Fusion imaging guidance for endovascular recanalization of peripheral occlusive disease.

OBJECTIVE: Endovascular procedures are now the first line option for treatment of lower extremity arterial disease. Fusion imaging guidance has been reported to reduce radiation exposure and reintervention rates during fenestrated and branched endovascular repairs, but limited literature exists on its benefits during lower extremity arterial disease endovascular procedures, and more specifically peripheral occlusive disease (POD). This study aims to evaluate the radiation exposure and technical success benefits of fusion imaging guidance in a large cohort of patients treated endovascularly for complex POD. METHODS: From January 2017 to September 2019, in a single center, all consecutive patients presenting symptomatic occlusions (Rutherford Baker categories 3 to 6) in the setting of POD and treated endovascularly were retrospectively assessed for inclusion. All procedures were performed under augmented fluoroscopy guidance (Vessel ASSIST, GE Healthcare), overlaying on live imaging the 3D path for transluminal recanalization based on the preoperative computed tomography angiography. Technical success, dose area product (DAP), total cumulated air kerma (CAK), and fluoroscopy time were collected. DAP results were compared with the literature. RESULTS: During the study period, 179 patients were treated for iliac (n = 56) or femoropopliteal (n = 123) symptomatic arterial occlusions. Technical success was reported in 171 of 179 procedures (95.5%). The use of a re-entry catheter was required to achieve technical success in 11 patients (6.1%). Mean DAP and CAK were 12.70 Gy·cm2 and 135 mGy, respectively, with a mean fluoroscopy time of 15.26 minutes. DAP and CAK were significantly higher in the iliac group when compared with the femoropopliteal group, although fluoroscopy time was not significantly different. DAP was lower than levels reported in the literature. CONCLUSIONS: Routine use of fusion imaging guidance during POD endovascular treatment is associated with low radiation exposure, high technical success, and reduced need for re-entry systems.

C-reactive protein and prognosis after percutaneous coronary intervention and bypass graft surgery for left main coronary artery disease: Analysis from the EXCEL trial.

BACKGROUND: The prognostic impact of high-sensitivity C-reactive protein (CRP) levels in patients with left main coronary artery disease (LMCAD) treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) is unknown. We sought to determine the effect of elevated baseline CRP levels on the 3-year outcomes after LMCAD revascularization and to examine whether CRP influenced the relative outcomes of PCI versus CABG. METHODS: In the EXCEL trial, patients with LMCAD and Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) scores ≤32 were randomized to PCI versus CABG. The primary composite outcome of death, myocardial infarction (MI), or stroke was analyzed according to baseline CRP levels. RESULTS: Among 999 patients with available CRP levels, median CRP was 3.10 mg/L (interquartile range 1.12-6.40 mg/L). The rate of the primary composite end point of death, MI, or stroke at 3 years steadily increased with greater baseline CRP levels. The adjusted relationship between the 3-year composite rate of death, MI, or stroke and baseline CRP modeled as a continuous log-transformed variable demonstrated steadily increasing event rates with greater CRP levels (adjusted hazard ratio, 1.26, 95% CI 1.10-1.44, P = .0008). Similarly, patients with CRP ≥10 mg/L had a 3-fold higher risk of the 3-year primary end point compared to patients with lower CRP levels (adjusted hazard ratio 2.92, 95% CI 1.88-4.54, P < .0001). The association between an elevated CRP level and the adjusted 3-year risk of the primary composite end point did not differ according to revascularization strategy (Pinteraction = .75). CONCLUSIONS: In patients with LMCAD undergoing revascularization, elevated baseline CRP levels were strongly associated with subsequent death, MI, and stroke at 3 years, irrespective of the mode of revascularization. Further studies are warranted to determine whether anti-inflammatory therapies may improve the prognosis of high-risk patients with LMCAD following revascularization.

Validity and internal consistency of the French version of the revised Skin Management Needs Assessment Checklist in people with spinal cord injury.

