Ultrasound-Guided Venous Axillary Access Versus Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI Randomized Trial.

BACKGROUND: Axillary vein puncture (AVP) and cephalic vein surgical cutdown are recommended in international guidelines because of their low risk of pneumothorax and chronic lead complications. Directly visualizing and puncturing the axillary vein under ultrasound guidance reduces radiation exposure, provides direct needle visualization, and lowers periprocedural complications. Our hypothesis is that ultrasound-guided axillary access is safer and more feasible than the standard fluoroscopic technique. OBJECTIVES: The purpose of this study was to assess the efficacy and safety of ultrasound-guided axillary venous access during cardiac lead implantation for pacemakers (PMs) and implantable cardioverter-defibrillator (ICD) implantations. METHODS: Patients were randomized in a 1:1 fashion to either axillary venous access under fluoroscopic guidance or ultrasound-guided axillary venous access. The composite outcome, including pneumothorax, hemothorax, inadvertent arterial puncture, pocket hematoma, pocket infection, lead dislodgement, and death, was evaluated 30 days after implantation. RESULTS: We randomized 270 patients into 2 groups: the standard group for fluoroguided AVP (n = 134) and the experimental group for ultrasound-guided AVP (n = 136). No disparities in baseline characteristics were observed between the groups. The median age of the patients was 81 years, with women comprising 41% of the population. The majority of patients received single- and dual-chamber PMs (87% vs 88%; P = 1.00), and slightly over 10% in both groups received ICDs (13% vs 12%; P = 0.85). In total, we placed 357 leads in PMs and 48 leads in ICDs. Among these, 295 leads were inserted via axillary vein access and 110 via cephalic vein access. Notably, the subclavian vein was never used as a vascular access. The composite outcome was lower in the ultrasound group according to intention-to-treat analysis (OR: 0.55; 95% CI: 0.31-0.99; P = 0.034). The main difference within the composite outcome was the lower incidence of inadvertent axillary arterial puncture in the experimental group (17% vs 6%; P = 0.004). The ultrasound group also exhibited lower total procedural x-ray exposure (10,344 µGy × cm2 vs 7,119 µGy × cm2; P = 0.002) while achieving the same rate of success at the first attempt (61% vs 69%; P = 0.375). CONCLUSIONS: Ultrasound-guided AVP is safer than the fluoroscopy-guided approach because it achieves the same rate of acute success while maintaining low total procedural radiation exposure. Ultrasound AVP should be considered the optimal venous access method for cardiac lead implantation. (Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation [ZEROFLUOROAXI]; NCT05101720).

Prevención quirúrgica del linfedema del miembro superior relacionado con la cirugía axilar en el cáncer de mama / Surgical prevention of upper limb lymphoedema related to axillary surgery in breast cancer

El linfedema (LE) es una de las secuelas más graves e incapacitantes secundarias al tratamiento en el cáncer de mama debido a las limitaciones funcionales, implicaciones estéticas y riesgo de infección que conlleva. Se estima que entre el 29 y 39% de las pacientes que se sujetan a una linfadenectomía axilar desarrollan LE, frente a entre 5 y 7% de los que casos que se realiza una biopsia selectiva de ganglio centinela. Para intentar reducir su incidencia, se ha desarrollado el mapeo axilar inverso. El objetivo de esta técnica es diferenciar las distintas vías de drenaje linfático axilar y del brazo mediante la inyección de un colorante azul en el brazo ipsilateral, para poder respetar los linfáticos que drenan la extremidad superior durante la disección linfática axilar. Otra posibilidad es usar verde de indocianina y así combinar el procedimiento de mapeo axilar inverso con el trazador dual estándar en la biopsia selectiva de ganglio centinela. Gracias a la microcirugía se han desarrollado técnicas como la anastomosis linfático-venosa para la prevención secundaria de LE, de manera que los linfáticos aferentes del brazo se pueden redirigir a ramas colaterales de la vena axilar para restaurar el flujo linfático fisiológico. Este procedimiento es más eficaz en las etapas precoces de LE. En los últimos años se está llevando a cabo la técnica LYMPHA, que consiste en anastomosar los vasos linfáticos del brazo a una rama colateral de la vena axilar en el momento de la disección ganglionar. Esta se ha demostrado útil en la prevención primaria de LE y en la reducción de complicaciones tempranas. (AU)

