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Ozan Yazar is a vascular and endovascular surgeon with international training acquired in various countries including Belgium, The Netherlands, and Germany. He is currently working at Zuyderland Medical Center in Heerlen, The Netherlands, where he performs a comprehensive range of endovascular and vascular surgeries in aortic and peripheral arteries. He has obtained a doctorate in fenestrated and branched endovascular aneurysm repair (F/BEVAR) for complex aortoiliac aneurysms and organised numerous workshops covering topics such as vascular closure devices (VCDs), BEVAR, and iliac branched devices (IBDs). Here, Yazar speaks to Vascular News about his clinical experience using the Manta VCD (Teleflex) in the treatment of abdominal aortic aneurysms (AAAs) and thoracoabdominal aortic aneurysms (TAAAs), as well as the available data on this device.
Could you please describe your experience dealing with AAAs and TAAAs?
I have had the privilege of working in multiple tertiary centres, which has greatly enriched my expertise in vascular and endovascular surgery. During my training, I gained experience in dealing with complex (T)AAAs. In our centre, we offer a comprehensive range of treatment options for complex aortoiliac aneurysms, including open aneurysm surgery, EVAR, IBD, and F/BEVAR. On average, we have 35 ruptured AAA cases per year. If suitable, a percutaneous EVAR under local anaesthesia will be performed and we use the Manta closure device.
You were an active investigator in the study ‘Clinical outcomes of Manta closure device in percutaneous endovascular aortic aneurysm repair’ recently published in the Journal of Vascular Surgery. Could you please describe the objective, the method, and the results of this study?
The objective of our study was to evaluate the use of the Manta closure device in percutaneous EVAR. We recognised a gap in the literature regarding comprehensive data on the application of the Manta device in EVAR patients. Most of the existing data came from the cardiology field, primarily from experiences in transcatheter aortic valve implantation (TAVI) patients. Given the distinct perspective on vascular issues, we deemed it crucial to investigate this topic within our EVAR population. Therefore, together with Maxim Peeters and our vascular team Lee Bouwman, Pieters Salemans, and ChunYu Wong, we collected data from patients who underwent elective percutaneous EVAR with the Manta device between October 2018 and December 2022. Preoperative computed tomography angiography (CTA) scans were evaluated using an adapted version of the Peripheral Artery Calcium Scoring System (PACSS) to assess arterial calcifications.
Our primary outcome measure was procedural technical success, defined as the placement of the Manta closure device resulting in vascular closure with a patent common femoral artery (CFA), without the need for immediate open or endovascular surgery. In total, we included 152 patients who underwent percutaneous EVAR with 291 CFA closures using the Manta device. Our results demonstrated a high technical success rate of 96.6%. Major vascular complications occurred in 4.5% of cases, with the most identified issue being failure to achieve complete closure of the puncture site. Overall, our findings suggested that the Manta closure device is a safe and feasible option with a high rate of technical success for vascular closure of large-bore arteriotomies in patients undergoing percutaneous EVAR.
Could you please describe when and how Manta should be selected for EVAR and thoracic endovascular aortic repair (TEVAR) procedures?
Patient selection is critical for ensuring favourable outcomes with the Manta closure device in (T)EVAR procedures. Ideal candidates have a normal body mass index (BMI), CFA diameter ≥6mm, minimal calcifications, and normal CFA bifurcation heights. One of the major benefits of the Manta device is that you don’t need to use a ‘preclose technique’. Especially in ruptured AAA cases, this prevents unnecessary time loss.
We advocate that (T)EVAR procedures are well-suited for the Manta device, particularly due to their relatively shorter duration. This contrasts with more complex aortic surgeries, where downsizing of the sheath may be preferred in longer procedures. In our practice, we prioritise a percutaneous-first approach for EVAR. We consistently utilise ultrasound guidance for puncturing the CFA. We base our decision on the preoperative CTA and/or ultrasound. If the CFA shows a diameter of <6mm or severe calcification, we opt for a femoral cut-down approach. However, it’s important to note that patient selection isn’t always straightforward, and the final decision may be influenced by the preference or experience of the surgeon.
How does the learning curve define and impact the clinical outcomes in EVAR?
While we don’t have clear data on the learning curve for the Manta closure device, we do recognise its importance. In our experience, the Manta closure device is easy to learn and shares similarities in other closure mechanisms. Teleflex offers support and certification programmes for Manta, which we highly recommend physicians take advantage of. Certification ensures that surgeons receive proper training and guidance, ultimately contributing to safer and more successful procedures.
By actively engaging in certification programmes and continuous learning, surgeons can enhance their skills, reduce procedural complications, and ultimately improve patient outcomes in (T)EVAR procedures. We organise annual VCD workshops because we recognise the importance of this final step in closing the artery hole for a successful operation and clinical outcome.
INDICATIONS
The 14F MANTA is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F).
CONTRAINDICATIONS
The MANTA device is contraindicated in the following:
• Severe calcification of the access vessel.
• Severe peripheral artery disease.
• Puncture in the origin of the profundal femoral artery, above the inguinal ligament, or above the most inferior border of the epigastric artery (IEA).
• Sheath insertion in vessel other than the femoral artery.
• Marked tortuosity of the femoral or iliac artery.
• Marked obesity or cachexia (BMI >40 or <20).
• Blood pressure >180mmHg.
• Patients who cannot be anti-coagulated for the procedure.
Disclaimers:
• This advertorial is intended for healthcare professionals only, please consult your doctor/healthcare professional regarding the suitability of the device
• This information is provided for clinical education purposes and is not intended to be a substitute for sound clinical judgment or decision making, or professional experience relative to diagnostic and treatment options of a specific patient’s medical condition. Refer to package insert provided with the product for complete warnings, indications, contraindications, precautions, potential complications, and instructions for use.
• Results from case studies are not predictive of results in other cases. Results in other cases may vary. Please see the instructions for use for complete product information.
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