Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting. AIMS: We aimed to evaluate the safety and feasibility of Myval in NCAR. METHODS: This was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed. RESULTS: A total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm2. The annular area was beyond the recommended range for extra-large sizes in 2.6% of cases, and additional volume was added in 92% (median 4 cc, up to 9 cc). The extra-large sizes were used in 95 patients (84.1%), and the mean oversizing was 17.9±11.0%. The technical success rate was 94.7%; the rate of residual ≥moderate aortic regurgitation was 8.9%, and the pacemaker rate was 22.2%. There were no cases of annular rupture, cardiac tamponade, or aortic dissection, but in 4 patients (3.5%) valve embolisation occurred (1 antegrade and 3 ventricular), all in cases with a tapered left ventricle outflow tract (p=0.007). Thirty-day and 1-year mortality were 5.3% and 9.7%, respectively. Technical success was associated with better survival (97.1% vs 72.7%; p=0.012), and valve embolisation was the main determinant of mortality (p=0.047). CONCLUSIONS: Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.

Ratio between right ventricular longitudinal strain and pulmonary arterial systolic pressure: A novel prognostic parameter in patients with severe tricuspid regurgitation.

BACKGROUND: In terms of pathophysiology, tricuspid regurgitation (TR), right ventricular function and pulmonary artery pressure are linked to each other. Our aim was to analyze whether the echocardiography-derived right ventricular free wall longitudinal strain/pulmonary artery systolic pressures (RVFWLS/PASP) ratio can improve risk stratification in patients with severe tricuspid regurgitation (TR). METHODS: In this single-center retrospective study, 250 consecutive patients with severe TR were enrolled from December 2015 to December 2018. Baseline clinical and echocardiographic parameters were collected. Echocardiography-derived TAPSE/PASP and RVFWLS/PASP were evaluated. The primary endpoint was all-cause mortality. RESULTS: Out of 250 consecutive patients, 171 meet inclusion criteria. Patients were predominantly female, with several cardiovascular risk factors and comorbidities. RVFWLS/PASP ≤0.34%/mmHg (AUC 0.68, p < 0.001, sensitivity 70%, specificity 67%) was associated with baseline clinical RV heart failure (p = 0.03). After univariate and multivariate analyses, RVFWLS/PASP, but not TAPSE/PASP, independently correlated with all-cause mortality (HR 0.004, p = 0.02). Patients with RVFWLS/PASP >0.26%/mmHg (AUC 0.74, p < 0.001, sensitivity 77%, specificity 52%) showed higher survival rates (p = 0.02). In addition at 24 months follow-up, the Kaplan-Meyer curves showed patients with RVFWLS >14% & RVFWLS/PASP >0.26%/mmHg had the best survival rate compared to patients without. CONCLUSION: RVFWLS/PASP is independently associated with baseline RV heart failure and poor long-term prognosis in patients with severe TR.

Extracellular volume fraction (ECV) derived from pre-operative computed tomography predicts prognosis in patients undergoing transcatheter aortic valve implantation (TAVI).

AIMS: Transcatheter aortic valve implantation (TAVI) is the treatment of choice for high-risk patients with severe aortic stenosis (AS). A portion of TAVI recipients has no long-term clinical benefit, and myocardial fibrosis may contribute to unfavourable outcomes. We aimed to assess the prognostic value of an interstitial fibrosis marker, extracellular volume fraction (ECV), measured at planning computed tomography (CT) before TAVI. METHODS AND RESULTS: From October 2020 to July 2021, 159 consecutive patients undergoing TAVI planning CT were prospectively enroled. ECV was calculated as the ratio of myocardium and blood pool differential attenuations before and 5 min after contrast administration, pondered for haematocrit. A composite endpoint including heart failure hospitalization (HFH) and death was collected by telehealth or in-person follow-up visits in the 113 patients constituting the final study population. Cox proportional hazards model was used to assess association between ECV and the composite endpoint.Median follow-up was 13 (11-15) months. The composite endpoint occurred in 23/113 (20%) patients. These patients had lower aortic valve mean pressure gradient [39 (29-48) vs. 46 (40-54) mmHg, P = 0.002] and left ventricular and right ventricular ejection fraction [51 (37-69) vs. 66 (54-74)%, P = 0.014; 45 (31-53) vs. 49 (44-55)%, P = 0.010] and higher ECV [31.5 (26.9-34.3) vs. 27.8 (25.3-30.2)%, P = 0.006]. At multivariable Cox analysis, ECV higher than 31.3% was associated to increased risk of death or HFH at follow-up (hazard ratio = 5.92, 95% confidence interval 2.37-14.75, P < 0.001). CONCLUSION: In this prospective observational cohort study, ECV measured at TAVI planning CT predicts the composite endpoint (HFH or death) in high-risk severe AS patients.

Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) with the ACURATE neo device has been associated with a non-negligible incidence of paravalvular aortic regurgitation (AR). The new-generation ACURATE neo2 has been designed to mitigate this limitation. AIMS: The aim of the study was to compare TAVR with the ACURATE neo and neo2 devices. METHODS: The NEOPRO and NEOPRO-2 registries retrospectively included patients undergoing transfemoral TAVR with self-expanding valves at 24 and 20 centres, respectively. Patients receiving the ACURATE neo and neo2 devices (from January 2012 to December 2021) were included in this study. Predischarge and 30-day VARC-3 defined outcomes were evaluated. The primary endpoint was predischarge moderate or severe paravalvular AR. Subgroup analyses per degree of aortic valve calcification were performed. RESULTS: A total of 2,026 patients (neo: 1,263, neo2: 763) were included. Predischarge moderate or severe paravalvular AR was less frequent for the neo2 group (2% vs 5%; p<0.001), resulting in higher VARC-3 intended valve performance (96% vs 90%; p<0.001). Furthermore, more patients receiving the neo2 had none/trace paravalvular AR (59% vs 38%; p<0.001). The reduction in paravalvular AR with neo2 was mainly observed with heavy aortic valve calcification. New pacemaker implantation and VARC-3 technical and device success rates were similar between the 2 groups; there were more frequent vascular and bleeding complications for the neo device. Similar 1-year survival was detected after TAVR (neo2: 90% vs neo: 87%; p=0.14). CONCLUSIONS: TAVR with the ACURATE neo2 device was associated with a lower prevalence of moderate or severe paravalvular AR and more patients with none/trace paravalvular AR. This difference was particularly evident with heavy aortic valve calcification.

Intravascular Ultrasound-Guided Coronary Lithotripsy Treatment of In-Stent Restenosis in Saphenous Venous Graft.

To the best of our knowledge, this is the first description of intravascular-ultrasound guided coronary lithotripsy on saphenous vein graft because of severely calcific in-stent restenosis, showing good result without procedural complications.

Right ventricular systolic function in severe tricuspid regurgitation: prognostic relevance of longitudinal strain.

AIMS: The aim of this study is to analyse the prognostic implications of right ventricular (RV) dysfunction as detected by strain analysis in patients with severe tricuspid regurgitation (TR). The evaluation of RV systolic function in presence of severe TR is of paramount importance for operative risk stratification; however, it remains challenging, as conventional echocardiographic indexes usually lead to overestimation. METHODS AND RESULTS: We enrolled 250 consecutive patients with severe TR referred to our centre. Baseline clinical and echocardiographic data and follow-up outcomes were collected. Patients were predominantly female, with multiple cardiovascular risk factors and comorbidities, history of heart failure, and atrial fibrillation. Most of them had presented with clinical signs of RV heart failure (RVHF) and advanced New York Heart Association class. The RV strain analysis [both RV free wall longitudinal strain (RVFWLS) and RV global longitudinal strain (RVGLS)] reclassified ∼42-56% of patients with normal RV systolic function according to conventional parameters in patients with impaired RV systolic function. RVFWLS ≤17% (absolute values, AUC: 0.66, P = 0.002) predicted the presence of RVHF [odds ratio (OR) 0.93, P = 0.01]. At follow-up, patients with RVFWLS >14% (absolute values, AUC: 0.70, P = 0.001, sensitivity 72%, specificity 54%) showed a better survival (P = 0.01). CONCLUSION: Different ranges of RVFWLS have different implications in patients with severe TR, allowing to identify a preclinical and a clinical window, with correlations to RVHF and survival.

Self-expanding transcatheter aortic valve infolding: Current evidence, diagnosis, and management.

BACKGROUND: Prosthetic valve infolding is a rare but severe complication of transcatheter aortic valve implantation (TAVI) with self-expanding valves. However, currently available clinical data are limited and fragmented. OBJECTIVES: This report aims to provide a comprehensive overview of this complication focusing on predisposing factors, clinical presentation, diagnostic findings, treatment and clinical outcomes. METHODS: A systematic review of the literature was performed to identify cases of infolding occurring during TAVI with self-expanding valves published until August 2020. These data were pooled with all the retrospectively identified infolding cases occurred at San Raffaele Scientific Institute between December 2014 and August 2020. RESULTS: A total of 34 cases were included. Among patients with available data, 38% received a first-generation CoreValve, and 62% a second-generation Evolut R (82%) or Evolut PRO (18%). Infolding occurred mostly with ≥29-mm valves (94%). Predisposing factors included resheathing of a second-generation valve (82%), heavy calcification of the native valve (65%), lack of predilatation (16%), Sievers type-1 bicuspid aortic valve (11%), and improper valve loading (5%). Infolding resulted in severe PVL causing hemodynamic instability (29%) or cardiac arrest (12%). Postdilatation was the treatment strategy in 68%, while prosthesis replacement with a new device in 23% of cases. Device success rate was 82%. Death and stroke occurred in 3% and 12% of cases. CONCLUSIONS: Prosthetic valve infolding is typically observed after resheathing of a large-size self-expanding TAVI. When infolding is timely diagnosed, prosthesis removal and replacement should be pursued. Further studies are required to precisely define predisposing factors to prevent this complication.

