Transradial approach and subclavian wired temporary pacemaker to increase safety of alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy: The TRASA trial




Summary


Background


Alcohol septal ablation (ASA) is a therapeutic catheter-based option and an alternative to surgical myectomy in the treatment of patients with hypertrophic obstructive cardiomyopathy. Although the safety of the ASA procedure has been consistently improved, a temporary transvenous pacemaker is recommended for at least 48 h postprocedure, with several drawbacks, including the risk of cardiac perforation and infection, and the absence of any fixation mechanism. In addition, femoral artery catheterization has resulted in a concomitant increase in bleedings and iatrogenic femoral artery injuries.


Aims


To evaluate and validate the feasibility of less invasive management of ASA using the transradial approach and a subclavian wired temporary pacemaker.


Methods


To avoid transfemoral temporary pacing, we used a subclavian bipolar active-fixation permanent pacing lead, stitched to the skin and connected to a desterilized recuperation pacemaker. The day before discharge, if there was no high-degree atrioventricular block, the pacemaker lead was removed. In all patients, we used the right radial access and the left main was cannulated with a 6F Judkins left 3.5 guiding catheter.


Results


Thirty consecutive patients were prospectively and successfully included in our study. No complication was observed during the hospital stay, neither access-site nor stimulation-lead related.


Conclusions


Our study shows the feasibility and safety of a transradial approach and a subclavian wired temporary pacemaker. The reduction in periprocedural complications offered by this strategy reflects the less invasive nature of ASA, without increasing the cost and complexity of the procedure.


Résumé


Contexte


L’alcoolisation septale est une alternative à la chirurgie dans la prise en charge des cardiomyopathies hypertrophiques obstructives. Malgré l’amélioration de la sécurité de cette technique percutanée, le risque de trouble conductif nécessite une stimulation externe pour au moins 48 heures après la procédure. La technique habituelle de stimulation temporaire transfémorale expose à un risque de tamponnade, de déplacement de sonde ou d’infection. De plus, la voie d’abord artérielle fémorale qui est utilisée dans toutes les études majore le risque hémorragique de la procédure.


Objectifs


Notre objectif est d’évaluer la faisabilité et l’intérêt d’un abord artériel radial associé à une stimulation temporaire par sonde vissée sous-clavière pour réduire le risque de complication périprocédurale.


Méthodes


Nous avons utilisé des sondes de stimulation bipolaires vissées introduites par voie sous-clavière, la partie proximale de la sonde restant externe et connectée à un boîtier de pacemaker de récupération programmé en VVI. La veille de la sortie, en l’absence de trouble conductif, le dispositif était retiré. La voie artérielle radiale a été également proposée à tous les malades, avec utilisation de cathéter guide JL 3.5 6F.


Résultats


Trente patients consécutifs ont pu bénéficier avec succès de cette approche. Nous n’avons observé durant la phase hospitalière aucune complication liée à la stimulation temporaire ou à la voie d’accès artérielle.


Conclusions


Notre étude montre la faisabilité et l’intérêt en terme de sécurité de l’abord radial et de la stimulation temporaire sous-clavière par sonde vissée. La réduction des complications et l’amélioration du confort du patient s’inscrivent dans la logique du développement de l’alcoolisation septale, sans majoration du coût ou de la complexité de la procédure.


Background


ASA is a therapeutic catheter-based option and an alternative to surgical myectomy in the treatment of patients with HOCM . Both techniques currently appear to provide equivalent results in mortality, and in subjective and objective measurements of performance in symptomatic HOCM patients . The total number of ASAs performed largely outnumbers surgical septal reduction. However, the procedural complication rate probably still exceeds that of myectomy, especially related to AV conduction problems , transient pacing and femoral access site. The safety of the ASA procedure has been consistently improved, using myocardial contrast echocardiography to improve localization of the targeted septal branch, with smaller volumes of alcohol injected at a slower rate . Onset of delayed complete heart block may occur up to several days after an uncomplicated ASA procedure . Therefore, a temporary transvenous pacemaker is recommended for at least 48 hours postprocedure, and telemetric monitoring for 5 to 8 days is recommended by some groups . Transfemoral temporary pacing catheters have several drawbacks, including the risk of cardiac perforation and infection, and the absence of any fixation mechanism. In addition, femoral artery catheterization has resulted in a concomitant increase in bleedings and iatrogenic femoral artery injuries. The aim of the present study was to evaluate and validate the feasibility of less invasive management of ASA using the transradial approach and a subclavian wired temporary pacemaker.




