A system-wide extracorporeal membrane oxygenation quality collaborative improves patient outcomes.

OBJECTIVE: Extracorporeal membrane oxygenation (ECMO) use in adult patient populations has grown rapidly with wide variation in practices and outcomes. We evaluated the impact on patient outcomes, resource use, and costs of an initiative to coordinate and standardize best practices across ECMO programs within a large integrated health care system. METHODS: The ECMO Collaborative Project brought clinicians and service-line leaders from 4 programs within a single health care system together with operational subject matter experts tasked with developing and implementing standardized guidelines, order sets, and an internal database to support an automated quarterly report card. Patient outcomes, resource use, and financial measures were compared for the 16 months before (January 2017 to April 2018; "precollaborative," n = 185) versus the 14 months after (November 2018 to December 2019, "postcollaborative," n = 243) a 6-month implementation and blanking period. Subset analyses were performed for venoarterial ECMO, venovenous ECMO, and extracorporeal cardiopulmonary resuscitation. RESULTS: Survival to discharge/transfer increased significantly (in-hospital mortality hazard ratio, 0.75; 95% confidence interval [95% CI], 0.58-0.99) for the postcollaborative versus the precollaborative period (107/185, 57.8% vs 113/243, 46.5%, P = .03), predominantly due to improvement among patients receiving venoarterial ECMO (hazard ratio, 0.61; 95% CI, 0.41-0.91). The percentage of patients successfully weaned from ECMO increased from 58.9% (109/185) to 70% (170/243), P = .02. Complication rates decreased by 40% (incidence rate ratio, 0.60; 95% CI, 0.49-0.72). No significant changes were observed in ECMO duration, intensive care unit or hospital length of stay, or cost-per-case; payment-per-case and contribution-margin-per-case both decreased significantly. CONCLUSIONS: The ECMO Collaborative Project improved survival to discharge/transfer, weaning rates and complications, without additional costs, through coordination and standardization across ECMO programs within a health care system.

High-quality cardiac surgery through teamwork.

The high-quality cardiothoracic surgery program is primed for mindful effective surgery. The challenge lies in attaining mindful skills and efficiency. Herein is one journey toward high departmental quality over two decades.

Outcomes of Moderate-to-Severe Acute Kidney Injury following Left Ventricular Assist Device Implantation.

BACKGROUND: Although acute kidney injury (AKI) is a common complication following cardiac surgery, less is known about the occurrence and consequences of moderate/severe AKI following left ventricular assist device (LVAD) implantation. METHODS: All patients who had an LVAD implanted at our center from 2008 to 2016 were reviewed to determine the incidence of, and risk factors for, moderate/severe (stage 2/3) AKI and to compare postoperative complications and mortality rates between those with and those without moderate/severe AKI. RESULTS: Of 246 patients, 68 (28%) developed moderate/severe AKI. A multivariable logistic regression comprising body mass index and prior sternotomy had fair predictive ability (area under the curve = 0.71). A 1-unit increase in body mass index increased the risk of moderate/severe AKI by 7% (odds ratio = 1.07; 95% confidence interval: 1.03-1.11); a prior sternotomy increased the risk more than 3-fold (odds ratio = 3.4; 95% confidence interval: 1.84-6.43). The group of patients with moderate/severe AKI had higher rates of respiratory failure and death than the group of patients with mild/no AKI. Patients with moderate/severe AKI were at 3.2 (95% confidence interval: 1.2-8.2) times the risk of 30-day mortality compared to those without. Even after adjusting for age and Interagency Registry for Mechanically Assisted Circulatory Support profile, those with moderate/severe AKI had 1.75 (95% confidence interval: 1.03-3.0) times the risk of 1-year mortality compared to those without. DISCUSSION: Risk-stratifying patients prior to LVAD placement in regard to AKI development may be a step toward improving surgical outcomes.

Reoperative sternotomy is associated with primary graft dysfunction following heart transplantation.

