Cardiac resynchronization therapy using a pacemaker or a defibrillator: Patient selection and evidence to support it
Section snippets
Background
Heart failure (HF)1, 2, 3, 4, 5 is a disease of epidemic proportions in the United States (US) affecting over 5 million individuals. While the incidence of many diseases in the US is decreasing, HF represents one of few human diseases that are increasing in frequency.2,3 It is estimated than nearly 400,000 new cases of HF will be diagnosed in the next year,2 one million patients will be hospitalized, and 300,000 patients will die from HF in the US3. Although the development of new medications
CRT using a pacemaker (CRT-P) versus a defibrillator (CRT-D)
CRT can be delivered through a pacemaker (CRT-P) or a combined pacemaker-defibrillator (CRT-D). CRT-P devices are smaller (i.e. require a smaller surgical incision at implantation and protrude less under the skin) and cost a fraction of the price of CRT-D devices (cost of CRT-D is roughly $36,000 compared to $16,000 for CRT-P).12 Compared to optimal pharmacological treatment, both CRT-P and CRT-D have been shown in RCTs9,10 to reduce all-cause mortality and improve patient symptoms and cardiac
Current practices of implanting CRT devices in the US and other parts of the world
Absent clear guidance from cardiac societies on the choice of CRT device type, the practice across the world has gravitated towards more CRT-D implantations, with significant variations by region of the world and specific countries, perhaps partially driven by economic considerations.14,15 The preponderance of CRT-D use likely reflects the common notion among providers that defibrillator function adds protection to CRT recipients but also results from the fact that the indications for CRT and
Arguments for and against the use of defibrillator therapy in addition to CRT
Although it seems plausible that the CRT-D adds protection to HF patients, since it can serve as a safety net in the event of the occurrence of lethal VAs, this is not as plausible as it may seem on first examination. Conceptually, in the presence of one life-saving therapy (i.e. CRT), another life-saving therapy (i.e. an ICD) does not necessarily confer additive survival benefit, particularly when the burden of VAs is reduced with CRT in the context of improved cardiomyopathy and HF symptoms.11
Guidance as to the choice of the type of CRT device
Given the absence of clear guidance from published guidelines13 with regards to CRT device choice, many in the US have and continue to err on the side of ‘safety’ by overwhelmingly choosing to implant CRT-D devices. These trends are in part tempered in other parts of the world, partially driven by economic considerations. With these patterns of practice, there may be some reluctance from industry sponsors to fund trials of CRT-P versus CRT-D in all CRT-eligible HF patients or in a subset of
The way forward: an urgent need for device specific CRT guidelines
There is an evident paucity of information that guides the choice of CRT device in HF patients, particularly when it comes to randomized controlled data that can change guidelines and alter practice patterns. Except for the COMPANION trial9 which randomized HF patients to CRT-P, CRT-D, or guideline directed medical therapy, and has shown no significant outcome differences between the two CRT treatment arms, no other randomized trials have examined the impact of CRT device choice on mortality or
Disclosures
Dr. Saba reports research support from Abbott, Boston Scientific and Medtronic. Dr. Canterbury has nothing to disclose.
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