Investigating the necessity of preoperative coronary angiography for infection-related cardiac implantable electronic device explantation

TL;DR

This study examines whether preoperative coronary angiography is necessary for patients undergoing cardiac device removal due to infection, finding it does not significantly affect outcomes.

Contribution

The study provides evidence that routine preoperative coronary angiography may not be essential for CIED explantation in infected cases.

Findings

Preoperative coronary angiography did not significantly affect 30-day mortality in patients with infected cardiac devices.

There was no significant difference in major postoperative complications between patients who had or did not have preoperative coronary angiography.

Non-invasive imaging may be increasingly relevant for preoperative evaluation in these cases.

Abstract

Device-associated endocarditis is a potentially life-threatening condition that typically requires the removal of the cardiac implantable electronic device (CIED). The role of routine coronary angiography (CAG) as part of preoperative evaluation remains uncertain.

This study aims to assess the necessity of preoperative CAG and its impact on clinical outcomes in patients who underwent isolated CIED explantation due to infection.

A single-center retrospective analysis was conducted at Jena University Hospital between 2007 and 2023. The primary outcome was 30-day mortality. The secondary outcomes were major perioperative complications. The data were displayed using descriptive statistics and classic 2-sided tests.

A total of 287 high-risk patients underwent isolated CIED explantation due to infection, of whom 120 underwent a preoperative CAG while 167 did not. Preoperatively, almost the half of the patients did not present history of coronary artery disease (No CAG: 53.9% and CAG: 45.0%), and the CAG group presented higher rates of lead vegetation (65.0% vs 52.7%, p = 0.04). Preoperative CAG had no significant effect on 30-day mortality (9.2% vs 9.6%, p = 1.00, mostly due to sepsis). Additionally, there was no significant difference in postoperative complications between the groups, including myocardial infarction (p = 1.00), bleeding (p = 1.00), acute renal failure (p = 0.76), or surgical conversion (p = 0.29).

The analysis suggests that preoperative CAG does not significantly influence short-term outcomes after CIED explantation due to infection in our patient population. Systematic preoperative CAG may not be necessary for all patients. Moreover, non-invasive imaging modalities may have emerging importance in scenarios like this.

Full text

Introduction

1

Device-associated endocarditis is a serious, potentially life-threatening condition that often requires the removal of the cardiac implantable electronic device (CIED) [1], [2]. This infection can lead to complications such as septicemia, heart failure, or embolic events [3], [4], [5]. The treatment typically involves both antibiotic therapy and, in most cases, the removal of the CIED to prevent further systemic infection [6], [7].

Since removal of CIED‑leads can result in the need for emergently opening the sternum, exposing the heart and the potential use of cardiopulmonary bypass, most centers routinely perform a coronary angiograms (CAG) before the operation [8], [9]. CIED patients are often comorbid and carry an elevated risk of potentially asymptomatic but relevant coronary artery disease (CAD), which may complicate coming-off bypass in an emergency setting. However, the number of emergencies in CIED explantations is low and the management of such complications has never been thoroughly evaluated. We therefore assessed our experience with patients who underwent isolated CIED explantation due to infection in relation to the presence or absence of a preoperative CAG.

Methods

2

Study design

2.1

This is a single-center cohort retrospective observational study in patients with CIED infection who underwent isolated CIED explantation in our center between 2007 and 2023. The primary reasons why patients did not receive CAG were the surgeon's decision and alternative diagnostic strategies. The study was approved by our Ethical Committee (Nr. 2023-3020) and was conducted according to the Helsinki Declaration. Data from the patients were retrieved from clinical records. The patient consent was present and written during hospital admission. The dataset included detailed patient information relevant to their surgical and medical history.

Study outcomes

2.2

The primary outcome was 30-day mortality. The secondary outcomes were major perioperative complications: cerebrovascular event, vascular rupture, gastrointestinal complications, pericardial effusion, pleural effusion, pneumothorax as well as rhythm at discharge.

Statistical analysis

2.3

Continuous variables were reported using median and interquartile range (IQR) in the baseline demographics and as mean and standard deviation in the endpoint's description. Categorical variables were summarized by absolute and relative frequencies. Fisher exact test, Wilcoxon Mann-Whitney test, and Student's t-test were applied to compare binary and continuous variables. The null hypothesis was rejected if the p value related was ≤0.05.

