Is Transcatheter Aortic Valve Replacement Futile in Patients Over Ninety Years of Age?

Background: Clinical outcomes and quality of life (QoL) indices are not well described after transcatheter aortic valve replacement (TAVR) in patients aged ≥ 90 years. Methods: We conducted a retrospective cohort study of TAVR among nonagenarian patients between 2008 and 2020. The survival of TAVR patients among nonagenarians was compared to the provincial estimated survival for an age- and sex-matched general population. QoL was assessed up to 1 year postintervention, using standardized questionnaires. Results: During the study period, n = 268 patients aged ≥ 90 years were evaluated for severe aortic stenosis. TAVR was performed in n = 171 (48% female; median [IQR] Rockwood Clinical Frailty Scale score: 4 [3-4]); n = 84 underwent medical therapy; and n = 13 underwent surgical aortic valve replacement. Survival was significantly better following TAVR, compared to that after MT (adjusted hazard ratio [95% CI]: 1.99 [1.37-2.88], P < 0.001). TAVR patients demonstrated a survival advantage compared with the general population, with an estimated relative mortality of 0.86 (0.75-0.87). TAVR patients showed sustained improvements in functional status and QoL up to 1 year compared to baseline (all P < 0.05): the 6-minute walk test results improved from 192 to 252 m; the Kansas City Cardiomyopathy Questionnaire score improved from 64 to 81; the Duke Activity Status Index score improved from 13 to 16; and the health state scale result of the Euro Quality of life - 5 Dimensions improved from 63% to 74%. Conclusions: Nonagenarians undergoing TAVR experience a slightly better survival rate, compared to that of an age- and sex-matched general population, and they have significant improvements in functional status and several QoL indices following the procedure.

Introduction: Les résultats cliniques et les indices de la qualité de vie (QdV) après le remplacement valvulaire aortique par cathéter (RVAC) chez les patients ≥ 90 ans ne sont pas bien décrits. Méthodes: Nous avons réalisé une étude de cohorte rétrospective sur le RVAC chez les patients nonagénaires entre 2008 et 2020. Nous avons comparé la survie des patients nonagénaires qui avaient subi un RVAC à la survie provinciale estimée d'une population générale appariée selon l'âge et le sexe. Nous avons évalué la QdV jusqu'à 1 an après l'intervention au moyen de questionnaires standardisés. Résultats: Durant la période étudiée, nous avons inclus des patients (n =268) âgés de ≥ 90 ans et évalués pour une sténose aortique sévère. Le RVAC a été réalisé chez 171 patients (48 % de sexe féminin ; score médian [écart interquartile] à l'échelle de fragilité clinique de Rockwood [Rockwood Clinical Frailty Scale] : 4 [3-4]) ; 84 ont reçu un traitement médical (TM) ; 13 ont subi un remplacement valvulaire aortique chirurgical. La survie était significativement meilleure à la suite du RVAC, comparativement à celle des patients TM (rapport de risque ajusté [IC à 95 %] : 1,99 [1,37-2,88], P < 0,001). Par rapport à la population générale, les patients ayant subi un RVAC ont démontré un avantage sur le plan de la survie, soit une mortalité relative estimée de 0,86 (0,75-0,87). Les patients ayant subi un RVAC ont montré des améliorations continues de l'état fonctionnel et de la QdV jusqu'à 1 an par rapport au début (toutes les valeurs P < 0,05) : les résultats à l'épreuve de marche de 6 minutes sont passés de 192 à 252 m ; les scores au questionnaire Kansas City Cardiomyopathy Questionnaire (KCCQ) sont passés de 64 à 81 ; les scores au questionnaire Duke Activity Status Index (DASI) sont passés de 13 à 16 ; les résultats à l'échelle de l'état de santé de l'EQ-5D (de l'EuroQol Group) sont passés de 63 % à 74 %. Conclusions: Les nonagénaires qui subissent un RVAC ont un taux de survie légèrement meilleur à celui d'une population générale appariée selon l'âge et le sexe, et montrent des améliorations significatives de leur état fonctionnel et de plusieurs indices de la QdV à la suite de l'intervention.

Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease.

