Cardiovascular Implantable Electronic Devices Implantation Research Articles

Abstract 15795: Outcomes After Cardiac Implantable Electronic Devices Among People With and Without HIV

Introduction: The long-term outcomes of cardiovascular implantable electronic devices (CIED) in people with HIV (PWH) is unknown despite higher rates of sudden cardiac death and heart failure in HIV. Objective To compare outcomes between PWH and the general population who have CIEDs. Methods: Retrospective cohort study of patients receiving care at two academic hospitals in San Francisco who got CIEDs (pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy ± defibrillator) from 2000-2018. Since CIEDs were rarer in PWH than in those without HIV, we also did a nested case-control study. Case and controls were matched by age, sex, and CIED type. Death data was obtained from the National Death Index. Results: We identified 3,268 patients who got CIEDs; 1% was PWH. In PWH at CIED implantation, mean HIV duration was 19 years, mean CD4 count was 449 cells/uL, 78% had undetectable viral loads, and all were on antiretroviral therapy. PWH were younger than the control (mean age 62 vs. 69 years, p < 0.01). Both groups had similar rates of hypertension, diabetes, CAD, smoking, and drug use, but more PWH had hepatitis C than the control (25% vs. 3.0%, p < 0.01). Both groups had a similar number of pacemakers (56% vs. 58%, p = 0.86) and defibrillators (44% vs. 39%, p = 0.56). Post-procedure, five (16%) PWH had lead failure or infection while nine (14%) controls had lead failure. One PWH with site infection reported IV drug use. Post CIED placement, median survival in years was 5.3 in PWH vs. 6.4 in controls. No strong association between HIV status and survival (HR 1.9 [95% CI 0.7 to 5.0]) was seen ( F igure ). Conclusions: To our knowledge, this is the first study looking at survival post CIED between PWH and the general population. Our findings suggest that the number of PWH getting CIEDs remains low despite no definitive evidence of procedural complications; and that PWH have similar survival to those without HIV. More studies exploring barriers to CIED placement in PWH are needed.

The Life Experience of Patients after the Implantation of Cardiovascular Implantable Electronic Devices: A Qualitative Meta-Synthesis.

Cardiovascular implantable electronic devices (CIED) are more and more widely used in the clinical treatment of cardiovascular diseases. However, CIED implantation may also result in a variety of physical, psychological, and social problems among patients. To help patients adapt to life after CIED implantation, it is important to know patients' needs from their perspectives. Explore the needs of CIED patients from their perspectives to guide healthcare providers to improve their quality of life. PubMed, Web of Science, Embase, the Cochrane Library, CNKI, the VIP database, the Wanfang database, and the China Biomedical Literature database were searched for qualitative studies on the experience of patients with CIED dating from January 2000 to August 2022. The quality of each article was evaluated according to the 2016 edition of the Joanna Briggs Institute Evidence-Based Health Care Center Qualitative Research Quality Evaluation Criteria and an integrative meta-synthesis was undertaken. A total of 18 documents were included, and 111 categories were extracted. Analysis of the data resulted in the identification of 3 themes and 12 subthemes. The first theme, Equipment Symbiosis, included "Mixed feelings about the device as part of the body", "Mixed feelings about the patient's role", and "Mixed feelings about an electrical stimulus". The second theme, External Support, included "Husband and wife relationship damaged", "Eager to participate, unwilling to be overprotected", "Want to return to work but are forced to leave", and "Information supply and demand mismatch". The third theme, Self-coping, included "How to face a doctor", "How to deal with activity restrictions", "How to face yourself", "How to face the future", and "How to face death". Healthcare providers need to accelerate technological innovation and clinical adoption of CIED. Additionally, healthcare providers need to establish a diverse support system led by medical staff, with family members, peers, and society working together, and improve CIEDs remote monitoring to help patients improve their quality of life.

Imaging in patients with cardiovascular implantable electronic devices: part 1-imaging before and during device implantation. A clinical consensus statement of the European Association of Cardiovascular Imaging (EACVI) and the European Heart Rhythm Association (EHRA) of the ESC.