Results

3

Study population

3.1

The entire population comprised 287 patients who underwent isolated CIED explantation due to infection, of whom 120 underwent a preoperative CAG while 167 did not. Table 1 shows the baseline characteristics of the overall population. There was no significant difference in the average age between the groups (69.2 ± 0.9 years for non-CAG vs. 73.2 ± 0.9 years for CAG, p = 0.53) or in the proportion of male patients (77.8% in non-CAG vs. 72.5% in CAG, p = 0.33).Table 1. Demographics characteristics.Table 1. No angiographyn = 167Angiographyn = 120p-ValueAge (years)69.2 ± 0.973.2 ± 0.90.53Male130 (77.8)87 (72.5)0.33Body-mass-index27.2 ± 0.428.2 ± 0.40.12Clinical signs0.43

Clinical presentationPacemaker pocket infection78 (46.7)47 (39.2) Fever38 (22.8)37 (20.8) Fatigue5 (3.0)3 (2.5) Poor appetite1 (0.6)0 (0) Weight loss2 (1.2)1 (0.8) Neurological symptoms4 (2.4)3 (2.5) Dyspnea17 (10.2)9 (7.5) Muscle and joint symptoms1 (0.6)1 (0.8) Cough1 (0.6)1 (0.8) Low back pain0 (0)2 (1.7) Chest pain4 (2.4)1 (0.8) Arrhythmia2 (1.2)0 (0) Skin lesions0 (0)0 (0) Sepsis2 (1.2)3 (2.5)EuroSCORE II13.3 ± 15.512.7 ± 13.40.76LVEF (%)43.6 ± 18.047.9 ± 17.70.05Lead vegetation88 (52.7)78 (65.0)0.04Largest vegetation (mm)15.5 ± 8.913.9 ± 7.90.33Smoking status0.07 Smoked in the last 2 months14 (8.4)4 (3.3) Never smoked58 (34.7)45 (37.5) Ex-smoker45 (26.9)22 (18.3) Daily smoker5 (3.0)2 (1.7)Hyperlipidemia0.40 Treated100 (59.9)77 (64.2) Untreated5 (3.0)1 (0.8)Hypertension0.11 Treated139 (83.2)96 (80.0) Untreated1 (0.6)2 (1.7)Rhythm at admission0.69 Sinus rhythm59 (35.3)46 (38.3) Atrial fibrillation47 (28.1)36 (30.0) Other rhythm61 (36.5)38 (31.7)Pre-operative ventilation9 (5.39)5 (4.2)0.78Vitamin K antagonist intake38 (22.8)22 (18.3)0.38COPD0.77 With long-term medication25 (15.0)19 (15.8) Without long-term medication8 (4.8)4 (3.3)Peripheral arterial disease22 (13.2)19 (15.8)0.61Previous CVA22 (13.2)14 (11.7)0.25Antibiotics intake at admission98 (58.7)72 (60.0)0.90Previous PCI46 (27.9)35 (29.2)0.89Pre-operative RRT19 (11.4)22 (18.3)0.26Diabetes0.42 Diet-controlled diabetes15 (9.0)13 (10.8) Oral antidiabetics22 (13.2)15 (12.5) Insulin + oral medications9 (5.4)2 (1.7) Insulin-dependent diabetes35 (21.0)32 (26.7)Surgery urgency0.17 Elective29 (17.4)18 (15.0) Urgent99 (59.3)60 (50.0) Emergency36 (21.6)40 (33.3) Ultima ratio3 (1.8)2 (1.7)Type of CIED ICD80 (47.9)59 (49.2)0.91 Pacemaker86 (51.5)61 (50.8)1.00Leads older than one year126 (75.5)106 (88.3)0.05Prior myocardial infarction41 (24.7)28 (23.4)0.50History of CAD0.03 One-vessel CAD22 (13.2)19 (15.8) Two-vessel CAD14 (8.4)23 (19.2) Three-vessel CAD34 (20.4)24 (20.0) Unspecified3 (1.8)0 (0) No CAD90 (53.9)54 (45.0) Unknown4 (2.4)0 (0)NYHA0.90 I35 (21.0)28 (23.3) II49 (29.3)34 (28.3) III65 (38.9)48 (40.0) IV16 (9.6)8 (6.7)Number of prior heart surgeries0.28 136 (21.6)17 (14.2) 26 (3.6)4 (3.3) 32 (1.2)2 (1.7) 40 (0)0 (0) 53 (1.8)0 (0)The values are displayed in n (%) or mean ± SD. CAD = coronary artery disease, CIED = cardiac implantable electronic device, COPD = chronic obstructive pulmonary disease, CVA = cerebrovascular accident, ICD = implantable cardioverter defibrillator, LVEF = left ventricular ejection fraction, NYHA = New York Heart Association, RRT = renal replacement therapy.

