Early clinical outcomes after transaxillary versus transfemoral TAVI. Data from the Spanish TAVI registry.

INTRODUCTION AND OBJECTIVES: Transaxillary access (TXA) has become the most widely used alternative to transfemoral access (TFA) in patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to compare total in-hospital and 30-day mortality in patients included in the Spanish TAVI registry who were treated by TXA or TFA access. METHODS: We analyzed data from patients treated with TXA or TFA and who were included in the TAVI Spanish registry. In-hospital and 30-day events were defined according to the recommendations of the Valve Academic Research Consortium. The impact of the access route was evaluated by propensity score matching according to clinical and echocardiogram characteristics. RESULTS: A total of 6603 patients were included; 191 (2.9%) were treated via TXA and 6412 via TFA access. After adjustment (n=113 TXA group and n=3035 TFA group) device success was similar between the 2 groups (94%, TXA vs 95%, TFA; P=.95). However, compared with the TFA group, the TXA group showed a higher rate of acute myocardial infarction (OR, 5.3; 95%CI, 2.0-13.8); P=.001), renal complications (OR, 2.3; 95%CI, 1.3-4.1; P=.003), and pacemaker implantation (OR, 1.6; 95%CI, 1.01-2.6; P=.03). The TXA group also had higher in-hospital and 30-day mortality rates (OR, 2.2; 95%CI, 1.04-4.6; P=.039 and OR, 2.3; 95%CI, 1.2-4.5; P=.01, respectively). CONCLUSIONS: Compared with ATF, TXA is associated with higher total mortality, both in-hospital and at 30 days. Given these results, we believe that TXA should be considered only in those patients who are not suitable candidates for TFA.

Transfemoral TAVR in Nonagenarians: From the CENTER Collaboration.

OBJECTIVES: This study aimed to compare differences in patient characteristics and clinical outcomes of nonagenarians undergoing transcatheter aortic valve replacement (TAVR) versus patients younger than 90 years of age and to test the predictive accuracy of the logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), the EuroSCORE II, and the STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) for mortality after TAVR in nonagenarians. BACKGROUND: The prevalence of severe aortic valve stenosis is increasing due to the rising life expectancy. However, there are limited data evaluating outcomes in patients older than 90 years of age. Moreover, the predictive accuracy of risk scores for mortality has not been evaluated in nonagenarian patients undergoing transfemoral TAVR. METHODS: The CENTER (Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation) collaboration (N = 12,381) is an international collaboration consisting of 3 national registries, 6 local or multicenter registries, and 1 prospective clinical study, selected through a systematic online search. The primary endpoint of this study was the difference in 30-day all-cause mortality and stroke after TAVR in nonagenarians versus patients younger than 90 years of age. Secondary endpoints included differences in baseline characteristics, in-hospital outcomes, and the differences in predictive accuracy of the logistic EuroSCORE, the EuroSCORE II, and STS-PROM. RESULTS: A total of 882 nonagenarians and 11,499 patients younger than 90 years of age undergoing transfemoral TAVR between 2007 and 2018 were included. Nonagenarians had considerably fewer comorbidities than their counterparts. Nevertheless, rates of 30-day mortality (9.9% vs. 5.4%; relative risk [RR]: 1.8; 95% confidence interval [CI]: 1.4 to 2.3; p = 0.001), in-hospital stroke (3.0% vs. 1.9%; RR: 1.5; 95% CI: 1.0 to 2.3; p = 0.04), major or life-threatening bleeding (8.1% vs. 5.5%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.004), and new-onset atrial fibrillation (7.9% vs. 5.2%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.01) were higher in nonagenarians. The STS-PROM adequately estimated mortality in nonagenarians, with an observed-expected mortality ratio of 1.0. CONCLUSIONS: In this large, global, patient-level analysis, mortality after transfemoral TAVR was 2-fold higher in nonagenarians compared with patients younger than 90 years of age, despite the lower prevalence of baseline comorbidities. Moreover, nonagenarians had a higher risk of in-hospital stroke, major or life-threatening bleeding, and new-onset atrial fibrillation. The STS-PROM was the only surgical risk score that accurately predicted the risk of mortality in nonagenarians.

