A press statement released last week by the Heart Failure Society of America (HFSA; Minneapolis) bannered the release of new guidelines for “living with and treating“ heart failure (HF), and in so doing it promised expanded inclusion of new recommendations concerning the use of medical devices to treat HF.
Now available this week, the lengthy list of protocols does provide greater focus on devices than in the organization's existing guidelines, issued in 1999 – but not by very much.
The guidelines issued six years ago – and currently still available on the HFSA web site (www.hfsa.com) – have a fairly narrow focus: primarily pharmacological approaches for treating heart failure caused by left ventricular dysfunction. (And rather parenthetically, we could not help wondering why more than five-year timeline in producing the updated and broadened guidelines.)
Compared to the emphasis on drugs, the presence of device therapies and device therapy recommendations in the 1999 document is slender indeed; in 26 pages of single-spaced verbiage (and 10 pages more of appendices and references), the document provides just one section dealing with devices, lumping these also with pharmacology in a section titled “Antiarrhythmic Drug and Device Therapy.“
Additionally, this section offers essentially only one recommendation, and one paragraph of supportive background information, focused on the use of implantable cardioverter defibrillators (ICDs).
The recommendation is for use of ICDs in “patients with heart failure who have been resuscitated from primary ventricular fibrillation or who have experienced hemodynamically destabilizing sustained ventricular tachycardia.“
As background it refers to the MADIT, AVID, CIDS and CASH trials, saying that they “indicate that survival of patients with life-threatening arrhythmias is improved with ICD placement compared with antiarrhythmic therapy.“ And it notes the lack of completed trials (as of 1999) for use of ICD therapy “specifically“ in HF patients and the need for such data – the apparent rationale for the limited recommendations for device use.
Six years, many trials later, and much more overall experience in all phases of HF therapy, the new guidelines are titled “HFSA 2006 Comprehensive Heart Failure Practice Guideline“ and are indeed more comprehensive than the 1999 offering.
But while extending to nearly 60 pages, the new protocols provide little more than two pages of recommendations and “considerations“ concerning the use of ICDs and other “electrophysiologic interventions.“
This is rather short shrift, considering the statement before a list of recommendations saying that: “Perhaps no area of HF therapy has changed more in recent years than the use of implanted devices as a treatment option.“
Following are some of the main recommendations provided for use of devices (which come also with a “strength of evidence“ rating indicating their importance, from A to C).
Under “Disease management program“:
- “Consideration of assist devices as destination therapy,“ (C); and also as “end-of-life care“ that “inactivation of an implantable defibrillation device should be discussed“.
Under “General Considerations,“ primarily focusing on ICDs:
- Prophylactic use of ICDs “In patients with or without concomitant coronary artery disease“ (B); “for those with mild to moderate HF symptoms“ (A); “concomitant placement “in patients undergling implantation of a biventricular pacing device“ (B); “for survivors of cardiac arrest from ventricular fibrillation to hemodynaically unstable sustained ventricular tachycardia without evidence of acute [myocardial infarction] or if the event occurs more than 48 hours after the onset of infarction in the absence of a recurrent ischemic event“ (A).
- Biventricular pacing therapy for “selected ambulatory NYHA [Class] IV patients may be considered“ (B).
- Under a section on heart transplantation, primarily focused on “mechanical support devices“:
- Patients awaiting heart transplantation who have become refractory to all means of medical circulatory support should be considered for a mechanical support device as a bridge to transplant“ (B).
- “Permanent mechanical assistance using an implantable assist device may be considered in highly selected patients with severe HF refractory to conventional therapy who are not candidates for heart transplantation“ (B).
Several recommendations also state those circumstances where ICDs and ventricular assist devices are not indicated.
In sum, the new guidelines offer a clear advance over the single-paragraph treatment by the 1999 version of the protocols. And the updated guidelines do cover a very much wider spectrum of heart failure issues, beyond the device and heavily drug-weighted recommendations; these range from new considerations about ejection fraction and diet and nutrition to education and counseling for better self-management and the above-mentioned end-of-life protocols.
Overall, the new document serves to indicate the opportunities that cardiovascular device manufacturers have for penetrating this important therapeutic sector.
And it is just as clear that with the continuing increase of technology rollouts and longer-term clinical trials addressing HF, the next update of the HSFA guidelines should not wait for another five years or so, and their emphasis on device technologies should be incrementally expanded to reflect these advances.