Axillary vein puncture guided by ultrasound, using a readily learned technique, was superior to cephalic vein dissection via cut-down for implantation of cardiac device leads in a small, multicenter, randomized clinical trial from Brazil. Use of the axillary vein provided better success with shorter procedure time.
In a comparison of the two approaches for pacemaker or defibrillator implantations, “the success rate…was significantly higher in the axillary group, 97.7% vs 54.5%” for the cephalic group, lead author Ana Paula Tagliari, MD, MSc, Hospital de Clinicas de Porto Alegre, said in March at an online presentation for the virtual congress of the European Heart Rhythm Association (EHRA) 2020.
Tagliari is also lead author on the study’s April 29 publication in Heart Rhythm.
For context, she noted, an EHRA survey of 62 centers had found that the preferred technique for first venous access was via the cephalic vein in about 60% of the centers and via intrathoracic subclavian vein or extrathoracic subclavian vein in approximately 20% each.
Cephalic dissection is the standard and a safe approach but has a high failure rate Tagliari said; use of the subclavian vein is common and has a high success rate but also the drawback of frequent complications. The researchers said they wanted to see whether using an approach that was not part of the “culture” could be better, as well as how easily one could learn it.
Their comparison of ultrasound-guided axillary vein puncture with cephalic vein cut down used success rate as the primary end point, which was defined as all leads in the superior vena cava in 15 minutes or less using three or fewer puncture attempts. Eighty-eight subjects were randomly assigned to either procedure, 44 to each group. The operators assigned to using the axillary approach had no previous experience with it.
Baseline demographic and clinical characteristics, other than age, did not differ between the two groups; the cephalic group was older than the axillary group (74.5 vs 67.5 years; P = .019).
The majority of implants were left sided, 68.2% of them for the axillary group and 59.1% for the cephalic group; 68.2% of each group received dual-chamber devices and 31.8% single-chamber devices. Approximately three-quarters of each group received the device in a subcutaneous pocket and the rest a submuscular pocket.
The success rate was 97.7% for the ultrasound-guided axillary route and 54.5% using the cephalic vein (P < .001). There were far fewer venous access-site changes needed with the axillary than the cephalic approach (2.3% vs 40.9%; P < .001).
Both the time to obtain venous access and the total procedure time were significantly shorter with axillary vein puncture than use of the cephalic vein.
|Median Access and Total Procedure Times, Ultrasound-Guided Axillary Vein Approach vs Cephalic Vein Approach|
|End Point||Ultrasound-Guided Axillary Vein||Cephalic Vein||P Value|
|Venous access, m||5||15||<.001|
|Total procedure, m||40||51||<.010|
Complications within 30 days consisted of one pneumothorax, three lead displacements, and one pocket hematoma in the cephalic group (11.4%). The 2.3% complication rate for the axillary group included just one pneumothorax (P = .742).
Coauthor Adriano Nunes Kochi, MD, MSc explained to theheart.org | Medscape Cardiology that the one pneumothorax with the axillary approach occurred in “a challenging patient because he was very skinny, very malnourished,” and required “a very medial puncture” because of a small vein. Bone in the area obscured ultrasound visualization of the needle, which punctured a lung.
Independent predictors of success in multivariate analysis included:
Ultrasound-guided axillary approach (odds ratio [OR], 53.3; 95% CI, 5.97 - 476.1; P < .001)
Use of a single-chamber device (OR 8.71; 95% CI, 1.51 - 50.0; P < .015)
Greater body mass index (OR, 1.23; 95% CI, 1.04 - 1.45; P < .015)
The learning curve for the self-taught ultrasound-guided axillary puncture was flat; the time to venous access did not differ significantly for operators with no more than five procedures, six to 10 procedures, or more than 10 procedures (5.5 min, 5.4 min, and 7.3 min, respectively).
Outcomes adjudication in the study was blinded, although blinding to type of procedure was not possible, Tagliari noted. In another limitation, results were limited to what could be learned from radiography at 24 hours; the study didn’t capture any late lead-related complications.
Ultrasound-guided axillary vein puncture for implantation of pacemaker or defibrillator leads is a good first-line or alternative approach when, for example, the cephalic vein is absent or unsuitable for insertion of multiple leads, Tagliari said.
Given its short procedure time, she added, the axillary vein approach may allow a faster patient turnover. And the axillary vein itself has several advantages over the cephalic vein, including extrathoracic location, larger caliber, and greater distance from an artery.
Kochi added that with the axillary approach, “you can do a more medial puncture, so the generator of the pacemaker will be more medial.” And that, he said, may be more comfortable for the patient than implantation in the axillary region, especially for a thinner patient when moving the arm.
“You need to have a plan B,” Kochi said. “And it’s very good as a plan B because it’s safe and a very straight-to-the-point technique. It’s not complicated to do.”
The investigators “powered the study for success rather than for complications,” Elena Arbelo, MD, PhD, MSc, Hospital Clinic of Barcelona and University of Barcelona, Spain, said to theheart.org | Medscape Cardiology. It shows that “axillary puncture guided by ultrasound has better success rate than the cephalic,” whereas it is already known that the cephalic approach has a lower success rate than other approaches.
“I would have liked a larger sample size,” she said, in which case the study might have been “able to demonstrate that the complication rate with this technique is at least as safe or as low as the others.” Arbelo, not connected with the current study, also would have preferred a longer follow-up to assess the integrity and function of the leads by access method.
The axillary approach’s higher success rate and shorter procedure time “are intriguing findings. They illustrate how a small step can actually substantially improve these procedures,” Paulus Kirchhof, MD, University Heart and Vascular Center UKE Hamburg, Germany, commented to theheart.org | Medscape Cardiology.
The study was multicenter, but all institutions were in the same region in southern Brazil, he observed. “So we don’t know whether the standard of care was different at different centers. And because the study only randomized 88 patients, there was also a difference in some of the baseline characteristics of the patients.”
Kirchhof, not an author on the analysis, nonetheless praised the investigators for their “well designed” small randomized study, and for the “patience of the investigators” and “the audacity and perseverance actually to test this in a randomized study,” with impressive results.
The observed effect is, “like in many of these small studies, probably a bit of an overestimation of the true effect, but I think it is justified to consider a larger trial and further validation of this.”
Tagliari received research support from the Coordenaçâo de Aperfeiçoamento de Pessoal de Nível Superior –Brasil. Kochi and Arbelo reported no conflicts of interest. Kirchhof discloses support for basic, translational, and clinical research projects from the European Union, the British Heart Foundation, the Leducq Foundation, the Medical Research Council (UK), and the German Centre for Cardiovascular Research, and from several drug and device companies active in atrial fibrillation, from which he has received honoraria in the past but not in the past 3 years. He is listed as inventor on two patents held by the University of Birmingham .
Heart Rhythm. Published online April 29, 2020. Full text
European Heart Rhythm Association Congress 2020. Presented online March 29-31, 2020.