|Year : 2022 | Volume
| Issue : 2 | Page : 81-86
Success and complication rate of fluoroscopic, doppler, and contrast venography-guided subclavian venous puncture for implantation of cardiovascular electronic devices
Ashok Kumar1, Khandy Aashaq Hussain2, Tauseef Nabi3, Ashish Kumar Golwara4, Ajeet Kumar Singh4
1 Department of Interventional Cardiology, Paras Hospital Gurugram, Haryana, India
2 Department of Cardiology, MMIMSR, Ambala, Haryana, India
3 Department of Endocrinology, All is Well Multi-Speciality Hospital, Burhanpur, Madhya Pradesh, India
4 Department of Cardiology, BHMRC, Delhi, New Delhi, India
|Date of Submission||01-Jan-2021|
|Date of Decision||23-Jul-2021|
|Date of Acceptance||07-Sep-2021|
|Date of Web Publication||30-Oct-2021|
Dr. Tauseef Nabi
All is Well Multi-Speciality Hospital, Burhanpur, Madhya Pradesh
Source of Support: None, Conflict of Interest: None
Background: Cardiovascular implantable electronic devices (CIED) are life-saving devices, but may lead to puncture-related complications during implantation. Aim: The aim of this study was to compare the success and complications of the subclavian venous puncture under the guidance of fluoroscopy, venography, and Doppler. Methods: This was a prospective observational study conducted for one year at a tertiary health center in North India. We studied the clinical profile, success, and complications in three puncture techniques for CIED lead implantation in 75 adult patients of >18 years of age, randomized in three equal groups of 25 participants. Results: The mean age was 66.6 ± 15.6 years, with the majority being males. The left-sided approach for lead implantation was common (84%). Pacemakers were most commonly implanted CIED devices. The overall success of punctures was 100% each in Doppler and venography group, and 92% in the fluoroscopic-guided venous puncture group. Success in the first attempt was observed in 48% in the Doppler group and 24% each in the fluoroscopic and venographic group. There were total of 12 complications, the most common were arterial puncture (10.7%), followed by major hematoma (4%), and pneumothorax (1.3%). The fluoroscopic group had maximum complications (83%), followed by the venography group. Significantly higher arterial punctures occurred in the fluoroscopic venous puncture group. Conclusion: There were 100% success in the Doppler and venographic groups and only 92% success in the fluoroscopic venous puncture group. Maximum complications were seen in the fluoroscopic group, with significantly higher arterial punctures seen in the fluoroscopic venous puncture group.
Keywords: Cardiac implantable electronic device, subclavian venous puncture, Fluoroscopy, Doppler, venography, complications
|How to cite this article:|
Kumar A, Hussain KA, Nabi T, Golwara AK, Singh AK. Success and complication rate of fluoroscopic, doppler, and contrast venography-guided subclavian venous puncture for implantation of cardiovascular electronic devices. J Med Sci 2022;42:81-6
|How to cite this URL:|
Kumar A, Hussain KA, Nabi T, Golwara AK, Singh AK. Success and complication rate of fluoroscopic, doppler, and contrast venography-guided subclavian venous puncture for implantation of cardiovascular electronic devices. J Med Sci [serial online] 2022 [cited 2022 May 27];42:81-6. Available from: https://www.jmedscindmc.com/text.asp?2022/42/2/81/329721
| Introduction|| |
Center venous access is an essential step for successful lead implantation of cardiovascular implantable electronic devices (CIED). Subclavian vein is the most common approach for implanting CIED leads. Although this method is easy, quick, and has high success rates, it may be associated with serious acute complications including pneumothorax, or hemothorax, brachial plexus injury, and longer-term complications such as lead fracture, loss of lead insulation, and subclavian crush syndrome. Extrathoracic subclavian, cephalic, or axillary venous puncture has been recommended to avoid these complications.
