Compliant Balloon Research Articles

Clampless 2 Device: Experimental Study of a Lateral Aorto-Prosthetic Anastomosic Device Without Clamping or Suturing

To offer an alternative to conventional techniques of lateral prosthetic anastomosis on arteries which require a long training, and impose an extensive open surgery, we are proposing the clampless 2 device (C2D) implanted by a simple arterial puncture and allows a lateral implantation of a polytetrafluoroethylene (PTFE) vascular graft in an artery, without arterial clamping or suture. C2D is a "T" shaped 25-mm long and 8-mm diameter Nitinol stent with a 6-mm PTFE graft prosthesis mounted laterally on the stent, and implanted in an artery, via a 21-French sheath, and a compliant balloon inflation. Invitro testing of the C2D was first performed on a bench including a segment of a 7-mm internal diameter pig abdominal aorta. A series of 5 consecutive C2D implantation was analyzed with evaluation of the implantation time and the fluid losses at a fluid pressure of 80 and 150mm Hg. The C2D implantation was finally controlled by angioscopy. An aorto-iliac bypass was then secondly performed on 8 living sows, with a side-to-end C2D implantation in the infrarenal abdominal aorta, followed by a conventional end-to-end prosthetic left iliac trunk anastomosis. The C2D and distal conventional anastomotic times were evaluated, as well as the total operative time and blood loss. A postoperative angiogram was systematically performed. The C2D was successfully implanted in all 5 invitro tests, with an average implantation time of 2'58 (range: 2'25-3'22). The mean value of fluid losses was 84ml (range: 67-94ml), with no fluid leakage occurring at 80- and 150-mm Hg pressure. All anastomoses were patent after macroscopic study by angioscopy with a perfect application of the stent in the aortic wall. In 8 living sows (mean weight: 42kg, 37-50kg), an aorto-left iliac bypass was successfully implanted in all cases, with a total mean procedure time of 101min (range: 90-130min), and an average fluid loss of 77ml (range:20-120ml). The mean implantation time was 4'39 (range 3'29-5'52) for C2D and 16min (range 12-17min) to perform the conventional distal prosthetic-iliac anastomosis. Systematic arteriographic and angioscopy control showed perfect patency of the C2D implantations. Preliminary invitro and acute invivo testing of C2D implantation show good early results, allowing further long-lasting pig experiments on the way to human homologation.

Effect of Post Dilatation on TIMI Flow in Patients Undergoing Primary Percutaneous Coronary Intervention

Objective: To evaluate the impact of post dilatation performed with Non- Compliant Balloon on Angiographical outcome (that is TIMI flow grade) in patients who underwent the primary percutaneous coronary intervention.
 Study Design: Retrospective cross-sectional study.
 Place and Duration of Study: At Tertiary Cardiac Care Center, Rawalpindi Pakistan from Nov 2020 to Apr 2021.
 Methodology: The retrospective data of the all the patients with STEMI was assessed via non-probability consecutive sampling technique and analyzed statistically. The study participants were classified into two categories based on whether they underwent post-dilatation or not, i.e., Category-I: patients who underwent post-dilatation with NC balloon and Category-II: patients who did not undergo post-dilatation. The primary study end-point was post-dilatation TIMI flow grade. Continuous study variables were expressed as Mean±S.D and categorical variables as frequencies and percentages. Chi square test was applied to find the association between study variables by keeping 95% CI and 5 % margin of error. p-value <0.05 was considered statistically significant.
 Results: The study included (n=410) eligible patients in total. Majority were males (n=303; 73.9%), 217 (52.9 %) patients underwent PD procedure. TIMI flow grade did not differ significantly between the two study categories (p-value > 0.05). Postprocedural success rate was 81.3% for patients with PD.
 Conclusion: The current study illustrates that PD does not adversely affect the final angiographic outcomes when performed after primary angioplasty.

