Long-Term Outcomes After Transcatheter Aortic Valve-in-Valve Replacement.

BACKGROUND: Data on long-term outcomes after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) are scarce. The objective of this study was to determine the long-term clinical outcomes and structural valve degeneration (SVD) over time in patients undergoing ViV-TAVR. METHODS AND RESULTS: Consecutive patients undergoing ViV-TAVR in 9 centers between 2009 and 2015 were included. Patients were followed yearly, and clinical and echocardiography data were collected prospectively. SVD was defined as subclinical (increase >10 mm Hg in mean transvalvular gradient+decrease >0.3 cm2 in valve area or new-onset mild or moderate aortic regurgitation) and clinically relevant (increase >20 mm Hg in mean transvalvular gradient+decrease >0.6 cm2 in valve area or new-onset moderate-to-severe aortic regurgitation). A total of 116 patients (mean age, 76±11 years; 64.7% male; mean Society of Thoracic Surgeons score, 8.0±5.1%) were included. Balloon- and self-expandable valves were used in 47.9% and 52.1% of patients, respectively, and 30-day mortality was 6.9%. At a median follow-up of 3 years (range, 2-7 years), 30 patients (25.9%) had died, 20 of them (17.2%) from cardiovascular causes. Average mean transvalvular gradients remained stable up to 5-year follow-up ( P=0.92), but clinically relevant SVD occurred in 3/99 patients (3.0%), and 15/99 patients (15.1%) had subclinical SVD. One patient with SVD had redo ViV-TAVR. CONCLUSIONS: About one-fourth of ViV-TAVR recipients had died after a median follow-up of 3 years. Overall valve hemodynamics remained stable over time and clinically relevant SVD was infrequent, but 1 out of 10 patients exhibited some degree of SVD.

Warfarin and Antiplatelet Therapy Versus Warfarin Alone for Treating Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVES: The study sought to examine the risk of ischemic events and bleeding episodes associated with differing antithrombotic strategies in patients undergoing transcatheter aortic valve replacement (TAVR) with concomitant atrial fibrillation (AF). BACKGROUND: Guidelines recommend antiplatelet therapy (APT) post-TAVR to reduce the risk of stroke. However, data on the efficacy and safety of this recommendation in the setting of a concomitant indication for oral anticoagulation (due to atrial fibrillation [AF]) with a vitamin K antagonist (VKA) are scarce. METHODS: A multicenter evaluation comprising 621 patients with AF undergoing TAVR was undertaken. Post-TAVR prescriptions were used to determine the antithrombotic regimen used according to the following 2 groups: monotherapy (MT) with VKA (n = 101) or multiple antithrombotic therapy (MAT) with VKA plus 1 or 2 antiplatelet agents (aspirin or clopidogrel; n = 520). Endpoint definitions were in accordance with Valve Academic Research Consortium-2 criteria. The rate of stroke, major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death), major or life-threatening bleeding events, and death were assessed by a Cox multivariate model regression survival analysis according to the antithrombotic regime used. RESULTS: During a median follow-up of 13 months (interquartile range: 3 to 31 months) there were no differences between groups in the rate of stroke (MT: 5%, MAT: 5.2%; adjusted hazard ratio [HR]: 1.25; 95% confidence interval [CI]: 0.45 to 3.48; p = 0.67), major adverse cardiovascular events (MT: 13.9%, MAT: 16.3%; adjusted HR: 1.33; 95% CI: 0.75 to 2.36; p = 0.33), and death (MT 22.8%, MAT: 19.2%; adjusted HR: 0.93; 95% CI: 0.58 to 1.50; p = 0.76). A higher risk of major or life-threatening bleeding was found in the MAT group (MT: 14.9%, MAT: 24.4%; adjusted HR: 1.85; 95% CI: 1.05 to 3.28; p = 0.04). These results remained similar when patients receiving VKA plus only 1 antiplatelet agent (n = 463) were evaluated. CONCLUSIONS: In TAVR recipients prescribed VKA therapy for AF, concomitant antiplatelet therapy use appears not to reduce the incidence of stroke, major adverse cardiovascular events, or death, while increasing the risk of major or life-threatening bleeding.

