Percutaneous extraction of cardiac device leads is a complex procedure associated with a non-negligible risk of morbidity and mortality.1–3 Nonetheless, there is considerable variability in its management. Key aspects, such as the setting of the procedure, the team responsible, and safety measures, lack widespread consensus.

To improve the safety of these procedures, the Bridge Occlusion Balloon (BOB)—an endovascular device designed to occlude the superior vena cava—has been developed by Philips (Philips Healthcare, The Netherlands). However, clear guidelines for its use are still lacking.

With the aim of creating a protocol focused on safety in this context, a multidisciplinary team of specialists was convened, including cardiologists, cardiac surgeons, and international experts. This report summarizes their main conclusions and proposes a management algorithm based on the estimated procedural risk.

Lead extraction is an integrated process that involves clinical evaluation, antibiotic therapy, surgical indication, and postoperative follow-up. To ensure proper management, formation of a multidisciplinary team is recommended, similar to the Heart Team model. This collaborative group should include cardiologists, cardiac surgeons, electrophysiologists, and specialists in infectious diseases, cardiac imaging, and anesthesiology.

The preprocedural protocol should take into account all relevant imaging studies, particularly computed tomography, to assess lead trajectory, identify anatomical anomalies, and evaluate the presence of adhesions or calcifications. The reimplantation strategy should also be defined at this stage. A contingency plan to address potential complications should then be established. All members of the team should be informed of the procedure's schedule and location. The procedure room must be fully equipped with all necessary resources to manage any complications that may arise. If the surgical team is not present at the start, their location and immediate availability must be ensured.

Prophylactic preparation, with insertion of introducers to provide access to the femoral vessels, should be considered in most procedures. This approach enables fluid administration, temporary pacemaker placement, the use of extraction tools, and allows for rapid cannulation to initiate extracorporeal circulation, if needed.

The BOB significantly reduces bleeding in cases of superior vena cava (SVC) laceration by providing a 30-minute window to stabilize the patient and plan surgical management.4 It can be deployed in under 2minutes if a 12 Fr femoral venous introducer has been placed beforehand, or immediately if its prophylactic use has been planned and it is advanced over a prepositioned guidewire in the SVC. Balloon inflation is recommended at the first signs of pericardial effusion or hemodynamic instability.

Although the overall incidence of SVC rupture is low (around 0.5%), it is associated with a mortality rate of up to 43%. Recent observational data suggest that BOB use may reduce this rate to 11.8%, although this evidence is not derived from randomized trials.4

The proposed algorithm (figure 1) classifies patients into 3 risk levels—low, moderate, and high—using validated scoring systems such as EROS5 and SAFeTY.6

Figure 1.

Safety strategy for lead extraction based on risk level. * Validated tools such as EROS5 or SAFeTY6 are recommended for this evaluation.

(0.4MB).

Patients classified as EROS 1 or low SAFeTY are considered at low risk, EROS 2 or intermediate SAFeTY at moderate risk, and EROS 3 or high/very high SAFeTY at high risk.

Five safety levels are proposed based on patient risk: 1. balloon use is not required; 2. prophylactic placement of a 12 Fr femoral introducer; 3. prophylactic placement of a femoral venous introducer and a stiff guidewire in the SVC (balloon available in the room); 4. BOB prepositioned for immediate deployment (deflated balloon in the inferior vena cava over the stiff guidewire); and 5. prepositioned BOB, with arterial and venous introducers placed in the contralateral femoral vessels.

In low-risk patients, the use of a balloon or introducers is generally not required, unless the leads have been implanted for more than 2 years or a temporary pacemaker is needed. In such cases, a venous introducer is recommended from the outset.

In moderate-risk patients without prior sternotomy, if the surgical team is not present from the start of the procedure, level 4 preparation is recommended. Prepositioning of the balloon allows for immediate inflation in the event of vessel rupture, facilitating hemodynamic stabilization while awaiting the arrival of the surgical team. Deployment can be achieved in as little as 14seconds, compared to 2minutes if the balloon is not prepositioned, a critical difference in the context of massive bleeding. If the surgical team is present, level 3 preparation can be used. In patients with prior sternotomy or pericarditis, Level 5 is recommended. This enables femoral cannulation and initiation of extracorporeal circulation before performing the sternotomy, thus avoiding delays caused by mediastinal adhesions, which can complicate conventional central cannulation.

High-risk patients include those with an EROS score of 3, whose rate of major complications can reach up to 5%. The risk in this group should not be underestimated. In patients with a history of sternotomy, it is recommended to maintain level 5. In the absence of prior cardiac surgery, it is advisable to position the balloon over the guidewire to allow for immediate inflation in case of vessel rupture, and proceed with medial sternotomy and central cannulation, avoiding the femoral route.