OBJECTIVES: The INSPIRIS aortic valve combines the RESILIA proprietary tissue preservation process and an expandable stent frame to benefit future transcatheter valve-in-valve procedures. As the INSPIRIS valve became commercially available in 2017, mid-term outcome reports are scarce. We aimed to evaluate mid-term safety and echocardiographic performance of the INSPIRIS valve in comparison to its predecessor, the Carpentier Edwards Perimount Magna Ease (ME). METHODS: This study was a retrospective single-centre study. Clinical results included early postoperative outcomes, mid-term mortality and readmission for cardiovascular cause or stroke. Echocardiographic follow-up (FU) was performed at discharge and 1-3, 6, 12 and 24 months. Clinical end point analyses were accomplished with a propensity score matching analysis and FU echocardiographic data comparisons using pairwise analyses and linear mixed-effect models. RESULTS: We included 953 patients who received an INSPIRIS (n = 488) or ME (n = 463) bioprosthesis between January 2018 and July 2021. In the matched population (n = 217 per group), no significant difference in short-term outcomes was observed, survival was similar at 30 months (INSPIRIS: 94% vs ME: 91%, P = 0.89), but freedom from readmission was higher in the INSPIRIS group (94% vs 86%, P = 0.014). INSPIRIS valves had a lower gradient at discharge (∼10 vs 14 mmHg, P < 0.001), 1-3 months (∼10 vs 12 mmHg, P < 0.001) and 24 months (∼11 vs 17 mmHg, P < 0.001) in paired analyses and significantly lower evolution of mean transvalvular gradients compared to ME. CONCLUSIONS: This study represents the largest comparative evaluation of the INSPIRIS to the ME valves, which demonstrated safe clinical outcomes and favourable haemodynamic performance at 2 years. Long-term FU is underway.

Long-term echocardiographic data, mechanisms of failure, and reintervention outcomes of the Epic valve in mitral position-a large observational cohort.

OBJECTIVES: Long-term echocardiographic reports on mitral valve (MV) porcine xenograft bioprosthesis (Epic) are lacking, and postreintervention outcomes of failed Epic are unknown. We aimed to assess the mechanisms and independent predictors of Epic failures and to compare short- and mid-term outcomes according to reintervention type. METHODS: We included consecutive patients (n = 1397; mean age: 72 ± 8 years; 46% female; mean follow-up: 4.8 years) who received the Epic during mitral valve replacement (MVR) at our institution. Clinical, echocardiographic, reintervention, and outcomes data were retrieved from our prospective institution's database or government statistics. RESULTS: Gradients and effective orifice area of the Epic were stable over 5-years follow-up. A total of 70 (5%) patients had a MV reintervention at median follow-up of 3.0 (0.7-5.4) years due to prosthesis failure, by redo-MVR (n = 38; 54%), valve-in-valve (n = 19; 27%), paravalvular leak (PVL) closure (n = 12; 17%), or thrombectomy (n = 1). Mechanisms of failure were 27 (1.9%) structural valve deterioration (SVD; all leaflet tear); 16 (1.1%) non-SVD (15 PVL, 1 pannus); 24 (1.7%) endocarditis; and 4 (0.3%) thrombosis. Freedom from all-cause and SVD-related MV reintervention at 10 years are 88% and 92%, respectively. Independent predictors of reintervention were age, baseline atrial fibrillation, initial MV etiology, and moderate or greater PVL at discharge (all P ≤ .05). Comparison of redo-MVR and valve-in-valve revealed no significant difference in early outcomes or mid-term mortality (all P ≥ .16). CONCLUSIONS: The Epic Mitral valve has stable hemodynamics through 5 years and is associated with low incidence of SVD and reintervention, mostly due to endocarditis and leaflet tear without calcification. Reintervention type had no influence on early outcomes and mid-term mortality.

Preoperative physical frailty assessment among octogenarians undergoing cardiac surgery: Upgrading the "eyeball" test.