Lymphoedema (LE) is one of the most serious and disabling sequelae secondary to breast cancer treatment due to the functional limitations, cosmetic implications and risk of infection it entails. Twenty-nine to thirty-nine per cent of patients who undergo axillary lymphadenectomy (AL) are estimated to develop LE, compared to 5-7% in those who undergo selective sentinel lymph node biopsy (SLNB). In an attempt to reduce its incidence, Reverse Axillary Mapping (ARM) has been developed. The aim of this technique is to differentiate the different axillary and arm lymphatic drainage pathways by injecting a blue dye into the ipsilateral arm, in order to respect the lymphatics draining the upper extremity during axillary lymphatic dissection. Another possibility is to use indocyanine green and thus combine the ARM procedure with the standard dual tracer in SLNB. Thanks to microsurgery, techniques such as lymphatic-venous anastomosis (LVA) have been developed for secondary prevention of lymphoedema, so that afferent lymphatics in the arm can be redirected to collateral branches of the axillary vein to restore physiological lymphatic flow. In recent years, the LYMPHA technique, which involves anastomosing the lymphatic vessels of the arm to a collateral branch of the axillary vein at the time of lymph node dissection, has been implemented. This has been shown to be useful in the primary prevention of LE and in the reduction of early complications. (AU)

Intra-pocket ultrasound-guided axillary vein puncture vs. cephalic vein cutdown for cardiac electronic device implantation: the ACCESS trial.

BACKGROUND AND AIMS: Intra-pocket ultrasound-guided axillary vein puncture (IPUS-AVP) for venous access in implantation of transvenous cardiac implantable electronic devices (CIED) is uncommon due to the lack of clinical evidence supporting this technique. This study investigated the efficacy and early complications of IPUS-AVP compared to the standard method using cephalic vein cutdown (CVC) for CIED implantation. METHODS: ACCESS was an investigator-led, interventional, randomized (1:1 ratio), monocentric, controlled superiority trial. A total of 200 patients undergoing CIED implantation were randomized to IPUS-AVP (n = 101) or CVC (n = 99) as a first assigned route. The primary endpoint was the success rate of insertion of all leads using the first assigned venous access technique. The secondary endpoints were time to venous access, total procedure duration, fluoroscopy time, X-ray exposure, and complications. Complications were monitored during a follow-up period of three months after procedure. RESULTS: IPUS-AVP was significantly superior to CVC for the primary endpoint with 100 (99.0%) vs. 86 (86.9%) procedural successes (P = .001). Cephalic vein cutdown followed by subclavian vein puncture was successful in a total of 95 (96.0%) patients, P = .21 vs. IPUS-AVP. All secondary endpoints were also significantly improved in the IPUS-AVP group with reduction in time to venous access [3.4 vs. 10.6 min, geometric mean ratio (GMR) 0.32 (95% confidence interval, CI, 0.28-0.36), P < .001], total procedure duration [33.8 vs. 46.9 min, GMR 0.72 (95% CI 0.67-0.78), P < .001], fluoroscopy time [2.4 vs. 3.3 min, GMR 0.74 (95% CI 0.63-0.86), P < .001], and X-ray exposure [1083 vs. 1423 mGy.cm², GMR 0.76 (95% CI 0.62-0.93), P = .009]. There was no significant difference in complication rates between groups (P = .68). CONCLUSIONS: IPUS-AVP is superior to CVC in terms of success rate, time to venous access, procedure duration, and radiation exposure. Complication rates were similar between the two groups. Intra-pocket ultrasound-guided axillary vein puncture should be a recommended venous access technique for CIED implantation.

Axillary vein puncture versus cephalic vein cutdown for cardiac implantable electronic device implantation: A meta-analysis.

