from 24.1% to 38.1% at 3 years, underscoring the durability of the currently available technology.

On June 3, 2021 Medtronic, Inc announced discontinuation of the HVAD left ventricular assist device. The purpose of this analysis was to provide summary data on surgical risks of HVAD to HeartMate 3 exchange and compare survival after HVAD to HeartMate 3 exchange to survival after primary HVAD implantation.Three cohorts within The Society of Thoracic Surgeons Intermacs database were identified: primary HVAD implant cohort (January 2017 to March 2021, n = 3797), HVAD to HeartMate 3 exchange cohort (December 2017 to March 2021, n = 45), and HVAD to HVAD exchange cohort (January 2017 to March 2021, n = 234). Mortality after HVAD to HeartMate 3 exchange was modeled and compared with the constant hazard phase for risk of mortality while on continued HVAD support. As a secondary analysis outcomes and survival were compared between patients who underwent HVAD to HeartMate 3 and HVAD to HVAD exchange.HVAD to HeartMate 3 exchange was associated with significantly reduced survival compared with survival while remaining on HVAD support (6 months after exchange, 73.8% [70% confidence interval, 68.6-77.8] vs 79.0% [70% confidence interval, 78.3-79] for continued HVAD support). Compared with HVAD to HVAD exchange, survival was higher after replacement with HeartMate 3 (1 year: 85.9% [70% confidence interval, 79.5-90.5] vs 66.6% [70% confidence interval, 63.0-70.0], P = .009).Compared with continued support on HVAD, an exchange to HeartMate 3 was found to be associated with a significant increase in mortality. For patients who required pump exchange on HVAD support, exchange to HeartMate 3 demonstrated superior survival. Currently there is insufficient evidence to support elective exchange from an HVAD to HeartMate 3.

BACKGROUND The Society of Thoracic Surgeons (STS) Intermacs Registry represents a real-world data source of durable, left ventricular assist devices that can address knowledge gaps not informed through randomized clinical trials. We sought to compare survival with contemporary left ventricular assist device technologies using multiple analytic approaches to assess concordance of treatment effects and to validate prior STS Intermacs observations. METHODS Patients (≥19 years of age) enrolled into STS Intermacs between August 2017 and June 2019 were stratified by device type (continuous flow, centrifugal left ventricular assist device with hybrid levitation [CF-HL] or full magnetic levitation [CF-FML]). The primary outcome was 1-year survival assessed by 3 statistical methodologies (multivariable regression, propensity score matching, and instrumental variable analysis). RESULTS Of 4448 patients, 2012 (45.2%) received the CF-HL and 2436 (54.8%) received the CF-FML. One-year survival for the CF-FML was 88% vs 79% for the CF-HL (overall P < .001), with a hazard ratio for mortality of 3.18 for the CF-HL (P < .0001) after risk adjustment. With propensity score matching (n = 1400 each cohort), 1-year survival was 87% for the CF-FML vs 80% for the CF-HL, with a hazard ratio of 3.20 for mortality with the CF-HL (P < .0001) after risk adjustment. With an instrumental variable analysis, the probability of receiving the CF-HL was associated with a hazard ratio of 3.11 (P < .0001). CONCLUSIONS Statistical methodology using propensity score matching and instrumental variable analysis increased the robustness of observations derived from real-world data and demonstrates the feasibility of performing comparative effectiveness research using STS Intermacs. These analyses provide additional evidence supporting a survival benefit of the CF-FML vs CF-HL.

The Society of Thoracic Surgeons (STS)-Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) 2020 Annual Report reviews outcomes on 25,551 patients undergoing primary isolated continuous-flow left ventricular assist device (LVAD) implantation between 2010 and 2019. In 2019, 3198 primary LVADs were implanted, which is the highest annual volume in Intermacs history. Compared with the previous era (2010-2014), patients who received an LVAD in the most recent era (2015-2019) were more likely to be African American (26.8% vs 22.9%, P

Background Although cardiac surgery among renal allograft recipients is relatively safe, less is known about the impact of cardiac surgery on the functioning renal allograft. This study assessed postoperative renal failure among renal transplant recipients undergoing cardiac surgery. Methods The study population was identified by matching medical record numbers from the United Network for Organ Sharing Kidney Transplant Database to a cardiovascular surgery database and The Society of Thoracic Surgeons Adult Cardiac Surgery Database for the authors’ institution from January 1992 through August 2018. Results One hundred seventy-nine renal transplant recipients with a functioning allograft underwent cardiac surgery a mean of 6.4 ± 5.6 years after renal transplantation. Thirty (17.6%) of the 170 patients either died or had allograft failure during the first postoperative year. Receiver-operating characteristics curve analysis using Cox regression demonstrated an optimal cutoff point for preoperative serum creatinine predicting postoperative allograft loss is 1.9 mg/dL (hazard ratio 3; 95% confidence interval, 1.5 to 6.9) with a model C statistic of 0.642. Conclusions The current study affirms findings in the literature that cardiac surgery in renal transplant recipients carries acceptable perioperative morbidity and mortality. Renal transplant recipients who underwent cardiac surgery had a constant hazard of renal allograft loss similar to that of the general transplant population. A preoperative serum creatinine value greater than 1.9 mg/dL increases the risk for long-term renal allograft loss after cardiac surgery.

