Percutaneous Closure Systems Are Safe in TAVR and Aneurysms

Courtesy of Dr. Carlos Fava.

Currently, one of our medical challenges is to conduct procedures requiring access with large introducer sheaths in a simpler way, without requiring surgical intervention and closing with percutaneous devices while maintaining procedural quality and safety. There are several devices, but they require a learning curve and the only information available comes from small, non-randomized studies.

This study included 221 patients who underwent transcatheter aortic valve replacement (TAVR) and 33 who underwent endoprosthetic thoraco-abdominal aortic aneurysm repair. The percutaneous closure system used was Perclose ProGlide® Suture-Mediated Closure System (Abbott Vascular), which was placed before the procedure so as to conduct a vascular access-site closure after it. Additionally, Glubran 2 was injected after closure for hemostatic control. Moreover, a 0.018” guidewire and a peripheral angioplasty balloon were used through the contralateral access, for hemostasis.

The mean age was 82 years; over half the patients were female, 32% had diabetes, and 23.2% had had a prior infarction. The EuroSCORE score was 20.2 ± 2.32. About 78% of the patients had an estimated glomerular filtration rate (e-GFR) <60 mL/min and 3.6% underwent dialysis.

Read also: Amplatzer and Figulla Devices Prove to Be Safe for Percutaneous Patent Foramen Ovale Closure.

The overall success rate of the Perclose ProGlide® plus Glubran 2 access-site closure technique was 98.4%. Four patients (1.6%) required balloon dilation of the closure site after the suture due to the presence of severe stenosis; the strategy was successful.

Four patients (1.6%) had minor VARC-2 bleeding events. No patients experienced major VARC-2 bleeding events and no patients required surgery for access-site closure. The time of manual compression was 3.5 ± 1.5 minutes and the total procedure time was 89.35 ± 29.34 minutes.

Read also: Contemporary Results for Septal Embolization in Hypertrophic Cardiomyopathy.

At 30 days, the non-cardiac mortality rate was 0.4% and no patient experienced VARC-2 bleeding.

Conclusion

The results of this study suggest that the ProGlide/Glubran technique is a safe and effective method for the closure of transfemoral access-sites after TAVR and thoraco-abdominal aneurysm repair. However, those results need to be confirmed in randomized controlled trials before being adopted in routine clinical practice.

Courtesy of Dr. Carlos Fava.

Original title: A new Percutaneous technique for effective vascular Access Site closure in patients undergoing Transfemoral aortic valve implantation and thoraco-abdominal aortic aneurysm rEpair: The PASTE Study.

Reference: Giovanni Sorropago et al. EuroIntervention 2018;14: e1278-e1285.

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