JCM | Free Full-Text | Cephalic Vein Cutdown Is Superior to Subclavian Puncture as Venous Access for Patients with Cardiac Implantable Devices after Long-Term Follow-Up
2. Materials and Methods
2.1. Study Population
The aim of the present study was to analyze the effects of venous access on the patency of the ipsilateral venous system in long-term follow-up. In particular, the study aimed to analyze of the grade of stenosis in the subclavian vein based on the applied access site for the initial CIED lead placement (cephalic vein cutdown versus puncture of the subclavian vein). With this scope, the cardiology database of the Luedenscheid Hospital (Gerseveral) was screened retrospectively.
All patients who underwent a second CIED implantation or device upgrade between 2005 and 2013 were identified. If a phlebography was performed before the operation and the operation protocol of the first implantation was present, the patient was included for the final analysis. Klinikum Luedenscheid is a high-volume center for treatment of diverse arrhythmia disorders and is especially associated with high experience for device treatment. To prevent unexpected complications during the planned procedure, there was a standard protocol to perform phlebographies whenever possible and in absence of obvious contraindications. The median time between first implantation and phlebography was 6.4 years.
The study conforms to the guiding principles of the Declaration of Helsinki. The study protocol was approved by the local ethics committee. Due to the retrospective character of the study, the local ethic committee waived patient informed consent, especially since the study is of a retrospective nature without any consequences relating to patient management, and without active follow-up.
Prior to scheduled CIED generator change, upgrade, or lead revision, phlebographies were performed routinely in our hospital. A standard 1.3-gauge venous cannula was placed on the ipsilateral upper extremity. Complete cineangiography of the axillary vein, the subclavian vein, and the brachiocephalic trunk was obtained after the forced injection of 20 mL of contrast medium. Before the injection, a tourniquet was place at the upper arm. Immediate after the injection, the tourniquet was released and an additional flush with 20 mL saline solution followed.
QS = 1 − DS ÷ 50% × (DD + DP)
where the following are defined: QS: stenosis ratio; DS: stenosis diameter; DD: distal/pre-stenotic diameter; DP: proximal/post-stenotic diameter.
As some phlebographies were performed in external radiology departments or were older than 10 years, only 215 phlebographies were considered appropriate.
2.3. Primary Endpoint and Sample Size Calculation
The primary endpoint was the occurrence of a venous occlusion with stenosis Type III or IV. To show an expected difference in venous occlusion (stenosis Type III or IV) of 30% (subclavian) to 10% (cephalic) to a significance level of 5% and a power of 80% with a two-sided Fisher test, at least 69 people per group had to be included in the study.
2.4. Statistical Analysis
The descriptive primary analysis was carried out by calculating the frequency and odds ratio of the occurrence of stenosis of grade I or II versus III or IV. Fisher’s exact test was used to determine whether there was a significant difference in the incidence of stenosis of grade III or IV between the two groups. The level of significance for this comparison was 5%.
Additional descriptive analyses were carried out by determining relative and absolute frequencies and using boxplots.
Seventy-four percent of the patients were male, and the median age was 73 years (Q1–Q3: 67–79). The patients presented due to a CIED replacement, upgrade, or lead revision from a pacemaker (n = 70) or an ICD (n = 92).
Due to the retrospective nature of the study, the basic characteristics were presented in a descriptive manner. Patients in the cephalic vein group presented with a higher percentage with oral anticoagulation treatment compared to the subclavian vein group (38% versus 30%). In contrast, in the subclavian vein group, more patients were treated with antiplatelets compared to the cephalic vein group: subclavian vein group with ASA (45%) and Clopidogrel (16%) versus cephalic vein group with ASA (31%) and Clopidogrel (13%).
The odds ratio was higher and had a value of 3.03 for the risk of developing stenosis Type III or IV in the subclavian vein puncture group. Fisher’s exact test yielded a p value of 0.02, which was less than 0.05; therefore, a significant difference in the occurrence of stenosis Type III or IV was found between the two groups.
This is a single-center observational, retrospective, nonrandomized study. The observed heterogeneity between the groups may have led us to under- or overestimate the current findings. Due to the multiple different patient characteristics, a much higher number of patients might be necessary to confirm causality. Furthermore, the accurate analysis of the initial CIED implantation as well as the availability of phlebographies several years after index implantation limited the number of eligible patients. Furthermore, there still can be a bias regarding the selection of the patients in whom phlebography was performed. Although phlebography was a standard procedure before planned replacements, some patients may have contraindications, or due to a very short hospital stay, phlebography may be skipped. Finally, the study did not have the power to analyze further comorbidities, and additionally, the power limits the desired extensive statistical workup. Therefore, these data are presented only in a descriptive manner.
CIED implantation is a daily applied therapy for the treatment of bradycardias by pacemakers and for the prevention of sudden cardiac death by ICDs. Although both therapies have, over the years, become commonly used operations, there is a lack of a standard approach regarding the venous access of the implanted leads. Operators decide according to their individual preference about access via subclavian vein puncture, axillary vein puncture, or cephalic vein cutdown.
Besides the acute complications and success rates, physicians should also consider the potential long-term complications and outcomes. For the choice of the best or a standardized strategy, sufficient prospective, randomized data are unsatisfactory.
The presented data offer additional evidence for the effects of the used access route on the long-term outcome of the venous alterations over a period of years.
Venous access using cephalic vein cutdown for the implantation of a CIED was associated with a statistically significantly higher patency of the ipsilateral subclavian vein compared to subclavian puncture as the vein access method after a median period of 6.4 years.
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