Clinical observations with Closed Loop Stimulation pacemakers in a large patient cohort: the CYLOS routine documentation registry (RECORD).

AIMS: Closed Loop Stimulation (CLS) pacemakers couple pacing rate to myocardial contraction dynamics by monitoring unipolar right ventricular impedance on a beat-to-beat basis. The aim of this large-scale registry was to evaluate the safety and efficacy of the CLS therapy under clinical routine conditions. METHODS AND RESULTS: A total of 706 patients was enrolled in the clinical investigation 'Registry: CYLOS Routine Documentation' (RECORD) at 57 investigational sites in Europe and Hong Kong. Not to interfere with clinical routine and therapeutic decisions of health care providers, the registry was implemented as a part of the standard follow-up schedule. Two follow-ups were conducted within 12 months of enrolment in order to evaluate typical programming of CLS-related parameters, reasons for their later reprogramming, frequency of patient intolerance to CLS, and physicians' satisfaction with medical benefits and technical performance of CLS in each patient. The investigators' medical and technical notes on CLS rated it excellent in ~80% of patients, poor in 1.4% (medical benefit) or 0.5% (technical performance), and adequate in rest of the patients. Closed Loop Stimulation functionality was not influenced by pacing site variation within the right ventricle (septal, outflow tract) or by advanced heart failure (New York Heart Association classes II-IV). Permanent or temporary CLS deactivation was undertaken for various reasons in 6.2% of patients. Signs of intolerance to CLS or rate-adaptive pacing were reported by 2.3% of patients. Reprogramming of CLS-related parameters was seldom undertaken, with >90% of pacemakers operating with default settings in the long term. CONCLUSION: Clinical performance of CLS was very satisfactory in the large cohort studied.

Near elimination of ventricular pacing in SafeR mode compared to DDD modes: a randomized study of 422 patients.

AIMS: SafeR performance versus DDD/automatic mode conversion (DDD/AMC) and DDD with a 250-ms atrioventricular (AV) delay (DDD/LD) modes was assessed toward ventricular pacing (Vp) reduction. METHODS: After a 1-month run-in phase, recipients of dual-chamber pacemakers without persistent AV block and persistent atrial fibrillation (AF) were randomly assigned to SafeR, DDD/AMC, or DDD/LD in a 1:1:1 design. The main endpoint was the percentage of Vp (%Vp) at 2 months and 1 year after randomization, ascertained from device memories. Secondary endpoints include %Vp at 1 year according to pacing indication and 1-year AF incidence based on automatic mode switch device stored episodes. RESULTS: Among 422 randomized patients (73.2±10.6 years, 50% men, sinus node dysfunction 47.4%, paroxysmal AV block 30.3%, bradycardia-tachycardia syndrome 21.8%), 141 were assigned to SafeR versus 146 to DDD/AMC and 135 to DDD/LD modes. Mean %Vp at 2 months was 3.4±12.6% in SafeR versus 33.6±34.7% and 14.0±26.0% in DDD/AMC and DDD/LD modes, respectively (P<0.0001 for both). At 1 year, mean %Vp in SafeR was 4.5±15.3% versus 37.9±34.4% and 16.7±28.0% in DDD/AMC and DDD/LD modes, respectively (P<0.0001 for both). The proportion of patients in whom Vp was completely eliminated was significantly higher in SafeR (69%) versus DDD/AMC (15%) and DDD/LD (45%) modes (P<0.0001 for both), regardless of pacing indication. The absolute risk of developing permanent AF or of remaining in AF for >30% of the time was 5.4% lower in SafeR than in the DDD pacing group (ns). CONCLUSIONS: In this selected patient population, SafeR markedly suppressed unnecessary Vp compared with DDD modes.

Slow breathing increases arterial baroreflex sensitivity in patients with chronic heart failure.

BACKGROUND: It is well established that a depressed baroreflex sensitivity may adversely influence the prognosis in patients with chronic heart failure (CHF) and in those with previous myocardial infarction. METHODS AND RESULTS: We tested whether a slow breathing rate (6 breaths/min) could modify the baroreflex sensitivity in 81 patients with stable (2 weeks) CHF (age, 58+/-1 years; NYHA classes I [6 patients], II [33], III [27], and IV [15]) and in 21 controls. Slow breathing induced highly significant increases in baroreflex sensitivity, both in controls (from 9.4+/-0.7 to 13.8+/-1.0 ms/mm Hg, P<0.0025) and in CHF patients (from 5.0+/-0.3 to 6.1+/-0.5 ms/mm Hg, P<0.0025), which correlated with the value obtained during spontaneous breathing (r=+0.202, P=0.047). In addition, systolic and diastolic blood pressure decreased in CHF patients (systolic, from 117+/-3 to 110+/-4 mm Hg, P=0.009; diastolic, from 62+/-1 to 59+/-1 mm Hg, P=0.02). CONCLUSIONS: These data suggest that in patients with CHF, slow breathing, in addition to improving oxygen saturation and exercise tolerance as has been previously shown, may be beneficial by increasing baroreflex sensitivity.