STUDY DESIGN: Cross-sectional psychometrics study. OBJECTIVES: To determine the construct validity and internal consistency of the revised Skin Management Needs Assessment Checklist (revised SMnac). SETTING: Six spinal cord rehabilitation centers. METHODS: One-hundred and thirty-two community-dwelling individuals with spinal cord injury (SCI) were included. Construct validity was assessed by a Spearman's rank correlation coefficient between the revised SMnac and several questionnaires: Rosenberg Self-Esteem Scale, Ways of Coping Questionnaire, Hospital Anxiety and Depression Scale (HADS), Braden scale; or clinical variables: educational level, presence of a pressure ulcer (PU), history of multiple PUs, time since injury, and pain. RESULTS: The study evidenced construct validity with a fair to moderate correlation coefficient between the revised SMnac and Rosenberg scale (rs = 0.25; p = 0.03), active coping (rs = 0.29; p = 0.001), HADS (rs = -0.43; p < 0.0001), and time since injury (rs = 0.49; p < 0.0001). The presence of PU and history of multiple PUs were strongly correlated with the revised SMnac score (respectively, p = 0.01 and 0.001). Internal consistency was excellent (α = 0.907). CONCLUSION: These results show that the revised SMnac is a valid tool to assess PU self-management in individuals with SCI. Further studies are needed to assess the revised SMnac's responsiveness to change.

Safety and efficacy outcomes of 3rd generation DES in an all-comer population of patients undergoing PCI: 12-month and 24-month results of the e-Biomatrix French registry.

OBJECTIVES: The French Ebiomatrix registry aimed to confirm the results of the Leaders trial in an all-comer population in France. BACKGROUND: The Leaders trial showed the Biolimus-eluting-sent (BES) to be equivalent to the Cypher stent in terms of safety and efficacy at 1 year and superior regarding stent thrombosis after 1 year. METHODS: BES recipients were enrolled in 42 French centers with up to 24-month clinical follow up. RESULTS: 2365 patients were included. Mean age: 65.7 ±11.2 years, 76.1% males, 31.8% had diabetes, 36.5% ACS (28.7% non-ST-elevation MI and 7.8% with ST-elevation MI). 1.7 ± 1.0 stents/patient were implanted and procedural success was 99.5%. 12-month follow-up was completed in 94.3% patients and 24 months in 91.4%. MACCE rates at 12 and 24 months were 5.8% and 9% (all cause-death 1.5% and 2.2%; stent thrombosis definite/probable 0.4% and 0.6%), respectively. MACCE were not significantly higher in diabetic patients compared with non-diabetics but cardiac death was higher (1.6% vs. 0.6%, P = 0.01 at 1 year and 1.9% vs. 0.6, P = 0.005 at 2 years) as was stent thrombosis (0.9% vs. 0.2%, P = 0.009 and 1.2 vs. 0.3% P = 0.008). Compared with non-ACS patients, MACCE was significantly higher in the ACS subgroup (7.5% vs. 4.8%, P = 0.001 at 1 year and 10.3% vs.8.1%, P = 0.07 at 2 years). CONCLUSION: In this large real-world registry, the BES with biodegradable polymer showed excellent acute and mid-term outcomes with a 5.8% and 9% rate of MACCE at one and 2 years and a very low rate of stent thrombosis between 1 and 2 years (0.2%), thus demonstrating the replicability of the LEADERS trial in a registry population. © 2017 The Authors Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

Modification of the Unipolar Atrial Electrogram as a Local Endpoint During Common Atrial Flutter Ablation.

INTRODUCTION: Complete elimination of the negative component of the unipolar atrial electrogram recently proved predictive of lesions transmurality. We prospectively assessed its relevance as a real-time local ablative endpoint for each individual lesion created across the cavotricuspid isthmus (CTI) in order to constitute a line of bidirectionnal block during common atrial flutter (AFL) ablation. METHODS AND RESULTS: Sixty-two consecutive patients underwent common AFL ablation following an electrophysiological approach guided by real-time electrogram modification analysis. In 31 patients (unipolar group), the local ablative endpoint was complete elimination of the negative component of the unipolar atrial electrogram, while the other 31 patients (control group) were treated following our standard approach based on the currently used local ablative endpoint defined by a ≥50% amplitude decrease of the bipolar atrial electrogram. Bidirectional block was achieved in all patients (mean age 67.9 ± 11.5 with 80.6% of men). Mean ablation time (164.3 ± 88.3 seconds vs 332.8 ± 151.5 seconds; P < 0.001) and mean energy delivery (7.5 ± 4.1 kJ vs 14.2 ± 6 kJ; P < 0.001) were significantly shorter in the unipolar group compared to the control group. No statistical differences were seen in procedure time (68.5 ± 22.6 min vs 77.5 ± 20.2 min; P = 0.10). CONCLUSION: Real-time unipolar electrogram modification is a relevant local endpoint during common AFL ablation and leads to a substantial reduction of ablation time and energy delivery compared to a standard ablative approach while displaying a similar short- and long-term success rate.