OBJECTIVES: Prior sternotomy is associated with increased morbidity and mortality following heart transplantation. However, its effect on primary graft dysfunction (PGD), a major contributor to early mortality, is unknown. Herein, this effect is studied using the International Society for Heart and Lung Transplantation consensus definition for PGD. METHODS: Medical records of consecutive adult cardiac transplants between 2012 and 2016 were reviewed. Baseline characteristics, postoperative findings and 1-year survival were compared between patients with and without prior sternotomy. RESULTS: Among 255 total patients included, 139 (55%) had undergone prior sternotomy; these recipients were older, more often male, had higher body mass index, higher frequencies of united network for organ sharing (UNOS) 1A status and ischaemic cardiomyopathy and experienced longer waitlist times when compared with those without prior sternotomy (all P < 0.018). Postoperatively, the prior sternotomy group exhibited higher rates of mild to severe PGD (32% vs 18%; P = 0.015) and higher short-term mortality (P = 0.017) and 1-year mortality (P = 0.047). They required more blood transfusions, had more postoperative pneumonia, wound infection and longer hospital stays. A stepwise multivariable regression model identified prior sternotomy as a predictor of PGD (odds ratio 2.7). Multiple prior sternotomies was associated with even more UNOS 1A status, ischaemic cardiomyopathy and pneumonia. However, logistic modelling did not show a difference in the rate of PGD between those with 1 or ≥2 prior sternotomies. CONCLUSIONS: Our data suggest that prior sternotomy is a risk factor for PGD. Consistent with previous reports, prior sternotomy is associated with increased morbidity, blood product utilization and 1-year mortality following cardiac transplantation.

Major Adverse Renal and Cardiac Events After Coronary Angiography and Cardiac Surgery.

BACKGROUND: Patients at high risk for having postprocedural complications may receive iodixanol, an iso-osmolar contrast, during coronary angiography to minimize the risk of renal toxicity. For those who also require cardiac surgery, the wait time between angiography and surgery may be a modifiable factor capable of mitigating poor surgical outcomes; however, there have been inconsistent reports regarding the optimal wait time. We sought to determine the effects of wait time between angiography and cardiac surgery, as well as contrast-induced acute kidney injury on the development of major adverse renal and cardiac events (MARCE). METHODS: We merged datasets to identify adults who underwent coronary angiography with iodixanol and subsequent cardiac surgery. RESULTS: Of 965 patients, 126 (13.1%) had contrast-induced acute kidney injury; 133 (13.8%) had MARCE within 30 days and 253 (26.2%) within 1 year of surgery. After adjusting for contrast-induced acute kidney injury, age, and Thakar acute renal failure score, the effect of wait time lost significance for the full cohort, but remained for the subgroup of 654 who had coronary artery bypass graft surgery. Patients undergoing coronary artery bypass graft surgery within 1 day of coronary angiography had an approximate twofold increase in risk of MARCE (30-day hazard ratio 2.13, 95% confidence interval: 1.16 to 3.88, p = 0.014; 1-year hazard ratio 2.07, 95% confidence interval: 1.32 to 3.23, p = 0.002) compared with patients who waited 5 or more days. CONCLUSIONS: Patients who had contrast-induced acute kidney injury and had cardiac surgery within 1 day of angiography had an increased risk of MARCE.

Application of the International Society for Heart and Lung Transplantation (ISHLT) criteria for primary graft dysfunction after cardiac transplantation: outcomes from a high-volume centre†.

OBJECTIVES: A standardized definition for primary graft dysfunction (PGD) after cardiac transplantation was recently proposed by the International Society of Heart and Lung Transplantation (ISHLT). We sought to characterize the outcomes associated with and identify risk factors for PGD following cardiac transplantation using these criteria at a high volume centre. METHODS: Donor and recipient medical records of 201 consecutive adult cardiac transplantations performed between November 2012 and March 2015 were retrospectively reviewed. Patients undergoing isolated heart transplantation were diagnosed with none, mild, moderate, or severe PGD using ISHLT criteria. Cumulative survival was calculated according to the Kaplan­Meier method. Associations of risk factors for combined moderate/severe PGD were assessed with univariate and multivariate analyses. RESULTS: A total of 191 consecutive patients underwent isolated heart transplantation, and 59 (30%) met ISHLT criteria for PGD: 35 (18%) mild, 8 (4%) moderate and 16 (8%) severe. Thirty-day/in-hospital mortality occurred in six (3%) patients, all of whom were diagnosed with severe PGD. Patients with moderate/severe PGD also had significantly increased intensive care unit length of stay (LOS), total LOS, reoperations for bleeding and postoperative infections. Survival at 1-year was diminished with increasing severity of PGD (none 93%, mild 94%, moderate 75% and severe 44%; log-rank P < 0.001). Elevated preoperative creatinine, pretransplantation hospitalized recipient and undersized donor were independently predictive of moderate/severe PGD. CONCLUSIONS: A diagnosis of PGD portends worse outcomes including increased 30-day and 1-year mortality. The ISHLT diagnostic criteria for moderate and severe PGD identify and discriminate patients with PGD in a clinically relevant manner.

