Transcatheter aortic valve implantation in patients with severe symptomatic aortic valve stenosis—predictors of mortality and poor treatment response

doi:10.1016/j.ahj.2011.05.011

American Heart Journal

Volume 162, Issue 2, August 2011, Pages 238-245.e1

https://doi.org/10.1016/j.ahj.2011.05.011 Get rights and content

Background

Transcatheter aortic valve implantation (TAVI) has emerged as an alternative technique in patients with severe symptomatic aortic valve stenosis. However, a number of patients have no benefit after implantation. This prospective study attempted to identify predictors of poor treatment response.

Methods

From June 2008 to September 2010, consecutive patients with symptomatic severe aortic valve stenosis and high surgical risk were submitted to TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, MN). The primary end point was all-cause mortality at 6 months. Secondary end point (poor treatment response) was defined as no improvement of symptoms assessed with the New York Heart Association class 6 months after TAVI.

Results

A total of 145 patients (mean age 79.1 ± 6.4 years, mean logistic EuroSCORE 21% ± 16.2%) were included. During the follow-up period, 23 (15.9%) patients died. Independent predictors of all-cause mortality were as follows: aortic mean gradient ≤40 mm Hg (odds ratio [OR] 3.93), moderate and severe tricuspid valve regurgitation (OR 4.50), and moderate and severe postprocedural aortic valve regurgitation (OR 4.26). In 122 surviving patients, 25 patients (20%) showed no improvement in symptoms. Independent predictors of poor treatment response were severe mitral valve regurgitation (OR 7.42) and moderate and severe postprocedural aortic valve regurgitation (OR 10.1).

Conclusions

Cardiac comorbidities (low-gradient aortic stenosis, tricuspidal valve regurgitation) are associated with all-cause mortality, whereas mitral valve regurgitation is a risk factor for poor treatment response after TAVI. Postprocedural aortic valve regurgitation is a strong predictor of both—mortality and poor treatment response.

Section snippets

Patients

From June 2008 to September 2010, consecutive patients with native symptomatic severe and calcified aortic valve stenosis (aortic valve area ≤1 cm²) and a risk precluding surgical aortic valve replacement were referred for TAVI. In the present study, no patient had from bicuspid aortic valve. Overall, 5 patients had associated porcelain aorta. Risk of surgical aortic valve replacement was estimated with the logistic EuroSCORE.⁹ Indications, contraindications, and anatomical requirements for

Results

The mean age of study patients was 79.1 ± 6.4 years, and mean logistic EuroSCORE was 21% ± 16.2%. Patients were severely symptomatic (NYHA class III and IV: 95% of patients) before TAVI (Table I).

Discussion

Transcatheter aortic valve implantation has emerged as an alternative technique in patients with severe and symptomatic aortic valve stenosis and high surgical risk. Given the increasing number of patients treated with TAVI, a suitable method of selecting patients that could predict which patients are most and least likely to benefit seems to be necessary.

This is the first study to identify predictors of poor treatment response in patients with severe symptomatic aortic valve stenosis

Conclusions

Transcatheter aortic valve implantation is a promising treatment for patients who are ineligible for surgical valve replacement due to comorbidities. Our study suggests that also in this highly selected cohort, some patients are poor candidates for TAVI. Particularly, patients with cardiac comorbidities (low-gradient aortic valve stenosis, concomitant valve disease) showed disappointing results. Moreover, our study demonstrates the unfavorable effects of postprocedural moderate or severe aortic

Disclosures

Dr Bojara is a physician proctor for CoreValve (Medtronic, Minneapolis, MN). The remaining authors report no disclosures.

