Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial.

BACKGROUND: Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). METHODS: We conducted an EPC feasibility study (4/1/14-8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. RESULTS: We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients' hospital and ICU days and emergency visits. CONCLUSIONS: Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. TRIAL REGISTRATION: Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).

Tricuspid Regurgitation Following Implantation of Endocardial Leads: Incidence and Predictors.

BACKGROUND: Endocardial leads, permanent pacemaker (PPM), or implantable cardioverter defibrillator (ICD) placed across the tricuspid valve can lead to tricuspid regurgitation (TR). The reported incidence of this complication has varied widely. There are limited data predicting which patients will develop this complication. This study sought to describe the incidence of worsening TR post-PPM or ICD and to identify patient-specific predictors of increased TR following lead placement. METHODS: Patients (N = 382) who received a PPM or ICD from January 1, 2006 to December 31, 2010 and had echocardiograms both within 365 days prior to and up to 1,200 days after device placement were studied. TR was assessed on a 6-point scale (none/trace, mild, mild to moderate, moderate, moderate to severe, severe). Primary outcome was a two-grade increase in the severity of TR. Echocardiographic and clinical predictors of worsening TR were examined using multivariate regression. RESULTS: A two-grade increase in TR occurred in 10.0% of our patient population. Age, lead position, atrial fibrillation, right atrial (RA) area, right ventricular systolic pressure (RVSP), left atrial area, and severity of mitral regurgitation were univariate predictors of worsening TR post lead placement. In the multivariate analysis, predevice RA area and RVSP were associated with increased TR after endocardial lead placement. Percentage of time spent pacing did not appear to be associated with increased TR. CONCLUSION: The incidence of increased TR postendocardial lead placement was 10.0%; this is lower than prior estimates. Predevice RA area and RVSP are predictors of increased TR after lead placement.

COOL-ARREST: Results from a Pilot Multicenter, Prospective, Single-Arm Observational Trial to Assess Intravascular Temperature Management in the Treatment of Cardiac Arrest.

Targeted temperature management (TTM) is recommended postcardiac arrest. The cooling method with the highest safety and efficacy is unknown. The COOL-ARREST pilot trial aimed to evaluate the safety and efficacy of the most contemporary ZOLL Thermogard XP Intravascular Temperature Management (IVTM) system for providing mild TTM postcardiac arrest. This multicenter, prospective, single-arm, observational pilot trial enrolled patients at eight U.S. hospitals between July 28, 2014, and July 24, 2015. Adult (≥18 years old), out-of-hospital cardiac arrest subjects of presumed cardiac etiology who achieved return of spontaneous circulation (ROSC) were considered for inclusion. Patients were excluded if (1) awake or consistently following commands after ROSC, (2) significant prearrest neurological dysfunction, (3) terminal illness or advanced directives precluding aggressive care, and (4) severe hemodynamic instability or shock. Patient temperature was maintained at 33.0°C ± 0.3°C for a total of 24 hours followed by controlled rewarming (0.1-0.2°C/h). Logistic regressions were used to assess association of good functional outcome (modified Rankin Scale ≤3) measured at the time of hospital discharge with shockable rhythm (yes/no), age, gender, race/ethnicity, lay-rescuer cardiopulmonary resuscitation, time to basic life support (minutes), time to ROSC (minutes), lactate (mg/dL), and pH on admission. The ZOLL IVTM system was effective at inducing TTM (median time to target temperature from initiation, 89 minutes [interquartile range 42-155]). Adverse events most often included electrolyte abnormalities and dysrhythmias. Of patients surviving to hospital discharge, 16/20 patients had a good functional outcome. A total of 18 patients survived through 90-day follow-up, at which time 94% (17/18) of patients had good functional outcome. The COOL-ARREST pilot trial demonstrates high safety and efficacy of the ZOLL Thermogard XP IVTM system in the application of mild TTM postcardiac arrest. This observational trial also revealed noteworthy variability in the management of postcardiac arrest patients, particularly with the use of early withdrawal of life-sustaining therapy.

Stress-Induced Cardiomyopathy Complicated by Dynamic Left Ventricular Outflow Obstruction, Cardiogenic Shock, and Ventricular Septal Rupture.

We describe the case of a 68-year-old woman presenting with stress cardiomyopathy (SCM), with concomitant cardiogenic shock, left ventricular outflow tract obstruction, and ventricular septal rupture. These complications have not simultaneously been reported in a single SCM case. The importance of early diagnosis of serial complications of SCM and using mechanical circulatory support as a treatment strategy are highlighted.

Precipitation of ventricular fibrillation by intravenous diltiazem and metoprolol in a young patient with occult Wolff-Parkinson-White syndrome.

We report the case of a young man who presented with a rapid, narrow-complex atrial fibrillation. A few hours after being administered intravenous metoprolol and diltiazem for rate control, he developed intermittent ventricular preexcitation on the electrocardiogram (ECG) and experienced ventricular fibrillation, from which he was successfully defibrillated. A subsequent electrocardiogram in sinus rhythm demonstrated previously unknown Wolff-Parkinson-White pattern. A left lateral accessory pathway was successfully ablated. Wolff-Parkinson-White syndrome should be included in the differential diagnosis when a young patient presents with atrial fibrillation, even if the ventricular complexes on the ECG are not preexcited.