Impact of donor age on cardiac transplantation outcomes and on cardiac function.

OBJECTIVES: Although the impact of older donors on heart transplant outcomes has been previously published, the survival results are conflicting. We herein analyse the impact of older donors on transplant survival and myocardial function. METHODS: The records of the patients who underwent heart transplant at Baylor University Medical Center at Dallas from November 2012 until March 2015 were reviewed and the data were extracted. The heart recipients were divided into two groups based on donors age; 50 years of age was the division point. The two groups were compared with regard to the following transplant outcomes: in-hospital and 1-year survival, severe (3R) rejection, primary graft dysfunction, myocardial performance as reflected by the inotropic score, left ventricular ejection fraction, intensive care unit and overall length of stay. RESULTS: Anoxia was more common cause of death in younger donors (43.9%), whereas intracranial bleeding was more frequent in older donors (48.1%, P = 0.016). The in-hospital survival and 1-year survival were the same between the two groups. Additionally, cardiac transplantation from older donors was not associated with higher incidence of graft dysfunction, higher inotropic support score, longer intensive care unit and total hospital length of stay or more frequent severe rejection episodes. The left ventricular ejection fraction was similar between the two groups. CONCLUSIONS: Heart transplant from older donors is not associated with lower in-hospital and mid-term survival if donors are carefully selected; furthermore, the graft function is comparable. The use of hearts from donors older than 50 years of age can be expanded beyond critically ill recipients in carefully selected recipients.

Effectiveness and Safety of the Impella 5.0 as a Bridge to Cardiac Transplantation or Durable Left Ventricular Assist Device.

Many patients with end-stage heart failure require mechanical circulatory support as a temporizing measure to enable multidisciplinary assessment for the most suitable therapeutic strategy. Impella 5.0 can be used as a bridge to decision to evaluate patients for potential recovery or bridge to next therapy (bridge to heart transplantation [BTHT] or bridge to durable left ventricular assist device or VAD [BLVAD]. Our goal was to examine single-center outcomes with the Impella 5.0 device as a bridge to next therapy (BTHT or BTLVAD). Forty patients underwent Impella 5.0 support from December 2009 to December 2015 with the intent of BTHT (n = 20) or BTLVAD (n = 20). The primary end point was survival to next therapy. Secondary end points included hemodynamic assessments and in-hospital/30-day complications. All patients were inotrope-dependent, with severely depressed left ventricular ejection fraction (12%) and renal insufficiency (creatinine 2.0 mg/dl). Most were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 2 (66%) with biventricular failure (65%). Thirty patients (75%) survived to next therapy, including transplant (n = 13), durable LVAD (n = 15), and recovery of native heart function (n = 2). No strokes or major bleeding events requiring surgery were observed. Acute renal dysfunction, bleeding requiring transfusion, hemolysis, device malfunction, limb ischemia occurred in 13 (33%), 11 (28%), 3 (8%), 4 (10%), and 1 (3%) patients, respectively. Survival rate to discharge and/or 30 days was 68% (27 of 40). Temporary support with the Impella 5.0 allows for an effective bridge to decision strategy for hemodynamic stabilization and multidisciplinary heart team assessment of critically ill patients with heart failure. In conclusion, many of these patients can be subsequently bridged to the next therapy with favorable outcomes.

How to Do It: The Commando Operation for Reconstruction of the Fibrous Skeleton with Double Valve Replacement.

