Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry

Purpose: This postmarketing surveillance study aimed to assess effectiveness and safety of a peripheral self-expanding stent with high torsional strength (POLARIS stent) for the treatment of de novo superficial femoral artery (SFA) lesions in the routine clinical practice. Materials and Methods: Consecutive patients with symptomatic de novo SFA occlusive disease who underwent POLARIS stent implantation were enrolled into the prospective, multicenter, observational postmarket surveillance study. Primary outcome measure was freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Main secondary outcomes were procedural success, primary clinical improvement, and freedom from major adverse cardiovascular and limb events (MACLE) throughout 24 months. Results: A total of 199 participants (70±11 years, 70.4% men) were included in the study at 9 German sites from December 2014 to August 2018. Half of them (52.6%) were current smokers, 37.6% had diabetes, and 25.0% were obese. Most participants suffered from intermittent claudication (88.4%). Mean lesion length was 98±83 mm, 43.5% of lesions were occluded, and 27.3% were severely calcified. Freedom from 12 months cdTLR was 94.4% (95% confidence interval [CI], 90.6–98.2). At 24 months, freedom from cdTLR was 88.7% (95% CI, 83.0–94.4). Procedural success was achieved in 96.2% of participants. Primary clinical improvement occurred in 87.5% and 85.4% of participants at 12 and 24 months, respectively. Freedom from MACLE was 94.8% (95% CI, 91.4–98.1) and 93.8% (95% CI, 89.9–97.6) at 12 and 24 months, respectively. Conclusions: Treatment of SFA occlusive disease in a real-world setting using the POLARIS stent with high bidirectional torsional strength is efficacious and does not raise any safety concern in the medium term. The study is registered with ClinicalTrials.gov (Identifier: NCT02307292).

Prediction of procedural success of transcatheter mitral valve repair with normal and extended clip arms

TMVR using different clip sizes is a treatment option for selected patients with mitral regurgitation (MR). This study sought to identify predictors of successful transcatheter mitral valve repair (TMVR) by 3-dimensional (3D) echocardiography and to compare different effects of the larger XTR and the smaller NT/NTR devices. 3D transesophageal echocardiography was performed on 54 patients with secondary MR undergoing TMVR with one clip (55.6% NT/NTR, 44.4% XTR). All NT/NTR and 96% of XTR patients had MR reduction ≤ 2+. Despite more severe baseline MR (3D vena contracta area (VCA): 0.67 ± 0.34 cm2 vs. 0.43 ± 0.19 cm2, p = 0.004) and greater mitral valve area (MVA) (6.8 ± 2.1 cm2 vs. 5.1 ± 1.6 cm2, p = 0.001) in the XTR group, MR severity after TMVR was not different between XTR and NT/NTR patients (3D VCA: 0.19 ± 0.14 vs. 0.17 ± 0.10, p = 0.51). Baseline 3D VCA > 0.45 cm2 in NT/NTR (AUC = 0.802, 95% CI 0.602 to 1.000) and 3D VCA > 0.54 cm2 in XTR devices (AUC = 0.868, 95% CI 0.719 to 1.000) were associated with ineffective MR reduction defined as residual VCA ≤ 0.2 cm2. Baseline MVA ≤ 4.2 cm2 in NT/NTR (AUC = 0.920, 95% CI 0.809 to 1.000) and MVA ≤ 6.0 cm2 in XTR devices (AUC = 0.865, 95% CI 0.664 to 1.000) were associated with postprocedural transmitral pressure gradient (TMPG) ≥ 5 mmHg. TMVR using the XTR device resulted in an equally effective reduction of MR despite of a greater baseline MR. Distinct cut-off values of baseline 3D VCA and MVA for prediction of successful MR reduction and postprocedural increase of TMPG were identified for the different devices.

