Complications of Transcatheter Paravalvular Leak Closure



Fig. 11.1
TEE view of an elongated blood clot that formed on the transseptal needle





11.3 Complications of the Trans-apical Approach


The left ventricular apex can be used for PVL closure. It can be accessed through a surgical approach, performing a mini-thoracotomy in a hybrid catheterization laboratory, or percutaneously.


11.3.1 Surgical Trans-apical Approach


The majority of reports in the literature regarding a surgical transcatheter approach to structural interventions deal with valve implantations. These require very large sheaths and are not comparable in risk to PVL closure which requires much smaller sheaths and devices. In two series, 17 patients in one and seven in the other, the procedure was uneventful [2, 10], and in a third series, involving 37 patients, there were four cases of hemothorax requiring surgical re-thoracotomy. Procedure-related mortality occurred in one patient within 72 h and in two within 30 days [11].

At Rabin Medical Center, PVL closure through the apex is rarely performed and only through a surgical approach. There was one severe complication as follows:


Case No. 1

A 78-year-old gentleman presents with severe paravalvular mitral leak and advanced heart failure. The left ventricular apex was prepared with a purse-string suture very close to the ventricular septum, so that initial introduction of the sheath and wire was into the right ventricle. The sheath was pulled back and redirected toward the mitral valve ring, but most probably remained very close if not within the septum, so that when crossing the leak with a wire was attempted, a left atrial wall dissection occurred (Fig. 11.2). The procedure was abandoned, and the patient who was extremely sick prior to the procedure remained surprisingly stable for several days, despite the menacing appearance of the huge atrial wall hematoma that seemed to almost obliterate the left atrial chamber. However, he succumbed during a salvage operation.

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Fig. 11.2
Left atrial wall hematoma inside a dissection of the atrial wall caused by the wire while attempting to cross the leak. (a) Appearance at the cath. lab (b) Three days later, despite the appearance of the hematoma as if entirely obliterating the atrium and obstructing the valve, it had no clinical effect


11.3.2 Percutaneous Trans-apical Approach


The percutaneous approach has been used extensively by one group, led by Prof. Ruiz of New York. Complications include hemothorax, pericardial effusion and tamponade, coronary laceration, pneumothorax, cardiac arrhythmia, and death. There is potential for the development of left ventricular apical pseudoaneurysm.

Hemothorax is the most frequent complication. It can be related to coronary or intercostal vessel laceration or bleeding from the left ventricular puncture site. Coronary laceration can potentially be avoided with CT imaging guidance and coronary angiography when obtaining trans-apical access. A chest tube may be required for evacuation of the hematoma if the patient is symptomatic or difficult to ventilate. For cardiac tamponade, pericardial drainage is required with percutaneous drainage generally sufficient. However, emergent left lateral thoracotomy may be required to control access site bleeding, with intramyocardial placement of pledgeted sutures [12].


11.4 Access Site Complications


Access site complications are common to all percutaneous interventions, and the reporting of complications has become standardized by the VARC-2 definitions [13]. Access site complications of PVL closure are rare and usually mild, because most procedures are done transvenously, and arterial sheaths required rarely exceed 8F.


11.5 Wire Complications



11.5.1 Wire Perforation: Left Atrium


Having crossed the interatrial septum, efforts are directed toward crossing the leak. In leaks located directly at the orifice of the left atrial appendage, care should be taken not to introduce the catheter and wire inadvertently into the appendage, risking perforation of this relatively delicate organ. Focusing on the TEE image rather than fluoroscopy is key for preventing such complications.

Similarly, certain fluoroscopic angulations may superimpose structures, so that a wire that seems to cross a leak is actually in a completely different structure.


Case No. 2

An 82-year-old gentleman with severe paravalvular mitral leak had one device placed with what seemed as a significant residual leak. However, it was impossible to introduce a catheter over a second wire that was still across the leak, in order to implant a second device. The wire was removed in order to attempt recrossing the leak elsewhere. The wire could not be advanced properly into what was assumed to be the left ventricle. Also, it was not demonstrated on TEE and was therefore removed (Fig. 11.3a, b). It was decided to end the procedure with partial success.