Evaluación de los criterios apropiados para la indicación de ecocardiografía de estrés en un centro cardiovascular de referencia / Assessment of the appropriateness criteria for the indication of stress echocardiography in a cardiovascular reference center

Reseña: El propósito de este estudio es evaluar la aplicación clínica e indicación de los criterios apropiados para la ecocardiografía de estrés de acuerdo a la Fundación del Colegio Americano de Cardiología/Sociedad Americana de Ecocardiografía, en la práctica diaria de un centro cardiovascular de referencia. Materiales y métodos: Fueron incluidos los estudios consecutivos realizados entre enero de 2012 y julio de 2013. Los datos fueron revisados, analizados y clasificados por cuatro cardiólogos expertos teniendo en cuenta: la demografía, la especialidad que refiere, la indicación primaria y su clasificación final como apropiados, inapropiados o inciertos. Resultados: Un total de 1.556 estudios fueron incluidos inicialmente, 450 fueron excluidos por estar relacionados con programas de trasplante de órgano sólido y en 170 no se pudo determinar una indicación clara para el estudio. Los 936 estudios restantes (85%) fueron analizados para la determinación de criterios apropiados. De estos 679 (73%) tenían una indicación apropiada, 70 (7%) eran inciertos y 187 (20%) fueron inapropiados. Cuatrocientos veintiocho (46%) fueron referidos por medicina interna, 375 (40%) por cardiología, 51 (5%) por anestesiología y 82 (10%) por medicina general y otras especialidades. Un total de 159 (17%) estudios arrojaron un resultado anormal, todos ellos estaban apropiadamente indicados, ninguno fue anormal en los inapropiadamente indicados. Conclusiones: La revisión de la aplicación de los criterios apropiados para la ecocardiografía de estrés no solo permite una implementación clínica efectiva en un centro cardiovascular de referencia, sino que también estratifica razonablemente la posibilidad de tener un resultado anormal en aquellos con una indicación apropiada. Sin embargo, esto debería validarse extensamente en una cohorte multicéntrica.

Background: The purpose of this study is to evaluate the clinical application and assessment of appropriate criteria for the indication of stress echocardiograms according to the American College of Cardiology Foundation/American Society of Echocardiography in daily clinical practice at a cardiovascular reference center. Materials and methods: All consecutive studies carried out between January 2012 and July 2013 were included. The data was reviewed, analyzed and classified by four expert cardiologists regarding issues such as demography, referred specialty, primary indication and its final classification as appropriate, inappropriate or uncertain. Results: A total of 1,556 studies were initially included, 450 which were excluded as being related to program of solid organ transplantation and 170 as no clear indication of the study could be determined. Therefore, the remaining 936 were analyzed for the evaluation of appropriateness criteria. Of these 679 (73%) had appropriate indication, 70 (7%) were uncertain and 187 (20%) inappropriate. 428 (46%) were referred by internal medicine, 375 (40%) by cardiology, 51 (5%) by anesthesiology and 82 (10%) by general medicine and other specialties. A total of 159 (17%) studies rendered an abnormal result, all of them which were properly indicated, and no one was abnormal in the inappropriately indicated. Conclusions: Reviewing appropriateness criteria for SE not only allows an effective characterization and clinical performance in a single center, but also reasonably stratifies the possibility of having an abnormal result in those with an appropriate indication. However, this should be validated extensively in a multicenter cohort.

Incidence, Timing, and Predictors of Valve Hemodynamic Deterioration After Transcatheter Aortic Valve Replacement: Multicenter Registry.

BACKGROUND: Scarce data exist on the incidence of and factors associated with valve hemodynamic deterioration (VHD) after transcatheter aortic valve replacement (TAVR). OBJECTIVES: This study sought to determine the incidence, timing, and predictors of VHD in a large cohort of patients undergoing TAVR. METHODS: This multicenter registry included 1,521 patients (48% male; 80 ± 7 years of age) who underwent TAVR. Mean echocardiographic follow-up was 20 ± 13 months (minimum: 6 months). Echocardiographic examinations were performed at discharge, at 6 to 12 months, and yearly thereafter. Annualized changes in mean gradient (mm Hg/year) were calculated by dividing the difference between the mean gradient at last follow-up and the gradient at discharge by the time between examinations. VHD was defined as a ≥10 mm Hg increase in transprosthetic mean gradient during follow-up compared with discharge assessment. RESULTS: The overall mean annualized rate of transprosthetic gradient progression during follow-up was 0.30 ± 4.99 mm Hg/year. A total of 68 patients met criteria of VHD (incidence: 4.5% during follow-up). The absence of anticoagulation therapy at hospital discharge (p = 0.002), a valve-in-valve (TAVR in a surgical valve) procedure (p = 0.032), the use of a 23-mm valve (p = 0.016), and a greater body mass index (p = 0.001) were independent predictors of VHD. CONCLUSIONS: There was a mild but significant increase in transvalvular gradients over time after TAVR. The lack of anticoagulation therapy, a valve-in-valve procedure, a greater body mass index, and the use of a 23-mm transcatheter valve were associated with higher rates of VHD post-TAVR. Further prospective studies are required to determine whether a specific antithrombotic therapy post-TAVR may reduce the risk of VHD.

