A randomized double-blind crossover comparison of four rate-responsive pacing modes

Abstract

The aim of this study was to compare, both subjectively and objectively, four modern rate-responsive pacing modes in a double-blind crossover design. Twenty-two patients, aged 18 to 81 years, had an activity-sensing dual chamber universal rate-responsive (DDDR) pacemaker implanted for treatment of high grade atrioventricular block and chronotropic incompetence. They were randomly programmed to VVIR (ventricular demand rate-responsive), DDIR (dual chamber demand rate-responsive), DDD (dual chamber universal) or DDDR (dual chamber universal rate-responsive) mode and assessed after 4 weeks of out-of-hospital activity. Five patients, all with VVIR pacing, requested early reprogramming. The DDDR mode was preferred by 59% of patients; the VVIR mode was the least acceptable mode in 73%. Perceived "general well-being," exercise capacity, functional status and symptoms were significantly worse in the VVIR than in dual rate-responsive modes. Exercise treadmill time was longer in DDDR mode (p less than 0.01), but similar in all other modes. During standardized daily activities, heart rate in VVIR and DDIR modes underresponded to mental stress. All rate-augmented modes overresponded to staircase descent, whereas the DDD mode significantly underresponded to staircase ascent. Echocardiography revealed no difference in chamber dimensions, left ventricular fractional shortening or pulmonary artery pressure in any mode. Cardiac output was greater at rest in the dual modes than in the VVIR mode (p = 0.006) but was similar at 120 beats/min. Beat to beat variability of cardiac output was greatest in VVIR mode (p less than 0.0001), with DDIR showing greater variability than DDD or DDDR modes (p less than 0.05). Mitral regurgitation estimated by Doppler color flow imaging was similar in all modes, but tricuspid regurgitation was significantly greater in VVIR than in dual modes (p less than 0.03). Subjects who preferred the DDDR mode and those who found the VVIR mode least acceptable had significantly greater increases in stroke volume when paced in the DDD mode than in the ventricular-inhibited (VVI) mode at rest (22%) when compared with subjects who preferred other modes (2%, p = 0.03). No other objective variable was predictive of subjective benefit from any rate-responsive pacing mode. Thus, dual sensor rate-responsive pacing (DDDR) is superior objectively and subjectively to single sensor (VVIR, DDIR and DDD) pacing and subjective benefit from dual chamber rate-augmented pacing is predictable echocardiographically.

The effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber pacemakers for bradycardia due to atrioventricular block or sick sinus syndrome: systematic review and economic evaluation

“…58,60,63 The treadmill test was equally used in studies with participants of younger and intermediate ages, and the bicycle ergometer was predominantly used in studies with individuals older than 65 years. The use of the bicycle or treadmill test was not associated with differences in 67 Sulke, 1991 74 Deharo, 1996 62 Mitsuoka, 1988 69 Kenny, 1986 65 Channon, 1994 60 Menozzi, 1990 68 Kamalvand, 1997 64 Jordaens, 1988 50 Hargreaves, 1995 63 Davis, 1985 61 Kristensson, 1985 66 Perrins, 1983 71 Avery, 1994 58 Yee, 1984 77 Saner, 1996 73 Capucci, 1993 59 Oldroyd, 1991 70 Rediker 67 Sulke, 1991 74 Hargreaves, 1995 63 Deharo, 1996 62 Menozzi, 1990 68 Saner, 1996 73 Oldroyd, 1991 65 Channon, 1994 60 Jordaens, 1988 50 Hargreaves, 1995 63 Avery, 1994 58 Rediker reporting benefits, and with both instruments a benefit was found for dual-chamber pacemakers. Conversely, studies that used the 6-minute walking test reported no additional benefit for dualchamber pacing.…”

“…An exploration of the possible sources of variation was conducted, with stratification by pacing mode, age of recipients and outcome measure used. There were variations in the type of ventricular pacing mode (seven studies included rate response 62,63,67,68,70,73,76 ) and in the type of dualchamber pacing mode considered, with four studies of rate-modulated dual-chamber 59,64,73,74 and four of VDD pacemakers. 61,66,71,77 Three studies 63,73,74 compared ventricular pacing to two dual-chamber modes and were included in more than one group.…”

“…However, this conclusion is not robust, since there were several sources of heterogeneity. There were some 67 Sulke, 1991 74 Mitsuoka, 1988 69 Kamalvand, 1997 64 Davis, 1985 61 Kristensson, 1985 66 Perrins, 1983 71 Yee, 1984 77 Capucci, 1993 59 Oldroyd, 1991 70 Saner, 1996 73 Rediker, 1988 72 Sulke …”

The relevance of health related quality of life in paced patients

“…However, in the field of cardiac pacing until recently several instruments were used to measure HRQoL that were not properly validated and applied [4][5][6][7][8][9][10][11][12][13][14][15][16][17]. Consequently these HRQoL data should be interpreted cautiously.…”

Evidence Base for Pacemaker Mode Selection

“…62 Small crossover studies in highly selected patients already have suggested that DDDR pacing leads to superior quality of life. 63 These small studies, however, do not provide definitive support for the concept that all or most pacemaker patients with sinus rhythm should have a DDDR pacer implanted; and indeed, it may be a realistic concern that more aggressive DDDR programming may lead to a greater frequency of ventricular pacing and more V-V dyssynchrony.…”