Search

An 82-year-old man with a HeartMate II left ventricular assist device presented with low-flow alarms and cardiogenic shock secondary to left ventricular assist device outflow graft obstruction. Given high risk for redo sternotomy, the heart team decided on percutaneous intervention with peripheral stents, a procedure that is currently limited to case reports. (Level of Difficulty: Advanced.), Central Illustration

Background In-hospital ST-elevation myocardial infarction (STEMI) is associated with a higher mortality rate than out-of-hospital STEMI. Quality measures and universal protocols for treatment of in-hospital STEMI do not exist, likely contributing to delays in recognition and treatment. Hypothesis To analyze differences in mortality among three subsets of patients who develop in-hospital STEMI. Methods This was a multicenter, retrospective observational study of patients who developed in-hospital STEMI at six United States medical centers between 2008 and 2017. Patients were stratified into three groups: (1) cardiac, (2) periprocedure, or (3) noncardiac/nonpostprocedure. Outcomes examined include time from electrocardiogram (ECG) acquisition to cardiac catheterization lab arrival (ECG-to-CCL) and survival to discharge. Results We identified 184 patients with in-hospital STEMI (mean age 68.7 years, 58.7% male). Group 1 (cardiac) patients had a shorter average ECG-to-CCL time (69 minutes) than group 2 (periprocedure, 215 minutes) and group 3 (noncardiac/nonpostprocedure, 199 minutes). Compared to group 1, survival to discharge was lower for group 2 (OR 0.33, P = .102) and group 3 (OR 0.20, P = .016). After adjusting for prespecified covariates, the relationship between group and survival showed a similar trend but did not reach statistical significance. Conclusions Patients who develop in-hospital STEMI in the context of a preceding procedure or noncardiac illness appear to have longer reperfusion times and higher in-hospital mortality than patients admitted with cardiac diagnoses. Larger studies are warranted to further investigate these observations. Health systems should place an increased emphasis on developing quality metrics and implementing quality improvement initiatives to improve outcomes for in-hospital STEMI.

More than 1 million heart failure hospitalizations occur annually, and congestion is the predominant cause. Rehospitalizations for recurrent congestion portend poor outcomes independently of age and renal function. Persistent congestion trumps serum creatinine increases in predicting adverse heart failure outcomes. No decongestive pharmacological therapy has reduced these harmful consequences. Simplified ultrafiltration devices permit fluid removal in lower-acuity hospital settings, but with conflicting results regarding safety and efficacy. Ultrafiltration performed at fixed rates after onset of therapy-induced increased serum creatinine was not superior to standard care and resulted in more complications. In contrast, compared with diuretic agents, some data suggest that adjustment of ultrafiltration rates to patients' vital signs and renal function may be associated with more effective decongestion and fewer heart failure events. Essential aspects of ultrafiltration remain poorly defined. Further research is urgently needed, given the burden of congestion and data suggesting sustained benefits of early and adjustable ultrafiltration.

Timely reperfusion therapy reduces complications and improves survival in ST elevation myocardial infarction (STEMI). An effective chain of survival has been established for STEMIs occur in the community (outpatient STEMI). Recent studies have identified a subgroup of patients who develop STEMI while hospitalized for primary conditions, often not directly related to coronary artery disease (in-hospital STEMI or inpatient STEMI). This article summarizes current understanding of patient demographics, clinical characteristics, care delivery system and outcomes of in-hospital STEMI, comparing with outpatient STEMI. We also identified opportunities for quality improvement and proposed strategies and future directions to improve care for these patients.

Objectives Without early revascularization, both inpatient and outpatient STEMIs have poor outcomes. Reasons for denying PCI for STEMI, however, remain uncertain. This single-center retrospective cohort study compares factors and outcomes associated with ineligibility for PCI between inpatients and outpatients following ST-elevation myocardial infarction (STEMI). Methods A total of 1,759 STEMI patients between June 2009 and January 2015 were assessed. Individual medical records were reviewed to obtain reasons for PCI ineligibility for STEMI patients who did not receive reperfusion therapy. Results Compared to outpatients with STEMI (n = 1,688), inpatients (n = 71) were less likely to receive coronary angiography (60.6% vs 95.9%; P

Purpose Approximately 5.7 million adults in the United States are diagnosed with heart failure (HF). Durable mechanical circulatory support (MCS) is a proven therapy to improve survival for those who progress to stage IV HF and have failed guideline directed medical therapy (GDMT). When selecting candidates for durable MCS, ISHLT guidelines recommend a detailed psychosocial assessment including: treatment adherence/health behaviors, mental health history, substance use history, cognitive status and capacity to give consent, knowledge and understanding of illness and treatment options, coping with illness, social support, social history, knowledge about and capacity to operate MCS devices. Currently, there are no formally validated psychosocial evaluation tools for LVAD candidacy; though they are commonly used for heart transplant evaluation. The Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) uses a multidisciplinary algorithm to evaluate the impact of pre-transplant risk factors on post-transplant outcomes. Emerging literature suggests that the SIPAT might be useful for assessing psychosocial risk factors for LVAD intervention; though further research is needed. Methods This study examined the association of SIPAT scores for patients undergoing evaluation for durable MCS with 30-day readmission, 30-day mortality, two-year readmission and two-year mortality rates. Two hundred and sixty-eight (268) consecutive patients (median age 66 years, 15.4% female) with terminal HF were evaluated prior to LVAD implantation with a SIPAT assessment. Two hundred and thirty-four (234) of those patients had available 30-day and 2-year outcome data. Results Results indicated a significant relationship between total scores on the SIPAT and two-year mortality rates (r= .251, n= 234, p Conclusion Consistent with transplant outcomes, higher SIPAT scores were associated with poorer outcomes, specifically mortality, in LVAD patients.

