6F Sheath Research Articles

Feasibility of standby ECMO with preset femoral vascular sheaths for high-risk transcatheter aortic valve replacement

Objective Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can provide temporary circulatory and respiratory support allowing hemodynamic stabilization during high-risk transcatheter aortic valve replacement (TAVR). However, the optimal timing of VA-ECMO use in high-risk TAVR remains controversial. We aimed to report our experience using a novel standby ECMO strategy during high-risk TAVR. Methods We retrospectively evaluated consecutive patients who received high-risk TAVR with standby ECMO between March 1,2023 and March 1,2024 at the Beijing Anzhen Hospital. Small, 5F or 6F sheaths were placed in ipsilateral femoral vein and artery before TAVR procedures. The primary outcome of this study was survival to hospital discharge with good neurological recovery defined as cerebral performance category (CPC) 1-2. Results A total of 24 patients undergoing high-risk TAVR with standby ECMO were included. Six (25.0%) of the 24 patients with standby ECMO suffered from cardiogenic shock or cardiac arrest and required emergency VA-ECMO institution. The median (IQR) cannulation time was 8 (6–11) minutes, and the median (IQR) ECMO duration was 35 (24–48) hours. All of the 24 patients underwent successful TAVR procedures and survival to hospital discharge with CPC1-2. Conclusions Standby ECMO with preset femoral vascular sheaths was feasible and effective for refractory cardiogenic shock and cardiac arrest during high-risk TAVR.

Active aortic aneurysm sac treatment with shape memory polymer during endovascular aneurysm repair.

Preprocedural image analysis and intraprocedural techniques to fully treat infrarenal abdominal aortic aneurysm sacsoutside of the endograft with shape memory polymer (SMP) devices during endovascular aneurysm repair were developed. Prospective, multicenter, single-arm studies were performed. SMP is a porous, self-expanding polyurethane polymer material. Target lumen volumes (aortic flow lumen volume minus endograft volume) were estimated from thepreprocedural imaging studies and endograft dimensions. SMP was delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. Technical success was achieved in all cases, defined asimplanting enough fully expanded SMP volume to treat the actual target lumen volume.

Factors Affecting Radial Artery Occlusion After Right Transradial Artery Catheterization for Coronary Intervention and Procedures.

To determine the factors influencing proximal radial artery occlusion (PRAO) right radial artery after coronary intervention. This is a single-center prospective observational study. A total of 460 patients were selected to undergo coronary angiography (CAG) or percutaneous coronary intervention (PCI) via the proximal transradial approach (PTRA) or distal transradial approach (DTRA). The 6F sheath tube were received by all patients. Radial artery ultrasound was performed 1 day before procedure and 1-4 days after procedure. Patients were divided into the PRAO group (42 cases) and the non-PRAO group (418 cases). General clinical data and preoperative radial artery ultrasound indexes of the two groups were compared to analyze related factors leading to PRAO. The total incidence of PRAO was 9.1%, including 3.8% for DTAR and 12.7% for PTRA. The PRAO rate of DTRA was significantly lower than that of PTRA (p < 0.05). Female, low body weight, low body mass index (BMI) and CAG patients were more likely to develop PRAO after procedure (p < 0.05). The internal diameter and cross-sectional area of the distal radial artery and proximal radial artery were smaller in the PRAO group than in the non-PRAO group, and the differences were statistically significant (p < 0.05). Multifactorial model analysis showed that the puncture approach, radial artery diameter and procedure type were predictive factors of PRAO, and the receiver operating characteristic curve showed a good predictive value. A larger radial artery diameter and DTRA may reduce the incidence of PRAO. Preoperative radial artery ultrasound can guide the clinical selection of appropriate arterial sheath and puncture approach.

A Referral Center Experience with Cerebral Protection Devices: Challenging Cardiac Thrombus in the EP Lab

Cerebral protection devices (CPD) are designed to prevent cardioembolic stroke and most evidence that exists relates to TAVR procedures. There are missing data on the benefits of CPD in patients that are considered high risk for stroke undergoing cardiac procedures like left atrial appendage (LAA) closure or catheter ablation of ventricular tachycardia (VT) when cardiac thrombus is present. This work aimed to examine the feasibility and safety of the routine use of CPD in patients with cardiac thrombus undergoing interventions in the electrophysiology (EP) lab of a large referral center. The CPD was placed under fluoroscopic guidance in all procedures in the beginning of the intervention. Two different CPDs were used according to the physician's discretion: (1) a capture device consisting of two filters for the brachiocephalic and left common carotid arteries placed over a 6F sheath from a radial artery; or (2) a deflection device covering all three supra-aortic vessels placed over an 8F femoral sheath. Retrospective periprocedural and safety data were obtained from procedural reports and discharge letters. Long-term safety data were obtained by clinical follow-up in our institution and telephone consultations. We identified 30 consecutive patients in our EP lab who underwent interventions (21 LAA closure, 9 VT ablation) with placement of a CPD due to cardiac thrombus. Mean age was 70 ± 10 years and 73% were male, while mean LVEF was 40 ± 14%. The location of the cardiac thrombus was the LAA in all 21 patients (100%) undergoing LAA-closure, whereas, in the 9 patients undergoing VT ablation, thrombus was present in the LAA in 5 cases (56%), left ventricle (n = 3, 33%) and aortic arch (n = 1, 11%). The capture device was used in 19 out of 30 (63%) and the deflection device in 11 out of 30 cases (37%). There were no periprocedural strokes or transitory ischemic attacks (TIA). CPD-related complications comprised the vascular access and were as follows: two cases of pseudoaneurysm of the femoral artery not requiring surgery (7%), 1 hematoma at the arterial puncture site (3%) and 1 venous thrombosis (3%) resolved by warfarin. At long-term follow-up, 1 TIA and 2 non-cardiovascular deaths occurred, with a mean follow-up time of 660 days. Placement of a cerebral protection device prior to LAA closure or VT ablation in patients with cardiac thrombus proved feasible, but possible vascular complications needed to be taken into account. A benefit in periprocedural stroke prevention for these interventions seemed plausible but has yet to be proven in larger and randomized trials.

