High Procedural Success Research Articles

Upgrades from Previous Cardiac Implantable Electronic Devices Compared to De Novo Cardiac Resynchronization Therapy Implantations: Results from CRT Survey-II in the Turkish Population.

Cardiac resynchronization therapy is the guideline-directed treatment option in selected heart failure with reduced left ventricular ejection fraction patients. Data regarding the contemporary clinical practice of cardiac resynchronization therapy in Turkey have been published recently. This sub-study aims to compare clinical and periprocedural characteristics between cardiac resynchronization therapy upgrade and de novo implantations. Turkish arm of the Cardiac Resynchronization Therapy Survey-II was conducted between October 1, 2015, and December 31, 2016, at 16 centers. All consecutive patients who underwent an upgrade to cardiac resynchronization therapy system (n=60) or de novo cardiac resynchronization therapy implantation (n=335) were eligible. Distribution of age, gender, and heart failure etiology were similar in the 2 groups. Atrial fibrillation, valvular heart disease, and chronic kidney disease were more common in cardiac resynchronization therapy upgrade patients. Narrow intrinsic QRS duration and left ventricular ejection fraction being 75% in both groups, and only beta-blockers were prescribed at rates of >90% in both groups. Cardiac resynchronization therapy upgrades are performed with high procedural success rates and without excess periprocedural complication risk. Feared complications of cardiac resynchronization therapy upgrades due to the pre-existing device should not delay the procedure if indicated.

Upgrades from Previous Cardiac Implantable Electronic Devices Compared to De Novo Cardiac Resynchronization Therapy Implantations: Results from CRT Survey-II in the Turkish Population.

Cardiac resynchronization therapy is the guideline-directed treatment option in selected heart failure with reduced left ventricular ejection fraction patients. Data regarding the contemporary clinical practice of cardiac resynchronization therapy in Turkey have been published recently. This sub-study aims to compare clinical and periprocedural characteristics between cardiac resynchronization therapy upgrade and de novo implantations.Turkish arm of the Cardiac Resynchronization Therapy Survey-II was conducted between October 1, 2015, and December 31, 2016, at 16 centers. All consecutive patients who underwent an upgrade to cardiac resynchronization therapy system (n=60) or de novo cardiac resynchronization therapy implantation (n=335) were eligible.Distribution of age, gender, and heart failure etiology were similar in the 2 groups. Atrial fibrillation, valvular heart disease, and chronic kidney disease were more common in cardiac resynchronization therapy upgrade patients. Narrow intrinsic QRS duration and left ventricular ejection fraction being 75% in both groups, and only beta-blockers were prescribed at rates of >90% in both groups.Cardiac resynchronization therapy upgrades are performed with high procedural success rates and without excess periprocedural complication risk. Feared complications of cardiac resynchronization therapy upgrades due to the pre-existing device should not delay the procedure if indicated.

Mitral valve edge-to-edge repair versus indirect mitral valve annuloplasty in atrial functional mitral regurgitation.

We aimed to compare indirect mitral annuloplasty using the Carillon Mitral Contour System and edge-to-edge repair via MitraClip in atrial functional mitral regurgitation (aFMR). In patients with left ventricular dilation, both edge-to-edge repair and indirect mitral annuloplasty are effective in reducing mitral regurgitation, while no clinical trial has compared both interventional methods in aFMR. In a retrospective single-center analysis, 41 patients with aFMR underwent either edge-to-edge mitral valve repair (MitraClip group, n = 20) or indirect annuloplasty (Carillon group, n = 21). Both treatment groups showed high procedural success (100%) and low complication rates. Both treatment groups showed a comparable reduction of New York Heart Association (NYHA) classification postimplantation, after 3- and 12-months follow-up. Quantitative reduction in echocardiographic FMR parameters was significantly pronounced in the MitraClip group (reduction in vena contracta MitraClip vs. Carillon: postimplantation -74.6 ± 25.8 vs. -29.1 ± 17.8%, 3-months follow-up -65.8 ± 31.2 vs. -33.9 ± 17.5%, 12-months follow-up -50.8 ± 27.9 vs. -23.9 ± 17.0%, p < 0.05). Qualitative mitral valve assessment showed improved FMR class postimplantation, at 3-and 12-months follow-up in both treatment groups. Edge-to-edge repair revealed better results with lower average FMR classification compared to indirect coronary sinus-based annuloplasty. After 12-months left atrial (LA) volume was significantly reduced in the Carillon group, while in the MitraClip group no LA remodeling was found (reduction in LA volume MitraClip vs. Carillon at 12 months: +9.6 ± 25.1% vs. -12.3 ± 12.7%, p < 0.05). Both indirect mitral valve annuloplasty and edge-to-edge repair are feasible and safe in patients with aFMR, while the reduction in FMR was pronounced in the edge-to-edge repair group.

