Impact of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty on Procedural and Clinical Outcomes

Deharo, Pierre; Jaussaud, Nicolas; Grisoli, Dominique; Camus, O.; Resseguier, Noémie; Breton, Hervé; Auffret, Vincent; Verhoye, Jean Philippe; Köning, René; Lefèvre, Thierry; Belle, Éric Van; Eltchaninoff, Hélène; Gilard, Martine; Leprince, Pascal; Iung, Bernard; Lambert, Marc; Collart, Frédéric; Cuisset, Thomas

doi:10.1016/j.jcin.2018.06.023

Cited by 42 publications

(43 citation statements)

References 24 publications

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“…Multiple TF-TAVI studies have found procedural durations to be significantly shorter in the absence of predilation, with reported times of 50.5–133.7 min where BAV is performed compared with 34.0–108.7 min when it is not 6 7 17–20. Concurrently, omission of BAV in the present study resulted in procedural times that were an average of 34 min shorter, as well as reduced fluoroscopy times, confirming its time-saving advantage.…”

Section: Discussionsupporting

confidence: 77%

Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry

et al. 2019

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BackgroundPredilation of the native valve has long been deemed necessary in transfemoral transcatheter aortic valve implantation (TF-TAVI), despite little trial evidence to support its clinical use. As most evidence is derived from retrospective analyses of observational studies, we conducted a two-armed, prospective multicentre registry.MethodsPatients undergoing TF-TAVI with the Edwards SAPIEN 3 valve, with or without balloon aortic valvuloplasty (BAV), were included and their procedural characteristics, short-term safety and short-term efficacy outcomes compared. We hypothesised that BAV may be safely omitted in many patients and omission could be associated with procedural benefits.ResultsOverall, 196 consecutive patients underwent TF-TAVI, 56 with BAV and 140 without. The mean age was 81.2±6.2 years, and the mean logistic EuroSCORE I was 17.1±13.6. Device success according to Valve Academic Research Consortium-2 (VARC-2) was achieved in 96.4%. The median procedural duration was shorter without BAV (56 min vs 90 min; p=0.001), as was fluoroscopy time (10 min vs 13 min; p=0.001). The need for balloon postdilation was less frequent in patients without BAV (15.7% vs 30.4%, p=0.029). There was no difference in the proportion of patients meeting the VARC-2 defined composite safety endpoint at 30 days (9.3% without vs 8.9% with BAV; adjusted OR (adjOR) 2.55; 95% CI 0.56 to 18.84) and at 6 months (15.2% without vs 16.4% with BAV; adjOR 1.66; 95% CI 0.49 to 6.55).ConclusionsIn the majority of patients, BAV can be safely omitted from the TAVI procedure without adverse effects. The omission of BAV is associated with shorter procedural duration and could be advantageous for the majority of patients.Trial registration numberNCT02760771.

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Section: Discussionsupporting

confidence: 77%

Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry

et al. 2019

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“…Multivariate analysis found postdilatation a significant predictor for brain lesions, whereas predilatation and VIV procedure itself turned out to be none‐significant predictors. Predilatation was the operator's discretion, performed in a rate comparable with the common practice . The main reason to postdilate was the presence of a significant paravalvular leak.…”

Section: Discussionmentioning

confidence: 99%

Does valve in valve TAVR carry a higher risk for thromboembolic events compared to native valve TAVR?

