Echocardiographic assessment of functional changes of prosthetic valve after transcatheter aortic valve implantation in one year follow up: insights from the multicenter, randomized DIRECT trial

Abstract Introduction The DIRECT trial (Predilatation in Transcatheter Aortic Valve Implantation (TAVI) Trial) was a multicenter, randomized, clinical trial designed to evaluate the safety and efficacy of TAVI with or without balloon aortic valvuloplasty (BAV) in patients with symptomatic, severe aortic valve stenosis. Purpose To investigate by echocardiography the functional changes of self-expanding prosthetic valves during the first year after TAVI with or without BAV. Methods One hundred seventy one consecutive patients with severe aortic stenosis were enrolled at 4 centers and randomized to TAVI using self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). Transthoracic echocardiography was obtained at baseline, 30 days and 1 year after TAVI. Results Of 171 patients, 86 patients were randomized to pre-BAV group and 85 to no-BAV group. Over the one year, 7 (4%) patients died and in 18 (10%) there was no available paired 30 day/1 year echo. At baseline echocardiography the peak and mean aortic valve gradient and the aortic valve area (AVA) in no-BAV group were 77.31±22.56 mmHg, 47.23±14.98 mmHg and 0.69±0.16cm2 and in pre-BAV group 81.97±23.17 mmHg, 49.39±14.78 mmHg and 0.65±0.15cm2 respectively. One year after TAVI, patients in no-BAV and pre-BAV group showed stable peak and mean aortic valve gradients similar to those at 30 days (from 16.36±7.88 to 14.51±6.6 mmHg vs. 17.17±8.88 to 15.95±9.97 mmHg and from 8.87±4.23 to 7.99±4.04 mmHg vs. 9.39±4.79 to 8.38±5.02 mmHg respectively, P<0.001 vs. baseline). The AVA was similarly stable in one year follow up in no-BAV group (from 1.85±0.43cm2 to 1.85±0.44cm2, P<0.001 vs. baseline) and in pre-BAV group (from 1.86±0.49cm2 to 1.84±0.39cm2, P<0.001 vs. baseline). The incidence of moderate or severe paravalvular regurgitation remained unchanged in both groups (from 4.7% to 5.7% in no-BAV group and from 5.8% to 6.6% in pre-BAV group). Conclusions In both pre-BAV and no-BAV groups the improvement in hemodynamics of self-expanding prosthetic valves remained durable during the one year echocardiographic follow up assessment. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): MEDTRONIC

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One-year echocardiographic outcomes of transcatheter aortic valve implantation with or without predilatation of the aortic valve: insights from the multicenter, randomized DIRECT trial

European Heart Journal ◽

10.1093/ehjci/ehaa946.0065 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

M Karmpalioti ◽

G Benetos ◽

M Drakopoulou ◽

M Xanthopoulou ◽

K Stathogiannis ◽

...

Keyword(s):

Aortic Valve ◽

Transcatheter Aortic Valve Implantation ◽

Funding Source ◽

Aortic Valve Area ◽

Transcatheter Aortic Valve ◽

Significant Difference ◽

Aortic Valve Implantation ◽

One Year ◽

Valve Implantation

Abstract Introduction Transcatheter aortic valve implantation (TAVI) has become the standard of care for high-risk and inoperable surgical patients and a valid alternative in intermediate-risk patients with severe aortic stenosis.The DIRECT trial (Predilatation in Transcatheter Aortic Valve Implantation Trial) was a multicenter, randomized, clinical trial designed to evaluate the safety and efficacy of TAVI with or without balloon aortic valvuloplasty (BAV) in patients with symptomatic, severe aortic valve stenosis. Purpose To compare the one year echocardiographic findings among patients, who underwent TAVI using a self-expanding valve with or without BAV. Methods A total of 171 patients with severe aortic stenosis were randomly assigned at 4 tertiary centers to undergo TAVI with the use of self-expanding prostheses with (pre-BAV) or without pre-dilatation (no-BAV). Follow up transthoracic echocardiography was performed 1 year after TAVI. Results Of 171 patients, 86 patients were randomized to pre-BAV group and 85 to no-BAV group. One year echocardiographic follow up was available in 146 patients. In one year follow up there was no significant difference between pre-BAV and no-BAV group in aortic valve area (1.84±0.39cm2 vs. 1.85±0.44cm2, p=0.79), peak aortic valve gradient (15.95±9.97 mmHg vs. 14.51±6.60 mmHg, p=0.35), mean aortic valve gradient (8.37±5.01 mmHg vs. 7.99±4.04 mmHg, p=0.64), aortic valve peak velocity (1.90±0.51 m/s vs. 1.80±0.42m/s, p=0.24), ejection fraction (54.19±8.36% vs. 53.19±9.58%, p=0.52) and pulmonary artery systolic pressure (41.86±14.34 mmHg vs. 40.71±12.40 mmHg, p=0.64). The incidence of moderate or severe paravalvular regurgitation (PVL) in 1 year follow up was 6.2% without significant difference between the 2 study groups (5.7% in the no-BAV group vs. 6.6% in the pre-BAV group, p=0.83). Conclusions Direct transcatheter aortic valve implantation has no impact on one-year prosthesis function and PVL in patients undergoing TAVI with self-expanding valve Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic

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First Egyptian experience of Transcatheter Aortic Valve Implantation: Immediate results and one year follow up

The Egyptian Heart Journal ◽

10.1016/j.ehj.2013.10.003 ◽

2014 ◽

Vol 66 (1) ◽

pp. 17-21 ◽

Cited By ~ 1

Author(s):

Ahmed A. Khashaba ◽

Walaa Adel ◽

Alaa Roshdi ◽

Ahmed Gafar ◽

Sherif Essam ◽

...