Changes in activation timing of knee and ankle extensors during gait are related to changes in heteronymous spinal pathways after stroke.

BACKGROUND: Extensor synergy is often observed in the paretic leg of stroke patients. Extensor synergy consists of an abnormal stereotyped co-activation of the leg extensors as patients attempt to move. As a component of this synergy, the simultaneous activation of knee and ankle extensors in the paretic leg during stance often affects gait pattern after stroke. The mechanisms involved in extensor synergy are still unclear. The first objective of this study is to compare the co-activation of knee and ankle extensors during the stance phase of gait between stroke and healthy individuals. The second objective is to explore whether this co-activation is related to changes in heteronymous spinal modulations between quadriceps and soleus muscles on the paretic side in post-stroke individuals. METHODS: Thirteen stroke patients and ten healthy individuals participated in gait and heteronymous spinal modulation evaluations. Co-activation was measured using peak EMG activation intervals (PAI) and co-activation amplitude indexes (CAI) between knee and ankle extensors during the stance phase of gait in both groups. The evaluation of heteronymous spinal modulations was performed on the paretic leg in stroke participants and on one leg in healthy participants. This evaluation involved assessing the early facilitation and later inhibition of soleus voluntary EMG induced by femoral nerve stimulation. RESULTS: All PAI were lower and most CAI were higher on the paretic side of stroke participants compared with the co-activation indexes among control participants. CAI and PAI were moderately correlated with increased heteronymous facilitation of soleus on the paretic side in stroke individuals. CONCLUSIONS: Increased co-activation of knee and ankle extensors during gait is related to changes in intersegmental facilitative pathways linking quadriceps to soleus on the paretic side in stroke individuals. Malfunction of intersegmental pathways could contribute to abnormal timing of leg extensors during the stance phase of gait in hemiparetic individuals.

Catheter ablation in selected patients with depressed left ventricular ejection fraction and persistent atrial fibrillation unresponsive to current cardioversion.

AIMS: In congestive heart failure (CHF) patients with persistent atrial fibrillation (AF), direct current cardioversion (DCC) may reveal participation of tachycardiamediated process to left ventricular (LV) dysfunction by restoring sinus rhythm (SR). However, if DCC fails to restore SR, patients' management remains challenging. The aim of the study was to assess the AF catheter ablation benefit in a selected group of CHF patients with LV ejection fraction (LVEF) <40% and persistent AF unresponsive to DCC, in whom a tachycardia-mediated process is thought to be predominant. METHODS AND RESULTS: Between January 2008 and September 2011, among 129 CHF patients with persistent AF referred to our institution, 34 (63.8 ± 9-year old, 24 men) presented AF refractory to DCC with an estimated high likelihood of tachycardia-mediated LV dysfunction according to a specific set of criteria. These 34 patients underwent stepwise AF ablation and were closely followed up. After a mean 1.9 AF ablation procedures per patient and 17.6 ± 7 months after the last procedure, all patients were in SR. The New York Heart Association class improved from 2.8 ± 0.3 to 1 ± 0.2 (P< 0.001) and the LVEF increased from 30.4 ± 6 to 54.6 ± 6% (P< 0.0001) after 3-6 months of SR, with a persistent benefit as long as the SR was maintained. CONCLUSION: Atrial fibrillation catheter ablation in selected CHF patients with persistent AF refractory to DCC and without any other evidence for secondary LV dysfunction leads to a substantial LVEF improvement in the majority of them. However, redo procedures are frequent in order to achieve mid-term SR maintenance.

Effect of preoperative coronary CT for planning of percutaneous coronary intervention for complex chronic total occlusion (CTS-C-CTOPCI): study protocol for an open-label randomised controlled trial.

