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עמוד בית
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November 2024
Tamar Slobodov MD, Gergana Marincheva MD, Michael Rahkovich MD, Andrei Valdman MD, Yonatan Kogan MD, Avishag Laish-Farkash MD PhD

Background: Cardiac implantable electronic devices (CIEDs) with endocardial leads crossing the tricuspid valve can lead to or worsen tricuspid regurgitation (TR), causing substantial morbidity and mortality. Despite a recent randomized controlled study revealing a low short-term incidence of device-related TR (DRT) post-CIED implantation, uncertainties persist regarding the efficacy of intra-procedural 2-dimensional transthoracic echocardiography (2DTTE) in preventing long-term TR.

Objectives: To conduct a long-term follow-up study on patients with CIED implants based on a previous study conducted at our hospital.

Methods: In a retrospective study at Assuta Ashdod Medical Center (2018–2019), patients undergoing de-novo CIED implantation with (n=39, group 1) or without (n=51, group 2) intra-procedural 2DTTE were analyzed. Clinical, demographic, and long-term (> 1 year) echocardiographic data were collected and compared.

Results: The study included 90 patients (mean age 72.3 ± 11.0 years, 63% male, 23% ICD, 50% active leads, follow-up 32.8 ± 11 months). TR aggravation was found in 25% of patients (13 in group 1, 10 in group 2), with no statistical difference between groups. Multivariate analysis identified a history of atrial fibrillation (AF) as the sole significant factor in long-term TR deterioration (OR=3.44, 95%CI 1.13–10.43, P = 0.029). Other clinical, demographic, echocardiographic, and device-related factors did not significantly contribute to long-term DRT.

Conclusions: After one-year post-CIED implantation, the incidence of DRT significantly increases. Intra-procedural 2DTTE does not effectively reduce long-term DRT, suggesting that implantation-related mechanisms are less likely the primary cause. AF likely plays a major role in the pathogenesis of long-term TR in this subset post-CIED implantation.

Yana Kakzanov MD, Yamama Alsana, Tal Brosh-Nissimov MD, Emanuel Harari MD, Michael Rahkovich MD, Yonatan Kogan MD, Emma Shvets RN MA, Gergana Marincheva MD, Lubov Vasilenko MD, Avishag Laish-Farkash MD PhD

Background: Cardiac implantable electronic devices (CIEDs) are associated with risks of device-related infections (DRI) impacting major adverse outcomes. Staphylococcus aureus (SA) is a leading cause of early pocket infection and bacteremia. While studies in other surgical contexts have suggested that nasal mupirocin treatment and chlorhexidine skin washing may reduce colonization and infection risk, limited data exist for CIED interventions.

Objectives: To assess the impact of SA decolonization on DRI rates.

Methods: We conducted a retrospective, single-center observational study on consecutive patients undergoing CIED interventions (March 2020–March 2022). All patients received pre-procedure antibiotics and chlorhexidine skin washing. Starting in March 2021, additional pre-treatment with mupirocin for SA decolonization was administered. DRI rates within 6 months post-implantation were compared between patients treated according to guidelines (Group 1) and those receiving mupirocin in addition to the recommended guidelines (Group 2).

Results: The study comprised 276 patients (age 77 ± 10 years; 60% male). DRI occurred in five patients (1.8%);80% underwent cardiac resynchronization therapy procedures. In Group 1 (n=177), four patients (2.2%) experienced DRI 11–48 days post-procedure; three with pocket infection (two with negative cultures and one with local Pseudomonas) and one with methicillin-sensitive SA endocarditis necessitating device extraction. In Group 2 (n=99), only one patient (1%) had DRI (Strep. dysgalactiae endocarditis) 135 days post-procedure (P = NS).

Conclusions: The routine decolonization of SA with mupirocin, in addition to guideline-directed protocols, did not significantly affect DRI rates. Larger prospective studies are needed to evaluate the preventive role of routine SA decolonization in CIED procedures.

March 2023
Batya Wizman MD, Moti Haim MD, Ido Peles, Roi Westreich MD, Amjad Abu-Salman MD, Gal Tsaban MD MPH, Natalie Yasoor, Orit Barrett MD, Yuval Konstantino MD

Background: Existing cardiac disease contributes to poor outcome in patients with coronavirus disease 2019 (COVID-19). Little information exists regarding COVID-19 infection in patients with a cardiac implantable electronic device (CIED).

Objectives: To assess the association between CIEDs and severity of COVID-19 infection.