More than 500 000 cardiovascular implantable electronic devices (CIEDs) are implanted in the European Society of Cardiology countries each year. The role of cardiovascular imaging in patients being considered for CIED is distinctly different from imaging in CIED recipients. In the former group, imaging can help identify specific or potentially reversible causes of heart block, the underlying tissue characteristics associated with malignant arrhythmias, and the mechanical consequences of conduction delays and can also aid challenging lead placements. On the other hand, cardiovascular imaging is required in CIED recipients for standard indications and to assess the response to device implantation, to diagnose immediate and delayed complications after implantation, and to guide device optimization. The present clinical consensus statement (Part 1) from the European Association of Cardiovascular Imaging, in collaboration with the European Heart Rhythm Association, provides comprehensive, up-to-date, and evidence-based guidance to cardiologists, cardiac imagers, and pacing specialists regarding the use of imaging in patients undergoing implantation of conventional pacemakers, cardioverter defibrillators, and resynchronization therapy devices. The document summarizes the existing evidence regarding the use of imaging in patient selection and during the implantation procedure and also underlines gaps in evidence in the field. The role of imaging after CIED implantation is discussed in the second document (Part 2).

The utility of postoperative systemic antibiotic prophylaxis following cardiovascular implantable electronic device implantation: A systematic review and meta‐analysis

There is insufficient evidence regarding postoperative systemic antibiotic prophylaxis use for more than 24h following cardiovascular implantable electronic devices (CIED) implantation and its impact on infection prevention. However, this strategy remains a common practice in many institutions. We conducted a systematic review and meta-analysis including studies that compared the outcomes of patients: (1) who received preoperative plus 24h or more of postoperative antibiotic prophylaxis (intervention group); and (2) who received either preoperative only or preoperative plus less than 24h of antibiotic prophylaxis (control group). Risk of bias was assessed with ROBINS-I and ROB-2 tools. Risk ratio (RR) was pooled using random-effect meta-analyses with inverse variance method. Eight studies that included two randomized controlled trials (RCTs) and six cohort studies with a total of 26,187 patients were included in the analysis. Overall, there were no differences in outcomes between the two groups, which included rates of CIED infection (RR 0.77, 95% CI 0.42, 1.42), mortality (RR 1.19, 95% CI 0.69, 2.06), pocket hematoma (RR 1.15, 95% CI 0.44, 3.00) or reintervention (RR 0.87, 95% CI 0.22, 3.46). Of note, the results were primarily impacted by the larger RCT. There was no benefit of postoperative antibiotic prophylaxis for more than 24h following CIED implantation in the current systematic review and meta-analysis. This supports the practice advocated by current guidelines which foster antibiotic stewardship and may result in reductions of adverse drug events, selection for antibiotic resistance, and financial costs of prolonged postoperative antibiotic prophylaxis.

Outcomes of intracutaneous sutures in comparison with intracutaneous staples in cardiac implantable-electronic device pocket closure.

With the increase in cardiovascular implantable-electronic devices (CIEDs), complications from insertion and healing are also increasing. Therefore, the objective of this study was to compare the intracutaneous stapling method to the absorbable suture technique in terms of complications, procedure time, and pocket closure time. An observational study was conducted over the course of three months on patients with CIED implantation. The patients were divided in two groups according to pocket closure technique. Group 1 included patients with pocket closure using intracutaneous sutures; whereas in Group 2, the pocket was closed by intracutaneous staples. Data were collected regarding patient characteristics and wound problems. The endpoints were wound problems, including early and late wound problems (primary), total procedure time, and the time taken for pocket closure (secondary). One hundred and nineteen patients and 107 patients were allocated to Group 1 and Group 2, respectively. During the three-month observation period, 27 (22.6%) patients in Group 1 and 13 (12.1%) patients in Group 2 suffered from early wound problems, and the combined primary endpoint reached was statistically significant (p=0.021). Minor and major bleeding events were more common in Group 1 [Odds ratio (OR): 4.49, p=0.024; OR: 0.96, p=0.052]. The time to close the pocket was markedly reduced in Group 2 (7.29±1.42 vs. 3.98±1.19, p<0.001). The rate of early wound problems is higher using intracutaneous sutures; and therefore, intracutaneous staples should be preferred to prevent these problems.