Pheochromocytomas are rare neuroendocrine tumors. They can present with signs of catecholamine excess, multi organ failure and features of stress induced (Takotsubo) cardiomyopathy. A 34-year-old female presented to urgent care for chest and abdominal pain following exercise. After transfer to the

Journal of synchrotron radiation 25(4), 1030 - 1035 (2018). doi:10.1107/S1600577518005945, In the context of a novel, high-resolution resonant inelastic X-ray scattering spectrometer, a flat-crystal-based quartz analyzer system has recently been demonstrated to provide an unprecedented intrinsic-energy resolution of 3.9 meV at the Ir L3 absorption edge (11.215 keV) [Kim et al. (2018) Sci. Rep. 8, 1958]. However, the overall instrument resolution was limited to 9.7 meV because of an 8.9 meV incident band pass, generated by the available high-resolution four-bounce Si(844) monochromator. In order to better match the potent resolving power of the novel analyzer with the energy band pass of the incident beam, a quartz(309)-based double-bounce, high-resolution monochromator was designed and implemented, expected to yield an overall instrument resolution of 6.0 meV. The choice of lower-symmetry quartz is very attractive because of its wealth of suitable near-backscattering reflections. However, it was found that during room-temperature operation typical levels of incident power, barely affecting the Si monochromator, caused substantial thermal distortions in the first crystal of the quartz monochromator, rendering it practically unusable. Finite-element analyses and heat-flow analyses corroborate this finding. As a high-flux, lower resolution (15.8 meV) alternative, a two-bounce sapphire(078) version was also tested and found to be less affected than quartz, but notably more than silicon., Published by Wiley-Blackwell, [S.l.]

Importance In-hospital ST-segment elevation myocardial infarction (STEMI) is a unique clinical entity with epidemiology, incidence, and outcomes distinct from that of out-of-hospital STEMI and has only within the past 10 years begun to receive increased attention and research. Patients with in-hospital STEMI are older, have more comorbidities, and more frequently have coagulopathies and contraindications for anticoagulation and fibrinolytic therapy. A standardized clinical definition of in-hospital STEMI is lacking. The objectives of this special communication are to (1) summarize the knowledge base regarding in-hospital STEMI; (2) review the challenges of diagnosis and treatment of patients with in-hospital STEMI; (3) present a standardized clinical definition for in-hospital STEMI; and (4) provide a quality improvement protocol to improve diagnosis, triage, and treatment of patients with in-hospital STEMI. Observations Patients with in-hospital STEMI less frequently present with typical angina symptoms, and an electrocardiogram is often obtained owing to changes in clinical status, changes on telemetry, or a finding of elevated cardiac biomarker. The frequent nontypical presentations often lead to substantial delays in the diagnosis of STEMI. Only 34% to 71% of patients with in-hospital STEMI undergo diagnostic catheterization, and only 22% to 56% undergo percutaneous coronary intervention. Even in contemporary reports, some studies report in-hospital mortality in the range of 31% to 42%. Three areas of delay in the treatment of patients with in-hospital STEMI that merit particular attention are (1) delays in electrocardiogram acquisition, (2) delays in electrocardiogram interpretation, and (3) delays in activation of existing STEMI systems of care. Conclusions and Relevance Treatment of patients with in-hospital STEMI is more complex and challenging than treatment of patients who develop out-of-hospital STEMI, leading to delays in diagnosis and triage and less frequent use of reperfusion therapy. Quality improvement programs targeted at decreasing delays and streamlining treatment of such patients may improve treatment and outcome.

In the 1620s two attempts were made to date the Utrecht Psalter (c.830, in or around Reims): by its owner Robert Cotton and by the theologian James Ussher. Their results offer an insight into how a collector and a scholar practised palaeography before this became a modern study in the decades around 1700. The Utrecht Psalter, as well as the Cotton Genesis and other manuscripts, were dated in relation to their script, decoration and content. This case study underlines that the history of palaeography and codicology before Mabillon and Montfaucon is worth studying, not only in its own right, but also with regard to the development of humanism and its scholarly networks.

Mitral regurgitation commonly improves after implantation of a left ventricular assist device without concomitant valvular repair owing to the mechanical unloading of the left ventricle. However, the development (or persistence) of significant mitral regurgitation after implantation of a left ventricular assist device is associated with adverse clinical events. We present a case of a left ventricular assist device patient who successfully underwent a percutaneous MitraClip procedure for repair of persistent late postoperative mitral insufficiency with demonstrable clinical and hemodynamic improvement.

Objectives This study was a multicenter, single-arm, double-blinded observational prospective clinical trial designed to monitor daily concentrations of B-type natriuretic peptide (BNP) and to determine how these concentrations correlate with acute clinical heart failure decompensation (ADHF) and related adverse clinical outcomes in at-risk HF patients. Background Although BNP at discharge is predictive of 30-day outcomes, outpatient serial testing may improve the risk of detecting early decompensation. Methods A total of 163 patients with HF signs and symptoms of ADHF discharged from the hospital or in an outpatient setting measured their weight and BNP levels daily for 60 days with a finger-stick test. Patients and physicians were blinded to BNP levels. The composite outcome was ADHF events: cardiovascular death, admission for decompensated HF, or clinical HF decompensation requiring either parenteral HF therapy or changes in oral HF medications. Results A total of 6,934 daily BNP values were recorded, with a median of 46 measures per patient over a monitoring period of 65 days. Forty patients had 56 events. Correlations between BNP measures weakened over time, and the dispersion between BNP measures grew. During 10,035 patient-days, there were 494 (4.9%) days of weight gain (≥5 lbs). The hazard ratio per unit increase of ln BNP was 1.84, and the hazard ratio on a day of weight gain was 3.63. These effects retained significance when controlling for symptoms. When the monitoring period for each subject was broken into intervals based on ADHF events, there were 39 (18.4%) intervals of upward trending BNP corresponding to a risk increase of 59.8% and 64 (30.2%) downward trending intervals corresponding to a risk decrease of 39.0%. There were 94 (44.3%) intervals with 1 or more days of weight gain corresponding to a risk increase of 26.1%. Conclusions This pilot study demonstrates that home BNP testing is feasible and that trials using home monitoring for guiding therapy are justifiable in high-risk patients. Daily weight monitoring is complementary to BNP, but BNP changes correspond to larger changes in risk, both upward and downward. (Heart Failure [HF] Assessment with B-type Natriuretic Peptide [BNP] In the Home [HABIT]; NCT00946231)

Objectives The aim of this study was to derive and validate a model to predict survival in candidates for HeartMate II (HMII) (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) support. Background LVAD mortality risk prediction is important for candidate selection and communicating expectations to patients and clinicians. With the evolution of LVAD support, prior risk prediction models have become less valid. Methods Patients enrolled into the HMII bridge to transplantation and destination therapy trials (N = 1,122) were randomly divided into derivation (DC) (n = 583) and validation cohorts (VC) (n = 539). Pre-operative candidate predictors of 90-day mortality were examined in the DC with logistic regression, from which the HMII Risk Score (HMRS) was derived. The HMRS was then applied to the VC. Results There were 149 (13%) deaths within 90 days. In the DC, mortality (n = 80) was higher in older patients (odds ratio [OR]: 1.3, 95% confidence interval [CI]: 1.1 to 1.7 per 10 years), those with greater hypoalbuminemia (OR: 0.49, 95% CI: 0.31 to 0.76 per mg/dl of albumin), renal dysfunction (OR: 2.1, 95% CI: 1.4 to 3.2 per mg/dl creatinine), coagulopathy (OR: 3.1, 95% CI: 1.7 to 5.8 per international normalized ratio unit), and in those receiving LVAD support at less experienced centers (OR: 2.2, 95% CI: 1.2 to 4.4 for Conclusions The HMRS might be useful for mortality risk stratification in HMII candidates and may serve as an additional tool in the patient selection process.