Simulation study of inflation of a high compliant balloon inside idealized non-linear tissue geometry

Article Simulation study of inflation of a high compliant balloon inside idealized non-linear tissue geometry was published on August 1, 2022 in the journal Current Directions in Biomedical Engineering (volume 8, issue 2).

“Aortic Balloon Molding” during Ovation Endograft Implantation Expands Graft Use for Hostile Neck Anatomy

Challenging aortoiliac anatomy such as short neck and narrow access vessels is responsible for endovascular repair of abdominal aortic aneurysm (EVAR) ineligibility in up to 50% of cases. The Ovation stent graft helped widen the range of abdominal aortic aneurysms (AAAs) suitable for EVAR thanks to its low-profile delivery system and polymer-filled sealing rings. However, its advantages are offset by a tight sizing chart that can lead to increased risk of type Ia endoleak or endograft infolding from under- or oversizing, respectively. We sought to assess the safety and efficacy of a novel endovascular technique developed to expand the use of the Ovation endograft while avoiding these issues. We conducted a retrospective review of all patients who underwent EVAR with the Ovation endograft at our institution between March 2019 and December 2020. "Aortic Balloon Molding" or ABM is a novel endovascular technique in which the graft is pre-cannulated and a compliant aortic balloon is inflated at the site of the graft's sealing rings during polymer administration. The technique was preferentially performed in patients with hostile neck anatomy (HNA) defined as any or all of angulation >60°, reverse taper configuration, ≥50% circumferential thrombus, or calcification. Patients undergoing traditional deployment were compared to those in whom ABM was performed. End points included neck-related adjunctive procedures, technical success, type Ia endoleak at completion angiogram, and 1-year freedom from type Ia endoleak and migration. A total of 43 patients were included in the study, of which 26 (60.5%) were treated with the ABM technique. Mean follow-up was 7.9±6months. Patients in the ABM group were more likely to have a reverse taper neck (61.5% vs. 41.2%, P=0.1), have significant circumferential thrombus or calcium (23.1% vs. 5.9%, P=0.1), and be treated outside of the Ovation indications for use regarding anatomic characteristics (65.4% vs. 41.2%, P=0.1). Technical success was achieved in 100% of cases. However, patients in the ABM group were less likely to require a neck-related adjunctive procedure (7.7% vs. 23.5%, P=0.1). Only 1 type Ia endoleak was observed at completion angiogram in a patient treated without ABM. At 1 year, freedom from type Ia endoleak or migration was 100% for both groups. ABM proves to be a safe and effective adjunctive technique for the treatment of AAAs with HNA using the Ovation stent graft. This may allow optimal endograft sizing to achieve adequate seal in complex aortic anatomies. Further research is warranted to evaluate the long-term outcomes of this technique.

Cushioned on the way up, controlled on the way down during resuscitative endovascular balloon occlusion of the aorta (REBOA): investigating a novel compliant balloon design for optimizing safe overinflation combined with partial REBOA ability

BackgroundThere are a variety of devices capable of performing resuscitative endovascular balloon occlusion of the aorta (REBOA), with most containing compliant balloon material. While compliant material is ideal for balloon...

Comparison of left atrial lesion size and troponin release of two novel single shot devices for pulmonary vein isolation: pulsed field ablation vs. multi-electrode radiofrequency balloon