Calcific Plaque Modification by Acoustic Shockwaves: Intravascular Lithotripsy in Cardiovascular Interventions.

To provide a review of recent literature on the treatment of moderate-to-severe calcification in coronary and peripheral vasculature with intravascular lithotripsy (Shockwave Medical, Santa Clara, CA). Moderate-to-severe calcific plaques constitute a significant proportion of lesions treated with transcatheter interventions in the coronary and peripheral vascular beds and portend lower procedural success rates, increased periprocedural major adverse events, and unfavorable long-term clinical outcomes compared to non-calcific plaques. Intravascular lithotripsy (IVL) is a new technique that uses acoustic shock waves in a balloon-based system to induce fracture in the calcium deposits to facilitate luminal gain and stent expansion. IVL demonstrated high procedural success and low complication rates in the management of moderate-to-severe calcification in coronary and peripheral vascular beds and led to large luminal gain by modification of calcific plaque as assessed by optical coherence tomography. Further studies will determine the role of IVL in an integrated, protocolized approach to the treatment of severely calcified plaques in the coronary and peripheral vascular beds.

Use of catheter-based cholangioscopy in the diagnosis of indeterminate stenosis: a multicenter experience.

Direct bile ducts visualization through cholangioscopy has gained popularity due to its better diagnostic accuracy than a standard ERCP in indeterminate biliary stricture. We aimed to review our catheter-based cholangioscopy interventions in patients with indeterminate biliary stenosis, using the SpyGlass Direct Visualization System (SDVS) and summarize our experience in terms of procedures and results. We collected 25 consecutive patients with indeterminate biliary stricture over 3 years. The overall procedural success in our cohort amounted to 96% (24/25). If we focus on the diagnostic procedures, the ability to merely visualize the region of interest/lesion and perform biopsy of the lesion was possible in 96% (24/25) In our cohort localization in the common bile duct (P=0.03; 95% CI: 0.27-0.96) was found as positive determining factor for diagnosis. Sensitivity, specificity and accuracy for visual diagnosis by SDVS in our cohort were 100, 83.3 and 96%, respectively. The use of biopsy or obtaining a histological diagnosis to assist in identifying patients with malignant stenosis, to exclude malignancy and to correctly classify diagnosed patients resulted in a sensitivity of 100%, a specificity of 73% with an overall accuracy of 94.4%. Only a mild adverse event (cholangitis, treated conservatively) occurred. Today, the SDVS should be considered essential in diagnosing indeterminate biliary strictures, since the procedure is associated with high procedural success in terms of diagnostic accuracy, alters clinical outcome in over 80% of considered insolvable cases, with an acceptable safety profile.

Retrograde Percutaneous Tibial Approach for Complex Infrainguinal Occlusions in Chronic Limb-Threatening Ischemia After Failed Antegrade Transfemoral Approach