BACKGROUND: Patients undergoing left ventricular assist device (LVAD) implantation are at risk for death and postoperative adverse outcomes. Interhospital variability and concordance of quality metrics were assessed using STS Intermacs. METHODS: A total of 22,173 patients underwent primary, durable LVAD implantation across 160 hospitals from 2012–2020, excluding hospitals implanting

Background The influence of ventricular assist device (VAD) use in the care of children with end-stage heart failure is growing rapidly through increasing numbers, new devices, expanding indications, and improving outcomes. Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), a National Institutes of Health–sponsored United States database, provides a platform to understand this emerging population. Methods Between September 19, 2012, and December 31, 2017, 30 hospitals implanted 508 devices in 423 patients aged younger than 19 years. This past year was one of evolution for the database as its management was transitioned to The Society of Thoracic Surgery; therefore, this report does not include data from institutions not under contract by August 1, 2018. Results Of the 423 patients, the diagnosis was cardiomyopathy in 261 (62%), myocarditis in 48 (11%), other in 28 (7%), and congenital heart disease (CHD) in 86 (20%), with 52 of these patients having single-ventricle physiology. The two most common support strategies included left VAD in 342 (81%) and biventricular assist device in 64 (15%). Positive outcome (alive on device or bridge to transplantation/recovery) was 80% at 6 months (overall mortality of 20%). The patient cohort for implantable continuous-flow (IC) pumps (n = 197; age at implant, 13.4 ± 3.8 years; 19% Interagency Registry for Mechanically Assisted Circulatory Support [Intermacs] profile 1, 21% intubated at implant, and 12% with CHD) was significantly different from the paracorporeal continuous-flow (PC) pump cohort (n = 79; age, 3.9 ± 5.2 years; 49% Intermacs profile 1, 86% intubated at implant, and 38% with CHD) and the paracorporeal pulsatile (PP) pump cohort (n = 121; age, 3.3 ± 3.9 years; 41% Intermacs profile 1, 77% intubated at implant, and 21% with CHD). Consistent with their cohort composition, device type positive outcomes at 6 months were PC, 63%; PP, 77%; and IC, 92%. Parametric hazard modeling showed an early hazard for death was associated with Intermacs profile 1, biventricular assist device, percutaneous devices, PC devices, small-volume institutions, low age, and low weight, whereas a constant hazard was associated with intubation and liver dysfunction at time of implant. Conclusions IC VADs are the most common VAD type placed in children. The positive outcomes for the IC VADs exceed 90% at 6 months, which may represent our field’s maturation in both patient selection and timing of implantation. The PP/PC devices are currently limited to supporting our most challenging patients, those weighing less than 20 kg and those with CHD. The introduction of new devices and our communities’ commitment to shared learning and improvement will lead to more pediatric lives saved by VAD support and will also focus on improving the quality of life of children supported with VADs.

The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) provides detailed information on pediatric patients supported with ventricular assist devices (VADs).From September 19, 2012, to December 31, 2020, 1229 devices in 1011 patients were reported to the registry from 47 North American Hospitals in patients aged younger than 19 years.Cardiomyopathy was the most common underlying etiology (58%), followed by congenital heart disease (CHD; 25%) and myocarditis (10%). The most common devices implanted were implantable continuous (IC; 419 [41%]), followed by paracorporeal pulsatile (PP; 269 [27%]), paracorporeal continuous (PC; 263 [26%]), and percutaneous (53 [5%]). Overall, at 6 months after VAD implantation, 83% had a positive outcome (transplant, explant, or alive on device). The freedom from stroke at 3 months was highest in IC VADs (93%), compared with PP VADs (84%) and with PC VADs (75%). There were differences in survival by device type, with patients on IC VADs having the best overall survival and those on PC having the lowest overall survival, though the patient populations being supported by each VAD type differed significantly from each other.This Fifth Pedimacs Report demonstrates the continued robust growth of VADs in the pediatric community, now with more than 1000 patients reported to the registry. The multiple available device types (PC, PP, IC) serve different populations with different pre-VAD risk profiles, which may account for differences in survival and adverse events between device types.

Although the current wide-scale adoption of the HeartMate 3 left ventricular assist device can be attributed to favorable clinical trial outcomes, restrictive clinical trial eligibility criteria may result in lack of generalizability to real-world populations. We assessed the generalizability of left ventricular assist device clinical trial outcomes and evaluated the prognostic value of specific inclusion and exclusion criteria.The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) eligibility criteria were applied to patients identified in The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) who underwent HeartMate 3 implantation (n = 4610) between August 2017 and March 2020. Patients were categorized as trial-eligible or trial-ineligible and by number of ineligibility criteria. The effect of trial eligibility on mortality was estimated using Cox models.Indications for HeartMate 3 implant included destination therapy (n = 2827, 61%), bridge to candidacy (n = 969, 21%), and bridge to transplant (n = 702, 15%). A total of 1941 recipients (42%) were trial-ineligible, with 1245 (27%) meeting one ineligibility criterion, 470 (10%) meeting two, and 226 (5%) meeting three or more. Estimated 1-year mortality for trial-ineligible recipients was higher than for trial-eligible recipients (17% ± 1% vs 10% ± 1%, P.001). Compared with trial-eligible patients, 1-year mortality was incrementally higher for patients meeting one ineligibility criterion (15% ± 1%), two criteria (16% ± 2%), and three or more criteria (30% ± 3%). Thrombocytopenia and elevated creatinine, bilirubin, and international normalized ratio in trial-ineligible patients were independently associated with increased mortality.Despite differences in mortality, both trial-eligible and trial-ineligible HeartMate 3 recipients had excellent outcomes in real-world practice, suggesting future trial eligibility criteria could be expanded.