INTRODUCTION: Cephalic vein cutdown (CVC) and axillary vein puncture (AVP) are both recommended for transvenous implantation of leads for cardiac implantable electronic devices (CIEDs). Nonetheless, it is still debated which of the two techniques has a better safety and efficacy profile. METHODS: We systematically searched Medline, Embase, and Cochrane electronic databases up to September 5, 2022, for studies that evaluated the efficacy and safety of AVP and CVC reporting at least one clinical outcome of interest. The primary endpoints were acute procedural success and overall complications. The effect size was estimated using a random-effect model as risk ratio (RR) and relative 95% confidence interval (CI). RESULTS: Overall, seven studies were included, which enrolled 1771 and 3067 transvenous leads (65.6% [n = 1162] males, average age 73.4 ± 14.3 years). Compared to CVC, AVP showed a significant increase in the primary endpoint (95.7 % vs. 76.1 %; RR: 1.24; 95% CI: 1.09-1.40; p = .001) (Figure 1). Total procedural time (mean difference [MD]: -8.25 min; 95% CI: -10.23 to -6.27; p < .0001; I2  = 0%) and venous access time (MD: -6.24 min; 95% CI: -7.01 to -5.47; p < .0001; I2  = 0%) were significantly shorter with AVP compared to CVC. No differences were found between AVP and CVC for incidence overall complications (RR: 0.56; 95% CI: 0.28-1.10; p = .09), pneumothorax (RR: 0.72; 95% CI: 0.13-4.0; p = .71), lead failure (RR: 0.58; 95% CI: 0.23-1.48; p = .26), pocket hematoma/bleeding (RR: 0.58; 95% CI: 0.15-2.23; p = .43), device infection (RR: 0.95; 95% CI: 0.14-6.60; p = .96) and fluoroscopy time (MD: -0.24 min; 95% CI: -0.75 to 0.28; p = .36). CONCLUSION: Our meta-analysis suggests that AVP may improve procedural success and reduce total procedural time and venous access time compared to CVC.

Site of left axillary vein crossing the clavicle: an analysis with computed tomography venography as a guide for vein puncture for device implantation.

BACKGROUND: Blind axillary venous access is a convenient but technically difficult approach for cardiac rhythm device lead implantation. We try to explore whether there are rules on the axillary vein course to facilitate blind venous cannulation. METHODS: In a single-center, retrospective study, we included 155 patients who underwent computed tomography venography (CTV) examination of left axillary vein. All scans were reviewed for the relationship between left axillary vein and clavicle, vein steepness, and depth. Factors probably affecting above indicators were analyzed. RESULTS: The location of left axillary vein crossing the clavicle was mainly concentrated around the medial 1/3 of clavicle, with mean crossing location of the medial 1/3 of clavicle, which was not correlated with sex, age, abdominal subcutaneous fat thickness, upper thoracic kyphosis angle, or the angle between clavicle and anterior midline (P < 0.05). The average angle between axillary vein and horizontal line was 31.57 ± 11.72°, which was positively associated with age, whereas inversely associated with the angle between clavicle and anterior midline (P < 0.05). The proximal axillary vein ran more and more shallow until becoming the subclavian vein (P < 0.01); and it had a mean depth of 3 cm, which was significantly associated with abdominal subcutaneous fat thickness (P < 0.05). CONCLUSIONS: The left axillary vein and clavicle had a relatively fixed relationship that axillary vein commonly crossed the medial 1/3 of clavicle. The average angle between axillary vein and horizontal line was 31.57 ± 11.72°, associated with age and the clavicle course. The mean depth of proximal axillary vein was 3 cm, and patients with larger weight had a deeper position of axillary vein.

A simple method of axillary venipuncture using single landmark for pacemaker leads implantation.