Introduction: A significant proportion (20%) of patients with complex infrainguinal arterial occlusions cannot be recanalized using a conventional antegrade endovascular approach. Most of these patients will be poor candidates for open surgical reconstruction owing to the concomitant cardiovascular and pulmonary comorbidities or poor venous conduit. We present our experience using the percutaneous retrograde pedal approach for revascularization of infrainguinal arterial occlusions after failed conventional endovascular options. Materials and Methods: This is a retrospective observational study of all the patients admitted in our center from May 2019 to May 2021 for chronic limb-threatening ischemia with infrainguinal occlusive disease and attempted retrograde tibial approach after failed antegrade transfemoral approach. Procedural success was defined as residual stenosis of &lt;30% after balloon angioplasty or stenting. Limb salvage was defined as freedom from major amputation during the follow-up period. Results: In a total of 20 patients managed with retrograde tibial approach, procedural success was achieved in 18 patients (90%). Limb salvage was achieved in 17 of the 18 patients who had procedural success during the follow-up period. One patient underwent below-knee amputation due to spreading infection. Conclusion: Retrograde tibial approach to recanalize infrainguinal arterial occlusions after failed traditional endovascular methods is safe and effective and should be advocated to avoid more invasive, time-consuming, and high-risk procedures as it offers high technical and procedural success rates with minimal complications.

Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience.

Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real-world data have not yet been reported. This study aimed to assess procedural and 30-day outcomes of TMVI in a real-world patient cohort. All consecutive patients undergoing implantation of a transapically delivered self-expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high-risk patients included (43% female, mean age 75 ± 7 years, mean STS-PROM 7.2 ± 5.3%), 25% was treated for an off-label indication (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (New York Heart Association [NYHA] functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 95% (38% primary, 37% secondary, and 25% mixed aetiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30-day all-cause mortality was 12%. At early clinical follow-up, MR reduction was sustained and there were significant reductions of pulmonary pressure (systolic pulmonary artery pressure 52 vs. 42 mmHg, p < 0.001), and tricuspid regurgitation severity (p=0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p < 0.001). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off-label indication (74% vs. 81% for off- vs. on-label, p=0.41). In a real-world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement.

Procedural and clinical outcomes after repeat edge-to-edge transcatheter mitral valve repair.

Evidence regarding redo percutaneous interventions for recurrent mitral regurgitation is scarce. We ought to evaluate procedural and clinical outcomes of repeated edge-to-edge transcatheter mitral valve repair (TMVR) interventions. This multicenter study collected individual data from eight high-volume TMVR Centers in Spain. Between 2012 and 2020, all patients undergoing a second edge-to-edge TMVR intervention (Redo) were included in the study. Among a total of 1028 procedures, 31 patients (3%) with residual MR ≥ 3 at follow-up underwent a second procedure (Redo). Redo intervention was mainly conducted between the first and second year after the first procedure. The most common cause of MR progression was partial detachment (46.7%) followed by LV remodeling (35.5%). Procedural success was achieved in 87% of cases. After a mean follow-up of 1.75 ± 1.54 years, all-cause and cardiovascular mortality were 48.1% and 25%, respectively. Nearly half of the patients (48.1%) required at least one hospital admission for CHF within the follow-up period. However, most of the patients presented symptomatic improvement as depicted by an NYHA class ≤2. Elective mitral surgery was conducted in only one patient at follow-up due to insufficient MR reduction. According to our findings, redo edge-to-edge TMVR interventions were feasible and safe with a high procedural success rate. Clinical and echocardiographic follow-up showed however modest long-term results in this specific setting.

Safety and procedural outcomes of intravascular lithotripsy in calcified coronaries in Indian patients

ObjectiveCalcified coronaries still remain a major challenge for interventional cardiologist. This study aims to evaluate safety and efficacy of intravascular lithotripsy (IVL) in management of coronary artery calcification. MethodsThis was a retrospective single centre study regarding the utility of IVL in management of calcified coronaries. Patients with hemodynamically stable acute coronary syndrome or symptomatic chronic coronary syndrome (CCS) and calcified coronaries on angiography and who underwent IVL were enrolled. Intravascular imaging was performed wherever feasible. The primary endpoint was procedural success. In addition, data regarding procedural complications were collected. ResultsA total of 29 patients underwent IVL with a majority being males and having comorbidities such as hypertension and diabetes. A procedural success rate of 93.1% was achieved with no patient having >50% residual stenosis. IVL catheter was successfully delivered in all patients. The mean catheter diameter was 3.3 ± 0.4 mm and mean number of delivered pulses was 70.3 ± 16.4. The arteries most commonly intervened were the left main coronary and the left anterior descending artery. Intracoronary imaging revealed a significant increase in minimum luminal cross-sectional area (MLA) post IVL (pre-MLA: 5.1 ± 2.5 mm2; post-MLA: 10.7 ± 2.9 mm2; P<0.001). Two patients had in-hospital MACE in form of peri-procedural non Q-wave MI. No patient had arrhythmias, stent thrombosis, coronary perforation, or slow flow/no-reflow. Two patients had a rupture of IVL balloon while four had coronary artery dissection. ConclusionsIVL is a safe and highly effective modality with high procedural success rate in management of calcified coronaries.