Fluoroscopy is used to adequately visualize the first rib for extrathoracic subclavian venous puncture and to avoid subclavian artery tear and brachial plexus damage. Doppler-guided venous puncture for the placement of CIED lead is quick to learn, faster to achieve, and has high success rate of around 88%, but is unsuitable in extremely obese patients. Doppler-guided approach can potentially reduce the complications related to access and also reduce the incidence of lead crush by assisting in extrathoracic venous puncture. Contrast venography has been extensively used to guide puncture of the subclavian vein, as it delineates its anatomical course and reveals anomalies such as stenosis, tortuosity, and occlusion. It also enables the venous entry site to be placed more laterally (e.g., over the second rib) for reducing the risk of subclavian crush. The intrathoracic subclavian venous puncture technique has been compared previously with the extrathoracic subclavian venous puncture. However, a prospective comparison of the fluoroscopic bony landmark, Doppler, and contrast venogram-guided subclavian venous puncture techniques has not been reported previously. The purpose of this study was to compare and evaluate the feasibility, efficacy, safety, and complication rates of these three techniques guided subclavian extrathoracic and intrathoracic vein puncture for venous access, in lead implantation for CIED.
| Materials and Methods|| |
This was a single-center, three-arm prospective observational study of adult patients attending the Department of Cardiology and undergoing CIED implantation, at a tertiary care hospital in North India. The Institutional ethical committee approved the study (IEC/BHMRC/2016-110 dated June 2016).
The study recruited consecutive patients who were admitted to the cardiology department and underwent CIED implantation. This study was conducted for 12 months, from December 2016 to December 2017. All the recruited participants provided informed consent and the research was conducted following the Declaration of Helsinki. After taking history, a detailed physical examination of the participants was carried based on a study protocol. The eligibility criteria for including the participants in the study were: Both male and female patients (≥18 years of age) and needing CIED implantation for any indication. The exclusion criteria were the patients aged <18 years and those who were unable to provide informed consent. The procedure was done by two experienced cardiologists, who used to do >30 cases of CIED implantation per year for more than a decade.
Seventy-five patients who underwent CIED implantation and fulfilled inclusion criteria were enrolled in this study and were randomized into 1:1:1 ratio (25 patients in each group) by simple random method into one of the three procedure groups. All patients underwent subclavian venous puncture using the standard method. (i) Fluoroscopic group-Bony landmark-guided puncture was done by keeping the entry point of the puncture needle toward the point where the second rib met the thoracic cage in PA view on fluoroscopic image of chest, with patient's hands resting by side of the thorax and the head turned 45° to the contralateral side. The needle was subsequently advanced toward intersection between the outer border of the first rib and clavicle (gently aspirating on an attached syringe as with any other indirect puncture), aiming for the space below the clavicle and over the first rib until either the vein was punctured or the rib was struck. An angle of about 45°-60° to the skin surface was maintained while the needle was being introduced. If the rib was struck, the needle was gently withdrawn 1–2 cm with continuous aspirating for venous blood and if there was still no flashback of blood, the caudo-cephalad angle of the needle was changed to aim for either a slightly more cephalic or caudal position on the first rib and the same process was repeated. (ii) Doppler group-Doppler was used for evaluation of subclavian vein anatomy and measurements before puncture. Doppler probe (3–8 MHz) was used for accurate subclavian venous puncture and exact angulations from the horizontal and vertical plane of the patients were recorded [Figure 1]. For example, in a typical case for localization of subclavian vein, horizontal angle and vertical angle of the needle with patient's skin were 25°–60° and 30°–55°, respectively and 2 cm depth from the patient's skin. (iii) Contrast venography group-Dye was injected through antecubital venous cannula and venogram was taken to assess vein at the puncture time. If venous access was not obtained, the operator could opt to change to the contralateral side or another approach.
|Figure 1: Ultrasonogram showing the long-axis view of the subclavian vein with the subclavian artery (a). Doppler color flow mapping identifies the vein by the direction of blood flow. Schematic presentation of US-guided venipuncture. The needle is inserted from the edge of the transducer (b)|
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After puncture of central vein in the subclavicular area, fluoroscopic image in AP view of the introducer needle with clearly visible tip and guidewire positioned toward tip were recorded in all patients. The following offline recordings and analyses were done after the procedure.
- Depth of vein from the skin, and needle angle from the horizontal and vertical plane of the patients was recorded in the Doppler group
- The side of puncture (left or right-sided) and the venous access technique were also noted
- Number of leads placed was recorded per patient as part of the study protocol.
The success of puncture was defined by drawing of venous blood and insertion of the guidewire into the central vein. One-time success was defined by minor adjustment of needle direction at the puncture point, without withdrawing the needle. Follow-up chest X-ray and clinical examination was done after the procedure for assessment of the complications such as major hematoma (>5 mm, or required surgical drainage), arterial puncture, pneumothorax, lead-dislodgement, and other complications, that required surgical interventions during the index hospitalization.