BACKGROUND: Axillary venipuncture for pacemaker lead implantation has been demonstrated to be an effective method without fatal complications encountered with standard subclavian access approach, but the relatively high complexity limits its clinical practicability. OBJECTIVE: We are proposing a simple technique for axillary venipuncture using single point on clavicle as anatomical landmark with the possibility of alternative fluoroscopic assisted puncture as a backup. METHODS: Connecting point of medial to middle third of clavicle is located as the landmark. Deflected lateral 45°from sagittal line, an 18-guage needle tip is laid on the point and tangential to upper border of clavicle. Penetrated from the hub site, the needle is directed to the landmark at approximately 30-45° relative to body surface for venipuncture. If blind puncture failed, an alternative fluoroscopic method is performed. Upon successful venipuncture, a guide wire is positioned in inferior vena cava and a skin incision and subcutaneous pocket is made at the puncture site. RESULTS: Axillary vein puncture was successful for 106 of 113 patients (93.8%) in the study with mean access time of 3.6 ± 1.4 min. In 84 patients (74.3%), the vein was cannulated by blind puncture, and fluoroscopy guided method was required in other 22 patients (19.5%). The puncture of axillary artery occurred in one patient (0.09%) and no haemorrhage was observed after local pressure. No pneumothorax, hemothorax, or brachial plexus injury was found. CONCLUSIONS: The approach of axillary vein puncture using single landmark on the clavicle is simple, effective and safe for pacemaker lead implantation.

Ultrasound-guided access to the axillary vein for implantation of cardiac implantable electronic devices: A systematic review and meta-analysis.

The aims of our systematic review were to quantify the expected rate of procedural success, early and late complications during CIED implantation using US-guided puncture of the axillary vein and to perform a meta-analysis of those studies that compared the US technique (intervention) versus conventional techniques (control) in terms of complication rates. MEDLINE, ISI Web of Science, and EMBASE were searched for eligible studies. Pooled Odds Ratio (OR) and Pooled Mean Difference (PMD) for each predictor were calculated. The quality of evidence (QOE) was evaluated according to the GRADE guidelines. Thirteen studies were included a total of 2073 patients. The overall success of US-guided venipuncture for CIED implantation was 96.8%. As regards early complications, pneumothorax occurred in 0.19%, arterial puncture in 0.63%, and severe hematoma/bleeding requiring intervention in 1.1%. No cases of hemothorax, brachial plexus, or phrenic nerve injury were reported. As regards late complications, the incidence of pocket infection, venous thromboembolism, and leads dislodgement was respectively 0.4%, 0.8%, and 1.2%. In the meta-analysis (five studies), the intervention group (US-guided venipuncture) had a trend versus a lower likelihood of having a pneumothorax (0.19% vs 0.75%, p = 0.21), pocket hematoma (0.8% vs 1.7%, p = 0.32), infection (0.28% vs 1.05%, p = 0.29) than the control group, but this did not reach statistical significance. The overall QOE was low or very low. In conclusions we found that the US-guided axillary venipuncture for CIEDs implantation was associated with a low incidence of early and late complications and a steep learning curve.

A surgical method to be reminded for the treatment of symptomatic ipsilateral central venous occlusions in patients with hemodialysis access: Axillo-axillary venous bypass case report and review of the literature.

BACKGROUND: In this case report, we present two chronic hemodialysis patients with upper extremity swelling due to central venous occlusions together with their clinical presentation, surgical management and brief review of the literature. METHODS: The first patient who was a 63-year-old female patient with a history of multiple bilateral arteriovenous fistulas (AVFs) was referred to our clinic. Physical examination demonstrated a functioning right brachio-cephalic AVF, with severe edema of the right arm, dilated venous collaterals, facial edema, and unilateral breast enlargement. In her history, multiple ipsilateral subclavian venous catheterizations were present for sustaining temporary hemodialysis access. The second patient was a 47-year-old male with a history of failed renal transplant, CABG surgery, multiple AV fistula procedures from both extremities, leg amputation caused by peripheral arterial disease, and decreased myocardial functions. He was receiving 3/7 hemodialysis and admitted to our clinic with right arm edema, accompanied by pain, stiffness, and skin hyperpigmentation symptoms ipsilateral to a functioning brachio-basilic AVF. He was not able to flex his arms, elbow, or wrist due to severe edema. RESULTS: Venography revealed right subclavian vein stenosis with patent contralateral central veins in the first patient. She underwent percutaneous transluminal angioplasty (PTA) twice with subsequent re-occlusions. After failed attempts of PTA, the patient was scheduled for axillo-axillary venous bypass in order to preserve the AV access function. In second patient, venography revealed right subclavian vein occlusion caused secondary to the subclavian venous catheters. Previous attempts for percutaneously crossing the chronic subclavian lesion failed multiple times by different centers. Hence, the patient was scheduled for axillo-axillary venous bypass surgery. CONCLUSION: In case of chronic venous occlusions, endovascular procedures may be ineffective. Since preserving the vascular access function is crucial in this particular patient population, venous bypass procedures should be kept in mind as an alternative for central venous reconstruction, before deciding on ligation and relocation of the AVF.

