First-in-human cases and preclinical experience of a novel ICE catheter.

Introduction: The primary objective of our study was to evaluate the first use of a novel intracardiac echocardiography (ICE) catheter in human subjects. This study aimed to assess its practicality, image clarity, and guidance role during electrophysiology procedures. Methods: Two patients underwent procedures using the novel ICE catheter. Post-procedure evaluations were conducted by four operators, who assessed the imaging quality and overall performance of the catheter. Anatomical and blood test results were also analyzed to determine the safety and impact on internal cardiac structures. Results: Both patients were discharged one day after the procedure without any complications. The novel ICE catheter provided comparable imaging quality to existing commercial catheters. The catheter's advanced design allowed for detailed imaging at short distances, essential for accurate diagnosis and treatment planning. Moreover, it successfully navigated complex anatomical structures like the atrial septum and left atrial appendage. Discussion: These preliminary studies indicate that the novel ICE catheter achieves a level of safety and effectiveness comparable to previously available commercial catheters. The findings highlight its potential to meet current clinical needs, particularly in sophisticated anatomic interventions. Despite the prolonged thrombin time after anticoagulant administration, both types of ICE catheters were non-damaging to cardiac structures during routine operations. The study underscores the importance of using trans-septal large inner diameter sheaths to minimize complications when advancing the catheter into the left atrium.

Patent Foramen Ovale Embryology, Anatomy, and Physiology.

Patent foramen ovale (PFO) is a common finding in the general population but may lead to serious conditions such as stroke from paradoxical embolism and platypnea orthodeoxia. A thorough understanding of the interatrial septal anatomy along with its assessment by different imaging modalities is critical in performing safe transcatheter PFO closure. Investigating the anatomy and right heart to left heart flows using transesophageal echocardiography or intracardiac echocardiography imaging must be done before undertaking closure of a PFO.

Intracardiac vs transesophageal echocardiography for left atrial appendage occlusion: An updated systematic review and meta-analysis.

BACKGROUND: Multiple studies continue to evaluate the use of intracardiac echocardiography (ICE) and transesophageal echocardiography (TEE) for guiding left atrial appendage occlusion (LAAO). OBJECTIVE: The purpose of this study was to conduct an updated meta-analysis comparing the effectiveness and safety outcomes of both imaging modalities. METHODS: PubMed, Cochrane, and Embase were searched for studies comparing ICE vs TEE to guide LAAO. Odds ratios (ORs) with 95% confidence intervals (CIs) were pooled using a random-effects model. The primary effectiveness endpoint was procedural success. The primary safety endpoint included the overall complications rate. Additional safety outcomes were assessed as secondary endpoints. Subgroup analysis of primary endpoints was conducted according to device type (Amulet, LAmbre, Watchman, Watchman FLX) and study region (American, Asia, Europe). R Version 4.3.1 was used for all statistical analyses. RESULTS: Our meta-analysis included 19 observational studies encompassing 42,474 patients, of whom 4415 (10.4%) underwent ICE-guided LAAO. Compared with TEE, ICE was associated with a marginally higher procedural success (OR 1.33; 95% CI 1.01-1.76; P = .04; I2 = 0%). There was no significant difference in the overall complications rate (OR 1.02; 95% CI 0.77-1.36; P = .89; I2 = 5%). However, ICE showed higher rates of pericardial effusion (OR 2.11; 95% CI 1.47-3.03; P <.001; I2 = 0%) and residual iatrogenic atrial septal defect (iASD) (OR 1.52; 95% CI 1.15-2.03; P <.004; I2 = 0%). Subgroup analysis revealed variations in procedural success within the ICE group across study regions (P = .02). CONCLUSION: In this updated meta-analysis, the increasing adoption of ICE-guided LAAO demonstrated higher procedural success rates compared to TEE, although with limited statistical significance. Overall complication rates were similar; however, ICE showed higher rates of pericardial effusion and residual iASD.

Comparison of Conventionally Performed and Intracardiac Echocardiography Guided Catheter Ablation of Atrioventricular Node in Patients with Permanent Atrial Fibrillation-A Retrospective Single-Center Study.

