Assessment of the MANTA closure device in real-life transfemoral transcatheter aortic valve replacement: A single-centre observational study.

BACKGROUND: Vascular complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). Data involving suture-based percutaneous vascular closure devices (VCDs) have been extensive. Although promising, data regarding the efficacy and safety of the MANTA VCD (Teleflex) are scarce. We sought to assess the safety and effectiveness of the MANTA device in a real-life unselected cohort of patients undergoing transfemoral-TAVR (TF-TAVR). METHODS: This single-center retrospective observational study included a cohort of consecutive patients with severe aortic stenosis (AS) treated by our team using TAVR between January 2020 to December 2022. The primary outcome measure was access-related major and minor vascular complications according to the Valve Academic Research Consortium (VARC-3) definition criteria. RESULTS: From January 2020 to December 2022, a total of 347 patients underwent TF-TAVR were treated using the MANTA 18 Fr VCD system for vascular closure. Mean age was 82.4 ± 6.1 years (56-98 years). There were no significant differences in preoperative and procedural characteristics between patients with and without VCD-related major vascular complications. Access site-related major and minor vascular complications occurred in 20 of 347 patients (5.7%). Overall, major vascular complications occurred in 5 patients (1.4%) and device failure was seen in 17 patients (4.9%). CONCLUSION: This French real world evaluation of large-bore arteriotomy closure in TF-TAVR indicated that MANTA VCD is a feasible alternative with an acceptable low rate of access-site-related complications.

In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease.

Objectives: The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France. Background: The efficacy and safety of the first-generation PF-SES have already been demonstrated by randomized controlled trials and "all-comers" observational studies. Methods: For this all-comers observational, prospective, multicenter study, 1456 patients were recruited in 22 French centers. The primary endpoint was target lesion revascularization (TLR) rate at 12 months and secondary endpoints included major adverse cardiac events (MACE) and bleeding. Results: 895 patients had stable CAD and 561 had ACS. At 12 months, 2% of patients had a TLR, with similar rates between stable CAD and ACS (1.9% vs 2.2%, p = 0.7). The overall MACE rate was 5.2% with an expected higher rate in patients with ACS as compared to those with stable CAD (7.3% vs 3.9%, p = 0.007). The overall bleeding event rate was 4.5%, with similar rates in stable CAD as compared to ACS patients (3.8% vs 5.6%, p = 0.3). Dual antiplatelet therapy (DAPT) interruptions prior to the recommended duration occurred in 41.7% of patients with no increase in MACE rates as compared to patients who did not prematurely interrupt DAPT (3.9% vs 6.1%, p = 0.073). Conclusions: The latest generation PF-SES is associated with low clinical event rates in these all-comers patients. There was a high rate of prematurely terminated DAPT, without any effect on MACE at 12 months. This trial is registered with NCT03809715.

Watchman FLX vs. Watchman 2.5 in a Dual-Center Left Atrial Appendage Closure Cohort: the WATCH-DUAL study.

AIMS: No studies have compared Watchman 2.5 (W2.5) with Watchman FLX (FLX) devices to date. We aimed at comparing the FLX with W2.5 devices with respect to clinical outcomes, left atrial appendage (LAA) sealing properties and device-related thrombus (DRT). METHODS AND RESULTS: All consecutive left atrial appendage closure (LAAC) procedures performed at two European centres between November 2017 and February 2021 were included. Procedure-related complications and net adverse cardiovascular events (NACE) at 6 months after LAAC were recorded. At 45-day computed tomography (CT) follow-up, intra- (IDL) and peri- (PDL) device leak, residual patent neck area (RPNA), and DRT were assessed by a Corelab. Out of 144 LAAC consecutive procedures, 71 and 73 interventions were performed using W2.5 and FLX devices, respectively. There were no differences in terms of procedure-related complications (4.2% vs. 2.7%, P = 0.626). At 45-day CT, the FLX was associated with lower frequency of IDL [21.3% vs. 40.0%; P = 0.032; odds ratio (OR): 0.375; 95% confidence interval (CI): 0.160-0.876; P = 0.024], similar rate of PDL (29.5% vs. 42.0%; P = 0.170), and smaller RPNA [6 (0-36) vs. 40 (6-115) mm2; P = 0.001; OR: 0.240; 95% CI: 0.100-0.577; P = 0.001] compared with the W2.5 group. At 45 days, rate of DRT as detected by CT and/or transoesophageal echocardiography (TOE), was higher with W2.5 (6.0% vs. 0%, P = 0.045). At 6-month follow-up, NACE did not differ between groups. CONCLUSIONS: In this cohort of consecutive LAACs, FLX as compared to W2.5, was associated with similar procedure-related complications and 6-month NACE, but with improved LAA neck coverage, and lower IDL and DRT.

Sodium Chloride Physiological Saline Solution Versus Water Preparations Injectable in the Use of Shockwave Intravascular Lithotripsy: A Single-Center Experience.

