Cardiovascular Implantable Electronic Device Implantation Research Articles

Predictors of cardiovascular implantable electronic device dependence at long-term follow-up after alcohol septal ablation in hypertrophic cardiomyopathy patients.

The most common complication of alcohol septal ablation (ASA) is transient periprocedural high-grade AV block (HGAVB). To date, no long-term follow-up of cardiovascular implantable electronic device (CIED) utilization after ASA has been reported. We hypothesized that CIED dependence on long-term follow-up can be predicted by ECG or procedural characteristics. We analyzed all patients with HCM who underwent ASA from December 1998 to December 2019 and received their first CIED within 30days after ASA for HGAVB. All follow-up interrogations were reviewed. CIED dependence was defined as ventricular pacing of ≥ 5%. A total of 138 patients with HCM underwent ASA. Of these, 35 had a prior device and were excluded. Of the remaining 103 patients, 25 patients received a CIED for HGAVB within 30days after ASA. Average follow-up duration was 10.1years. On long-term follow-up, 16 patients (64%) were found to be CIED-dependent. Baseline characteristics, including pre- and post-ASA ECG, were not significantly different between dependent and non-dependent patients. The only predictor for CIED dependence was > 1ml of alcohol injected (OR 6.0, p = 0.031). CIED implantation after ASA is common. Almost two thirds of patients who received a CIED for post-procedural HGAVB were CIED-dependent on long-term follow-up. CIED dependence can be predicted by the amount of injected alcohol > 1ml.

Long-Term Outpatient Care and Rehospitalizations in Patients after Cardiac Electrotherapy Device Implantation.

Background and Objectives: Cardiovascular implantable electronic device (CIED) treatment is widely used in modern cardiology. Indications for this type of treatment are increasing. However, a significant proportion of CIED implantation patients require subsequent hospitalization for cardiovascular reasons. Older age and the associated complex clinical picture necessitate multidisciplinary outpatient specialist care for these patients. The aim of this study was to analyze the reasons for subsequent hospitalizations in the cardiology department and the impact of outpatient specialty care on these hospitalizations. To the best of our knowledge, there are no such studies in the available literature. Materials and Methods: This study was conducted on a population of patients treated with CIED. Reasons for subsequent hospitalizations were divided into clinically and statistically valid groups according to the main diagnosis. Using an electronic database, causes of hospitalization were determined based on this diagnosis. Using data on consultations at outpatient specialty clinics, a logistic regression model was created for the probability of subsequent hospitalization for cardiovascular causes according to the specialty of the clinic. Results: The 9-year follow-up included a population of 2071 patients treated with CIED. During the follow-up period, 508 patients (approximately 24.5%) required subsequent hospitalization for cardiovascular reasons. The most common leading causes were heart failure, atrial fibrillation, and coronary artery disease. The need for consultation at outpatient specialty clinics increased the likelihood of hospitalization. Moreover, the need to consult patients in nephrology outpatient, pulmonary disease outpatient, and orthopedic outpatient clinics was the most significant. Conclusions: The use of electronic implantable cardiovascular devices is a very important part of therapy in modern cardiology. The methods for their use are constantly being improved. However, they represent only one stage of cardiac treatment. After CIED procedures, patients require further care in both inpatient and outpatient specialty care settings. In this paper, we outline the reasons for subsequent hospitalizations and the importance of outpatient specialty care in this context. Effective organization of care after CIED procedures may be important in reducing the most expensive component of this care, that is, inpatient treatment.

Effect of a pocket compression device on hematomas, skin reactions, and comfort in patients receiving a cardiovascular implantable electronic device: a randomized controlled trial.

Aim to evaluate the safety and effectiveness of a pocket compression device in patients undergoing cardiovascular implantable electronic device (CIED) implantation. This randomized controlled trial included 54 patients in the control group (elastic adhesive tape) and 54 patients in the experimental group (pocket compression device). A sandbag was positioned over the pocket after CIED implantation, using elastic adhesive tape in the control group and a novel pocket compression device in the experimental group. The primary outcome was the incidence of pocket hematomas, and the secondary outcomes were adverse skin reactions, the need for sandbag positional adjustments, and patient comfort. The distributions of age, sex, and clinical and procedure characteristics was not significantly different between the two groups (P>0.05). The occurrence of hematomas was lower when using the pocket compression device than in the control group (13.0% vs. 44.4%, P<0.001). The incidence rates of hematomas of grades 1 and the grade 2 hematomas were significantly lower in the experimental group than in the control group (13.0% vs. 31.5%, 0% vs. 11.1% respectively, [all P<0.05]). The incidence rates of adverse skin reactions and sandbag positional adjustments were much lower and the patient comfort score was significantly higher in the experimental group than in the control group (all P<0.001). A pocket compression device can significantly decrease the incidence of pocket hematomas, adverse skin reactions, and positional adjustments when patients are undergoing CIED, which can improve patient comfort and decrease the nursing workload. GOV : NCT04389398.