Standardized Forearm Angiography Increases Procedural Success Rates of Coronary Angiography and PCI: A Retrospective Analysis of an All-Comers Patient Cohort

Background: There is a consensus, that transradial-access (TRA) for coronary procedures should be preferred over transfemoral-access (TFA). Previously, forearm-artery-angiography was mainly performed when difficulties during the advancement of the guidewire were encountered. We explored the implication of a standardized forearm-angiography (SFA) on procedural success rates of TRA.Methods: 1191 consecutive cases were assessed retrospectively. Primary TFA rates, crossover to TFA, reasons for forearm-artery-access (FAA) failure, the prevalence of kinking at the level of the forearm and the occurrence of vascular complications were analyzed.Results: Primary FAA access was attempted in 97.9%. Crossover to TFA after a primary or secondary FAA attempt was necessary in 2.8%. Severe kinking was the most frequent cause of FAA failure and occurred in 3.0%. A second or third FAA attempt to avoid TFA was successful in 81%. Severe kinking at the level of the forearm was reported in 1.8%.Conclusion:This is the first study to provide detailed success rates of a primary FAA strategy combined with SFA. While severe kinking proved to be a rare but relevant challenge for FAA success, the prevalence of arterial spasm was marginal. Multiple attempts of FAA to avoid TFA might be safe possibly due to collateral blood supply.

Hemodynamics in mitral regurgitation – before and after correction with MitraClip

Haemodynamic changes in mitral regurgitation underlie triggering of patient’s symptoms and development of heart failure. A number of endovascular methods for the correction of mitral regurgitation successfully counteract pathological hemodynamics and thus manage to improve both the manifestations of heart failure and the patient's symptoms. This article is a review of the physiology of the mitral valve and the changes that occur in the presence of mitral regurgitation. The peculiarities of the hemodynamics of the left atrium in the conditions of mitral regurgitation and after some types of transcatheter treatment – edge-to-edge correction of the valve with Mitraclip and the implantation of an occluder in paraprosthetic mitral regurgitation are considered. The change in left atrial parameters immediately after correction of the defect is of value both for the assessment of immediate procedural success and for the patient's prognosis.

Endovascular salvage of failing arterio-venous fistulas utilising sirolimus eluting balloons: Six months results from the ISABELLA trial

Background: Aim of this pilot clinical study was to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-eluting balloon (SEB) for improving failing arterio-venous fistulas (AVF) patency in Asian haemodialysis patients. Methods: Prospective single-centre, multi-investigator, non-consecutive, non-blinded single arm trial. Forty end-stage renal failure Asian patients with a dysfunctional AVF underwent SEB angioplasty between May and November 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to SEB angioplasty. Endpoints of interest included target lesion primary patency and circuit access patency and safety through 30 days. All patients received dual antiplatelet therapy for 1 month and were followed up with Duplex ultrasound at 6 months. Results: There was one subject dropout so final n = 39 patients (mean age 65.0 ± 11.9; males = 26 (66.7%)) and n = 43 target lesions treated. Main indication for intervention was dropping access flow (24/39; 61.5%) and most common target lesion was in the juxta-anastomosis (24/43; 54.5%). There was 100% technical and procedural success. There were no adverse events related to the SEB. Target lesion primary patency rates at 3 and 6 months were 39/41 (95.1%) and 28/39 (71.8%) respectively. Access circuit patency rates at 3 and 6 months were 35/37 (94.6%) and 22/35 (62.9%) respectively. There were 3 (7.7%) deaths all attributable to patients’ underlying co-morbidities. Conclusions: Fistuloplasty using the novel Selution SLR™ SEB for dysfunctional AVF circuits seems a safe and effective modality in Asian haemodialysis patients at 6 months but larger randomised controlled studies are required now to determine its true efficacy against plain balloon angioplasty.