Treatment for cephalic arch stenosis with cephalic vein to external jugular vein bridging graft.

AIM: Percutaneous transluminal angioplasty or cephalic vein transposition to the axillary vein is mainly used for treatment of cephalic arch stenosis, a common complication of brachiocephalic fistulas. However, the results of such interventions have been disappointing. METHODS: We used a polytetrafluoroethylene prosthesis with a 6 mm diameter to bridge the cephalic vein and the ipsilateral external jugular vein, and successfully created a new drainage outlet and established immediate restoration of flow through brachiocephalic fistulas. RESULTS: This surgery allowed the cephalic venous arch and subclavian vein, which are vulnerable to stenosis, to be bypassed altogether and the puncture segment could be elongated by about 20 cm. CONCLUSION: It is a safe and effective alternative to traditional methods of treatment for cephalic arche stenosis.

UltraSound Axillary Vein Access (USAA): Learning curve and randomized comparison to traditional venous access for cardiac device implantation.

BACKGROUND: Many techniques exist for venous access (VA) during cardiac implantable electronic device (CIED) implantation. OBJECTIVE: We sought to evaluate the learning curve with ultrasound (US) guided axillary vein access (USAA). METHODS: Single-center prospective randomized controlled trial of patients undergoing CIED implantation. Patients were randomized in a 2:1 fashion to USAA versus conventional VA techniques. The primary outcomes were the success rates, VA times and 30-day complication rates. RESULTS: The study included 100 patients (age 68 ± 14 years, BMI 27 ± 4 kg/m2 ). USAA was successful in 66/70 implants (94%). Initial attempts at conventional VA included 47% axillary (n = 14), 30% (n = 9) cephalic, and 23% (n = 7) subclavian. The median access time was longer for USAA than conventional access (8.3 IQR 4.2-15.3 min vs. 5.2 IQR 3.4-8.6 min, p = .009). Among the five inexperienced USAA implanters, there was a significant improvement in median access time from first to last tertile of USAA implants (17.0 IQR 7.0-21.0 min to 8.6 IQR 4.5-10.8 min, p = .038). The experienced USAA implanter had similar access times with USAA compared with conventional access (4.0 IQR 3.3-4.7 min vs. 5.2 IQR 3.4-8.6 min, p = .15). Venograms were less common with USAA than conventional access (2% vs. 33%, p < .0001). The 30-day complication rate was similar with USAA (n = 4/70, 6%) versus conventional (n = 3/30, 10%, p = .44). CONCLUSION: Although the success rate with USAA was high, there was a significant learning curve. Once experienced with the USAA technique, there is the potential for reduced complications without adding to the procedure duration.

Conversion of Arterio-Venous Access of Hemodialysis to Arterio-Arterial Access for Treatment of Venous hypertension with Central Venous Occlusion.

This report describes conversion of arterio-venous graft or fistula to arterio-arterial vascular access as a new surgical treatment option for central venous occlusion. It starts with control of the axillary vein and the synthetic graft or superficialized vein proximally, the suture line of venous anastomosis is closed and end-to-side anastomosis of the synthetic graft or vein to the brachial artery (BA) is done, then ligation of the BA distal to the anastomosis is done. Now the blood flow is directed through synthetic graft or vein from proximal to distal BA that can be used as arterio-arterial vascular access for hemodialysis.

