Journal of Invasive Cardiology (JIC)SAFE-SEAL: A Bail-Out Technique for Percutaneous Femoral Closure After Failed Hybrid Closure

⚠️ Small Study / Early Comparative Evidence

Large-bore femoral access remains a critical component of contemporary TAVR practice, and access-site bleeding continues to contribute to procedural morbidity. Hybrid closure strategies that combine suture-based and plug-based devices have gained popularity because they may reduce vascular complications compared with suture-only approaches. However, failure of the plug component after guidewire removal can create a particularly challenging scenario because conventional percutaneous bailout options often require secondary access, covered stent implantation, or surgical intervention. This report describes the first clinical use of the SAFE-SEAL (Suture-Assisted Femoral Emergency SEALing) technique in an 83-year-old patient undergoing transfemoral TAVR.

Clinical Considerations

• The technique was developed for a specific failure mode in which the plug-based component of a hybrid closure strategy fails after loss of guidewire access.
• SAFE-SEAL uses retained ProGlide suture limbs as a delivery rail to advance a bioresorbable extravascular sealant directly to the arteriotomy site.
• Complete angiographically confirmed hemostasis was achieved without additional femoral access, covered stent placement, or surgical repair.
• The reported case involved FemoSeal dislocation during closure in a patient with minimal subcutaneous tissue depth, a recognized risk factor for plug-device failure.
• Potential procedural risk includes inadvertent intravascular migration of the sealant during advancement.
• The technique represents an off-label adaptation of an existing vascular closure device and has only been reported in a single patient.

Practice Applications

• Recognize SAFE-SEAL as a potential rescue strategy for persistent femoral bleeding after hybrid closure failure when guidewire access has already been lost.
• Interpret the findings as proof of feasibility rather than evidence of efficacy, safety, or superiority compared with existing bailout approaches.
• Consider that the technique may be most relevant in structural heart programs performing large-bore transfemoral procedures.
• Avoid routine adoption until additional cases or prospective evaluations establish reproducibility and complication rates.
• Continue to view covered stent implantation, prolonged balloon tamponade, and surgical repair as established bailout options supported by broader clinical experience.