A patient-specific algorithm to achieve commissural alignment with Acurate Neo: The sextant technique

Aims: The aim of this proof-of-concept study was to investigate safety and efficacy of a CT-scan based patient-specific algorithm to maximize coronary clearance and secondarily to achieve anatomically correct commissural alignment with the Acurate Neo device. Method and results: A total of 45 consecutive patients undergoing TAVR with the Acurate Neo THV were prospectively enrolled in the study. Mean age was 81.6 ± 5.5 years, mean STS score was 6.1 ± 3.7. Device success rate was 100%. Aim of the technique was to rotationally deploy the TAVR device with a commissure lying on the bisector between the coronary ostia as calculated on the pre-procedural CT-scan. At post-TAVR CT-scan, coronary clearance was achieved in 98% of patients with no cases of severe coronary artery overlap. In 42 out of 45 patients, THV was aligned or, at most, mildly misaligned; there were 2 cases of moderate misalignment without any case of severe misalignment. Post-TAVR selective coronary artery engagement was attempted and succeeded in all patients (100%). Conclusion: Our CT-scan based patient-specific algorithm is safe and proven to be effective in avoiding coronary artery overlap and providing commissural alignment with Acurate Neo in all treated patients

One-year safety and efficacy profile of transcatheter aortic valve-in-valve implantation with the portico system

Objective: This study sought to investigate the procedural and mid-term outcomes of transcatheter aortic valve implantation for failed surgical bioprostheses (TAVI-ViV) with Portico device. Background: Limited evidence coming from early experience on Portico system does not allow to fully assess safety and efficacy of this device in this ViV patients. Methods: From January 2016 up to June 2019, 56 consecutive patients undergoing TAVI-ViV with Portico were prospectively included in our institutional TAVI database. Results: The prevalent mechanism of failure was stenosis (58.9%); true internal diameter (ID) was <21 mm in 71.4% of cases. Device success rate were 69.6% with 14 (25%) patients showing a residual gradient ≥20 mmHg, 2 (3.6%) a PVL ≥ moderate and 1 (1.8%) required a second THV implantation due to device embolization. At 1-year follow-up 5 patients (8.9%) died whereas moderate SVD was reported in 2 (3.6%). Patients with a post-procedural mean gradient ≥20 mmHg showed a significantly higher rate of CV hospitalization (21.4% vs. 2.4%, p =.02) whereas no differences in procedural and 1-year outcomes were noticed according to true ID diameter or degeneration mode. Chimney stenting (ChT) was performed in 23 (41%) patients without significant differences in procedural and 1-year outcomes compared to non-ChT group. Conclusions: TAVI-ViV with Portico valve was associated with good procedural and 1-year outcomes, even in patients with features of high procedural and anatomical complexity

Epidemiology of stroke and cerebral protection in patients undergoing transcatheter aortic valve replacement

The introduction into clinical practice of transcatheter aortic valve implantation (TAVI) has led to a significant change in the therapeutic paradigm for patients with valvular aortic stenosis. However, in parallel with the benefits obtained in prognosis and quality of life, an inherent risk of major cerebral thromboembolic events has been observed. In different studies this risk has been estimated between 2% and 6%. In order to reduce the incidence of cerebrovascular accidents during TAVI, several brain protection systems have been developed but, to date, none has obtained sufficient clinical evidence to be implemented on a large scale, and they are therefore used only in selected cases. Furthermore, periprocedural drug therapy and follow-up are still the subject of extensive discussion in the scientific community. This paper reviews the topic of stroke prevention in patients undergoing TAVI for both the periprocedural and postprocedural aspects

XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial

Background: Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure. Aim: To evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD). Methods: XLIMIT is a multicenter randomized controlled trial targeting 180 patients requiring percutaneous coronary interventions (PCI). Patients will be treated with Xlimus SES or Synergy EES implantation and randomization will be performed in a 2:1 ratio. The primary endpoint will be the reendothelialization grade of the Xlimus stent in terms of strut coverage and neointimal hyperplasia volume as compared to Synergy. Secondary endpoints will be represented by clinical and procedural outcomes. The first patient was enrolled on February 2019. Conclusions: A clearer understanding of the endothelialization process of new generation DES could significantly impact the treatment with dual antiplatelet therapy in the future. Moreover, although not powered for clinical end-points, the XLIMIT trial will provide randomized data in a population with minimal exclusion criteria. Trial registration: ClinicalTrials.gov Identifier: NCT03745053. Registered on November 19, 2018

