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.................................................................................... 5.4.1 Indications for pacing This Task Force found sufficient evidence in the literature to recommend pacing in highly selected patients with reflex syncope (i.e. those >40 years of age with severe recurrent unpredictable syncopal episodes when asystole has been documented, induced by either CSM or tilt testing, or recorded through a monitoring system)133,222228

(see Supplementary Table 7). There is sufficient evidence that DDD pacing should be considered in order to reduce recurrence of syncope in patients with dominant cardioinhibitory CSS (asystolic pause >3 s and spontaneous syncope during CSM) and in those in whom there is a correlation between spontaneous symptoms and ECG who are >40 years of age and have severe recurrent unpredictable syncope.62 Permanent pacemaker therapy may be effective if asystole is a dominant feature of reflex syncope. Establishing a correlation between symptoms and bradycardia should be the goal of the clinical evaluation of patients with syncope and a normal baseline ECG. The efficacy of pacing depends on the clinical setting. A comparison of results in different settings is presented in Supplementary Table 8. Since the publication of the 2018 ESC Guidelines on syncope,62 some trials have added relevant information regarding the subset of patients with tilt-induced asystolic vasovagal syncope. The SPAIN trial was a multicentre, randomized, controlled, crossover study, performed in 46 patients aged >40 years affected by severely recurrent (>5 episodes during life) syncope and cardioinhibitory tilt test response (defined as bradycardia <40 b.p.m. lasting >10 s or asystole >3 s).226 During the 24-month follow-up, syncope recurred in 4 (9%) patients treated with a DDD pacemaker with closed loop stimulation vs. in 21 (46%) patients who had received a sham pacemaker programmed off (P = 0.0001). In a propensity score-matched comparison study,229 the 5-year actuarial syncope-free rate was 81% in the pacing group and 53% in propensity-matched patients (P = 0.005; HR = 0.25). Finally, the BioSync CLS trial was a multicentre RCT that investigated the usefulness of the tilt-table test to select candidates for cardiac pacing.228 Patients aged >_40 years who had at least two episodes of unpredictable severe reflex syncope during the past year and a tilt-induced syncope with an asystolic pause >3 s were randomized to receive either an active (63 patients) or an inactive (64 patients) dual-chamber pacemaker with close loop stimulation. The study showed that, after a median follow-up of 11.2 months, syncope occurred in significantly fewer patients in the pacing group than in the control group [10 (16%) vs. 34 (53%), respectively; HR 0.23; P = 0.00005). This study supports inclusion of tilt testing as a useful method to select patients with reflex syncope for cardiac pacing.

Based on the results of the above studies, sufficient evidence exists to upgrade from IIb to I the indication for pacing in patients aged >40 years with asystolic tilt response >3 s. Figure 8 summarizes the recommended indication for pacing. Although there is also a rationale for pacing in patients aged <_40 years who have the same severity criteria as those >40 years, this Task Force cannot make any recommendation due to the lack of evidence from trials addressing this specific population. There is weak evidence that DDD may be useful in reducing recurrences of syncope in patients with the clinical features of adenosinesensitive syncope.62 In a small multicentre trial performed in 80 highly

Indications for pacing in patients above age 40 with reflex syncope

Spontaneous asystolic pause(s) Y

Y

N

N Test-induced asystolic pause(s)

Extrinsic (functional) vagally-mediated or adenosine-sensitive

Pacing indicated

(Class I) CI-CSS

Pacing indicated

(Class I)

Asystolic tilt

Pacing indicated

(Class I)

Adenosine induced AV block > 10 sec

Pacing indicated

(Class IIb) Undocumented syncope

Pacing not indicated

(Class III)

Figure 8 Summary of indications for pacing in patients >40 years of age with reflex syncope. CI-CSS = cardioinhibitory carotid sinus syndrome. Note: spontaneous asystolic pause = 3 s symptomatic or 6 s asymptomatic. Adapted from Brignole et al.62 Downloaded from academic.oup.com/eurheartj/article/42/35/3427/6358547 by guest on 07 October 2026