Standardized algorithm for cardiac pacing in older patients affected by severe unpredictable reflex syncope: 3-year insights from the Syncope Unit Project 2 (SUP 2) study

Brignole, Michele; Arabia, Francesco; Ammirati, Fabrizio; Tomaino, Marco; Quartieri, Fabio; Rafanelli, Martina; Rosso, Attilio Del; Vecchi, Maria Rita; Russo, Vitantonio; Gaggioli, Germano

doi:10.1093/europace/euv343

Cited by 69 publications

(38 citation statements)

References 23 publications

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“…Subsequent data from the SUP-2 study in Italian Syncope Clinics [23,24] offered support for the above ISSUE-3 observations. Using a decision algorithm for older patients with syncope, involving first, carotid sinus massage and treating CSS if found, followed by a tilt test and treating the findings, if positive, and finally, implanting an ILR if both preliminary tests were negative, provided some succour for the tilt-positive patients as results for them were better in longer follow-up than for patients with unpaced VVS.…”

Section: Historical Developmentstudiesmentioning

confidence: 84%

“…Continue observation Fig. 6 Vasovagal syncope decision algorithm; modified from SUP-2 [23,24]. VVS, vasovagal syncope; CSM, carotid sinus massage [37]; Resp., response; VASIS, vasovagal syncope international study; ILR, insertable/implantable ECG loop recorder.…”

Section: Ilr Negativementioning

confidence: 99%

“…6). This is the SUP-2 (Syncope Unit Project) study [23,24] which has shown encouraging results in applying pacing to patients with older neurally mediated syncope with the greatest possible benefit. One-hundred and thirtyseven patients (49% of the total) received a dualchamber pacemaker and were followed for mean 26 AE 11 months.…”

Section: Ilr Negativementioning

confidence: 99%

“…Syncope recurred in 18%. The actuarial syncope recurrence rate at 3 years was calculated to be 20% (95% confidence interval [CI] [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] and was significantly lower than in 142 patients who were not paced because their tests were all negative, remaining under observation by ILR. The 3-year recurrence rate was not different in the three positive groups, but it was lower in 20 patients with negative tilt tests (5% [CI 0-15]) than in 61 patients with positive TT (24% [CI ).…”

Section: Ilr Negativementioning

confidence: 99%

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Should we treat severe vasovagal syncope with a pacemaker?

Sutton

2017

J Intern Med

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Cardiac pacing for vasovagal syncope (VVS) addresses the cardioinhibitory component of the reflex but cannot directly affect vasodepression, which occurs in every reflex even when hidden by dominant cardioinhibition. The randomized controlled trials of pacing in VVS have, after almost 2 decades, determined that a small number of patients can benefit because their vasodepressor component is not severe. Early studies compared pacing with no therapy yielding highly significant benefits. Subsequently, all study patients had implanted devices with half being switched off. No benefit was seen. The ISSUE‐3 study found significant benefit (P < 0.039) in prevention of syncope recurrence in older patients. A sub‐study later showed those with negative tilt tests, otherwise indistinguishable from tilt‐positives, had 5% recurrence in 21 months (P < 0.004). There is acceptance that pacing must be dual chamber, but the question of how pacing is delivered remains open. Relying on falling heart rate is insufficient, probably because it occurs too late. Other algorithms which indirectly detect neuroendocrine changes earlier than heart rate fall may have useful application. In clinical terms, the patient to be considered for pacing should not be young and have severe symptoms. Ideally, tilt testing should be negative implying vasodepression of lesser severity and, therefore, yielding fewer syncope recurrences. When selecting pacing, additional concern must be given to regression to the mean of symptoms, severe to less severe. Patients seek help when they are at their worst. Moreover, many years of pacing are unlikely to be free of complications related to implanted hardware.

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Section: Historical Developmentstudiesmentioning

confidence: 84%

Section: Ilr Negativementioning

confidence: 99%

Section: Ilr Negativementioning

confidence: 99%

Section: Ilr Negativementioning

confidence: 99%

See 2 more Smart Citations

Should we treat severe vasovagal syncope with a pacemaker?

Sutton

2017

J Intern Med

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show abstract

“…The risk of recurrence was reduced by 57%. In the ILR subgroup of the multicentre Syncope Unit Project (SUP) 2 study, 292 the estimated rates of syncope recurrence with pacing were 11% at 1 year, 24% at 2 years, and 24% at 3 years, and were significantly lower than the corresponding rates observed in untreated control patients.…”

Section: Evidence From Trials In Suspected or Certain Reflex Syncope mentioning

confidence: 94%