Anatomical Classification and Posttreatment Remodeling Characteristics to Guide Management and Follow-Up of Neonates and Infants With Coronary Artery Fistula: A Multicenter Study From the Coronary Artery Fistula Registry

Background: Coronary artery fistulas (CAFs) presenting in infancy are rare, and data regarding postclosure sequelae and follow-up are limited. Methods: A retrospective review of all the neonates and infants (<1 year) was conducted from the CAF registry for CAF treatment. The CAF type (proximal or distal), size, treatment method, and follow-up angiography were reviewed to assess outcomes and coronary remodeling. Results: Forty-eight patients were included from 20 centers. Of these, 30 were proximal and 18 had distal CAF; 39 were large, 7 medium, and 2 had small CAF. The median age and weight was 0.16 years (0.01–1) and 4.2 kg (1.7–10.6). Heart failure was noted in 28 of 48 (58%) patients. Transcatheter closure was performed in 24, surgical closure in 18, and 6 were observed medically. Procedural success was 92% and 94 % for transcatheter closure and surgical closure, respectively. Follow-up data were obtained in 34 of 48 (70%) at a median of 2.9 (0.1–18) years. Angiography to assess remodeling was available in 20 of 48 (41%). I. Optimal remodeling (n=10, 7 proximal and 3 distal CAF). II. Suboptimal remodeling (n=7) included (A) symptomatic coronary thrombosis (n=2, distal CAF), (B) asymptomatic coronary thrombosis (n=3, 1 proximal and 2 distal CAF), and (C) partial thrombosis with residual cul-de-sac (n=1, proximal CAF) and vessel irregularity with stenosis (n=1, distal CAF). Finally, (III) persistent coronary artery dilation (n=4). Antiplatelets and anticoagulation were used in 31 and 7 patients post-closure, respectively. Overall, 7 of 10 (70%) with proximal CAF had optimal remodeling, but 5 of 11 (45%) with distal CAF had suboptimal remodeling. Only 1 of 7 patients with suboptimal remodeling were on anticoagulation. Conclusions: Neonates/infants with hemodynamically significant CAF can be treated by transcatheter or surgical closure with excellent procedural success. Patients with distal CAF are at higher risk for suboptimal remodeling. Postclosure anticoagulation and follow-up coronary anatomic evaluation are warranted.

680 Peripheral intravascular lithotripsy of ILEO-femoral arteries to facilitate transfemoral TAVI: a multicentric prospective registry

Aims The presence of severe calcific atherosclerosis at the iliofemoral axis may preclude transcatheter aortic valve implantation (TAVI) by transfemoral (TF) approach. Intravascular lithotripsy (IVL) is a novel technology that fractures intimal/medial calcium and increases vessel compliance allowing TF-TAVI in selected patients with peripheral artery disease (PAD). To report on the safety and efficacy of IVL-assisted TF-TAVI in an all-comers population. Methods and results Clinical, imaging and procedural data on all consecutive patients treated by IVL-assisted TF-TAVI in six high-volume European centres (2018–2020) were collected in this prospective, real-world, multicentre registry. IVL-assisted TF-TAVI was performed in 108 patients, increasing from 2.4% to 6.5% of all TAVI in 2018 to 2020, respectively. The target lesion was most often localized at the common and/or external iliac artery (93.5% of cases; average TL-MLD 4.6 ± 0.9 mm with 318 degrees of calcium arc). Transfemoral aortic valve delivery was successful in 100% of cases; final procedural success in 98.2% (two conversion to cardiac open surgery for annular rupture and valve migration). Complications of the IVL-treated segments consisted of one perforation and three major dissections requiring stent implantation (two covered stents and two BMS). Access site related complication included three major bleedings. Three in-hospital deaths were recorded (2.8%, one failed surgical conversion after annular rupture, one cardiac arrest after initial valvuloplasty, one late hyperkalaemia in renal dysfunction). Conclusions IVL-assisted TF-TAVI proved to be a safe and effective approach, which helps expanding the indications for TF-TAVI in patients with severe calcific PAD. Still, these patients maintain a higher than average incidence of peri-procedural complication.