Methods: We performed a retrospective analysis including 13,000 patients > 18 years old with COVID-19 infection between January and December 2020. Patients with COVID-19 who had a permanent pacemaker or defibrillator were matched 1:4 based on age and sex followed by univariate and multivariate analyses. Baseline characteristics and clinical outcomes were assessed.

Results: Forty patients with CIED and 160 patients without CIED were included in the current analysis. Mean age was 72.6 ± 13 years, and approximately 50% were females. Majority of the patients in the study arm had a pacemaker (63%), whereas only 15 patients (37%) had a defibrillator. Patients with COVID-19 and CIED presented more often with atrial fibrillation, coronary artery disease, heart failure, hypertension, diabetes, and chronic kidney disease. They were more likely to be hospitalized in the intensive care unit (ICU) and required more ventilatory support (35% vs. 18.3%). Thirty-day mortality (22.5% vs. 13.8%) and 1-year mortality (25% vs. 15%) were higher among patients with COVID-19 and CIED.

Conclusions: Patients with COVID-19 and CIED had a significantly higher prevalence of co-morbidities that were associated with increased mortality. Although,CIED by itself was not found as an independent risk factor for morbidity and mortality, it may serve as a warning for severe illness with COVID-19.

January 2022
Gergana Marincheva MD, Tal Levi MD, Olga Perelshtein Brezinov MD, Andrei Valdman MD, Michael Rahkovich MD, Yonatan Kogan MD, and Avishag Laish-Farkash MD PhD

Background: Endocardial leads of permanent pacemakers (PPM) and implantable defibrillators (ICD) across the tricuspid valve (TV) can lead to tricuspid regurgitation (TR) or can worsen existing TR with subsequent severe morbidity and mortality.

Objectives: To evaluate prospectively the efficacy of intraprocedural 2-dimentional-transthoracic echocardiography (2DTTE) in reducing/preventing lead-associated TR.

Methods: We conducted a prospective randomized controlled study comparing echocardiographic results in patients undergoing de-novo PPM/ICD implantation with intraprocedural echo-guided right ventricular (RV) lead placement (Group 1, n=56) versus non-echo guided implantation (Group 2, n=55). Lead position was changed if TR grade was more than baseline in Group 1. Cohort patients underwent 2DTTE at baseline and 3 and/or 6 months after implantation. Excluded were patients with baseline TR > moderate or baseline ≥ moderate RV dysfunction.

Results: The study comprised 111 patients (74.14 ± 11 years of age, 58.6% male, 19% ICD, 42% active leads). In 98 patients there was at least one follow-up echo. Two patients from Group 1 (3.6%) needed intraprocedural RV electrode repositioning. Four patients (3.5%, 2 from each group, all dual chamber PPM, 3 atrial fibrillation, 2 RV pacing > 40%, none with intraprocedural reposition) had TR deterioration during 6 months follow-up. One patient from Group 2 with baseline mild-moderate aortic regurgitation (AR) had worsening TR and AR within 3 months and underwent aortic valve replacement and TV repair.

Conclusions: The rate of mechanically induced lead-associated TR is low; thus, a routine intraprocedural 2DTTE does not have a significant role in reducing/preventing it

June 2021
Dante Antonelli MD, Alexander Feldman MD, Nahum Adam Freedberg MD, and Yoav Turgeman MD
December 2019
Oholi Tovia-Brodie MD, Sevan Letourneau-Shesaf MD, Aviram Hochstadt MD, Arie Steinvil MD, Raphael Rosso MD, Ariel Finkelstein MD and Yoav Michowitz MD

Background: Patients with right bundle branch block (RBBB) prior to transcatheter aortic valve implantation (TAVI) are at high risk for immediate post-procedural heart block and long-term mortality when discharged without a pacemaker.

Objectives: To test whether prophylactic permanent pacemaker implantation (PPI) is beneficial.

Methods: Of 795 consecutive patients who underwent TAVI, 90 patients had baseline RBBB. We compared characteristics and outcomes of the prophylactic PPI with post-TAVI PPI. Need for pacing was defined as  greater than 1% ventricular pacing.