Aortic valve area calculation using 3D transesophageal echocardiography: Implications for aortic stenosis severity grading.

AIMS: Aortic stenosis (AS) grading by 2D-transthoracic echocardiography (2D-TTE) aortic valve area (AVA) calculation is limited by left ventricular outflow tract (LVOT) area underestimation. The combination of Doppler parameters with 3D LVOT area obtained by multidetector computed tomography (MDCT) can improve AS grading, reconciling discordant 2D-TTE findings. This study aimed to systematically evaluate the role of 3D-transesophageal echocardiography (3D-TEE) in AS grading using MDCT as reference standard. METHODS AND RESULTS: 288 patients (81 ± 6.3 years, 52.4% female) with symptomatic AS underwent 2D-TTE, 3D-TEE, and MDCT for transcatheter aortic valve implantation. Doppler parameters were combined with 3D LVOT areas measured by manual and semi-automated software 3D-TEE and by MDCT to calculate AVA, reassessing AS severity. Both 3D-TEE modalities demonstrated good correlation with MDCT, with excellent intra-observer and inter-observer variability. Compared to MDCT, 3D-TEE measurements significantly underestimated AVA (PANOVA  < .0001), although the difference was clinically acceptable. Compared to 2D-TTE, 3D-TEE manual and semi-automated software reclassified severe AS in 21.9% and 25.2% of cases, respectively (P < .0001), overcame grading parameters discordance in more than 40% of cases in patients with low-gradient AS (P < .0001) and reduced the proportion of low-flow states in nearly 75% of cases when combined to stroke volume index assessment (P < .0001). 3D-TEE imaging modalities showed a reduction in the proportion of patients with low-gradient and pathological AVA as defined by 2D-TTE, and improved AVA and mean pressure gradient agreement with current guidelines cutoff values. CONCLUSION: 3D-TEE AVA calculation is a reliable tool for AS grading with excellent reproducibility and good correlation with MDCT measurements.

Long-term follow-up of BVS from a prospective multicenter registry: Impact of a dedicated implantation technique on clinical outcomes.

OBJECTIVES: The aim of this study was to evaluate the impact of a consistent and dedicated implantation strategy on long-term outcomes after implantation of bioresorbable vascular scaffold (BVS) in a real-world cohort of patients with a high prevalence of complex lesions. BACKGROUND: Bioresorbable vascular scaffolds may result in a reduced incidence of late and very-late scaffold thrombosis (ScT) after the complete reabsorption of the scaffold, but this hypothesis is hampered by data from RCTs that showed a higher than expected incidence of late events. However, these studies did not adopt a dedicated implantation technique, that proved to be fundamental in reducing the incidence of adverse events. METHODS: 573 consecutive patients (912 lesions) treated with bioresorbable scaffolds between May 2012 and December 2014 were enrolled in 3 high-volume centers that used a dedicated implantation strategy from the beginning. Primary endpoints were target-lesion failure (TLF) and definite and probable ScT. Secondary endpoints included myocardial infarction, target-lesion and target-vessel revascularization. RESULTS: The registry enrolled a high complexity subset of lesions (69.4% of type B2 or C lesions; 10.3% of severe calcific lesions; 26.1% of bifurcations). Predilatation was performed in almost all cases (99.2%); intracoronary imaging was liberally adopted (37.3%). Mean scaffold length was 42.9 ±â€¯27.4 mm per patient, and post-dilation with a 1:1 high-pressure (22 ±â€¯3.5 atm) balloon was performed in 99.9% of lesions. Median follow-up (available for 98.6% of patients) was 981 days (IQR 802-1133). Overall incidence of ScT was reassuringly low: three thrombotic events occurred during the first year (0.5%), while only one event ensued in the second year of follow-up, and ScT rate remained stable thereafter up to the fourth year (0.7%). Cumulative TLF rates at 1, 2, 3 and 4 years were 3.0%, 6.0%, 7.8% and 12.2%. CONCLUSIONS: These long-term results from a complex "real-world" population appear to be reassuring as regards to the incidence of ScT and TLF when BVS are implanted by experienced operators with a dedicated implantation technique.