Summary Background Sarcoplasmic/endoplasmic reticulum Ca 2+ -ATPase (SERCA2a) activity is deficient in the failing heart. Correction of this abnormality by gene transfer might improve cardiac function. We aimed to investigate the clinical benefits and safety of gene therapy through infusion of adeno-associated virus 1 (AAV1)/SERCA2a in patients with heart failure and reduced ejection fraction. Methods We did this randomised, multinational, double-blind, placebo-controlled, phase 2b trial at 67 clinical centres and hospitals in the USA, Europe, and Israel. High-risk ambulatory patients with New York Heart Association class II–IV symptoms of heart failure and a left ventricular ejection fraction of 0·35 or less due to an ischaemic or non-ischaemic cause were randomly assigned (1:1), via an interactive voice and web-response system, to receive a single intracoronary infusion of 1 × 10 13 DNase-resistant particles of AAV1/SERCA2a or placebo. Randomisation was stratified by country and by 6 min walk test distance. All patients, physicians, and outcome assessors were masked to treatment assignment. The primary efficacy endpoint was time to recurrent events, defined as hospital admission because of heart failure or ambulatory treatment for worsening heart failure. Primary efficacy endpoint analyses and safety analyses were done by modified intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01643330. Findings Between July 9, 2012, and Feb 5, 2014, we randomly assigned 250 patients to receive either AAV1/SERCA2a (n=123) or placebo (n=127); 243 (97%) patients comprised the modified intention-to-treat population. Patients were followed up for at least 12 months; median follow-up was 17·5 months (range 1·8–29·4 months). AAV1/SERCA2a did not improve time to recurrent events compared with placebo (104 vs 128 events; hazard ratio 0·93, 95% CI 0·53–1·65; p=0·81). No safety signals were noted. 20 (16%) patients died in the placebo group and 25 (21%) patients died in the AAV1/SERCA2a group; 18 and 22 deaths, respectively, were adjudicated as being due to cardiovascular causes. Interpretation CUPID 2 is the largest gene transfer study done in patients with heart failure so far. Despite promising results from previous studies, AAV1/SERCA2a at the dose tested did not improve the clinical course of patients with heart failure and reduced ejection fraction. Although we did not find evidence of improved outcomes at the dose of AAV1/SERCA2a studied, our findings should stimulate further research into the use of gene therapy to treat patients with heart failure and help inform the design of future gene therapy trials. Funding Celladon Corporation.

The proposed Advanced Photon Source (APS) upgrade from a double-bend achromats (DBA) to multi-bend achromats (MBA) lattice with ring energy change from 7 GeV to 6 GeV and beam current from 100 mA to 200 mA poses new challenges for front ends. All front ends must be upgraded to fulfill the following requirements: 1) handle the high heat load from two insertion devices in either inline or canted configuration, 2) include a clearing magnet in the front end to deflect and dump any electrons in case the electrons escape from the storage ring during swap-out injection with the safety shutters open, 3) incorporate the next generation x-ray beam position monitors (XBPMs) into the front end to meet the new stringent beam stability requirements. This paper presents the evaluation of the existing APS front ends and standardizes the insertion device (ID) front ends into two types: one for the single beam and one for the canted beams. The conceptual design of high heat load front end (HHLFE) and canted undulator front...

Background Out-of-hospital cardiac arrest carries a dismal prognosis. Percutaneous extracorporeal membrane oxygenation (ECMO) has been used with success for in-hospital arrests, and some literature suggests improvement in long-term survival for out-of-hospital arrests as well. Objectives This case highlights the use of ECMO in the emergency department. Case Report We report a case in which emergency physician-initiated ECMO was used as a bridge to definitive care in an out-of- hospital cardiac arrest in the United States. Conclusions ECMO is a novel adjunct for patients in cardiac arrest in whom the usual advanced life support techniques have failed.

Background The HeartMate II (Thoratec Corp, Pleasanton, CA) continuous-flow left ventricular assist device (LVAD) improved survival in destination therapy (DT) patients during a randomized trial compared with pulsatile-flow LVADs. This study documented changes in cognitive performance in DT patients from that trial to determine if there were differences between continuous-flow and pulsatile-flow support. Methods Data were collected in a sub-study from 96 HeartMate II continuous-flow and 30 HeartMate XVE pulsatile-flow LVAD patients from 12 of the 35 trial sites that followed the same serial neurocognitive (NC) testing protocol at 1, 3, 6, 12, and 24 months after LVAD implantation. Spatial perception, memory, language, executive functions, and processing speed were the domains assessed with 10 standard cognitive measures. Differences over time and between LVAD type were evaluated with linear mixed-effects modeling. Results From 1 to 24 months after LVAD implantation, changes in NC functions were stable or showed improvement in all domains, and there were no differences between the continuous-flow and pulsatile-flow groups. Data at 24 months were only available from patients with the continuous-flow LVAD due to the limited durability of the HeartMate XVE device. There was no decline in any NC domain over the time of LVAD support. Missing data not collected from patients who died could have resulted in a bias toward inflated study results. Conclusions The NC performance of advanced heart failure patients supported with continuous-flow and pulsatile-flow LVADs shows stabilization or improvement during support for up to 24 months.

