Procedural success in transaxillary transcatheter aortic valve implantation according to type of transcatheter heart valve: results from the multicenter TAXI registry.

BACKGROUND: Transaxillary (TAx) transcatheter aortic valve implantation (TAVI) is a preferred alternative access in patients ineligible for transfemoral TAVI. AIMS: This study used the Trans-AXillary Intervention (TAXI) registry to compare procedural success according to different types of transcatheter heart valves (THV). METHODS: For the TAXI registry anonymized data of patients treated with TAx-TAVI were collected from 18 centers. Acute procedural, early and 1-month clinical outcomes were adjudicated in accordance with standardized VARC-3 definitions. RESULTS: From 432 patients, 368 patients (85.3%, SE group) received self-expanding (SE) THV and 64 patients (14.8%, BE group) received balloon-expandable (BE) THV. Imaging revealed lower axillary artery diameters in the SE group (max/min diameter in mm: 8.4/6.6 vs 9.4/6.8 mm; p < 0.001/p = 0.04) but a higher proportion of axillary tortuosity in BE group (62/368, 23.6% vs 26/64, 42.6%; p = 0.004) with steeper aorta-left ventricle (LV) inflow (55° vs 51°; p = 0.002) and left ventricular outflow tract (LVOT)-LV inflow angles (40.0° vs 24.5°; 0.002). TAx-TAVI was more often conducted by right sided axillary artery in the BE group (33/368, 9.0% vs 17/64, 26.6%; p < 0.001). Device success was higher in the SE group (317/368, 86.1% vs 44/64, 68.8%, p = 0.0015). In logistic regression analysis, BE THV were a risk factor for vascular complications and axillary stent implantation. CONCLUSIONS: Both, SE and BE THV can be safely used in TAx-TAVI. However, SE THV were more often used and were associated with a higher rate of device success. While SE THV were associated with lower rates of vascular complications, BE THV were more often used in cases with challenging anatomical circumstances.

Impact of Intraprocedural Pressure Changes on Hemodynamic Outcome During Self-Expanding TAVR.

INTRODUCTION: During the transcatheter aortic valve replacement (TAVR) procedure, hemodynamic measurements can be used to evaluate transcatheter heart valve (THV) performance. We hypothesized that the occurrence of a significant decrease in invasive aortic pressure immediately after annular contact by a self-expanding THV indicates effective annular sealing. This phenomenon could thus be used as a marker for the occurrence of paravalvular leak (PVL). METHODS: Thirty-eight patients undergoing TAVR procedure with a self-expandable Evolut R or Evolut Pro (Medtronic) valve prosthesis were included in the study. Drop in aortic pressure during valve expansion was defined as a decrease in systolic pressure of 30 mmHg immediately after annular contact. The primary endpoint was the occurrence of more than mild PVL immediately after valve implantation. RESULTS: A pressure drop was seen in 60.5% (23/38) of patients. More than mild PVL requiring balloon post-dilatation (BPD) was significantly more frequent in patients who did not have a systolic pressure decrease > 30 mmHg during valve implantation (46.7% [7/15] vs. 13.0% [3/23], respectively; p = 0.03). Patients without a systolic pressure decrease > 30 mmHg also had a lower mean cover index on computed tomography analysis (16.2% vs. 13.3%; p = 0.016). The 30-day outcomes were similar between the two groups, and echocardiography at 30 days demonstrated more than none/trace PVL in 21.1% (8/38) of patients, with no difference between the two groups. CONCLUSION: A decrease in aortic pressure after annular contact is associated with an increased probability of good hemodynamic outcome after self-expanding TAVR implantation. In addition to other methods, this parameter could be used as an additional marker for optimal valve positioning and hemodynamic outcome during the implantation procedure.