Background: Atrioventricular node (AVN) ablation is an effective treatment for atrial fibrillation (AF) with uncontrolled ventricular rates despite maximal pharmacological treatment. Intracardiac echocardiography (ICE) can help with visualizing structures, positioning catheters, and guiding the ablation procedure. We compared only fluoroscopy-guided and ICE-guided AVN ablation regarding patients with permanent AF. Methods: Sixty-two consecutive patients underwent AVN ablation were enrolled in our retrospective single-center study (ICE group: 28 patients, Standard group: 34 patients). Procedural data, acute and long-term success rate, and complications were analyzed. Results: ICE guidance for AVN ablation significantly reduced fluoroscopy time (0.30 [0.06; 0.85] min vs. 7.95 [3.23; 6.59] min, p < 0.01), first-to-last ablation time (4 [2; 16.3] min vs. 26.5 [2.3; 72.5] min, p = 0.02), and in-procedure time (40 [34; 55] min vs. 60 [45; 110], p = 0.02). There was no difference in either the total ablation time (199 [91; 436] s vs. 294 [110; 659] s, p = 0.22) or in total ablation energy (8272 [4004; 14,651] J vs. 6065 [2708; 16,406] J, p = 0.28). The acute success rate was similar (ICE: 100% vs. Standard: 94%, p = 0.49) between the groups. Conclusions: In our retrospective trial, ICE-guided AVN ablation reduced fluoroscopy time, procedure time, and first-to-last ablation time. There was no difference in ablation time, total ablation energy, acute and long-term success, and complication rate.

Simplifying Transcatheter Tricuspid Valve Replacement With 3-Dimensional Intracardiac Echocardiography.

Transcatheter tricuspid valve replacement (TTVR) offers the potential for improved outcomes for the significant number of patients with severe tricuspid valve regurgitation relative to current treatment options. Imaging is a critical component of the success of this procedure. Here we describe strategies and techniques for the use of 3-dimensional intracardiac echocardiography as an adjunct to standard transesophageal echocardiography during TTVR procedure.

Intracardiac echocardiography-guided biopsies for right-sided intracardiac tumors: An optimized diagnostic algorithm and case illustrations.

Intracardiac tumors, though uncommon, necessitate a swift and accurate diagnosis for personalized treatment and prognosis estimation. While multi-modality imaging often determines the etiology of these cardiac masses, histological confirmation remains essential for definitive diagnosis and its specific treatment. Since cardiac tumors are often found in high-risk locations (ventricular free wall or atria), precision biopsy is paramount. The least invasive strategy would be to achieve this by means of endomyocardial biopsy (EMB); however real-time additional imaging is essential to reduce the risk of perforation/tamponade and to minimize sampling error. Intracardiac echocardiography (ICE) emerges as an excellent tool to achieve this goal preventing procedural complications and reducing the likelihood of sampling errors obtaining a definitive histopathological diagnosis in all cases. This paper outlines our diagnostic algorithm for optimal patient selection, details three illustrative cases, and elucidates the steps to acquire histopathology via percutaneous transvenous biopsy with ICE guidance in patients with right-sided cardiac tumors. Given the rarity of intracardiac tumors, we advocate these patients be managed by a dedicated multidisciplinary cardio-oncology team including an interventional cardiologist.

The use of Intracardiac Echocardiography in Catheter Ablation of Atrial Fibrillation.

PURPOSE OF THE REVIEW: Intracardiac echocardiography (ICE) provides real-time, fluoroless imaging of cardiac structures, allowing optimal catheter positioning and energy delivery during ablation procedures. This review summarizes the use of ICE in catheter ablation of atrial fibrillation (AF). RECENT FINDINGS: Growing evidence suggests that the use of ICE improves procedural safety and facilitates radiofrequency and cryoballoon AF ablation. ICE-guided catheter ablation is associated with reduced procedural duration and fluoroscopy use. Recent studies have examined the role of ICE in guiding novel ablation techniques, such as pulsed field ablation. Finally, the use of ICE allows for early detection and timely management of potentially serious procedural complications. Intracardiac echocardiography offers significant advantages during AF ablation procedures and its use should be encouraged to improve procedural safety and efficacy.

Idiopathic ventricular arrhythmia originating from the vicinity of lateral tricuspid annulus: The precise origin and anatomic concerns.

