Medtronic (Italy)

Background: Spinal cord stimulation (SCS) is a treatment for chronic intractable pain powered by an implantable pulse generator that may be rechargeable or not rechargeable (NR). It is performed in 2 stages (a trialing phase followed by permanent device implantation) and necessitates 2 hospitalizations, which may increase infection risk. Objective: This analysis explores the cost impact of improvements in battery longevity and the adoption of 1-step (direct-to-implant [DTI]) SCS implantation. Methods: Since 2019, 3 leading NR-SCS devices have been launched: Device A (2019), Device B (2020), and Device C (2021). The battery longevity of the newest Device C was estimated at comparable stimulation settings for Devices A and B. A Markov model simulated individual patient pathways across 2 scenarios: Device A vs Device C and Device B vs Device C (both with the DTI approach and 2-step approach). Costs considered were the initial device implantation procedure, device replacements, and serious adverse event (SAE) management. Italian diagnosis-related group (DRG) tariffs were applied for costs, and a 15-year time horizon was used. Results: Over 15 years, using a DTI approach, the undiscounted total costs for Device A vs Device C were €26 860 and €22 633, respectively, and €25 111 and €22 399 for Device B vs Device C, respectively. Compared with Devices A and B, Device C offered savings of €4227 and €2712, respectively; similar savings were predicted with a 2-step implant approach. Discussion: The battery longevity of NR-SCS devices directly impacts long-term costs to a payer. The longer the device lasts, the lower mean total cumulative costs the patient will have, especially with regard to device replacement costs. With novel devices and specific programming settings, the lifetime cost per patient to a payer can be decreased without compromising the patient's safety and positive clinical outcome. Conclusions: Extended SCS battery longevity can translate into tangible cost savings for payers. The DTI approach for SCS supports National Healthcare System cost efficiencies and offers the additional benefits of optimizing operating room time while having only one recovery period for the patient.

Remote monitoring is recommended for patients with implantable cardiac monitors (ICMs), but compared to other cardiac implantable devices, ICMs are less accurate and transmit a higher number of alerts. The aim of this study was to investigate the predictors of false-positive (FP) arrhythmic alerts in patients with unexplained syncope who were implanted with ICM and followed by an automatic remote monitoring system. We retrospectively evaluated all consecutive patients who received a long-sensing vector ICM for unexplained syncope between January 2019 to September 2021 at our Syncope Unit. The primary endpoint was the incidence of the first FP episode. The secondary endpoints included assessing the incidence of FP episodes for all types of algorhythms and indentifying the reasons for the misdetection of these episodes. Among 105 patients (44.8% males, median age 51 years), 51 (48.6%) transmitted at least one FP alert during a median follow-up of 301 days. The presence of pre-ventricular complexes (PVCs) on the resting electrocardiogram was the only clinical characteristic associated with an increased risk of FP alerts (adjusted Hazard ratio [HR] 5.76 [2.66-12.4], p=0.010). The other significant device-related variables were a low-frequency filter at 0.05Hz versus the default 0.5Hz (adjusted HR 3.82 [1.38-10.5], p=0.010) and the R-wave amplitude (adjusted HR 0.35 [0.13-0.99], p=0.049). Patients who have PVCs are at higher risk of inappropriate ICM activations. To reduce the occurrence of FP alerts, it may be beneficial to target a large R-wave amplitude during device insertion and avoid programming a low-frequency filter at 0.05Hz.

Abstract Funding Acknowledgements Type of funding sources: None. Background To evaluate myocardial injury in Atrial Fibrillation (AF) patients undergoing High Power Short Duration radiofrequency (HPSD) and visually guided Laser Balloon Ablation (LBA). Methods and results In this single center registry we prospectively enrolled 40 patients (67% male), mean age 63±9, with paroxysmal or persistent AF (see table I). The ablation target has been the pulmonary vein isolation (PVI) with LBA and wide area circumferential ablation (WACA) with HPSD. 6 and 18 hours post-procedure samples of high sensitive cardiac troponin I (cTnI) were collected. The results show not significant differences in target population and no significant differences in high sensitive cardiac troponin I (cTnI pg/ml) levels at 6h (HPSD cTnI =806±496 pg/ml vs laser cTnI = 664±339 pg/ml p=0.17) and 18 hours after ablation (HPSD cTnI =833±540 pg/ml vs laser cTnI = 1081±962 pg/ml p=0.07). Conclusion These results indicate that myocardial injury induced by HPSD and LBA at 6 and 18 hours after procedure are similar targeting WACA and PVI respectively. This registry is ongoing to evaluate freedom from AF at 12 months follow up.

No studies have investigated whether optimizing implantable cardiac monitors (ICM) programming can reduce false-positive (FP) alerts. We identified patients implanted with an ICM (BIOMONITOR III) who had more than 10 FP alerts in a 1-month retrospective period. Uniform adjustments of settings were performed based on the mechanism of FP triggers and assessed at 1 month. Eight patients (mean age 57.5 ± 23.2 years; 37% female) were enrolled. In 4 patients, FPs were caused by undersensing of low-amplitude premature ventricular contractions (PVCs). No further false bradycardia was observed with a more aggressive decay of the dynamic sensing threshold. Furthermore, false atrial fibrillation (AF) alerts decreased in 2 of 3 patients. Two patients had undersensing of R waves after high-amplitude PVCs; false bradycardia episodes disappeared or were significantly reduced by limiting the initial value of the sensing threshold. Finally, the presence of atrial ectopic activity or irregular sinus rhythm generated false alerts of AF in 2 patients that were reduced by increasing the R-R variability limit and the confirmation time. In conclusion, adjustments to nominal settings can reduce the number of FP episodes in ICM patients. More research is needed to provide practical recommendations and assess the value of extended ICM programmability.

