Remote-only monitoring for patients with cardiac implantable electronic devices: a before-and-after pilot study.

BACKGROUND: Outcomes for patients with cardiac implantable electronic devices are better when follow-up incorporates remote monitoring technology in addition to in-clinic visits. For patients with implantable devices, we sought to determine the feasibility, safety and associated health care utilization of remote-only follow-up, along with its effects on patients' quality of life and costs. METHODS: This multicentre before-and-after pilot study involved patients with new or existing pacemakers or implantable cardioverter defibrillators. The "before" phase of the study spanned the period October 2015 to February 2017; the "after" phase spanned the period October 2016 to February 2018. The exposure was remote-only follow-up in combination with Remote View, a service that facilitates access to device data, allowing device settings to be viewed remotely to facilitate remote programming. Outcomes at 12 months were feasibility (adherence to remote monitoring), safety (rate of adverse events) and health care utilization (remote and in-clinic appointments). We also assessed quality of life, using 3 validated scales, and costs, taking into account both health care system and patient costs. RESULTS: A total of 176 patients were enrolled. Adherence (defined as at least 1 successful remote transmission during follow-up) was 87% over a mean follow-up of 11.7 (standard deviation 2.2) months. There was a reduction in in-clinic visits at specialized sites among patients with both implantable defibrillators (26 v. 5, p < 0.001, n = 48) and pacemakers (42 v. 10, p < 0.001, n = 51). There was no significant change in visits to community sites for patients with defibrillators (13 v. 17, p = 0.3, n = 48). The composite rate of death, stroke, cardiovascular hospitalization and device-related hospitalization was 7% (n = 164). No adverse events were linked to the intervention. There was no change in quality-of-life scales between baseline and 12 months. Health care costs were reduced by 31% for patients with defibrillators and by 44% for those with pacemakers. INTERPRETATION: This pilot study showed the feasibility of remote-only follow-up, with no increase in adverse clinical outcomes and no effect on quality of life, but with reductions in costs and health care utilization. These results support progression to a larger-scale study of whether superior effectiveness and reduced cost can be achieved, with preservation of safety, through use of remote-only follow-up. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT02585817.

Association of History of Dizziness and Long-term Adverse Outcomes With Early vs Later Orthostatic Hypotension Assessment Times in Middle-aged Adults.

Importance: Guidelines recommend assessing orthostatic hypotension (OH) 3 minutes after rising from supine to standing positions. It is not known whether measurements performed immediately after standing predict adverse events as strongly as measurements performed closer to 3 minutes. Objective: To compare early vs later OH measurements and their association with history of dizziness and longitudinal adverse outcomes. Design, Setting, and Participants: This was a prospective cohort study of middle-aged (range, 44-66 years) participants in the Atherosclerosis Risk in Communities Study (1987-1989). Exposures: Orthostatic hypotension, defined as a drop in blood pressure (BP) (systolic BP ≥20 mm Hg or diastolic BP ≥10 mm Hg) from the supine to standing position, was measured up to 5 times at 25-second intervals. Main Outcomes and Measures: We determined the association of each of the 5 OH measurements with history of dizziness on standing (logistic regression) and risk of fall, fracture, syncope, motor vehicle crashes, and all-cause mortality (Cox regression) over a median of 23 years of follow-up (through December 31, 2013). Results: In 11 429 participants (mean age, 54 years; 6220 [54%] were women; 2934 [26%] were black) with at least 4 OH measurements after standing, after adjustment OH assessed at measurement 1 (mean [SD], 28 [5.4] seconds; range, 21-62 seconds) was the only measurement associated with higher odds of dizziness (odds ratio [OR], 1.49; 95% CI, 1.18-1.89). Measurement 1 was associated with the highest rates of fracture, syncope, and death at 18.9, 17.0, and 31.4 per 1000 person-years. Measurement 2 was associated with the highest rate of falls and motor vehicle crashes at 13.2 and 2.5 per 1000 person-years. Furthermore, after adjustment measurement 1 was significantly associated with risk of fall (hazard ratio [HR], 1.22; 95% CI, 1.03-1.44), fracture (HR, 1.16; 95% CI, 1.01-1.34), syncope (HR, 1.40; 95% CI, 1.20-1.63), and mortality (HR, 1.36; 95% CI, 1.23-1.51). Measurement 2 (mean [SD], 53 [7.5] seconds; range, 43-83 seconds) was associated with all long-term outcomes, including motor vehicle crashes (HR, 1.43; 95% CI, 1.04-1.96). Measurements obtained after 1 minute were not associated with dizziness and were inconsistently associated with individual long-term outcomes. Conclusions and Relevance: In contrast with prevailing recommendations, OH measurements performed within 1 minute of standing were the most strongly related to dizziness and individual adverse outcomes, suggesting that OH be assessed within 1 minute of standing.