There were no statistically significant differences in initial symptoms between the groups (p = 0.43). The most common clinical presentation in both groups were pacemaker pocket infection and fever. Other symptoms, such as fatigue, poor appetite, weight loss, neurological symptoms, and dyspnea, had similarly low prevalence and did not differ significantly between groups.

Although the EuroSCORE II was similar between the groups, the CAG group showed significantly higher rates of lead vegetation, with 65.0% of patients in this group affected compared to 52.7% in the non-CAG group (p = 0.04); and was more likely to have a prior history of two-vessel CAD, with a prevalence of 19.2% compared to only 8.4% in the non-CAG group (p = 0.03).

Study outcomes

3.2

Table 2 shows a summary of the postoperative outcomes between the two groups. There was no significant difference in postoperative complications between the groups in most measured outcomes.Table 2. Summary of outcomes.Table 2. No angiographyn = 167angiographyn = 120p-Value30-day mortality16 (9.6)11 (9.2)1.00Myocardial infarction0 (0)0 (0)–Bleeding16 (9.6)12 (10.0)1.00Acute renal failure33 (19.8)21 (17.7)0.76Surgical conversion3 (1.8)5 (4.2)0.29Reason for conversion0.16 Severe lead adhesions0 (0)1 (20.0) Lead torn off0 (0)3 (60.0) Pulseless electrical activity1 (33.3)0 (0)CABG performed after conversion0 (0)0 (0)–Cerebrovascular event5 (3.0)2 (1.7)0.48Vascular rupture0 (0)0 (0)–Gastrointestinal complications7 (4.2)5 (4.1)0.42Pericardial effusion6 (3.6)3 (2.5)0.89Pleural effusion72 (43.1)64 (53.3)0.32Pneumothorax0.38 Drainage4 (2.4)1 (0.8) Punction0 (0)1 (0.8) Conservative treatment1 (0.6)0 (0)Rhythm at discharge0.27 Sinus rhythm68 (40.7)53 (44.2) Atrial fibrillation37 (22.2)23 (19.2) Atrioventricular block2 (1.2)0(0) Pacemaker rhythm40 (24.0)26 (21.7)Discharge with pacemaker65 (38.9)47 (39.2)1.00Discharge with ICD32 (19.2)25 (20.8)0.77Discharge with defibrillation west19 (11.4)24 (20.0)0.05The values are displayed in n (%). CABG = coronary artery bypass grafting, ICD = implantable cardioverter defibrillator.

The rates of 30-day mortality were nearly identical, with 9.6% in the non-CAG group compared to 9.2% in the CAG group (p = 1.00). Similarly, there were no occurrences of myocardial infarction in either group. There was no difference regarding bleeding events (p = 1.00) and acute renal failure rates (p = 0.76).

The surgical conversion rates were low in both groups, with 1.8% in the non-CAG group and 4.2% in the CAG group (p = 0.29). Importantly, no coronary artery bypass (CABG) procedures were performed after conversion in both groups. Finally, the discharge outcomes were consistent across the patient groups, with no significant differences observed in the rates of discharge with pacemaker (p = 1.00) or implantable cardioverter defibrillator (p = 0.77).

Discussion

4

Our analysis suggests that preoperative CAG does not significantly influence short-term outcomes after CIED explantation due to infection such as mortality and major postoperative complications.

Currently, there is no definitive guideline in the literature advocating for routine CAG before CIED explantation due to infection [10], [11]. Nonetheless, surgeons typically want to ensure that if they proceed with opening the sternum and potentially need to use the heart-lung machine, the presence of significant CAD will not interfere with the preoperative strategy or complicate the weaning from cardiopulmonary bypass. Although our numbers are small, the results suggest that routine CAG before CIED may not be required. This raises the possibility that, among the converted patients, potential targets for intervention were simply absent. The intention behind the sternotomy seems to be solely to manage potential bleeding due to an unexpected perforation. However, for appropriate assessment of this question, randomized studies are needed.

Potentially omitting CAG before CIED removal may be associated with a reduction in healthcare-related costs, including those related to personnel, procedural expenses, and overall hospital stay. In our analysis, none of the patients requiring CIED explantation underwent concomitant bypass surgery. This observation strongly suggests that routine preoperative CAG may not be necessary in all patients, particularly when the likelihood of significant CAD requiring simultaneous revascularization is low. The literature appears somewhat sparse on this topic, as there are no other major series that have investigated this hypothesis.