Impact of aortic angle on transcatheter aortic valve implantation outcome with Evolut-R, Portico, and Acurate-NEO

Objectives: To investigate paravalvular leak (PVL) and devices success rates according to aortic angle (AA) in patients undergoing transcatheter aortic valve implantation (TAVI) with three new-generation self-expanding devices. Background: The impact of aortic angle (AA) on TAVI device success and PVL rates is controversial. Methods: This retrospective study included 392 patients submitted to TAVI for severe aortic stenosis with Portico, Evolut-R and Acurate-NEO, and available AA measurements at computed tomography (CT) angiography. AA was calculated from the implantation projection and was defined as the angle between the plane of aortic annulus and an ideal horizontal plane. Aorta was defined horizontal if AA>57° (75th percentile). Results: In the horizontal group, the rates of moderate/severe PVL was higher in the Evolut-R group (20.8%), which was also characterized by a lower implant compared to that of Acurate-NEO, whereas device success was comparable among the three devices. AA was a significant predictor of moderate/severe PVLs (AUC 0.72, p =.002) only in the Evolut-R population. On multivariate analysis, calcium volume 850HU, bicuspid aortic valve, and implantation depth at the level of left coronary cusp were independent predictors of moderate/severe PVL. On univariate analysis in the horizontal aorta population, implantation depth was confirmed among the most significant predictors of moderate/severe PVL. Conclusions: Despite comparable device success rates, horizontal aorta represented a technical challenge only in the Evolut-R subgroup, which showed higher rates of moderate/severe PVL than Portico and Acurate-NEO, and was associated with a low implant

Outcome of transcatheter aortic valve replacement in bicuspid aortic valve stenosis with new-generation devices

OBJECTIVES: To compare device success and paravalvular leak rates of 3 new-generation transcatheter aortic valve replacement devices in patients with bicuspid aortic valve stenosis and to test their biomechanical performance in a computer-based simulation model of aortic root with increasing ellipticity. METHODS: This retrospective multicentre study included 56 bicuspid aortic valve patients undergoing transcatheter aortic valve replacement with new-generation devices: Lotus/Lotus Edge (N = 15; 27%), Evolut-R (N = 20; 36%) and ACURATE neo (N = 21; 37%). Three virtual simulation models of aortic root with increasing index of eccentricity (0-0.25-0.5) were implemented. Stress distribution, stent-root contact area and paravalvular orifice area were computed. RESULTS: Device success was achieved in 43/56 patients (77%) with comparable rates among Lotus (87%), Evolut-R (60%) and ACURATE neo (86%; P = 0.085). Moderate paravalvular leak rate was significantly lower in the Lotus group as compared to Evolut-R group (0% vs 30%; P = 0.027) and comparable to the ACURATE neo group (0% vs 10%; P = 0.33). By index of eccentricity = 0.5, Lotus showed a uniform and symmetric pattern of stress distribution with absent paravalvular orifice area, ACURATE neo showed a mild asymmetry with small paravalvular orifice area (1.1 mm2), whereas a severely asymmetric pattern was evident with Evolut-R, resulting in a large paravalvular orifice area (12.0 mm2). CONCLUSIONS: Transcatheter aortic valve replacement in bicuspid aortic valve patients with new-generation devices showed comparable device success rates. Lotus showed moderate paravalvular leak rate comparable to that of ACURATE neo and significantly lower than Evolut-R. On simulation, Lotus and ACURATE neo showed optimal adaptability to elliptic anatomies as compared to Evolut-R

Transcatheter edge-to-edge mitral valve repair in atrial functional mitral regurgitation: insights from the multi-center MITRA-TUNE registry

Background: A-FMR is considered a specific sub-type of secondary MR in patients with atrial fibrillation (AF) and preserved left ventricle ejection fraction (LVEF). Aim of the study was to investigate the acute and mid-term outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) with the MitraClip in atrial functional mitral regurgitation (A-FMR). Methods: The study included patients with A-FMR and concomitant AF who underwent to the MitraClip at 7 Italian Centers. Aim of the study was to assess the safety, efficacy and mid-term cardiovascular outcomes. Results: After reviewing 1153 patients with FMR treated with TMVr from 2009 to 2021, 87 patients (median age 81 years, 61% female) with A-FMR were identified. Technical success was achieved in 97%, 30-day device success in 83% and 30-day procedural success in 80%. All-cause death at 30-day was 5%. Estimated two-year freedom from all-cause death and cardiac death was 60% and 77%, respectively, whereas freedom from all-cause death/heart failure hospitalization was 55%. Residual MR ≤ 2+ was encountered in 89% (n = 47/53) and improvement in NYHA class I/II in 79% (n = 48/61). Post-procedural MR ≥ 2+ (HR 5.400, CI 1.371–21.268) and inter-commissural annular diameter ≥ 35 mm (HR 4.159, CI 1.057–16.363) were independent predictors of all-cause death/heart failure hospitalization during the follow-up. Positive reverse remodeling of left atrium and mitral annular dimensions occurred after TMVr during the follow-up. Conclusions: MitraClip resulted to be a safe and effective option to treat A-FMR in elderly patients