Angina e isquemia a los 2 años con armazón vascular bioabsorbible y stents farmacoactivos metálicos. Estudio ESTROFA Isquemia AVB-SFAm / Angina and ischemia at 2 years with bioresorbable vascular scaffolds and metallic drug-eluting stents. ESTROFA Ischemia BVS-mDES study

Introducción y objetivos: Los armazones vasculares bioabsorbibles (AVB) tienen el potencial de restaurar la vasomotilidad, pero se desconocen las implicaciones clínicas. En este estudio se evalúan la angina y la isquemia a largo plazo tras el implante de AVB y stents farmacoactivos metálicos (SFAm). Métodos: Estudio multicéntrico, que incluyó a pacientes tras 24 ± 6 meses de evolución sin eventos a los que se realizó ecografía de estrés y se aplicó el Seattle Angina Questionnaire (SAQ). El objetivo primario fue el resultado positivo en la ecografía de estrés. Resultados: Se incluyó a 102 pacientes tratados con AVB y 106 con SFAm, sin diferencias basales significativas. Se produjo recurrencia de la angina en 18 pacientes (17,6%) con AVB frente a 25 (23,5%) con SFAm (p = 0,37), pero los resultados del SAQ fueron significativamente mejores en el grupo AVB (frecuencia de angina, 96.0 ± 8.0 frente a 89,2 ± 29,7; p = 0,02). La ecografía de estrés fue positiva en 11/92 (11,9%) con AVB frente a 9/96 (9,4%) con SFAm (p = 0,71) y se indujo angina en 2/102 (1,9%) frente a 7/106 (6,6%) (p = 0,18), pero el desempeño en el ejercicio fue mejor con AVB incluso en aquellos con tests positivos (duración del ejercicio, 9,0 ± 2,0 frente a 7,7 ± 1,8 min; p = 0,02). Un análisis por puntuación de propensión de tratamiento ofreció resultados similares. Conclusiones: El objetivo primario fue comparable en ambos grupos. La recurrencia de la angina fue similar entre los tratados con AVB y con SFAm. El mejor estado funcional, medido por SAQ y nivel de ejercicio, detectado en pacientes con AVB tendría que confirmarse en futuros estudios

Introduction and objectives: Bioresorbable vascular scaffolds (BVS) have the potential to restore vasomotion but the clinical implications are unknown. We sought to evaluate angina and ischemia in the long-term in patients treated with BVS and metallic drug-eluting stents (mDES). Methods: Multicenter study including patients with 24 ± 6 months of uneventful follow-up, in which stress echocardiography was performed and functional status was assessed by the Seattle Angina Questionnaire (SAQ). The primary endpoint was a positive result in stress echocardiography. Results: The study included 102 patients treated with BVS and 106 with mDES. There were no differences in the patients' baseline characteristics. Recurrent angina was found in 18 patients (17.6%) in the BVS group vs 25 (23.5%) in the mDES group (P = .37), but SAQ results were significantly better in the BVS group (angina frequency 96.0 ± 8.0 vs 89.2 ± 29.7; P = .02). Stress echocardiography was positive in 11/92 (11.9%) of BVS patients vs 9/96 (9.4%) of mDES patients in the (P = .71) and angina was induced in 2/102 (1.9%) vs 7/106 (6.6%) (P = .18), respectively, but exercise performance was better in the BVS group even in those with positive tests (exercise duration 9.0 ± 2.0 minutes vs 7.7 ± 1.8 minutes; P = .02). A propensity score matching analysis yielded similar results. Conclusions: The primary endpoint was similar in both groups. In addition, recurrent angina was similar in patients with BVS and mDES. The better functional status, assessed by means of SAQ and exercise performance, detected in patients receiving BVS should be confirmed in further studies

Angina and Ischemia at 2 Years With Bioresorbable Vascular Scaffolds and Metallic Drug-eluting Stents. ESTROFA Ischemia BVS-mDES Study.