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Pulsed-field ablation (PFA) and the multi-electrode radiofrequency balloon (RFB) are two novel ablation technologies to perform pulmonary vein isolation (PVI). It is currently unknown whether these technologies differ in lesion formation and lesion extent. Purpose We compared the acute lesion extent after PVI induced by PFA and RFB by measuring low-voltage area in high-density maps and the release of biomolecules reflecting cardiac injury. Methods PVI was performed with a pentaspline catheter (FARAPULSE) applying PFA or with the compliant multi-electrode radiofrequency balloon (HELIOSTAR). Before and after PVI high-density mapping with CARTO3 was performed. In addition, blood samples were taken before transseptal puncture and after post-PVI remapping. Serum concentrations of high-sensitive Troponin I (hsTropI) were quantified by Immunoassay. Results 50 patients undergoing PVI by PFA (n=26, age 71±10 y, 58% males, 58% persistent AF) or RFB (n=24; age 64±13 y, 54% males, 25% persistent AF) were evaluated. Acute PVI was achieved in all patients in both groups. Mean number of PFA pulses were n=34±5 and mean number RFB applications were n=8±3. Total posterior ablation area was bigger in PFA (19.0±6.2 cm²) than in RFB (9.0±2.2 cm²; p<0.001). The posterior distance between septal and lateral lesions was shorter in PFA (23.7±10.5 mm) than in RFB (30.0±7.3 mm; p=0.021). In a total of 38 patients increase of hsTropI was higher after PFA (625±138 pg/ml, n=28) vs. RFB (148±36 pg/ml; n=10; p=0.049) supporting the evidence of larger lesion extent by PFA. Conclusion Pulse-field ablation delivers larger acute lesion areas and higher troponin release upon successful pulmonary vein isolation than multi-electrode array balloon-based pulmonary vein isolation in this single-center series.

P78 AN ANTEGRADE RECANALIZATION OF LEFT ANTERIOR DESCENDING CHRONIC TOTAL OCCLUSION WITH ORBITAL ATHERECTOMY IN PATIENT WITH SEVER LEFT VENTRICULAR DISFUNCTION

Abstract We share the case of a 71–year old man, affected by hypertension, presented in Emergency Room (ER) with chest pain. No clinical evidence of heart failure. EKG showed fast atrial fibrillation with QS complex and ST elevation in precordial leads. Echocardiogram confirmed sept and apex akinesia. Troponin I peak was 72pg/ml. In ER electrical cardioversion was efficacy performed. He was referred for invasive coronary angiography, that showed a left anterior descending (LAD) chronic total occlusion (CTO), with Rentrop grade 2 collaterals providing retrograde flow from the right coronary artery (RCA), a severe stenosis of ramus intermedius (RI) and a moderate stenosis of circumflex. A stress–echocardiogram demonstrated vitality of medio–basal anterior wall. Subsequent, recanalization procedure of LAD CTO was planned. J–CTO score was 1 (tapered calcific, lesion, <20mm). double radial access and ante grade approach was chosen. An EBU3.5 guiding catheter was engaged in the left coronary artery, and 8000 units of heparin administered. The iFR of Cx was 0.99, indicative of non significant myocardial ischemia. During hemodynamic evaluation of RI, a ventricular fibrillation occurred, treated by DC–SHOCK and PCI with stenting with no polymer, eluted with Biolimus A9 (3.0x24mm) with good result. The occlusion was crossed via an antegrade approach with an Asahi Gaia II wire and with microcatheter support. Gaia II was changed in favor of Asai Sion blu, and the IVUS catheter was enable of cross the lesion. Efficacy orbital atherectomy with Diamondback 260 was performed (5 ante and retro grade run at 80Krpm and a retro grade run at 120 Krpm. Ivus was able to cross the lesion. Efficacy pre–dilatation with semi and non compliant balloon (2.5–3.5mm) was performed and then stented with a 3.0 × 36 mm Bioloimu A9–eluting stent. Finally, IVUS confirmed correct stent expansion, achieving an excellent angiographic result. Patient was discharged with triple anti–thrombotic therapy, with indication to “life jacket” till the assessment at 1 month.

