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  JACC : Heart Failure
   Full-text available via subscription Subscription journal
   ISSN (Online) 2213-1779
   Published by American College of Cardiology Foundation Homepage  [1 journal]
  • Reading RVUs How Can We Meet the Informational Needs
           of Cardiologists'
    • Authors: O’Connor CM.
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • Upgrade Ambulatory Extra-Aortic Counterpulsation to Full-Support LVAD
    • Authors: Zeriouh M; Sabashnikov A, Banner NR, et al.
      Abstract: We read with interest the study by Abraham et al. (1) in which the Sunshine Heart C-Pulse implantable extra-aortic counterpulsator (Sunshine Heart, Inc., Eden Prairie, Minnesota) was used for the treatment of patients with advanced heart failure (New York Heart Association functional class III and IV). In recent years, significant technologic improvements in the field of mechanical circulatory support have led to the development of smaller and more reliable continuous-flow blood pumps resulting in improved morbidity and mortality (2). In addition to these full-support devices, the concept of partial support has been successfully demonstrated in “less sick” patients (i.e., not sick enough to justify the use of full-support left ventricular assist devices [LVADs]). One such partial-support system—the Synergy CircuLite Micropump (CircuLite Inc., Saddle Brook, New Jersey)—has been used successfully to treat this patient group, as described previously (3). In addition, our group showed that this pump was also capable of supporting inotropic dependent patients and those in cardiogenic shock (4). However, despite initial successes with demonstrated improvements hemodynamics and quality of life, the Synergy had to be withdrawn from the market and is currently undergoing design enhancements to resolve issues that became evident during initial clinical use.
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • Reply Upgrade Ambulatory Extra-Aortic Counterpulsation to Full-Support
    • Authors: Abraham WT; Aggarwal S, Prabhu SD, et al.
      Abstract: We very much appreciate the letter from Dr. Zeriouh and colleagues, referencing our early experience with ambulatory extra-aortic counterpulsation in patients with moderate to severe chronic heart failure (1). We agree with their conclusions regarding the advantages of the C-Pulse device, compared to left ventricular assist devices (LVADs). As noted in our paper and in the letter from Zeriouh et al., the C-Pulse device is an extravascular partial-support device that eliminates: 1) the risk of device thrombosis, significantly reducing the risk of thromboembolism; and 2) the need for systemic anticoagulation, significantly reducing the risk of bleeding, in contrast to full- and partial-support LVADs. The C-Pulse device is intended for patients with advanced but not end-stage heart failure, where the need for a full-support LVAD is less and the intolerance for thromboembolism and bleeding is greater.
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • Correction
    • Abstract: Safdar Z, Tamez E, Chan W, Arya B, Ge Y, Deswal A, Bozkurt B, Frost A, Entman M.
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • Opportunity to Increase Life Span in Narrow QRS Cardiac Resynchronization
           Therapy Recipients by Deactivating Ventricular Pacing Evidence From
           Randomized Controlled Trials
    • Authors: Sohaib S; Finegold JA, Nijjer SS, et al.
      Abstract: ObjectivesThis study examined the time course of clinical events in cardiac resynchronization therapy (CRT) trials.BackgroundRecent randomized controlled trial results suggest that in heart failure with narrow QRS, biventricular pacing (CRT) may increase mortality. The authors proposed implant complications as the cause, rather than a progressive adverse physiological effect.MethodsThe study identified all trials comparing CRT with no CRT, which reported Kaplan-Meier curves in groups defined by QRS: narrow, non–left bundle branch block (LBBB) broad, and LBBB broad. For each trial, the change in life span every 3 months up to 3.5 years (the longest time for which data are available) was calculated and a power law was fitted, that is, ∝ timen.ResultsFour trials (MADIT-CRT [Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy], RAFT [Resynchronization-Defibrillation for Ambulatory Heart Failure Trial], REVERSE [REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction], and EchoCRT [Echocardiography Guided Cardiac Resynchronization Therapy]), totaling 4,717 patients, reported curves for mortality or heart failure–related hospitalization, or for mortality. In patients with LBBB broad QRS (within MADIT-CRT), life span gain increased in proportion to time1.94. In contrast, in patients with non-LBBB broad QRS (within MADIT-CRT) and patients with narrow QRS (EchoCRT), life span was lost in proportion to time1.92 and time,1.96 respectively. Hospitalization-free survival showed similar patterns.ConclusionsThe nonlinear growth of life span gained when a CRT device is implanted in patients with LBBB broad QRS is unfortunately mirrored by a similarly progressive loss in life span in narrow QRS heart failure. This suggests the culprit is a progressive physiological effect of pacing rather than implant complications. If these data are not sufficient, a randomized controlled trial of deactivating CRT in patients with narrow QRS may now be needed, with a primary endpoint of increasing survival.