The association of QRS duration with atrial fibrillation in a heart failure with preserved ejection fraction population: a pilot study.

BACKGROUND: Heart failure is a significant cause of morbidity and mortality, yet patient risk stratification may be difficult. Prevention or treatment of atrial fibrillation (AF) may be an important strategy in these patients that could positively affect their outcome. It has been demonstrated that in patients with systolic dysfunction, prolonged QRS duration (QRSd), an easily measured electrocardiographic parameter, is associated with AF. HYPOTHESIS: Prolonged QRSd is associated with an increase in prevalence of AF in patients with heart failure with preserved ejection fraction(HFPEF). METHODS: Between February 2006 and February 2009, 718 patients were discharged with a diagnosis of HF from the Dartmouth-Hitchcock Medical Center. Of these, 206 had EF ≥50% by echocardiography performed within 72 hours of admission. After exclusions, 82 patients remained, of which 25 had AF and 57 had sinus rhythm. Characteristics of the AF and sinus-rhythm patients were compared in this pilot study. RESULTS: After adjustment for age, prior diagnosis of HF, and left atrial area, there was a nonsignificant trend (odds ratio: 2.2, 95% CI of 0.3-17.2) for a QRSd >120 ms to be associated with AF. CONCLUSIONS: Similar to results in patients with systolic dysfunction, patients with preserved EF may have an association between a prolonged QRSd and AF.

Maximizing the Benefit-Cost Ratio of Anthracyclines in Metastatic Breast Cancer: Case Report of a Patient with a Complete Response to High-Dose Doxorubicin.

Despite the clinical efficacy of anthracycline agents such as doxorubicin, dose-limiting cardiac toxicities significantly limit their long-term use. Here, we present the case of a 33-year-old female patient with extensive metastatic ER+/PR+/HER2- mucinous adenocarcinoma of the breast, who was started on doxorubicin/cyclophosphamide therapy after progressing on paclitaxel and ovarian suppressor goserelin with aromatase inhibitor exemestane. The patient was comanaged by cardiology, who carefully monitored measures of cardiac function, including EKGs, serial echocardiograms, and profiling of lipids, troponin, and pro-BNP every 2 months. The patient was treated with the cardioprotective agent dexrazoxane, and changes in cardiac markers [e.g. decreases in ejection fraction (EF)] were immediately addressed by therapeutic intervention with the ACE inhibitor lisinopril and beta-blocker metoprolol. The patient had a complete response to doxorubicin therapy, with a cumulative dose of 1,350 mg/m2, which is significantly above the recommended limits, and to our knowledge, the highest dose reported in literature. Two and a half years after the last doxorubicin cycle, the patient is asymptomatic with no cardiotoxicity and an excellent quality of life. This case highlights the importance of careful monitoring and management of doxorubicin-mediated cardiotoxicity, and that higher cumulative doses of anthracyclines can be considered in patients with ongoing clinical benefit.

Therapeutic hypothermia-induced electrocardiographic changes and relations to in-hospital mortality.

BACKGROUND: Therapeutic hypothermia improves survival for selected patients who remain comatose after cardiac arrest. Hypothermia triggers changes in electrocardiographic (ECG) parameters; however, the association of these changes to in-hospital mortality remains unclear. HYPOTHESIS: QT interval changes induced by therapeutic hypothermia are not associated with in-hospital mortality. METHODS: We retrospectively compared precooling ECG parameters to ECG parameters during hypothermia on all consecutive patients with available information who received hypothermia at our academic medical center between December 2006 and July 2012 (N = 101; 24% women). Paired 2-sample t test was used to compare precooling vs cooling ECG parameters. In-hospital mortality related to ECG parameter changes was compared using the Pearson χ(2) test. RESULTS: Therapeutic hypothermia resulted in increases in PR and QTc intervals and decreases in heart rate and QRS intervals (P for all <0.02). During hospitalization, 45 of the 101 patients died. Survivors vs nonsurvivors did not differ in heart rate change (P = 0.74), PR change (P = 0.57), QRS change (P = 0.09), or QTc change (P = 0.67). Comparing patients who had reduced QTc intervals with hypothermia to those who had prolonged QTc with hypothermia, 14 out of 30 died in the former group, whereas 31 out of 71 died in the latter group (46.7% vs 43.7%, odds ratio [OR]: 1.13, 95% CI: 0.48-2.66). Patients presenting with right bundle branch block (RBBB) had a higher risk of in-hospital death compared to those without RBBB (72.2% vs 38.6%, OR: 4.14, 95% CI: 1.35-12.73). CONCLUSIONS: Therapeutic hypothermia prolonged QTc interval with no association to in-hospital mortality. Presence of RBBB on initial presentation was related to increased mortality.