C27 SHOCKWAVE DEFERRED USE IN A CASE OF INFERIOR STEMI

Abstract A 62–years–old female patient, smoker, hypertension, dyslipidemia and TIA in history, was admitted for inferior STEMI; urgent coronary angiography from radial access was done, revealing diffuse calcific coronary artery disease with thrombotic occlusion of the proximal right coronary artery. Primary PCI was done with a direct implantation of a 3,0/24 mm drug–eluting stent. The stent expansion was not optimal in the mid–portion, due to severe calcification, requiring then post–dilatations. Nevertheless, the use of several non–compliant balloons (3,0/12 mm, 3,0/8 mm, 3,0/6 mm, 3,25/12 mm) was not effective to fully expand the stent, even dilating at very high pressure (rupturing one of the balloon). A ventricular fibrillation episode complicated the procedure, promptly resolved. After the stenting, even if not fully expanded, TIMI 3 flow was gained, with ST segment elevation resolution, in a quite asymptomatic patient; no more devices were available, so the procedure was stopped and the patient transferred in the coronary care unite. A second procedure was scheduled with the support of the intravascular lithotripsy device (Shockwave). Through the radial access the second PCI was done, using at first the Shockwave balloon 2,5/12 mm, with its total 8 treatments; then the Shockwave balloon 3,0/12 mm was used, effective at the seventh treatment in the final rupture of the calcific lesion, obtaining the full expansion of the stent. A good final angiographic result was documented, the patient tolerated very well the procedure.

P72 TWO SIDES OF THE SAME … PATIENT: CRITICAL LEFT MAIN STEM STENOSIS IN A CANDIDATE FOR TAVI

Abstract Best timing for left main stem (LMS) revascularization (staged or combined) is matter of debate in patients with severe aortic stenosis (AS), candidates for transcatheter aortic valve implantation (TAVI). LMS disease represents an additional challenge for 3 reasons: 1) the potential interaction between the coronary stent and the prosthesis due to the anatomic proximity of the LM ostium to the aortic annulus; 2) the risk for hemodynamic compromise during LMS percutaneous coronary intervention (PCI) in the presence of severe AS or TAVI; 3) the optimal treatment strategy for LMS bifurcations. Previous studies showed that outcomes of TAVI plus LMS–PCI were not influenced by an unprotected/protected LMS, the location of the stent or the timing of PCI. Case report. We present the case of an 82–year–old man with severe AS presenting with non–ST–segment elevation myocardial infarction. Coronary angiography revealed a highly complex, calcific LMS lesion. To safeguard the patient, in the event of rapid deterioration of cardiac output and coronary perfusion, a rescue balloon aortic valvuloplasty (BAV) and the Impella device were arranged. PCI was successfully performed by predilatation with Grip and non–compliant balloons, followed by double stenting with Mini–Crush technique. An additional stent in the ostium of the LMS was required without using a circulation support system. Due to the low take–off of the ostium of the LMS, an Edwards Sapien 3 was implanted, protecting the LMS with a guide–catheter and guide–wire. The patient was discharged from hospital on Day 5 post–procedure. Discussion. According to guidelines, decision should be performed case by case, based on the severity/complexity of either AS or LMS disease. The strategy of treating LMS lesions first may limit the risk of potential ischaemic complications during TAVI; its downside is the risk of hemodynamic crash with potential catastrophic evolution in case of PCI complications in severe AS. Mini–crushing can be a good, quick way to treat complex diseases of the LMS bifurcation, less complex to perform in emergency situations. “Bailout BAV” and Impella technology can be helpful bystanders to prevent any complications, being a salvage–strategy in case of advanced status of haemodynamic impairment. These approaches are a very last resort, while appropriate pre–procedural planning is still highly recommended in order to prevent potentially fatal procedural complications in this fragile clinical setting.

P62 LEFT ANTERIOR DESCENDING CACIFIED LESION IN A PATIENT WITH RECENT INFERIOR STEMI SUPPORTED WITH VENTRICULAR ASSISTANCE FROM IMPELLA 2.5, TREATED WITH ORBITAL ATHERECTOMY AND DRUG ELUTING STENT AND OPTIMIZED WITH IVUS CO–REGISTRATION