Abstract 16099: Predictors of Cardiovascular Implantable Electronic Device-dependence at Long-term Follow-up After Alcohol Septal Ablation in Hypertrophic Cardiomyopathy Patients

Introduction: The most common complication of alcohol septal ablation (ASA) is periprocedural high grade AV block (HGAVB). No long-term follow-up of cardiovascular implantable electronic device (CIED) utilization after ASA has been reported. Hypothesis: Pacemaker dependence on long-term follow up can be predicted by ECG or procedural characteristics. Methods: We analyzed all patients with hypertrophic cardiomyopathy who underwent ASA from December 1998 to December 2019 at our institution and received their first CIED within 30 days after ASA for HGAVB. All available follow-up interrogations were reviewed. CIED dependence was defined as ventricular pacing of ≥5%. CIED programming was determined by the patients’ cardiologists' discretion. Results: A total of 103 patients with hypertrophic cardiomyopathy underwent ASA. The average follow up duration was 10.1 years. Within 30 days after ASA, a total 25 patients received a CIED for HGAVB. On long term follow-up 16 patients (64%) were found to be CIED-dependent. Baseline characteristics, including pre and post-ASA ECG, were not significantly different between dependent and non-dependent patients (Table). The only predictor for CIED dependence was &gt;1 ml of alcohol injected during ASA (OR 6.0, p&lt;0.046). Conclusions: CIED implantation after ASA is common. Almost two thirds of patients who received CIED for postprocedural HGAVB were CIED-dependent on long term follow up. CIED dependence can be predicted by amount of injected alcohol &gt;1 ml during ASA.

Pericardial complications and postcardiac injury syndrome after cardiovascular implantable electronic device placement : Ameta-analysis and systematic review.

Postcardiac injury syndrome (PCIS) is an emerging condition including pericarditis with or without pericardial effusion after an injury to cardiac tissue. Data are lacking on its incidence and clinical predictors after cardiovascular implantable electronic device (CIED) placement. We therefore performed this meta-analysis to determine the incidence of PCIS. Medline, Embase, and Cochrane CENTRAL databases were searchedaccording to PRISMA guidelines from February 2007 to February 2017 for studies evaluating pericardial complications subsequent to CIED implantation. Primary outcome was the total number of cases of pericarditis, pericardial effusion, and cardiac tamponade documented. Of 2931 references, 22articles (enrolling 188,944 patients) were included. Pooled estimates from random-effects analysis showed an overall incidence of 5.82 per 1000 patients (95% confidence interval [CI], 4.33-8.17) at 30days, and 1.60 per 1000 (95% CI: 0.13-3.07) at 1year. Advanced age and prior coronary artery bypass graft (CABG) surgery were associated with increased rates of pericardial complications. Our analysis revealed that CIED implantations are associated with alow incidence (0.6%) of pericardial complications at 30days. Patients with advanced age and prior CABG are high-risk patients for pericardial complications.

Healthcare Costs Associated with Early Complications Following Cardiovascular Implantable Electronic Device Implantation

Background: Healthcare costs associated with complications following cardiovascular implantable electronic device (CIED) procedures are poorly understood. We examined the direct healthcare costs associated with CIED complications, and how these costs varied by the type of complication and device implanted. Method: We included patients aged ≥18 years with new CIEDs (pacemakers, ICDs and CRT-D/P) from 2010–15 from all states and territories except NT. We assessed major complications occurring in-hospital and within 90-days of discharge by linking records with subsequent hospitalisations and death registries. Costs were identified by matching the admission Diagnostic Related Group to the published schedules of public and private hospital costs from the National Hospital Cost Data Collection and converted to 2018 dollars. In-hospital costs were estimated by calculating the incremental costs associated with a complication using a generalised linear model, adjusted for other patient characteristics. To estimate post-discharge complications, we computed the cost of one or more readmissions for device-related complications. Results: 40,155 CIEDs (29,391 PPMs, 6,921 ICDs, 3,843 CRT-D/P) were included. Of these, 8.3% experienced a device-related complication with 3.3% occurring in-hospital and 5.3% post-discharge. In-hospital complications were associated with an average of $9,186 increase in costs per patient with post-procedural shock ($24,235) associated with the highest incremental cost. Post-discharge complications cost an average of $22,296 per patient with the highest cost in patients who required a generator reoperation ($49,167/patient). Conclusion: Early complications following CIED implantation are exceedingly costly. Reducing CIED complications not only reduces patient harm but offers a significant opportunity to reduce avoidable healthcare costs.