Assessment of a standardized algorithm for cardiac pacing in older patients affected by severe unpredictable reflex syncopes.

AIMS: 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. METHODS AND RESULTS: 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. POPULATION: 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). CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01509534.

Risk stratification for implantable cardioverter defibrillator therapy: the role of the wearable cardioverter-defibrillator.

The benefit of implantable cardioverter-defibrillator (ICD) therapy depends upon appropriate evaluation of a persisting risk of sudden death and estimation of the patient's overall survival. Assessment of a stable and unchangeable arrhythmogenic substrate is often difficult. Structural abnormality and ventricular dysfunction, the two major risk parameters, may recover, and heart failure symptoms can improve so that ICD therapy may not be indicated. Risk stratification can take time while the patient continues to be at high risk of arrhythmic death, and patients may need temporary bridging by a defibrillator in cases of interrupted ICD therapy. The wearable cardioverter-defibrillator (WCD) combines a long-term electrocardiogram (ECG)-monitoring system with an external automatic defibrillator. The LIfeVest® (ZOLL, Pittsburgh, PA, USA) is composed of a garment, containing two defibrillation patch electrodes on the back, and an elastic belt with a front-defibrillation patch electrode and four non-adhesive ECG electrodes, connected to a monitoring and defibrillation unit. The WCD is a safe and effective tool to terminate ventricular tachycardia/ventricular fibrillation events, unless a conscious patient withholds shock delivery. It may be used in patients in the early phase after acute myocardial infarction with poor left ventricular function, after acute coronary revascularization procedures (percutaneous coronary intervention or coronary artery bypass grafting) and reduced left ventricular ejection fraction (≤35%), in patients with acute heart failure in non-ischaemic cardiomyopathy of uncertain aetiology and prognosis. The WCD may be helpful in subjects with syncope of assumed tachyarrhythmia origin or in patients with inherited arrhythmia syndromes. The WCD may replace ICD implantation in patients waiting for heart transplantation or who need a ventricular-assist device. This review describes the technical details and characteristics of the WCD, discusses its various potential applications, and reports the currently available experience with the wearable defibrillator.

Fainting and hemolysis during blood sampling in youngsters: prevalence study.

OBJECTIVE: To assess the incidence of fainting and hemolysis in taking blood samples from adolescents in a school setting. DESIGN: A cross-sectional school-based survey. All blood samples and data were collected during September and October 2005. SUBJECTS: A community sample of 869 youngsters attending third grade secondary education in 14 secondary schools in the Flemish province of Antwerp, Belgium (mean age: 17.3 years, +/-1.2 years). MEASUREMENTS: Fasting blood samples were obtained on-site for measurement of levels of glucose, high density lipoprotein cholesterol and triglycerides. The incidence of fainting and hemolysis was assessed. RESULTS: In 60% of the total sample a blood sample was taken, 15% refused. In the remaining 25%, taking a blood sample was not possible due to problems in drawing blood from the vein (4%) or not fasting (21%). The incidence of fainting was 2.5%. Hemolysis occurred in 2.4% of the blood samples. CONCLUSION: When taking blood samples in this age group, there seems to be a great willingness to participate. Precaution should be taken though when taking blood samples in youngsters. In this study, about 1 in 40 students fainted. When blood samples are taken on-site and transported to a laboratory, an incidence of hemolysis of 2.4% should be taken into account.

Predictive value of presyncope in patients monitored for assessment of syncope.