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Fig. 11.3
(a) Fluoroscopy showing passage of catheter on wire parallel to the original device, assuming the leak was recrossed. (b) The catheter could not be seen on TEE and was withdrawn. The first device was released. (c) Collapse on extubation. Urgent coronary angiography shows air bubbles in coronary circulation. (d) TEE shows accumulation of air in the LV apex. (e) After a short resuscitation, the patient stabilized. On TEE the following day, no air remains, myocardial function restored to baseline, and the residual leak mild

However, when the patient was extubated, he had an immediate collapse, requiring resuscitation including cardiac massage. An urgent coronary arteriography demonstrated air bubbles in the coronary circulation and bypass grafts (Fig. 11.3c), and TEE showed air bubbles in the left atrium and accumulation of air at the LV apex (Fig. 11.3d). Within a few minutes, the patient’s condition stabilized with recovery of blood pressure. A pigtail was introduced into the apex of the LV to evacuate as much of the accumulated air as possible. Recovery was uneventful. On the next day’s echocardiogram, myocardial function was back to previous levels, and the residual leak was milder than expected (Fig. 11.3e).

It is assumed that on trying to recross the valve, the wire was inadvertently introduced into the left lower pulmonary vein and punctured it. Upon extubation and resumption of spontaneous breathing, air was sucked into the pulmonary vein causing this dramatic complication. Luckily, the puncture had sealed off within a few minutes, and normal circulation was restored.

Atrial wall wire perforation can occur when crossing the mitral valve leak retrogradely, entering the left ventricle from the aorta or through the apex. When it is chosen to “reverse sides” by creating a complete arterial venous wire loop, there will be a wire through the leak and a snare catheter through the transseptal puncture. The left atrium which is often dilated may make snaring challenging, and care should be taken when manipulating the wires to avoid perforation. When the retrograde approach for device placement is chosen, there is often a need to exchange for a stiffer wire, again with a risk of perforation of the atrial wall.


11.5.2 Wire Perforation: Left Ventricle


Crossing antegradely through a leak of the mitral valve or retrogradely through a leak of the aortic valve, there is potential for wire perforation of the left ventricular free wall. In order to reduce the risk of perforation, several precautions should be taken. Crossing the leak with a J-tipped hydrophyllic guidewire is preferable to a straight one. When the glidewire is replaced with a stiffer one to enable advancement of the sheath, wire position should be well secured while applying force against resistance of the often rough surface of the leak. Hydrophilic sheaths, e.g., Terumo Destination, enable smoother passage with less force applied on the system. Also, using several smaller devices enables the use of smaller sheaths with less resistance to crossing compared to a single large device. Finally, if the patient with para-mitral leak has a native aortic valve, performing a complete venous-arterial loop or even advancing the wire to the ascending aorta will reduce the risk of free wall myocardial perforation by the wire.


Case No. 3

A 65-year-old gentleman presents with para-aortic leak. The procedure was monitored with intracardiac echocardiography (ICE), and the patient was awake. At the time of advancing the sheath through the leak, over the extra-stiff wire, the patient complained of chest discomfort, and the whole system was immediately withdrawn. There were no ST changes on the monitor, and both on ICE and TTE, no pericardial effusion could be seen. As the symptoms subsided, the procedure was resumed, and a device was placed in the leak. Despite what was seemed a good seal of the leak, aortic regurgitation persisted, in a mechanism that was difficult to delineate. Therefore, several days later, the patient had a gated CT scan. On the CT scan, a wire perforation of the left ventricular apex was apparent, with accumulation of the blood only around the apex. This was treated conservatively and remained stable on a follow-up CT a week later. In patients who had several heart operations, there are multiple adhesions around the heart that may prevent cardiac tamponade from occurring after free wall puncture. It was the coincidence of an awake patient during the procedure, and a CT scan performed for another indication, that revealed this complication, which was initially suspected but then “ruled out” (Fig. 11.4).
Sep 12, 2017 | Posted by in CARDIOLOGY | Comments Off on Complications of Transcatheter Paravalvular Leak Closure

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