Mary Norine Walsh

Noninvasive quantitation of myocardial blood flow in human subjects with oxygen-15-labeled water and positron emission tomography

Noninvasive measurement of myocardial blood flow in absolute terms (i.e., milliliters per gram per min) has been difficult to accomplish despite the intrinsically quantitative power of positron emission tomography because of the nonphysiologic nature of tracers that have been employed conventionally as well as the limited spatial resolution of currently available instruments. It was previously demonstrated that myocardial blood flow in animals can be quantitated accurately with the diffusible tracer oxygen-15-labeled water (H2(15)O) when the arterial input function and myocardial radiotracer concentration were measured directly. To extend the approach for completely noninvasive measurement of blood flow, a parameter estimation procedure was developed whereby effects of limited tomographic spatial resolution and cardiac motion were compensated for within the operational flow model. In validation studies in 18 dogs, myocardial blood flow measured with positron emission tomography after intravenously administered H2(15)O correlated closely with flow measured with concomitantly administered radiolabeled microspheres over the range of 0.29 to 5.04 ml/g per min (r = 0.95). Although regional ischemia was clearly identifiable tomographically, absolute flow could not be determined accurately in ischemic regions in four dogs because of poor count statistics related to wall thinning. Subsequently, myocardial blood flow was measured in 11 normal human subjects. Flow was homogeneous throughout the myocardium, averaged 0.90 +/- 0.22 ml/g per min at rest and increased to 3.55 +/- 1.15 ml/g per min after intravenous administration of dipyridamole. Therefore, positron emission tomography with H2 15O and the approach developed permits noninvasive measurement of myocardial blood flow in absolute terms in humans and should facilitate objective assessment of interventions designed to enhance nutritive perfusion.

Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: the Weight Monitoring in Heart Failure (WHARF) trial.

BACKGROUND Heart failure treatment guidelines emphasize daily weight monitoring for patients with heart failure, but data to support this practice are lacking. Using a technology-based heart failure monitoring system, we determined whether daily reporting of weight and symptoms in patients with advanced heart failure would reduce rehospitalization and mortality rates despite aggressive guideline-driven heart failure care. METHODS This was a randomized, controlled trial. Patients hospitalized with New York Heart Association class III or IV heart failure, with a left ventricular ejection fraction < or =35% were randomized to receive heart failure program care or heart failure program care plus the AlereNet system (Alere Medical, Reno, Nev) and followed-up for 6 months. The primary end point was 6-month hospital readmission rate. Secondary end points included mortality, heart failure hospitalization readmission rate, emergency room visitation rate, and quality of life. RESULTS Two hundred eighty patients from 16 heart failure centers across the United States were randomized: 138 received the AlereNet system and 142 received standard care. Mean age was 59 +/- 15 years and 68% were male. The population had very advanced heart failure, New York Heart Association class III (75%) or IV (25%), as evidenced by serum norepinepherine levels, 6-minute walk distance and outcomes. No differences in hospitalization rates were observed. There was a 56.2% reduction in mortality (P <.003) for patients randomized to the AlereNet group. CONCLUSIONS This is the largest multicenter, randomized trial of a technology-based daily weight and symptom-monitoring system for patients with advanced heart failure. Despite no difference in the primary end point of rehospitalization rates, mortality was significantly reduced for patients randomized to the AlereNet system without an increase in utilization, despite specialized and aggressive heart failure care in both groups.

Improving Evidence-Based Care for Heart Failure in Outpatient Cardiology Practices Primary Results of the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF)

Background— A treatment gap exists between heart failure (HF) guidelines and the clinical care of patients. The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) prospectively tested a multidimensional practice-specific performance improvement intervention on the use of guideline-recommended therapies for HF in outpatient cardiology practices. Methods and Results— Performance data were collected in a random sample of HF patients from 167 US outpatient cardiology practices at baseline, longitudinally after intervention at 12 and 24 months, and in single-point-in-time patient cohorts at 6 and 18 months. Participants included 34 810 patients with reduced left ventricular ejection fraction (≤35%) and chronic HF or previous myocardial infarction. To quantify guideline adherence, 7 quality measures were assessed. Interventions included clinical decision support tools, structured improvement strategies, and chart audits with feedback. The performance improvement intervention resulted in significant improvements in 5 of 7 quality measures at the 24-month assessment compared with baseline: &bgr;-blocker (92.2% versus 86.0%, +6.2%), aldosterone antagonist (60.3% versus 34.5%, +25.1%), cardiac resynchronization therapy (66.3% versus 37.2%, +29.9%), implantable cardioverter-defibrillator (77.5% versus 50.1%, +27.4%), and HF education (72.1% versus 59.5%, +12.6%) (each P<0.001). There were no statistically significant improvements in angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use or anticoagulation for atrial fibrillation. Sensitivity analyses at the patient level and limited to patients with both baseline and 24-month quality measure data yielded similar results. Improvements in the single-point-in-time cohorts were smaller, and there were no concurrent control practices. Conclusions— The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting, a defined and scalable practice-specific performance improvement intervention, was associated with substantial improvements in the use of guideline-recommended therapies in eligible patients with HF in outpatient cardiology practices. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00303979.

ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy

Steven R. Bailey, MD, FACC, FSCAI, FAHA, Moderator Andrea M. Russo, MD, FACC, FHRS, Writing Group Liaison [⁎][1] Suraj Kapa, MD, Writing Group Liaison Michael B. Alexander, MD, FACC[§][2] Steven R. Bailey, MD, FACC, FSCAI, FAHA[∥][3] Ulrika Birgersdotter-Green, MD, FHRS[∥][3] Alan S.

Hospital Strategies Associated With 30-Day Readmission Rates for Patients With Heart Failure

Background—Reducing hospital readmission rates is a national priority; however, evidence about hospital strategies that are associated with lower readmission rates is limited. We sought to identify hospital strategies that were associated with lower readmission rates for patients with heart failure. Methods and Results—Using data from a Web-based survey of hospitals participating in national quality initiatives to reduce readmission (n=599; 91% response rate) during 2010–2011, we constructed a multivariable linear regression model, weighted by hospital volume, to determine strategies independently associated with risk-standardized 30-day readmission rates (RSRRs) adjusted for hospital teaching status, geographic location, and number of staffed beds. Strategies that were associated with lower hospital RSRRs included the following: (1) partnering with community physicians or physician groups to reduce readmission (0.33% percentage point lower RSRRs; P=0.017), (2) partnering with local hospitals to reduce readmissions (0.34 percentage point; P=0.020), (3) having nurses responsible for medication reconciliation (0.18 percentage point; P=0.002), (4) arranging follow-up appointments before discharge (0.19 percentage point; P=0.037), (5) having a process in place to send all discharge paper or electronic summaries directly to the patient’s primary physician (0.21 percentage point; P=0.004), and (6) assigning staff to follow up on test results that return after the patient is discharged (0.26 percentage point; P=0.049). Although statistically significant, the magnitude of the effects was modest with individual strategies associated with less than half a percentage point reduction in RSRRs; however, hospitals that implemented more strategies had significantly lower RSRRs (reduction of 0.34 percentage point for each additional strategy). Conclusions—Several strategies were associated with lower hospital RSRRs for patients with heart failure.

Impact of Implantable Cardioverter-Defibrillator, Amiodarone, and Placebo on the Mode of Death in Stable Patients With Heart Failure Analysis From the Sudden Cardiac Death in Heart Failure Trial

Background— The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) demonstrated that implantable cardioverter-defibrillator (ICD) therapy reduces all-cause mortality in patients with New York Heart Association class II/III heart failure and a left ventricular ejection fraction ≤35% on optimal medical therapy. Whether ICD therapy reduced sudden death caused by ventricular tachyarrhythmias without affecting heart failure deaths in this population is unknown. Methods and Results— SCD-HeFT randomized 2521 subjects to placebo, amiodarone, or shock-only, single-lead ICD therapy. Over a median follow-up of 45.5 months, a total of 666 deaths occurred, which were reviewed by an Events Committee and initially categorized as cardiac or noncardiac. Cardiac deaths were further adjudicated as resulting from sudden death presumed to be ventricular tachyarrhythmic, bradyarrhythmia, heart failure, or other cardiac causes. ICD therapy significantly reduced cardiac mortality compared with placebo (adjusted hazard ratio, 0.76; 95% confidence interval, 0.60 to 0.95) and tachyarrhythmia mortality (adjusted hazard ratio, 0.40; 95% confidence interval, 0.27 to 0.59) and had no impact on mortality resulting from heart failure or noncardiac causes. The cardiac and tachyarrhythmia mortality reductions were evident in subjects with New York Heart Association class II but not in subjects with class III heart failure. The reduction in tachyarrhythmia mortality with ICD therapy was similar in subjects with ischemic and nonischemic disease. Compared with placebo, amiodarone had no significant effect on any mode of death. Conclusions— ICD therapy reduced cardiac mortality and sudden death presumed to be ventricular tachyarrhythmic in SCD-HeFT and had no effect on heart failure mortality. Amiodarone had no effect on all-cause mortality or its cause-specific components, except an increase in non-cardiac mortality in class III patients. Clinical Trial Registration Information— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000609.

