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Optimized Axillary Vein Technique versus Subclavian Vein Technique in Cardiovascular Implantable Electronic Device Implantation: A Randomized Controlled Study.

ABSTRACT: The conventional venous access for cardiovascular implantable electronic device (CIED) is the subclavian vein, which is often accompanied by high complication rate. The aim of this study was to assess the efficacy and safety of optimized axillary vein technique.A total of 247 patients undergoing CIED implantation were included and assigned to the axillary vein group or the subclavian vein group randomly. Success rate of puncture and complications in the perioperative period and follow-ups were recorded.The overall success rate (95.7% vs. 96.0%) and one-time success rate (68.4% vs. 66.1%) of punctures were similar between the two groups. In the subclavian vein group, pneumothorax occurred in three patients. The subclavian gaps of three patients were too tight to allow operation of the electrode lead. In contrast, there were no puncture-associated complications in the axillary vein group. In the patient follow-ups, two patients in the subclavian vein group had subclavian crush syndrome and both of them received lead replacement. The incidence of complications during the perioperative period and follow-ups of the axillary vein group and the subclavian vein group was 1.6% (2/125) and 8.2% (10/122), respectively (?2 = 5.813, P = 0.016).Optimized axillary vein technique may be superior to the conventional subclavian vein technique for CIED lead placement.www.clinicaltrials.gov, NCT02358551; https://clinicaltrials.gov/ct2/show/NCT02358551?term=NCT02358551& rank=1.

SUBMITTER: Liu P

PROVIDER: S-EPMC5126153 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Optimized Axillary Vein Technique versus Subclavian Vein Technique in Cardiovascular Implantable Electronic Device Implantation: A Randomized Controlled Study.

Liu Peng P Zhou Yi-Feng YF Yang Peng P Gao Yan-Sha YS Zhao Gui-Ru GR Ren Shi-Yan SY Li Xian-Lun XL

Chinese medical journal 20161101 22

<h4>Background</h4>The conventional venous access for cardiovascular implantable electronic device (CIED) is the subclavian vein, which is often accompanied by high complication rate. The aim of this study was to assess the efficacy and safety of optimized axillary vein technique.<h4>Methods</h4>A total of 247 patients undergoing CIED implantation were included and assigned to the axillary vein group or the subclavian vein group randomly. Success rate of puncture and complications in the periope ...[more]

PMID: 27823994

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Project description:Background and aimsIntra-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.MethodsACCESS 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.ResultsIPUS-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).ConclusionsIPUS-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.

Project description:Key clinical messageVenous spasm is an important reason for complicated or failed implantations of cardiac implantable electronic devices. Prevention or risk reduction of venous spasm during cardiac implantable electronic device implantation may be achieved by ultrasound or fluoroscopic imaging prior to puncture, cephalic vein cut-down, sufficient pre- and perioperative hydration, nitroglycerin injection and effective sedation, and analgesia.AbstractThis case report with literature review focuses on venous spasm as a potential cause for complicated implantations of cardiac implantable electronic devices. The case report is clinically relevant as it describes a progressive spasm affecting the axillary and the subclavian vein. A 66-year-old female complained of symptomatic atrial fibrillation (AF) and atypical atrial flutter despite interventional and medical treatment. As an ultimate treatment, she was scheduled for pacemaker implantation and atrioventricular node ablation. Several puncture attempts of the axillary vein failed. Despite venous blood aspiration, no guidewires could be advanced into the axillary vein. We performed a first venogram revealing significant spasm of the axillary vein. Another failed venous puncture occurred after change of access site to the subclavian vein. A second venogram displayed progression of the spasm, now affecting both the axillary and the subclavian veins. Normal saline perfusion was administered as well as intravenous isosorbide. Unfortunately, a repeated venogram after 15 min waiting time showed persistence of the spasm, still affecting both veins. The procedure was discontinued as the patient became uncomfortable. Venous spasm is an important reason for complicated or failed implantations of cardiac implantable electronic devices. Commonly used medical prevention and treatment are intravenous fluids and nitroglycerin. Prevention or risk reduction of venous spasm during cardiac implantable electronic device implantation may be achieved by ultrasound or fluoroscopic imaging prior to puncture, cephalic vein cut-down, sufficient pre- and perioperative hydration, nitroglycerin injection and effective sedation and analgesia.

Project description:Background Unplanned hospitalizations are common in patients with cardiovascular disease. The "Triage Heart Failure Risk Status" (Triage-HFRS) algorithm in patients with cardiac implantable electronic devices uses data from up to 9 device-derived physiological parameters to stratify patients as low/medium/high risk of 30-day heart failure (HF) hospitalization, but its use to predict all-cause hospitalization has not been explored. We examined the association between Triage-HFRS and risk of all-cause, cardiovascular, or HF hospitalization. Methods and Results A prospective observational study of 435 adults (including patients with and without HF) with a Medtronic Triage-HFRS-enabled cardiac implantable electronic device (cardiac resynchronization therapy device, implantable cardioverter-defibrillator, or pacemaker). Cox proportional hazards models explored association between Triage-HFRS and time to hospitalization; a frailty term at the patient level accounted for repeated measures. A total of 274 of 435 patients (63.0%) transmitted ≥1 high HFRS transmission before or during the study period. The remaining 161 patients never transmitted a high HFRS. A total of 153 (32.9%) patients had ≥1 unplanned hospitalization during the study period, totaling 356 nonelective hospitalizations. A high HFRS conferred a 37.3% sensitivity and an 86.2% specificity for 30-day all-cause hospitalization; and for HF hospitalizations, these numbers were 62.5% and 85.6%, respectively. Compared with a low Triage-HFRS, a high HFRS conferred a 4.2 relative risk of 30-day all-cause hospitalization (8.5% versus 2.0%), a 5.0 relative risk of 30-day cardiovascular hospitalization (3.6% versus 0.7%), and a 7.7 relative risk of 30-day HF hospitalization (2.0% versus 0.3%). Conclusions In patients with cardiac implantable electronic devices, remotely monitored Triage-HFRS data discriminated between patients at high and low risk of all-cause hospitalization (cardiovascular or noncardiovascular) in real time.

Dataset Information

Optimized Axillary Vein Technique versus Subclavian Vein Technique in Cardiovascular Implantable Electronic Device Implantation: A Randomized Controlled Study.

Publications

Optimized Axillary Vein Technique versus Subclavian Vein Technique in Cardiovascular Implantable Electronic Device Implantation: A Randomized Controlled Study.

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