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.

Cerebrovascular Events in Older Patients With Patent Foramen Ovale: Current Status and Future Perspectives.

Patent foramen ovale (PFO) closure, along with medical therapy, has emerged as the therapeutic gold standard in younger (<60-year-old) patients with a PFO-related stroke for preventing recurrent events. However, PFO management guidelines lack definite recommendations for older (>60 years) patients with a PFO-related cerebrovascular event, a complex group of patients who were mostly excluded from PFO closure clinical trials. Nevertheless, several studies have shown a higher prevalence of PFO among older patients with cryptogenic stroke, and its presence has been associated with an increased risk of recurrent events. Furthermore, older patients exhibit a higher prevalence of high-risk PFO anatomical features, present inherent age-related risk factors that might increase the risk of paradoxical embolism through a PFO, and have a higher incidence of ischemic events after a PFO-related event. Additionally, observational studies have shown the safety and preliminary efficacy of PFO closure in older PFO-related stroke patients. Yet, higher rates of recurrent cerebrovascular events and new-onset atrial fibrillation were observed in some studies among older patients compared to their younger counterparts. After careful case-by-case evaluation, including the assessment of hidden potential cardioembolic sources of a cryptogenic stroke other than PFO, transcatheter PFO closure might be a safe and effective therapeutic option for preventing recurrent thromboembolic events in patients >60 years with a high-risk PFO-associated stroke. Ongoing trials will provide important insights into the role of PFO closure in the elderly population.

Incidence, Predictors, and Prognostic Impact of Bleeding Events After TAVR According to VARC-3 Criteria.

BACKGROUND: The updated Valve Academic Research Consortium (VARC) definition for bleeding events after transcatheter aortic valve replacement (TAVR) lacks of clinical validation. OBJECTIVES: The aim of this study was to determine the incidence, predictors, and clinical impact of bleeding events following TAVR as defined by recent VARC-3 criteria. METHODS: A total of 2,384 consecutive patients with severe symptomatic aortic stenosis undergoing TAVR were included. Early (at index hospitalization) and late (after hospital discharge) bleeding complications were defined according to VARC-3 criteria as type 1, 2, 3, or 4. Baseline, procedural, and follow-up (24 [IQR: 12-43] months) data were prospectively collected. RESULTS: Bleeding events occurred in 761 patients (31.9%): types 1, 2, 3, and 4 in 169 (22.2%), 399 (52.4%), 149 (19.6%), and 44 (5.8%) patients, respectively. The primary vascular access site and gastrointestinal locations were the most common bleeding sources among early and late bleeding events, respectively. Female sex, thoracotomy access, larger (14-F) sheath use, and dual antiplatelet therapy determined an increased risk of early bleeding events (P < 0.02 for all). The use of the radial artery for secondary access was associated with a significant risk reduction of early bleeding (P < 0.001). Type 2 and type 3 events were associated with an increased mortality risk at 30-day (HR: 2.94 [95% CI: 1.43-6.03; P = 0.003] and HR: 4.91 [95% CI: 2.19-11.03; P < 0.001], respectively) and 1-year (HR: 1.86 [95% CI: 1.28-2.69; P = 0.001] and HR: 2.28 [95% CI: 1.41-3.66; P = 0.001], respectively) follow-up. A similar prognostic pattern was observed when applying VARC-2 criteria but with a much lower global incidence of early bleeding events (19% vs 27%; P < 0.001). CONCLUSIONS: Bleeding events after TAVR were associated with poorer short- and long-term survival. The magnitude of this correlation was proportional to bleeding severity defined according to VARC-3 criteria. Further studies on bleeding prevention following TAVR are warranted to improve procedural safety and patient prognosis.

Sex Differences in Patients With Cryptogenic Cerebrovascular Events Undergoing Transcatheter Closure of Patent Foramen Ovale.

