23 Dec 2019
Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement (EASY TAVI)
Selected in JACC: Cardiovascular Interventions by M. Alasnag , K Park
This study reports the results of using the Left ventricular (LV) guidewire for pacing instead of introducing a temporary RV pacing wire. The safety of this approach is weighed against the potential complications of temporary pacing wires that include access and right ventricular perforation.
References
Authors
Benjamin Faurie, Géraud Souteyrand, Patrick Staat, Matthieu Godin, Christophe Caussin, Eric Van Belle, Lionel Mangin, Pierre Meyer, Nicolas Dumonteil, Mohamed Abdellaoui, Jacques Monségu, Isabelle Durand-Zaleski, Thierry Lefèvre and for the EASY TAVI Investigators
Reference
Volume 12, Issue 24, December 2019
Published
December 2019
Link
Read the abstractReviewers
Our Comment
Why this study – the rationale/objective?
Transcatheter aortic valve replacement (TAVR) procedures have evolved significantly in the last eighteen years. A minimalistic approach that limits procedure time, radiation, contrast and hospital stay has been adopted widely. It includes deep sedation rather than general anesthesia and radial access rather than dual femoral access. Even though valve technology has evolved, pacing is still essential for the majority of procedures. That is conventionally achieved using a temporary transvenous pacing wire in the right ventricle (RV). As an additional minimalistic measure, this study reports the results of using the Left ventricular (LV) guidewire for pacing instead of introducing a temporary RV pacing wire . The safety of this approach is weighed against the potential complications of temporary pacing wires that include access and right ventricular perforation.
Guidewire in TAVR
How was it executed – the methodology?
The EASY TAVI trial was a prospective, multicenter, single-blinded, superiority, randomized controlled trial in patients undergoing TAVR implantation with planned transfemoral approach using the SAPIEN 3 or XT valve. Patients were enrolled at 10 centers in France between May 2017 and May 2018. Patients were randomly allocated (1:1) to TAVR with either LV or RV stimulation before the TAVR procedure. In the experimental group, rapid ventricular pacing was provided via the 0.035-inch stiff guidewire placed in the LV for valve advancement (one of four standard guidewires was used - Safari, Amplatz Super Stiff, Amplatz Extra Stiff or Confida). The cathode of an external pacemaker was attached to the distal external end of the guidewire using a crocodile clip. The anode (second crocodile clip) was attached to the incised skin at the insertion site of the arterial sheath in the anesthetized groin (see figure). The primary endpoint was procedure duration, secondary endpoints included efficacy and safety of pacemaker stimulation, other major cardiovascular events, length of hospital-stay, and cost at 30 days.
What is the main result?
303 patients were included in the analysis: 151 in the LV stimulation group and 152 in the RV stimulation group. There were no significant differences in group characteristics, pacing efficacy, overall procedural success of valve implantation and no difference in 30-day MACE rate between RV and LV stimulation. Mean procedure duration was significantly shorter in the LV stimulation group compared with the RV stimulation group (48.4 min versus 55.6, p-value: 0.0013). In the LV stimulation group, bailout placement of an RV temporary pacing lead because of intra-procedural conduction disturbance occurred in 14 (9.3%) patients, whereas in the RV stimulation group, the temporary pacing lead was left in situ in 38 (25.0%) patients (p < 0.001). Fluoroscopy time was significantly lower in the LV stimulation compared with RV stimulation group. There was no significant difference in length of hospital stay between the treatment groups; however, LV stimulation was associated with significantly lower overall costs at 30 days and procedural costs compared with RV stimulation, while costs of the index hospital stay and re-hospitalization stay did not significantly differ between the treatment groups.
Critical reading and the relevance for clinical practice
This is the first randomized data that confirms the safety of using the LV wire for pacing. The study did not detect any significant difference in procedural success, complications (including valve migration) or clinical outcomes. These results are comparable only to those from the Sapien 3 and Sapien XT PARTNER 3, PARTNER 2A and CHOICE studies (balloon vs self expandable valves). At this time, these results are not applicable to other valves, particularly the self-expandable valves. Furthermore, this study was not powered to demonstrate outcome differences.
Although the duration of the procedure was shorter with LV pacing, the practical significance of a 7-10 minute difference in a procedure that has been streamlined and already shorter than the previous standard of care (surgical aortic valve replacement) remains debatable.
It is notable that bailout RV pacing was required in 9.3% of those initially paced via the LV. In the RV pacing arm, the lead was left in place 25% of the time. This suggests we need to stratify patients further to better predict conduction abnormalities and the suitability of LV pacing. The investigators recommend upfront RV pacing for those with a high likelihood of developing heart block. They also recommend placement of an RV pacing wire in those paced via the LV who develop a high grade block during the procedure.
Finally, these results primarily represent an intermediate risk cohort. The low and very high risk patients are not captured. The very high risk patients are the ones with the most to gain from a minimalistic approach that limits access and other complications. However, they are also often at high risk of developing conduction abnormalities particularly if they are of advanced age or have significant left ventricular outflow tract calcification making LV pacing unsuitable.
In conclusion, based on the findings of the EASY TAVI, patients with a low likelihood of conduction abnormalities and planned for a transfemoral Sapien 3 TAVR, LV pacing through the guidewire is a safe and suitable option.|
2 comments
Complications of RV pacing (RV perforation) and venous access versus loss of capture (valve migration) is the question I don’t believe that saving 7 min in procedure time is of any value or is the cost of a temp wire Implications of RV perforation usually are pericardiocentesis and occasionally surgery Implications of valve embolization due to loss of capture with balloon expandable valves is placing a second valve and/or potential surgical intervention to retrieve the embolized valve plus (SVR) Clearly people are doing it with success. I think operators need to make choices based on their individual risk assessment and comfort level Furthermore this study did not look into self expanding valves where pacing and loss of capture may not be as critical but in whom conduction abnormalities are more common These points are nicely highlighted in your review of the article.
throughLV wire , the balloons and valve are advanced and it is prone for frequent movements of wire in and out of lv contact and leads to failure to capture during non contact period. your attention will be diverted , it is better to use RV pacing , and concentrate on valve placement .