Under the new heart allocation policy patients needing durable left ventricular assist devices receive lower priority on the transplant list. We sought to identify predictors of successful heart transplant after durable device implant as a means to inform patient care in the current era.All patients (N = 25,164) undergoing primary durable left ventricular device implant in The Society of Thoracic Surgeons Intermacs database (2010-2019) were evaluated. Patients identified as bridge to transplant (BTT; n = 5242) or bridge to candidacy (n = 6248) were analyzed with the endpoint of transplant before (n = 10,588) and after (n = 902) the change in the heart allocation system on October 18, 2018. Multivariable hazard modeling was used to assess risk-adjusted time to event associations.Of 11,490 patients, 45.5% progressed to transplant (BTT, 53.0%; bridge to candidacy, 36.6%), most by 14 months after left ventricular assist device implant. Under the new allocation system progression to transplant was significantly lower at 14 months (18.6% vs 34.8%, P.001). Factors associated with successful BTT before the allocation change included BTT status, white race, and married. Under the new allocation system BTT status (hazard ratio, 1.79; 95% confidence interval, 1.19-2.69; P.0054) remained a positive predictor, whereas blood type O (hazard ratio, 0.43; 95% confidence interval, 0.28-0.65; P.0001) remained a negative predictor.Despite having priority in the previous allocation system, less than half of BTT and bridge to candidacy patients progressed to transplant. Under the current system these numbers are further reduced. Heart teams should consider the implications of longer wait times for a durable left ventricular assist device when determining the optimal bridging strategy.

Patients receiving a right ventricle to pulmonary artery conduit (PC) in infancy will require successive procedures or replacements, each with variable longevity. We sought to identify factors associated with time-related risk of a subsequent surgical replacement (PC3) or transcatheter pulmonary valve insertion (TPVI) after a second surgically placed PC (PC2).From 2002 to 2016, 630 patients from 29 Congenital Heart Surgeons' Society member institutions survived to discharge after initial valved PC insertion (PC1) at age ≤ 2 years. Of those, 355 underwent surgical replacement (PC2) of that initial conduit. Competing risk methodology and multiphase parametric hazard analyses were used to identify factors associated with time-related risk of PC3 or TPVI.Of 355 PC2 patients (median follow-up, 5.3 years), 65 underwent PC3 and 41 TPVI. Factors at PC2 associated with increased time-related risk of PC3 were smaller PC2 Z score (hazard ratio [HR] 1.6, P.001), concomitant aortic valve intervention (HR 7.6, P = .009), aortic allograft (HR 2.2, P = .008), younger age (HR 1.4, P.001), and larger Z score of PC1 (HR 1.2, P = .04). Factors at PC2 associated with increased time-related risk of TPVI were aortic allograft (HR: 3.3, P = .006), porcine unstented conduit (HR 4.7, P.001), and older age (HR 2.3, P = .01).Aortic allograft as PC2 was associated with increased time-related risk of both PC3 and TPVI. Surgeons may reduce risk of these subsequent procedures by not selecting an aortic homograft at PC2, and by oversizing the conduit when anatomically feasible.

Background The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), originally a National Institutes of Health–sponsored U.S. database, provides a platform to understand the population of children supported with ventricular assist devices (VADs) during this time of increasing numbers, new devices, expanding indications, and improved outcomes. Methods Between September 19, 2012, and December 31, 2019, 44 hospitals implanted 1031 devices in 856 patients under 19 years of age. Results Overall, diagnosis was cardiomyopathy in 497 (58%) patients, congenital heart disease (CHD) in 216 (25%), myocarditis in 85 (10%), and other in 58 (7%). Positive outcome (alive on device or bridge to transplantation and recovery) occurred in 82% at 6 months. The patient cohort for implantable continuous (IC) pumps (n = 365) (age 13.2 ± 3.9 years, 18% Interagency Registry for Mechanically Assisted Circulatory Support [Intermacs] profile 1, 23% intubated at implantation, 16% with CHD) was significantly different from the paracorporeal continuous (PC) pump cohort (n = 212) (age 3.6 ± 4.9 years, 46% Intermacs profile 1, 81% intubated, 42% CHD) and the paracorporeal pulsatile (PP) pump cohort (n = 230) (age 2.7 ± 3.5 years, 31% Intermacs profile 1, 76% intubated, 26% CHD). Consistent with their cohort composition, positive outcomes at 6 months based on device type were the following: IC, 92%; PC, 68%; and PP, 81%. The incidence of cerebrovascular accidents in the IC, PC, and PP cohorts was 7%, 14%, and 15%, respectively. Conclusions IC VADs, the most common VAD type placed in children, are associated with improved outcomes compared with PP and PC devices, though PP and PC devices are limited to supporting our most challenging patients. Noteworthy, the incidence of cerebrovascular accidents for pediatric VADs has significantly decreased and is now 11% overall. This report demonstrates again that although often attributed to age, size, or device type, much of the burden in mortality and adverse events is correlated to the patient’s overall state at VAD implantation.

Background The effect of the timing of stage-2-palliation (S2P) on survival through single ventricle palliation remains unknown. This study investigated the optimal timing of S2P that minimizes pre-S2P attrition and maximizes post-S2P survival. Methods The Congenital Heart Surgeons' Society's critical left ventricular outflow tract obstruction cohort was used. Survival analysis was performed using multiphase parametric hazard analysis. Separate risk factors for death after the Norwood and after S2P were identified. Based on the multivariable models, infants were stratified as low, intermediate, or high risk. Cumulative 2-year, post-Norwood survival was predicted. Optimal timing was determined using conditional survival analysis and plotted as 2-year, post-Norwood survival versus age at S2P. Results A Norwood operation was performed in 534 neonates from 21 institutions. The S2P was performed in 71%, at a median age of 5.1 months (IQR: 4.3 to 6.0), and 22% died after Norwood. By 5 years after S2P, 10% of infants had died. For low- and intermediate-risk infants, performing S2P after age 3 months was associated with 89% ± 3% and 82% ± 3% 2-year survival, respectively. Undergoing an interval cardiac reoperation or moderate-severe right ventricular dysfunction before S2P were high-risk features. Among high-risk infants, 2-year survival was 63% ± 5%, and even lower when S2P was performed before age 6 months. Conclusions Performing S2P after age 3 months may optimize survival of low- and intermediate-risk infants. High-risk infants are unlikely to complete three-stage palliation, and early S2P may increase their risk of mortality. We infer that early referral for cardiac transplantation may increase their chance of survival.