Abstract 9421: Additional Wiping of the Skin With 70% Isopropil Alcohol Just Before Routine Povidone-Iodine Antisepsis Reduces Cardiac Implantable Electronic Device Infections

Introduction: Cardiovascular Implantable Electronic Device(CIED) Infections are one of the most serious complication after CIED implantation or replacement. To prevent infection, appropriate skin antisepsis and perioperative antibiotic prophylaxis at CIED implantation/replacement are important. But the most optimal antisepsis for CIED surgery is not well defined. Then we assessed whether additional wiping of the skin with 70% isopropyl alcohol just before routine skin antisepsis with povidone-iodine reduces the incidence of CIED infection. Methods: Consecutive 473 cases of CIED implantation or generator replacement from Jan.2008 to Dec.2013 at one community hospital were divided into two groups according to preoperative skin antisepsis with 70% isopropyl alcohol wipes lasting for at least 1 minute just before povidone-iodine scrub and paint(IPA group, n=183), or povidone-iodine only(No IPA group, n=290). All cases received perioperative antibiotic prophylaxis 30 minute before and 6 hours after procedure. Incidence of CIED infection requiring complete extraction of the leads and the generator within 1-year after implantation/replacement were compared between two groups by Kaplan-Meier analysis. Results: There were no significant difference in background CIED infection risk factors identified by past studies (diabetes, renal insufficiency, anticoagulant use, corticosteroid use, tempolary pacing, and generator replacement) between two groups. During the follow up period, 8 cases of confirmed CIED infection requiring complete extraction were identified, 6 pacemaker and 2 implantable cardioverter-defibrillator(ICD) or biventricular ICD. All infected cases belonged to No IPA group (p = 0.0235). Conclusions: In conclusion, wiping of the skin with 70% isopropyl alcohol just before routine antisepsis with povidone-iodine at CIED implantation/replacement significantly reduces the incidence of infection.

Cardiovascular Implantable Electronic Device Implantation with Uninterrupted Dabigatran: Comparison to Uninterrupted Warfarin

While continuation of oral anticoagulation (OAC) with warfarin may be preferable to interruption and bridging with heparin for patients undergoing cardiovascular implantable electronic device (CIED) implantation, it is uncertain whether the same strategy can be safely used with dabigatran. To determine the risk of bleeding and thromboembolic complications associated with uninterrupted OAC during CIED implantation, replacement, or revision, the outcomes of patients receiving uninterrupted dabigatran (D) were compared to those receiving warfarin (W). D was administered the day of CIED implant in 48 patients (age 66 ± 12.4 years, 13 F and 35 M, 21 ICDs and 27 PMs), including new implant in 25 patients, replacement in 14 patients, and replacement plus lead revision in 9 patients. D was held the morning of the procedure in 14 patients (age 70 ± 11 years, 4 F and 10 M, 5 ICDs and 9 PMs). W was continued in 195 patients (age 60 ± 14.4 years, 54 F, and 141 M), including new implant in 122 patients, replacement in 33 patients, and replacement plus lead revision or upgrade in 40 patients. Bleeding complications occurred in 1 of 48 patients (2.1%) with uninterrupted dabigatran (a late pericardial effusion), 0 of 14 with interrupted D, and 9 of 195 patients (4.6%) on W (9 pocket hematomas), P = 0.69. Fifty percent of bleeding complications were associated with concomitant antiplatelet medications. The incidence of bleeding complications is similar during CIED implantation with uninterrupted D or W. The risks are higher when OAC is combined with antiplatelet drugs.

Implantation of a cardiac resynchronization therapy defibrillator in a patient with bilateral deep brain stimulator: feasibility and technique

Uncommonly, a patient with a NeuroStimulator Device (NSD) for a neurologic indication requires a cardiovascular implantable electronic device (CIED) for a cardiac indication. Typically in those with a unilateral pectoral NSD, the contralateral pectoral space is used for CIED implantation; however, in very rare occasions the patient has bilateral pectoral NSDs which makes subsequent implantation of a CIED challenging both because of placement and device interaction. Herein, we introduce the case of a 68-year-old gentleman with bilateral pectoral deep brain stimulators for Parkinsonism who received cardiac resynchronization therapy-defibrillator (CRT-D) for advanced heart failure. The CRT-D generator was implanted in the abdomen and the CRT-D leads were placed through a minimally invasive epicardial approach. Both devices were tested without any evidence of device interaction.

Contemporary management of cardiovascular implantable electronic device infections

Cardiovascular implantable electronic device (CIED) implantation rate has substantially risen in the foregoing decades. Unfortunately, this upsurge in CIED implantation rate has been accompanied by a disproportionate rise in the rate of CIED infections. Device infection is a major complication of CIED implantation, necessitating removal of an infected device followed by systemic antimicrobial therapy and reimplantation of a new system. In this article, we review the current epidemiology, risk factors, diagnostic strategy and contemporary management of CIED infection. In addition, we address the vexing question of how to best manage patients with Staphylococcus aureus bacteremia, in the setting of an implanted device, but no overt clinical signs of CIED infection. Lastly, we discuss the preventive strategies to minimize risk of CIED infection.