BACKGROUND: Treatment of chronic total occlusion (CTO) by percutaneous coronary intervention (PCI) is associated with the difficulty of guidewire manipulation through the occluded segment, particularly when there is hard tissue due to calcification. The purpose of this randomised controlled trial is to determine whether improved planning of CTO-PCI using coronary computed tomographic angiography (CCTA) (versus conventional angiography) increases success rates of wire crossing in ≤ 60 min in difficult cases. METHODS: This is a randomised controlled open-label multi-centre trial in a superiority framework with 1:1 allocation ratio. Participants (n = 130) will be randomised into two groups: the study group who will receive standard of care with the addition of preoperative coronary computed tomographic angiography (CT group), and the control group that will receive standard of care (angiography group). The primary endpoint will be the rate of successful wire crossing in ≤ 60 min in complex CTO (J-CTO ≥ 2). Wire crossing will be considered successful if TIMI flow 3 is restored and residual stenosis is < 30%. The safety endpoint will be mortality due to the intervention or major adverse cardiac events (MACE). Secondary endpoints are success rates at any time; total time of PCI; time of wire crossing; rate of PCI complications; radiation levels during PCI; volume of iodine contrast medium administered; and cost of the PCI. DISCUSSION: This randomised trial will provide insight into whether pre-procedural CCTA as opposed to conventional angiography for planning of CTO-PCI yield higher success rates of wire crossing in ≤ 60 min. Potential benefits of CCTA include shorter successful procedure times of CTO-PCI leading to less irradiation and contrast medium with lower complication rates. TRIAL REGISTRATION: Clinical Trials.gov NCT04549896. Registered on December 21, 2021.

3D-Printing to Plan Complex Transcatheter Paravalvular Leaks Closure.

BACKGROUND: Percutaneous closure of paravalvular leak (PVL) has emerged as an alternative to surgical management in selected cases. Achieving complete PVL occlusion, while respecting prosthesis function remains challenging. A multimodal imaging analysis of PVL morphology before and during the procedure is mandatory to select an appropriate device. We aim to explore the additional value of 3D printing in predicting device related adverse events including mechanical valve leaflet blockade, risk of device embolization and residual shunting. METHODS: From the FFPP registries (NCT05089136 and NCT05117359), we included 11 transcatheter PVL closure procedures from three centers for which 3D printed models were produced. Cardiac CT was used for segmentation for 3D printed models (3D-heartmodeling, Caissargues, France). Technology used a laser to fuse very fine powders (TPU Thermoplastic polyurethane) into a final part-laser sintering technology (SLS) with an adapted elasticity. A simulation on 3D printed model was performed using a set of occluders. RESULTS: PVLs were located around aortic prostheses in six cases, mitral prostheses in four cases and tricuspid ring in one case. The device chosen during the simulation on the 3D printed model matched the one implanted in eight cases. In the three other cases, a similar device type was chosen during the procedures but with a different size. A risk of prosthesis leaflet blockade was identified on 3D printed models in four cases. During the procedure, the occluder was removed before release in one case. In another case the device was successfully repositioned and released. In two patients, leaflet impingement was observed post-operatively and surgical device removal had to be performed. CONCLUSION: In a case-series of complex transcatheter PVL closure procedures, hands-on simulation testing on 3D printed models proved its usefulness to plan and facilitate these challenging procedures.

Abnormal coactivation of knee and ankle extensors is related to changes in heteronymous spinal pathways after stroke.