Methods


Patients


Consecutive patients with symptomatic HOCM despite optimal medical treatment (New York Heart Association functional class III to IV) were prospectively included in our study. All subjects demonstrated a dynamic left ventricular outflow tract gradient of at least 50 mmHg at rest or on provocation and a septal thickness > 18 mm. Patients with a negative Allen’s test or specific contraindication for radial access were excluded. Our institutional review committee approved the study and all patients gave written informed consent.


Subclavian external temporary pacing


To avoid transfemoral temporary pacing, we performed a safer approach the day before ASA. Using a subclavian 7Fr peel-away introducer sheath, a bipolar active-fixation permanent pacing lead was positioned in the right ventricle under fluoroscopy guidance, with the tip screwed into the apical septum ( Fig. 1 ). Taking into account the potential complications of subclavian way (infection, haemopneumothorax and bleeding), lead insertion was performed only by skilled personnel, under stringent aseptic technique in the electrophysiology lab. The lead was stitched to the skin using the anchoring sleeve, then connected to a VVI permanent pacemaker that had been preprogrammed in bipolar mode for stimulation and detection (rate 60 beats/minute, output 5 V). This was secured to the skin with an occlusive sticking ( Fig. 1 ). We used a desterilized recuperation pacemaker for cost-effectiveness.




Figure 1


Chest radiography showing the position of the pacing lead. The active-fixation screwed mechanism is visible, connected to a reusable generator secured to the skin with a large occlusive dressing to maintain sterility (insert).


Percutaneous transluminal septal myocardial ablation


In all patients, we used right radial access and the left main was cannulated with a 6F Judkins left 3.5 guiding catheter. After identification of the septal branches of the left anterior descending coronary artery, a 1.5–2.5 × 10 mm balloon was introduced over a 0.014 inch guidewire and positioned into the first septal branch. If the position of the balloon was considered satisfactory, the guidewire was removed and the balloon inflated. Subsequently, 1 mL of echocontrast agent (Levovist, Schering AG, Berlin, Germany) was injected through the balloon catheter shaft. With echocardiography, the myocardial territory supplied by this septal branch was identified and retrograde spill of contrast into the left anterior descending coronary artery or the right ventricle was excluded. If satisfying images were obtained, 1 mL of concentrated ethanol (at a rate of 0.5 mL/30 sec) was injected through the balloon catheter shaft under close echocardiogram surveillance. After 5 min, the balloon was deflated and coronary angiography was repeated to confirm septal occlusion and the integrity of the left anterior descending coronary artery ( Fig. 2 ). A second perforator artery was cannulated and ablated if gradient reduction < 50% was not achieved after the first septal ablation.




Figure 2


(A) Radial access and left anterior descending coronary artery visualization before therapy, showing large first septal branch (arrow). (B) Inflation of the balloon catheter in the proximal part of the septal branch was determined. (C) Final visualization of the vessel stump (arrow) of the occluded septal branch. Generator and active-fixation screwed lead are visible.


After the procedure, patients were observed for 2 days in the intensive care unit and 6 days on the cardiology ward. Radial access and our original temporary pacing method allowed rapid ambulation. The day before discharge, if there was no high-degree AV block, the pacemaker lead was removed.


Statistical analysis


Statistical analysis was performed using Graphpad Prism software (version 4.00; Graphpad Software, Inc., San Diego, CA, USA). Continuous variables are expressed as means ± standard deviations and categorical variables as frequencies and percentages.

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Jul 14, 2017 | Posted by in CARDIOLOGY | Comments Off on Transradial approach and subclavian wired temporary pacemaker to increase safety of alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy: The TRASA trial

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