Opinions differ regarding the effectiveness of cardiac pacing in patients affected by reflex syncope. We assessed a standardized guideline-based algorithm in different forms of reflex syncope.
In ...this prospective, multi-centre, observational study, patients aged >40 years, affected by severe unpredictable recurrent reflex syncopes, underwent carotid sinus massage (CSM), followed by tilt testing (TT) if CSM was negative, followed by implantation of an implantable loop recorder (ILR) if TT was negative. Those who had an asystolic response to one of these tests received a dual-chamber pacemaker.
253 patients, mean age 70 ± 12 years, median 4 (3-6) syncopes, 89% without or with short prodromes. Of these patients, 120 (47%) received a pacemaker and 106 were followed up for a mean of 13 ± 7 months: syncope recurred in 10 (9%). The recurrence rate was similar in 61 CSM+ (11%), 30 TT+ (7%), and 15 ILR+ (7%) patients. The actuarial total syncope recurrence rate was 9% (95% confidence interval (CI), 6-12) at 1 year and 15% (95% CI, 10-20) at 2 years and was significantly lower than that observed in the group of 124 patients with non-diagnostic tests who had received an ILR: i.e. 22% (95% CI, 18-26) at 1 year and 37% (95% CI, 30-43) at 2 years (P = 0.004).
About half of older patients with severe recurrent syncopes without prodromes have an asystolic reflex for which cardiac pacing goes along with a low recurrence rate. The study supports the clinical utility of the algorithm for the selection of candidates to cardiac pacing in everyday clinical practice.
http://www.clinicaltrials.gov. Unique identifier: NCT01509534.
The aim of this study was to determine the long-term effects and determinants of success of cardiac pacing in patients affected by reflex syncope enrolled in the Syncope Unit Project 2 (SUP 2) study. ...Initial results have validated the effectiveness of a standardized guideline-based algorithm which can be used in clinical practice in order to select suitable candidates for cardiac pacing.
In this prospective, multicentre, observational study, patients aged >40 years, affected by severe unpredictable recurrent reflex syncope, underwent carotid sinus massage (CSM), followed by tilt testing (TT) if CSM was negative, followed by implantation of an implantable loop recorder (ILR) if TT was negative. Those who had an asystolic response to one of these tests received a dual-chamber pacemaker. Of 281 patients who met the inclusion criteria, 137 (49%) received a pacemaker and were followed up for a mean of 26 ± 11 months: syncope recurred in 25 (18%) of them. At 3 years, the actuarial syncope recurrence rate was 20% 95% confidence interval (CI) 12-30 and was significantly lower than in 142 patients who did not receive a pacemaker and were observed by means of an ILR 43% (95% CI 29-57), P = 0.01. The 3-year recurrence rate was not different among 78 CSM+, 38 TT+, and 21 ILR+ patients, whereas it was lower in 20 patients with negative TT 5% (95% CI 0-15) than in 61 patients with positive TT 24% (95% CI 10-38).
The benefit of cardiac pacing is maintained at 3 years, irrespective of the index diagnostic test, and is maximum in patients with negative TT.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01509534.
Background
Novel implantable defibrillators (ICDs) allow first (S1) and third (S3) heart sounds to be measured by means of an embedded accelerometer. ICD-measured S1 and S3 have been shown to ...significantly correlate with hemodynamic changes in acute animal models. The HeartLogic algorithm (Boston Scientific) measures and combines multiple parameters, including S3 and S1, into a single index to predict impending heart failure decompensation. We evaluated the echocardiographic correlates of ICD-measured S1 and S3 in patients with ICD and cardiac resynchronization therapy ICD.
Methods
The HeartLogic feature was activated in 104 patients. During in-office visits, patients underwent echocardiographic evaluation, and parameters of systolic and diastolic function were correlated with S3 and S1 amplitude measured on the same day as the visit.
Results
S3 amplitude inversely correlated with deceleration time of the E-wave (r = −0.32; 95% CI -0.46 – -0.17;
P
< 0.001), and S1 amplitude significantly correlated with left ventricular ejection fraction (r = 0.17; 95% CI 0.03–0.30;
P
= 0.021). S3 > 0.9 mG detected a restrictive filling pattern with 85% (95% CI 72%–93%) sensitivity and 82% (95% CI 75%–88%) specificity, while S1 < 1.5 mG detected ejection fraction < 35% with 28% (95% CI 19%–40%) sensitivity and 88% (95% CI 80%–93%) specificity.
Conclusion
ICD-measured heart sound parameters are significantly correlated with echocardiographic indexes of systolic and diastolic function. This confirms their utility for remote patient monitoring when used as single sensors and their potential relevance when considered in combination with other physiological ICD sensors that evaluate various aspects of heart failure physiology.