BACKGROUND: Abnormal coactivation of leg extensors is often observed on the paretic side of stroke patients while they attempt to move. The mechanisms underlying this coactivation are not well understood. This study (1) compares the coactivation of leg extensors during static contractions in stroke and healthy individuals, and (2) assesses whether this coactivation is related to changes in intersegmental pathways between quadriceps and soleus (Sol) muscles after stroke. METHODS: Thirteen stroke patients and ten healthy individuals participated in the study. Levels of coactivation of knee extensors and ankle extensors were measured in sitting position, during two tasks: maximal isometric voluntary contractions in knee extension and in plantarflexion. The early facilitation and later inhibition of soleus voluntary EMG evoked by femoral nerve stimulation were assessed in the paretic leg of stroke participants and in one leg of healthy participants. RESULTS: Coactivation levels of ankle extensors (mean ± SEM: 56 ± 7% of Sol EMG max) and of knee extensors (52 ± 10% of vastus lateralis (VL) EMG max) during the knee extension and the ankle extension tasks respectively were significantly higher in the paretic leg of stroke participants than in healthy participants (26 ± 5% of Sol EMG max and 10 ± 3% of VL EMG max, respectively). Early heteronymous facilitation of Sol voluntary EMG in stroke participants (340 ± 62% of Sol unconditioned EMG) was significantly higher than in healthy participants (98 ± 34%). The later inhibition observed in all control participants was decreased in the paretic leg. Levels of coactivation of ankle extensors during the knee extension task were significantly correlated with both the increased facilitation (Pearson r = 0.59) and the reduced inhibition (r = 0.56) in the paretic leg. Measures of motor impairment were more consistently correlated with the levels of coactivation of biarticular muscles than those of monoarticular muscles. CONCLUSION: These results suggest that the heteronymous pathways linking quadriceps to soleus may participate in the abnormal coactivation of knee and ankle extensors on the paretic side of stroke patients. The motor impairment of the paretic leg is strongly associated with the abnormal coactivation of biarticular muscles.

Transcatheter aortic valve replacement performed with selective telemetry monitoring: A prospective study.

BACKGROUND: Telemetry monitoring (TM) with or without intensive care unit (ICU) admission is the standard of care after Transcatheter aortic valve replacement (TAVR). Regarding to improvements of the technique and procedural results, TM may be considered only in selected patients. We aimed to confirm feasibility and safety of selective TM in patients undergoing TAVR. METHODS: We prospectively evaluated 449 consecutive patients undergoing TAVR. Patients were transferred to general cardiology ward (GCW) without TM after the procedure when stable clinical state, transfemoral access, no baseline right bundle branch block (RBBB), left ventricular ejection fraction (LVEF) > 40%, and no complication including any electrocardiogram (ECG) change within 1 h after the procedure ("low-risk" group). Others patients were considered for TM in ICU ("high-risk" group). The primary endpoint evaluated in-hospital major adverse events after unit admission according to VARC-2 criteria. RESULTS: The mean age was 81.8 ± 7.5 years and mean EuroSCORE II was 7.5 ± 4.8%. In total, 116 patients (25.8%) were considered as "low-risk" patients and 163 patients (36.3%) were referred to GCW, including those with immediate pacemaker implantation. A total of 96 patients (21.3%) reached the primary endpoint including mainly conductive disorders (12.8%). No major adverse events, particularly no late severe conductive disorder, occurred in the "low-risk" group (negative predictive value of 100%). Baseline RBBB (p < 0.01), LVEF < 40% (p = 0.02) and "high-risk" group (p < 0.01) were predictive of outcomes. CONCLUSIONS: Using rigorous periprocedural selection criteria, patients' admission in GCW without TM can be routinely and safely performed in 1/3 of patients after TAVR.

Radiofrequency ablation of an atrial tachycardia emanating from the non-coronary aortic Cusp guided by an electroanatomic navigation system.

We report on an atrial tachycardia (AT), emanating from the non-coronary (NC) aortic cusp, ablated with the aid of an electro-anatomical navigation system. In this setting, the electrocardiographic, electrophysiologic (EP), anatomical, and ablative considerations are discussed.Although NC aortic cusp focal ATs are an uncommon EP finding, their ablation is effective and safe, especially from an atrio-ventricular (AV) conductive point of view. This origin of AT must be invoked and systematically disclosed when a peri-AV nodal AT origin is suspected, in order to avoid a potentially harmful energy application at the vicinity of the AV conductive tissue.

Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial.