696 Moderate sedation for transesophageal echocardiography guidance of percutaneous left atrial appendage closure: the MID-DEX protocol

Aims Left atrial appendage closure (LAAC) is usually performed under general anesthesia to allow prolonged transesophageal echocardiography (TEE) guidance. There is scarce knowledge about the feasibility and safety of moderate conscious sedation (MCS) in LAAC. We aimed to assess the feasibility, effectiveness and safety of an innovative MCS protocol of dexmedetomidine plus midazolam (MID-DEX), in a retrospective population of LAAC patients. Methods and results A total of 100 patients underwent LAAC with MCS using the MID-DEX protocol between May 2019 and January 2021 in a single centre. Clinical and procedural outcomes of these patients have been collected in the context of a retrospective registry on LAAC with the Watchman FLX device. All patients were treated preoperative with Dex, administered with initial bolus infusion (1.0 mcg/kg) in 10 min, then i.v. infusion was maintained throughout the LAAC procedure (0.2–1.0 μg/kg/h), tailored on patient’s frailty (advanced age, low body mass index) and haemodynamic status (BP, HR). Midazolam was administered to patients after Dex bolus, to induce sedation and to ease probe insertion, according to patient age and respiratory status (from 2.5 to max 10 mg). The ease of insertion of the TEE probe (one very easy—five impossible), and the duration of the TEE (m′) were recorded. Additional variables were: total amount of each drug given, time to recovery from sedation. After procedure a verbal survey about the quality of sedation, level of comfort, recall of the procedure, and future acceptance of this type of sedation was administered. The operators also rated the procedural conditions on a scale of 1–5 (5 = excellent). Mean patient age was 78.5 ± 6.96 years and 34% were women. The mean LVEF was 62.9 ± 8.9%. All patients underwent LAAC under MID-DEX MCS protocol with an acute procedural success rate of 100%. Ninety patients (90%) successfully underwent TEE under MCS; in 10 patients ICE guidance was required. Fluoroscopic time was 31 ± 21.7 min. The median required dosage of Dex infusion was 0.08–0.09 μg/kg/h and midazolam was 6.2 ± 2.4 mg. No complications were observed from MCS. There was no need for conversion to GA during the procedure. We observed five cases of bradycardia (solved by reducing to half Dex infusion) and three of hypotension (only two requiring Ringer’s solution infusion). Echocardiographist rated procedural conditions as perfect (5) in 85% of cases and good (4) in 6%. Interventionalist rated procedural comfort with 5 (excellent) in 90% of cases and 4 (good) in 3%. Patients satisfaction was high with best rate (5) in 80% with 5% of 4 (good); 12% described the procedure as fair, without memory of discomfort. Conclusions LAAC is safe and effective when performed under MCS. Thus, applying MCS may simplify the LAAC procedure, as well as reduce procedural time and procedural costs, while increasing overall patient and physician satisfaction.

637 Real-world experience with the new watchman FLX device: data from two high volume sicilian centres. The FLX-iest registry

