Transvenous Lead Extraction (TLE) Procedure: Experience from a Tertiary Care Center in Thailand.

BACKGROUND: Transvenous Lead Extraction (TLE) is a standard treatment for some late Cardiac Implantable Electronics Device (CIED) complications. The outcome of transvenous lead extraction procedure in Thailand is not robust. METHODS: A Single-center retrospective cohort of TLE procedures performed at Ramathibodi hospital between January 2008 and December 2020 was studied. RESULTS: There were 157 leads from 105 patients who underwent lead removal procedure during the specified period. Data analysis was performed from 79 TLE patients due to incomplete data and lead explant procedure of the excluded subjects. Mean patients' age was 57.7 ± 18.7 years, with 70.9% male. There were 82 pacemaker leads, 35 ICD leads, and 5 CS leads (mean number of leads were 1.54 ± 0.66 per patient), with mean implanted duration of 87.8 ± 68.2 months. Main indication for TLE was infection-related, which accounted for 67.1% of the cases. Overall clinical success rate was 97.5%. Mean operative time was 163.8 ± 69.5 min. Major complications occurred in 4 patients (5.1%) with one in-hospital mortality from severe sepsis. CONCLUSION: TLE using laser sheath and rotating mechanical sheath for transvenous lead extraction is effective and safe, even outside high-volume center.

Comparison of Outcomes with Midodrine and Fludrocortisone for Objective Recurrence in Treating Syncope (COMFORTS trial): Rationale and design for a multi-center randomized controlled trial.

BACKGROUND: The cornerstone of the treatment of vasovagal syncope (VVS) is lifestyle modifications; however, some patients incur life-disturbing attacks despite compliance with these treatments which underscores the importance of pharmacological interventions. METHODS: In this open-label multi-center randomized controlled trial, we are going to randomize 1375 patients with VVS who had ≥2 syncopal episodes in the last year into three parallel arms with a 2:2:1 ratio to receive midodrine, fludrocortisone, or no medication. All patients will be recommended to drink 2 to 3 liters of fluids per day, consume 10 grams of NaCl per day, and practice counter-pressure maneuvers. In medication arms, patients will start on 5 mg of midodrine TDS or 0.05 mg of fludrocortisone BD. After one week the dosage will be up-titrated to midodrine 30 mg/day and fludrocortisone 0.2 mg/day. Patient tolerance will be the principal guide to dosage adjustments. We will follow-up the patients on 3, 6, 9, and 12 months after randomization. The primary outcome is the time to first syncopal episode. Secondary outcomes include the recurrence rate of VVS, time interval between first and second episodes, changes in quality of life (QoL), and major and minor adverse drug reactions. QoL will be examined by the 36-Item Short Form Survey questionnaire at enrollment and 12 months after randomization. CONCLUSION: The COMFORTS trial is the first study that aims to make a head-to-head comparison between midodrine and fludrocortisone, against a background of lifestyle modifications for preventing recurrences of VVS and improving QoL in patients with VVS.

Discordance between the European and the United States guideline criteria for atrial septal defect closure in adult patients with pulmonary hypertension and its clinical impact.

BACKGROUND: The criteria for ASD closure in patients with PAH are different between the AHA/ACC and the ESC guidelines. We aimed to study the prevalence of patients with different guideline criteria for ASD closure and its impact on the clinical outcome after closure. METHODS AND RESULTS: A retrospective cohort study recruiting patients who underwent ASD closure from 2011-2020 was conducted in a single university hospital. Patients were grouped into ASD closure recommended (class I, class IIa, and class IIb) and ASD closure not recommended groups (class III). The primary outcome was the prevalence of patients with discordant criteria and the clinical outcomes and echocardiographic parameters after ASD closure. A total of 17 of 66 ASD patients (25.8 %) were diagnosed with ASD with pulmonary hypertension. Two patients were excluded due to incomplete right heart catheterization data. 13 patients (86.7 %) were classified as ASD-closure recommended group by both guidelines. Two patients, classified as class IIb by ACC/AHA guidelines, were unsuitable for ASD closure by ESC guidelines. After ASD closure, all 15 patients reported functional class improvement and no significant difference in the echocardiography parameters. However, the number of patients with a low probability of PHT was higher in patients with ESC guideline-recommended closure. CONCLUSIONS: Most patients (86.7 %) are in concordant classification regarding ASD closure recommendations. The ESC guidelines are more restrictive than the AHA/ACC guidelines, allowing fewer patients for ASD closure. However, the clinical outcomes after ASD closure are not significantly different between these guidelines.

Effect of ElectroMagnetic interference from SmartPHone on cardiac ImplaNtable electronic device (EMI-PHONE study).

Background: Smartphone can emit two types of electromagnetic waves, static field and dynamic field. Evidence showed the interference from phones to cardiac implantable electronic devices (CIEDs). The smartphones and CIEDs are reportedly better designed to reduce electromagnetic interference (EMI). Methods: 80 consecutive subjects with CIEDs were recruited and tested for EMI. Subject was tested with three different smartphones (Nokia 3310, Iphone 7, and Samsung 9S). Phone was attached to chest wall at 0 cm at generator site, at atrial lead level, and at ventricular lead level. During the tests, real-time interrogations were performed to detect any EMI from smartphone in standby mode, and during calling-in and out for 30 s. After the tests, post-test interrogations were performed to detect any parameter change. Adverse events including pacemaker inhibition, false ICD shock, CIEDs device malfunction, and urgent electrophysiologist consultations were recorded. Results: 80 subjects (mean age 70.5-year-old, 50% male) recruited in the study, all completed the testing protocol. The most common type of CIEDs tested was pacemaker (N = 56, 70%), followed by ICD (N = 16, 20%), and CRT (N = 8, 10%). Most patients (N = 62, 77.5%) had more than one lead implanted. The mean year of implantation was 5.2±2.8 (devices were implanted from 2008 to 2019). Of all the tests performed, there was no EMI or adverse events observed. Conclusion: Current generation of smartphones has no EMI effect on CIEDs in our study and can be used safely with less concern about adverse events including pacemaker inhibition, inappropriate ICD shock, and CIEDs device malfunction.