Background Myocardial injury is associated with higher mortality after transcatheter aortic valve replacement (TAVR) and might be increased by prior balloon aortic valvuloplasty (BAV). We aimed to evaluate the impact of prior BAV versus direct prosthesis implantation on myocardial injury occurring after (TAVR) with balloon-expandable prostheses. Methods and Results The DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) trial, an open-label randomized study, demonstrated noninferiority of TAVR without BAV (direct TAVR group) compared with systematic BAV (BAV group) with the Edwards SAPIEN 3 valve. High-sensitivity troponin was assessed before and the day after the procedure. Incidence of myocardial injury after the procedure (high-sensitivity troponin elevation >15× the upper reference limit [14 ng/L]) was the main end point. Impact of myocardial injury on 1-month adverse events (all-cause mortality, stroke, major bleeding, major vascular complications, transfusion, acute kidney injury, heart failure, pacemaker implantation, and aortic regurgitation) was evaluated. Preprocedure and postprocedure high-sensitivity troponin levels were available in 211 patients. The mean age of patients was 83 years (78-87 years), with 129 men (61.1%). Mean postprocedure high-sensitivity troponin was 124.9±81.4 ng/L in the direct TAVR group versus 170.4±127.7 ng/L in the BAV group (P=0.007). Myocardial injury occurred in 42 patients (19.9%), including 13 patients (12.2%) in the direct TAVR group and 29 (27.9%) in the BAV group (P=0.004). BAV increased by 2.8-fold (95% CI, 1.4-5.8) myocardial injury probability. Myocardial injury was associated with 1-month adverse events (P=0.03). Conclusions BAV increased the incidence and magnitude of myocardial injury after TAVR with new-generation balloon-expandable valves. Myocardial injury was associated with 1-month adverse events. These results argue in favor of direct SAPIEN 3 valve implantation. Registration URL: https://www.Clinicaltrials.gov; Unique identifier: NCT02729519.

Five-year clinical outcome of multicenter randomized trial comparing amphilimus - with paclitaxel-eluting stents in de novo native coronary artery lesions.

OBJECTIVES: Long-term data from randomized studies on polymer-free stents are scarce. Long-term data of Cre8 amphilimus eluting stent are still not available. We sought to investigate contribution of a polymer-free design versus a permanent-polymer one on the long-term. METHODS AND RESULTS: Patients undergoing percutaneous coronary intervention for de novo lesions were randomized 1:1 to Cre8 or Taxus Liberté (323 overall, 126 Cre8). Original primary endpoint (6-month angiographic in-stent late lumen loss) already demonstrated the superiority of Cre8 vs Taxus (0.14 + 0.36 mm vs. 0.34 + 0.40 mm; p < 0.001). Secondary endpoints were the device oriented composite endpoint (DOCE), patient oriented composite endpoint (POCE) up to 5-year. Long-term follow-up data confirmed the superiority shown by Cre8 in the analysis of the angiographic endpoint at 6-month, especially in the diabetic patients, where the device strongly reduced the clinical difference with non-diabetic. Landmark analysis demonstrated that the incidence of DOCE after 1-year and up to 5-year follow up was significantly lower in patients implanted with Cre8 AES (2.1% Cre8 vs. 9.3% Taxus, p = 0.009). While no differences were found in terms of DOCE rate among diabetic and non-diabetic patients treated with the Cre8 AES (HR 1.039; 95%CI 0.320-3.374), this was not true for Taxus (HR 2.64; 95%CI 1.112-6.278). CONCLUSIONS: Cre8 showed favourable safety and efficacy results versus Taxus at 5-years follow-up, with a superior clinical performance for the DOCE endpoint from 1 to 5 years. Cre8, differently from Taxus, has been able to strongly reduce the differences in clinical outcome between diabetic and non-diabetic up to 5 years, suggesting the higher efficacy of Cre8 in the treatment of diabetic patients.

Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial.

OBJECTIVES: The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV). BACKGROUND: Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV. METHODS: DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events. RESULTS: Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: -4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation. CONCLUSIONS: Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519).

Hemodynamic Performances and Clinical Outcomes in Patients Undergoing Valve-in-Valve Versus Native Transcatheter Aortic Valve Implantation.