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The landscape of aortic valve replacement (AVR) has evolved dramatically over the years, but time-varying outcomes have yet to be comprehensively explored. This study aimed to compare the all-cause mortality among 3 AVR techniques: transcatheter (TAVI), minimally invasive (MIAVR), and conventional AVR (CAVR). An electronic literature search was performed for randomized controlled trials (RCTs) comparing TAVI with CAVR and RCTs or propensity score-matched (PSM) studies comparing MIAVR with CAVR or MIAVR to TAVI. Individual patient data for all-cause mortality were derived from graphical reconstruction of Kaplan-Meier curves. Pairwise comparisons and network meta-analysis were conducted. Sensitivity analyses were performed in the TAVI arm for high risk and low/intermediate risk, as well as patients who underwent transfemoral (TF) TAVI. A total of 27 studies with 16,554 patients were included. In the pairwise comparisons, TAVI showed superior mortality to CAVR until 37.5 months, beyond which there was no significant difference. When restricted to TF TAVI versus CAVR, a consistent mortality benefit favoring TF TAVI was seen (shared frailty hazard ratio [HR] = 0.86, 95% confidence interval [CI] = 0.76 to 0.98, p = 0.024). In the network meta-analysis involving majority PSM data, MIAVR demonstrated significantly lower mortality than TAVI (HR = 0.70, 95% CI = 0.59 to 0.82) and CAVR (HR = 0.69, 95% CI = 0.59 to 0.80); this association remained compared with TF TAVI but with a lower extent of benefit (HR = 0.80, 95% CI = 0.65 to 0.99). In conclusion, the initial short- to medium-term mortality benefit for TAVI over CAVR was attenuated over the longer term. In the subset of patients who underwent TF TAVI, a consistent benefit was found. Among majority PSM data, MIAVR showed improved mortality compared with TAVI and CAVR but less than the TF TAVI subset, which requires validation by robust RCTs.
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Transcatheter aortic valve implantation (TAVI) is an effective alternative to surgical valve replacement in high-risk patients with severe aortic stenosis. Although measures of frailty have been used to attempt to predict outcomes in this population, few studies have demonstrated changes in these measures.
We performed a prospective, observational study of 171 patients undergoing TAVI, of whom 44 had maximal follow-up of 1 month and 50 had maximal follow-up of 1 year. Quality of life was assessed using the Minnesota Living With Heart Failure Questionnaire, Katz Index of Independence in Activities of Daily Living questionnaire, and patient perception of overall well-being. Frailty was measured using the 10-m walk test and handgrip strength testing.
In the overall cohort, participants demonstrated improvements in quality of life metrics, but deterioration in 10-m walk test and handgrip at 1 month. These trends continued at 1 year. However, patients in the lowest quintile of handgrip and 10-m walk test demonstrated a trend of improvements in these metrics during follow-up.
Despite improvements in quality of life after TAVI, no improvements in frailty were observed in patients at 1 year.
Le remplacement valvulaire aortique par cathéter (TAVI) est une solution de rechange efficace à la chirurgie de remplacement valvulaire chez les patients atteints de sténose aortique grave et présentant un risque élevé. Les mesures de la fragilité sont utilisées pour tenter de prévoir les résultats au sein de cette population. Néanmoins, peu d’études ont permis d’objectiver les variations de ces mesures.
Nous avons réalisé une étude observationnelle prospective portant sur 171 patients ayant subi un TAVI, dont 44 suivis pendant un mois ou moins, et 50 durant un an ou moins. La qualité de vie a été évaluée au moyen de questionnaires – Minnesota Living With Heart Failure Questionnaire et Katz Index of Independence in Activities of Daily Living Questionnaire – et en fonction de la perception du patient relativement à son bien-être général. La fragilité a été mesurée à l’aide d’un test de marche sur dix mètres et d’un test de force de préhension.
Dans l’ensemble de la cohorte, une amélioration des mesures de la qualité de vie a été observée parallèlement à une détérioration des résultats au test de marche sur dix mètres et au test de force de préhension après un mois. Les tendances à cet égard se sont poursuivies au bout d’un an. Cependant, les résultats des patients du quintile inférieur au test de marche sur 10 m et au test de force de préhension ont eu tendance à s’améliorer au cours de la période de suivi.
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Guidelines for the Evaluation of Valvular Regurgitation After Percutaneous Valve Repair or Replacement: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Angiography and Interventions, Japanese Society of Echocardiography, and Society for Cardiovascular Magnetic Resonance
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Clinical InvestigationValvular and Congenital Heart DiseaseTranscatheter aortic valve implantation in patients with severe symptomatic aortic valve stenosis—predictors of mortality and poor treatment response

Background

Methods

Results

Conclusions

Section snippets

Patients

Results

Discussion

Conclusions

Disclosures

J Am Coll Cardiol

J Am Coll Cardiol

Ann Thorac Surg

J Am Coll Cardiol

JACC Cardiovasc Interv

J Am Soc Echocardiogr

J Am Soc Echocardiogr

J Am Coll Cardiol

J Am Coll Cardiol

Ann Thorac Surg

Am Heart J

Ann Thorac Surg

J Am Coll Cardiol

Clinical Investigation
Valvular and Congenital Heart Disease
Transcatheter aortic valve implantation in patients with severe symptomatic aortic valve stenosis—predictors of mortality and poor treatment response