Rationale and design of the Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure (TAVR UNLOAD) trial

Spitzer, Ernest; Mieghem, Nicolas Van; Pîbarot, Philippe; Hahn, Rebecca T.; Kodali, Susheel; Maurer, Mathew S.; Nazif, Tamim; Rodés‐Cabau, Josep; Paradis, Jean‐Michel; Kappetein, Arie Pieter; Ben‐Yehuda, Ori; Es, Gerrit‐Anne van; Kallel, Faouzi; Anderson, William N.; Tijssen, Jan G.P.; Leon, Martin B.

doi:10.1016/j.ahj.2016.08.009

Cited by 154 publications

(97 citation statements)

References 36 publications

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“…One third of the patients have undergone a transapical TAVI with no dedicated subgroup analysis of TF-TAVI data, which may account for different results from ours.Taken together, our results confirm the prognostic value of LGAS after TF-TAVI in addition to LVEF and are clearly in line with the current practice guidelines that recommend aortic valve replacement by surgery or TAVI in all symptomatic patients with severe AS despite an abnormal baseline LVEF as long as the mean gradient is more than 40 mm Hg 22. The ongoing randomized TAVR-UNLOAD clinical trial (NCT02661451) may provide here important novel insights 34. In the minority of patients with both moderately/severely abnormal LVEF and LGAS (83 of 624[13.3%] patients in this study and 8.4%-22.5% in other studies with variable definition of an abnormal LVEF3,4,26,28 ), TAVI may still be considered given the fact that 1-year mortality after TAVI, although high, is lower when compared to patients with medical management only 8.…”

supporting

confidence: 86%

“…The ongoing randomized TAVR-UNLOAD clinical trial (NCT02661451) may provide here important novel insights. 34 In summary, we found that moderately/severely abnormal LVEF (≤40%) at baseline is associated with increased mortality after TF-TAVI, especially when the mean transvalvular aortic gradient is <40 mm Hg, while outcomes in patients with normal and mildly abnormal LVEF are comparable regardless the pressure gradient across the native aortic valve.…”

Section: Our Data Show Thatmentioning

confidence: 64%

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Impact of baseline left ventricular ejection fraction on outcome after transfemoral transcatheter aortic valve implantation in patients with and without low‐gradient aortic stenosis

et al. 2018

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Objectives:To evaluate the impact of baseline left ventricular ejection fraction (LVEF) and its interaction with low-gradient aortic stenosis (LGAS) on all-cause mortality after transfemoral aortic valve implantation (TF-TAVI). Methods:We reviewed mortality data of 624 consecutive single center TF-TAVI patients and categorized LVEF according to current ASE/EACVI recommendations (normal, mildly-, moderately-, and severely abnormal). Results:Baseline LVEF was normal in 336 (53.8%), mildly abnormal in 160 (25.6%), moderately abnormal in 91 (14.6%), and severely abnormal in 37 (5.9%) patients, and 1-year mortality was 19%, 17%, 23%, and 43% (P = 0.002), respectively. Patients with LGAS had a similar 1-year mortality compared to those without LGAS in groups with normal (19% vs 19%, P = 0.899) and mildly abnormal LVEF (16% vs 17%, P = 0.898). One-year mortality of patients with LGAS was significantly greater than in those without LGAS in presence of moderately abnormal LVEF (31% vs 11%, P = 0.022), and it was numerically greater than in those without LGAS in presence of severely abnormal LVEF (48% vs 25%, P = 0.219). In multivariate analysis, only the combination of moderately/severely abnormal LVEF and LGAS predicted increased 1-year mortality (HR: 2.12, 95% CI: 1.4-3.2, P < 0.001). Other variables, including EuroSCORE I did not affect this result. Conclusions:Moderately/severely abnormal LVEF (≤40%) at baseline is associated with increased mortality after TF-TAVI, especially when the mean transvalvular aortic gradient is <40 mm Hg (LGAS), while outcomes in patients with normal and mildly abnormal LVEF are comparable regardless of the pressure gradient across the native aortic valve. (DRKS00013729). K E Y W O R D Sleft ventricular ejection fraction, low-gradient aortic stenosis, mortality, transfemoral aortic valve implantation | 29 EL-CHILALI Et AL.