Abstract We present a case of a 65 years old patient with hypertension.He comes to our cath lab with an inferior STEMI treated with primary PCI of right coronary artery and we found a sub–occlusive and severly calcified lesion on proximal left anterior descending artery (LAD) and a diffused disease of its middle and distal portion (Fig 2). After collegial discussion on Heart Team we decided to proceed with a staged percutaneous revascularization on LAD. After an accurate planning we decided to proceed with a single femoral access a 14f femoral sheat was positioned on femorl artery, so we put the ventricular assistance catheter and then on the same sheat we put our 7 f guiding catheter to use only a single access for IMPELLA and for the guiding catheter (Fig. 1).The IVUS catheter doesn’t be able to cross the calcified lesion on LAD so we go on with a debulking using the orbital atherectomy of Diamond Back, with several passages antegrade and retrograde.At this point we are able to perform an IVUS Co–registration that demostrated also a critical lesion on ostial LAD.After multiple pre–dilatation to prepare the lesion we put three big drug eluting stent till 5 mm of diameter.The IVUS shows us a little malapposition so we proceed with a big non compliant balloon of 6mm with optimal result (Fig 3).In conclusion we go on with a reduction of ventricular assistance and final removal of IMPELLA catheter and closure of 14f vascular access with a single Pro–glide previously implanted.This procedure has some discussion points, first of all the possibility to treat a sub–occlusive lesion of an important non culprit artery after a few days of an acute coronary syndrome in safe mode with a ventricular assistance, that allowed us to work peacefully, being able to carry out all the maneuvers we considered appropriate (multiple balloon dilatations, IVUS evaluations, orbital atherectomy).An other point of discussion is the use of this new orbital atherectomy easy to use because with a single device,6f guiding catheter compatible, we are able to treat artery from 2.5 till 4mm only setting the rotational speed and removing not only the intraluminal calcium but also the deeper one and this allows a better stent expansion.The procedure is IVUS guided associated with angiographic images on Co–registration that allow us to obtain even more informations.The last comment is for the new stent Megatron, the only stent that are able to treat coronary artery till 6 mm.

P63 OPTICAL COHERENCE TOMOGRAPHY–ANGIO CO–REGISTRATION (OCT–ACR) OF LEFT ANTERIOR DESCENDING IN PATIENT WITH ONGOING ANIGNA

Abstract We share the case of a 50–year old man, with no cardiovascular risk factor, presented in ER with ongoing angina and positive exercise stress testing. No clinical evidence of heart failure. EKG and echocardiogram was negative. He was referred for invasive coronary angiography, that showed severe stenosis of mid–LAD and moderate ostial LAD stenosis. Subsequent Optical Coherence Tomography–Angio Co–Registration (OCT–ACR) of Left Anterior Descending was performed. An EBU3.5 guiding catheter was engaged in the left coronary artery, and 8000 units of heparin administered. After a pre–dilatation with a semi–compliant balloon of mid LAD, a plaque rupture with thrombus was documented at mid–LAD and a fibro–lipidic plaque with a severe flow limitation (MLA<4mm2) at the ostium, with no involvement of left main (Fig. 1b). Pre–dilatation with SC and NC balloon (2.5–3.5mm) was performed and then stented with a 4.0 × 26 mm DES. Finally, OCT confirmed correct stent expansion, achieving an excellent angiographic result, without carina shifting and compromise of the circ. Patient was discharged, asymptomatic. OCT–ACR guided PCI, taking advantage of its high spatial resolution, permits to plain better the PCI, establish correct stent size, evaluate early complications especially if left main or bifurcation are involved and thanks to co–registration also measurement of long axis of the vessel are facilitated.

Use of the Rocket Technique after Failure of the Direct Aspiration First-Pass Technique in Acute Stroke Thrombectomy

The technical feasibility of the rocket technique was evaluated for patients treated for stroke where the direct aspiration first-pass technique (ADAPT) failed to reach the occlusion site. This single-center retrospective study included data on consecutive patients with a large vessel occlusion of the anterior circulation who underwent mechanical thrombectomy. Of 138 patients, 100 met the inclusion criteria. In 84 patients, a large 0.072-inch inner lumen aspiration catheter was able to reach the occlusion site when deployed with a coaxial microcatheter. In 16 patients, this technique failed, and the microcatheter was replaced with a compliant balloon inflated at the extremity of the aspiration catheter (rocket technique). In 15 of these 16 patients, the rocket technique brought the catheter into contact with the thrombus. In conclusion, when deployment of the ADAPT with a coaxial microcatheter fails to reach the clot site, the rocket technique can safely advance the aspiration catheter to the clot.