The field of mechanical circulatory support has been impacted by the approval of new continuous-flow left ventricular assist devices (LVADs) and changes to the United States heart allocation system.Primary isolated continuous-flow LVAD implants in The Society of Thoracic Surgeons Intermacs registry from January 2014 through September 2019 were evaluated. Survival and freedom from major adverse events were compared between axial-flow, centrifugal-flow with hybrid levitation (CF-HL), and centrifugal-flow with full magnetic levitation (CF-FML) devices.Of 2603 devices implanted in 2014, 1824 (70.1%) were axial flow and 1213 (46.6%) were destination therapy (DT); through September 2019, 1752 devices were implanted, but only 37 (2.1%) were axial flow and 1230 (70.2%) were DT. Implants were performed in 13,016 patients between 2014 and 2018. Patients receiving implants in 2017-2018 compared with 2014-2016 were more likely to be at Intermacs profile 1 (17.1% vs 14.3%, P.001) and to have preimplant temporary mechanical circulatory support (34.8% vs 29.3%, P.001). Overall survival and freedom from major adverse events were higher with CF-FML devices. In multivariable analysis of survival between CF-HL and CF-FML, device type was not a significant early hazard, but the use of CF-HL devices had a late hazard ratio for death of 3.01 (P .001).Over the past 5 years, centrifugal-flow LVADs have become the dominant technology and DT the most common implant strategy. While outcomes with CF-FML devices are promising, comparisons with other devices from nonrandomized registry studies should be made with caution.

There is a paucity of information available regarding the impact of cardiac surgical procedures on patients who have undergone previous liver transplantation. The primary purpose of this study was to ascertain the survival rate and predictors of death in this specific patient population.This retrospective cohort study consisted of a consecutive series of patients with a functioning liver allograft who subsequently underwent cardiac surgical procedures between January 1991 and December 2012. The optimal Model for End-Stage Liver Disease (MELD) score for predicting late death was identified using receiver operating characteristic curve analysis. Risk of postoperative death was determined by parametric hazard analysis.Between January 1991 and December 2012, 43 patients (median age, 60 years) underwent cardiac surgical procedures after liver transplantation. The median interval between liver transplant and cardiac operation was 63 months (range, 1.1 to 217 months). Three operative deaths and 24 late deaths occurred. Receiver operating characteristic curve analysis identified the optimal preoperative and postoperative MELD score cut points for predicting late death as greater than 13.8 (area under the curve = 0.674) and greater than 17 (area under the curve = 0.633), respectively. Patients with a preoperative MELD score of 13.8 or less had significantly greater survival rates than those with a MELD score greater than 13.8 (p = 0.028); patients with a postoperative MELD score of 17 of less had significantly greater survival rates than those with a MELD score greater than 17 (p0.001). Multivariate parametric hazard analysis identified postoperative peak creatinine level as a statistically significant predictor of death (relative risk, 1.8; p = 0.01). The 1-, 5-, and 10-year Kaplan-Meier survival rates were 90%, 51%, and 35%, respectively; postoperative mortality rates followed a constant phase model with a hazard of death of 10% per year.Cardiac surgical procedures can be performed with acceptable short-term and long-term outcomes in liver transplant recipients. Elevated preoperative and postoperative MELD scores and postoperative peak creatinine level may portend death in this cohort. There is a constant hazard of death of 10% per year.

Background The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) is a United States registry for adults receiving durable United States Food and Drug Administration–approved mechanical circulatory support devices (MCSDs). We merged INTERMACS records with Medicare claims to investigate the uncertainty of penetrance of Medicare beneficiaries within INTERMACS. Methods INTERMACS records and Medicare claims (January 1, 2008, through December 31, 2013) from the Centers for Medicare and Medicaid (CMS) were linked using a deterministic matching methodology. Results There was annual growth of CMS and INTERMACS centers performing durable MCSD implants among adults from 2008 through 2013 (54% and 87% increase, respectively). The number of CMS centers outnumbered INTERMACS centers throughout all years, with the 68% to 88% of CMS centers being represented in INTERMACS. Although annual patient volume was greatest for INTERMACS, the absolute number of patients significantly increased annually across both data sets from 2008 through 2013 (149% increase in CMS; 268% increase in INTERMACS). As a proportion of all INTERMACS registrants, Medicare beneficiary representation grew from 30% in 2008 to a high of 48% in 2010 and remained stable thereafter. Representation within INTERMACS of MCSDs implanted in Medicare beneficiaries more than doubled, from 36% in 2008 to 77% in 2013. Conclusions Using a merged data set of MCSDs implanted between 2008 and 2013, we report that the vast majority of CMS centers and Medicare beneficiaries receiving MCSDs are increasingly captured in INTERMACS. Accordingly, contemporary studies in INTERMACS are relevant and generalizable to the Medicare population.

Background Historically, patients with a prior Fontan procedure for complex congenital heart disease (CHD) have been considered at higher risk for death after heart transplant (HT) compared with other HT transplant candidates. With the overall trend of improved survival of pediatric HT recipients, it is unclear of Fontan patient post-HT survival has also improved in the current era. Methods Data from the Pediatric Heart Transplant Study database for Fontan patients who underwent HT was compared between the early era (1993 to 2006, n = 150) and late era (2007 to 2014, n = 252). Post-HT survival and pre-HT characteristics were compared among eras and also with non-Fontan CHD patients. Results At time of HT, Fontan patients in the late era were more likely to require inotropic support, have protein-losing enteropathy, have failure to thrive, and be further from time of Fontan, although less likely to be on ventilator support. Only ventilator support and earlier year of HT were significant risk factors for death in the multivariate analysis. Post-HT Fontan patient survival significantly improved from the early to late era ( p = 0.02), particularly in the early phase, with 1-year survival of 77% in the early era and 89% in the late era. Late era non-Fontan CHD patient 1-year post-HT survival was similar to Fontan patients at 92%. Conclusions Survival of Fontan patients after HT has significantly improved in the current era. Currently, expected post-HT survival for Fontan patients is on par with other CHD patients. Fontan patients should not be excluded from consideration for HT solely on a history of Fontan.