Background— Adeno-associated virus type 1/sarcoplasmic reticulum Ca 2+ -ATPase was assessed in a randomized, double-blind, placebo-controlled, phase 2 study in patients with advanced heart failure. Methods and Results— Thirty-nine patients received intracoronary adeno-associated virus type 1/sarcoplasmic reticulum Ca 2+ -ATPase or placebo. Seven efficacy parameters were assessed in 4 domains: symptoms (New York Heart Association class, Minnesota Living With Heart Failure Questionnaire), functional status (6-minute walk test, peak maximum oxygen consumption), biomarker (N-terminal prohormone brain natriuretic peptide), and left ventricular function/remodeling (left ventricular ejection fraction, left ventricular end-systolic volume), plus clinical outcomes. The primary end point success criteria were prospectively defined as achieving efficacy at 6 months in the group-level (concordant improvement in 7 efficacy parameters and no clinically significant worsening in any parameter), individual-level (total score for predefined clinically meaningful changes in 7 efficacy parameters), or outcome end points (cardiovascular hospitalizations and time to terminal events). Efficacy in 1 analysis had to be associated with at least a positive trend in the other 2 analyses. This combination of requirements resulted in a probability of success by chance alone of 2.7%. The high-dose group versus placebo met the prespecified criteria for success at the group-level, individual-level, and outcome analyses (cardiovascular hospitalizations) at 6 months (confirmed at 12 months) and demonstrated improvement or stabilization in New York Heart Association class, Minnesota Living With Heart Failure Questionnaire, 6-minute walk test, peak maximum oxygen consumption, N-terminal prohormone brain natriuretic peptide levels, and left ventricular end-systolic volume. Significant increases in time to clinical events and decreased frequency of cardiovascular events were observed at 12 months (hazard ratio=0.12; P =0.003), and mean duration of cardiovascular hospitalizations over 12 months was substantially decreased (0.4 versus 4.5 days; P =0.05) on high-dose treatment versus placebo. There were no untoward safety findings. Conclusions— The Calcium Upregulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID) study demonstrated safety and suggested benefit of adeno-associated virus type 1/sarcoplasmic reticulum Ca 2+ -ATPase in advanced heart failure, supporting larger confirmatory trials. Clinical Trial Registration— http://www.clinicaltrials.gov . Unique identifier: NCT00454818.

Objectives The primary objective of this study was to determine outcomes in left ventricular assist device (LVAD) patients older than age 70 years. Background Food and Drug Administration approval of the HeartMate II (Thoratec Corporation, Pleasanton, California) LVAD for destination therapy has provided an attractive option for older patients with advanced heart failure. Methods Fifty-five patients received the HeartMate II LVAD between October 5, 2005, and January 1, 2010, as part of either the bridge to transplantation or destination therapy trials at a community hospital. Patients were divided into 2 age groups: ≥70 years of age (n = 30) and Results Pre-operatively, all patients were in New York Heart Association functional class IV refractory to maximal medical therapy. Kaplan-Meier survival for patients ≥70 years of age (97% at 1 month, 75% at 1 year, and 70% at 2 years) was not statistically different from patients Conclusions The LVAD patients ≥70 years of age have good functional recovery, survival, and quality of life at 2 years. Advanced age should not be used as an independent contraindication when selecting a patient for LVAD therapy at experienced centers.

Granting clinical staff privileges to physicians is a primary mechanism institutions use to uphold quality care. The Joint Commission on Accreditation of Healthcare Organizations requires that medical staff privileges be based on professional criteria specified in medical staff bylaws. Physicians

Neurocognitive (NC) changes in heart failure patients receiving left ventricular assist devices (LVADs) are not well understood. The purpose of this study was to document changes in the cognitive performance of patients with the continuous-flow HeartMate II LVAD as a bridge to transplant (BTT).A NC protocol was used to evaluate patient performance at 1, 3 and 6 months after LVAD implantation at 11 centers. A total of 239 test sessions were completed in 93 patients including paired evaluations in 51 to 57 patients from 1 to 3 months, and in 20 to 28 patients with results from 1, 3 and 6 months. Five NC domains were assessed, including visual spatial perception, auditory and visual memory, executive functions, language and processing speed.There were statistically significant (p0.05), but limited improvements between 1, 3 and 6 months in NC domain performances as seen in visual memory, executive functions, visual spatial perception and processing speed. There were no significant declines in any neurocognitive test in any domain over these time periods.The cognitive performance of advanced heart failure patients remained stable or showed slight improvements from Month 1 to Month 6 of continuous-blood-flow support with the HeartMate II LVAD.

Giant cell myocarditis (GCM) is a rare and highly lethal disorder. The only multicenter case series with treatment data lacked cardiac function assessments and had a retrospective design. We conducted a prospective, multicenter study of immunosuppression including cyclosporine and steroids for acute, microscopically-confirmed GCM. From June 1999 to June 2005 in a standard protocol, 11 subjects received high dose steroids and cyclosporine, and 9 subjects received muromonab-CD3. In these, 7 of 11 were women, the mean age was 60 +/- 15 years, and the mean time from symptom onset to presentation was 27 +/- 33 days. During 1 year of treatment, 1 subject died of respiratory complications on day 178, and 2 subjects received heart transplantations on days 2 and 27, respectively. Serial endomyocardial biopsies revealed that after 4 weeks of treatment the degree of necrosis, cellular inflammation, and giant cells decreased (p = 0.001). One patient who completed the trial subsequently died of a fatal GCM recurrence after withdrawal of immunosuppression. Her case demonstrates for the first time that there is a risk of recurrent, sometimes fatal, GCM after cessation of immunosuppression. In conclusion, this prospective study of immunosuppression for GCM confirms retrospective case reports that such therapy improves long-term survival. Additionally, withdrawal of immunosuppression can be associated with fatal GCM recurrence.

Mortality events in studies of cardiovascular disease are currently adjudicated using different methodologies depending on the investigators’ preferences. Traditionally, deaths have been categorized by a single term, such as sudden, ischemic, or pump failure, a method that can be referred to as “categorical”. In contrast, deaths may be categorized using several specific pieces of information about the event, a method that can be referred to as “multiparameter descriptive.” Herein, we describe an adaptation of this descriptive method in a trial of patients with heart failure and arrhythmias. Case examples were selected from two clinical trials of an investigational implantable cardioverter–defibrillator (ICD)–biventricular pacing system in patients with symptomatic heart failure and a class I indication for ICD implantation, and the complete results for one of the trials are given. Deaths were classified according to the new descriptive method, and also according to published categorical methods for heart failure and arrhythmia trials. The descriptive method preserved traditional arrhythmia and heart failure trial single category classifications of death. Furthermore, there was agreement between the arrhythmia and heart failure category classifications in 126 of the 148 of the mortality events adjudicated (85%). A descriptive method for the classification of death retains more data and allows for comparison among trials using different classification schemes. This may allow greater mechanistic insight into study populations that have diverse and frequently multiple etiologies of death.

