key: cord-0784093-r053jl83 authors: Sogade, Omolade O.; Aben, Rieta N.; Eyituoyo, Harry; Arinze, Nkechi C.; Sogade, Felix O. title: Feasibility study for echocardiography‐guided lead insertion for permanent cardiac implantable electronic devices date: 2021-07-18 journal: Pacing Clin Electrophysiol DOI: 10.1111/pace.14296 sha: 3cd62d3c3a11b63cd681b6140d3afde4906efaee doc_id: 784093 cord_uid: r053jl83 BACKGROUND: Permanent cardiac implantable electronic devices (CIEDs) are traditionally implanted with the assistance of fluoroscopy. While clinically effective, this technique exposes both patients and providers to radiation which is associated with adverse health effects and represents an occupational hazard. In this study, we investigate the safety and feasibility of permanent CIED placement under the guidance of transthoracic echocardiography (TTE). There is also increasing interest in use of non‐fluoroscopic options for noninvasive cardiac electrophysiologic procedures. METHODS: Fifteen patients consecutively consented for initial implant of CIEDs, specifically dual chamber pacemakers (DCPM) and dual chamber implantable cardioverter defibrillators (DCICDs). Patients were excluded if they had previous implants, abandoned leads, or anatomic anomalies including congenital and known persistent left superior vena cava (PLSVC). We used TTE to guide and implant atrial and ventricular leads. RESULTS: Eleven patients received DCPMs and four patients received DCICDs. The procedure duration was 49.3 min for DCICD and 52.3 min for DCPM, p = .807. The average number of right atrial lead attempts was 1.6 for DCPMs and 1.8 for DCICD, p = .860. The average number of right ventricular lead attempts for DCPMs was 2.2 and 1.0 attempt for DCICDs, p = .044. There were no complications at 90‐day follow‐up. CONCLUSION: We demonstrate the feasibility of TTE‐guided DCPM/DCICD implantation without use of fluoroscopy. We present this method as a safe alternative for permanent CIED placement that may reduce risk of radiation exposure and cost while maintaining safety and efficacy. No operators wore lead aprons during the procedure. Cardiac implantable electronic devices (CIEDs) are increasingly utilized around the world, with roughly one million pacemakers implanted each year. In the United States, more than 200,000 devices are implanted annually. 1 The technique for the implantation of CIEDs has evolved from thoracotomy placement to less invasive approaches with transvenous lead placement using fluoroscopic guidance. Although less invasive, the use of fluoroscopy is associated with occupational injuries including orthopedic strain due to the use of leaded aprons in electrophysiology and cardiac catheterization laboratories. 2, 3 The fluoroscopy-guided approach predisposes patients and healthcare providers to increased radiation exposure and subsequent adverse health effects. Furthermore, the use of fluoroscopy is a limiting factor to widespread implantation of CIED in resource-limited settings. Prior studies have explored non-fluoroscopic alternatives for temporary device insertion, including electromagnetic mapping systems, ultrasound, and echocardiography in device implantation. [4] [5] [6] [7] However, there is limited data on the use of transthoracic echocardiography (TTE) in the complete insertion of dual chamber permanent pacemaker (DCPM) and dual chamber implantable cardioverter defibrillator (DCICD). In this study, we demonstrate the safety and feasibility of TTE-guided DCPMs and DCICDs implantation. We enrolled a convenience sample of 15 The implanting physician performed the procedures with the assistance of the clinical support staff and an echocardiography techni- We documented the total implant time required for the PPM and ICD systems. Procedure duration was defined as the time of initial skin incision to skin closure. Implant criteria for adequate sensing and adequate threshold was defined as (1) threshold of less than 1 V at 0.4 or 0.5 ms, p wave amplitude more than 1 mV, or R wave amplitude of more than 5 mV; (2) stable impedance measurement; and (3) a current of injury amplitude deflecting positive current of injury recording after the active fixation in the RA and RV. If all three criteria were not satisfied, the lead was repositioned. All the leads were targeted for septal pacing with lower to mid septal positioning for DCICD and high to mid septal positioning for DCPM (video S7). We used septal positioning due to lower incidence of cardiac perforation compared to apical positioning within our institution and due to lower mortality compared to apically placed leads. 9, 10 All lead parameters were documented at implant and at 90-day follow-up. Defibrillation thresholds testing (DFTs) were performed in the ICD subpopulation to provide a confirmatory step for ascertaining satisfactory performance of the implanted device. A minimum of 10 joules safety margin was achieved in all four DCICDs. We utilized the Statistical analyses were performed with SPSS (version 27, IBM Corp, Armonk, NY, United States) and R statistical software (version 3.6.0, Vienna, Austria). A Student's t-test was used for continuous variables. A p-value of < .05 was considered statistically significant. Fifteen patients were enrolled, with 11 patients receiving DCPM and four patients receiving DCICDs. The average age was 74.5 years and average BMI was 27.3 kg/mš. There were no statistically significant differences between the DCPM and DCICD groups, p = .111 and p = .389, respectively. Demographic data is summarized in Table 2 Table 3 . All patients underwent successful TTE-guided device implantation, Table 4 . This including malignancy and hematological, dermatologic, reproductive, and immunologic disorders. 