Background The optimal management of tricuspid regurgitation (TR) in patients undergoing left ventricular assist device (LVAD) implantation is controversial. This study was undertaken to determine the impact of tricuspid valve repair (TVR) at the time of LVAD implantation on survival. Methods The Interagency Registry for Mechanically Assisted Circulatory Support was used to analyze the outcomes of patients undergoing LVAD implantation as destination therapy with or without concomitant TVR. Results Among 2,527 patients undergoing implant of a continuous flow LVAD as destination therapy during the study period, 989 (39%) had moderate or severe TR. The management of TR was not uniform among these patients. Patients with moderate and severe TR underwent TVR in 16.7% and 35.3% of cases, respectively. Moderate and severe TR at the time of LVAD implantation were associated with poorer survival over the entire follow-up period ( p = 0.009). Interestingly, TVR at the time of LVAD implantation did not confer improved survival, even among patients with preimplant moderate or severe TR. A potential explanation for this finding is that patients with preimplant moderate or severe TR who underwent LVAD implant with concomitant TVR commonly experienced recurrent, late TR (21% to 27%). Conclusions Tricuspid valve repair is performed commonly at the time of LVAD implant despite the fact that it does not confer a clear survival benefit. For many patients, LVAD implant alone relieves preimplant TR as effectively as LVAD implant with TVR. Further study is necessary to determine what factors lead to recurrence of late TR in LVAD patients both with and without TVR.

Infection is one of the most important challenges to the use of implanted mechanical circulatory support systems (MCSS), particularly as we enter the era of permanent device use in patients who are not candidates for cardiac transplantation. This paper describes the pathogenesis of MCSS infection, with particular attention to the role of biofilm-forming bacteria. Suggestions are presented for the prevention and treatment of infections in implanted MCSS.

A novel technique of valve-sparing aortic root replacement was applied to 2 children younger than 3 years of age with Marfan syndrome and large aortic root aneurysms. Using elements of both the remodeling and reimplantation techniques, circumferential rings from a 20-mm to 22-mm polyester graft provide stabilization at the subannular and sinotubular levels, and bovine pericardial patches create pseudosinuses. Follow-up at 2 years in 1 patient and 7 months in a second patient revealed satisfactory valve function with stable aortic root size.

Background . Initiating outpatient therapy with ventricular assist devices (VAD) was important in the progress of mechanical circulatory support. This article reviews our experience with VAD therapy from the start of our outpatient program until the present. Methods . Medical records of patients who received a Thoratec para-corporeal VAD, HeartMate vented electrical VAD, or HeartMate pneumatic VAD between 12/1/97 and 9/1/01 were reviewed. Variables included age, type of devices, total duration of VAD support, discharge status, duration of outpatient support, outcome (transplanted, died on support, ongoing), in-hospital length of stay after transplantation, and complications during VAD support. Results . There were 53 device implants in 46 patients. The cumulative patient-days of VAD support was 7,468 (mean duration of support, 138 ± 195 days; median, 95 days; range, 2 to 948 days). Twenty of the 46 patients were discharged with a VAD. The cumulative outpatient days was 3,600 (mean outpatient duration, 157 ± 164 days; median, 83 days; maximum, 560 days). Of the 20 outpatients, 11 received cardiac transplantation, 5 died, and 4 are ongoing as of 9/1/01. Major complications that occurred in the outpatient setting included 5 deaths after hospital readmission (1 sepsis, 1 conduit tear, 3 neurologic events); 4 device infections (3 sepsis, 1 pouch infection); and 3 device malfunctions that required reoperation for pump replacement (1 HeartMate pneumatic and 2 HeartMate vented electrical). No deaths occurred in an outpatient setting. Conclusions . Ventricular assist devices effectively support outpatients for months to years. The anticipated time for postoperative recovery and VAD training before discharge is approximately 14 to 21 days, although shorter times may be possible in the future. Establishing a successful outpatient VAD program is a crucial step toward VAD as definitive therapy for end-stage heart disease.

Background . Air leaks (ALs) are a common complication after pulmonary resection, yet there is no consensus on their management. Methods . An algorithm for the management of chest tubes (CT) and ALs was applied prospectively to 101 consecutive patients who underwent elective pulmonary resection. Air leaks were graded daily as forced expiratory only, expiratory only, inspiratory only, or continuous. All CTs were kept on 20 cm of suction until postoperative day 2 and were then converted to water seal. On postoperative day 3, if both a pneumothorax and AL were present, the CT was placed to 10 cm H 2 O of suction. If a pneumothorax was present without an AL, the CT was returned to 20 cm H 2 O of suction. Air leaks that persisted after postoperative day 7 were treated with talc slurry. Results . There were 101 patients (67 men); on postoperative day 1, 26 had ALs and all were expiratory only. Univariable analysis showed a low ratio of forced expiratory volume in 1 second to forced vital capacity (FEV 1 /FVC) ( p = 0.005), increased age ( p = 0.007), increased ratio of residual volume to total lung capacity (RV/TLC) ( p = 0.04), increased RV ( p = 0.02), and an increased functional residual capacity (FRC) ( p = 0.02) to predict the presence of an AL on postoperative day 1. By postoperative day 2, 22 patients had expiratory ALs. After 12 hours of water seal, 13 of the 22 patients' ALs had stopped, and 3 more sealed by the morning of postoperative day 3. However, 2 of the 6 patients whose ALs continued experienced a pneumothorax. Five of the 6 patients with ALs on postoperative day 4 still had ALs on postoperative day 7, and all were treated by talc slurry through the CT. All ALs resolved within 24 hours after talc slurry. Conclusions . Most ALs after pulmonary resection are expiratory only. A low FEV 1 /FVC ratio, increased age, increased RV/TLC ratio, increased RV, and an increased FRC were predictors of having an ALs on postoperative day 1. Conversion from suction to water seal is an effective way of sealing expiratory AL, and pneumothorax is rare. If an expiratory AL does not stop by postoperative day 4 it will probably persist until postoperative day 7, and talc slurry may be an effective treatment.