Background Heart failure (HF) remains a major cause of morbidity and mortality in North America. With an aging population and an unmet clinical need by current pharmacologic and device-related therapeutic strategies, novel treatment options for HF are being explored. One such promising strategy is gene therapy to target underlying molecular anomalies in the dysfunctional cardiomyocyte. Prior animal and human studies have documented decreased expression of SERCA2a, a major cardiac calcium cycling protein, as a major defect found in HF. Methods and Results We hypothesize that increasing the activity of SERCA2a in patients with moderate to severe HF will improve their cardiac function, disease status, and quality of life. Gene transfer of SERCA2a will be performed via an adeno-associated viral (AAV) vector, derived from a nonpathogenic virus with long-term transgene expression as well as a clinically established favorable safety profile. Conclusions We describe the design of a phase 1 clinical trial of antegrade epicardial coronary artery infusion (AECAI) administration of AAVI/SERCA2a (MYDICAR) to subjects with HF divided into 2 stages: in Stage 1, subjects will be assigned open-label MYDICAR in one of up to 4 sequential dose escalation cohorts; in Stage 2, subjects will be randomized in parallel to 2 or 3 doses of MYDICAR or placebo in a double-blinded manner.

Objectives This study was designed to compare the safety and efficacy of veno-venous ultrafiltration and standard intravenous diuretic therapy for hypervolemic heart failure (HF) patients. Background Early ultrafiltration may be an alternative to intravenous diuretics in patients with decompensated HF and volume overload. Methods Patients hospitalized for HF with ≥2 signs of hypervolemia were randomized to ultrafiltration or intravenous diuretics. Primary end points were weight loss and dyspnea assessment at 48 h after randomization. Secondary end points included net fluid loss at 48 h, functional capacity, HF rehospitalizations, and unscheduled visits in 90 days. Safety end points included changes in renal function, electrolytes, and blood pressure. Results Two hundred patients (63 ± 15 years, 69% men, 71% ejection fraction ≤40%) were randomized to ultrafiltration or intravenous diuretics. At 48 h, weight (5.0 ± 3.1 kg vs. 3.1 ± 3.5 kg; p = 0.001) and net fluid loss (4.6 vs. 3.3 l; p = 0.001) were greater in the ultrafiltration group. Dyspnea scores were similar. At 90 days, the ultrafiltration group had fewer patients rehospitalized for HF (16 of 89 [18%] vs. 28 of 87 [32%]; p = 0.037), HF rehospitalizations (0.22 ± 0.54 vs. 0.46 ± 0.76; p = 0.022), rehospitalization days (1.4 ± 4.2 vs. 3.8 ± 8.5; p = 0.022) per patient, and unscheduled visits (14 of 65 [21%] vs. 29 of 66 [44%]; p = 0.009). No serum creatinine differences occurred between groups. Nine deaths occurred in the ultrafiltration group and 11 in the diuretics group. Conclusions In decompensated HF, ultrafiltration safely produces greater weight and fluid loss than intravenous diuretics, reduces 90-day resource utilization for HF, and is an effective alternative therapy. (The UNLOAD trial; http://clinicaltrials.gov/ct/show/NCT00124137?order=1; NCT00124137).

Background— Cardiac resynchronization therapy (CRT) alone or combined with an implantable defibrillator (CRT-D) has been shown to improve exercise capacity and quality of life and to reduce heart failure (HF) hospitalizations and mortality in patients with New York Heart Association (NYHA) class III and IV HF. There is concern that the device procedure may destabilize these very ill class IV patients. We sought to examine the outcomes of NYHA class IV patients enrolled in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial to assess the potential benefits of CRT and CRT-D. Methods and Results— The COMPANION trial randomized 1520 patients with NYHA class III and IV HF to optimal medical therapy, CRT, or CRT-D. In the class IV patients (n=217), the primary end point of time to death or hospitalization for any cause was significantly improved by both CRT (hazard ratio [HR], 0.64; 95% CI, 0.43 to 0.94; P =0.02) and CRT-D (HR, 0.62; 95% CI, 0.42 to 0.90; P =0.01). Time to all-cause death and HF hospitalization was also significantly improved in both CRT (HR, 0.57; 95% CI, 0.37 to 0.87; P =0.01) and CRT-D (HR, 0.49; 95% CI, 0.32 to 0.75; P =0.001) Time to all-cause death trended to an improvement in both CRT (HR, 0.67; 95% CI, 0.41 to 1.10; P =0.11) and CRT-D (HR, 0.63; 95% CI, 0.39 to 1.03; P =0.06). Time to sudden death appeared to be significantly reduced in the CRT-D group (HR, 0.27; 95% CI, 0.08 to 0.90; P =0.03). There was a nonsignificant reduction in time to HF deaths for both CRT (HR, 0.68; 95% CI, 0.34 to 1.37; P =0.28) and CRT-D (HR, 0.79; 95% CI, 0.41 to 1.52; P =0.48). Conclusions— CRT and CRT-D significantly improve time to all-cause mortality and hospitalizations in NYHA class IV patients, with a trend for improved mortality. These devices should be considered in ambulatory NYHA class IV HF patients similar to those enrolled in COMPANION.

Objectives The AVOID-HF (Aquapheresis versus Intravenous Diuretics and Hospitalization for Heart Failure) trial tested the hypothesis that patients hospitalized for HF treated with adjustable ultrafiltration (AUF) would have a longer time to first HF event within 90 days after hospital discharge than those receiving adjustable intravenous loop diuretics (ALD). Background Congestion in hospitalized heart failure (HF) patients portends unfavorable outcomes. Methods The AVOID-HF trial, designed as a multicenter, 1-to-1 randomized study of 810 hospitalized HF patients, was terminated unilaterally and prematurely by the sponsor (Baxter Healthcare, Deerfield, Illinois) after enrollment of 224 patients (27.5%). Aquadex FlexFlow System (Baxter Healthcare) was used for AUF. A Clinical Events Committee, blinded to the randomized treatment, adjudicated whether 90-day events were due to HF. Results A total of 110 patients were randomized to AUF and 114 to ALD. Baseline characteristics were similar. Estimated days to first HF event for the AUF and ALD group were, respectively, 62 and 34 (p = 0.106). At 30 days, compared with the ALD group, the AUF group had fewer HF and cardiovascular events. Renal function changes were similar. More AUF patients experienced an adverse effect of special interest (p = 0.018) and a serious study product-related adverse event (p = 0.026). The 90-day mortality was similar. Conclusions Compared with the ALD group, the AUF group trended toward a longer time to first HF event within 90 days and fewer HF and cardiovascular events. More patients in the AUF group experienced special interest or serious product-related adverse event. Due to the trial’s untimely termination, additional AUF investigation is warranted.