Aims Left Atrial Appendage closure (LAAC) represents a standard therapy for patients with Atrial Fibrillation and contraindication to oral anticoagulation (OAC). The ‘Watchman FLX’ presented innovative features: higher conformability to LAA shapes, reduced length of the device, closed ‘atraumatic’ distal end with ‘flex-ball’ shape during deployment, flattened covered external surface. We report the early ‘real-world’ experience with the innovative Watchman-FLX device, in two centres at high-procedural volume with consolidated LAAC experience. Methods and results From May 2019 to January 2021, we enrolled 200 consecutive patients treated with Watchman FLX in a non-randomized double-centre registry. We collected procedural data and followed up the patients for mid-term clinical outcomes. Mean age was 77 ± 7.18 years (67.5% male). Patients presented hypertension in 93% of cases, CKD in 57.5% (mean creatinine level 2 ± 1.1), Diabetes mellitus in 41.5%, Coronary artery disease and Heart failure in 55%. 29% had previous stroke and 56.5 bleeding events. Mean CHA2DS2-VASc was 5 ± 1.40 and HAS-BLED 4 ± 1.01. LAAC indication was: 39.5% of cases symptomatic Haemorrhage, 39% need for Triple antithrombotic therapy, 32% gastro-intestinal bleeding; 18% of patients presented OAC intolerance. TEE guidance was feasible in 186 cases (93%), of which 96 (48%) in general anesthesia and 90 (45%) in conscious sedation (MID-DEX) protocol. 14 ICE cases (7%) were performed in local anesthesia. FLX device repositioning after first attempt was required in 40 cases (20%) without any complication. Device size change, after first choice was needed in eight cases (4%). In one exceptional case simultaneous implant of two Watchman FLX devices was performed in a bi-lobed LAA. Peri-device leak was found in two cases (1%), one solved by changing FLX size (31 to 35 mm). Final procedural success was 99.5%; one unsuccessful case due to LAA reverse chicken-wing with very short depth; no device embolization. Six complications were related to access-site (3%), two cases of combined LAAC-Mitraclip procedure; two major bleedings occurred and one in-hospital death due to hemorrhagic shock (HAS-BLED = 6). At mean follow-up of 272 ± 172.76 days, only 2% of (non-device-related) stroke and 0.6% fatal bleeding resulted. Conclusions Our registry in a high-risk population treated with the innovative Watchman FLX device, showed high technical procedural success with easy implant and repositioning, no embolization, good LAA sealing and low rate of ischaemic/bleeding complications. 637 Figure

732 TEE role in patients selection for transcatheter edge to edge tricuspid repair

Aims The natural history of tricuspid valve (TV) regurgitation is characterized by dismal prognosis and high in-hospital mortality when treated with isolated TV surgery. Although the anatomy and the imaging of the TV are very challenging, the edge-to-edge repair with the TriClip (Abbott Vascular, Santa Clara, CA) showed promising results. We report preliminary results of our experience with the TriClip System in a cohort of ‘real life’ patients with functional tricuspid regurgitation (TR). Methods and results From January to September 2021, 30 consecutive patients with severe TR has been screened, 8 underwent transcatheter TriClip repair. The anatomical feasibility was established according to a complete transesophageal echocardiogram (TEE) and a dedicated CT scan for the right cardiac chambers. All the echocardiographic projections focused on right ventricle were used during the procedure, with the aim of optimizing the visualization of the catheters and device with respect to the anatomical structures of the tricuspid valve complex. The procedure was conducted under general anesthesia, guided by TEE and fluoroscopy. In-hospital and 30-day clinical and echocardiographic outcomes were recorded. The annulus septo-lateral diameter was enlarged in all cases, and functional TR was present in all patients. In two patients, the pacemaker lead interfered with leaflets coaptation. TR jet was predominantly central. The implant and procedural success were achieved in all cases, implanting one device in five patients and two in three patients. The final TR grade was 2+ in four patients and and 1+ in the others. All patients were extubated in the catheterization laboratory. There were no procedural or in-hospital adverse events. At 30-day follow-up, we observed significant improvement in clinical and echocardiographic outcomes. Conclusions In our experience, 26% of screened patients were selected for the procedure. Favourable anatomical findings for the TV edge-to-edge repair were the following: moderate leaflet tethering (coaptation depth &lt;10 mm); large annulus but with small coaptation gap (&lt;7 mm); antero-septal or postero-septal jet location; commissural jet; small right ventricular dimensions; pacemaker lead with no leaflet tethering. The best transcatheter approach consists of obliterating the antero-septal coaptation rim for a more favourable angle between the inferior vena cava and valvular plane. High-quality TEE imaging during the procedure is required for obtaining procedural success. Patient selection and tricuspid valve anatomy characterization with TEE and cardiac CT scan is critical for procedural success and clinical improvements.