Abstract 13005: Tips and Tricks for Successful Trans-EVAR TAVR: Buddy Up

Trans-catheter aortic valve replacement (TAVR) via tortuous iliofemoral access with prior endovascular aneurysm repair (EVAR) is challenging. 83 year old male with severe aortic stenosis and prior EVAR was evaluated for TAVR with 29 mm Edwards Sapien 3 valve. Right femoral access was planned with ipsilateral protection. CT angiogram showed EVAR with tortuosity, rigidity, and graft protrusion concerning for advancement of equipment. The right iliofemoral system was accessed using a 4F radial sheath, Judkins JR4 catheter, and 0.035” angled glide wire exchanged for Amplatz Superstiff wire. A 30 cm 6F sheath was advanced over the wire followed by additional Superstiff buddy wire. Two Proglides were deployed over two separate wires, without rewiring. To overcome friction on removing second Proglide, predilatation of the arteriotomy should have been performed with a 8-9F sheath. An 8F sheath was advanced over one of two Superstiff wires. A V18 0.018” wire was placed in the ipsilateral protect site, exchanged for a third Superstiff wire to ease insertion of the Edwards sheath. The sheath was advanced followed by successful valve deployment. After removing the delivery system, two pre-deployed Proglides closed the arteriotomy site. Detailed planning enables operators to overcome challenges using the following strategies: 1) avoid unnecessary rewiring of the iliofemoral system by use of a 30 cm 6F sheath, 2) predilate the TAVR arteriotomy with larger sheaths prior to deploying Proglides to avoid limited manipulation space for Proglides and two wires, 3) use buddy wires if TAVR sheath advancement has failed over one wire and consider additional buddy wires from within the TAVR arteriotomy or ipsilateral protection site, and 4) use ipsilateral protection to avoid challenges of crossing over from contralateral iliofemoral. Although trans-EVAR TAVR remains somewhat unpredictable, these strategies may simplify and reduce the inherent failure rate of such procedures.

Radial versus femoral approach for rotational atherectomy – technical aspects and procedural outcomes

Abstract Background Rotational atherectomy (RA) is a well-established therapy for the treatment of heavily calcified coronary lesions. While the radial approach has evolved into the gold-standard for standard percutaneous coronary intervention (PCI), RA is still often performed via a femoral approach. Concerns over guiding size, sheath size, the delivery of the burr as well as the need for a temporary pacemaker play a role in that decision. Methods This retrospective analysis includes all patients undergoing RA from 03/2013 to 06/2019 at one institution. We sought to investigate the procedural outcome and the influence of the percutaneous approach. Results A total of 228 patients were planned to undergo RA. Based on operator preference, RA was attempted via the radial approach (RAD) in 78 (34.2%) patients and via the femoral approach (FEM) in 150 (65.8%) patients. The procedure failed in 2.6% (RAD 1.3% vs. FEM 3.3%, p=0.359) due to crossing failure of either the RotaWire (n=5) or the burr (n=1). The left anterior descending was the most frequently treated vessel in the radial group and significantly more often targeted in comparison to the femoral group (LAD: RAD 44.6% vs. FEM 26.5%, p=0.004). All other vessels were similarly often treated in both groups (LM: RAD 13.3% vs. FEM 17.3%, p=0.414; LCX: RAD 15.7% vs. FEM 23.5%, p=0.155; RCA: RAD 25.3% vs. FEM 31.5%, p=0.315; Bypass: RAD 1.2% vs. FEM 1.2%, p=0.984). RAD-RA was significantly more often performed with a 6F sheath in comparison to FEM-RA (RAD 47.4% vs. FEM 16.7%, p&amp;lt;0.001). A 7F sheath was used in 52.6% of the cases for RAD-RA (men: 85.4%, women: 14.6%, p=0.176) and is therefore the most frequently chosen sheath size within that group. A 7F or 8F sheath was used in 75.3%, respectively 8.0% of the cases in the FEM group (7F: p&amp;lt;0.001; 8F: p=0.010 compared to RAD). There were no significant differences regarding the burr sizes (RAD 1.43±0.17mm vs FEM 1.41±0.18mm, p=0.442). Whereas the placement of a temporary pacemaker was equal in both groups (RAD 20.8% vs. FEM 30.8%, p=0.110), the femoral group showed a higher number of patients with any back-up pacing, permanent or temporary (RAD 24.7% vs. FEM 39.0%, p=0.031). There were no significant differences in terms of fluoroscopy time (RAD 00:24:65±00:12:48 vs. FEM 00:28:33±00:17:05, p=0.180) and the volume of contrast medium (RAD 217.2±96.3ml vs. FEM 192.9±86.0ml, p=0.118). Moreover, procedural complications (RAD 17.9% vs. FEM 18.0%, p=0.992) and access site related complications (RAD 6.4% vs. FEM 10.0%, p=0.363) occurred equivalently in both groups. Conclusion This analysis shows that RA via radial access is as safe and successful as via femoral access. Despite the more frequent use of 6F sheaths, burr sizes did not differ. Additionally, neither fluoroscopy time nor contrast volume indicated a higher complexity of the RAD approach. Funding Acknowledgement Type of funding sources: None.