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • When Is it Appropriate to Withdraw Cardiac Resynchronization Therapy'
           Guesses and Evidence ∗
    • Authors: Cleland JF; Butcher C.
      Abstract: In designing clinical trials, investigators consider many factors. The population should have the disease in question and have needs unmet by conventional care that might be improved by intervention. Guessing which clinical variables will identify patients who respond to a therapy, especially when its mechanism of action is uncertain, is hazardous. It would be astonishing if such guesses, and the hypotheses on which they were based, proved to be entirely correct. For cardiac resynchronization therapy (CRT), those planning trials guessed that a QRS duration >120 to 130 ms would identify patients likely to benefit from CRT. This guess turns out to be accurate to within 10 to 20 ms. That ventricular dyssynchrony, measured by imaging, is the key substrate on which CRT acts has, so far, proved a somewhat poorer guess (1).
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • Anti–Factor Xa and Activated Partial Thromboplastin Time
           Measurements for Heparin Monitoring in Mechanical Circulatory
    • Authors: Adatya S; Uriel N, Yarmohammadi H, et al.
      Abstract: ObjectivesThis study investigated the relationship between anti–factor Xa (anti-FXa) and activated partial thromboplastin time (aPTT) for monitoring intravenous unfractionated heparin (IV-UFH) in patients with continuous-flow left ventricular assist devices (CF-LVADs).BackgroundCF-LVADs have become mainstream therapy for patients with advanced heart failure. Thromboembolic events, device thrombosis, and bleeding continue to be a challenge with this technology. Adequate anticoagulation is required to prevent these adverse events.MethodsA prospective study of consecutive patients implanted with a CF-LVAD was conducted. Paired samples were considered concordant if aPTT values fell into expected ranges for subtherapeutic, therapeutic, and supratherapeutic anti-FXa levels. Heparin dosing was on the basis of anti-Xa levels.ResultsA total of 340 paired values from 38 patients were evaluated. Anti-FXa and aPTT were discordant in 253 samples (74.4%), with a high degree of variability in aPTT for any given anti-FXa level (r2 = 0.57). Results were discordant in 104 samples (63.8%) from patients undergoing bridging therapy with warfarin and in 149 samples (84.2%) from patients with device obstruction and/or hemolysis (p < 0.001). The most common pattern of discordance was a supratherapeutic aPTT value despite a therapeutic anti-FXa level (49.1% for bridging vs. 75.8% for device obstruction and/or hemolysis; p < 0.001).ConclusionsLevels of aPTT were disproportionately prolonged relative to the corresponding anti-FXa levels in CF-LVAD patients, particularly those with device obstruction. Hemolysis and warfarin administration may falsely elevate aPTT, resulting in overestimation of heparin concentration and under-anticoagulation. Use of aPTT and anti-FXa to guide heparin therapy may lead to different estimates of heparin concentration in the same patient.
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • Gold Standard in Anticoagulation Assessment of Left Ventricular
           Assist Device Patients' How About Bronze ∗
    • Authors: Stehlik J; Johnson SA, Selzman CH.
      Abstract: Continuous-flow left ventricular assist devices (CF-LVADs) have become a standard therapeutic option in the management of eligible patients with advanced forms of heart failure. Although survival after LVAD implant has improved dramatically in the past decade, the cumulative incidence of LVAD-related adverse events is still high (1). Systemic anticoagulation is recommended in all CF-LVADs currently approved for clinical use. The balance of bleeding and thrombosis remains a constant and often perplexing challenge. Indeed, thrombotic and bleeding complications are a major source of morbidity and serve as a significant threat to the intended goals of LVAD therapy: improved quality of life and improved survival. Approaches that will decrease both bleeding and thrombotic complications are therefore needed.
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • Left Ventricular Assist Devices Ramp Studies Truth or Consequences'
    • Authors: Starling RC.