Eitan

Brinkmann

Haselbach

et al. 2019

Cathet Cardio Intervent

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Objective To evaluate the risk for brain lesions in valve in valve (VIV)‐transcatheter aortic valve replacement (TAVR) compared to native valve procedures (NV‐TAVR). Background TAVR is associated with the risk of stroke and a high incidence of brain lesions in diffusion‐weighted magnetic resonance imaging (DW‐MRI). The risk in VIV procedures is unknown. Methods Patients were included, if they received a Sapien‐3 or an Evolut‐R valve for an NV‐TAVR or VIV‐TAVR and a DW‐MRI within 3–5 days after the procedure. Results Two hundred nine patients had NV‐TAVR and 41 patients had VIV‐TAVR. The VIV group was significantly younger (mean 82.3 vs. 74.7 years old, p < .001) but had higher mean EuroSCORE II (4.8 vs. 7.8, p < .001). Predilatation was significantly more common with native valve (39% vs. 2%, p < .01), postdilatation rate was lower in VIV but without statistical significance (17% vs. 7%, p = .110). Combined in‐hospital safety outcome was comparable [13(6.6%) vs. 5(12.2%), p = .205]. Any stroke was documented in four (0.5%) patients after native valve and in one (2.4%) after VIV‐TAVR. New DW‐MRI brain lesions were significantly more often found in patients with native valves [153(73.2%) vs. 21(51.2%), p = .005], mean number of new lesions was also higher with native valve (2.8 ± 3.2 vs. 1.0 ± 1.4, p < .001). Forward stepwise of logistic regression found age and post dilatation significant predictors of new MRI lesions. Conclusions Compared to native valves, VIV procedures were associated with lower incidence and number of brain lesions according to DW‐MRI; these were explained by lower patients' age and lower rate of postdilatation.

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“…The geriatric population has grown, leading to an increased number of patients undergoing TAVR. Taking this epidemiological fact into consideration, improve- ments in transcatheter technology and increased operator experience leading to further simplification of the procedure are key to achieving the best result in such a fragile population [6,7]. According to recent data, the incidence of periprocedural complications defined by the Valve Academic Research Consortium may be similar between the different age groups [4].…”

Section: Incidence Of Age-associated Complications and Impact Of Incrmentioning

confidence: 99%

“…Balloon aortic valvuloplasty can improve annular sizing, facilitate the delivery system passing through the stenotic native valve, and is supposed to optimize valve expansion [7,17]. Nevertheless, BAV has been related to hemodynamic instability, acute aortic regurgitation, renal failure, increased incidence of stroke, and pacemaker implantation [7,[18][19][20].…”

Section: Incidence Of Age-associated Complications and Impact Of Incrmentioning

confidence: 99%

Outcomes after transcatheter aortic valve replacement in older patients

Kara

Kloppe

Ewers

et al. 2020

Herz

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Background The prevalence of aortic valve stenosis is increasing due to the continuously growing geriatric population. Data on procedural success and mortality of very old patients are sparse, raising the question of when this population may be deemed as “too old even for transcatheter aortic valve replacement (TAVR).” We, therefore, sought to evaluate the influence of age on outcome after TAVR and the impact of direct implantation. Methods The data of 394 consecutive patients undergoing TF-TAVR were analyzed. Patients were divided into four age groups: ≤75 (group 1, n = 28), 76–80 (group 2, n = 107), 81–85 (group 3, n = 148), and >85 (group 4, n = 111) years. Direct implantation was performed when possible according to current recommendations. Survival was evaluated by Kaplan–Meier analysis. Results Mortality at 30 days and 1 year was not significantly different between the four age groups (3.6 vs. 6.7 vs. 5.4 vs. 2.7% and 7.6 vs. 17 vs. 14.5 vs. 13%m respectively, log-rank p = 0.59). Direct implantation without balloon aortic valvuloplasty was more frequently performed on patients aged >85 vs. ≤85 years (33.3 vs. 14.1%, p < 0.001). the incidence of procedural complications frequently associated with advanced age (stroke, vascular complications) was not significantly increased in group 4. Conclusion Outcome after TF-TAVR is comparable among different age cohorts, even in very old patients. Direct implantation simplifies the procedure and could therefore play a role in reducing the incidence of peri-interventional complications in patients of advanced age.

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Impact of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty on Procedural and Clinical Outcomes

Abstract: We confirmed that TAVR without BAV is frequently performed in France with good procedural results. This procedure is associated with procedural simplification and lower rates of residual aortic regurgitation.

Cited by 42 publications

References 24 publications

Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry

Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry

Does valve in valve TAVR carry a higher risk for thromboembolic events compared to native valve TAVR?

Outcomes after transcatheter aortic valve replacement in older patients

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