Iatrogenous puncture of the aortic arch closed with ProGlide.

An 89-year-old woman was referred to our hospital owing to syncope caused by an atrioventricular conduction disease. She presented with a past medical history of hypertension, dyslipidemia, and depression. A temporary balloon-tipped pacemaker electrode was inserted in the emergency department through the right jugular vein. Jugular catheter placement is a routine procedure. Several authors recommend the use of ultrasound guidance to avoid complications, such as arterial injury. Saugle et al1Saugle B. Scheeren T.W.L. Teboul J.L. Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice.Crit Care. 2017; 21: 225Crossref PubMed Scopus (135) Google Scholar reviewed the literature and described six steps to perform ultrasound-guided jugular catheter placement: identify the anatomy of the insertion site and localize the vessels, confirm the patency of the jugular vein with a compression test, use real-time ultrasound guidance for puncture of the vein, confirm needle position in the vein, confirm the wire position, and confirm the catheter position in the vein. In our case, a percutaneous echocardiography-guided puncture of the jugular vein was made; however, once the 6F sheath was placed inside, an arterial flow was obtained from the sheath; therefore, the on-call cardiologist considered it to be placed in the carotid artery. Upon examination, an abnormally oblique position of the sheath was observed in the patient's neck (A). Doppler ultrasound examination revealed no contact between the sheath and the supra-aortic trunks. Arteriography was performed through the sheath, revealing an introducer placed in the aortic arch (B and C/Cover). After a multidisciplinary consensus, owing to the patient's age and the difficulty of open sheath withdrawal, a percutaneous artery closure device was used. Under general anesthesia and controlled hypotension, the 6F sheath was removed and the aortic arch was closed with a ProGlide (Abbott Laboratories, Chicago, Ill). A computed tomography scan after the procedure revealed a hematoma at the superior mediastinum close to supra-aortic trunks without signs of bleeding (D). The patient was admitted to the coronary unit with strict control of the blood pressure. After 48 hours, a permanent pacemaker was inserted. One week later, the patient was discharged home. The patient provided consent for the publication of her case details and imaging. Inadvertent arterial puncture during central venous catheter placement is a well-known complication.2Bowdle A. Vascular complications of central venous catheter placement: evidence-based methods for prevention and treatment.J Cardiothorac Vasc Anesth. 2014; 28: 358-368Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar In the majority of cases of misplaced jugular catheters, the carotid artery is punctured. Accidental aortic arch puncture is a rare complication and its treatment includes open surgery with median sternotomy.3Sellem M.I. Al-Hashemy A.A. Al-Naemi A. Ectopic intra-aortic insertion of a subclavian central venous catheter: case report and review of the literature.J Thorac Cardiovasc Surg. 2004; 127: 1515-1516Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar Since the advent of percutaneous closures, some authors have described their use in the management of accidental artery puncture.4Pikwer A. Acosta S. Kölbel T. Malina M. Sonesson B. Akeson J. Management of inadvertent arterial catheterisation associated with central venous access procedures.Eur J Vasc Endovasc Surg. 2009; 38: 707-714Abstract Full Text Full Text PDF PubMed Scopus (53) Google Scholar We found one case in the literature where an aortic arch puncture was treated with a percutaneous closure. In this case, the puncture of the aorta was done during subclavian catheter placement and they used Angio-Seal Vascular Closure Device (St Jude Medical, Saint Paul, Minn).5Leijdekkers V.J. Go H.L.S. Legemate D.A. Reekers J.A. The use of percutaneous closure device for closure of an accidental puncture of the aortic arch; a simple solution for a difficult problem.Eur J Vasc Endovasc Surg. 2006; 32: 94-96Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar In our case, there was no option for open repair owing to patients comorbidities. We preferred to use a suture-mediated closure system (ProGlide) because we have experience using this system in peripheral arteries. This case highlights that complications may occur and, even though there is no indication for the use of the ProGlide system in aortic puncture, we have to be able to individualize the treatment plan for this patients without other available options. The authors thank Dr Bernat Lloret Villas for his expertise and assistance with patient management.

Impact of Opioid Analgesia and Inhalation Sedation Kalinox on Pain and Radial Artery Spasm during Transradial Coronary Angiography.