Percutaneous vs. surgical axillary access for transcatheter aortic valve implantation: the TAXI registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established management strategy for severe aortic valve stenosis. Percutaneous axillary approach for TAVI holds the promise of improving safety without jeopardizing effectiveness in comparison to surgical access. We aimed at appraising the comparative effectiveness of percutaneous vs. surgical axillary approaches for TAVI. METHODS: We performed an international retrospective observational study using de-identified details on baseline, procedural, and 1-month follow-up features. Valve Academic Research Consortium (VARC)-3 criteria were applied throughout. Outcomes of interest were clinical events up to 1 month of follow-up, compared with unadjusted and propensity score-adjusted analyses. RESULTS: A total of 432 patients were included, 189 (43.8%) receiving surgical access, and 243 (56.2%) undergoing percutaneous access. Primary hemostasis failure was more common in the percutaneous group (13.2% vs. 4.2%, P<0.001), leading to more common use of covered stent implantation (13.2% vs. 3.7%, P<0.001). Irrespectively, percutaneous access was associated with shorter hospital stay (-2.6 days [95% confidence interval: -5.0; -0.1], P=0.038), a lower risk of major adverse events (a composite of death, myocardial infarction, stroke, type 3 bleeding, and major access-site related complication; odds ratio=0.44 [0.21; 0.95], P=0.036), major access-site non-vascular complications (odds ratio=0.21 [0.06; 0.77], P=0.018), and brachial plexus impairment (odds ratio=0.16 [0.03; 0.76], P=0.021), and shorter hospital stay (-2.6 days [-5.0; -0.1], P=0.038). CONCLUSIONS: Percutaneous axillary access provides similar or better results than surgical access in patients undergoing TAVI with absolute or relative contraindications to femoral access.

Early and late pace-maker implantation after transcatheter and surgical aortic valve replacement.

BACKGROUND: Conduction defects requiring permanent pacemaker (PPM) implantation are frequent complications occurring after surgical (SAVR) and transcatheter aortic valve replacement (TAVR). METHODS: Patients who underwent TAVR or SAVR with a bioprosthesis from the nationwide FinnValve registry were the subjects of this study. Patients with prior PPM, who received a sutureless prosthesis, or required cardiac resynchronization therapy or implantable cardioverter defibrillator were excluded from this analysis. RESULTS: Four thousand and ten patients underwent SAVR and 1,897 underwent TAVR. TAVR had an increased risk of PPM implantation at 30-day (10.1% vs. 3.5%, unadjusted OR 3.11, 95%CI 2.56-3.87) and 5-year (15.7% vs. 8.6%, unadjusted SHR, 2.12, 95%CI 1.81-2.48) compared to SAVR. PPM implantation within 30 days from the index procedure did not increase the risk of 5-year mortality after either SAVR or TAVR. Among 1,042 propensity score matched pairs, TAVR had an increased risk of PPM implantation at 30-day (9.9% vs. 4.7%, p < .0001) and 5-year (14.7% vs. 11.4%, p = .001), but late (>30 days) PPM implantation at 5-year (4.7% vs. 6.9% SHR 0.72, 95%CI 0.47-1.10) was comparable to SAVR. The types of prosthesis had an impact on 30-day PPM implantation after TAVR, but not on late (>30 days) PPM implantation. CONCLUSIONS: Although the risk of 30-day PPM implantation is higher after TAVR compared to SAVR, late (>30 days) PPM implantation was comparable with these treatment methods. PPM implantation within 30 days did not affect late survival.

Occurrence and Features of Childhood Myocarditis: A Nationwide Study in Finland.

BACKGROUND: Epidemiology of myocarditis in childhood is largely unknown. Men are known to have a higher incidence of myocarditis than women in adults aged <50 years, but whether this is true by sex in pediatric age groups is unknown. We set out to study the occurrence and potential sex differences of myocarditis in a general pediatric population. METHODS AND RESULTS: Data of all hospital admissions with myocarditis in Finland occurring in patients aged ≤15 years from 2004 to 2014 were collected from a mandatory nationwide registry. All patients with myocarditis as a primary, secondary, or tertiary cause of admission were included. Total and age- and sex-specific incidence rates were calculated using corresponding population data. There were 213 admissions with myocarditis in pediatric patients. Myocarditis was the primary cause of admission in 86%. The overall incidence rate of myocarditis was 1.95/100 000 person-years. Of all patients, 77% were boys, but sex differences in incidence rates were age-dependent. In children aged 0 to 5 years, there was no sex difference in the occurrence of myocarditis. Boys aged 6 to 10 years had a higher incidence rate compared with girls (72% boys; incidence rate ratio: 2.46; 95% confidence interval, 1.03-5.89; P=0.04). Sex difference further increased in children aged 11 to 15 years (80% boys; incidence rate ratio: 3.5; 95% confidence interval, 2.68-5.67; P<0.0001). CONCLUSIONS: Myocarditis leading to hospital admission is relatively uncommon in children, but occurrence of myocarditis increases with age. There is no sex difference in the risk of myocarditis during the first 6 years of life, but boys have a significantly higher risk at ages 6 to 15 years.