Background In patients hospitalized with acutely decompensated heart failure, unresolved signs and symptoms of fluid overload have been consistently associated with poor outcomes. Regardless of dosing and type of administration, intravenous loop diuretics have not reduced heart failure events or mortality in patients with acutely decompensated heart failure. The results of trials comparing intravenous loop diuretics to mechanical fluid removal by isolated venovenous ultrafiltration have yielded conflicting results. Studies evaluating early decongestive strategies have shown that ultrafiltration removed more fluid and was associated with fewer heart failure–related rehospitalization than intravenous loop diuretics. In contrast, when used in the setting of worsening renal function, ultrafiltration was associated with poorer renal outcomes and no reduction in heart failure events. Methods The AVOID-HF trial seeks to determine if an early strategy of ultrafiltration in patients with acutely decompensated heart failure is associated with fewer heart failure events at 90 days compared with a strategy based on intravenous loop diuretics. Study subjects from 40 highly experienced institutions are randomized to either early ultrafiltration or intravenous loop diuretics. In both treatment arms, fluid removal therapies are adjusted according to the patients' hemodynamic condition and renal function. The study was unilaterally terminated by the sponsor in the absence of futility and safety concerns after the enrollment of 221 subjects, or 27% of the originally planned sample size of 810 patients. Conclusions The AVOID-HF trial's principal aim is to compare the safety and efficacy of ultrafiltration vs that of intravenous loop diuretics in patients hospitalized with acutely decompensated heart failure. Because stepped treatment approaches are applied in both ultrafiltration and intravenous loop diuretics groups and the primary end point is time to first heart failure event within 90 days, it is hoped that the AVOID-HF trial, despite its untimely termination by the sponsor, will provide further insight on how to optimally decongest patients with fluid-overloaded heart failure.

Background Heart failure is a common cause of hospitalization and can be divided into types with preserved and reduced ejection fraction (HFpEF and HFrEF, respectively). In this subanalysis of the HABIT (Heart Failure Assessment With BNP in the Home) trial, we examined the differences between home B-type natriuretic peptide (BNP) testing and weight monitoring in patients with HFpEF and with HFrEF before decompensation. Methods and Results This was a retrospective review of patients with HFpEF and HFrEF from the HABIT trial. The HFpEF patients compared with HFrEF patients were older and more obese and had lower baseline BNP values. Intra-individual BNP dispersion (spread of distribution over time) was greater in HFpEF than in HFrEF owing to rapid fluctuations (within 3 days). Slowly varying changes in BNP (estimated by a moving average) were equally predictive of ADHF risk in both HFpEF and HFrEF. However, in HFpEF, a rapid rise in BNP >200 pg/mL within 3 days was associated with an increased risk of acute decompensated heart failure (ADHF; hazard ratio 4.0), whereas a similar association was not observed in HFrEF. Weight gain ≥5 lb in 3 days had a high specificity but low sensitivity for ADHF in both HFpEF and HFrEF, whereas a lower threshold of ≥2 lb weight gain over 3 days in patients with HFpEF (but not HFrEF) was a moderately sensitive cutoff associated with decompensation (60% sensitivity). Conclusions Patients with HFpEF and HFrEF have variations in their BNP and weight before decompensation. The rapid time scale behaves differently between the groups. In those with HFpEF, a 3-day period characterized by ≥2 lb weight gain and/or >200 pg/mL BNP rise was significantly associated with decompensation. Future prospective studies investigating different weight and BNP cutoffs for home monitoring of HFpEF and HFrEF patients should be performed to fully learn the value of BNP changes before clinical deompensation.

Background Patients with advanced heart failure may require long-term support with an intracorporeal left ventricular assist device (LVAD) before cardiac transplant, while awaiting myocardial recovery, or during destination therapy. Compared with the diagnosis of native heart dysfunction, there is less experience with the assessment of recurrent heart failure after LVAD placement. Methods Ten patients (9 men, 1 woman; age, 58 ± 11 years) were studied after LVAD placement. Six patients were studied because of recurrent heart failure; the remaining 4 had other indications for study and are reported here as controls. Cardiac catheterization, including LVAD and cannulae catheterization, and angiography were performed. Results Inflow cannula valve regurgitation by LVAD angiography was found in 3 cases. Patients with regurgitation had a mean increased resting LVAD rate of 105 beats/min (range, 90–120); LVAD output exceeded forward cardiac output (LVAD − thermodilution cardiac output = +3.7 liters/min [0.6–6.4]). Inflow cannula obstruction identified with a filling phase pressure gradient between the left ventricle and the LVAD was found in 3 additional patients. Patients with obstruction had decreased resting LVAD rates (50 beats/min, all patients); LVAD output was less than the forward cardiac output (LVAD − thermodilution cardiac output = −2.3 liters/min [−0.8 to −3.5]). Compared with those with inflow valve regurgitation, patients with cannula obstruction had higher pulmonary capillary wedge pressures; phasic left ventricular pressure variation was reduced. Patients with cannula dysfunction underwent surgical intervention, and 4 of 6 were long-term survivors. Conclusions When heart failure recurs after LVAD placement, abnormalities of the inflow cannula are common. Cardiac catheterization can confirm the diagnosis before surgical intervention. Hemodynamic coupling between the left ventricle and the LVAD is increased with inflow valve regurgitation and reduced with cannula obstruction.