Transcatheter Versus Surgical Closure of Acute Ruptured Sinus of Valsalva Aneurysms with Associated Ventricular Septal Defects.

Transcatheter ruptured sinus of valsalva aneurysm (RSOVA) closure is an alternative to surgery. When a restrictive ventricular septal defect (rVSD) coexists, there are doubts about support for an occluder and persistent left ventricular (LV) dilatation. We compared the outcomes of patients from a single centre with rVSD and RSOVA after surgery or transcatheter intervention in the past 8years in this study. Location of rVSD did not alter the approach. Compliant balloon interrogation before transcatheter closure was occasionally used to assess significance of interventricular shunt or aortic regurgitation. Procedural success and LV dimensions before and after treatment were analyzed. Seventeen patients with a mean age of 36.64 ± 12.58years were analyzed. 12/13 catheter procedures (92%) were successful, of whom eight patients had an outlet VSD. rVSD was closed with device in one patient with perimembranous rVSD, but unaddressed in others. Four patients underwent balloon interrogation. Surgery included the single patient who failed intervention. Transcatheter group had more acute symptoms and advanced functional class than surgical group, though not significant. At a median follow-up of 4.5 (1-7.5) years, the mean LV dimensions (50.3 ± 10.1mm and 50.1 ± 3.1mm, p = 0.46) were not different in the transcatheter and surgical groups. Mean end-diastolic volumes (110.5 ± 42. 1ml and 98.5 ± 37.5ml, p = 0.91) were not significantly different either. Transcatheter RSOVA closure success was not altered by rVSD despite their location underneath the aneurysms, including outlet rVSD with defect in aortoventricular junction. Persistent LV dilatation was not observed after catheter intervention even when the VSD was not closed.

Midterm safety and outcome of balloon angioplasty of native aortic coarctation in neonates and young infants and initial experience of prepartial dilatation using high-pressure noncompliant balloon.

Background:Balloon angioplasty (BA) for aortic coarctation in neonates and infants remains controversial due to high recurrence rate and vascular complications.Aim:This study aimed to determine the safety and outcome of percutaneous treatment of coarctation in neonates and infants and to share the initial experience of strategy of prepartial dilatation with high-pressure noncomplaint balloon before final targeted dilatation using low-pressure compliant balloon.Materials and Methods:Retrospective analysis of records of all neonates and infants aged <6 months who underwent BA either using only low-pressure balloon (Group A) or those with prepartial dilatation using high-pressure noncomplaint balloon followed by low-pressure compliant balloon (Group B) between July 2017 and February 2020 was performed. Demographic, clinical, echocardiographic, interventional, and follow-up data were collected for all.Results:A total of 51 patients (41.2% neonates) were included in the study. Median age was 1 month 14 days (60.8% girls) and mean weight was 3.6 ± 1.5 kg. The mean peak trans-coarctation gradient was 53 ± 12 (34–80) mmHg. The final pressure gradient dropped to <10 mmHg in all cases of Group B and only in 26.3% (5) patients of Group A (P < 0.001). Recoarctation rate was 25.5% (13) overall and was significantly higher in Group A patients (P < 0.001), in those with borderline/mildly hypoplastic arch (P = 0.04) and in those with postprocedure gradient between 10 and 20 mmHg (P = 0.02). Median time to re-coarctation was significantly delayed in Group B (P < 0.001). There were no major complications or mortality in either group.Conclusions:BA in neonates and young infants has an excellent short and mid-term safety and efficacy. The recoarctation rate is significantly reduced as well as delayed with prepartial dilatation using high-pressure noncompliant balloon.