With respect to the transfemoral approach, transradial procedures enable a drastic reduction of bleeding events and are associated with a reduction of mortality. Radial artery spasm (RAS) is one of the most common complications and may lead to patient discomfort and procedural failure. Currently, there is no consensus on the optimal sedation protocol to avoid RAS. The aim of this study was to investigate the respective impact of opioids analgesia and inhalation sedation with a 50% nitrous oxide/oxygen premix (Kalinox) on pain and occurrence of RAS during transradial coronary procedures. Consecutive patients undergoing transradial coronary angiography were prospectively enrolled in one, single center observational study (Nouvel Hôpital Civil, Strasbourg, France). Patients received opioids analgesia or inhalation sedation with Kalinox. The primary endpoints of the study were the incidence of a pain scale ≥5/10 and the occurrence of RAS. The secondary endpoints were the incidence of side effects. A total of 325 patients were enrolled (185 in the opioids analgesia group, 140 in the Kalinox group). RAS and pain scale ≥5 rates were not significantly different in the opioids analgesia and Kalinox groups (respectively 13.5% vs. 10.0% and 16.2% vs. 11.4%). Headache was more frequently observed in the Kalinox group (6.4% vs. 0.0%; p = 0.002). By multivariate analysis, female gender, BMI <25 kg/m2, puncture difficulty, the use of plastic needle and 6F sheath were identified as independent predictors of RAS. Procedural inhalation sedation by Kalinox is as safe as opioids analgesia during transradial coronary angiography.

Upper Extremity Dysfunction after Trans-Radial Interventions- Experience from a Tertiary Care Center of North India

Introduction: Coronary artery disease treatment by percutaneous intervention has revolutionised the management of this disease and the choice and safety of vascular access site has significantly contributed to the outcome of the overall procedure. Aim: To assess upper extremity dysfunction in patients undergoing Transradial Coronary Angiography (CAG) and Percutaneous Coronary Interventions (PCI). Materials and Methods: This study involved patients planned for transradial coronary intervention. Patients were assessed for development of upper extremity dysfunction and other local complications post procedure at 24 hours, 2 weeks, 1 month and 6 months. Data analysis was done using SPSS Version 21. Results: A total of 165 patients were enrolled in the study. There were 123 (74.5%) males. Total 156 patients (94.5%) had stable angina as underlying diagnosis, 4 (2.4%) had unstable angina, 2 (1.2%) had Non ST Elevation Myocardial Infarction (NSTEMI), 1 (0.6%) had ST Elevation Myocardial Infarction (STEMI) and 2 (1.2%) required CAG before valve replacement. A 5F sheath was used in 110 (66.67%) and 6F sheath in 55 (33.33%) cases. Tiger catheter was used in all 165 patients initially for diagnostic angiography. Dynamometer testing showed reversible downgrading of hand grip in 49% of patients post-procedure. Local site haematoma was seen in 3 (1.8%) at 24 hours, reversible vascular occlusion in 2 (1.2%) at 24 hours and Thrombolysis in Myocardial Infarction (TIMI) Minor bleed in 1 (0.6%) at 24 hours. No significant correlation was seen between sheath or catheter size with dynamometer testing or local complication. Conclusion: There was no significant upper extremity dysfunction after trans-radial intervention in the study population.

LEA 38. Retrograde Use of the Outback Re-entry Catheter in Complex Infrainguinal Arterial Recanalization

The objective of this study was to demonstrate the efficacy and safety of the Outback (Cordis, Santa Clara, Calif) re-entry catheter in complex retrograde subintimal infrainguinal arterial recanalization for patients affected by critical limb ischemia. Between 2015 and 2019, the Outback re-entry catheter was used to re-enter the true lumen in 29 patients with critical limb ischemia who underwent retrograde superficial femoral artery, with or without popliteal artery subintimal recanalization, after failed guidewire and catheter-assisted re-entry. The retrograde access site was distal superficial femoral artery in 21 patients, proximal anterior tibial artery in 5 patients (Fig 1), and proximal peroneal artery in 3 patients. The re-entry target was common femoral artery in 27 patients, proximal superficial femoral artery in 1 patient, and proximal anterior tibial artery in 1 patient. Technical success was 89% (26/29). In all the successful cases, the re-entry was accurate (Fig 2), without damage to the profunda femoral artery. In 25 of 26 successful cases, the lesion was stented after plain balloon angioplasty. Supera (Abbott, Abbott Park, Ill) stent (with the proximal one always deployed from the retrograde access) was the most commonly used stent in 19 cases. The Outback was inserted through a 6F sheath in 13 cases and without any sheath in 16 cases (always when the retrograde access was at the level of below-knee vessels), passing the device over a 0.018-inch guidewire. In all cases, there were no significant complications correlated to the retrograde access. The use of the Outback re-entry catheter after complex retrograde subintimal infrainguinal recanalization has been demonstrated to be effective and safe. The possibility of passing it over a 0.018-inch guidewire gives the chance of doing it without inserting a sheath, reducing the size of the access and possible complications.Fig 2Precise re-entry obtained at the level of the short superficial femoral artery stump and at the anterior tibial origin in two different cases, with wire always eventually passed into the sheath coming from the antegrade access.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

P1814A novel method of transradial approach for left ventricular endomyocardial biopsy