Infiltrative processes that extend into the intervalvular fibrosa, such as infection or calcification, often mandate a complex reconstructive procedure known as the Commando operation. First described less than 20 years ago, this operation is not widely implemented, with experience limited to a few select centers. This report provides a detailed summary of our approach to this intricate procedure.

Utility of cardiac computed tomography for inflow cannula patency assessment and prediction of clinical outcome in patients with the HeartMate II left ventricular assist device.

OBJECTIVES: Proper inflow cannula orientation during implantation of the HeartMate II (HMII) left ventricular assist device (LVAD) is important for optimal pump function. This article describes our experience with cardiac computed tomography (CCT) to evaluate inflow cannula patency and predict future adverse outcomes (AE) after HMII LVAD implantation. METHODS: Ninety-three patients underwent HMII LVAD implantation for end-stage cardiomyopathy from January 2010 until March 2014. A total of 25 consecutive patients had CCT after the implantation; 3 patients were excluded from the analysis due to associated abnormality of the outflow graft. The 22 patients with CCT after HMII LVAD were censored for adverse events related to LVAD malfunction after HMII LVAD implantation. The maximum percentage of inflow cannula obstruction on CCT was recorded. We analysed the predictive value of CCT in addition to other clinical and diagnostic variables for future AEs. RESULTS: Seven of the 22 patients (32%) experienced AEs after HMII LVAD implantation. The degree of inflow cannula obstruction was higher in the group of patients who experienced an AE (70 vs 14%; P < 0.001). Inflow cannula obstruction >30% showed excellent correlation with AE longitudinally based on receiver operating curve (0.829). The group with AEs more frequently experienced CHF symptoms (P = 0.054). CONCLUSIONS: Inflow cannula obstruction >30% on CCT predicts future adverse events in patients with HMII LVAD; the need for surgical intervention in terms of LVAD exchange or urgent listing for heart transplantation should be considered in good surgical risk patients. Cardiac computed tomography should be considered routinely postoperatively in patients with HMII LVAD.

The two extremes of cardiac sarcoidosis and the effect of Prednisone therapy.

Described herein are clinical and morphologic findings in 2 patients who underwent heart transplantation because of severe heart failure resulting from cardiac sarcoidosis. Although the explanted hearts in each patient had characteristic gross changes of cardiac sarcoidosis, one patient who had been treated with prednisone, had no residual sarcoid granulomas in the myocardium, whereas the other patient, in whom diagnosis was not made until heart transplantation, had innumerable sarcoid granulomas in her heart. This report suggests that prednisone can eliminate sarcoid granulomas in the heart but that their replacement is by dense fibrous tissue, something also likely the result of the granulomas themselves, creating a situation where the treated (prednisone) and the non-treated sarcoid heart may appear similar by gross examination.

Outcomes of axillary artery side graft cannulation for extracorporeal membrane oxygenation.

OBJECTIVE: To determine the safety, efficacy, and frequency of side graft axillary artery cannulation for extracorporeal membrane oxygenation support and compare it with other cannulation techniques. METHODS: From January 2001 to October 2011, 308 adult patients were supported with extracorporeal membrane oxygenation at a single center. In 81 patients (26.3%), the extracorporeal membrane oxygenation circuit was composed of an arterial inflow by a side graft sewn to the axillary artery. Of the 308 patients, 166 (53.9%) underwent femoral arterial cannulation and 61 (19.8%) underwent ascending aortic cannulation The pertinent variables and postprocedural events were retrospectively analyzed in this cohort of patients. RESULTS: The most common complication in the axillary artery group was hyperperfusion syndrome of the ipsilateral upper extremity (n = 20, 24.7%), followed by bleeding from the arterial outflow graft (n = 14, 17.3%). Lower extremity ischemia and fasciotomy were more frequent after femoral arterial cannulation (n = 27, 16%, and n = 18, 10.8%, respectively). The predictors for a poor in-hospital outcome for the entire group of patients were age and postoperative cerebral vascular accident. The cannulation method was not a predictor of in-hospital outcomes. CONCLUSIONS: Extracorporeal membrane oxygenation support with side graft axillary artery technique was more frequently associated with hyperperfusion syndrome than other cannulation sites. Lower extremity ischemia and compartment syndrome was more common after femoral arterial cannulation.