Profile of the Ovation ALTO abdominal stent graft for the treatment of abdominal aortic aneurysms: overview of its safety and efficacy

ABSTRACT Introduction The Ovation ALTO is the next generation aortic stent graft from Endologix for the treatment of infra-renal abdominal aortic aneurysms. The device uses polymer-injected rings to create a proximal seal at the aneurysm neck. Areas Covered Results from the first clinical study of the ALTO graft are analyzed and the potential benefits of the graft in minimizing post-treatment aneurysmal neck dilation discussed. The implications of the ALTO’s Instructions-For-Use (IFU) and low-profile delivery system are also reviewed. Expert Opinion The re-positioning of the sealing rings higher on the graft and an integrated compliant balloon are the most significant improvements on the Ovation iX, facilitating accurate placement of the proximal sealing ring and prompt balloon dilation of the polymer rings. The expansion the IFU to include neck lengths of ≥7 mm will mean more patients are eligible for infra-renal EVAR within IFU with the ALTO device. The published data on the device to date is limited. With over 1000 implants worldwide we would hope for more published data to become available. If this demonstrates similar mid-term results to that seen with the Ovation iX in arguably more hostile neck anatomy, then the Ovation ALTO is likely to be more widely used.

The optimized clinical workflow for pulmonary vein isolation with the radiofrequency balloon.

Pulmonary vein isolation (PVI) with radiofrequency (RF) catheter ablation is an effective treatment option for patients with paroxysmal AF. However, traditional point by point RF ablation can be time consuming and technically challenging. To simplify the ablation procedure, without compromising procedure outcome, several "single shot" ablation systems have been developed. The multi-electrode RF Balloon catheter HELIOSTAR is a 28-mm compliant balloon compatible with the CARTO 3D electroanatomical mapping system; an optimized step-by-step workflow to perform PVI is described. Procedures are performed under general anesthesia with unique transseptal puncture. To evaluate the optimal electrode-tissue contact and best RF Balloon positioning, the following baseline indicators should be fulfilled: inflation index > 0.8, impedance range close to 100 Ohms with a variability of less than 20 Ohms across electrodes, temperature variability on all electrodes < 3°C with a maximum temperature of 31°C. RF delivery along the posterior wall is programmed to 20s or shorter in case of esophageal temperature rise (> 2°C compared to baseline) and 60s for all the other segments. Target parameters for PVI are 1) time to isolation less than 12s; 2) impedance drop > 12 Ohms; 3) temperature rise > 6°C. Standardized workflow for RF Balloon is mandatory to achieve efficacy and safety with this new promising technology. In the absence of international guidelines, a single high-volume center procedural strategy is described for PVI.

Abstract 10208: Quantitative Comparison of Ablation Area Created by the Conventional- and Larger-Sized Visually Guided Laser Balloon

Introduction: The visually guided laser balloon (VGLB) ablation catheter has been designed to facilitate pulmonary vein (PV) isolation in patients with atrial fibrillation (AF). Because VGLB is characterized by a compliant and variable diameter balloon, the balloon at the larger inflation size can isolate wider-area circumferential PV antrum. Though the importance of a wider circumferential isolation of PVs, which includes a large portion of the left atrial posterior wall (LAPW), has been suggested in several studies, the extension of the isolation area created by the new VGLB technique remains to be elucidated. We report the quantitative examination of the isolation areas after the conventional- and larger-sized VGLB ablation. Methods: Fifty-five patients with AF who underwent VGLB ablation were enrolled in this prospective study. An electroanatomic map of the left atrium was obtained with the PENTARAY catheter and the CARTO-3 system before and after PV isolation using conventional-sized VGLB. The isolation areas were extended by the larger-sized VGLB ablation and remapped in the same way. As demonstrated in figure, the isolation areas were measured after each ablation. Results: After PV isolation using the conventional-sized VGLB, the mean left- and right-sided antral PV surface areas of ablation were 13.5±2.9 cm 2 and 16.4±3.7 cm 2 , respectively. The total area of LAPW ablation was 10.9±2.1 cm 2 (45.6±9.3% of the posterior wall). On the other hand, they were 18.6±4.0 cm 2 , 23.7±5.2 cm 2 and 16.3±2.8 cm 2 (65.9±11.2%) after ablation with the larger-sized VGLB. These results revealed that the new VGLB technique yielded statistically greater areas of isolation than the conventional-sized VGLB. Conclusions: The larger VGLB ablation technique can create a significantly wider antral PV and LAPW isolation than the conventional-sized VGLB. The resulting LAPW debulking may be greater than the other balloon-based ablation lesions that have been reported previously.