OBJECTIVES The aim of this study was to evaluate the mode of death in patients with advanced chronic heart failure (HF) and intraventricular conduction delay treated with optimal pharmacologic therapy (OPT) alone or OPT with biventricular pacing to provide cardiac resynchronization therapy (CRT) or CRT + an implantable defibrillator (CRT-D). BACKGROUND Limited data are available on mode of death in advanced HF. No data have existed on mode of death in these patients who also have an intraventricular conduction delay and are treated with CRT or CRT-D. METHODS Using prespecified definitions and source materials, seven cardiologists assessed mode of death among the 313 deaths that occurred in the Comparison of Medical, Pacing, and Defibrillation Therapies in Heart Failure (COMPANION) trial. RESULTS A primary cardiac cause was present in 78% of deaths. Pump failure (44.4%) was the most common mode of death followed by sudden cardiac death (SCD) (26.5%). Compared with OPT, CRT-D significantly reduced the number of cardiac deaths (38%, p = 0.006), whereas CRT alone was associated with a non-significant 14.5% reduction (p = 0.33). Both CRT and CRT-D tended to reduce pump failure deaths (29%, p = 0.11 and 27%, p = 0.14, respectively). The CRT-D significantly reduced SCD (56%, p = 0.02), but CRT alone did not. CONCLUSIONS Pump failure deaths are the predominant mode of death in patients with advanced HF and are modestly reduced by both CRT and CRT-D. Only CRT-D reduced SCD and thus produced a favorable effect on cardiac mortality.

Fluid congestion is the hallmark of decompensated heart failure. As heart failure progresses, reduced response to diuretics is common. In these patients, ultrafiltration has been found to alleviate excess volume and improve diuretic sensitivity. Compared with diuretics, ultrafiltration provides a more predictable and safer way to achieve euvolemia with minimal electrolyte abnormalities and neurohormonal activation. The emerging familiarity and ease of use of ultrafiltration suggests that in the future this will be an important therapy for the treatment of acute and chronic volume overload associated with decompensated heart failure.

Background— Progression of heart failure can lead to cardiac transplantation, but when patients are ineligible, long-term mechanical circulatory support may improve survival. The REMATCH trial showed that left ventricular assist devices (LVADs) prolonged survival in patients with end-stage disease, but with a significant number of adverse events. We report on the neurological outcomes in the REMATCH trial. Methods and Results— We examined new neurological events in the 129 patients randomized to either LVAD placement (n=68) or medical management (n=61), classified as stroke, transient ischemic attack, toxic-metabolic encephalopathy, and other. There were 46 neurological events: 42 in 30 LVAD patients and 4 in 4 patients in the medical arm (χ 2 , 30/68 versus 4/61, P P =0.002). The mean interval from implantation to stroke was 221.8 days (±70.4 days). History of stroke, age, and sepsis were not stroke risk factors in the LVAD group. Conclusions— Fewer than half of the patients in the LVAD group had a neurological event, and there were few neurological deaths. Survival analysis combining stroke or death demonstrated a significant benefit for long-term circulatory support with an LVAD over medical therapy. Future trials will need to address prospectively all neurological outcomes, including neurocognitive function, and the role of long-term neuroprotection.

Background: As therapeutic options evolve for advanced heart failure, the appropriate role for cardiac transplantation will require survival analyses that reflect changing trends in causes of death and patient and institutional risk profiles. Results from multi-institutional studies could be used to monitor progress in individual centers. Methods: Between 1990 and 1999, 7290 patients undergoing cardiac transplantation in 42 institutions entered a formal outcomes study. Changing survival, causes of death, and patient risk profiles were analyzed. Multivariable risk-factor equations were applied to a single institution (300 primary heart transplants) to examine differences in risk-adjusted expected versus observed actuarial outcomes over time. Results: Overall survival in the 42 institutions improved during the decade ( P =.02). One- and 3-year cardiac transplant research database survival was as follows: era 1 (1990-1992), 84% and 76%, respectively; era 2 (1993-1995), 85% and 79%, respectively; and era 3 (1996-1999), 85% and 79%, respectively. Causes of death changed over time. Pretransplantation risk profiles increased over time ( P =.0001), with increases in reoperations, devices, diabetes, severely ill recipients, pulmonary vascular resistance, sensitization, ischemic times, donor age, and donor inotropic support. Three-year actuarial survival in a single institution was 3% less than risk-adjusted predicted survival in era 1, 1% higher than predicted in era 2, and 7% higher than predicted in era 3. Conclusions: Survival after cardiac transplantation is gradually improving, despite increasing risk profiles. Further improvement requires periodic re-evaluation of risk profiles and causes of death to target areas of surveillance, therapy, and research. By using these methods, progress at individual institutions can be assessed in a time-related, risk-adjusted manner that also reflects changing institutional experience, expertise, or both. J Thorac Cardiovasc Surg 2003;125:881-90

In this subanalysis of the HF Assessment with Bnp In The Home (HABIT) trial, we examine the results of the home B-type natriuretic peptide (BNP) testing and weight monitoring in 160 patients with HFPEF and HFREF. The study was a multi-center, single-arm double-blinded observational prospective

Exponential growth of self-amplified spontaneous emission at 530 nm was first experimentally observed at the Advanced Photon Source low-energy undulator test line in December 1999. Since then, further detailed measurements and analysis of the results have been made. Here, we present the measurements and compare these with calculations based on measured electron beam properties and theoretical expectations.

Background Although the left ventricular assist device (LVAD) has been increasingly used as a bridge to transplant, its effect on post-transplant outcome is uncertain. We, therefore, designed this study using the Cardiac Transplant Research Database to compare patients supported on an LVAD before transplant with those treated with intravenous inotropic medical therapy. Methods and results Of the 5,880 patients transplanted between 1990 and 1997, a total of 502 received support from LVADs and 2,514 received intravenous inotropic medical therapy at the time of transplant. Kaplan-Meier analysis showed no significant difference in post-transplant survival between the LVAD and medical-therapy groups ( p = 0.09). Results of a multivariate Cox regression analysis were consistent with that of the Kaplan-Meier analysis and did not identify LVAD as a significant risk factor for mortality. The percentage of patients who received LVADs as a function of total transplants increased from 2% in 1990 to 16% in 1997. Furthermore, although the number of extracorporeal LVADs remained relatively constant, the number of intracorporeal LVADs increased over time. Multivariate parametric analysis found that the risk factors for post-transplant death in the LVAD group were extracorporeal LVAD use ( p = 0.0004), elevated serum creatinine ( p = 0.05), older donor age ( p = 0.03), increased donor ischemic time ( p p = 0.03). Conclusions Given a limited donor supply, the intracorporeal LVAD helps the sickest patients survive to transplant and provides post-transplant outcome similar to that of patients supported on inotropic medical therapy. Therefore, patients supported on LVADs before transplant may receive the greatest marginal benefit when compared with other transplant candidates.

