*2.3.3 Puncture point reinforcement*

*Cardiac Diseases - Novel Aspects of Cardiac Risk, Cardiorenal Pathology and Cardiac Interventions*

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**Figure 1.**

*2.3.2 Avoid damage to Enclose membrane*

Most of the damage occurred in the process of aortic wall incision with circular knife and suturing. The aortic wall should be cut perpendicular to the connecting rod as much as possible to avoid cutting the diaphragm. When suturing, the needle should be carefully pressed against the inner wall of the aorta from internal to external, to avoid massive hemorrhage caused by deep penetration of Enclose diaphragm or vertical needle insertion. Slight injury of diaphragm may lead to increased bleeding risk in the operation area. In most cases, operations can be continued under the control of blood pressure and sufficient suction. If the diaphragm's damage is too serious, most of the surgeons will have to use other methods to avoid massive blood loss.

*Enclose device demonstration. (A) Needle puncture; (B) Enclose insertion; (C) Membrane unscrewed; (D)* 

*Upper jaw downward; (E) Circular knife cut; (F) Perforation; (G) Anastomosis.*

Although we use 2–0 polypropylene suture to reinforce the puncture points during the operation for the Enclose cases, there are still a few patients in intensive care unit (ICU) with pericardial drainage fluid increase sharply and in bright red color. This is found to be blood leakage at the puncture point during emergency thoracotomy and hemostasis. The secondary suture for reinforcement with 2–0 polypropylene and felt pad can effectively stop bleeding. The reason for bleeding may be attributable to the inaccurate suture during the process. When the blood pressure is stable without obvious bleeding under anesthesia, the huge postoperative blood pressure fluctuation may increase the arterial pressure and lead to suture avulsion.

### *2.3.4 Mechanical failure*

We have met several cases where the Enclose membrane could not be opened and the equipment was replaced. It is considered to be related to the technology and process in the production process. Therefore, it is necessary to test whether the membrane can open and close smoothly before each aortic implantation.

#### *2.3.5 Aortic wall injury*

Implantation and use of Enclose may also lead to injury, rupture and even aneurysm formation of the aortic wall. It may be due to the insertion of Enclose's lower jaw into the wall of ascending aorta, or due to the damage of aortic intima caused by overcompression, which is easy to form aneurysm when the blood pressure rises. Therefore, it is very important to control blood pressure during the operation and, at the same time, on the premise of no blood environment in the operation area, to loosen the knob as much as possible to reduce the excessive pressure on the aortic wall.

#### *2.3.6 Re-implantation*

It is often the case that the intimal dissection of the internal mammary artery (IMA) has to be replaced by the total vein coronary artery bypass grafting. Thus, Enclose was re-implanted after the injury of the IMA or when the flow of the IMA graft is poor. The distance between the suture and the punch hole should not be

too wide (≤5 cm); otherwise, the hemostasis effect of membrane will be affected. The suction tube of the stabilizer should be connected with the suction device or 50 ml syringe to eliminate possible blood accumulation and keep the operation field clean.