Very long-term outcomes after catheter ablation of atrioventricular nodal reentrant tachycardia: How does cryoenergy differ from radiofrequency?

Either cryoenergy or radiofrequency can be used during atrioventricular nodal reentrant tachycardia (AVNRT) ablation. There is still limited data comparing their respective long-term efficacy (> 1 year). This study sought to compare the very long-term outcomes of AVNRT ablation using radiofrequency or cryotherapy. We retrospectively included all patients who had undergone a first AVNRT ablation in our institution between January 2010 and December 2017. The primary endpoint was recurrence of documented AVNRT. The study population consisted of 409 patients (274 females, mean age 49.9 year-old). Ablation was performed using cryoenergy in 260 patients and radiofrequency in 149. High acute procedural success rate (> 98%) was obtained and no permanent AV block was observed using both techniques. During a mean follow-up of 3.3 ± 2.3 years, documented AVNRT recurrence occurred in 24 (9.2%) and 4 patients (2.7%) in the cryoablation and radiofrequency group respectively. The risk of AVNRT recurrence was significantly higher in the CA group as compared to the RF group (hazard ratio = 3.7, 95% CI: 1.3 to 5.9). Most of the recurrences after cryoablation occurred between 1- and 6-year follow-up (14/24; 58.3%), with 1/3rd of late recurrences after 3-year follow-up. In multivariable analysis, only Koch's triangle anatomical variant was associated with AVNRT recurrence after cryoablation (hazard ratio = 6.7, 95% CI: 2.7–16.3) ( Fig. 1 ). While AVNRT recurrence rates were similar at one year of follow-up regardless of the energy used, long-term efficacy appeared higher after radiofrequency ablation. Strikingly, recurrences occurred much later after cryotherapy compared to radiofrequency ablation.

Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Lesions: 1-Year Results From the Disrupt CAD III Study.

Coronary calcification impairs stent delivery and optimal expansion, a significant predictor of subsequent stent thrombosis and restenosis. Current calcium ablative technologies may be limited by guidewire bias and periprocedural complications. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance, and optimize stent deployment. The Disrupt CAD III study demonstrated high (92.4%) procedural success and low (7.8%) 30-day major adverse cardiac event (MACE) rates following IVL, but longer term follow-up is required to determine the durability of clinical benefit and the late impact of optimized stent implantation associated with IVL. This analysis evaluates 1-year outcomes from the Disrupt CAD III study. Disrupt CAD III (NCT03595176) was a prospective, single-arm approval study designed to assess the safety and effectiveness of IVL as an adjunct to coronary stenting in de novo, severely calcified coronary lesions (n= 384). MACE was defined as the composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization; target lesion failure was defined as cardiac death, MI, or ischemia-driven target lesion revascularization (ID-TLR). At 1 year, MACE occurred in 13.8% of patients (cardiac death: 1.1%, MI: 10.5%, ischemia-driven target vessel revascularization: 6.0%) and target lesion failure occurred in 11.9% (ID-TLR: 4.3%), both driven by non-Q-wave MI (9.2%). Stent thrombosis (definite or probable) occurred in 1.1% of patients (including 1 event [0.3%] beyond 30​days). Disrupt CAD III represents the largest long-term (1-year) analysis of coronary IVL to date. IVL treatment prior to coronary stent implantation in severely calcified lesions was associated with low 1-year rates of MACE, ID-TLR, and stent thrombosis.