BACKGROUND: Although the electrocardiographic and electrophysiological properties of ventricular arrhythmias (VAs) from the vicinity of the lateral tricuspid annulus (TA) have been reported in previous studies, their precise site of origin have not been addressed. OBJECTIVE: The purpose of this study was to describe the precise origin of lateral TA-VA and the relevant anatomy. METHODS: Consecutive patients with idiopathic lateral TA-VAs were reviewed and analyzed. Three-dimensional mapping system combined with intracardiac echocardiography (ICE) was used for anatomic reconstruction, mapping, and ablation. RESULTS: During the study period, 63 patients with lateral TA-VAs were included. Under ICE view, a prominent enfoldment structure was observed under the valve along the lateral TA. The muscular bundle was documented in all patients (100%) within the subvalvular enfoldment with an average number and diameter of 4 ± 2 and 4.10 ± 0.73 mm, respectively. Initial ablation was attempted via the anterograde approach in 15 patients but succeeded in none. To reach the ventricular side of the TA, the catheter needed to enter the ventricular chamber and retroflexed toward the atrial side with a reverse curve. The earliest activation site was found at the valvular end of muscular bundles in 51 of the 63 patients (80.9%) with a local activation time of -26.78 ± 4.63 ms. The VAs were eliminated after an average of 4 ± 2 seconds of ablation. CONCLUSION: The ventricular side adjacent to the lateral TA exhibits a subvalvular enfoldment-like structure, which is rich in muscular bundles and serves as the origin of TA-VAs in most patients. To reach the origins, a reverse technique is required.

Same-day discharge after percutaneous closure of persistent foramen ovale using intracardiac echocardiography and the Gore Septal Occluder.

Aim: Periprocedural and postinterventional care of patients undergoing closure of patent foramen ovale (PFO) varies significantly across care providers. Same-day discharge (SDD) after transcatheter interventions is an evolving concept. This study aimed to assess the same-day discharge rate and incidence of complications in patients undergoing PFO closure with intracardiac echocardiography (ICE) using the Gore®Cardioform Septal Occluder (GSO) device. The secondary aim was to analyse the efficacy of femoral vein closure with Perclose ProGlide. Methods: Patients who underwent PFO closure with the GSO device at a university hospital in Stockholm, Sweden, were retrospectively included between March 1, 2017, and June 30, 2020, all with cryptogenic stroke as the indication for the procedure. All patients underwent PFO closure with conscious sedation and local anaesthesia. The indication for all patients was a cryptogenic stroke. Periprocedural imaging was performed using ICE and fluoroscopy in all patients. Patient characteristics and periprocedural data were collected from patient charts. Patients were kept on bed rest for 4-6 h post-intervention. Transthoracic echocardiography and clinical examination, including groin status, were performed before discharge. No clinical routine follow-up was performed the day following the intervention. Clinical follow-up was done by phone call two weeks after the procedure, and echocardiographic follow-up was done after 12 months. Data were analysed using linear and logistic regression models. Results: In total, 262 patients were included, of which 246 (94%) had SDD. 166 patients (63%) received the ProGlide™ system for femoral vein access closure. Post-procedural arrhythmias occurred in 17 (6%) patients, and vascular complications in 9 patients (3%). The overall closure rate at follow-up was 98.5%. 25 out of 264 patients (9.5%) had to be readmitted within the first eight weeks after PFO closure, 16 due to atrial fibrillation warranting electric cardioversion, one due to an arteriovenous fistula that was operated, four due to chest pain/pain at the access site, and four patients developed fever. There was no difference in SDD among patients who received ProGlide™ vs. patients who did not receive ProGlide™. Conclusion: SDD appears safe after transcatheter PFO closure with the GSO device with high procedural success rates. Low rates of complications and readmissions make the intervention suitable for this patient-friendly and cost-effective concept.

Left atrial appendage occlusion and patent foramen ovale closure using a steerable sheath and intracardiac echocardiography.

A patient presenting with acute ischemic stroke associated with patent foramen ovale (PFO) had concurrent deep vein thrombosis, pulmonary embolism, and new-onset atrial fibrillation. Upon initiation of anticoagulation therapy, the patient developed hemorrhagic transformation of the stroke. The patient's multiple potential sources of embolic stroke were treated with concomitant left atrial appendage occlusion and PFO closure through the PFO, made possible by using the Steerable Amulet Sheath under 3D-intracardiac echocardiography guidance.

Structural Heart Imaging Using 3-Dimensional Intracardiac Echocardiography: JACC Cardiovascular Imaging Position Statement.

