VersaCross Transseptal System for Mitral Transcatheter Edge-To-Edge Repair With the PASCAL Repair Platform.

Background: VersaCross is a novel radiofrequency transseptal solution that may improve the efficiency and workflow of transseptal puncture (TSP). The aim of this study was to compare the VersaCross transseptal system with mechanical needle systems during mitral transcatheter edge-to-edge repair (M-TEER) with the PASCAL device. Methods: This is a single-center retrospective study of consecutive patients who underwent M-TEER with the PASCAL. Transseptal puncture was undertaken with either a mechanical needle or the VersaCross wire. The primary endpoints were success of TSP and successful delivery of the Edwards sheath on the chosen delivery wire. Secondary endpoints included number of wires used, tamponade rate, interval from femoral venous access to TSP and first PASCAL device deployment, procedural death, and stroke. Results: Thirty-three consecutive patients (10 with mechanical needle, 23 with VersaCross) who underwent M-TEER with the Edwards PASCAL device were identified. All patients had successful TSP. In the mechanical needle group, the Edwards sheath was successfully delivered on the Superstiff Amplatz wire in all cases. In the VersaCross arm, the radiofrequency wire was used successfully for delivery of the sheath in all cases. There were no cases of pericardial effusion/tamponade in either arm. Interval from femoral venous access to TSP and to deployment of the first PASCAL device was shorter with the VersaCross system. Significantly fewer wires were used with VersaCross. There were no procedural deaths or strokes in either group. Conclusions: VersaCross appears a safe and effective method of TSP and for delivery of the 22Fr sheath for M-TEER with PASCAL.

Routine postaccess-closure angiography to detect vascular complications following transfemoral TAVR.

BACKGROUND: Vascular complications following transfemoral TAVR are associated with increased morbidity and mortality. Measures that may mitigate this risk are important. AIM: To evaluate the utility of routine, access-vessel angiography post sheath-removal in the detection and management of complications in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS: This was a retrospective study of 512 consecutive patients who underwent transfemoral TAVR with routine post access-closure angiography from the radial artery. Rates of mild angiographically evident bleeding, bleeding requiring surgery/interventional-radiology, ischemia, 90-day access-site-related events, and major and minor vascular complications using Valve Academic Research Consortium 3 definitions were recorded. RESULTS: Of 512 patients, digital subtraction angiography (DSA) was undertaken via the radial artery in 467 patients (91%). In the remaining patients (9%) DSA was either not attempted, due to concerns regarding kidney disease and contrast volume, or failed due to anatomical factors (aortic tortuosity/calcification). Significant chronic kidney disease was present at baseline in 72.4% of this cohort (stages III-IV or dialysis). Ninety-four percent of cases underwent TAVR using a balloon-expandable platform. Mild iliofemoral extravasation was observed in 7.7% of the DSA cases. These cases were managed by manual compression with none requiring any vascular intervention subsequently. Valve Academic Research Consortium 3 major and minor access-site-related complications were observed in 0.4% and 12.2%, respectively. Access-site-related bleeding and ischemic events requiring interventional-radiology or vascular-surgery were observed in 0.9% and 1.7% of the DSA cases, respectively. No new renal replacement therapy was needed in any of the DSA cases. Discharge to 90-day access-related complications was 0.8%. CONCLUSIONS: Routine post access-closure angiography is feasible via the radial artery in patients undergoing transfemoral TAVR and appears safe. It facilitates early identification of complications and mitigates risk by enabling prompt action to be taken. Larger studies are needed to confirm these findings.

Intraprocedural versus next day transthoracic echocardiography following minimalist transfemoral TAVI.

BACKGROUND: Routine pre-discharge echocardiography (ECHO) is recommended post transcatheter aortic valve implantation (TAVI) as a baseline for future comparison. However, there is no clear guidance on the optimal timing of this study. AIM: The purpose of this retrospective study was to investigate the safety and work-force efficiency of intraprocedural same-day ECHO versus next-day ECHO, following transfemoral TAVI. METHODS AND RESULTS: In this retrospective study 100 consecutive patients who underwent intraprocedural ECHO only were compared with 100 consecutive patients undergoing both intraprocedural and routine next-day ECHO following elective transfemoral TAVI. All patients received the Sapien 3/Ultra transcatheter heart valve and were treated with a minimalist procedure with conscious sedation. The composite of in-hospital mortality, urgent ECHO and new tamponade after leaving the cath lab and before discharge was not different between the two groups (4 vs. 4%, P = 1). There was no paravalvular leak more than mild in any of the cases. Length of stay was similar (1 day). CONCLUSIONS: Intraprocedural post-TAVI ECHO appears as safe as next day pre-discharge ECHO and obviates the need for a routine next day study, thereby reducing burden on echocardiography services and allows better utilisation of resources.

A Modified Buddy-Wire Technique for Crossing of the Interatrial Septum With the Sapien 3 Valve During Transseptal Mitral Valve-in-Valve/Ring Procedures.

