Pain, pain, go away

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Science Translational Medicine  18 Feb 2015:
Vol. 7, Issue 275, pp. 275ec29
DOI: 10.1126/scitranslmed.aaa8317

Opening blocked arteries with stents or bypass surgery can improve blood circulation to the heart and alleviate incapacitating symptoms, such as chest pain. Yet, many patients with severe blockages are not candidates for standard approaches and continue to experience pain with minimal exertion. In these individuals, a new study by Verheye et al. demonstrates the potential of a device implanted in the coronary sinus that improves symptoms by counterintuitively resisting blood flow. As the coronary sinus is the major cardiac vein and is downstream of arterial blockages, this treatment is thought to increase backpressure and redistribute blood flow to poorly oxygenated heart tissue.

In the phase II randomized study, 52 patients with refractory pain symptoms received the 'reducer' device, compared with 52 controls who underwent a mock procedure (both patient and follow-up investigators were blinded). After 6 months, patients receiving the device had markedly reduced chest pain—the equivalent of going from severe limitation with minimal activity to essentially no limitation at all. Although objective measures such as exercise tolerance and imaged heart motion did not improve significantly, quality of life did.

In addition to showcasing the technology's promise, the trial highlights the growing importance of subjective metrics in modern cardiology—a field classically driven by objective outcomes like heart attack and death. To focus on quality of life, we must better understand the nuances of subjective responses to get the most out of emerging technologies aimed at symptom relief. Indeed, 40% of refractory patients in the control arm also had reduced pain—testament to the strength of placebo. As the reducer device continues to be vetted, it will be important to dissect which aspects of its effectiveness are linked to patient/provider perception and whether these effects can also be harnessed in clinical practice, outside the controlled context of a trial.

S. Verheye et al., Efficacy of a device to narrow the coronary sinus in refractory angina. N. Engl. J. Med. 372, 519–527 (2015).[Abstract]

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