OBJECTIVES: There are many well-described, but as yet unproven, physical ability tools to assess frailty. The objective of this study was to evaluate the effectiveness of 4 preoperative physical tests in predicting mortality, morbidity, and functional outcomes among octogenarians undergoing cardiac surgery. METHODS: Between 2016 and 2019, 200 patients aged 80 years or more undergoing elective cardiac surgery were prospectively recruited. Four physical tests were performed preoperatively: 5-m walk time, timed up-and-go, 5 time sit-to-stand, and handgrip strength tests. The primary end point was a composite of in-hospital mortality, neurologic, and pulmonary complications. Multivariate analysis was performed. RESULTS: In-hospital mortality was 1.5%. Slow performance on the 5-m walk test (time ≥6.4 seconds) was the only independent predictor of the composite end point among the tests evaluated (odds ratio, 2.70; 95% confidence interval, 1.34-5.45; P = .006). At follow-up, patients with a slow 5-m walk test had a significantly lower midterm survival compared with patients with a normal test result (1-year survival 91.5% vs 98.7%, log-rank P = .03). Mean Physical and Mental Component Scores of the 12-item short form survey were 47.2 ± 8.3 and 53.6 ± 5.9, respectively, which are comparable to those of a general population aged more than 75 years. CONCLUSIONS: The 5-m walk time test is an independent predictor of a composite of in-hospital mortality and major morbidity, as well as midterm survival. This test could be used as a simple adjunctive preoperative tool for octogenarians undergoing cardiac surgery.

Should Bilateral Internal Thoracic Arteries be Used in Patients with Chronic Kidney Disease?

Preoperative renal dysfunction is a major determinant of operative and long-term mortality following cardiac surgery. The objective of this study was to assess early and long-term results of CABG in patients with preoperative chronic kidney disease (CKD) using a bilateral internal thoracic artery (BITA) strategy, compared to those without CKD. We retrospectively analyzed data for 2,111 consecutive patients who underwent CABG with BITA between 2000 and 2019. One-to-many propensity score matching was performed to produce a cohort of 132 patients with CKD (defined as an estimated glomerular filtration rate <60 mL/min/1.73 m2), matched to 358 patients with normal renal function (non-CKD). The primary end-point of interest was late freedom from all-cause mortality. Late hospital readmissions were also assessed. Mean eGFR and serum creatinine were: 49.8 versus 84.3 mL/min/m2 and 146.1 versus 83.6 µmol/L (CKD vs non-CKD, P< 0.001). In-hospital outcomes were similar among matched patients, including mortality (CKD 0.8% vs non-CKD 0%, P= 0.31). At a median follow-up of 6.9 years, there was no significant difference in survival between both groups (hazard ratio (HR) 1.37, 95% confidence interval (CI) 0.87-2.16, P= 0.17). Hospital readmission for cardiovascular causes (including repeat coronary revascularization) was comparable between the 2 groups. However, the risk of hospital readmission for renal causes was higher in patients with CKD (6.7%) compared to non-CKD (1.2%). In a propensity score-matched cohort of patients undergoing BITA-CABG, CKD was not associated with increased early or late mortality, nor was there a greater risk of hospital readmission for cardiovascular events.

Macroscopic and microscopic features of surgically explanted transcatheter aortic valve prostheses.

OBJECTIVES: With the extended indications of transcatheter aortic valve (TAV) replacement (TAVR) to lower-risk patients, there is an increasing number of patients requiring surgical explantation of failed TAV. We sought to describe macroscopic and microscopic features of surgically explanted percutaneous aortic valve prostheses. METHODS: Preoperative and surgical characteristic of patients undergoing surgical explantation of TAV were retrospectively analyzed from 2007 to 2020. Surgical and pathologic features of these valves, and outcomes of the surgical valve replacement were described. RESULTS: Out of 1764 patients who underwent a TAVR procedure, 21 were operated for TAV failure. Isolated or combined indications for surgery included: significant paravalvular leak (n = 15), delayed prosthesis migration (n = 5), significant increase of trans-TAV gradients (n = 6), and endocarditis (n = 3). Mean time elapsed between TAVR and explantations was 674.9 ± 803.9 days. Macroscopic lesions found on explanted percutaneous valves were severe adhesions to the aorta (n = 10), calcifications (n = 7), leaflet thrombosis (n = 4), and vegetations (n = 3). Except for patients with endocarditis, one or more pathological lesions were found in 15 patients. Pathology analyses on these valves showed fibro-calcific degenerations (n = 12), pannus formation (n = 9), and chronic inflammation (n = 3). One patient (4.8%) died after surgical explantation, and 13 (61.9%) had concomitant procedures. The survival rate at 1 year was 94.4%. CONCLUSIONS: Microscopic findings of fibro-calcific leaflet degeneration, and pannus formation in addition to macroscopic calcification and thrombosis present early, (within a mean of 2 years) after TAVR. Further investigation with a higher number of patients and echocardiographic follow-up is warranted.