Performance and Physician Experience of INGEVITY+ Active Fixation Leads: Prospective INGEVITY+ Lead Clinical Study in Korea.

Background: Boston Scientific INGEVITY+ pacing lead (Boston Scientific, Marlborough, MA, USA) has been upgraded to INGEVITY. The performance of the INGEVITY+ pacing lead has not yet been reported. This study aimed to evaluate the short- and long-term safety, effectiveness, and handling experience of INGEVITY+ leads. Methods: Consecutive patients were included from 9 institutions in Korea, where 400 leads (200 right ventricular active fixation leads and 200 right atrial active fixation leads) were implanted or attempted in 200 subjects. Results: During the implantation, only one patient required a lead change because of lead screw failure. The handling questionnaires of the lead received very positive feedback with 88% of operators agreeing that it is easy for leads to pass through small vessels or vessels with multiple leads. At the 3-month follow-up, 95.7% of RA leads and 99.5% of RV leads had pacing thresholds less than 1.5 V. A total of 92.4% of atrial leads had amplitudes greater than 1.5 mV, and 96.5% of ventricular leads had sensing amplitudes greater than 5 mV at 3 months. A total of 99.8% had impedances between 300 and 1,300 ohms. The lead-related complication-free rate for all leads during follow-up was 100%, and the overall rates of lead dislodgment, perforation, and pericardial effusion were all 0.0%. Conclusions: The INGEVITY+ pacing lead exhibited exceptional clinical performance, with a high complication-free rate throughout the 3-month follow-up period. In addition, the lead displayed excellent electrical characteristics, and the lead-handling experience was reported to be very good.

Prevalence and Predictors of Clinically Relevant Atrial High-Rate Episodes in Patients with Cardiac Implantable Electronic Devices.

BACKGROUND AND OBJECTIVES: Atrial high-rate episodes (AHREs) can be continuously detected by cardiovascular implantable electronic devices (CIEDs); however, the predictors of clinically relevant AHREs are unclear. METHODS: This prospective multicenter study monitored 816 patients (median age 73 years, 40.4% male) without atrial fibrillation (AF) from September 2017 to July 2020. AHREs was defined as a programmed atrial detection rate >220 beats/min. The reference values of 6 minutes and 6 hours were set to analyze clinical implication of AHREs based on previously published data that the 6 minutes excluded most episodes of oversensing. RESULTS: During a median follow-up of 18 months (interquartile interval 9-26 months), AHREs with the longest durations of >15 seconds, >6 minutes, and >6 hours and clinically documented AF by electrocardiography were noted in 246 (30.1%), 112 (13.7%), 49 (6.0%), and 24 (2.9%) patients, respectively. Among patients developing AHREs >6 minutes, 102 (91.1%) of 112 patients were identified at the 6-month visit. Patients with AHREs >6 minutes had higher proportions of sick sinus syndrome, subjects with atrial premature beat >1% on Holter monitoring, and larger left atrium (LA) size than patients with AHREs ≤6 minutes. Multivariable logistic regression analysis showed that LA diameter >41 mm (odds ratio [OR], 2.08; 95% confidence interval [95% CI], 1.25-3.45), and sick sinus syndrome (OR, 3.22; 95% CI, 1.91-5.43) were associated with AHREs >6 minutes. CONCLUSIONS: In patients with LA diameter >41 mm, and sick sinus syndrome before CIEDs implantation is associated with risk of developing AHREs >6 minutes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03303872.

Predictors of an adverse clinical outcome in patients with long-term right ventricular apical pacing.

BACKGROUND: Right ventricular (RV) apical pacing can result in progressive left ventricular (LV) dysfunction and contribute to the development of heart failure (HF). This study aimed to predict the outcome after long-term RV apical pacing in patients with acquired atrioventricular (AV) block who required permanent pacing. METHODS: We included 247 patients who underwent long-term (>90% ventricular pacing with atrioventricular synchrony for more than 1 year) RV apical pacing for acquired AV block. We excluded patients with a reduced LV systolic function [ejection fraction (EF) <50%]. The paced QRS duration, degree of the axis, clinical characteristics, laboratory findings, and echocardiographic parameters were recorded. We evaluated the mortality and hospitalization due to HF. RESULTS: The mean follow-up duration was 6.9 years. Mortality and hospitalization due to HF occurred in 8.1% and 17%, respectively. In a multivariate analysis, a wider paced QRS duration and less superior paced QRS axis at the time of the implantation were independent risk factors for adverse events. The patients with a paced QRS duration of ≥163ms and axis of ≥-65° had a 5.8 times higher risk for adverse events compared to those with a paced QRS duration of <163ms and axis of <-65°. CONCLUSIONS: The paced QRS duration and axis could help us predict adverse clinical outcomes after permanent RV apical pacing in patients with high-degree AV block.

A comparison of tissue prolapse with optical coherence tomography and intravascular ultrasound after drug-eluting stent implantation.

The aim of this study was to compare the detection rate of tissue prolapse (TP) in optical coherence tomography (OCT) and intravascular ultrasound (IVUS) after drug-eluting stent (DES) implantation and evaluate clinical implication of TP at 2 years after percutaneous coronary intervention. In spite of the superiority of OCT in the aspect of resolution when it was compared to IVUS, there was little data about the superiority of OCT in detecting TP. And there has been controversy about the clinical significance of TP. We enrolled 38 patients who treated with DES implantation. OCT and IVUS measurements were performed in stented segments immediately after percutaneous coronary intervention. We matched OCT and IVUS images one by one, and analyzed TP quantitatively in both measurements. Thirty patients (78.9 %) were followed-up for 2 years to evaluate clinical outcome of TP. TP was detected in 95 % of stented lesions by OCT and 45 % of stented lesions by IVUS among 40 stented lesions in 38 patients. The best cut-off values of the area, depth and burden of TP on OCT for the detection of TP on IVUS were 0.17 mm(2), 0.17 mm and 1.98 %, respectively. There was no statistically significant relation between TP and major adverse cardiac event during hospitalization and 2-year follow-up.