A Referral Center Experience with Cerebral Protection Devices: Challenging Cardiac Thrombus in the EP Lab.

BACKGROUND: Cerebral protection devices (CPD) are designed to prevent cardioembolic stroke and most evidence that exists relates to TAVR procedures. There are missing data on the benefits of CPD in patients that are considered high risk for stroke undergoing cardiac procedures like left atrial appendage (LAA) closure or catheter ablation of ventricular tachycardia (VT) when cardiac thrombus is present. PURPOSE: This work aimed to examine the feasibility and safety of the routine use of CPD in patients with cardiac thrombus undergoing interventions in the electrophysiology (EP) lab of a large referral center. METHODS: The CPD was placed under fluoroscopic guidance in all procedures in the beginning of the intervention. Two different CPDs were used according to the physician's discretion: (1) a capture device consisting of two filters for the brachiocephalic and left common carotid arteries placed over a 6F sheath from a radial artery; or (2) a deflection device covering all three supra-aortic vessels placed over an 8F femoral sheath. Retrospective periprocedural and safety data were obtained from procedural reports and discharge letters. Long-term safety data were obtained by clinical follow-up in our institution and telephone consultations. RESULTS: We identified 30 consecutive patients in our EP lab who underwent interventions (21 LAA closure, 9 VT ablation) with placement of a CPD due to cardiac thrombus. Mean age was 70 ± 10 years and 73% were male, while mean LVEF was 40 ± 14%. The location of the cardiac thrombus was the LAA in all 21 patients (100%) undergoing LAA-closure, whereas, in the 9 patients undergoing VT ablation, thrombus was present in the LAA in 5 cases (56%), left ventricle (n = 3, 33%) and aortic arch (n = 1, 11%). The capture device was used in 19 out of 30 (63%) and the deflection device in 11 out of 30 cases (37%). There were no periprocedural strokes or transitory ischemic attacks (TIA). CPD-related complications comprised the vascular access and were as follows: two cases of pseudoaneurysm of the femoral artery not requiring surgery (7%), 1 hematoma at the arterial puncture site (3%) and 1 venous thrombosis (3%) resolved by warfarin. At long-term follow-up, 1 TIA and 2 non-cardiovascular deaths occurred, with a mean follow-up time of 660 days. CONCLUSIONS: Placement of a cerebral protection device prior to LAA closure or VT ablation in patients with cardiac thrombus proved feasible, but possible vascular complications needed to be taken into account. A benefit in periprocedural stroke prevention for these interventions seemed plausible but has yet to be proven in larger and randomized trials.

Patients with Cardiac Implantable Electronic Device Undergoing Radiation Therapy: Insights from a Ten-Year Tertiary Center Experience.

BACKGROUND: The number of patients with cardiac implantable electronic devices (CIEDs) receiving radiotherapy (RT) is increasing. The management of CIED-carriers undergoing RT is challenging and requires a collaborative multidisciplinary approach. AIM: The aim of the study is to report the real-world, ten-year experience of a tertiary multidisciplinary teaching hospital. METHODS: We conducted an observational, real-world, retrospective, single-center study, enrolling all CIED-carriers who underwent RT at the San Raffaele University Hospital, between June 2010 and December 2021. All devices were MRI-conditional. The devices were programmed to an asynchronous pacing mode for patients who had an intrinsic heart rate of less than 40 beats per minute. An inhibited pacing mode was used for all other patients. All tachyarrhythmia device functions were temporarily disabled. After each RT session, the CIED were reprogrammed to the original settings. Outcomes included adverse events and changes in the variables that indicate lead and device functions. RESULTS: Between June 2010 and December 2021, 107 patients were enrolled, among which 63 (58.9%) were pacemaker carriers and 44 (41.1%) were ICD carriers. Patients were subjected to a mean of 16.4 (±10.7) RT sessions. The most represented tumors in our cohort were prostate cancer (12; 11%), breast cancer (10; 9%) and lung cancer (28; 26%). No statistically significant changes in device parameters were recorded before and after radiotherapy. Generator failures, power-on resets, changes in pacing threshold or sensing requiring system revision or programming changes, battery depletions, pacing inhibitions and inappropriate therapies did not occur in our cohort of patients during a ten-year time span period. Atrial arrhythmias were recorded during RT session in 14 patients (13.1%) and ventricular arrhythmias were observed at device interrogation in 10 patients (9.9%). CONCLUSIONS: Changes in device parameters and arrhythmia occurrence were infrequent, and none resulted in a clinically significant adverse event.

Continuous Electrical Monitoring in Patients with Arrhythmic Myocarditis: Insights from a Referral Center.

BACKGROUND: The incidence and burden of arrhythmias in myocarditis are under-reported. OBJECTIVE: We aimed to assess the diagnostic yield and clinical impact of continuous arrhythmia monitoring (CAM) in patients with arrhythmic myocarditis. METHODS: We enrolled consecutive adult patients (n = 104; 71% males, age 47 ± 11 year, mean LVEF 50 ± 13%) with biopsy-proven active myocarditis and de novo ventricular arrhythmias (VAs). All patients underwent prospective monitoring by both sequential 24-h Holter ECGs and CAM, including either ICD (n = 62; 60%) or loop recorder (n = 42; 40%). RESULTS: By 3.7 ± 1.6 year follow up, 45 patients (43%) had VT, 67 (64%) NSVT and 102 (98%) premature ventricular complexes (PVC). As compared to the Holter ECG (average 9.5 exams per patient), CAM identified more patients with VA (VT: 45 vs. 4; NSVT: 64 vs. 45; both p < 0.001), more VA episodes (VT: 100 vs. 4%; NSVT: 91 vs. 12%) and earlier NSVT timing (median 6 vs. 24 months, p < 0.001). The extensive ICD implantation strategy was proven beneficial in 80% of the population. Histological signs of chronically active myocarditis (n = 73, 70%) and anteroseptal late gadolinium enhancement (n = 26, 25%) were significantly associated with the occurrence of VTs during follow up, even in the primary prevention subgroup. CONCLUSION: In patients with arrhythmic myocarditis, CAM allowed accurate arrhythmia detection and showed a considerable clinical impact.