Cardiovascular implantable electronic devices and native arteriovenous fistula in hemodialysis patients: novel perspectives.

The benefits from cardiovascular implantable electronic devices (CIED) implantation in hemodialysis (HD) patients are still far to be thoroughly defined, especially on primary prevention. In addition, CIED placement is not a risk-free procedure, because it could be followed by a not negligible burden of complications that could compromise the health and the vascular access of HD patients. In fact, the arteriovenous fistula (AVF) dysfunction following CIED implantation is usually due to a hemodynamically significant alteration of blood flow. This condition could lead to a potential decrease of dialysis efficacy and a raised risk of thrombosis of both the central vein and the efferent vein of the AVF.The pathological pathway that leads to AVF dysfunction after CIED implantation may involve the irritating actions of the CIED and their leads to the vascular wall in HD patients that are more prone to show previous vascular diseases.The aim of this review is to focus the physiopathology of the CIED-induced AVF dysfunction, the current treatment strategies and the novel perspectives that could be taken into consideration and offered to the HD population to preserve both their AVF and their quality of life.

Prevalence and Predictors of Clinically Relevant Atrial High-Rate Episodes in Patients with Cardiac Implantable Electronic Devices.

Background and ObjectivesAtrial high-rate episodes (AHREs) can be continuously detected by cardiovascular implantable electronic devices (CIEDs); however, the predictors of clinically relevant AHREs are unclear.MethodsThis prospective multicenter study monitored 816 patients (median age 73 years, 40.4% male) without atrial fibrillation (AF) from September 2017 to July 2020. AHREs was defined as a programmed atrial detection rate >220 beats/min. The reference values of 6 minutes and 6 hours were set to analyze clinical implication of AHREs based on previously published data that the 6 minutes excluded most episodes of oversensing.ResultsDuring a median follow-up of 18 months (interquartile interval 9–26 months), AHREs with the longest durations of >15 seconds, >6 minutes, and >6 hours and clinically documented AF by electrocardiography were noted in 246 (30.1%), 112 (13.7%), 49 (6.0%), and 24 (2.9%) patients, respectively. Among patients developing AHREs >6 minutes, 102 (91.1%) of 112 patients were identified at the 6-month visit. Patients with AHREs >6 minutes had higher proportions of sick sinus syndrome, subjects with atrial premature beat >1% on Holter monitoring, and larger left atrium (LA) size than patients with AHREs ≤6 minutes. Multivariable logistic regression analysis showed that LA diameter >41 mm (odds ratio [OR], 2.08; 95% confidence interval [95% CI], 1.25–3.45), and sick sinus syndrome (OR, 3.22; 95% CI, 1.91–5.43) were associated with AHREs >6 minutes.ConclusionsIn patients with LA diameter >41 mm, and sick sinus syndrome before CIEDs implantation is associated with risk of developing AHREs >6 minutes.Trial RegistrationClinicalTrials.gov Identifier: NCT03303872

Keeping up appearances: the radiographic evolution of cardiovascular implantable electronic devices

In recent years, there has been a significant evolution in the field of cardiovascular implantable electronic devices (CIEDs). Pacemakers can now be leadless, implantable cardioverter defibrillators can be entirely subcutaneous and implantable loop recorders have become miniaturized. Driven by technological advances and an ageing population implant numbers have also steadily increased. These highly prevalent systems are all radio-opaque and are frequently observed on chest radiographs, yet the devices are neither well recognized nor understood. We present a pictorial review of CIEDs; describing the chest radiograph appearances of both newer generation systems and their traditional predecessors. Furthermore, we discuss the clinical role of chest radiography in both CIED implantation and follow up, with the aim of improving understanding in this important and expanding field. Finally, we present a collection of interesting and challenging radiographs, where multiple CIED systems have been implanted.

Perioperative management of antithrombotic therapy in patients receiving cardiovascular implantable electronic devices: a network meta-analysis.