Abstract Background Left ventricular endomyocardial biopsy (LV-EMB) may offer a superior diagnostic yield compared with right ventricular endomyocardial biopsy (RV-EMB) in conditions predominantly affecting the LV. Recently, transradial way is used for LV-EMB, and it has lower complication rates and has an advantage of immediate post-procedural ambulation compared with transfemoral technique. Previous reports of transradial LV-EMB need relatively complicated sheathless guiding catheter exchanging. Purpose We aimed at finding a novel and easier transradial method with a 6F sheath and a 6F guiding catheter. Methods and results In this manuscript, we described a method that allowed interventional cardiologists to obtain LV-EMB via transradial access with a 6F sheath and a 6F guiding catheter. This technique was successfully conducted in 25 consecutive patients at our institution. The transradial success rate was 100% (25 of 25). Mild or moderate radial artery spasm occurred in only 1 (4%) patient, but no severe radial spasm was observed. All the patients were performed coronary angiography and left ventricular angiogram according to the indication, and they were performed EMB through the same radial sheaths without sheathless guiding catheter exchanging. Heparin was administered to 100% of patients at a dose of 5000IU. Median fluoroscopy time was 13.45min. Median total skin dose was 1478mGy. Median area product was 15486 cGy·cm2. All biopsy samples were graded as excellent quality. Immediate patient mobilization could be achieved in all patients. Radial artery patency was confirmed by doppler ultrasonography 24 hours after the sheath removal. There were no major complications (pericardial tamponade, life-threatening arrhythmia, cerebrovascular accident or death). Transradial LV-EMB with a 6F sheath Conclusions The present article demonstrates a result of feasibility, safety and efficacy of a novel transradial access for LV-EMB using a 6F sheath and a 6F guiding catheter. This is of clinical importance since this new technique may overcome the currently existing methods, and may be regarded as an interventional “one stop shop” technique.

P2804Initial experience with the novel BioMime Morph 40–60 mm long sirolimus-eluting tapered stent in long coronary lesions

Abstract Aims Aims: Long lesions treated with overlapping stents has been reported to be associated with healing problems and/or adverse events. The novel BioMime Morph is a 40, 50 and 60 mm long sirolimus-eluting cobalt chromium stent (65 μm strut thickness, biodegradable polymer) with a tapered design (0.5 mm taper from proximal to distal end) and is available in the following proximal and distal diameters (2.75–2.2 5mm, 3–2.5 mm and 3.5–3 mm). It can be a novel alternative for treatment of long coronary lesions, overcoming the limitations of overlapping stents. Methods and results Methods: Data was evaluated from our centre's prospective BioMime Morph database from August 2016 - January 2019. Primary endpoint was device oriented composite endpoint (DOCE: cardiac death, TV-MI, TLR and TVR). Secondary endpoints were technical (successful Morph implantation) and procedural success (successful procedure with Morph without in-hospital MACE). Results 103 patients had BioMime Morph stents implanted, with mean follow up of 411 (±214) days and a mean age of 66 (±11) years. Co-morbidities included hypertension (58%), hypercholesterolemia (38%), diabetes mellitus (28%), PVD (2%), CVD (5%), CKD (12%), previous MI (17%), smoking (40%) and positive family history (20%). There was history of previous PCI in 18% and CABG in 4%. Indication for PCI was predominantly ACS (78% including 13% STEMI), 15% were CTOs. 80% of the procedures were performed via radial access using 5–6F sheath in 73%. Vessels treated included LAD (43%), Cx (12%) and RCA (45%). Pre-dilatation was performed in 96% including use of non-complaint balloons in 51%, scoring balloons in 12% and rotablation in 4%. Post-dilatation was performed in 99%. Buddy wire was used in 41% while a guideliner used in 13%. Technical success (secondary endpoint) was achieved in 100 whilst procedural success was achieved in 96% (4 cases of contrast induced nephropathy). Cumulative DOCE (primary endpoint) was % (cardiac death 1%, TV-MI 1%, definitive ST 0%, possible ST 1%, TLR 2% and TVR 2%). OCT follow up at 1 month, 3 month and 6 months in 2 patients showed endothelialisation even at 1 month. Conclusions Our initial experience of the use of the novel BioMime Morph tapered DES for treatment of long coronary lesions exhibit promising results in short to medium follow-up. Elution of the drug in 1 month along with biodegradable polymer and ultra thin struts potentially helps early healing and raises the possibility of short DAPT even in these complex long lesions. BioMime Morph stents can potentially be an alternative to overlapping conventional stents for treating long coronary lesions.

Percutaneous Trans-Carotid Puncture for Mechanical Thrombectomy in Acute Ischemic Stroke Patients is Safe and Effective: A Large, Single-Center Case Series

