Dr. William Abraham,
In this session, four international experts in heart failure combined to present a state-of-the-art review of devices for managing and for monitoring heart failure. Kenneth Dickstein (Stavanger, Norway) began with a comprehensive review of current recommendations for device therapies in heart failure, with a focus on cardiac resynchronization therapy (CRT). Professor Dickstein reviewed the most recent ESC guidelines supporting the use of CRT in heart failure, noting that patients with NYHA class III and ambulatory class IV heart failure, a reduced LVEF ( 35%), and a prolonged QRS duration ( 120 msec) should receive CRT with or without an ICD. He also noted the recent expansion of the CRT indication into the NYHA class II population. However, in these patients the CRT indication is currently limited to those with a QRS duration 150 msec, according to ESC guidelines. Professor Dickstein acknowledged that since the publication of these guidelines evidence has come forth supporting QRS morphology, specifically LBBB, rather than QRS duration as the better predictor of CRT response in NYHA class II patients. Professor Dickstein cited data from Solomon et al (2010) demonstrating that the reduction in LV volume during CRT predicts improved outcomes, from Gasparini and colleagues (2008) suggesting that AV nodal ablation is superior to pharmacological AV nodal blockade in optimizing the delivery of CRT in patients with concomitant atrial fibrillation, and from Frolich and associates (2010) showing that those upgraded to CRT devices do as well as those receiving a de novo CRT device. Professor Dickstein emphasized the need to achieve a high percentage of biventricular pacing (> 95%) in optimizing CRT delivery. He concluded with some of the unanswered questions and ongoing challenges of CRT. This presentation was followed by a comprehensive review of remote telemonitoring in heart failure, presented by Andrea Mortara (Monza, Italy). Professor Mortara presented a recent Cochrane Reports meta-analysis from Cleland and colleagues that supports the efficacy of remote telemonitoring in heart failure. Professor Mortara noted that this meta-analysis was limited by the inclusion of small, single-center studies. He then reviewed four major multi-center trials including TELE-HF, TIM-HF, TEN-HMS, and his own Home or Hospital in Heart Failure (HHH) study. He noted that all of these large studies failed to demonstrate the efficacy of remote telemonitoring systems. He also noted the limitation in some of the parameters used in remote telemonitoring systems, specifically noting the poor sensitivity of daily weight monitoring (which was only 20% in the TEN-HMS study). Professor Mortara suggested that a “hub and spoke” approach to heart failure management using a multidisciplinary team and mid-level practitioners could be effective in heart failure care. Finally, he mentioned a possible but unproven role for device-based diagnostics – such as intrathoracic impedance monitoring – and the potential of implantable hemodynamic monitoring (IHM) in heart failure. This served as a nice transition to the following presentation from Martin Cowie (London, Great Britain). Professor Cowie began by endorsing the benefits of the multidisciplinary heart failure disease management team and by describing some of the goals of heart failure monitoring, including shifting the burden of heart failure care from the hospital to the home. He reviewed a number of device-based diagnostic studies most notably the PARTNERS study from Whellan et al showing the predictive value of multiple device-based diagnostic parameters when used together and the DOT-HF trial that suggests a possible increase in hospitalizations when such diagnostics are used in an attempt to prevent hospitalizations. Implicit in Professor Cowie’s comments was the conclusion that the role of device-based diagnostics remains uncertain in heart failure management. He then went on to describe two important studies of IHM. The CHAMPION trial (Abraham et al, 2011) randomized 550 patients to therapy guided by an implantable wireless pulmonary artery pressure monitoring system versus standard of care and showed a 28% reduction in heart failure hospitalizations at 6 months and a 37% reduction in heart failure hospitalizations over the full duration of follow-up (averaging 15 months). Professor Cowie noted that the system used in this study was awaiting CE Mark and FDA approval. He also described an implantable left atrial pressure monitoring system that was preliminarily shown to be effective in a small pilot study (Ritzema et al, 2010). He noted that the pivotal trial of this system, LAPTOP-HF, is now underway. Lynne Stevenson (Boston, USA) concluded the session with an integrated view of devices for advanced heart failure, focusing on left ventricular support devices (LVADs) with brief mention of the totally implantable artificial heart. Professor Stevenson began by describing the end-stage heart failure population. She emphasized the importance of the newer INTERMACS classification system for triaging this group to appropriate mechanical therapies. With INTERMACS 1 representing the sickest patients with advanced heart failure and INTERMACS 7 describing the least sick of this advanced population, current LVAD indications focus mainly on INTERMACS 1-4 patients. As technology has improved, there has been a movement from pulsatile LVADs to continuous flow devices, including axial flow pumps and centrifugal pumps. The role of LVADs as bridge-to-transplant is well established. Professor Stevenson noted that with improved devices and better patient selection (fewer IMTERMACS 1 and more INTERMACS 2-3 LVAD recipients), outcomes have improved and there has been a shift toward implanting more destination devices. She did note a number of limitations of continuous flow devices including an increased risk of gastrointestinal bleeding and aortic insufficiency. Finally, Professor Stevenson acknowledged the challenge of RV failure, which limits the utility of LVADs and may represent an indication for the totally implantable artificial heart – at least as a bridge to transplant.
Novel devices for heart failure
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