3-dimensional (3D) intracardiac echocardiography (ICE) is emerging as a promising complement and potential alternative to transesophageal echocardiography for imaging guidance in structural heart interventions. To establish standardized practices, our multidisciplinary expert position statement serves as a comprehensive guide for the appropriate indications and utilization of 3D-ICE in various structural heart procedures. The paper covers essential aspects such as the fundamentals of 3D-ICE imaging, basic views, and workflow recommendations specifically tailored for ICE-guided structural heart procedures, such as transeptal puncture, device closure of intracardiac structures, and transcatheter mitral and tricuspid valve interventions. Current challenges, future directions, and training requirements to ensure operator proficiency are also discussed, thereby promoting the safety and efficacy of this innovative imaging modality to support expanding its future clinical applications.

Long-term outcomes of catheter ablation for ventricular arrhythmias: comparing techniques with and without intracardiac echocardiography - what matters?

BACKGROUND: The increasing use of intracardiac echocardiography (ICE) in the ablation of premature ventricular complexes (PVCs) has raised questions about its true efficacy and safety. METHODS: This retrospective study collected the periprocedural complications and PVC burden post ablation. The risk factors of PVC recurrence was further explored. RESULTS: The study included patients treated without ICE (control group, n = 451) and with ICE (ICE group, n = 155) from May 2019 to July 2022. The ICE group demonstrated significantly lower fluoroscopy times and X-ray doses. There were no major complications in the ICE group, and the difference in the occurrence of periprocedural complications between the groups was not statistically significant (p = 0.072). The long-term success rates were similar for the control and ICE groups (89.6% and 87.1%, respectively). The origin of PVCs was identified as the independent factor for ablation success. CONCLUSIONS: The use of ICE did not confer an advantage with regard to long-term success in PVCs ablation. To thoroughly evaluate the safety and effectiveness of ICE in PVCs ablation, a prospective, multicenter, randomized study is warranted.

Intracardiac Echocardiography: An Invaluable Tool in Electrophysiological Interventions for Atrial Fibrillation and Supraventricular Tachycardia.

Researchers have investigated ways to develop optimal imaging techniques to increase the safety and effectiveness of electrophysiological (EP) procedures. Intracardiac echocardiography (ICE) is an advanced imaging tool that can directly visualize cardiac anatomical structures in high resolution, assess tissue heterogeneity and arrhythmogenic substrates, locate intracardiac catheters, monitor catheter-tissue contact and ablation injury in real-time, excluding intracardiac thrombi, and quickly detect procedural complications. Additionally, real-time imaging via ICE can be integrated with a three-dimensional (3D) electroanatomical mapping (EAM) system to reconstruct cardiac anatomy. This technique also promotes the development of zero-radiation EP procedures. Many EP studies and procedures have implemented ICE because it has several advantages over fluoroscopy and transesophageal echocardiography (TEE). ICE-guided EP procedures can be performed under conscious sedation; esophageal intubation and additional anesthesiologists are not required. Atrial fibrillation (AF) and supraventricular tachycardias (SVT) are the most common tachyarrhythmias in clinical settings. A comprehensive understanding of critical anatomical structures, such as the atrial septum, fossa ovalis (FO), and great heart vessels, is needed for the successful catheter ablation of these arrhythmias.

Clinical Results and Safety of Intracardiac Echocardiography Guidance for Combined Catheter Ablation and Left Atrial Appendage Occlusion.