A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure

Background Continuous‐flow left ventricular assist systems increase the rate of survival among patients with advanced heart failure but are associated with the development of pump thrombosis. We investigated the effects of a new magnetically levitated centrifugal continuous‐flow pump that was engineered to avert thrombosis. Methods We randomly assigned patients with advanced heart failure to receive either the new centrifugal continuous‐flow pump or a commercially available axial continuous‐flow pump. Patients could be enrolled irrespective of the intended goal of pump support (bridge to transplantation or destination therapy). The primary end point was a composite of survival free of disabling stroke (with disabling stroke indicated by a modified Rankin score >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove the device at 6 months after implantation. The trial was powered for noninferiority testing of the primary end point (noninferiority margin, ‐10 percentage points). Results Of 294 patients, 152 were assigned to the centrifugal‐flow pump group and 142 to the axial‐flow pump group. In the intention‐to‐treat population, the primary end point occurred in 131 patients (86.2%) in the centrifugal‐flow pump group and in 109 (76.8%) in the axial‐flow pump group (absolute difference, 9.4 percentage points; 95% lower confidence boundary, ‐2.1 [P<0.001 for noninferiority]; hazard ratio, 0.55; 95% confidence interval [CI], 0.32 to 0.95 [two‐tailed P=0.04 for superiority]). There were no significant between‐group differences in the rates of death or disabling stroke, but reoperation for pump malfunction was less frequent in the centrifugal‐flow pump group than in the axial‐flow pump group (1 [0.7%] vs. 11 [7.7%]; hazard ratio, 0.08; 95% CI, 0.01 to 0.60; P=0.002). Suspected or confirmed pump thrombosis occurred in no patients in the centrifugal‐flow pump group and in 14 patients (10.1%) in the axial‐flow pump group. Conclusions Among patients with advanced heart failure, implantation of a fully magnetically levitated centrifugal‐flow pump was associated with better outcomes at 6 months than was implantation of an axial‐flow pump, primarily because of the lower rate of reoperation for pump malfunction. (Funded by St. Jude Medical; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.)

Heart Failure Care in the Outpatient Cardiology Practice Setting: Findings from IMPROVE HF

Background—Few data exist regarding contemporary care patterns for heart failure (HF) in the outpatient setting. IMPROVE HF is a prospective cohort study designed to characterize current management of patients with chronic HF and ejection fraction ≤35% in a national registry of 167 US outpatient cardiology practices. Methods and Results—Baseline patient characteristics and data on care of 15 381 patients with diagnosed HF or prior myocardial infarction and left ventricular dysfunction were collected by chart abstraction. To quantify use of therapies, 7 individual metrics (use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, &bgr;-blocker, aldosterone antagonist, anticoagulation, implantable cardioverter defibrillator, cardiac resynchronization therapy, and HF education) and composite metrics were assessed. Care metrics include only patients documented to be eligible and without contraindications or intolerance. Among practices, 69% were nonteaching. Patients were 71% male, with a median age of 70 years, and a median ejection fraction of 25%. Use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (80%) and &bgr;-blocker (86%) was relatively high in eligible patients in the outpatient cardiology setting; other metrics, such as aldosterone antagonist (36%), device therapy (implantable cardioverter defibrillator/cardiac resynchronization therapy with defibrillator, 51%; cardiac resynchronization therapy, 39%), and education (61%), showed lower rates of use. A median 27% of patients received all HF therapies for which they were potentially eligible on the basis of chart documentation. Use of guideline-recommended therapies by practices varied widely. Conclusions—These data are among the first to assess treatment in the outpatient setting since the release of the latest national HF guidelines and to demonstrate substantial variation among cardiology practices in the documented therapies provided to HF patients.

Review of the Registry's Fourth Year, Incorporating Lead Data and Pediatric ICD Procedures, and Use as a National Performance Measure

tephen C. Hammill, MD, Mark S. Kremers, MD, Lynne Warner Stevenson, MD, aul A. Heidenreich, MD, Christine M. Lang, RN, MSN, Jeptha P. Curtis, MD, Yongfei Wang, MS, harles I. Berul, MD, Alan H. Kadish, MD, Sana M. Al-Khatib, MD, MHS, Ileana L. Pina, MD, ary Norine Walsh, MD, Michael J. Mirro, MD, Bruce D. Lindsay, MD, Matthew R. Reynolds, MD, athryn Pontzer, Laura Blum, Frederick Masoudi, MD, MSPH, John Rumsfeld, MD, PhD, alph G. Brindis, MD, MPH

The National ICD Registry Report: Version 2.1 including leads and pediatrics for years 2010 and 2011

Mark S. Kremers, MD, FHRS, Stephen C. Hammill, MD, FHRS, Charles I. Berul, MD, FHRS, Christina Koutras, RN, Jeptha S. Curtis, MD, Yongfei Wang, MS, Jim Beachy, RCIS, Laura Blum Meisnere, MA, Del M. Conyers, MPH, Matthew R. Reynolds, MD, Paul A. Heidenreich, MD, Sana M. Al-Khatib, MD, MHS, FHRS, Ileana L. Pina, MD, MPH, Kathleen Blake, MD, MPH, FHRS, Mary Norine Walsh, MD, Bruce L. Wilkoff, MD, FHRS, Alaa Shalaby, MD, FHRS, Frederick A. Masoudi, MD, MSPH, John Rumsfeld, MD, PhD