Up to 10% of patients who arrive at the hospital with acute myocardial infarction (AMI) present with or develop cardiogenic shock. Some patients, despite inotropes and intra-aortic balloon pump (IABP) placement, are not hemodynamically stable enough to undergo emergent revascularization. The use of percutaneous extracorporeal life support (ECLS) can stabilize patients to allow effective therapy. In a retrospective review of the first 100 patients emergently placed on ECLS by a nurse-supported physician insertion technique at Sharp Memorial Hospital, 10 patients underwent placement of ECLS after out-of hospital AMI. All AMI patients required intubation for respiratory failure and temporary CPR for cardiovascular collapse before initiation of ECLS. Of the 10 AMI patients placed on ECLS, four (40%) are currently long-term survivors (5.1 +/- 4.2 years; range, 6 months to 11 years). All survivors underwent successful revascularization after placement on ECLS. The cause of death in the other six patients was neurologic insufficiency in two, ineffective ECLS in two, and recurrent cardiovascular collapse after weaning from bypass in two. Total CPR time before initiation of cardiopulmonary bypass was 17 +/- 10.3 minutes for the survivors and 54.2 +/-11.1 minutes for the nonsurvivors (p < 0.001). The average time on ECLS was 29 +/- 26 hours for the survivors and 30 +/-67 hours for the nonsurvivors (p = NS). Leg complications were common among long-term survivors, associated with the use of ECLS (three ischemia, one infection). After AMI and cardiovascular collapse, insertion of ECLS may permit long-term patient survival.

Background: The use of inotropic agents in the therapy of patients with congestive heart failure (CHF) is controversial. One concern regarding inotropic therapy has been that drug withdrawal could be associated with a worsening of symptoms. Methods and Results: We took advantage of the discontinuation of the recent trial of vesnarinone in the therapy of CHF to assess the effects of withdrawal of the inotropic agent, vesnarinone, in patients with chronic CHF who had been randomized to receive either placebo or 30 or 60 mg of vesnarinone. Contrary to our initial hypothesis, withdrawal of vesnarinone did not impact on either morbidity or mortality over a period of 6 months. Conclusion: Although these results suggest vesnarinone withdrawal is safe, the applicability of these results to other inotropic agents remains unclear.

Background: The relationship between pre-transplant body weight and post-transplant outcome has only recently been identified using a single, indirect measure of weight (percent ideal body weight [PIBW]). The literature is equivocal regarding which index is the better indicator of body weight. The purpose of this study was to determine (1) if pre-heart transplant body weight, measured by body mass index (BMI) and PIBW, is associated with post-heart transplant morbidity and mortality and (2) if patient gender, age, and etiology of heart disease affect this association. Methods The sample included 4,515 patients who received a heart transplant from January 1, 1990–December 31, 1995 at 38 institutions participating in the Cardiac Transplant Research Database (CTRD). Patients were divided into groups according to their BMI and PIBW. Data were described using frequencies, measures of central tendency, Pearson correlation coefficients, stratified actuarial analyses and log rank tests for comparisons, and a multivariable risk factor analysis in the hazard domain. Results For all patients ( n = 4,515), being 140% of IBW before heart transplant was a risk factor for increased mortality after heart transplant. The association between pre-heart transplant PIBW and post-heart transplant survival was affected by gender, age, and etiology of heart disease. In males, a higher PIBW was a significant risk factor for death early after transplant ( p = .0003). Although not significant, there was a trend for a higher PIBW being a risk factor for death in females throughout the post transplant period ( p = .07). No differences in cause of death were found for PIBW and BMI. In male and female recipients 140% of IBW. Pre-heart transplant BMI and PIBW were not associated with acute rejection or cardiac allograft arteriopathy after transplant. Conclusions In conclusion, being cachectic or obese preoperatively is associated with decreased survival in all patients after heart transplantation. Being obese preoperatively is associated with increased infection after heart transplant in males and females

Background Long-term implantation of a left ventricular assist device (LVAD) may be a future alternative treatment for end-stage heart failure. The objective of the present study was to determine the hemodynamic effects of supine bicycle exercise and functional capacity during upright treadmill exercise in 10 patients after LVAD implantation placed for refractory heart failure as a bridge to cardiac transplantation. Methods and Results With supine bicycle exercise, 46±25 days after device placement, heart and LVAD rates increased in parallel from 87±12 to 117±14 bpm and 82±18 to 107±21 bpm, respectively. Peak O 2 consumption was 8.2±1.7 mL O 2 ·kg −1 ·min −1 . Fick systemic blood flow rose from 5.0±1.2 to 7.8±2.5 L/min. Right atrial and pulmonary capillary wedge pressures increased from 6±4 and 5±3 mm Hg to 12±5 and 13±8 mm Hg, respectively. End-diastolic left ventricular dimension increased from 3.9±1.3 to 4.8±1.6 cm; however, right ventricular dimension decreased from 3.2±1.0 to 2.3±0.9 cm. With upright treadmill exercise, peak O 2 consumption was 14.1±2.9 mL O 2 ·kg −1 ·min −1 . Conclusions This study indicates that exercise during long-term LVAD support is safe and is not limited by right heart decompensation. It also justifies a larger study to examine how exercise after LVAD implantation compares with that after cardiac transplantation.

Between June 1986 and October 1995, 81 patients were emergently resuscitated with a portable extracorporeal life support (ECLS) system. Venoarterial perfusion was achieved using a centrifugal pump (BioMedicus; Medtronic, Anaheim, CA) and a hollow fiber oxygenator (BARD in 56 patients; Medtronic heparin-bonded MAXIMA [MAXIMA, Medtronic, Minneapolis, MN] in the last 25 patients). The ECLS system was used at various locations in the hospital with the setup, priming, and initiation of perfusion done by ECLS trained intensive care unit nurses. Clinical data on these patients were reviewed to analyze variables influencing survival and trends that developed as the authors' experience accumulated and the technology evolved. The indication for ECLS was cardiac arrest in 68 patients and refractory cardiogenic shock in 13 patients. Thirty-five patients (43.2%) survived >24 hrs after termination of ECLS, whereas 20 patients (24.7%) are long-term survivors (>30 days). The ECLS system permitted an additional therapeutic surgical intervention in 45 cases. Patients who had a surgically remediable problem were more likely to survive. Prolongation of cardiopulmonary resuscitation beyond 30 mins before initiation of ECLS correlated with a decreased likelihood of survival.