Network meta-analysis (NMA) has advantages including being able to simultaneously compare and rank multiple treatments over traditional meta-analysis. We evaluated by a NMA the optimal antithrombotic strategy during the perioperative period of implantation of cardiovascular implantable electronic devices (CIEDs). We performed a network meta-analysis of observational studies (cohort and case-control studies). The eligible studies tested the following antithrombotic therapy during the CIED placement: aspirin, clopidogrel, warfarin, novel oral anticoagulants (NOACs), and heparin bridging. Thirty-one observational studies with 119 study arms were included (41,174 patients receiving long-term antithrombotic therapy; median age, 72.6years; 70.1% males; median follow-up, 3.6years). Aspirin (4.26 [2.88-7.22]), warfarin (3.37 [2.17-5.23]), and clopidogrel (3.30 [1.49-5.88]) reduced the risk of bleeding as compared with heparin bridging, and there was no significance difference between continued NOACs and heparin bridging (0.67 [0.21-2.18]). The comparison of commonly used protocols in the management of anticoagulant therapy revealed that continued warfarin (0.38 [0.20-0.74]), continued NOACs (0.19 [0.04-0.89]), and heparin bridging therapy (0.01 [0.05-0.21]) increased the risk of bleeding as compared that of control, and continued warfarin (3.74 [1.96-7.16]), interrupted warfarin (4.89 [2.20-10.88]), and interrupted NOACs (12.5 [1.25-100]) reduced the risk of bleeding compared with that of heparin bridging. Among various antithrombotic drugs, aspirin had the lowest bleeding risk, followed by warfarin, clopidogrel and NOACs, and heparin, with the greatest bleeding risk. NOACs therapy appears safe and effective, and interrupted NOACs may be the optimal anticoagulation protocol for use during the perioperative period of CIED implantation.

“Just Because We Can Doesn’t Mean We Should”: views of nurses on deactivation of pacemakers and implantable cardioverter-defibrillators

This study aims to identify nurses' concerns about the clinical, ethical, and legal aspects of deactivating cardiovascular implantable electronic devices (CIEDs). We used focus groups to discuss decision making in CIED management. Fourteen nurses described the informed consent process as overly focused on procedures, with inadequate coverage of living with a device (e.g., infection risks and device shocks). Elderly patients were especially vulnerable to physician or family pressure about CIED implantation. Nurses believed that initial advance care planning discussions were infrequent and rarely revisited when health status changed. Many patients did not know that CIEDs could be deactivated; it was often addressed reactively (i.e., after multiple shocks) or when patients became too ill to participate in decision making. Nurses generally were supportive of CIED deactivation when it was requested by a well-informed patient. However, nurses distinguished between withholding versus withdrawing treatment (i.e., turning off CIEDs vs. declining implantation). Although most patients viewed their device as lifesaving, others perceived them as a "ticking time bomb." Nurses identified concerns about CIED decision making from implantation through end-of-life care and device deactivation and suggested avenues for improving patient care including early and regular advance care planning.

The Single Center Experience of Pacing Device Implantation in Patients with Complex Congenital Heart Disease

Aim: Transvenous cardiovascular implantable electronic devices (CIEDs) implantation in patients with complex congenital heart disease (CCHD) is challenging because of their complex anatomy. We report our experience of CIEDs implantation in CCHD patients. Methods: CCHD patients underwent the CIEDs implantation, were analyzed retrospectively. Results: We implanted CIEDs (pacemaker n=19, ICD n=5, CRT-D n=2) in consecutive 26 CCHD patients (mean 25 y.o.) from 1994 to 2011. The underlying heart diseases were tricuspid atresia (n=2) and single RV (n=1) both after Fontan operation, single LV (n=1) underwent the septation, truncus arteiosus communis underwent Rastelli (n=1), transposition of great ateries (TGA) (n=9) and corrected TGA (n=12; SLL n=9, IDD n=3). Twelve patients with TGA and corrected TGA underwent atrial switch (n=6) or double switch (n=6) operation. The pacing leads were successfully positioned with favorable sensing and pacing threshold in all patients, transvenously, without major complications. In 2 patients with cTGA, we successfully positioned the leads at the LV apex and in the coronary vein for the resynchronization of anatomical RV. The lead revision was required during the follow-up period, due to the lead dislodgement (n=2) and the lead fracture (n=2). Conclusion: Transvenous implantation of CIEDs was safely performed and feasible even in patients with CCHD and sometimes with atrio-ventricular discordance.