A study looking at patients undergoing lead extraction found that they were more likely to survive superior vena cava tears when treatment included the Bridge occlusion balloon. Lead author, Roger Carrillo (University of Miami, Miami, USA) concluded that when used properly the novel device has the potential to save lives.
The aim of the study, carried out from July 2016 to December 2017, was to assess the impact of the compliant endovascular balloon on the management of superior vena cava tears and survival outcomes after more than one year in clinical practise. Each year in the USA there are between 15,000 and 20,000 lead extraction procedures, with 0.46% leading to superior vena cava tears.
The mandatory Manufacturer and User Facility Device Experience (MAUDE) database was used to collect data and additional demographic information was provided by the device manufacture and from telephone interviews with the extracting physician.
The data was then divided into three groups: Balloon cohort, not used/used improperly and non-superior vena cava events. To be included in the balloon cohort and balloon not used/used improperly cohort the superior vena cava tear needed to be surgically confirmed by sternotomy and the tear needed to occur between the innominate vein and right atrium. Patients were excluded if the superior vena cava tear was unconfirmed, the tear that occurred was not a superior vena cava tear (e.g. right atrium, right ventricle, innominate vein, subclavian vein, etc) or if surgical repair was not attempted.
During the study period there were 91 confirmed superior vena cava events. In 36 cases an endovascular balloon was used and there were 55 cases where no balloon was used. When an endovascular balloon was used 91.7% of patients survived but when the balloon was not used the survival rate was only 56.4%. The difference was statistically significant (p=0.0003). There was very little difference between the make-up of the groups, the age, indication for extraction and extraction tools were the same.
The balloon-use cohort was defined as having a stiff guidewire prepositioned from the right femoral vein to either the right internal jugular or right subclavian vein prior to extraction and the wire remained within the vein during deployment. The non-balloon cohort did not use the balloon, or the stiff guidewire was not in the vein during balloon deployment.
The superior vena cava tears occurred in a patient population identified as having a higher risk of complications during lead extraction, including female patients (53.4%), as well as patients with implantable cardiac devices (ICDs;51.7%) and older leads (>10 years).
The death rate due to superior vena cava injuries without balloon usage during the study period was consistent with existing finding, at around 44% but balloon use significantly increased the likelihood of survival to 91.7% (p=0.0003).
“During the procedure,” Carrillo commented, “We learnt that the wire must remain in the vein during the balloon deployment. We also learnt that we had to secure the introducer sheath into the femoral vein and over stiff guidewire prior to lead extraction and that balloon use does not substitute surgical repair.”
The study suggests that continued surveillance is needed to further assess the impact of the endovascular balloon and that future research should look at identifying risk factors for superior vena cava tears. The study was limited because of the small sample size due to the rare occurrence of major complications during lead extraction.
Carillo concluded that, “A simple change in workflow and a well-rehearsed team can make a difference in patient safety.”
The study led to a summary of seven recommendations for best practise:
1) Guidewire: All patients should have a stiff 0.035” guidewire deployed from either femoral vein through the superior vena cava, preferably to the right internal jugular of subclavian vein prior to every lead extraction procedure
2) Introducer sheath: All patients should have either a 6F peel away or 12F femoral vein introducer sheath inserted for introduction of the stiff 0.035” guidewire prior to every lead extraction procedure
3) Immediate deployment: The occlusion balloon and prefilled inflation syringe must be ready for deployment, without delay, as soon as a superior vena cava tear is suspected
4) Tamponade and haemothorax: The occlusion balloon should be immediately deployed when there is evidence of either cardiac tamponade or haemothorax. Intrapericardial superior vena cava tears may also cause cardiac tamponade.
5) Familiarity: All team member that are part of extraction cases should be familiar with the occlusion balloon and the deployment
6) Competence: Extracting physicians should become competent and comfortable in deployment and inflation of the occlusion balloon in nonemergent settings
7) Prophylaxis: prophylactic placement of the occlusion balloon may be considered for reasons including, but no limited to, procedures and patients deemed high risk, new physician practising lead extraction, low volume operators and intraprocedural increase in the perceived risk
These recommendations were published in Heart Rhythm. Heart Rhythm. 2017 Oct;14(10):1574-1578.