Integrative noetic therapies as adjuncts to percutaneous intervention during unstable coronary syndromes: Monitoring and Actualization of Noetic Training (MANTRA) feasibility pilot.

BACKGROUND: Patients undergoing percutaneous coronary intervention (PCI) for unstable coronary syndromes have substantial emotional and spiritual distress that may promote procedural complications. Noetic (nonpharmacologic) therapies may reduce anxiety, pain and distress, enhance the efficacy of pharmacologic agents, or affect short- and long-term procedural outcomes. METHODS: The Monitoring and Actualization of Noetic Training (MANTRA) pilot study examined the feasibility of applying 4 noetic therapies-stress relaxation, imagery, touch therapy, and prayer-to patients in the setting of acute coronary interventions. Eligible patients had acute coronary syndromes and invasive angiography or PCI. Patients were randomized across 5 treatment groups: the 4 noetic and standard therapies. Questionnaires completed before PCI reflected patients' religious beliefs and anxiety. Index hospitalization end points included post-PCI ischemia, death, myocardial infarction, heart failure, and urgent revascularization. Mortality was followed up for 6 months after hospitalization. RESULTS: Of eligible patients, 88% gave informed consent. Of 150 patients enrolled, 120 were assigned to noetic therapy; 118 (98%) completed their therapeutic assignments. All clinical end points were available for 100% of patients. Results were not statistically significant for any outcomes comparisons. There was a 25% to 30% absolute reduction in adverse periprocedural outcomes in patients treated with any noetic therapy compared with standard therapy. The lowest absolute complication rates were observed in patients assigned to off-site prayer. All mortality by 6-month follow-up was in the noetic therapies group. In patients with questionnaire scores indicating a high level of spiritual belief, a high level of personal spiritual activity, a low level of community-based religious involvement, or a high level of anxiety, noetic therapies appeared to show greater reduction in absolute in-hospital complication rates compared with standard therapy. CONCLUSIONS: Acceptance of noetic adjuncts to invasive therapy for acute coronary syndromes was excellent, and logistics were feasible. No outcomes differences were significant; however, index hospitalization data consistently suggested a therapeutic benefit with noetic therapy. Of all noetic therapies, off-site intercessory prayer had the lowest short- and long-term absolute complication rates. Definitive demonstration of treatment effects of this magnitude would be feasible in a patient population about 4 times that of this pilot study. Absolute mortality differences make safety considerations a mandatory feature of future clinical trials in this area.

Simultaneous ST-segment measurements using standard and monitoring-compatible torso limb lead placements at rest and during coronary occlusion.

Electrocardiographic recordings used to assess ST-segment deviation are performed using both standard and torso limb lead positions, where bony prominences give more artifact-free signal. Whereas significant QRS artifact can be introduced by such changes in lead location, the impact on ST-segment measurements has never been assessed. Digital electrocardiographic recordings were performed in 29 patients throughout elective angioplasty balloon inflation in the left anterior descending (n = 12), right coronary (n = 14), and circumflex (n = 3) arteries. In all cases, unipolar leads V1, V4, and V6 were affixed to the torso lead positions, allowing reconstruction of simultaneously acquired standard and modified 9-lead electrocardiograms (ECGs). ST levels in the 26 patients who had ST deviation during angioplasty were compared at both baseline and peak ischemia of up to 1,046 microV in the anterior, and 551 microV in the inferior leads. Differences in recorded ST levels for modified versus standard lead locations were all < 100 microV, even at peak ischemia. Although ST-segment elevation in the inferior leads appeared to show slightly more pronounced differences between lead sets than did anterior elevation, all differences were < 100 microV. Thus, measurement of ST-segment levels appears unlikely to be importantly affected by the intermixture of ECGs recorded with standard lead positions and ECGs recorded with monitoring-compatible lead positions on the torso. Recalibration of ST-segment measurements may be necessary for meticulous quantification of ischemia, infarct size, or other measurements that might be affected by variations < 100 microV.