Background: Crossing of the interatrial septum (IAS) with the Edwards Sapien-3 transcatheter heart valve (THV) may fail, despite preparatory balloon septostomy. A planned buddy guidewire placed in the left ventricle may help facilitate crossing of the IAS and mitral bioprosthesis with the THV. Methods: A retrospective study of 12 consecutive patients undergoing transseptal, mitral valve-in-valve or valve-in-ring procedures using the Edwards Sapien-3 THV since 2018 with a planned buddy-wire technique. The primary endpoint was the composite of successful delivery of the buddy wire and deployment of the first intended Sapien 3 within the mitral valve without removal from the body, additional interatrial septal puncture, or placement of a further buddy wire. Secondary objectives included safety endpoints, as follows: access-site bleeding, tamponade, stroke, intraprocedural death, sustained ventricular arrhythmia, and 30-day vascular complications. Results: From January 2018 to March 2022, a total of 12 consecutive patients who underwent transseptal mitral valve-in-valve (9) or valve-in-ring (3) procedures were identified. Three patients (25%) required repeat septostomy on the buddy wire after initial THV crossing failure. Crossing of the IAS and successful deployment in the mitral valve with the THV was achieved in all cases, without removal from the body or need for an additional wire or septal puncture. No access-site bleeding, stroke, tamponade, ventricular arrhythmia, intraprocedural death, or 30-day vascular complication occurred. Conclusions: The planned buddy-wire technique was successful in all cases and facilitated successful crossing of the IAS and deployment of the THV in the mitral position without removal from the body, additional wires, or septal punctures, with no adverse events.

Contexte: Malgré une septostomie par ballonnet, le passage à travers le septum interatrial (SIA) d'une valve cardiaque implantée par cathéter (VCC) Sapien-3 d'Edwards peut se solder par un échec. Un fil-guide planifié, placé dans le ventricule gauche, pourrait aider à faciliter le passage de la VCC à travers le SIA et la bioprothèse mitrale. Méthodologie: Une étude rétrospective a été réalisée auprès de 12 patients consécutifs ayant subi une implantation mitrale transseptale dans le cas d'une bioprothèse mitrale (valve-in-valve) ou d'une annuloplastie chirurgicale (valve-in-ring) d'une VCC Sapien-3 d'Edwards avec la technique du fil-guide planifié, depuis 2018. Le critère d'évaluation principale composé comprenait le placement avec succès du fil-guide et le déploiement de la première valve Sapien-3 prévue dans la valve mitrale, sans devoir la sortir du corps, sans effectuer de ponction supplémentaire du septum interatrial et sans devoir placer de fil-guide supplémentaire. Les objectifs secondaires incluaient les critères d'innocuité suivants : saignement lié à l'accès vasculaire, tamponnade, accident vasculaire cérébral (AVC), décès en cours d'intervention, arythmie ventriculaire soutenue et complication vasculaire dans les 30 jours après l'intervention. Résultats: Entre janvier 2018 et mars 2022, un total de 12 patients consécutifs ayant subi une implantation mitrale transseptale pour une bioprothèse mitrale (neuf) ou pour une annuloplastie chirurgicale (trois) ont été recensés. Pour trois de ces patients (25 %), une deuxième septostomie, sur le fil-guide, a été nécessaire avec un échec initial du passage de la VCC. Le passage du SIA et le déploiement dans la valve mitrale avec la VCC ont été réussis dans tous les cas, sans devoir sortir la valve du corps, avoir recours à un fil supplémentaire ou effectuer une ponction du septum. Aucun cas de saignement lié à l'accès vasculaire, d'AVC, de tamponnade, d'arythmie ventriculaire, de décès en cours d'intervention ou de complication vasculaire dans les 30 jours après l'intervention n'est survenu. Conclusions: La technique du fil-guide a été couronnée de succès dans la totalité des cas, et a facilité le passage du SIA et le déploiement de la VCC en position mitral sans avoir besoin de sortir la valve du corps, d'avoir recours à des fils supplémentaires ou d'effectuer une ponction du septum; aucun effet indésirable n'est survenu.

A time-efficient protocol for transthoracic echocardiography during transfemoral transcatheter aortic valve implantation: early identification and effective management of intraprocedural complications.

Transfemoral transcatheter aortic valve implantation (TAVI) under conscious sedation is the most widely used method of implantation. Echocardiography is used to detect complications and to assess the implantation result. The aim of this paper is to provide a time-efficient protocol when transthoracic echocardiography (TTE) is used to guide TAVI procedures.

Comparison of left ventricular with right ventricular rapid pacing on tamponade during TAVI.

BACKGROUND: Small studies have suggested left ventricular (LV) rapid pacing has similar safety and efficacy to conventional right ventricular (RV) rapid pacing in transcatheter aortic valve implantation (TAVI). However, there are limited data on the comparative rates of tamponade. The study compared the rate of cardiac tamponade between LV and RV-pacing during TAVI. METHODS: Between 2008 and 2021, 1226 consecutive patients undergoing transfemoral or transaxillary TAVI were included. 470(38.3%) patients had TAVI deployment with RV-pacing and 756(61.7%) with LV-pacing. The primary outcome was the frequency and cause of cardiac tamponade. Secondary outcomes included efficacy, procedure duration and crossover rates. RESULTS: There was a trend to less tamponade with LV-pacing, which did not reach statistical significance [11(2.3%) vs 11(1.5%);P = 0.27]. There was no significant difference in the frequency of tamponade due to annular tear [4(0.9%) vs 9(1.2%);P = 0.59] or LV free-wall perforation [1(0.2%) vs 2(0.3%);P = 0.86]. The frequency of tamponade due to RV perforation was significantly lower in the LV-pacing group [0 vs 6(2.3%);P < 0.005)]. Two patients with tamponade due to RV perforation required emergency sternotomy of whom one died. Deployment success was similar (99% vs 99.6%;P=NS). Procedure duration was shorter with LV-pacing (70 vs 80 mins;P < 0.005). Crossover to RV-pacing was low (0.9%). There were no embolizations caused by loss-of-capture in either group. CONCLUSIONS: LV-pacing appears equally efficacious and is associated with a lower risk of tamponade due to RV perforation caused by the temporary pacing wire. LV-pacing was not associated with an increased risk of tamponade due to LV free-wall perforation.