Lower extremity ischemia is an important source of morbidity with femoral venoarterial extracorporeal membrane oxygenation support. We describe our experience with the use of a side-arm graft sewn to the femoral artery that facilitates adequate extracorporeal membrane oxygenation flow while preventing lower extremity ischemia.

The purpose of this study is to present data comparing the penetration of cryolesions created by various sizes and shapes of cryoprobes in human cadaveric myocardium, fat, and tissue of the central fibrous body. Ten cryolesions were made for each combination of tissue and cryoprobe studied. All cryolesions enlarged most rapidly during the first minute of cryothermia (p less than 0.01). Maximal cryothermic penetration into nontrabeculated myocardium was 8.5 +/- 0.5 mm (15-mm flat probe) and 6.1 +/- 1.0 mm (5-mm small probe). Maximal cryothermic penetration into trabeculated myocardium was 9.4 +/- 1.0 mm (10-mm cone-tipped probe) and 7.4 +/- 0.5 mm (10-mm flat probe). Maximal cryothermic penetration into fat was 4.7 +/- 0.7 mm (15-mm flat probe) and 3.9 +/- 0.7 mm (5-mm flat probe). The deeper penetration of cryothermia into myocardium as compared with fat (p less than 0.05) is related to the lower thermal conductivity of fat. Maximal cryothermic penetration of the central fibrous body was similar to that of the myocardium with transmural freezing of the central fibrous body after 4.4 +/- 0.3 minutes of cryothermia. These data can be used when determining the optimal cryothermic exposure for ablation of arrhythmogenic tissue.

The pioneering surgical endeavors of Christiaan Barnard in human cardiac transplantation are well recognized. His contribution in the surgery of Ebstein's malformation has also been unique. In 1963, Barnard's classic paper on "Surgical correction of Ebstein's malformation with prosthetic tricuspid valve" presented his pioneering accomplishments in this complex cardiac malformation.

The coronary vascular response to controlled initial hyperkalemic reperfusion after global ischemia during cardiac transplantation was studied in 11 patients. The mean global ischemic time was 206 minutes (range, 143 to 245 minutes). All donor hearts received initial hyperkalemic crystalloid cardioplegia and subsequent oxygenated crystalloid cardioplegia during implantation. Coronary blood flow was highest during the first one to two minutes of controlled reperfusion but remained normal throughout the first ten minutes of reperfusion. Coronary vascular resistance was less than normal throughout the first ten minutes of controlled reperfusion, but there was a gradual increase throughout this period. Systemic vascular resistance remained within normal limits. The time to effective contraction was highly variable, but a greater potassium load during initial reperfusion was generally associated with a longer time to effective contraction.

Background Severely symptomatic neonates and young infants with Ebstein's anomaly usually die without surgical intervention. The relative risks and benefits of single-ventricle palliation versus a two-ventricle repair are uncertain. In a recent series, 69% early survival with single-ventricle palliation was reported in 16 neonates with Ebstein's anomaly. Our institutional bias has been to do a two-ventricle repair in all such patients. Methods We reviewed our entire surgical experience with a two-ventricle repair in the severely symptomatic neonate (n = 22) and young infant (n = 5). The indications for operation were ventilator dependence, severe cardiac failure, prostaglandin-dependent circulation, and gross cardiomegaly. Results Between 1994 and 2006, 27 consecutive patients with Ebstein's anomaly underwent operation. Associated comorbidities included anatomic or functional pulmonary atresia (n = 18), ventricular septal defects (n = 3), small left ventricle (n = 3), hypoplastic branch pulmonary arteries (n = 3), previous cardiac surgery (n = 4), significant intracranial hemorrhage (n = 3), hepatic necrosis and renal insufficiency (n = 3), and malignant tachyarrhythmias (n = 4). Operations consisted of tricuspid valve repair (n = 23) or valve replacement (n = 2), Blalock-Taussig shunt only (n = 1), and bilateral pulmonary arterioplasty with bidirectional Glenn (n = 1). Hospital survival was 74%, and there have been no late deaths during a median follow-up period of 5.4 years (range, 0.2 to 12 years). Three patients required tricuspid valve replacement during the follow-up period. Late arrhythmia requiring medication is present in 1 patient. All patients are currently in New York Heart Association functional class I. Conclusions Two-ventricle repair currently has similar early survival compared with single-ventricle palliation. The advantages of a better physiologic repair can be anticipated for a longer follow-up period.

Management of mild to moderate aortic insufficiency in patients with a left ventricular assist device remains controversial. We report 3 patients with aortic insufficiency and pulsatile left ventricular assist devices treated with a central aortic valve coapting suture. Two of the repairs have been durable for more than 1 year and aspirin appears to be sufficient anticoagulation.

We report the implantation of a HeartWare left ventricular assist device in a child. A 9-year-old girl presented in cardiogenic shock complicated by an embolic stroke. Catheter-based thrombolysis partially reversed the neurologic deficit, but worsening cardiac failure prompted consideration of mechanical circulatory support (MCS). Limited available pericardial space, anticoagulation requirements, and thromboembolic potential favored the use of the HeartWare left ventricular assist device (HeartWare International, Inc, Framingham, MA). After device implantation and intensive physical rehabilitation, the patient underwent successful cardiac transplantation after 60 days of support.

