Transcatheter Management of TAVI-Associated Paravalvular Leak



Fig. 10.1
Balloon post-dilation: under expanded Medtronic CoreValve after deployment with severe paravalvular leak (a), excellent results post-dilatation (b)



Complications of balloon post-dilation include device migration/displacement, aortic wall injury/rupture, cerebrovascular events, and injury to the conduction system. Cerebrovascular events are an area of intense research as they can offset the hemodynamic benefits of post-dilation [28]. Initial reports by Nombela-Franco and coworkers reported post-dilation as a risk factor for acute (<24 h) cerebrovascular events (OR, 2.46; 95% CI, 1.07–5.67) [29]. Data from Italy on ~1300 balloon-expandable and self-expandable TAVIs reported balloon post-dilation in 19.8% (63% success rate) and no association with all-cause and cardiovascular mortality and cerebrovascular events at 1 year [30]. In a recent analysis of the PARTNER 1 trial with Edwards SAPIEN valve, post-dilation was associated with increased risk of early acute/subacute stroke (<7 days) (HR, 1.90 [95% CI, 1.03–3.50], p = 0.041), but not of late (>7 days) stroke [27]. The study also reported no excess 1 year mortality associated with post-dilation on multivariable risk adjustment. More recent data in self-expanding valves show significant improvement in moderate or greater PVL and excellent safety [31]. Balancing the risk of early stroke with appropriate patient selection should be considered before performing post-dilation.



10.1.3 Snare Maneuvers and Valve-in-Valve Implantation


In the SAPIEN 3 and Evolut R valves, valve malpositioning results in infra-skirt PVL from high positioning or supra-skirt PVL due to low positioning, and balloon post-dilation is typically not helpful in these cases. A valve-in-valve approach is the most common treatment. In rare instances, snaring and removing the self-expanding CoreValve system may be successful although fine repositioning is very difficult with the snare method [3234]. Snares are either single (Amplatz GooseNeck™, Medtronic) or multiloop (EN Snare® Merit Medical Systems, Inc.) and come in different sizes. Improved traction has been reported with transbrachial approach and may be tried if transfemoral snare approach is unsuccessful [35]. If successfully snared the self-expanding CoreValve can usually be collapsed completely or partially into the delivery sheath but may need to be deployed in the ascending aorta. Caution should be exercised during snare as calcium debris may be dislodged into the arterial tree or aortic injury may inadvertently occur. A fully expanded but malpositioned SAPIEN valve is typically not easily snared, and this approach is not recommended. If snared, the SAPIEN valve is typically deployed in the aorta.

The goal of a valve-in-valve approach is to place the second valve incrementally higher or lower (depending on the original valve position) to provide the best sealing at the annulus and is the most common approach in cases of PVL due to malpositioning (Fig. 10.2).

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Fig. 10.2
Valve-in-valve: Worsening paravalvular leak 1 month post-Medtronic CoreValve implantation corrected with deployment of Edwards SAPIEN 3 valve-in-valve

Knowledge of the aortic complex dimensions is very important when attempting a valve-in-valve procedure. First an avoidable mechanism of malpositioning should be determined (septal bulge causing an upward displacement or VPC/suboptimal rapid pacing causing valve displacement). Coronary occlusion is a potentially lethal complication of a valve-in-valve procedure and most likely to occur in a CoreValve that has been placed too low. When the second valve is placed higher inside the first valve, the leaflets of the original valve are displaced upward creating a “tube graft” and may cause coronary obstruction if the sinotubular junction is too narrow or the sinuses of Valsalva are small. Data from the Italian CoreValve Registry reported outcomes in 3.6% of patients undergoing valve-in-valve procedure for severe PVL pot conventional TAVI (75% with too low/ventricular placement and 25% with too high/supra-annular placement). They reported a procedural success in 98% of cases. At 1 year, the major adverse cardiac events were numerically higher but did not meet statistical significance (4.5% conventional TAVI versus 14.1% in valve-in-valve group, p = 0.158) [36]. In a series from Quebec Heart and Lung Institute, St. Paul’s Hospital, and Cleveland Clinic, 90% success rate was reported for valve-in-valve TAVI for prosthesis malfunction/malposition [37]. At one-year follow-up, only one patient had residual moderate PVL with mild or none PVL in other cases. Mortality was higher at 30 days in the valve-in-valve group compared to TAVI group; however it did not meet statistical significance (14.3% versus 7.3%, p = 0.23). Survival at 1 year was comparable in both groups (76% in valve-in-valve group versus 78% in TAVI alone). This study included only the Edwards balloon-expandable systems. The authors described the approach of deploying the second valve 25–35% higher or lower relative to the stent frame height (depending on the initial malposition) using the similar valve size [37]. Data clearly underline the safety and feasibility of performing valve-in-valve procedures intraoperatively. It is also a viable therapeutic procedure for late onset valve degeneration or worsening PVL with time [38].


10.1.4 Transcatheter “Plugs”


Percutaneous vascular plugs can be implanted in scenarios where conventional techniques are not successful—for example, in patients with appropriate prosthesis implant height and incomplete apposition due to severe calcification with no improvement in PVL after post-dilation [39]. Transcatheter closures of paravalvular leaks were first reported in 1992 [40]. The first device used was the double-umbrella device by Rashkind and Cuaso [41]. Paravalvular leaks have complex anatomy with irregular serpiginous shape, and no dedicated plugs are available for this indication. Vascular plugs have been used to manage postsurgical valvular leaks. The issue with such complex anatomy is challenging wire manipulation and catheter crossing and inadequate sealing with self-expanding valves.

The most commonly employed transcatheter closure device for post-TAVI PVL has been Amplatzer Vascular Plugs (AVP, St. Jude Medical, St. Paul, MN, USA). AVP III is a self-expanding nitinol meshwork with oblong cross-sectional-shaped oval discs with enhanced stability and ability to recapture and reposition [42]. AVP IV has gained popularity recently due to lower crossing profile (4F catheters compared to minimum 6F for AVP III), narrow tapering ends that cause less damage to left ventricular outflow, and wide midbody that prevents device embolization. The limitation of lower-profile catheters is that large leaks cannot be sealed with single AVP IV as the maximum available device diameter is 8 mm (compared to 14 mm for AVP III) [4346]. Device selection is based on adequate sizing, location, and characteristics (calcification, anatomic landmarks in proximity) of PVL. Multimodality imaging is sometimes needed for challenging PVL anatomy.

Complications of vascular plugs are device embolization, obstruction to coronary blood flow, prosthetic leaflet injury, and hemolysis. Vascular plugs have been safely and effectively used for balloon-expandable and self-expandable aortic valves [4750].



10.2 Conclusions and Future Directions


PVL, post-TAVI, is a risk factor for poorer short-, medium-, and long-term outcomes. As indications expand for the utilization of TAVI, more emphasis needs to be placed on appropriate patient and device selection. Early recognition, hemodynamic consequences, and quantification of PVL are of paramount importance, especially in the immediate postimplantation period. Newer devices and novel imaging modalities will help decrease the incidence of PVL. In the interim, post-dilation, snare maneuvers, vascular plugs, and valve-in-valve are viable options in carefully selected patients with hemodynamically significant PVL post-procedure.


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Sep 12, 2017 | Posted by in CARDIOLOGY | Comments Off on Transcatheter Management of TAVI-Associated Paravalvular Leak

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