A Warm Welcome to The First Issue of JSCAI

A Warm Welcome to The First Issue of JSCAI

Can permanent His Bundle Pacing be safely started by operators new to this technique? Data from a multicenter registry

Right ventricular pacing (RVP) induces ventricular asynchrony in patients with normal QRS and increases the risk of heart failure and atrial fibrillation on long-term. His bundle pacing (HBP) is a physiological alternative to RVP, and could overcome its drawbacks. Recent studies assessed feasibility and safety of HBP in expert centers with a vast experience of this technique. These results may not apply to less experienced centers. We aim to evaluate feasibility and safety of permanent HBP performed by physicians who are new to this technique. We included all patients who underwent pacemaker implantation with attempt of HBP in 3 hospitals between September 2017 and January 2020. Indication for HBP was left to operators’ discretion. All the operators were new for HBP. His Bundle (HB) electrical parameters were recorded at implant, 3- and 12-month follow-up. HBP was successful in 141 of 170 patients (82.9%); selective HBP was obtained in 96 patients and nonselective HBP in 45. The mean procedure and fluoroscopy durations were 67.0 ± 28.8 min, and 7.3 ± 8.1 min (3.1 ± 4.1 Gy.cm 2 ), respectively. The mean HB paced QRS duration was 106 ± 18 ms. The mean HB capture threshold was 1.29 ± 0.77 V and did not increase at 3- and 12-month follow-up. Ventricular lead revision was required in 5 patients. Our results showed a rapid technical learning allowing a high procedure success rate (89.8%) after 15 procedures ( Fig. 1 ). HBP performed by operators new to this technique appeared feasible and safe. This should encourage HBP to be performed in patients expected to experience high RVP burden.

One-Year Outcomes for Patients Undergoing Transcatheter Aortic Valve Replacement: The Gulf TAVR Registry

BackgroundThe use of transcatheter aortic valve replacement (TAVR) is steadily increasing with TAVR procedures offered to patients across the entire spectrum of surgical risks. The Gulf TAVR registry captures the demographics of patients undergoing TAVR in the Gulf region, comorbidities that drive outcomes, procedural success, complications, and one-year outcomes of death or rehospitalization. MethodsThis is a retrospective cohort study for adult patients aged at least 18 years undergoing TAVR at eight centers in the Gulf region. The primary outcome was a composite of death or re-hospitalization at one-year. Secondary outcomes included the individual components of the composite, stroke, and myocardial infarction (MI). We used multivariable Cox regression to determine factors associated with the composite endpoint. ResultsA total of 795 patients (56% male) were included in the final analysis with a mean age of 74.6 (standard deviation (SD) 8.9) years, Society of Thoracic Surgeons Score (STS) Score 4.9 (4.2), ejection fraction of 53% (12.7%). Transfemoral approach was employed in over 95% (762/795). The primary outcomes rate was 12.8% (95% confidence interval [CI]: 10.6–15.4); secondary endpoints were death 5.4% (95% CI 4.0–7.2); stroke 0.8% (95% CI 0.3, 1.7), MI 0.8% (95% CI 0.4–1.9), rehospitalization: 9.3% (95% CI 7.5–11.5) of whom 71.6% were related to cardiovascular causes. 77% of the cardiovascular admissions were attributable to heart failure or the need for pacemaker implantation. Stage IV or V chronic kidney disease was significantly associated with the primary composite endpoint (Hazard Ratio: 2.49, [95% CI: 1.31, 4.73], p = 0.005). Although not significant, paravalvular leak and severe left ventricular dysfunction showed a 2-fold and 3-fold increased risk for the composite endpoint, respectively. ConclusionsThe Gulf TAVR registry is the first of its kind in the region. It profiles an elderly population with a high procedural success rate and a low rate of complications. One-year outcomes were primarily driven by repeat hospitalization for heart failure and pacemaker implantation indicating a need to optimize heart failure management and improve algorithms for the detection of conduction abnormalities.

Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry.