BACKGROUND: The purpose of this study was to assess the diagnostic value of recording the cardiac rhythm during presyncope in patients undergoing monitoring for undiagnosed syncope. METHODS AND RESULTS: Eighty-five patients (age, 59 +/- 18 years; 44 men, 41 women) with recurrent unexplained syncope underwent prolonged monitoring with an implantable loop recorder. Patients were examined for syncope, which was either recurrent or associated with at least 2 presyncopal episodes. Patients had a mean of 5.1 +/- 5.5 syncopal episodes in the previous 12 months, and 70% of patients had symptoms for >2 years. Sixty-two (73%) patients had recurrent symptoms during a 12-month follow-up period. Of 150 recurrent events captured by the implantable loop recorder, there were 38 (25%) episodes of syncope and 112 (75%) episodes of presyncope. Syncope alone recurred in 12 patients, presyncope in 25, and both in 16. An arrhythmia was present in 64% of syncopal events (bradycardia in 16, tachycardia in 2) versus 25% for presyncopal events (bradycardia in 7, tachycardia in 3, P =.001). An arrhythmia was detected in 9 (56%) of the 16 patients with both syncope and presyncope, which was present in all recorded episodes of syncope compared with 6 of 9 presyncopal episodes. Patient-related failure to freeze the device after symptoms occurred in 21 (36%) of 59 syncopal events compared with 15 (12%) of 127 presyncopal events (P =.0001). CONCLUSIONS: Syncope is more likely to be associated with an arrhythmia than is presyncope in patients undergoing extended monitoring. Presyncope is a nonspecific end point that is frequently associated with sinus rhythm. Patients undergoing extended monitoring for syncope should continue to be monitored after an episode of presyncope unless an arrhythmia is detected.

The impact of a dedicated "syncope and falls" clinic on pacing practice in northeastern England.

This study examined whether the increased demand for pacemaker implants for carotid sinus syndrome (CSS) at the Regional Pacing Service in northeastern England was related to the establishment of a dedicated "syncope and falls" clinic or to the publication of NASPE and BPEG guidelines for pacing symptomatic bradycardia. To this end, pacemaker rates for various indications at this institution were compared with those of a comparable region (Liverpool), as well as with BPEG's national pacemaker database. Findings indicate a distinct impact of the Newcastle syncope and falls clinic on recognition and pacemaker treatment of CSS.

[Bicavitary cardiac stimulation. Re-assessment and results]. / La stimulation cardiaque bicavitaire. Mise au point et résultats.

In each indication for cardiac stimulation, dual chamber pacing must be considered if stimulation or sensing in the atrium is possible. It is of particular importance in patients with diastolic ventricular dysfunction. The Heart rate is the most important parameter in stress-adaptation; for this reason we propose to use exclusively the VVIR or DDDR stimulation mode in physically active patients. Complications of dual chamber pacing are rare. During follow-up it is important to limit the energy of impulses and so to enhance the longevity of the generator, and to verify other parameters such as adaptation of the rate adaptation sensor and the AV delay intervals for sensed and paced atrial events. Modern technology allows us to reach the two most important goals of cardiac stimulation: avoid syncopes due to excessive bradycardia or asystole and optimize the quality of life of our patients.

Cost-effectiveness of in-hospital evaluation of patients with syncope.

In order to assess the utility of in-hospital evaluation of syncope we reviewed the records of 134 consecutive patients admitted within 6 h of a true syncopal episode, and obtained follow-up information on 130 of them 3 years later. All threatened cardiac rhythm and conduction disturbances were detected on the initial ECG recording. Prolonged ECG monitoring did not contribute additional diagnoses. Other diagnostic tests and procedures performed during the mean 7.5-day hospital stay only confirmed the findings of the initial history, physical and ECG examinations. Diagnostic evaluation was followed by therapeutic intervention in only 33 patients (24%); all interventions were clearly mandated by the initial admission evaluation. There were no cases of sudden death and no association between causes of death, the index syncope episode or prior history of syncope. We therefore propose that the evaluation of patients presenting within hours of a syncopal episode include only history taking, physical examination and the initial ECG recording. Further in-hospital evaluation should be limited to confirming initial positive findings. This approach may allow an estimated 85% reduction in costs involved in the management of similar patients, with probable negligible adverse effects on prognosis.