Keyword(s):

Aortic Valve ◽

Transcatheter Aortic Valve Implantation ◽

Transcatheter Aortic Valve ◽

Aortic Valve Implantation ◽

One Year ◽

Valve Implantation

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Percutaneous transcatheter aortic valve implantation for degenerated surgical bioprostheses: the first case series in Asia with one-year follow-up

Singapore Medical Journal ◽

10.11622/smedj.2016097 ◽

2016 ◽

Vol 57 (07) ◽

pp. 401-405 ◽

Cited By ~ 5

Author(s):

PT Chiam ◽

SH Ewe ◽

JL Soon ◽

KW Ho ◽

YK Sin ◽

...

Keyword(s):

Aortic Valve ◽

Transcatheter Aortic Valve Implantation ◽

Case Series ◽

Transcatheter Aortic Valve ◽

First Case ◽

Aortic Valve Implantation ◽

One Year ◽

Valve Implantation

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3326Infective endocarditis after transcatheter aortic valve implantation: findings from a UK nationwide linkage study

European Heart Journal ◽

10.1093/eurheartj/ehz745.0078 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

T J Cahill ◽

J Raby ◽

P D Jewell ◽

P F Brennan ◽

A P Banning ◽

...

Keyword(s):

Septic Shock ◽

Aortic Valve ◽

Cardiogenic Shock ◽

Transcatheter Aortic Valve Implantation ◽

Oral Streptococci ◽

Transcatheter Aortic Valve ◽

Aortic Valve Implantation ◽

One Year ◽

Valve Implantation

Abstract Introduction Infective endocarditis (IE) is a potentially fatal complication of prosthetic valve replacement and increasing use of transcatheter aortic valve implantation (TAVI) has resulted in a new elderly and frail population at increased risk of IE. The incidence of IE after TAVI and factors that influence the risk and subsequent outcome are relatively unknown. Purpose To describe the incidence, predictors, echocardiographic findings, microbiology and clinical outcomes of IE following TAVI in the United Kingdom (UK). Methods Patients who underwent TAVI between Jan 1 2007 and Dec 31 2016 were identified from the UK TAVI database held by the National Institute for Cardiovascular Outcomes Research. For this cohort, all hospital admissions with a primary diagnosis of IE were identified by linkage with the NHS Hospital Episode Statistics Admitted Patient Care database, or by contact with regional TAVI centres. Additional information concerning clinical presentation, imaging findings, microbiology, management and patient outcome were obtained where possible from the treating physician. Results A total of 16,014 patients underwent TAVI, of whom 157 developed IE over a median follow-up of 23.8 (IQR 7.8–52.4) months - an overall incidence of 0.98% (0.53% at one year post-TAVI). The mean age of patients with IE was 79.2±7.8 years, and 69% were male. The median time to IE following TAVI was 10.0 (IQR 4.0–22.3) months. On multivariate analysis, IE was significantly more common in men (HR 2.05, 95% CI 1.35–3.11, p=0.001) and in patients receiving mechanically-expandable (HR 2.15, 95% CI 1.16–4.01, p=0.015) or balloon-expandable valves (HR 1.60, 95% CI 1.01–2.52, p=0.045) compared to self-expanding valves. IE was also more common in those with an aortic valve peak gradient following TAVI deployment greater than median (HR 1.81, 95% CI 1.23–2.67, p=0.003). The most common presenting symptom was fever (present in 67.1%). The most frequent causal organisms were enterococci (25.9%), followed by oral streptococci (16.4%) and Staphylococcus aureus (11.8%). Transoesophageal echocardiography demonstrated vegetations in 72.5% of patients, most commonly on the TAVI valve leaflets (58.8%). Only 8.24% of patients underwent surgical valve intervention. Survival rates at hospital discharge and one year follow up were 61.4% and 54.4%, respectively. Specific factors associated with one-year mortality were cardiogenic shock (HR 4.6, 95% CI 2.1–10.3, p=0.0002), septic shock (HR 3.4, 95% CI 1.4–8.3, p=0.006) and stroke (HR 4.9, 95% CI 1.46–16.7, p=0.01). Conclusions The incidence of IE one year after TAVI was 0.53% and greater risk was associated with male sex, mechanically-expandable and balloon-expandable valves, and elevated post-deployment valve gradient. Enterococci were the most common causative organism. Overall survival at one year was 54.4%, with adverse outcome predicted by cardiogenic shock, septic shock or stroke.

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