Substantial progress has been made in clinical heart-lung transplantation. Although outcomes vary across centers, 1-year patient survival is now 59%. This study was an attempt to assess consensus among transplant program directors regarding the major determinants of patient outcome. In the National Cooperative Transplantation Study we evaluated consensus through a survey of all heart-lung transplant programs active in 1988. Of the eligible programs, 23 (85%) returned completed surveys. Data on the medical and surgical determinants of outcome were analyzed. There was considerable consensus among program directors as to the importance of several factors. The three most critical predictors of favorable outcomes were periodic pulmonary function tests to detect rejection (85.7%), avoidance of use of prednisone during the first 14 days after transplantation (76.2%), and annual left and right heart catheterization with coronary arteriography (76.2%). Several approaches were considered undesirable or unnecessary. These included electrocardiogram as standard rejection monitoring technique (71.4%), cytoimmunological monitoring as standard rejection monitoring technique (66.7%), and routine steroid discontinuation after transplantation (66.7%). On various other treatment approaches there was little evidence of consensus. These included prophylaxis with acyclovir and severe bronchiolitis as a criterion for retransplantation. Although controversial, consensus conferences are one means by which to evaluate technological innovations. Based on their results, practice guidelines can be developed to better inform third-party payers on issues related to transplantation.

Expanded polytetrafluoroethylene membrane was used to reconstruct the pericardium after ventricular assist device insertion in 7 consecutive patients. One patient remains on support with the membrane in place and 6 have had the membrane removed. The expanded polytetrafluoroethylene membrane protected the device cannulas during repeat sternotomy and expedited the dissection of the heart and great vessels at the time of device removal. Reconstruction of the pericardium with expanded polytetrafluoroethylene membrane is recommended at the time of ventricular assist device insertion.

Congenital abnormalities were encountered in three donor lungs. A donor tracheal bronchus was incorporated into the right bronchial anastomosis. Anomalous pulmonary venous return of the right upper lobe to the superior vena cava and the left upper lobe to the innominate vein were managed by bridging the anomalous veins to the left atrial cuff with autologous pericardium and donor iliac vein, respectively.

Background . This report describes technical details of the right thoracotomy approach for mitral surgery, and analyzes our experience with this procedure for patients with a prior sternotomy. Three methods for myocardial management (hypothermic cardioplegic arrest, beating heart, and fibrillating heart) are compared. Methods . Records were abstracted of patients who had a right thoracotomy between January 1, 1992 and July 1, 1999 for mitral surgery after at least one prior sternotomy. Demographic, operative, and outcome data were collected for analysis. Telephone follow-up was used to measure postoperative New York Heart Association functional status. Results . Eighty-four patients (mean age 60 ± 15 years) had reoperative mitral surgery via a right thoracotomy. Myocardial management included ventricular fibrillation in 10 patients, operation on the beating heart in 58 patients, and hypothermic blood cardioplegia arrest in 16 patients. The mean time in the operating room was 185 ± 73 minutes, and the mean duration of cardiopulmonary bypass was 63 ± 56 minutes. There were no perioperative strokes and the prevalence of death for patients who received cardioplegic arrest was significantly higher than the prevalence of death for patients who had mitral surgery with perfused fibrillating or beating heart techniques ( p = 0.007; Fisher's exact test comparing risk- unadjusted mortality). Conclusions . Right thoracotomy provides efficient exposure for reoperative mitral surgery. Mitral valve procedures on the fibrillating or beating heart are feasible in most patients and are at least as safe as surgery using cardioplegic arrest.

he article in this issue by Gu and colleagues [l] on the T protective effects of the membrane oxygenator on pulmonary injury during cardiopulmonary bypass (CPB) represents another important piece of the complex puzzle relating CPB to its deleterious effects on organ function. For many cardiac surgeons there may be skepticism about the importance, the magnitude, or even the existence of these so-called damaging effects of CPB. Clearly, in the most common cardiac surgical arena of acquired heart disease in the adult patient, the anticipated hospital mortality for patients in the first seven decades of life suffering from acquired mitral valve disease, aortic valve disease, or coronary artery disease who undergo cardiac operations is generally less than 3%. Most patients convalesce normally with little evidence of morbidity. The Phenomenon Despite the normal convalescence of the vast majority of patients undergoing open cardiac operations, the experienced surgeon will occasionally see the patient who has an adverse reaction to the CPB experience (the “postperfusion syndrome”), with evidence of prolonged pulmonary insufficiency, excessive accumulation of extravascular water, and to a variable degree, renal and other organ See also page 573.

Our patient developed a wound infection that involved an implanted left ventricular assist device. At surgery, the pump was washed with a detergent-containing bacteriocidal solution, then antibiotic-impregnated polymethylmethacrylate beads were placed around the pump. The wound was revised using rectus muscle to cover the pump. The incisions have healed and the patient is now at home. She is on no systemic antibiotics and has no evidence of infection 11 months postoperatively.

This study is a retrospective analysis of infections in patients supported by ventricular assist devices (VADs) as a bridge to cardiac transplantation.Infections were assigned to four classes. Class I were patient-related nonblood infections, class II were blood-borne infections, class III were percutaneous site infections, and class IV were infections of intracorporeal VAD components.The cumulative number and incidence of infections were higher during the early VAD experience than in more recent patients (p0.05), although the cumulative number and incidence of class II and IV infections were similar in earlier and later patients. There were 28 serious (ie, class II and IV) infections in 9 patients who died, and 35 serious infections in 11 patients who survived until transplantation. Three of 4 patients with class IV infections died. A larger cumulative number of infections (ie, total class I-IV) was associated with more fungal isolates (p0.001) and more class II and IV infections (p0.02). Positive fungal cultures were obtained in 16 patients, but there were only 3 class III and 1 class IV fungal isolates.Infection remains an important problem for patients with VADs. Bloodstream infections (class II) can often be controlled by appropriate therapy. However, intracorporeal device infections (class IV) are associated with substantial morbidity and mortality. Optimal implant techniques together with optimal wound care, appropriate use of prophylactic antibiotics, and avoidance of infection in indwelling catheters remain the most practical means for minimizing the risk of VAD infection.