Laser balloon in pulmonary vein isolation for atrial fibrillation: current status and future prospects

ABSTRACT Introduction Visually guided laser balloon (LB) catheter has been an established modality dedicated for pulmonary vein (PV) isolation in patients with atrial fibrillation. The newly updated version of this novel device has technically evolved recent years. Areas covered This review will summarize the contemporary technical evolution of LB catheter. Available efficacy outcomes and the historical change of ablation style will be evaluated. Furthermore, the future perspectives for clinical practice are discussed. Expert commentary The initial LB ablation system provided comparable clinical results in PV isolation with other technologies, but with a unique strategical concept enabling the direct visualization of the tissue to cauterize. With multigenerational development, the LB catheter has been equipped with more compliant balloon for favorable PV occlusion and a robotically motor driven continuous ablation mode (RAPID mode). These technical innovations changed the concept of the ablation strategy using LB catheter as ‘point-by-point’ into ‘single-shot’ fashion. The remaining tasks are further improvements such as equipping with real-time recording system of intracardiac electrogram, durable structured balloon and the instrument for visualizing the cauterization area in a 360-degree panoramic view, which includes potential possibilities to develop this novel device to the more optimal device for PV isolation.

479 Penetrating Chest Trauma Causing A Superior Mesenteric Artery-Inferior Vena Cava Fistula and Pancreatic Injury: A Case Report

Abstract Penetrating traumatic injuries can present a challenging scenario due to the potential for multisystem involvement requiring swift collaboration between surgical specialities. We present the case of a 66-year-old female who was stabbed in the right posterior chest. CT revealed a diaphragmatic injury, liver laceration involving segments 6/7 with active bleeding, and a posterior superior mesenteric artery (SMA) to anterior inferior vena cava (IVC) fistula. Due to the proximity of the SMA injury to a replaced right hepatic artery origin, the fistulous connection with the suprarenal IVC, and suspected pancreatic and duodenal injuries, a hybrid rather than a purely endovascular approach was taken. A large compliant occlusion balloon was placed percutaneously in the hepatic IVC. Subsequent trauma laparotomy and right medial visceral rotation identified SMA and SMV injuries, which were repaired with temporary supracoeliac aortic clamping. Further kocherisation of the duodenum revealed a 10 cm longitudinal IVC laceration causing sudden large volume venous haemorrhage. This was repaired after control was gained with supracoeliac aortic clamping, infrarenal IVC vessel loop and balloon inflation. An abdominal VAC dressing was applied. Before transfer to ICU, however, 1L of blood was noted in the VAC cannister and a relook laparotomy demonstrated more than 1L of intrabdominal fresh blood. Bleeding vessels around the uncinate process were ligated. After 48 hours, a relook laparotomy revealed no significant bleeding, and the abdomen was closed. A post-operative MRCP demonstrated pancreatic divisum and likely laceration of the aberrant ventral duct. A subsequent peripancreatic collection was managed conservatively.

In Reply: Combined Transradial and Transfemoral Approach Using a Compliant Balloon for Emboli Protection at the Vertebral Artery During Subclavian Stenosis Stenting: 2-Dimensional Operative Video.

In Reply: Combined Transradial and Transfemoral Approach Using a Compliant Balloon for Emboli Protection at the Vertebral Artery During Subclavian Stenosis Stenting: 2-Dimensional Operative Video.