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) emerged has a less invasive treatment than surgery for patients with degenerated bioprosthesis. However, few data are currently available regarding results of ViV versus TAVI in native aortic valve. We aimed to compare hemodynamic performances and 1-year outcomes between patients who underwent ViV procedure and patients who underwent non-ViV TAVI. This bicentric study included all patients who underwent aortic ViV procedure for surgical bioprosthetic aortic failure between 2013 and 2017. All patients who underwent TAVI were included in the analysis during the same period. ViV and non-ViV patients were matched with 1:2 ratio according to size, type of TAVI device, age (±5 years), sex, and STS score. Primary end point was hemodynamic performance including mean aortic gradient and aortic regurgitation at 1-year follow-up. A total of 132 patients were included, 49 in the ViV group and 83 in the non-ViV group. Mean age was 82.8 ± 5.9 years, 55.3% were female. Mean STS score was 5.2% ± 3.1%. Self-expandable valves were implanted in 78.8% of patients. At 1-year follow-up, aortic mean gradient was significantly higher in ViV group (18.1 ± 9.4 mm Hg vs 11.4 ± 5.4 mm Hg; p < 0.0001) and 17 (38.6%) patients had a mean aortic gradient ≥20 mm Hg vs 6 (7.8%) in the non-ViV group (p = 0.0001). Aortic regurgitation > grade 2 were similar in both groups (p = 0.71). In the ViV group, new pacemaker implantation was less frequent (p = 0.01) and coronary occlusions occurred only in ViV group (n = 2 [4.1%]). At 1-year follow-up, 3 patients (2.3%) died from cardiac cause, 1 (2.1%) in the ViV group vs 2 (2.4%) in the non-ViV group (p = 0.9). There was no stroke. In conclusion, compared with TAVI in native aortic stenosis, ViV appears as a safe and feasible strategy in patients with impaired bioprosthesis. As 1-year hemodynamic performances seem better in native TAVI procedure, long-term follow-up should be assessed to determinate the impact of residual stenosis on outcomes and durability.

Left atrial appendage occlusion simulation based on three-dimensional printing: new insights into outcome and technique.

AIMS: The aim of this study was to assess the predictive value of simulation based on 3D-printed models before left atrial appendage occlusion (LAAO) for peri-device leaks (PDL) and the impact on procedural outcomes compared to conventional imaging. METHODS AND RESULTS: Seventy-six patients referred for LAAO with double disc device underwent construction of a 3D-printed LA model using flexible photopolymer resin. An implant simulation was performed retrospectively in Group 1 (55 patients), blinded to implanted device size, and prospectively in Group 2 (21 patients). In Group 1, an off-axis device position occurred in 14 patients (25%) and the incidence of PDL was 27% (15 patients); mismatch between model and device size was the best predictor (area under the curve 0.88, CI: 0.77-0.99). When using 3D simulation prospectively, mean prosthesis number per patient (1.05±0.21 vs. 1.20±0.52, p=0.04) and incidence of leaks (5% vs. 27%, p<0.01) were reduced compared to conventional imaging alone, as well as fluoroscopy time (19 mins [13.4-23] vs. 13.5 mins [11.1-15], p=0.012) and total fluoroscopy dose (7,291 [1,811-12,734] vs. 1,978 (1,548-4,800) mGy·cm2, p=0.029). CONCLUSIONS: 3D-printed patient-specific adaptive and flexible LA models improve LAAO double disc device sizing. This can potentially reduce procedure time and the number of prostheses employed per patient.

Patellar tendon vibration reduces the increased facilitation from quadriceps to soleus in post-stroke hemiparetic individuals.

BACKGROUND: Stimulation of the femoral nerve in healthy people can facilitate soleus H-reflex and electromyography (EMG) activity. In stroke patients, such facilitation of transmission in spinal pathways linking the quadriceps and soleus muscles is enhanced and related to co-activation of knee and ankle extensors while sitting and walking. Soleus H-reflex facilitation can be depressed by vibration of the quadriceps in healthy people, but the effects of such vibration have never been studied on the abnormal soleus facilitation observed in people after stroke. OBJECTIVES: To determine whether vibration of the quadriceps can modify the enhanced heteronymous facilitation of the soleus muscle observed in people with spastic stroke after femoral nerve stimulation and compare post-vibration effects on soleus facilitation in control and stroke individuals. METHODS: Modulation of voluntary soleus EMG activity induced by femoral nerve stimulation (2×motor threshold) was assessed before, during and after vibration of the patellar tendon in 10 healthy controls and 17 stroke participants. RESULTS: Voluntary soleus EMG activity was facilitated by femoral nerve stimulation in 4/10 (40%) controls and 11/17 (65%) stroke participants. The level of facilitation was greater in the stroke than control group. Vibration significantly reduced early heteronymous facilitation in both groups (50% of pre-vibration values). However, the delay in recovery of soleus facilitation after vibration was shorter for the stroke than control group. The control condition with the vibrator turned off had no effect on the modulation. CONCLUSIONS: Patellar tendon vibration can reduce the facilitation between knee and ankle extensors, which suggests effective presynaptic inhibition but decreased post-activation depression in the lower limb of people after chronic hemiparetic stroke. Further studies are warranted to determine whether such vibration could be used to reduce the abnormal extension synergy of knee and ankle extensors in people after hemiparetic stroke.