BackgroundThe Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX.MethodsProspective, multicenter, “real-world” registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center’s prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared.Results359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centeŕs previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed.ConclusionsThe Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operatoŕs experience with its previous device iteration or the number of Watchman FLX devices implanted.

The Outcome of Ventricular Arrhythmias Associated With Mitral Valve Prolapse After Catheter Ablation: A Systematic Review and Meta-Analysis.

The presence of mitral valve prolapse (MVP) varies from asymptomatic to life-threatening arrhythmias. Catheter ablation (CA) is widely used to treat ventricular arrhythmias (VAs) associated with MVP. Despite having high procedural success, outcome data after CA is limited, especially in a long-term setting. Therefore, this systematic review and meta-analysis were performed. Literature searching was conducted in Pubmed, EuropePMC, Proquest, and Ebsco from inception to December 2020 using keywords: ventricular arrhythmia, premature ventricular complex, ventricular tachycardia, ventricular fibrillation, mitral valve prolapse, and catheter ablation. A total of 407 potential articles were retrieved for further review. The final review resulted in six articles for systematic review and meta-analysis. The study was registered in PROSPERO (CRD42020219144). The most common origin of VAs was papillary muscle. The acute success rate of CA in the MVP group varies between 66% and 94%. Follow-up studies reported a higher percentage of VAs recurrence after CA in the MVP group (22.22%) compared with the non-MVP group (11.38%). However, the difference is not significant (P-value = 0.16). Other studies reported a 12.5%-36% rate and 40% of repeat ablation in the medium term and the long term, respectively. Episodes of sudden cardiac death during exertion could still occur following CA in patients with MVP. Distinct origin of VAs was observed during repeated ablation procedures, which may explain arrhythmic substrate progression. Diffuse left ventricular fibrosis around papillary muscle rather than local fibrosis was observed among older patients. Furthermore, the presence of mitral annular disjunction (MAD) and Filamin C mutation might increase the risk of recurrent VAs. CAn has been done as the treatment of VAs associated with MVP. The acute success rate of CA varies between studies and the number of patients requiring repeat CA varied from 12.5% to 40%. Sudden cardiac death could still occur after CA. Older age during CA, genetic predisposition, deep arrhythmic foci, multifocal VAs origin, diffuse fibrosis, and the presence of MAD may contribute to the recurrence of VAs. Further studies, stratification, and evaluation are needed to prevent fatal outcomes in VA associated with MVP, even after CA.