Inflammation as a Predictor of Recurrent Ventricular Tachycardia After Ablation in Patients With Myocarditis.

BACKGROUND: Little is known about the risk stratification of patients with myocarditis undergoing ventricular tachycardia (VT) ablation. OBJECTIVES: This study sought to describe VT ablation results and identify factors associated with arrhythmia recurrences in a cohort of patients with myocarditis. METHODS: The authors enrolled 125 consecutive patients with myocarditis, undergoing VT ablation. Before ablation, disease stage was evaluated, to identify active (AM) versus previous myocarditis (PM). The primary study endpoint was assessment of VT recurrences by 12-month follow-up. Predictors of VT recurrences were retrospectively identified. RESULTS: All patients (age 51 ± 14 years, 91% men, left ventricular ejection fraction 52% ± 9%) had history of myocarditis diagnosed by endomyocardial biopsy (59%) and/or cardiac magnetic resonance (90%). Furthermore, all had multiple episodes of drug-refractory VTs. Multimodal pre-procedural staging identified 47 patients with AM (38%) and 78 patients with PM (62%). All patients showed low-voltage areas (LVA) at electroanatomical map (97% epicardial or endoepicardial); of them, 25 (20%) had wide borderzone (WBZ, constituting >50% of the whole LVA). VT recurrences were documented in 25 patients (20%) by 12 months, and in 43 (34%) by last follow-up (median 63 months; interquartile range: 39 to 87). At multivariable analysis, AM stage was the only predictor of VT recurrences by 12 months (hazard ratio: 9.5; 95% confidence interval: 2.6 to 35.3; p < 0.001), whereas both AM stage and WBZ were associated with arrhythmia recurrences anytime during follow-up. No VT episodes were found after redo ablation was performed in 23 patients during PM stage. CONCLUSION: Our findings suggest that VT ablation should be avoided during AM, but is often of benefit for recurrent VT after the acute phase of myocarditis.

Left atrial appendage closure: A single center experience and comparison of two contemporary devices.

OBJECTIVES: To compare indications and clinical outcomes of two contemporary left atrial appendage (LAA) percutaneous closure systems in a "real-world" population. BACKGROUND: Percutaneous LAA occlusion is an emerging therapeutic option for stroke prevention in atrial fibrillation. Some questions however remain unanswered, such as the applicability of results of randomized trials to current clinical practice. Moreover, currently available devices have never been directly compared. METHODS: We retrospectively analyzed consecutive patients who underwent LAA closure at San Raffaele Hospital, Milan, Italy between 2009 and 2015. Clinical indications and device selection were left to operators' decision; routine clinical and transesophageal echocardiography (TEE) follow-up was performed. RESULTS: One-hundred and sixty-five patients were included in the study, of which 99 were treated with the Amplatzer Cardiac Plug (ACP) and 66 with the Watchman system. During the follow-up period (median 15 months, interquartile range 6-26 months) five patients died. The incidence of ischemic events was low, with one patient suffering a transient ischemic attack and no episodes recorded of definitive strokes. Twenty-six leaks ≥1 mm were detected (23%); leaks were less common with the ACP and with periprocedural three-dimensional TEE evaluation, but were not found to correlate with clinical events. Clinical outcomes were comparable between the two devices. CONCLUSIONS: Our data show excellent safety and efficacy of LAA closure, irrespectively of the device utilized, in a population at high ischemic and hemorrhagic risk. The use of ACP and 3D-TEE minimized the incidence of residual leaks; however, the clinical relevance of small peri-device flow warrants further investigation. © 2016 Wiley Periodicals, Inc.

Advanced techniques for chronic lead extraction: heading from the laser towards the evolution system.

AIM: The evolution mechanical dilator sheath has been reported to be an effective tool for chronic lead extraction (LE). We examined safety and efficacy of evolution system as compared with laser system. METHODS AND RESULTS: From 2005 to 2009, all extractions requiring the use of a powered sheath were performed using the excimer laser system (n = 73). Since 2009, laser system was no longer available and the evolution system was introduced as the first-line method for powered extraction (n = 48). All procedures were performed by a single first operator. Success and complications were defined according to the current guidelines. Patients of the evolution group compared with those of the laser group had a greater number of extracted leads per patient (2.77 vs. 2.4, P = 0.049) and a longer implant duration (101.1 vs. 62.4 months, P = 0.001). Additional use of snare was required in 27.1% of the evolution group and 8.2% of the laser group (P = 0.005). Complete procedural success was achieved in 91.7% of the evolution group and 97.3% of the laser group (P = 0.16). There was also no difference between evolution and laser groups in clinical success (97.9 vs. 98.6%, P = 0.76), as well as regarding major (4.2 vs. 2.7%, P = 0.66) or minor complications (4.2 vs. 5.5%, P = 0.76). CONCLUSION: Use of the recently introduced evolution system for LE exhibit acceptably high levels of safety, as well as of procedural and clinical success, although additional use of snare was required more frequently in the evolution compared with the laser group.