Background Scarce data exist on sex differences in patients with cryptogenic cerebrovascular events undergoing patent foramen ovale (PFO) closure. This study aimed to determine the sex differences in clinical profile, procedural characteristics, and long-term outcomes of patients with cryptogenic cerebrovascular events undergoing PFO closure. Methods and Results A retrospective cohort was used, including 1076 consecutive patients undergoing PFO closure because of a cryptogenic cerebrovascular event. Patients were divided into 2 groups: 469 (43.6%) women and 607 (56.4%) men. The median follow-up was 3 years (interquartile range, 2-8 years). Women were younger (46±13 versus 50±12 years; P<0.01) and had a higher risk of paradoxical embolism score (6.9±1.7 versus 6.6±1.6; P<0.01). Procedural characteristics and postprocedural antithrombotic therapy were similar. At follow-up, there were no differences in atrial fibrillation (women versus men: 0.47 versus 0.97 per 100 patient-years; incidence rate ratio [IRR], 0.55 [95% CI, 0.27-1.11]; P=0.095; adjusted P=0.901), stroke (0.17 versus 0.07 per 100 patient-years; IRR, 2.58 [95% CI, 0.47-14.1]; P=0.274; adjusted P=0.201), or transient ischemic attack (0.43 versus 0.18 per 100 patient-years; IRR, 2.58 [95% CI, 0.88-7.54]; P=0.084; adjusted P=0.121); nevertheless, women exhibited a higher incidence of combined ischemic cerebrovascular events (0.61 versus 0.26 per 100 patient-years; IRR, 2.58 [95% CI, 1.04-6.39]; P=0.041; adjusted P=0.028) and bleeding events (1.04 versus 0.45 per 100 patient-years; IRR, 2.82 [95% CI, 1.41-5.65]; P=0.003; adjusted P=0.004). Conclusions Compared with men, women with cryptogenic cerebrovascular events undergoing PFO closure were younger and had a higher risk of paradoxical embolism score. After a median follow-up of 3 years, there were no differences in stroke events, but women exhibited a higher rate of combined (stroke and transient ischemic attack) cerebrovascular events and bleeding complications. Additional studies are warranted to clarify sex-related outcomes after PFO closure further.

Transcatheter Patent Foramen Ovale Closure in Patients With Transient Ischemic Attack.

Limited data exist on patients with a transient ischemic attack (TIA) who underwent patent foramen ovale (PFO) closure. The objectives of this study were to determine the clinical and procedural characteristics and long-term outcomes of patients with TIA who underwent transcatheter PFO closure. This was a multicenter study including 1,012 consecutive patients who underwent PFO closure after a cerebrovascular event. Patients were divided into 2 groups according to their index event leading to PFO closure: TIA (n = 183 [18%]), and stroke (n = 829 [82%]). The median follow-up was 3 (2 to 8) years (complete in 98% of patients). There were no significant differences between patients with TIA and stroke, except for a lower Risk of Paradoxical Embolism score in the TIA group (6.1 vs 6.9 in the stroke group, p <0.001). PFO closure was successful in all patients with a low rate of complications (<1%) in both groups. There were no differences in the incidence of neurologic events during long-term follow-up. There was 1 stroke event in the TIA group and 6 in the stroke group (0.08 vs 0.17 per 100 patients-years, p = 0.584). There were 2 TIA events in the TIA group and 10 in the stroke group (0.17 vs 0.28 per 100 patients-years, p = 0.557). In conclusion, our study showed that patients with TIA who underwent PFO closure have similar clinical characteristics as patients with stroke including a high Risk of Paradoxical Embolism score. Furthermore, these results suggest that PFO closure procedural results and long-term clinical outcomes are similar to their stroke counterparts, with a very low incidence of recurrent neurologic events. Further prospective randomized clinical trials are needed on this population.

Impact of residual transvalvular gradient on clinical outcomes following valve-in-valve transcatheter aortic valve replacement.