Results: Forty patients with RBBB received a prophylactic PPI (group 1), and in 50 the decision was based on standard post-procedural indications (group 2). There were no significant differences in clinical baseline characteristics. One patient developed a tamponade after a PPI post-TAVI. A trend toward shorter hospitalization duration in group 1 patients was observed (P = 0.06). On long-term follow-up of 848 ± 56 days, no differences were found in overall survival (P = 0.77), the composite event-free survival of both mortality and hospitalizations (P = 0.66), or mortality and syncope (P = 0.65). On multivariate analysis, independent predictors of the need for pacing included baseline PR interval increase of 10ms (odds ratio [OR] 1.21 per 10 ms increment 95% confidence interval [95%CI] 1.02–1.44, P = 0.028), and the use of new generation valves (OR 3.92, 95%CI 1.23–12.46, P = 0.023).

Conclusions: In patients with baseline pre-TAVI RBBB, no outcome differences were found with prophylactic PPI. On multivariate analysis, predictors of the need for pacing included baseline long PR interval, and the use of newer generation valves.

February 2018
October 2017
Ron Sela MD, Mark Gellerman MD, Shaul Atar MD, and Eli Kalfon MD
August 2017
Liron Hofstetter MD, Sagit Ben Zekry MD, Naama Pelz-Sinvani MD, Michael Kogan MD, Vladislav Litachevsky MD, Avi Sabbag MD and Gad Segal MD
August 2012
E. Kadmon, D. Menachemi, J. Kusniec, M. Haim, M. Geist and B. Strasberg

Background: The implantable loop recorder (ILR) is an important tool for the evaluation of unexplained syncope, particularly in cases of rarely occurring arrhythmia.

Objectives: To review the clinical experience of two Israeli medical centers with the ILR. Methods: We reviewed the medical records of patients with unexplained syncope evaluated with the ILR at Rabin Medical Center (2006–2010) and Wolfson Medical Center (2000–2009).

Results: The study group included 75 patients (44 males) followed for 11.9 ± 9.5 months after ILR implantation. Patients’ mean age was 64 ± 20 years. The ILR identified an arrhythmic mechanism of syncope in 20 patients (17 bradyarrhythmias, 3 tachyarrhythmias) and excluded arrhythmias in 12, for a diagnostic yield of 42.7%. It was not diagnostic in 17 patients (22.7%) at the time of explant 26 patients (34.7%) were still in follow-up. In two patients ILR results that were initially negative were reversed by later ILR tracings. The patients with bradyarrhythmias included 9 of 16 (56.3%) with surface electrocardiogram conduction disturbances and 2 of 12 (16.7%) with negative findings on carotid sinus massage. All bradyarrhythmic patients received pacemakers the seven patients for whom post-intervention data were available had no or mild symptoms.

Conclusions: The ILR has a high diagnostic yield. Pre-ILR findings correlating with the ILR results are conduction disturbances (positive predictor of arrhythmia) and negative carotid sinus massage results (negative predictor of arrhythmia). Proper patient instruction is necessary to obtain accurate results. Caution is advised when excluding an arrhythmia on the basis of ILR tracings, and long-term follow-up is warranted.

July 2010
O. Halshtok, O. Goitein, R. Abu Sham'a, H. Granit, M. Glikson and E. Konen
Background: Until recently, cardiac pacemakers and implantable cardioverter defibrillators were considered an absolute contraindication for magnetic resonance imaging. Given the significant increase in implanting such devices, these contraindications will preclude MRI scanning in a large patient population. Several recent reports have addressed the safety and feasibility of MRI in the presence of cardiac implantable devices.

Objectives: To summarize our experience with MRI scanning in the presence of pacemakers and implantable cardioverter defibrillators.

Methods: Eighteen patients (15 males and 3 females, median 59) were scanned using a 1.5 T MRI scanner. A clinical discussion was held to verify the absolute medical necessity of the study before performing the scan. Scan supervision included device interrogation and programming beforehand, patient monitoring during, and device interrogation and reprogramming after the scan. Full resuscitation equipment was available outside the MRI suite.

Results: Thirty-four scans were performed, and all but one were of diagnostic quality. Anatomic regions included the brain (N=26), cervical spine (N=2), lumbar spine (N=1), cardiac (N=2), abdomen (N=1), abdomen and pelvis (N=1) and pelvis (N=1). None of the patients reported any side effects and no life-threatening events occurred during or following the scans. Five cases of device spontaneous reversion to backup mode were recorded (four in the same patient). Device replacement was not required in any patient.

Conclusions: In this small cohort of patients MRI scanning in the presence of cardiac implantable devices was safe. MRI in these patients is feasible although not recommended for routine scans. Scans should be considered on a case-to-case basis and performed in a dedicated specialized setup.

 

February 2008
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