Author + information
- Lennart van Gils, MD,
- Peter P.T. De Jaegere, MD, PhD,
- Gary Roubin, MD, PhD and
- Nicolas. M. Van Mieghem, MD, PhD∗ ()
- ↵∗Department of Interventional Cardiology, Thoraxcenter, Erasmus MC, Room Bd 171, ‘s Gravendijkwal 230, Rotterdam 3015 CE, the Netherlands
Catheter-based therapies may offer a less invasive alternative to conventional surgery for a wide array of cardiovascular diseases. These percutaneous interventions often require large-bore catheters, and vascular access management may be challenging. Suture-based closure devices can be used for arteriotomy closure. Transcatheter aortic valve replacement (TAVR) involves such large-bore arteriotomy closure. Despite smaller device profiles and growing experience with TAVR, the reported incidence of vascular complications still varies between 1% and 13% (1–3). Up to two-thirds of major vascular complications after TAVR are due to failed arteriotomy closure (4).
The percutaneous MANTA vascular closure device (VCD) (Essential Medical Inc., Malvern, Pennsylvania) is a novel collagen-based technology dedicated to the closure of large bore arteriotomies. The MANTA VCD contains an 8-F puncture location dilator, a dedicated sheath, a closure unit, and a delivery system. The closure unit consists of a resorbable polymer (poly-lactic-co-glycolic acid) intra-arterial toggle, an extravascular hemostatic bovine collagen pad, a connecting nonresorbable polyester suture, and a stainless steel suture lock, illustrated in Figure 1. This closure unit is attached to the delivery system that contains a carrier/release tube and a device handle with a tension gauge. Both the puncture location dilator and the MANTA sheath have centimeter markers on the respective surfaces. MANTA comes in 14-F and 18-F sizes for closing punctures of 10 to 14 F and 15 to 22 F, respectively. Use of the MANTA VCD precludes a pre-closure technique. After common femoral artery access is obtained with a 6-F sheath, this sheath is exchanged for the 8-F puncture location dilator to determine the distance of the subcutaneous track from skin level to the endoluminal arterial space. The planned cardiovascular intervention is then executed by upscaling the access sheath. Thereafter the procedural sheath is exchanged for the dedicated MANTA sheath to receive the MANTA closure unit. The MANTA sheath-closure unit assembly is withdrawn up to the pre-determined deployment level. The toggle is released and the assembly is withdrawn from the patient. Pulling force can be monitored by the color code of the tension gauge. The blue tamper tube emerges and is advanced along the suture line to secure the stainless steel lock onto the vessel and further compact the collagen pad. The suture is cut above the tamper and at skin level. It takes 6 months for the MANTA components to resorb so that only the polymer suture and stainless steel suture lock remain at the access site.
In our initial MANTA experience in 10 consecutive patients undergoing TAVR (n = 8), balloon aortic valvuloplasty (n = 1), and high-risk percutaneous intervention with a 14-F circulatory support device (n = 1), sheath sizes varied from 14 to 22 F. MANTA access closure was successful in all patients. Hemostasis was obtained within 22 ± 20 s after starting MANTA deployment. A patent artery was angiographically confirmed in all cases. There were neither significant bleeding events nor vascular complications at the access site closed by MANTA.
Our initial experience supports further study to determine if use of the MANTA VCD could reduce access-site complications with large-bore cardiovascular interventions. The CE-mark study (NCT02521948) to evaluate the safety and performance of the MANTA VCD has completed enrollment, and results will be presented in 2016.
Please note: Dr. Van Mieghem has received research grants from Boston Scientific, Medtronic, and Edwards Lifesciences. Prof. Dr. De Jaegere is a proctor for Boston Scientific. Dr. Roubin is chief medical officer of Essential Medical Inc., with equity interest. Dr. van Gils has reported that he has no relationships relevant to the contents of this paper to disclose.
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