      Abstract: In this issue of JACC: Heart Failure, Adatya et al. (1) from the University of Minnesota prospectively investigated patients who received the Thoratec HeartMate II (Pleasanton, California) left ventricular assist device (LVAD) between June 2012 and February 2014. The investigators designed a prospective investigation to evaluate the incremental data provided by echocardiographic ramp studies. In 2012, Uriel et al. (2) described a novel technique (ramp study) that used echocardiographic techniques to assess the impact of changes in LVAD speed (rotations per minute) and the relation to LVAD power, the pulsatility index, LVAD flow, and left ventricular end-diastolic diameter (LVEDD). Uriel et al. (2) reported their prospective study at Columbia University Medical Center in 39 patients who underwent 52 ramp studies. The Columbia group suggested that ramp studies should be performed routinely to optimize LVAD speed to provide optimal unloading; they also noted that the ramp study slope (LVEDD/incremental speed changes in LVAD) could predict LVAD malfunction and need for surgical intervention, including urgent transplantation or LVAD exchange (2). The Columbia ramp study required full anticoagulation, reducing the LVAD speed to 8,000 rpm, echocardiographic measures at baseline, and sequential measures every 2 min as the pump speed was increased by increments of 400 rpm up to a speed of 12,000 rpm. Seventeen patients underwent ramp studies for suspected pump thrombosis and 10 had minimal change in LVEDD with the ramp study. The Columbia investigators confirmed pump thrombosis in 8 of 9 cases at the time of emergent device exchange, removal, or urgent transplantation. One patient remained stable on intensified anticoagulation. All 10 patients with suspected pump thrombosis but none of the remaining 7 had an LVEDD slope >−0.16.
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • Gastrointestinal Bleeding in Recipients of the HeartWare Ventricular
           Assist System
    • Authors: Goldstein DJ; Aaronson KD, Tatooles AJ, et al.
      Abstract: ObjectivesThis study evaluated gastrointestinal bleeding (GIB) in patients receiving the HeartWare HVAD System (HeartWare Inc., Framingham, Massachusetts) in the pivotal BTT (Bridge to Transplant) trial and under the continued access protocol (CAP).BackgroundGIB has become a significant problem for recipients of continuous flow device left ventricular assist devices (CF-LVAD). The need for anticoagulation and antiplatelet therapies complicates the management of GIB.MethodsBleeding events from 382 patients with advanced heart failure (140 patients enrolled in the BTT trial, and an additional 242 CAP patients) were analyzed. Post-implant anticoagulation consisted of heparin followed by warfarin at a target international normalized ratio of 2 to 3. Acetylsalicylic acid was recommended at 81 to 325 mg.ResultsOverall, 59 of 382 (15.4%) patients experienced 108 GIB events (0.27 events per patient year). Mean time to first bleed was 273.1 days and 86.1% of events occurred beyond 30 days. Freedom from GIB was 84.1% at 1 year. Median international normalized ratio at the time of first bleed was 2.4 ± 1.4. The most common etiology of bleeding identified was arteriovenous malformation and the most common site was the small intestine. Repeat bleeding was infrequent, though GIB patients required more readmissions and developed nondevice infections more frequently. No patients required surgical intervention and no deaths directly related to GIB occurred.ConclusionsRecipients of the HeartWare Ventricular Assist Device System had an incidence of 0.27 GIB/patient year with a freedom from GIB of 84.1% at 1 year. All patients with GIB events were managed with medical and endoscopic therapies, although 31% of patients experienced a recurrence of GIB. No surgical intervention was required. GIB did not impact survival. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure [ADVANCE]; NCT00751972)
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • Inside This Issue
    • PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • Left Atrial Decompression Pump for Severe Heart Failure With
           Preserved Ejection Fraction Theoretical and Clinical Considerations
    • Authors: Burkhoff D; Maurer MS, Joseph SM, et al.
      Abstract: ObjectivesThe purpose of this study was to provide insight into the potential for left atrium (LA) to aortic mechanical circulatory support as a treatment for patients with heart failure with preserved ejection fraction (HFpEF).BackgroundAlthough HFpEF arises from different etiologies, 1 hallmark of all forms of this syndrome is a small or minimally-dilated left ventricle (LV). Consequently, the use of traditional mechanical circulatory support in end-stage patients has been difficult. In contrast, HFpEF is also characterized by a large LA.MethodsHemodynamic characteristics of 4 distinct HFpEF phenotypes were characterized from the published data: 1) hypertrophic cardiomyopathies; 2) infiltrative diseases; 3) nonhypertrophic HFpEF; and 4) HFpEF with common cardiovascular comorbidities (e.g., hypertension). Employing a previously-described cardiovascular simulation, the effects of a low-flow, micropump-based LA decompression device were modeled. The effect of sourcing blood from the LV versus the LA was compared.ResultsFor all HFpEF phenotypes, mechanical circulatory support significantly increased cardiac output, provided a mild increase in blood pressure, and markedly reduced pulmonary and LA pressures. LV sourcing of blood reduced LV end-systolic volume into a range likely to induce suction. With LA sourcing, however, LV end-systolic volume increased compared with baseline. Due to pre-existing LA enlargement, LA volumes remained sufficiently elevated, thus minimizing the risk of suction.ConclusionsThis theoretical analysis suggests that a strategy involving pumping blood from the LA to the arterial system may provide a viable option for end-stage HFpEF. Special considerations apply to each of the 4 types of HFpEF phenotypes described. Finally, an HFpEF-specific clinical profile scoring system (such as that of INTERMACS [Interagency Registry for Mechanically Assisted Circulatory Support]) would aid in the selection of patients with the appropriate risk–benefit ratio for implantation of an active pump.