We hypothesized that an accurate assessment of preoperative venography could be useful in predicting transvenous lead extraction (TLE) difficulty. A dedicated preoperative venogram was performed in consecutive patients with cardiac implantable electronic device who underwent TLE. The level of stenosis was classified as without significant stenosis, moderate, severe, and occlusion. The presence of extensive lead-venous wall adherence (≥50 mm) was also assessed. A total of 105 patients (median age: 71 years; 72% male) with a median of 2 (1-2) leads to extract were enrolled. Preoperative venography showed moderate to severe stenosis in 31 (30%), complete occlusion in 15 (14%), and extensive lead-venous wall adherence in 50 (48%) patients. Complete TLE success was achieved in 103 (98%) patients. A total of 55 (52%) were advanced extractions as they required a powered mechanical and/or laser sheath. They were more prevalent in the group with extensive lead-venous wall adherence (72% vs. 34%, p < .001), while no differences were found between patients with and without venous occlusion. In multivariate analysis, the presence of adherence was a predictor of advanced extraction (odds ratio: 2.89 [1.14-7.32], p = .025). The fluoroscopy time was also significantly longer (14.0 [8.2-18.7] vs. 5.1 [2.1-10.0] min, p < .001). The rate of complications did not differ based on the presence of venous lesions. Although procedural success and complication rates were similar, patients with extensive lead-venous wall adherence required a longer fluoroscopy time and were three times more likely to need advanced extraction tools. Conversely, the presence of total venous occlusion had no impact on the procedure complexity.

Cardiac pacing has been studied extensively in patients with reflex syncope over the past two decades. The heterogeneity of the forms and clinical manifestations of reflex syncope explain the controversial results of older randomised clinical trials. New evidence from recent trials has changed medical practice, now leading to clear indications for pacing in patients with asystolic syncope documented during carotid sinus massage, implantable cardiac monitoring or tilt testing. Given that recent trials in reflex syncope have been performed using the closed-loop stimulation algorithm, the authors will briefly discuss this pacing mode, review hypotheses about the mechanisms underlying its activation during syncope and provide practical instructions for programming and troubleshooting.

Syncope without prodromes in subjects with normal heart and normal electrocardiogram (ECG) is classified as non-classical neurally mediated syncope and is characterized by low adenosine plasma levels (APLs) and frequent asystolic syncope. We assessed the efficacy of theophylline, a non-selective adenosine receptor antagonist, in preventing syncopal events. Participants received an implantable cardiac monitor, underwent APL measurement, and received oral theophylline at maximum tolerated dose (starting dose 300 mg b.i.d.). They were compared with a historical cohort of untreated patients with implantable cardiac monitor who had the same inclusion criteria and were balanced with the propensity score (PS) method as regard age, sex, lifetime syncopal episodes, APL, and antihypertensive drugs. Primary endpoint was time to first syncopal recurrence at 24 months. There were 76 patients in the theophylline group and 58 in the control group. Syncope recurred in 25 (33%) patients in the theophylline group and in 27 (47%) patients in the control group, with an estimated 2-year recurrence rate of 33% and 60%, respectively, and a hazard ratio of 0.53 [95% confidence interval (CI), 0.30-0.95; P = 0.034]. Most of the benefit of theophylline is derived from reduction of syncope due to asystolic atrioventricular (AV) block (hazard ratio of 0.13; 95% CI, 0.03-0.58; P = 0.008). Thirty (39%) patients discontinued theophylline after a median of 6.4 (interquartile range 1.7-13.8) months due to side effects. Theophylline was effective in preventing recurrences in patients with syncope without prodromes, normal heart, and normal ECG. The benefit was greater in patients with syncope due to asystolic AV block. NCT03803215.

Rationale:Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with increased morbidity, especially stroke and heart failure. There is also increasing awareness that atrial fibrillation is a major cause of embolic events which in 75% of cases are complicated by cerebrovascular accidents.Patient concerns:A 50-year-old woman with mitral bioprosthesis under warfarin for nonvalvular atrial fibrillation was referred to our Coronary Intensive Care Unit due to acute myocardial infarction without evidence of significant coronary artery stenosis.Diagnoses:Cardiovascular examination showed an irregular pulse and a grade II diastolic murmur was audible at the apical area. The patient underwent coronary angiography showing absence of obstructive coronary artery disease. We decided to replace Warfarin with direct oral anticoagulants as anticoagulant therapy.Interventions:Transoesophageal echocardiography revealed a thrombus in left atrial appendage that was treated by replacing warfarin with an oral direct thrombin inhibitor.Outcomes:At 2-month follow-up, the therapy showed to be effective for thrombus resolution.Lessons:Our case demonstrated how AF has high risk of thromboembolic complications, not only in terms of stroke but also of myocardial infarction and death.The use of direct oral anticoagulants in AF patients with bioprosthetic heart valves is still debated due to an unclear definition of “nonvalvular” AF.