2, 3 Regarding the ergonomic and orthopedic effects of radiation exposure and lead apron use for operators, 11, 12 further studies will be necessary to compare benefits of TTE-guided device placement over traditional fluoroscopy. We postulate that echocardiography-guided procedures will reduce long-term radiation complications and orthopedic strain; the reduction of radiation exposure will likely also be more beneficial to pregnant women, children, and clinical staff. In this study, no patients received passive leads reflecting the practice of our institution. We performed DFT testing to ascertain satisfactory performance of the implanted device as this was a clinical study defining a new technique, and we performed it as an additional cautionary step for the purpose of this study. In addition, one patient had an indication of hypertrophic cardiomyopathy with high-risk characteristics. We performed a careful risk benefit analysis for each patient prior to DFT testing in this study, and all had satisfactory parameters with greater than 10 Joules safety margin. While no patients in our study population had a coronary artery bypass graft (CABG), it is our opinion that for patients undergoing this procedure with prior CABG, atrial appendage resection will not significantly alter atrial lead placement. We believe it necessary to obtain echo visualization of the anterolateral atrial wall and to assess for phrenic nerve stimulation in this location. As a portable imaging modality, echocardiography could also be employed to facilitate temporary and permanent pacemaker implantation in intensive care units and reduce in-hospital transfer. 4, 6 Furthermore, the use of non-fluoroscopic lead implantation for temporary pacemakers has been reported using ultrasound, computed tomography (CT), and echocardiography. [4] [5] [6] [7] Subcostal echocardiograph views have been utilized in the acute, perioperative setting to guide insertion of a RV temporary transvenous pacemaker. 13 Intracardiac echocardiography and electroanatomic mapping have been reported in a permanent pacemaker placement of a pregnant patient. 6 In a case of a patient with congenital heart disease, echocardiography was used for determination of atrial capture for programming. 14 Our study is one the few studies in the literature that illustrates the feasibility of complete dual chamber device implantation using TTE, favored over alternative imaging techniques such as fluoroscopy and CT-guided implantation due to increased radiation exposure. In low-resource settings, access to fluoroscopy remains a limiting factor to implantation of CIEDs. The use of TTE provides a safe, efficacious, and cost-effective alternative for the implantation of permanent leads in low-resource environments, in combat settings, and in disaster response. Avoidance of fluoroscopy may contribute to reducing the economical barrier that precludes extensive device implantation in developing countries. In a multinational study seeking to determine reasons for cardiac implant refusal, inability to pay for the procedure was cited as the most common reason for implant refusal. Limitations of the study include the small sample size. Further study will include validation with a randomized controlled study in a larger population to evaluate procedure time between the use of TTE and fluoroscopy and to analyze the exposure time. Furthermore, we did not assess inter-operator variability as this study was performed by a single operator with extensive CIED implant experience. We demonstrate the feasibility of DCPM/DCICD implantation with limited use of fluoroscopy. Echocardiography-guided device insertion may prove beneficial in procedural time reduction, improve safety, reduced risk of radiation exposure, increased quality, and cost reduction. This is a pertinent technique that can be readily implemented in certain patient populations, including pregnant patients. The utility of echocardiography has previously been described for perioperative and temporary CIED placement; here we describe use of echocardiography in permanent device placement. This method can also be scaled to resource-limited settings as well as to the bedside or other constrained environments in the setting of the ongoing COVID-19 pandemic. We thank Angie Buice for her contribution to patient enrollment and data collection. FOS received a grant from Medtronic. For the remaining authors, there are no conflicts of interest to disclose. Felix O. Sogade conceptualized and designed the study, secured funding, and provided critical revision of the manuscript. Omolade O. Sogade performed data analysis and interpretation and wrote the manuscript. Rieta N. Aben, Harry Eyituoyo, Nkechi C. Arinze contributed to revision and all authors approved the article. The data that support the findings of this study are available from the corresponding author upon reasonable request. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009-a World Society of Arrhythmia's project Risks related to fluoroscopy radiation associated with electrophysiology procedures Radiation risk to the fluoroscopy operator and staff Feasibility and safety of exclusive echocardiography-guided intravenous temporary pacemaker implantation Zero-fluoroscopy permanent pacemaker implantation using Ensite NavX system: clinical viability or fanciful technique? Implantation of a dual-chamber permanent pacemaker in a pregnant patient guided by intracardiac echocardiography and electroanatomic mapping Predictors of successful ultrasound-guided lead implantation ACC/AHA guidelines for implantation of cardiac pacemakers and antiarrhythmia devices: executive Summary-a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Pacemaker Implantation) Right ventricular pacemaker lead position is associated with differences in long-term outcomes and complications Right ventricular outflow versus apical pacing in pacemaker patients with congestive heart failure and atrial fibrillation Occupational health risks in cardiac catheterization laboratory workers Radiation safety and ergonomics in the electrophysiology laboratory: update on recent advances The use of subcostal echocardiographic views to guide the insertion of a right ventricular temporary transvenous pacemaker-description of the technique Echocardiographyguided determination of reliable atrial pacing in a patient with congenital heart disease Improving the utilization of implantable cardioverter defibrillators for sudden cardiac arrest prevention (Improve SCA) in developing countries: clinical characteristics and reasons for implantation refusal Additional supporting information may be found online in the Supporting Information section at the end of the article.