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • The Heartmate Risk Score Predicts Morbidity and Mortality in Unselected
           Left Ventricular Assist Device Recipients and Risk Stratifies INTERMACS
           Class 1 Patients
    • Authors: Adamo L; Nassif M, Tibrewala A, et al.
      Abstract: ObjectivesThis study evaluated the Heartmate Risk Score (HMRS) and its potential benefits in clinical practice.BackgroundThe HMRS has been shown to correlate with mortality in the cohort of patients enrolled in the Heartmate II trials, but its validity in unselected, “real world” populations remains unclear.MethodsThis study identified a cohort of 269 consecutive patients who received a Heartmate II left ventricular assist device at our institution, the Barnes-Jewish Hospital in St. Louis, Missouri, between June 2005 and June 2013. Ninety-day and 2-year mortality rates, as well as frequency of several morbid events, were compared by retrospectively assigned HMRS category groups. The analysis was repeated within the subgroup of INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) class 1 patients.ResultsReceiver operating curve analysis showed that the HMRS correlated with 90-day mortality with an area under the curve of 0.70. Stratification in low, mid, and high HMRS groups identified patients with increasing hazard of 90-day mortality, increasing long-term mortality, increasing rate of gastrointestinal bleeding events, and increasing median number of days spent in the hospital in the first year post implant. Within INTERMACS class 1 patients, those in the highest HMRS group were found to have a relative risk of 90-day mortality 5.7 times higher than those in the lowest HMRS group (39.1% vs. 6.9%, p = 0.029).ConclusionsHMRS is a valid clinical tool to stratify risk of morbidity and mortality after implant of Heartmate II devices in unselected patients and can be used to predict short-term mortality risk in INTERMACS class 1 patients.
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
  • Echocardiographic Ramp Test for Continuous-Flow
           Left Ventricular Assist Devices Do Loading Conditions
    • Authors: Adatya S; Holley CT, Roy SS, et al.
      Abstract: ObjectivesThis study investigated whether continuous AI and/or elevated mean arterial pressure (MAP) were associated with false positive results for flow obstruction in echocardiographic ramp speed tests in patients with a continuous-flow left ventricular assist device.BackgroundFailure to reduce the left ventricular end-diastolic diameter (LVEDD) with increasing device speeds in a ramp test is predictive of pump obstruction. Aortic insufficiency (AI) or increased MAP can diminish the ability to unload the left ventricle.MethodsLVEDD was plotted against device speed, and a linear function slope was calculated. A flat LVEDD slope (≥–0.16) was considered abnormal (suggestive of obstruction). Ramp test results were compared in patients with or without either AI or increased MAP at baseline speed, and receiver-operator characteristic (ROC) curves were constructed for predictors of device obstruction. Device thrombosis was confirmed by direct visualization of clot at explantation or on inspection by the manufacturer.ResultsOf 78 ramp tests (55 patients), 36 were abnormal (18 true positive, 18 false positive), and 42 were normal (37 true negative, 5 false negative). In patients with AI, LVEDD slope was –0.14 ± 0.17, which was consistent with device obstruction (vs. –0.25 ± 0.11 in patients without AI; p < 0.001), despite no difference in mean lactate dehydrogenase concentration between the 2 groups (1,301 ± 1,651 U/l vs. 1,354 ± 1,365 U/l; p = 0.91). Area under the ROC curve (AUC) for LVEDD slope was 0.76 and improved to 0.88 after removal of patients with AI from the study. LVEDD slope in patients with MAP ≥85 mm Hg was similar to that for device obstruction (–0.18 ± 0.07) and was abnormal in 6 of the 12 ramp tests performed. Combining LVEDD slope with lactate dehydrogenase concentration increased the AUC to 0.96 as an indicator of device obstruction.ConclusionsAbnormal loading conditions due to AI or elevated MAP may result in false positive ramp tests.
      PubDate: Wed, 01 Apr 2015 00:00:00 GMT
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