Abstract INTRODUCTION Although endovascular thrombectomy is a highly effective treatment for patients with large-vessel occlusion stroke, the procedure can be prolonged, or even impossible, due to difficult vascular access. We hypothesized that patients undergoing percutaneous transcarotid puncture (PTCP) as an alternative approach would have improved functional outcome compared to patients where a transfemoral approach was precluded. METHODS For PTCP, a 6F (5.5-cm) sheath was placed in the common carotid artery using an ultrasound-guided, micropuncture technique. Mechanical thrombectomy (MT) was performed using a stent retriever with adjunctive contact aspiration. We compared patients with unsuccessful MT due to transfemoral access failure with patients who were treated using PTCP. Functional outcome was assessed using the modified Rankin scale (mRS) at 3-mo. Associations with outcome were analyzed using ordinal logistic regression, adjusted for age and admission NIHSS. RESULTS PTCP was performed in 20 cases and carotid access was successfully obtained in 19/20 patients (1 abandoned due to inability to safely cannulate the artery). A total of 17 patients who were well matched for age, gender, and admission NIHSS served as historical controls. A total of 36 patients were included in the final analysis (82 yr [SD 11], 25 M, mean admission NIHSS 17). Successful reperfusion (TICI 2b-3) was achieved in 16/19 (84%), with 26% achieving good outcome (mRS 0-3) at 90 d compared to 6% of historical controls. In the shift analysis, PTCP was independently associated with lower (better) mRS scores at 3 mo (adjusted common OR 5.2, 95% CI 1.02-24.5, P = .048). PTCP cases also had smaller infarct volumes (median 11 vs 48 ml, P = .041) and greater reduction in NIHSS (−4 vs + 2.9, P = .034). A single patient suffered a fatal carotid blowout on post-MT day 4. CONCLUSION PTCP for emergent MT is a safe and effective strategy that yields high recanalization rates, decreased infarct volumes and improved functional outcome among patients with transfemoral access failure.

Abstract TP15: Percutaneous Transcarotid Puncture is a Viable Alternative for Thrombectomy in Acute Ischemic Stroke Patients With Difficult Vascular Access

Introduction: Although endovascular thrombectomy is a highly effective treatment for patients with large-vessel occlusion stroke, the procedure can be prolonged, or even impossible, due to difficult vascular access. We hypothesized that patients undergoing percutaneous transcarotid puncture (PTCP) as an alternative approach would have improved functional outcome compared to patients where a transfemoral approach was precluded. Methods: For PTCP, a 6F (5.5-cm) sheath was placed in the common carotid artery using an ultrasound-guided, micropuncture technique. Mechanical thrombectomy (MT) was performed using stent retriever with adjunctive aspiration. We compared patients with unsuccessful MT due to transfemoral access failure with patients who were treated using PTCP. Functional outcome was assessed using the modified Rankin scale (mRS) at 3-months. Associations with outcome were analyzed using ordinal regression, adjusted for age and admission NIHSS. Results: We included 34 patients in the study (82 years [SD 11], 25M, mean admission NIHSS 17). PTCP was performed in 20 cases. 14 patients who were well matched for age, gender and admission NIHSS served as historical controls. Carotid access was obtained in 19/20 patients (1 abandoned due to inability to safely cannulate the artery). Successful reperfusion (TICI 2b-3) was achieved in 16/19 (84%), with 28% achieving good outcome (mRS 0-3) at 90 days compared to 7% of historical controls (p=0.087, Figure 1). PTCP cases also had a trend toward smaller infarct volumes (median 10 vs 38 ml, p=0.084) and greater reduction in NIHSS (-3.4 vs +2.8, p= 0.083). A single patient suffered a fatal carotid blowout on post-MT day 4. Conclusions: PTCP for emergent MT is a safe and effective strategy that yields high recanalization rates, and possibly improved functional outcome among patients with transfemoral access failure.

Abstract 17406: Early Experience With Ultrasound Guided Distal Trans-Radial Access in the Anatomical Snuffbox in Coronary Angiography and Intervention

Early experience with ultrasound guided distal trans-radial access in the anatomical snuffbox in coronary angiography and intervention. Objective: We aimed to demonstrate the feasibility and safety of the ultrasound guided distal trans-radial coronary angiography and intervention. Methods: Patients assigned to one operator program underwent diagnostic or procedural intervention through distal trans-radial approach in the anatomical snuffbox between January 2018 and May 2018. All of patients had palpable artery in their distal radial artery. The operator did the coronary procedure via distal radial access at anatomical snuffbox. When the pulse was weak or the target artery was very small, the operator punctured under ultrasound guidance (V-scan with dual probe, GE heathcare, USA) Results: 56 patients were enrolled. Mean age of patients was 65.1 years old and 68% were male. About 70% of patients were presented with stable angina feature. In diagnostic procedure, 4F (3, 5.6%) or 5F (29, 54.7%) sheath was used and we did coronary intervention via 6F (21, 39.6%) Sheath. Ultrasound guided puncture was done for 33 patients (58.9%). Overall Success rate of distal trans-radial angiography and intervention was 94.6% (3 failed cases). Success rate of ultrasound guided procedure was 97% (only 1 failed case). Left distal radial puncture was done for 18 patients (33.9%). 16% of patients had chronic kidney disease, especially end stage renal disease (11%) to preserve radial artery which was potential candidate of arteriovenous fistulae for dialysis. There was no BARC type 2-5 bleeding in hospital stay and follow up at out-patient clinic. Conclusion: Ultra sound guided distal radial approach is feasible and safe as a good alternative technique for coronary angiography and interventions.