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

Abstract 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

240 Left atrial appendage occlusion: safety, efficacy, and antiplatelet therapy in a single-centre experience

Abstract Aims Oral anticoagulation (OAC) is the cornerstone therapy for stroke prevention in patients with atrial fibrillation (AF). However, a not negligible proportion of AF patients experiences major bleeding events or is affected by concomitant disorders that represent a contraindication for OAC. Left atrial appendage occlusion (LAAO) has emerged as an effective strategy to minimize the risk of thromboembolism in AF patients (without moderate/severe mitral stenosis or mechanical prosthetic heart valves) that are poor candidates for OAC. After the procedure variable regimens of antithrombotic therapy are prescribed, in order to provide protection and prevent device-related thrombus (DRT). The optimal post-procedural antithrombotic strategy remains to be assessed. Therefore, we aim to evaluate the safety and efficacy of LAAO procedure and the relationship between antiplatelet therapy and outcomes at long-term follow-up. Methods and results We conducted a retrospective observational study including consecutive AF patients who underwent LAAO at Azienda Ospedaliero-Universitaria of Parma from October 2010 to June 2021. The incidence of major ischaemic events [DRT, ischaemic stroke, transient ischaemic attack (TIA) and systemic embolism], Bleeding Academic Research Consortium major bleeding events and net adverse clinical events (major ischaemic + bleeding events) were assessed at follow-up. We enrolled 130 patients [median age 77 years (73; 81)] characterized by both high ischaemic (mean CHA2DS2-VASc 4.48) and bleeding risk (mean HAS-BLED 3.24). Technical procedure success was achieved in 123 (94.6%). Thirty-nine (31.7%) patients were discharged on short (≤1 month)-dual antiplatelet therapy (DAPT); 35 (28.5%) on long-DAPT (1–12 months) and 49 (39.8%) on single antiplatelet therapy (SAPT). Antiplatelet therapy was chosen after multidisciplinary discussion on the basis on the hemorrhagic risk [mean HAS-BLED 3.55; 3.11; 2.97 (P = 0.038) in SAPT, short-DAPT and long-DAPT groups respectively], while no differences were observed in ischaemic risk between the three groups. Clinical follow-up was completed in 119 (98.2%) of successfully implanted patients. After a median follow-up of 31 ± 16 months, 24 (20.2%) patients had a major adverse event: 11 (9.2%) ischaemic events [8 (6.7%) strokes and 3 (2.5%) TIA] and 13 (10.9%) major bleedings. Patients on short-DAPT had a significantly lower occurrence of major bleedings [0 vs. 4 (11.4%) on long-DAPT vs. 9 (18.4%) on SAPT; P = 0.033] and net adverse clinical events [3 (7.7%) vs. 7 (20.0%) on long-DAPT vs. 14 (28.6%) on SAPT; P = 0.005] compared to the other two groups, while no difference was observed in the incidence of major ischaemic events [3 (7.7%) on short-DAPT vs. 3 (8.6%) on long-DAPT vs. 5 (10.2%) on SAPT; P = 0.340]. Conclusions In our cohort of AF patients with a contraindication for OAC therapy, LAAO showed high procedural success; however, long-term major ischaemic and bleeding events were not negligible. Short-DAPT therapy turned out to be the best antiplatelet regimen regarding net ischaemic-hemorrhagic balance. Evidence from well-designed randomized trials would be desirable to guide a tailored approach in the selection of post-procedural antithrombotic regimens.

349 Left atrial appendage closure with the II generation ultraseal device: an international registry. The ligate study

Abstract Aims Left atrial appendage (LAA) occlusion with first generation Ultraseal device (Cardia, Eagan, Minnesota) has been shown to be a feasible therapeutic option in patients with non-valvular atrial fibrillation (NVAF). However, there is a paucity of data regarding the novel Ultraseal device. To assess feasibility and safety of second generation LAA closure Ultraseal device in patients with NVAF. Methods and results All patients with NVAF undergoing second generation Ultraseal device implantation between February 2018 and September 2020 were included in a multicentre international registry. Periprocedural and post-discharge events were collected up to 6-months follow-up. Primary efficacy endpoints of interest were device success and technical success; primary safety endpoint was in-hospital major adverse events occurrence. A total of 52 patients were included: mean age 75 ± 8, 69.2% male, mean HAS-BLED 3 ± 1. The device was successfully implanted in all patients. Technical success was achieved in 51 patients (98.0%). In-hospital major adverse event occurred in three patients (5.8%). The incidence of 6-months all-cause death and major bleeding was 11.6% and 2.1%, respectively. No strokes, transient ischaemic attacks, systemic embolisms or device embolization were reported. Conclusions Second generation Ultraseal Device implantation was associated with high procedural success rate and a low incidence of peri-procedural complications. Larger studies with longer follow-up are warranted to evaluate the safety and the efficacy of this device, especially at medium and long term follow-up.

Robotic percutaneous coronary intervention: current evidence, practical aspects and future perspectives

Robotic percutaneous coronary intervention (R-PCI) is an emerging technology designed to improve operator safety and procedural precision. The interventional cardiologist is able to manipulate guidewires, catheters and devices from a specific cockpit. A number of studies evaluating R-PCI have shown high procedural success rates with low complications. R-PCI advantages include the possibility to perform an accurate stent positioning, to reduce the operator radiation exposure and orthopedic injuries. However, there is a limited experience regarding R-PCI in complex anatomies, that may still require manual assistance. Moreover, the technique is limited by current incompatibility with specific materials, the lack of tactile feedback and the possibility to robotically manage only one wire/device at the same time. Globally, R-PCI is a novel approach with future interesting implications, but further investigations are necessary to overcome current limitations.