Background. There are few studies about post myocardial infarction follow-up using telemedicine. We organized a post-discharge telemedicine service with a dedicated team. To do this, it was necessary ...that all stakeholders involved in the organization and use of the telemedicine service were properly educated and informed. Methods. We designed a theoretical–practical mini-course to train healthcare personnel and increase skills, with excellent learning outcomes and satisfaction. Thereafter, we enrolled patients affected by acute myocardial infarction with ST elevation (STEMI), MINOCA (myocardial infarction with no obstructive coronary atherosclerosis), Takotsubo syndrome or spontaneous coronary dissection, and high-risk acute myocardial infarction without ST elevation (NSTEMI). At discharge, the cardiology technician performed counselling for the patient, using regional platforms, such as televisit, at 1 and 4 months, allowed us to monitor major adverse cardiac events (MACE), heart failure, arrhythmias, unstable angina and non-cardiovascular events, therapy adherence, target therapy and customer satisfaction. Results. Between November 2021 and February 2023, we enrolled 110 patients: 72% affected by STEMI, 22% by NSTEMI. At the 1-month follow up, 12 patients did not reach the pressure target and 23 patients did not reach the LDL target. We observed three patients requiring hospital readmission, three requiring hospital visits for further investigation, and one death. To date, a four month follow up was performed for 54 patients. No readmissions or deaths occurred. We detected a rate of 96% of customer satisfaction. Conclusions. A health coordination center with a dedicated team makes televisit safe as a follow-up for post-myocardial infarction patients. Beforehand, it is fundamental for healthcare professionals to acquire theoretical knowledge and updates, and the acquisition of manual, technical and practical skills.
The potential benefits must be balanced against the risks associated with creating pacemaker dependency. ...AV junction ablation can be performed during CRT implantation or after correct lead and ...device functioning assessment. ...the EuroHeart Failure survey reported that up to 45% of patients with HF and sinus rhythm also presented with intermittent or permanent AF (13).
We explored the results of two tests of the novel HeartInsight algorithm for heart failure (HF) prediction, reconstructing trends from historical cases. Results suggest potential extension of ...HeartInsight to implantable cardioverter defibrillators patients without history of HF and illustrate the importance of the baseline clinical profile in enhancing algorithm specificity.
The efficacy of dual-chamber cardiac pacing in neuro-mediated reflex syncope with a cardio-inhibitory response to the Tilt-Table test (TT) has not been definitively assessed so far. The lack of ...reproducibility of results from previous studies may be partially explained by discrepancies in subject selection and some weaknesses in design and methods. The European Society of Cardiology (ESC) has set a class IIb indication to pacemaker implantation in this population recommending further research.
The BIOSync study is a multicenter, patient- and outcome-assessor-blind, randomized, parallel-arm, placebo-controlled trial with the objective of assessing the clinical benefit of cardiac pacing in patients with frequently recurrent reflex syncope, suspected (but not proven) to be triggered by asystolic pauses as showing a VASIS 2B response to the TT (>3-s pause regardless of blood pressure drop). The primary and secondary endpoints are time to first post-implantation recurrence of syncope or the combination of pre-syncope or syncope, respectively. One hundred and twenty-eight consenting patients will be 1:1 randomized to dual-chamber cardiac pacing 'on' or 'off' after pacemaker implantation, and followed up until the first adjudicated primary endpoint event for a maximum of 2 years. The so-called Closed Loop Stimulation function on top of dual-chamber pacing is the pacing mode selected in the study active arm. Participating patients are asked to self-report syncopal symptoms at least every 3 months with self-administered questionnaires addressed to an independent Adjudication Committee. Patients and members of the Adjudicating Committee are blinded to randomization. The study is designed to detect a 40% relative reduction in the 2-year incidence of syncopal recurrences with 80% statistical power.
The BIOSync study is designed to definitively assess the benefit of pacing against placebo in reflex syncope patients with a cardio-inhibitory response to the TT. The study will also provide important information on the efficiency of the TT in appropriately selecting reflex syncope patients for cardiac pacing.
ClinicalTrials.gov, identifier: NCT02324920 (27 October 2016, date last accessed).
The study hypothesis was that a decision-making approach improves diagnostic yield and reduces resource consumption for patients with syncope who present as emergencies at general hospitals.
This was ...a prospective, controlled, multi-centre study. Patients referred from 5 November to 7 December 2001 were managed according to usual practice, whereas those referred from 4 October to 5 November 2004 were managed according to a standardized-care pathway in strict adherence to the recommendations of the guidelines of the European Society of Cardiology. In order to maximize its application, a decision-making guideline-based software was used and trained core medical personnel were designated-both locally in each hospital and centrally-to verify adherence to the diagnostic pathway and give advice on its correct application. The 'usual-care' group comprised 929 patients and the 'standardized-care' group 745 patients. The baseline characteristics of the two study populations were similar. At the end of the evaluation, the standardized-care group was seen to have a lower hospitalization rate (39 vs. 47%, P=0.001), shorter in-hospital stay (7.2+/-5.7 vs. 8.1+/-5.9 days, P=0.04), and fewer tests performed per patient (median 2.6 vs. 3.4, P=0.001) than the usual-care group. More standardized-care patients had a diagnosis of neurally mediated (65 vs. 46%, P=0.001) and orthostatic syncope (10 vs. 6%, P=0.002), whereas fewer had a diagnosis of pseudo-syncope (6 vs. 13%, P=0.001) or unexplained syncope (5 vs. 20%, P=0.001). The mean cost per patient and the mean cost per diagnosis were 19 and 29% lower in the standardized-care group (P=0.001).
A standardized-care pathway significantly improved diagnostic yield and reduced hospital admissions, resource consumption, and overall costs.
Erratum for Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial. Trials. 2017
PDF