BACKGROUND: High (≥20 mmHg) postprocedural mean transvalvular gradients are relatively common among valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) recipients, but its clinical impact remains controversial. METHODS: Observational study including 190 consecutive ViV-TAVR recipients. Patients were classified according to the presence of high (≥20 mmHg) or low (<20 mmHg) residual mean transvalvular gradient on post-procedural echocardiography. Functional status (NYHA class, DASI), exercise capacity (6MWT), and quality of life (KCCQ) were evaluated at baseline and at 1-year follow-up. RESULTS: 73 (38.4%) and 117 (61.6%) patients exhibited high (HG) and low (LG) postprocedural gradients, respectively. Baseline characteristics were well balanced between groups except for a lower rate of large (>23 mm) surgical valves, atrial fibrillation, and aortic regurgitation as mechanism of valve failure in the HG group (p < 0.05 for all). After a median follow-up of 3 (1-5) years, there were no differences between HG and LG groups in HF hospitalization (HRadj: 1.38, 95%CI 0.44-4.22, p = 0.57), cardiac death (HRadj: 0.50; 95%CI 0.11-2.41, p = 0.39), all-cause mortality (HRajd: 0.71; 95%CI 0.35-1.46, p = 0.36), or the composite endpoint of heart failure/all-cause mortality (HRadj:1.00; 95%CI 0.52-1.94, p = 0.98). At 1-year follow-up, functional status (ΔDASI score, HG: 9.9 ± 10.9, LG: 9.9 ± 12.5, padj = 0.41), exercise capacity (Δ6MWT, HG: 111 ± 67 m, LG: 103 ± 124 m, padj = 0.14), and quality of life parameters (ΔKCCQ, HG: 27 ± 18, LG: 17 ± 21, padj = 0.12) improved similarly in both groups. CONCLUSIONS: HG as evaluated by echocardiography following ViV-TAVR were not associated with a negative effect on clinical outcomes including major adverse events, functional status, exercise capacity and quality of life parameters.

Changes in the clinical phenotype and behavior of pediatric luminal Crohn's disease at diagnosis in the last decade.

BACKGROUND AND AIMS: The aims of this study were to describe the trends in the behavior of pediatric CD during the last decade and to describe the seasonal variation of disease presentation. METHODS: Patients under 18 years old and diagnosed between 2009 and 2019 were included. The clinical, endoscopic, histological, and laboratory data were collected from the medical records. We analyzed the trends of these parameters according to the year and season of diagnosis. RESULTS: 654 patients were included in the study. The number of incident CD cases increased yearly. Patients diagnosed between 2015 and 2019 were younger at diagnosis (OR 2.53, p = 0.02), had more perianal diseases (OR: 2.30, p < 0.0001) and more granulomas (OR: 1.61, p = 0.003), but fewer eosinophils (OR: 0.35, p < 0.0001) and less chronic lymphoplasmacytic infiltrate (OR: 0.56, p = 0.008) as compared to the 2009-2014 cohort. There was fewer CD diagnosis during winter. Patients diagnosed in the fall had lower PCDAIs, less failure to thrive and less extensive digestive involvement. Colonic disease was significantly more frequent during summer and fall. CONCLUSION: The clinical and histological phenotype of CD has changed over time and there are important seasonal trends in the frequency and severity on disease behavior suggesting possible disease triggers.

Factors associated with time to clinical remission in pediatric luminal Crohn's disease: A retrospective cohort study.

BACKGROUND AND AIM: Data on factors influencing time to remission in pediatric Crohn's disease (CD) are very limited in the literature. The aim of this retrospective cohort study was to describe the trends of time to clinical remission over the past decade and to identify factors associated with time to clinical remission in children with luminal CD. METHODS: Patients under 18 years old diagnosed between 2009 and 2019 were included. All data were collected from the patients' medical records. Survival analyses and linear regression models were used to assess the impact of clinical, laboratory, endoscopic, histological, and therapeutic factors on time to clinical remission. RESULTS: A total of 654 patients were included in the study. There was no change in the time to clinical remission over the decade. Female sex in adolescents (adjusted bêta regression coefficient [aß] = 31.8 days, P = 0.02), upper digestive tract involvement (aß = 46.4 days, P = 0.04) perianal disease (aß = 32.2 days, P = 0.04), presence of active inflammation on biopsies at diagnosis (aß = 46.7 days, P = 0.01) and oral 5-aminosalicylates (5-ASA) exposure (aß = 56.6 days, P = 0.002) were associated with longer time to clinical remission. Antibiotic exposure (aß = -29.3 days, P = 0.04), increased eosinophils (aß = -29.6 days, P = 0.008) and combination of exclusive enteral nutrition with tumor-necrosis-factor-alpha (TNF-alpha) inhibitors as induction therapy (aß = -36.8 days, P = 0.04) were associated with shorter time to clinical remission. CONCLUSION: In children with newly diagnosed Crohn's disease, time to clinical remission did not shorten during the decade. It was associated with baseline clinical and histological data and treatment strategies. Combination of enteral nutrition and TNF-alpha inhibitors was associated with faster clinical remission.