The statistical analysis was conducted following the principles as specified in the International Council for Harmonization. For continuous measurements-mean, median, standard deviation, minimum and maximum were used to tabulate the data. To find the association between categorical variables, the Chi-square test or Fisher exact test was used. For all statistical analyses, a P < 0.05 was considered to indicate a significant difference at 5% level of significance. All the analyses were performed by using the Statistical Package for the Social Sciences software (SPSS, Chicago, IL, USA, version 20.0).
| Results|| |
[Table 1] shows different clinical variables of the study population. The mean age was 66.6 ± 15.6 years, with a range of (28–91 years). Patients <50 years of age were 4 in number, 43 patients were between 51 and 70 years of age and 28 patients were of >70 years age. Male patients were 45 (60%) and 30 (40%) were females. The mean body mass index (BMI) was 27.8 ± 4.7 kg/m2. The overall distribution of comorbidities revealed; 44 (58.7%) had coronary artery disease (CAD) and hypertension (HTN); diabetes mellitus (DM) was present in 33 (44%) patients. P shows that there was no significant difference in comorbidities in patients between the three groups.
[Table 2] shows different CIED device implantation. The permanent pacemakers (PMs) were implanted in 66 (88%) of study participants. Automated implanted defibrillators (AICD) and cardiac resynchronization therapy defibrillators were implanted in 4% and 6.7%, respectively. Total PMs implanted in each group were 21 (84%), 23 (92%), and 22 (88%), respectively in Doppler, fluoroscopic, and contrast venography groups. Old lead was observed in 1 (4%) patient in the contrast venography group. AICD was implanted in 4% each in three groups. Total leads of implanted devices on both sides were 151, of which 127 (84%) leads were implanted on the left side and only 24 (16%) leads implanted on the right side. Among 127 leads implanted by the left-sided approach, 43 (82.7%), 44 (88%), and 40 (81.6%) were implanted under fluoroscopy, venography, and Doppler groups, respectively. P shows that there was no statistically significant difference in any device-related characteristic. Time taken in doing puncture was divided into <5 min, 5–10 min, and >10 min. Time duration of puncture <5 min was found in 80% in the fluoroscopic group and 92% each in Doppler and venography group. Time taken >10 min for successful puncture was found in only 1 (4%) patient of the fluoroscopic group. The time taken for successful puncture was not statistically significant between the groups (P = 0.146). The minimum and maximum duration for the successful puncture was 0.3 min and 12 min, respectively, with the mean value of 2.99 ± 1.85 min. In our study, among the patients from the Doppler group, the minimum and maximum depth of vein from the skin surface was 16 mm and 23 mm, respectively, with the mean depth of 19.5 ± 3.6 mm. The average angle of the puncture needle ranged from 40° to 60° (mean of 49°) in horizontal and 49° and 52° in the vertical plane, although the entry angle was large.
|Table 2: Cardiovascular implantable electronic devices implantation related characteristics|
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[Table 3] shows the success rate of venous puncture techniques. In Doppler technique, 12 (48%) patients had successful venous puncture in the first attempt. The first attempt success rate was 24% in both fluoroscopy and venography-guided puncture groups. The overall success was 100% in Doppler and contrast venography groups, whereas it was 92% in the fluoroscopic group. There were two unsuccessful punctures in the fluoroscopic group, which were further punctured with the help of venography.
There were total of 12 (16%) complications observed in the study participants, as shown in [Table 4]. Most of the complications were arterial punctures 8 (10.6%), followed by major hematoma 3 (4%) and pneumothorax 1 (1.3%). The fluoroscopy group have maximum complications (83%) and there was no complication in the Doppler group. There was no significant difference in hematomas between the groups (P = 0.769). The percentage of arterial punctures in fluoroscopic, contrast venography, and Doppler groups were 28%, 4%, and 0%, respectively. There was no statistical significance between the groups (P = 0.366); however, on intergroup comparison, there were significantly higher arterial punctures seen in the fluoroscopic venous puncture group (P = 0.009).