Combined heart and liver transplantation: the Cleveland Clinic experience.

BACKGROUND: Combined heart-liver transplantation (CHLT) has been utilized as a life-saving procedure in those with end-stage cardiac and hepatic pathology. Techniques and outcomes of this procedure are varied. We sought to review the Cleveland Clinic experience with CHLT. METHODS: This study is a retrospective chart review of patients who received simultaneous heart and liver transplantation between January 2006 and December 2012. RESULTS: Five patients received CHLT. The mean age was 49 (± 20) years. All cardiac pathology was nonischemic cardiomyopathy, with a mean ejection fraction of 0.36 (± 0.13). Three of the 5 were on preoperative inotropic support, 1 of which required placement of a total artificial heart for support pretransplant. Liver pathology was amyloid in 1 patient and hepatitis C in the remaining 4. Mean Model for End-Stage Liver Disease score was 17 (± 5), and mean Childs-Pugh score was 8 (± 1). Survival, now at a mean of 38 (± 20) months remains 100%, with no cardiac or hepatic graft dysfunction or episodes of rejection. One hospital readmission was required for gastroenteritis at 15 months posttransplant. CONCLUSIONS: These results suggest that excellent outcomes can be achieved in this extremely sick cohort of patients, and add to the growing literature of perioperative management of CHLT recipients.

Inflow graft interruption as a simple method for left ventricular assist device removal after successful bridge to recovery.

In this report we provide another method of ventricular assist device separation by simply transecting the inflow graft of a Heart Mate II LVAD without the need of dissecting the left ventricular apex for cases of myocardial recovery.

Outcomes of simultaneous liver transplantation and elective cardiac surgical procedures.

BACKGROUND: Many centers are reticent to list patients for liver transplantation until coexistent cardiac disease is surgically corrected. Previous studies have documented considerable morbidity and mortality in liver failure patients undergoing cardiac operations. This study examined whether elective cardiac operations at the time of hepatic transplantation would yield enhanced outcomes. METHODS: Between July 1999 and June 2010, 10 patients underwent simultaneous liver transplantation and elective cardiac operations at a single institution. Postoperative outcomes were analyzed using a prospectively maintained database. RESULTS: The 10 patients were men (mean age, 59.8 ± 8.3 years): 7 were in Child-Pugh class B and 3 were in class C. Mean Model for End-Stage Liver Disease score was 17.0 ± 5.8. Cardiac operations included coronary artery bypass grafting in 1, aortic valve replacement in 4, coronary artery bypass grafting and aortic valve replacement in 3, coronary artery bypass grafting and mitral valve repair in 1, and tricuspid valve repair in 1. In-hospital mortality was 20%. Mean postoperative length of stay was 23 ± 8 days. Actuarial survival at 3 years was 70%. CONCLUSIONS: Survival was modestly improved relative to that observed in previous studies of advanced liver failure patients undergoing heart operations without concomitant hepatic replacement. Moreover, the medium-term survival outcomes approach those documented with liver transplant alone. Further studies are warranted with this combined surgical strategy to determine if such an approach would be routinely preferable to staged repair of cardiac pathology and liver transplant.

Impact of donor high-risk social behaviors on recipient survival in cardiac transplantation.

OBJECTIVE: To investigate the impact of cardiac donor participation in high-risk social behaviors (HRSBs) on recipient survival. METHODS: Retrospective chart review queried cardiac transplantations performed at our institution from August 1994 to November 2007 involving donors known to have engaged in HRSBs. Kaplan-Meier methodology was used to analyze survival rates, and a Cox proportional hazards regression was performed to determine the impact of donor HRSBs on survival. RESULTS: We identified 143 donors with social histories containing the following HRSBs: incarceration (n=69), unprofessional tattoos or piercings (n=44), alternative lifestyle practice (n=11), cocaine use (n=60), heroin smoking (n=6), marijuana use (n=79), oral narcotic abuse (n=20), and intravenous drug use (n=21). At the time of donation, viral screens detected 10 donors who were hepatitis B virus (HBV) positive, 11 donors who were hepatitis C virus (HCV) positive, and no donors who were positive for the HIV. One-year and 5-year survival were 92.2% and 84.4%, respectively. Cox regression analysis found only donor HCV infection to be associated with poorer recipient survival (P=0.14). CONCLUSION: Using cardiac allografts from high-risk donors who are serologically negative for viruses does not seem to impact recipient survival. There is a considerable risk for transmission of HBV and HCV when these are detected by pretransplant screens. However, if pretransplant screening does not discover donor HBV, HCV, or HIV infection, it is unlikely that subclinical disease transmission will occur.