Distal superficial femoral vein versus axillary vein central catheter placement under ultrasound guidance for neonates with difficult access: A randomized clinical trial.

BACKGROUND: Epicutaneo-caval catheters (ECCs) are extensively used in premature and ill neonates. This prospective, randomized, observational study aimed to compare the outcomes of ECC placement in the distal superficial femoral and axillary veins in neonates with difficult ECC access. METHODS: In a neonatal intensive care unit at a tertiary referral center, 60 neonates with difficult ECC access were randomized into two groups with catheters placed using the ultrasound-guided modified dynamic needle tip positioning (MDNTP) technique: distal superficial femoral vein (DSFV) and axillary vein (AV) groups. RESULTS: The first attempt success rate was significantly higher in the DSFV group than in the AV group [23/30 (76.7%) vs 11/30 (36.7%), p = 0.001; odds ratio (OR), 0.176; 95% confidence interval (CI) 0.057-0.543]. The mean procedural duration was significantly shorter in the DSFV group than in the AV group [mean: 308.5 (standard deviation: 81.1) s vs 522.74 (134.8) s, t = -7.17, p < 0.001]. The incidence of complications was significantly lower in the DSFV group than in the AV group [4/30 (13.3%) vs 12/30 (40.0%), p = 0.019; OR, 4.333; 95% CI 1.203-15.604]. The number of attempts was significantly fewer in the DSFV group than in the AV group (p = 0.012). CONCLUSIONS: The distal superficial femoral and axillary veins are two alternative and safe access points for ECC placement in premature neonates (weight < 2.5 kg) with difficult access. However, access through the distal superficial femoral vein was quicker, easier, and had fewer complications than through the axillary vein.

Late Basilic Vein Superficialization Combined with Revision Using Distal Inflow (RUDI) Operation to Treat a Symptomatic High Flow Fistula.

BACKGROUND: Vascular access (VA)-related high flows (HF) are common with brachial artery based fistulas. Flow-reduction procedures are indicated in symptomatic patients or asymptomatic ones with flows >2 L/min. However concomitant issues increase their complexity. We describe a case of a patient suffering congestive heart failure as a result of HF brachial-basilic fistula >3 L/min. A simultaneous late basilic vein transposition and revision using distal inflow (RUDI) was performed. METHODS: A large diameter untransposed arterialized basilic vein was carefully and completely mobilized up to the proximal upper arm. After harvesting an autologous great saphenous vein (GSV) segment, a new inflow anastomosis was performed in the proximal ulnar artery. At the final stage, and after tunneling the mobilizing basilic vein in a subcutaneous semicircular configuration, an end-to-end anastomosis joining the two stumps (basilic vein outflow portion and GSV inflow arterial portion) was performed. A decision-making process in order to reach this complex option is discussed. Results Access flow and cardiac output were greatly attenuated following our approach. After a mean follow-up of 9 months no VA complications were observed, with flow still detected below 2 L/min. All cardiac symptoms and ultrasound investigations improved. CONCLUSION: Multiple VA issues including HF pose a risk for abandonment and a challenge for the vascular surgeon. An effort toward increasing the "upper extremity life span" is advised.

Axillary vein access for antiarrhythmic cardiac device implantation: a literature review.

The current narrative review provides an update of available knowledge on venous access techniques for cardiac implantable electronic device implantation, with a focus on axillary vein puncture. Lower procedure-related and lead-related complications have been reported with extrathoracic vein puncture techniques compared with intrathoracic accesses. In particular, extrathoracic lead access through the axillary vein seems to be associated with lower complication incidence than subclavian vein puncture and higher success rate than cephalic vein cutdown. In literature, many techniques have been described for axillary vein access. The use of contrast venography-guided puncture has facilitated the diffusion of the axillary vein approach for device implantation. Venography may be particularly useful in specific demographic and clinical device implantation contexts. Ultrasound-guided or microwire-guided vascular access for lead positioning can be considered a valid alternative to venography, although current applications for axillary vein puncture need further evaluations.