An intracorporeal left ventricular assist device was placed as a bridge to cardiac transplantation in a 51-year-old man after an acute myocardial infarction. After 126 days of support, the left ventricular assist device malfunctioned. The pump, which had a tear in its pneumatic drive line, was successfully replaced.

The traditional incision for bilateral sequential lung transplantation is the bilateral anterolateral transsternal thoracotomy with approximation of the sternal fragments with interrupted stainless steel wire loops; this technique may be associated with an unacceptable incidence of postoperative sternal disruption causing chronic pain and deformity. Approximation of the sternal ends was achieved with peristernal cables that passed behind the sternum two intercostal spaces above and below the sternal division, which were then passed through metal sleeves in front of the sternum, the cables tensioned, and the sleeves then crimped. Forty-seven patients underwent sternal closure with this method, and satisfactory bone union occurred in all patients. Six patients underwent removal of the peristernal cables: 1 for infection (with satisfactory bone union after the removal of the cables), 3 for cosmetic reasons, 1 during the performance of a median sternotomy for an aortic valve replacement, and 1 in a patient who requested removal before commencing participation in football. This technique of peristernal cable approximation of sternal ends has successfully eliminated the problem of sternal disruption associated with this incision and is a useful alternative for preventing this complication after bilateral lung transplantation.

Background. The University of Alabama at Birmingham experience with investigational ventricular assist devices (VADs) used as a bridge to transplantation has increased over the past several years; it now includes 27 VAD implantations with 13 VAD runs lasting for extended periods (ie, >30 days). A review of complications experienced by patients during extended VAD runs is warranted before the further development and testing of chronically implanted mechanical circulatory support devices. Methods. This study focuses on the infectious complications of extended VAD support; it includes 13 patients who were supported by either a Thoratec or HeartMate VAD for longer than 30 days pending cardiac transplantation. Infection was defined as any positive culture. The infections were classed according to site and severity as follows: class I were patient-related non-blood-borne infections, class II were blood-borne infections, class III were VAD percutaneous site infections, and class IV were infections of the blood-contacting surfaces or intracorporeal components of the VAD. Results. The 8 Thoratec and 5 HeartMate patients were supported for a total of 1,648 days with a range of 33 to 279 days per patient. Every patient had at least one infection; however, there were 6 patients who had no class II or IV infections during the period of support. One of these 6 patients died of a stroke, whereas the other 5 patients survived VAD support. No trends were identified for a change in the incidence of bacterial compared with fungal infections during the course of VAD support. There was no trend for a greater number of infections in patients who died during VAD support compared with those who survived. Neither class II nor IV infections precluded transplantation. Three patients died during VAD support; 1 died as a direct consequence of fungal infection. Eight patients received transplants. One patient had an unanticipated recovery of cardiac function and the VAD was removed. Support in 1 patient is ongoing. Conclusions. Infection during VAD support pending cardiac transplantation is an important cause of morbidity and mortality in patients maintained for longer than 30 days by circulatory assist. Infectious complications will probably be a prominent component of the risk associated with the use of chronically implanted mechanical circulatory assist devices and will likely have an important effect on the quality of life experienced by these patients.

Profound circulatory failure developed in a 45-year-old man after an acute myocardial infarction. A left ventricular assist device was used successfully to bridge the patient to transplantation despite recurrent and medically refractory ventricular arrhythmias that lasted from the second through the 12th day of circulatory support.

Aortic valve endocarditis with an aortic root abscess cavity was treated by a modification of the standard technique of aortic homograft implantation in 3 patients. At a mean follow-up of 35 months, all 3 patients were well without reoperation or signs of aortic incompetence. This technique may, in some cases, be an alternative to the more complex procedure of homograft aortic root replacement with coronary reimplantation.

Despite increasing experience with the surgical treatment of tricuspid atresia, controversy exists regarding the early and late results of the various surgical options. Between January 1, 1967, and September 1, 1982, 92 patients underwent 147 operations for tricuspid atresia. Eighty-five patients underwent 1 or more palliative operations (108 procedures), with 8 hospital deaths (9%; confidence limits [CL], 6 to 14%). Thirty-eight patients underwent 44 classic (Blalock-Taussig or Gore-Tex) shunts, with 3 early (7%; CL, 3 to 13%) and 3 late deaths. Actuarial survival at 5 years was 78%, but only 56% were alive and free from having to undergo further operation at 5 years. Thirty-seven patients underwent a Fontan procedure, with 5 hospital deaths (14%; CL, 8 to 22%). Of these 37 patients, 34 (92%) had a nonvalved connection between the right atrium and the right ventricular infundibulum or the pulmonary artery. Incremental risk factors for hospital mortality after the Fontan procedure in patients with tricuspid atresia as well as other cardiac anomalies include young age (p = 0.0003), diagnosis other than tricuspid atresia (p = 0.03), and complex associated procedures (p = 0.02). During the year 1983, hospital mortality was 7% (1 out of 14; CL, 1 to 22%) for the Fontan procedure without complex additional procedures. Actuarial survival after a Fontan procedure was 71% at 5 years, with 3 patients requiring late reoperation. Of the survivors, 96% are in New York Heart Association Functional Class I or II. The Fontan procedure without a valve offers good intermediate survival, good functional results, and few reoperations. In patients with diminished pulmonary blood flow, a classic shunt also provides good palliation and good intermediate survival, but there is a necessity for additional operations in many patients within 5 years.