Outcomes of Brachial Artery Access for Endovascular Interventions

A percutaneous brachial artery (BA) approach is a suitable or even favorable alternative to femoral artery access when performing certain endovascular interventions. However, this approach may have a higher complication rate compared to femoral artery access. We analyzed our results using percutaneous BA approach for noncardiac endovascular interventions. Between January 1, 2003 and December 31, 2017, BA access was used in 157 cases performed on 136 patients. The procedures included 102 (65%) therapeutic interventions and 55 (35%) diagnostic studies. The vessels studied or treated included lower extremity arteries (48), the aorta and iliac arteries (45), mesenteric arteries (45), failing arterial revascularizations (24), renal arteries (9), subclavian arteries (8), carotid arteries (2), and visceral aneurysms (2), or in conjunction with endovascular aneurysm repair (EVAR), fenestrated EVAR, or thoracic EVAR (8). More than 1 vessel was studied or treated in 34 cases. Sheath sizes included 5F in 38 (24%) cases, 6F in 93 (59%) cases, and 7F in 26 (17%) cases. Percutaneous puncture was utilized in 142 (90.4%) cases and planned surgical exposure with primary closure of the BA in 15 (9.6%) cases (10, 7F; 4, 6F; 1, 5F). Manual compression was used for hemostasis at the conclusion of all percutaneous cases. There were 2 (1.3%; 2/157 cases) deaths in the perioperative period, one due to myocardial infarction and the other from mesenteric ischemia. Access site complications occurred in 10.6% (15/142) of percutaneous cases, which required open surgical repair for bleeding (8) and BA thrombosis (7). There was an increased risk of complications with increasing sheath size in the percutaneous approach: 5.4% (2/37), 12.4% (11/89), and 12.5% (2/16) for 5F, 6F, and 7F sheaths, respectively (P=0.49). None of the 15 patients who underwent surgical treatment suffered long-term vascular or neuropathic complications. In our experience, percutaneous BA access was associated with a 10% complication rate with an increased risk of complications associated with increasing sheath size. There was approximately the same incidence of bleeding as thrombosis. For patients who require 6 or 7F sheaths via a BA approach, we recommend more liberal use of open surgical exposure and primary BA repair.

FemoSeal® Device Use for Femoral Artery Closure by Different Techniques

Common femoral artery is still the most frequently used site for vascular access, mostly for peripheral arterial interventions, and its puncture remains a significant source of patient's morbidity. Manual compression (MC) has been the gold standard for hemostasis after femoral catheterization until recently, but only in the last few years, vascular closure devices (VCDs) are replacing MC due to their rapid development. Nowadays, vascular surgeons (VSs) are also becoming familiar with VCDs. The purpose of this study was to investigate FemoSeal® arterial closure system use in terms of safety and efficacy in patients undergoing transfemoral peripheral procedure and evaluate the complication risk factors. A retrospective analysis to compare 2 different specialists and technique with systematic implantation of FemoSeal® VCD was performed in a cohort of vascular patients treated by endovascular procedure with femoral artery access site over a 2-year period and sheaths ranged from 6F to 8F. All the patients were on antiplatelet therapy and received heparin during the procedure. The FemoSeal® was deployed in common femoral arteries. All patients were examined for access site complication by VS in both groups 20-24hrs after VCD deployment and 1 and 6weeks after the procedure with clinical visit and ultrasound duplex scan. Complications, as minor and major hematomas, pseudoaneurysm formation, vessel occlusion or dissection, and infection were recorded. During the study period, 130 FemoSeal® were deployed in 114 patients, 102 FemoSeal® in VS group, and 28 in interventionalist group. Mean age was 57±24years. There was no significant difference between the 2 groups in terms of comorbidities. Patient follow-up ranged from 1 to 15months. All but 3 of the FemoSeal® devices were successfully deployed (all 3 cases in group 2). Mobilization time was 6±4hrs following interventions, and the discharge time ranged from 6hrs to 7days after procedure. Early discharge (within 6hrs) was obtained in 23% of group 1 and in 0 cases of group 2 (P = 0.008). Delayed discharge was obtained in 74% of group 1 (67 pts) and in 70% of group 2 (18 pts) on postoperative day 1 (P = 0.47). Technical success was achieved in 99% of group 1 and in 93% of group 2 (P = 0.87). There were no perioperative deaths. There were no significant differences in terms of minor bleeding complications (P = 0.21) or infections or transfusion needing (P 0.06) in both groups. FemoSeal®-related complications occurred in 6 patients (1 in group 1 and 5 in group 2; P=0.0017). All complications occurred following therapeutic intervention with 6F sheath introducer. Complication rate resulted significatively higher in group 2 in terms of pseudoaneurysm development (P<0.0001) and transfusion needing (P = 0.03) in a subgroup analysis on peripheral arterial disease (Rutherford 3-5). Only chronic limb ischemia was found to be independent predictor of complications due to VCD use. Our data suggest that when simple guidelines are observed, the device is safe, effective, and easy to deploy and allows for early ambulation and discharge. However, appropriate randomized clinical trials could clarify the correct guideline to minimize the complication rates.