Predictive value for paravalvular regurgitation of 3-dimensional anatomic aortic annulus shape assessed by multidetector computed tomography post-transcatheter aortic valve replacement.

AIMS: Paravalvular regurgitation (PAR) remains a serious complication after trans-catheter aortic valve replacement (TAVR). Multidetector computed tomography (MDCT)-based measurements of the aortic basal virtual ring (BVR) are considered the gold standard for trans-catheter heart valve (THV) sizing. However, the real anatomic aortic annulus is a 3-dimensional structure. To compare measurement of 3D-anatomic annulus with BVR and secondly to assess independent predictive parameters that may impact on PAR > mild post-TAVR (PAR+). METHODS AND RESULTS: MDCT was performed in 92 patients before and after balloon or self-expandable TAVR. 3D-AA shape was obtained point by point following the semilunar attachment of aortic cusps (Osirix-MD 2.8.2). 3D-oversizing index (nominal THV area/3D-AA area - 1) × 100 was calculated as well as 2D-oversizing index using BVR area instead of 3D-AA area. PAR was quantified by planimetry of vena-contracta in transthoracic echocardiography short-axis view. Valvular calcium volume and annulus calcium area were measured using Hounsfield-intensity detection. ROC curves and logistic regression for PAR(+) were performed. BVR area overall underestimated 3D-AA area by 19 ± 9% (P< 0.001), significantly more in PAR(+) (26 ± 7%) vs. PAR(-) (17 ± 9%, P< 0.001). 3D-oversizing index had greater predictive value for PAR > mild (area under the curve, AUC = 0.88) with 88% sensibility (Se) and 82% specificity (Sp) than 2D-oversizing index (AUC = 0.68) with 84% Se, but only 41% Sp (P< 0.0001). Also, valvular calcium volume and annulus calcium area were less predictors for PAR > mild (AUC = 0.68, respectively, AUC = 0.75, P = 0.002). In a multivariate analysis, only 3D-oversizing index showed an independent value for PAR > mild (OR = 18.6, P< 0.001). CONCLUSION: Basal ring CT measurement significantly underestimated the real 3D-anatomic aortic annulus area. This may impact on THV sizing and PAR incidence. 3D-oversizing index is the most predictive factor for PAR > mild.

High frequency of endothelial vasomotor dysfunction after acute coronary syndromes in non-culprit and angiographically normal coronary arteries: a reversible phenomenon.

This study aimed to assess endothelium-dependent vasomotor function in non-culprit coronary vessels in patients with recent acute coronary syndrome (ACS). Endothelial dysfunction can also concern peripheral vessels during ACS, but the frequency of this phenomenon at coronary circulation level is unknown. Endothelial function was assessed by infusion of graded doses of acetylcholine (ACh) in a non-culprit coronary artery of normal appearance in 43 patients having recently suffered from non-ST ACS, and reassessed 6 months later. Endothelium-dependent vasoreactivity was impaired at baseline in 81% (35/43) of the patients, and only 19% (8/43) of patients showed a normal response to ACh. Among the 35 subjects with initial dysfunction, 77% showed a significant improvement 6 months later. All patients without initial endothelial dysfunction remained normal. C-reactive protein (CRP) level was elevated at month 0, and had declined at follow-up, tending towards normal levels. At that time, apolipoprotein A-I (apoA-I) levels were correlated with vasomotor improvement in univariate (p < 0.02) and multivariate analysis (p < 0.04). In conclusion, endothelium dysfunction is very frequently observed after recent ACS in non-culprit and angiographically normal coronary arteries, and an improvement occurs within 6 months in most cases. After resolution of the initial inflammation, apoA-I seems to play an important role in endothelial function.