One hundred days or more bridged on a ventricular assist device and effects on outcomes following heart transplantation.

BACKGROUND: Successful bridging to transplantation (BTT) with ventricular assist devices (VAD) is an alternative to mitigate the effects of end-stage heart failure on organ function while awaiting a heart. The effects of long-term VAD BTT on patient outcomes following transplantation are poorly studied. METHODS: A retrospective chart review identified 145 patients BTT with a VAD between November of 1996 and June of 2005 at the Cleveland Clinic. Patients were divided into two groups and outcomes were compared: group 1 was supported for <100 days (median=44 days) and group 2 was supported for > or =100 days (median=161 days). RESULTS: Patients in group 1 were less likely to be blood type O (33% vs 68%, p<0.0001). BTT <100 days trended towards independently predicting improved survival by multivariate proportional hazards analysis (risk ratio=0.75, 95% CI=0.52-1.08, p=0.12), largely due to reduced in-hospital mortality in this group (2% vs 11%, p=0.055); however, no significant difference with respect to long-term survival was observed by Kaplan-Meier analysis (p=0.14). Furthermore, causes of death differed between groups: group 1 more commonly died of coronary artery vasculopathy (26% vs 0%, p=0.022) and group 2 more commonly died of sepsis (60% vs 26%, p=0.026). Ultimately, 21% of all group 2 patients died from sepsis (compared to 7% of group 1 patients, p=0.018). CONCLUSIONS: This study suggests that prolonged BTT with a VAD is a viable treatment strategy but may lead to significantly more post-transplant deaths from sepsis and higher in-hospital mortality. These data may inform management of this high-risk patient population.

Prognosis of patients removed from a transplant waiting list for medical improvement: implications for organ allocation and transplantation for status 2 patients.

OBJECTIVES: To address the present controversy regarding optimal management of status 2 heart transplant candidates, we studied the short- and long-term fate of medically improved patients removed from our transplant waiting list to assess return of heart failure and occurrence of sudden cardiac death, identify interventions to improve outcomes, and compare their survival with that of similar transplanted patients. METHODS: From January 1985 to February 2004, 100 status 2 patients were delisted for medical improvement (median on-list duration, 314 days). Return of heart failure, sudden cardiac death, and all-cause mortality were determined from follow-up (mean, 7.7 +/- 3.9 years among survivors; 10% followed >12 years). Hazard function modeling, competing-risks analyses, simulation, and propensity matching to equivalent patients undergoing transplantation were used to analyze and compare outcomes and predict benefit of interventions. RESULTS: Freedom from return of heart failure was 77% at 5 years. The most common mode of death was sudden cardiac death, with risk peaking at 2.5 years after delisting but remaining at 3.5% per year thereafter. Event-free survival at 1, 5, and 10 years was 94%, 55%, and 28%, respectively; simulation demonstrated that implantable cardioverter-defibrillators could have improved this to 45% at 10 years. Overall survival after delisting was better than that of matched status 2 patients who underwent transplantation, but was demonstrably worse after 30 months. CONCLUSIONS: Status 2 patients, including those delisted, require vigilant surveillance and optimal medical management, implantable cardioverter-defibrillators, and a revised approach to transplantation timing, such that overall salvage is maximized while allocation of scarce organs is optimized.

Orthotopic heart transplantation through minimally invasive approach.

Minimal access approaches are a trend in cardiothoracic surgery. Gained experience in these minimally invasive techniques have allowed its application to more complicated procedures, such as heart transplantation. Both classic and bicaval techniques of cardiac transplant were performed through a partial lower sternotomy in 10 end-stage heart failure patients with no previous cardiac surgery. The procedure was considered safe with adequate exposure, minimal postoperative pain medication requirements, acceptable operative times, and good long-term outcome.