Safety and Efficacy of Arterial Closure Devices in an Office-Based Angiosuite

We aimed to compare the safety and efficacy of 5 arterial closure devices in an outpatient endovascular surgery center. We retrospectively reviewed all cases using femoral arterial access performed between January 2012 and December 2013. Five different arterial closure devices (AngioSeal, Perclose, StarClose, ExoSeal, and Mynx) were used by 7 endovascular surgeons. All femoral arteries were accessed with 6F sheaths under ultrasound guidance. All patients received systemic anticoagulation with sodium heparin (70 IU/kg). Sheath-shot angiograms of all arterial punctures were taken before deploying closure devices. Device failure was defined as any partial or complete failure requiring additional closure assistance. Minor complication was defined as any event that occurred because of incomplete hemostasis but did not result in hospitalization, including hematoma, hypotension, bleeding, arterial dissection, or extended recovery. Major complication was defined as any event that occurred because of incomplete hemostasis requiring inpatient management. Any device failure was identified per device and per surgeon. Device safety, efficacy, and relationships between other variables were analyzed using a binomial logistic regression. Results with P values<0.05 were considered to be statistically significant. During the study period, there were a total of 3142 endovascular procedures, including 1976 arterial cases (62.9%). Out of 1898 femoral artery punctures, closure devices were used in 1810 (95.4%), which forms the basis of this report. Device failure occurred in 151 cases (8.34%), and minor complications occurred in 53 cases (2.93%). There were 11 hospitalizations (0.61%). AngioSeal had both the lowest device failure rate (3.5%) and minor complication rate (1.3%). Our data showed a significant difference between the respective arterial closure devices for device failure rate (P=0.007) and minor complication rate (P=0.049), but not for major complication rate (P=0.199). No significant difference was observed between surgeons for device failure (P=0.798), minor complication (P=0.218), or major complication rate (P=0.899). With the lowest device failure and minor complication rate, AngioSeal is a consistently well-performing arterial closure device in the office surgical suite setting.

Procedural sedation during transradial coronary angiography. Impact of opiod analgesia and inhalation sedation by 50% nitrous oxide/oxygen premix (Kalinox) on pain and radial artery spasm

The aim of this study was to investigate the respective impact of opiods analgesia and inhalation sedation with a 50% nitrous oxide/oxygen premix (Kalinox) on pain and occurence of radial artery spasm (RAS) during transradial coronary procedures. Backgroud With respect to the transfemoral approach, transradial procedures enable a drastic reduction of bleeding events and are associated with a reduction of mortality. RAS is one of the most common complications and may lead to patient discomfort and procedural failure. Currently, there is no consensus on the optimal sedation protocol to avoid RAS. Consecutive patients undergoing transradial coronary angiography were prospectively enrolled in one single center study (Nouvel Hôpital Civil, Strasbourg, France). Patients were allocated to opioids analgesia or inhalation sedation with Kalinox. The primary endpoints of the study were the incidence of a pain scale more than or equal to 5 and the occurrence of RAS. The secondary endpoint included the occurrence of side effects including nausea, vomiting, dizziness or faintness and headache. From September 2016 to February 2017 a total of 325 patients were enrolled (Opiods Analgesia n = 185, Kalinox n = 140). RAS and Pain scale ≥ 5 rates were not significantly differents in Opiods Analgesia and Kalinox groups (respectively 13.5% vs. 10% and 16.2% vs. 11.4%). Headache was more frequently observed in the kalinox group (6.4% vs. 0%; P = 0.002). By multivariate analysis, female gender, BMI < 25 kg/m 2 , puncture difficulty, the use of plastic needle and 6F sheath were indentified as independent predictors of RAS. Procedural inhalation sedation by Kalinox is as safe as Opiods Analgesia during transradial coronary angiography.

TAVI WITH A SINGLE FEMORAL APPROACH: PRELIMINARY SINGLE-CENTRE EXPERIENCE

To describe our initial experience with the transradial approach as secondary access site in TAVI. As of April 2016, a strategy of systematic transradial approach as secondary access site for TAVI was adopted in our centre. A 5 F 125 cm multipurpose catheter was navigated from the left or right radial artery into the common iliac artery to assist in main access puncture. The catheter was then exchanged for a pigtail, which was positioned on the aortic valve to guide TAVI. The multipurpose catheter was used again at the end of the procedure to assess ilio-femoral integrity. In case of an iliac or femoral access complication, the radial sheath was exchanged for a 120 cm long 5F sheath. A 0.018’/400 cm nitinol guidewire was introduced beyond the lesion and a compatible long shaft (180 cm) 5F balloon or nitinol self-expandable stent was introduced and used accordingly. In case of a perforation, a balloon was inflated proximal to the lesion in order to stop the bleeding and contralateral femoral access was obtained in order to deploy a covered stent via a 6F sheath. From April 2016, 184 patients underwent TAVI using this strategy. Patients had a mean age of 83±5.9 years, 52.2% were male, mean Logistic Euroscore and STS score were 16.5±11.6% and 5.3±4.7%, respectively. 97 (52.7%) patients received a balloon-expandable valve and 87 (47.3%) received a self-expandable valve. Transradial access as secondary approach was not used in 30 of 184 patients (16.3%) for the following reasons: absence of radial pulse or unsuitable artery size (n=14; 7.6%), prohibitive patient height (n=1; 0.8%), physician preference n=15; 8.1%). TAVI was successful in all cases. No complications occurred due to transradial access. Transfemoral vascular access site complications occurred in 8 cases (4.3 %): three occlusion, two flow-limiting stenoses and three perforations of the common femoral artery. Five complications were successfully managed using self-expanding stents from the transradial access. The 3 cases of perforation (1.6%) were successfully treated with a covered stent delivered via femoral crossover. There were no additional major vascular complications at 30 days. Use of the radial approach for secondary access in TAVI is safe and feasible. Most primary access site complications were manageable from the radial access site. A low rate of crossover to the contralateral femoral approach (1.6 %) was necessary. Further large-scale studies are necessary to confirm the benefits of this approach.