Bailout From Sinus Jailing

Redo transcatheter aortic valve replacement (TAVR) may pose the risk of coronary flow obstruction. We report 2 cases of severe TAVR regurgitation due to different physiopathological mechanisms in which TAVR-in-TAVR could be at high risk for sinus sequestration. Both cases were successfully treated by in-series implantation of a second transcatheter heart valve, thus avoiding sinus sequestration. (Level of Difficulty: Intermediate.

Impact on clinical outcomes of right ventricular response to percutaneous correction of secondary mitral regurgitation

Aims: In patients with heart failure and reduced ejection fraction (HFrEF) and secondary mitral regurgitation (SMR), impaired right ventricular function (RVF) may negatively influence the prognosis. Percutaneous mitral valve repair (pMVR) can promote the recovery of RVF. We sought to characterize the response of the right ventricle to pMVR in HFrEF with SMR and to assess the association between improved RVF after pMVR and outcomes. Methods and results: Overall, 221 patients with HFrEF and SMR 653+ successfully treated with pMVR in four tertiary care centres for heart failure were included. Improved RVF was defined as \u394 right ventricular fractional area change (\u394RVFAC) 655% at early follow-up (median time 4\ua0months). The primary endpoint was a composite of death/heart transplantation (D/HT). Mean age was 69 \ub1 11 years, mean left ventricular ejection fraction was 31 \ub1 8% and mean RVFAC was 34 \ub1 9%. \u394RVFAC 655% occurred in 88 patients (40%) and was independent of the measures of left ventricular reverse remodelling. During a median follow-up of 29 months (interquartile range 12\u201346), 81 patients (37%) reached the primary endpoint. After adjustment for other significant covariates, \u394RVFAC 655% was significantly associated with lower risk of D/HT (hazard ratio 0.52, 95% confidence interval 0.29\u20130.94, P\ua0=\ua00.030). In the secondary outcome analysis exploring the risk of heart failure hospitalizations, \u394RVFAC 655% confirmed the prognostic association with the endpoint. Conclusions: In patients with HFrEF and SMR, about 40% of patients improved RVF after pMVR. RVF improvement was associated with better long-term survival free from HT and lower risk of heart failure hospitalization

Edge‐to‐edge percutaneous mitral repair for functional ischaemic and non‐ischaemic mitral regurgitation: a systematic review and meta‐analysis

Abstract Aim Randomized controlled trials comparing the use of the MitraClip device in addition to guideline directed medical therapy (GDMT) to GDMT alone in patients with secondary mitral regurgitation (MR) have shown conflicting results. However, if these differences could be due to the underlying MR aetiology is still unknown. Therefore, we aimed to evaluate if the effects of percutaneous edge‐to‐edge repair with MitraClip implantation could differ in patients with ischaemic (I‐MR) and non‐ischaemic mitral regurgitation (NI‐MR). Methods and results PubMed, Embase, BioMed Central, and the Cochrane Central Register of Controlled Trials were searched for all studies including patients with secondary MR treated with the MitraClip device. Data were pooled using a random‐effects model. Primary endpoint was the composite of all‐cause death and heart failure‐related hospitalization. Secondary endpoints were the single components of the primary endpoint, New York Heart Association functional Classes III and IV, and mitral valve re‐intervention. Seven studies enrolling 2501 patients were included. Patients with I‐MR compared with patients with NI‐MR had a similar risk of the primary endpoint (odds ratio: 1.17; 95% confidence interval: 0.93 to 1.46; I2: 0%). The risk of all‐cause death was increased in patients with I‐MR (odds ratio: 1.31; 95% confidence interval: 1.07 to 1.62; I2: 0%), while no differences were observed between the two groups in terms of the other secondary endpoints. Conclusions The risk of mortality after MitraClip implantation is lower in patients with NI‐MR than in those with I‐MR. No absolute differences in the risk of heart failure related hospitalization were observed between groups