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supporting

confidence: 86%

Section: Our Data Show Thatmentioning

confidence: 64%

Impact of baseline left ventricular ejection fraction on outcome after transfemoral transcatheter aortic valve implantation in patients with and without low‐gradient aortic stenosis

et al. 2018

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“…Recent trial data have even suggested that TAVR is non-inferior to surgical AVR in patients in intermediate-risk severe AS (13). Coexisting moderate AS and LV systolic dysfunction is not uncommon, and now with the advent of TAVR, upcoming clinical trials will seek to address whether a less invasive approach such as TAVR may be a viable strategy to reduce afterload in patient’s with LV systolic dysfunction and concomitant moderate aortic stenosis, who are of high surgical risk (14). …”

Section: Discussionmentioning

confidence: 99%

Aortic Valve Replacement for Moderate Aortic Stenosis with Severe Calcification and Left Ventricualr Dysfunction—A Case Report and Review of the Literature

Narang

Lang

Liarski

et al. 2017

Front. Cardiovasc. Med.

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A 55-year-old man with a history of erosive, seropositive rheumatoid arthritis (RA), and interstitial lung disease presented with shortness of breath. Echocardiography showed new-onset severe left ventricular (LV) dysfunction with an ejection fraction (EF) of 15% and moderately increased mean aortic valve gradient of 20 mmHg in a trileaflet aortic valve with severe sclero-calcific degeneration. Coronary angiography revealed no significant obstructive coronary disease. Invasive hemodynamic studies and dobutamine stress echocardiography were consistent with moderate aortic stenosis. Guideline directed medical therapy for heart failure with reduced EF was initiated; however, diuretics and neurohormonal blockade (beta-blocker and angiotensin receptor blocker) provided minimal improvement, and the patient remained functionally limited. Of interest, echocardiography performed 1 year prior to his presentation showed normal LV EF and mild aortic leaflet calcification with moderate stenosis, suggesting a rapid progressing of calcific aortic valve disease. Subsequently, the patient underwent surgical aortic valve replacement and demonstrated excellent postsurgical recovery of LV EF (55%). Calcific aortic valve disease is commonly associated with aging, bicuspid aortic valve, and chronic kidney disease. Pathophysiological mechanism for valvular calcification is incompletely understood but include osteogenic transformation of valvular interstitial cells mediated by local and systemic inflammatory processes. Several rheumatologic diseases including RA are associated with premature atherosclerosis and arterial calcification, and we speculated a similar role of RA accelerating calcific aortic valve disease. We present a case of accelerated aortic valve calcification with (only) moderate stenosis, complicated by a rapid decline in LV systolic performance. Guidelines for AVR in moderate stenosis without concomitant cardiac surgery are not well established, although it should be considered in selected patients.

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“…Despite the limitations of current retrospective data, the Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure (TAVR UNLOAD) trial has been developed (21). TAVR UNLOAD will be a multicenter, randomized trial comparing the efficacy of TAVR plus optimal heart failure therapy (OHFT) vs. OHFT alone in patients with moderate AS and a reduced ejection fraction.…”

Section: Editorialmentioning

confidence: 99%

Outcomes with moderate aortic stenosis and impaired left ventricular function: prelude to a randomized trial?

et al. 2017

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Rationale and design of the Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure (TAVR UNLOAD) trial

Cited by 154 publications

References 36 publications

Impact of baseline left ventricular ejection fraction on outcome after transfemoral transcatheter aortic valve implantation in patients with and without low‐gradient aortic stenosis

Impact of baseline left ventricular ejection fraction on outcome after transfemoral transcatheter aortic valve implantation in patients with and without low‐gradient aortic stenosis

Aortic Valve Replacement for Moderate Aortic Stenosis with Severe Calcification and Left Ventricualr Dysfunction—A Case Report and Review of the Literature

Outcomes with moderate aortic stenosis and impaired left ventricular function: prelude to a randomized trial?

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