INTRODUCTION AND OBJECTIVES: Bioresorbable vascular scaffolds (BVS) have the potential to restore vasomotion but the clinical implications are unknown. We sought to evaluate angina and ischemia in the long-term in patients treated with BVS and metallic drug-eluting stents (mDES). METHODS: Multicenter study including patients with 24 ± 6 months of uneventful follow-up, in which stress echocardiography was performed and functional status was assessed by the Seattle Angina Questionnaire (SAQ). The primary endpoint was a positive result in stress echocardiography. RESULTS: The study included 102 patients treated with BVS and 106 with mDES. There were no differences in the patients' baseline characteristics. Recurrent angina was found in 18 patients (17.6%) in the BVS group vs 25 (23.5%) in the mDES group (P = .37), but SAQ results were significantly better in the BVS group (angina frequency 96.0 ± 8.0 vs 89.2 ± 29.7; P = .02). Stress echocardiography was positive in 11/92 (11.9%) of BVS patients vs 9/96 (9.4%) of mDES patients in the (P = .71) and angina was induced in 2/102 (1.9%) vs 7/106 (6.6%) (P = .18), respectively, but exercise performance was better in the BVS group even in those with positive tests (exercise duration 9.0 ± 2.0minutes vs 7.7 ± 1.8minutes; P = .02). A propensity score matching analysis yielded similar results. CONCLUSIONS: The primary endpoint was similar in both groups. In addition, recurrent angina was similar in patients with BVS and mDES. The better functional status, assessed by means of SAQ and exercise performance, detected in patients receiving BVS should be confirmed in further studies.

Background, incidence, and predictors of antiplatelet therapy discontinuation during the first year after drug-eluting stent implantation.

BACKGROUND: Predictors of antiplatelet therapy discontinuation (ATD) during the first year after drug-eluting stent implantation are poorly known. METHODS AND RESULTS: This was a prospective study with 3-, 6-, 9-, and 12-month follow-up of patients receiving at least 1 drug-eluting stent between January and April 2008 in 29 hospitals. Individual- and hospital-level predictors of ATD were assessed by hierarchical-multinomial regression analysis. ATD could be assessed in 1622 candidates for follow-up (82.5%). A total of 234 patients (14.4%) interrupted at least 1 antiplatelet therapy drug, predominantly clopidogrel (n=182, 11.8%). Bleeding events or invasive procedures led to ATD in 109 patients. This was predicted by renal impairment (odds ratio [OR] 2.81, 95% confidence interval [CI] 1.48 to 5.34), prior major hemorrhage (OR 3.77, 95% CI 1.41 to 10.03), and peripheral arterial disease (OR 1.78, 95% CI 1.01 to 3.15). Medical decisions led to ATD in 70 patients; this was predicted by long-term use of anticoagulant therapy (OR 3.88, 95% CI 1.26 to 11.98), undergoing the procedure in a private hospital (OR 13.3, 95% CI 1.69 to 105), and not receiving instructions about medication (OR 2.8, 95% CI 1.23 to 6.36). Thirty-nine patients interrupted ATD on their own initiative, mainly immigrants (OR 3.78, 95% CI 1.2 to 11.98) and consumers of psychotropic drugs (OR 2.58, 95% CI 1.3 to 5.12). CONCLUSIONS: ATD during the first year after drug-eluting stent implantation is based mainly on patient decision or a medical decision not associated with major bleeding events or major surgical procedures. Individual- and hospital-level variables are important to predict ATD.

In-hospital and 12-month postprocedural clinical outcome of coronary bifurcational lesion treatment with the endeavor stent.

BACKGROUND: The zotarolimus-eluting stent (ZES) has been documented as significantly reducing restenosis and target lesion revascularization (TLR) requirement compared to bare metal stents (BMS). METHODS: In this single-centered, prospective study we sought to evaluate the short- and medium-term outcomes of ZES placement in bifurcated coronary artery lesions. Between August 2006 and December 2007, 107 consecutive patients (110 bifurcations) were recruited to have ZES placement in the lesion. The provisional T stenting (PTS) technique was used in 96.3%. Angiographic success was 100% in main vessel (MV) cases and 97.2% in that of side branch (SB). RESULTS: With a mean follow-up of 12.4 +/- 1.77 (mean +/- SD) months there were four deaths, three from cardiac cause (2.85%). There were 18 patients (19 bifurcations) requiring TLR (17.59%) for clinical reasons. The only predictor of TLR was the use diameter of ZES

Statins and diastolic heart failure.

Although nearly 50% of patients with heart failure have normal ejection fraction, there are only few studies for guiding the treatment of this patient population. We emphasize the possible clinical benefit of statins therapy in these patients.