| Discussion|| |
A prospective comparison of the Doppler, fluoroscopic, and contrast venography-guided subclavian venous puncture techniques has not been reported previously in the Indian population. The present study attempted to assess the success and complication rates of these three groups for CIED lead implantation. The study showed male predominance (60%) over females, which is comparable to study by Calkins et al. (males 60.5%, females 39.5%), Liu et al. (males 68%, females 32%) and Sharma et al. The mean age of study participants in our study was 66.6 ± 15.6 years, which is comparable to study by Calkins et al. (65 ± 15 years), Liu et al. (64 ± 8.6 years) and Andrikopoulos et al. (64.7 ± 12.7 years). The mean BMI of the participants in our study was 27.8 ± 4.7 kg/m2, with the majority of the participants being over-weight, which is comparable to study by Galloway and Bodenham.
DM and CAD were observed in 44% and 58.7% of the participants, respectively in our study. HTN was found in 58.7%, whereas CHF and previous CABG were present in 16% and 8%, respectively of total participants. No significant difference in comorbidities in patients between the three groups was noted. In a study done by Udo et al., percentage of DM, CAD, HTN, CHF, and CABG was 15.2%, 19.8%, 62.8%, 11%, and 17.9% respectively, whereas another study revealed percentage as 14%, 32%, 52%, 37%, and 19%, respectively. Our patients had almost similar baseline characteristics as previous studies, except the DM was higher in our study; the reason may be higher prevalence of DM in our country.
PMs (88%) were the most common implanted device in our study and also in studies done by Spencer et al. (86%) and Kirkfeldt et al. (75%). Most of the studies,, have used left-sided approach (82%–99%), whereas some studies, have used right-sided approach for PMs implantations, which is similar to our study where 84% had left-sided approach.
In our study, time duration of successful puncture was <5 min in the majority of the participants, with mean value of 2.99 ± 1.85 min (0.3–12 min). The study by Littleford et al. revealed slightly increased duration of puncture time (1.5 min to 15 min, mean 4 min), which could be explained by the fact that this study was done >4 decades ago, and several modification to the procedures have happened. The study done by Orihashi et al. showed that the depth of subclavian vein from the skin surface ranged from 10.0 mm to 32.4 mm (mean of 22.7 mm), with mean entry angle of the puncture needle of 52.4°, which is almost similar to our study, where the mean depth of 19.5 ± 3.6 mm and average angle of the puncture needle ranged from 40° to 60° (mean of 49°), among the patients from the Doppler group.
The studies done by Spencer et al. (in venography was 100%), Fyke. (Doppler 100%), and Littleford et al. (under fluoroscopy was 91.7%) revealed Doppler and venography-guided venous puncture groups have maximum success as compared to fluoroscopy, which is similar to our study, where success rate was 100% in Doppler and venography, and 92% in the fluoroscopic group.
In the study by Spencer et al. arterial complications were observed in 9% of cases and in a study by Sharma et al. major hematomas were observed in 4% and pneumothorax in 3%. In our study, there were total of 12 (16%) complications during the CIED implantation. Most complications occurred in the fluoroscopic group (83%). The most common complication in our study was arterial punctures occurring in 8 (10.7%) patients, 87.5% in the fluoroscopic group, and 12.5% in the venography group. The second most common complication was major hematoma found in 4% of study participants, whereas pneumothorax occurred in 1 (1.3%) of our study participants. The study by Kirkfeldt et al. identified age >80 years, a prior history of chronic obstructive pulmonary disease and implantation of a dual-chamber PM as risk factors for pneumothorax. The only patient having pneumothorax in our study was a 73-year-old female underwent dual-chamber PM implantation through subclavian intrathoracic fluoroscopy-guided puncture. This patient was managed with insertion of chest tube for pneumothorax. With of advancement of imaging devices and intervention techniques.
The main limitation was that it was a single-center study with small sample size. Another limitation was bias of the operators for the alteration of techniques cannot be ruled out. The absence of follow-up for accessing the long-term complications was not studies.
| Conclusion|| |
The left-sided lead device implantation is common. The overall success was 100% in the Doppler and venographic groups and 92% success in the fluoroscopic venous puncture group. Maximum complications were seen in the fluoroscopic group, followed by the venographic group, and no complication under Doppler group, with significantly higher arterial punctures seen in the fluoroscopic venous puncture group.
The authors would like to express their greatest gratitude to all participating patients, health professionals and community support group members, who provided assistance for this study. I also thank the technical department of Cardiology.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]