Background: The goal of this study was to compare the procedural safety and long-term outcome associated with a combined catheter ablation and left atrial appendage occlusion (LAAO) procedure utilizing intracardiac echocardiography (ICE) guidance versus transesophageal echocardiography (TEE) guidance. The study focuses on implementing LAmbre and Watchman devices in patients diagnosed with nonvalvular atrial fibrillation (AF). Methods: A total of 363 patients diagnosed with nonvalvular AF and who underwent a combined procedure were prospectively enrolled between November 2017 and May 2022. Following 1:1 propensity score matching, the TEE group (n = 132) and ICE group (n = 132) were systematically compared in terms of the combined procedure, imaging parameters, events related to the procedure, and subsequent outcomes during follow-up, including mortality, stroke, bleeding, device-related thrombus (DRT), and peri-device leaks (PDLs). Results: The ICE group exhibited a significant reduction in total procedural duration (153.71 ± 31.71 vs. 174.74 ± 18.79 min), fluoroscopy radiation dosage (207.24 ± 108.39 vs. 268.61 ± 122.88 mGy), left atrial appendage occlusion procedure time (34.69 ± 10.91 vs. 51.46 ± 15.84 min), and contrast agent exposure (108.71 ± 37.59 vs. 158.41 ± 45.00 mL) compared to the TEE group. Angiography and ICE demonstrated a substantial correlation between the left atrial appendage (LAA) orifice and landing zone/LAA ostium (Pearson's correlation coefficient r = 0.808 and 0.536/0.697, two-tailed p < 0.001). No occurrences of device-related embolism, thromboembolism, significant bleeding, or unexpected fatalities were observed in either group. Comparable rates of all-cause death (0.76% vs. 0.76%), stroke or transient ischemic attack (2.27% vs. 1.52%), severe bleeding (1.52% vs. 0.76%), PDL (23.81% vs. 24.62%), and DRT (1.52% vs. 1.52%) were noted after an average follow-up of 18.46 ± 7.70 months in both groups, with no discernible differences. Multivariate logistic regression analysis identified a correlation between LAA velocity and the risk of PDL. Conclusions: The effectiveness and safety of ICE-guided combined treatment were demonstrated to be comparable to TEE guidance, accompanied by the additional advantages of decreased procedure time and fluoroscopy radiation exposure. Clinical Trial Registration: NCT04391504, https://register.clinicaltrials.gov.

Radiofrequency Catheter Septal Ablation via a Trans-Atrial Septal Approach Guided by Intracardiac Echocardiography in Hypertrophic Obstructive Cardiomyopathy: One-Year Follow-Up.

Background: Percutaneous radiofrequency catheter ablation (RFA) in hypertrophic obstructive cardiomyopathy (HOCM) with intracardiac echocardiography (ICE) guidance is a novel method that has been proven to be safe and effective in a small sample size study. RFA of the interventricular septum through a trans-atrial septal approach in HOCM patients with a longer follow-up has not been reported. Methods: 62 consecutive patients from March 2019 to February 2022 were included in this study. The area between the hypertrophied septum and anterior mitral valve (MV) leaflet was established using the three-dimensional system (CARTO 3 system), and all patients received atrial septal puncture under the guidance of intracardiac echocardiography (ICE). Point-by-point ablation was performed to cover the contact area. After ablation, the patients were followed up for 1, 3, 6, and 12 months. Transthoracic echocardiography was performed at 1, 3, 6, and 12 months, and resting and exercise-provoked left ventricular outflow tract (LVOT) gradients were obtained. Results: During the 1-year follow-up, most patients' symptoms improved. The NYHA grading of the patient decreased from 2 (2, 3) at baseline to 2 (1, 2) (p < 0.001). LVOT peak gradient at rest was decreased from 59 ( ± 27) mmHg to 30 ( ± 24) mmHg (p < 0.001), and the provoked peak gradient was decreased from 99 ( ± 33) mmHg to 59 ( ± 34) mmHg (p < 0.001). The average maximum septal thickness was reduced from 21 ( ± 4) mm to 19 ( ± 4) mm (p < 0.001). Conclusions: After a 1-year follow-up, ice-guided radiofrequency ablation for HOCM might be a safe, accurate, and effective method. The catheter might be reliably attached to the ablation target area via trans-atrial septal access.

Intracardiac Echocardiography-Applications in the Electrophysiology and the Cardiac Catheterization Labs.

Background. Intracardiac echocardiography (ICE) is routinely used in cardiac electrophysiology and catheterization labs. It plays a vital role in understanding cardiac anatomy, procedural planning, and early identification of complications. In this review, we describe the utility of ICE for procedures in the electrophysiology lab, including atrial fibrillation ablation, left atrial appendage occlusion device implantation, and cardiac implantable electronic device (CIED) extraction. Intracardiac echocardiography also helps in the identification of complications such as pericardial effusion, pulmonary vein stenosis, and left atrial appendage thrombus. Compared with traditional echocardiographic modalities such as transesophageal echocardiogram (TEE), ICE has equivalent image quality, requires less sedation, and possesses no risk of esophageal injury. The disadvantages of ICE include a learning curve and necessity for central vascular access.