Background: Shockwave intravascular lithotripsy (IVL) coronary system is a very useful new technology for de novo severely calcified coronary artery plaques before percutaneous coronary intervention (PCI). The device uses a semi-compliant low-pressure balloon, integrated into a sterile catheter, to deliver by vaporizing fluid an expanding bubble that generates high-pressure ultrasonic energy by waves that create multiplane longitudinal micro-macro fractures in calcified plaques, which facilitate optimal stent placement and expansion, and luminal gain. Methods: The use of Shockwave IVL coronary system in our cardiac catheterization laboratory (Cath lab) at the "Clinique Saint-Hilaire" in Rouen, France, started in March 2019, with 42 procedures performed since this date: two patients in 2019, two patients in 2020, seven patients in 2021, 23 patients in 2022, and eight patients since the beginning of 2023. Results: We had experienced problems at the beginning of our activity for the first 11 patients (two patients in 2019, two patients in 2020, and seven patients in 2021): after less than five pulses, the shock therapy stopped. We used initially for Shockwave IVL semi-compliant low-pressure integrated balloons a mixture of 50% contrast and 50% water preparations injectable (PPI). After changing water PPI by sodium chloride physiological saline solution, we never encountered this problem again for the following 31 patients (23 patients in 2022, and eight patients since the beginning of 2023). In fact, the proper functioning of Shockwave IVL system requires ions in balloon mixture in addition to the contrast. It is thanks to the ions contained in sodium chloride physiological saline solution that the spark necessary for shocks delivery after balloon inflation is produced. Conclusions: Water PPI or sodium chloride physiological saline solution is used in angioplasty balloons in a lot of Cath labs worldwide. It is therefore essential to disseminate in the worldwide Cath lab the obligation to put in Shockwave IVL semi-compliant low-pressure integrated balloons sodium chloride physiological saline solution, rather than water PPI for optimal performance, and the importance of Shockwave Medical reporting this to interventional cardiologists.

Computed Tomography Scan Evidence for Left Atrial Appendage Short-Term Remodeling Following Percutaneous Occlusion: Impact of Device Oversizing.

Background The interrelationships between left atrial appendage (LAA) dimensions and device following implantation are unknown. We aimed to analyze the impact of Watchman device implantation on LAA dimensions following its percutaneous closure and potential predictors of remodeling. Methods and Results All consecutive LAA closure procedures performed at 2 centers between November 2017 and December 2020 were included in the WATCH-DUAL (Watchman 2.5 Versus Watchman FLX in a Dual-Center Left Atrial Appendage Closure Cohort) registry. This study included patients who had pre- and postintervention computed tomography scan analysis. The LAA and device dimensions were measured in a centralized core lab by 3-dimensional computed tomography scan reconstruction methods, focusing on the device landing zone. This analysis included 104 patients (age, 76.0 [range, 72.0-83.0] years; 72% men; 53% Watchman FLX; 47% Watchman 2.5). The baseline characteristics were comparable between Watchman 2.5 and Watchman FLX groups, except for the higher use of oversizing in the latter group. The median delay for computed tomography control was 49 (range, 43-64) days. The landing zone area (median, 446 [range, 363-523] versus 290 [222-366] mm2; P<0.001) and minimal diameter (median, 23.0 [range, 20.7-24.8] versus 16.7 [14.7-19.4] mm; P<0.001) significantly increased after implantation. The absolute (median, 157 [range, 98-220] versus 85 [18-148] mm2, P<0.001) and relative (median, 50% [range, 32%-79%] versus 26% [4%-50%]; P<0.001) increases in landing zone area were more pronounced in patients with oversized device. Baseline LAA dimensions were smaller, landing zone eccentricity larger, and oversized device more frequent in patients with significant overexpansion compared with the others. Conclusions LAA dimensions increased at the site of the Watchman prosthesis after implantation, suggesting a local positive remodeling after the procedure. This phenomenon was more pronounced in the case of oversized devices.

[Invasive and non-invasive imaging analysis for calcified coronary artery lesions]. / Imagerie invasive et non invasive des lésions coronaires calcifiées.

Coronary calcifications are frequently identified within coronary lesions as their incidence increases with age and cardiovascular risk factors. Their location can be superficial or deep, according to different pathological process. In all cases, the presence of calcifications within the vascular wall predicts poor clinical prognosis and unfavorable evolution after percutaneous revascularization. Coronary calcifications can be analyzed by angiography, CT or intracoronary imaging (IVUS or OCT) with variable accuracies. Angiography is the most frequently used method but is not very sensitive (sensitivity close to 50%) and insufficient for their precise quantification. The CT scan is a more effective non-invasive method leading to an accurate analysis of the lesion before coronary angiography. IVUS and OCT have an excellent spatial resolution and are the most sensitive methods for the identification (present in nearly 75-80% of lesions) and quantification of calcifications. These intracoronary imaging techniques offer interesting perspectives for identification of the highest-risk lesions, PCI procedures planning (including the choice of an optimal dedicated plaque preparation devices), the monitoring of their execution and the evaluation of the immediate post-stenting results.

Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry.

BACKGROUND: Randomized trials comparing the first-generation absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA) with a drug-eluting stent showed a moderate but significant increase in the rate of 3-year major adverse cardiac events and scaffold thrombosis, followed by a decrease in adverse events after 3 years. AIM: The objective of this study was to assess the 5-year outcomes of patients treated with at least one absorb BVS and included in the FRANCE ABSORB registry. METHODS: All patients treated in France with an absorb BVS were prospectively included in a large nationwide multicentre registry. The primary efficacy outcome was the occurrence of 5-year major adverse cardiac events. Secondary efficacy outcomes were the rates of 5-year target vessel revascularization and definite/probable scaffold thrombosis. RESULTS: Between September 2014 and April 2016, 2,070 patients were included in 86 centres (mean age 55±11 years; 80% men; 49% with acute coronary syndrome). The rates of 1-, 3- and 5-year major adverse cardiac events were 3.9%, 9.4% and 12.1%, respectively (including cardiac death in 2.5% and target vessel revascularization in 10.4%). By multivariable analysis, diabetes, oral anticoagulation, the use of multiple Absorb BVSs and the use of a 2.5mm diameter absorb BVS were associated with 5-year major adverse cardiac events. The rates of 1-, 3- and 5-year definite/probable scaffold thrombosis were 1.5%, 3.1% and 3.6%, respectively. By multivariable analysis, older age, diabetes, anticoagulation at discharge and the use of a 2.5mm diameter absorb BVS were associated with 5-year scaffold thrombosis. CONCLUSIONS: Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years.

ACURATE neo™ aortic valve implantation via carotid artery access: first case report.

BACKGROUND: The ACURATE neo™ transcatheter heart valve (Boston Scientific, Marlborough, Massachusetts) is predominantly implanted via femoral access. Transcarotid use of this prothesis has never been reported. CASE PRESENTATION: We present the case of an 89-year-old woman referred to us for a transcatheter aortic valve replacement (TAVR). After apparatus imaging of the aortic annulus and the peripheral vascular pathway, the heart team was confronted with a triple challenge: (i) The preferable choice of a self-expanding valve because of a small aortic annulus in an obese woman. (ii) Gaining favorable access to the coronary ostia, considering multiple recent coronary stenting. (iii) Utilizing an alternative arterial access because of iliac and femoral severely calcified stenosis. Implanting the ACURATE neo™ transcatheter heart valve (THV) via carotidal access allowed us to overcome these challenges. The procedure was performed successfully without any short-term complications. CONCLUSION: We report the first case of implantation of an ACURATE neo™ transcatheter heart valve (Boston Scientific, Marlborough, Massachusetts) via the right common carotid artery.

Covered Stent Implantation for Treatment of Iliac Vein Rupture During Percutaneous Left Atrial Appendage Occlusion.

An 82-year-old woman who experienced an iatrogenic external iliac vein perforation during a left atrial appendage occlusion procedure was successfully treated by endovascular graft implantation. We report the short- and long-term outcomes of the procedure. (Level of Difficulty: Advanced.).

Impact of left atrial appendage closure on circulating microvesicles levels: The MICROPLUG study.

BACKGROUND: Left atrial appendage occlusion (LAAO) has emerged as a valid alternative to oral anticoagulation therapy for the prevention of systemic embolism in patients with non-valvular atrial fibrillation (NVAF). Microvesicles (MVs) are shed-membrane particles generated during various cellular types activation/apoptosis that carry out diverse biological effects. LAA has been suspected to be a potential source of MVs during AF, but the effects its occlusion on circulating MVs levels are unknown. METHODS: N = 25 LAAO and n = 25 control patients who underwent coronary angiography were included. Blood samples were drawn before and 48 h after procedure for all. A third sample was collected 6 weeks after procedure in LAAO patients. In N = 10 extra patients, samples were collected from right atrium, LAA and pulmonary vein during LAAO procedure. Circulating AnnV + procoagulant, endothelial, platelets, red blood cells/RBC and leukocytes derived-MVs were measured using flow cytometry methods. RESULTS: In the LAAO group, AnnV+, platelets, RBC, and leukocytes MVs were significantly increased following intervention, whereas only AnnV + MVs levels significantly rose in controls. The 6-w analysis showed that RBC-MVs and AnnV + MVs levels were still significantly elevated compared to baseline values in LAAO patients. The in-site analysis revealed that leukocytes and CD62e + endothelial-MVs were significantly higher in left atrial appendage compared to pulmonary vein, suggesting a local increased production. No major adverse event was observed in any patient post procedural course. CONCLUSIONS: LAAO impacts circulating MVs and might create mild pro-coagulant status and potential erythrocytes activation due to the device healing during the first weeks following intervention.