Furthermore, it may be argued that patients presenting with sepsis may indicate a more severe clinical condition. Septic patients are often hemodynamically unstable, making invasive procedures such as CAG riskier and less feasible. In these cases, clinicians may have prioritized immediate infection control and hemodynamic stabilization over additional diagnostic procedures. This suggests a potential treatment allocation bias [12], as sicker patients were likely managed differently, with a more conservative approach that avoided unnecessary procedural risks. Consequently, the decision to decline CAG in these cases may reflect clinical judgment tailored to the urgency of infection management rather than a standardized protocol. In any case, despite this possibility, the group without CAG did not perform worse than the CAG group, which lends further support to our conclusion. Taking all those facts into consideration patients scheduled for CIED explantation due to infection might benefit most from omitting preoperative CAG in order to avoid delays to surgery and to prevent additional complications, without compromising patient safety. That's why this study focused on this patient cohort. Our intention was not to extrapolate the results of this single-center cohort to patients undergoing CIED explantation for other indications, such as chronic pain syndromes or lead dislodgement.

Ultimately, given the inherent risks of performing CAG in critically ill patients, alternative non-invasive imaging such as coronary CT angiography (CCTA) may be a valuable option in some specific scenarios for the following reasons: [I] advances in CCTA now allow high-resolution delineation of coronary anatomy with excellent sensitivity and specificity for significant CAD [13], [14], [15], [16], [17]. Notably, results from the FAST-TRACK trial led by Dr. Serruys suggest that a CCTA-first strategy can safely and efficiently rule out obstructive disease in selected patients, supporting its use as a gatekeeper to invasive angiography in appropriate clinical contexts [18]; [II] CCTA can be acquired alongside routine chest CT scans used for surgical planning, which is particularly useful in re-operative settings; [III] CCTA is non-invasive and avoids procedural complications associated with catheterization, such as vascular injury, bleeding or arrhythmias, making it particularly suitable for critically ill or high-risk patients who may not tolerate invasive procedures [13], [14], [15], [16], [17]. However, CCTA is less reliable in patients with prior PCI due to limitations in accurately characterizing stented segments and complex lesions [19].

Study limitations

4.1

The retrospective nature of the study implies different possible biases due to residual cofounders. Additionally, an important limitation of this study is the lack of follow-up data, which significantly restricts the capacity to evaluate long-term outcomes in patients undergoing CIED explantation. Without longitudinal data, it is not possible to assess the durability of short-term findings or other long-term implications of untreated conditions. Finally, we do not know whether patients receiving CAG experienced any complications before surgery, because we were only able to evaluate peri-operative outcome.

Conclusion

5

The single-center experience suggests that preoperative CAG does not significantly influence short-term outcomes after CIED explantation due to infection. Systematic preoperative CAG may not be necessary for all patients, but randomized evidence is required to make this conclusion generalizable.

CRediT authorship contribution statement

Tulio Caldonazo: Writing – review & editing, Writing – original draft, Visualization, Validation, Supervision, Software, Resources, Project administration, Methodology, Investigation, Funding acquisition, Formal analysis, Data curation, Conceptualization. Holly Scheler: Writing – review & editing, Writing – original draft, Methodology, Formal analysis, Data curation, Conceptualization. Johannes Fischer: Writing – review & editing, Writing – original draft, Methodology, Data curation, Conceptualization. Hristo Kirov: Writing – review & editing, Validation, Supervision, Software, Resources, Project administration, Methodology, Investigation, Formal analysis, Data curation, Conceptualization. Murat Mukharyamov: Writing – review & editing, Writing – original draft, Validation, Supervision, Resources, Methodology, Investigation, Conceptualization. Stephanie Gräger: Writing – review & editing, Validation, Supervision, Methodology, Formal analysis, Data curation, Conceptualization. Angelique Runkel: Writing – review & editing, Validation, Methodology, Investigation. Sebastian Reinartz: Writing – review & editing, Validation, Supervision, Methodology, Investigation, Conceptualization. Mahmoud Diab: Writing – review & editing, Validation, Supervision, Resources, Project administration, Data curation, Conceptualization. Torsten Doenst: Writing – review & editing, Writing – original draft, Validation, Supervision, Resources, Project administration, Methodology, Funding acquisition, Conceptualization.

Funding

TC was funded by the 10.13039/501100001659Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) Clinician Scientist Program OrganAge funding number 413668513, by the 10.13039/501100005971Deutsche Herzstiftung (DHS, German Heart Foundation) funding number S/03/23 and by the Interdisciplinary Center of Clinical Research of the Medical Faculty Jena.

Declaration of competing interest

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Tulio Caldonazo reports financial support was provided by German Heart Foundation. Tulio Caldonazo reports financial support was provided by German Research Foundation. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.