Prevalence, factors associated with, and prognostic effects of preoperative anemia on short- and long-term mortality in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: There is scant information on the prevalence and factors associated with preoperative anemia in patients undergoing transcatheter aortic valve implantation (TAVI) and whether it is associated with mortality. We sought to determine the prevalence and factors associated with preoperative anemia in addition to the prognostic effects of the various levels of preoperative hemoglobin level on mortality in patients undergoing TAVI. METHODS AND RESULTS: Ten-center observational study encompassing 1696 patients with aortic stenosis who underwent TAVI was conducted. Anemia was defined by the World Health Organization criteria (hemoglobin <12.0 g/dL in women and <13.0 g/dL in men). The prevalence of preoperative anemia was 57%. Patient-related factors associated with preoperative anemia were (descending order of odds ratio [95% confidence interval]) as follows: anemia-related medication (4.90 [3.08-7.80]), history of heart failure (1.77 [1.43-2.20]), male sex (1.69 [1.32-2.16]), mitral regurgitation grade ≥III (1.61 [1.15-2.25]), history of malignancy (1.44 [1.03-2.09]), and peripheral vascular disease (1.33 [1.04-1.70]). The creatinine clearance was inversely associated with preoperative anemia (odds ratio, 0.92 [0.87-0.97]). In multivariable analyses, preoperative anemia was not associated with 30-day mortality (1.72 [0.96-3.12]; P=0.073) but showed the strongest association with 1-year mortality with a hazard ratio (95% confidence interval) of 2.78 (1.60-4.82) in patients with hemoglobin <10 g/dL. Patients with anemia received ≥1 blood transfusion 2× more often, but the indication of transfusion was unrelated to overt bleeding in 60%. Blood transfusion was associated with mortality at 30 days (odds ratio, 1.25 [95% confidence interval, 1.08-3.67]) and during follow-up (hazard ratio, 1.09 [95% confidence interval, 1.03-1.14]). CONCLUSIONS: Preoperative anemia is prevalent in >50% of patients undergoing TAVI. Various baseline factors were related to anemia, which in turn was associated with 1-year mortality. Patients with anemia received more transfusions but mostly for indications unrelated to overt bleeding, whereas transfusion was independently associated with both early and 1-year mortality. These findings indicate that optimization of baseline factors related to preoperative anemia, in addition to more strict criteria of the use of blood products, may improve outcome after TAVI.

Valve-in-valve-in-valve transcatheter aortic valve implantation to treat a degenerated surgical bioprosthesis in a subaortic position.

Transcatheter aortic valve implantation for aortic stenosis has evolved as an alternative treatment for patients who are at high or excessive surgical risk. We report the case of an 84-year-old man with a degenerated surgically implanted valve in a subaortic position (9 mm below the native annulus) who underwent "valve-in-valve" transcatheter aortic valve implantation with use of a Medtronic CoreValve system. We planned to deploy the CoreValve at a conventional depth in the left ventricular outflow tract; we realized that this might result in paravalvular regurgitation, but it would also afford a "deep" landing site for a second valve, if necessary. Ultimately, we implanted a second CoreValve deep in the left ventricular outflow tract to seal a paravalvular leak. The frame of the first valve--positioned at the conventional depth--enabled secure anchoring of the second valve in a deeper position, which in turn effected successful treatment of the failing subaortic surgical prosthesis without paravalvular regurgitation.

Frequency, determinants and prognostic implications of infectious complications after transcatheter aortic valve implantation.

In-hospital infection (IHI) after transcatheter aortic valve implantation (TAVI) has received little attention, although it may have a significant effect on outcomes and costs because of prolonged hospital stay. Therefore, the aim of this study was to determine the incidence, type, predictors, and prognostic effects of IHI after TAVI. This study included 298 consecutive patients from 2 centers who underwent TAVI from November 2005 to November 2011. IHI during the hospital stay was defined on the basis of symptoms and signs assessed by the attending physician in the cardiac care unit or medium care unit in combination with all technical examinations performed to confirm infection. IHI after TAVI was observed in 58 patients (19.5%): urinary tract infections in 25 patients (43.1%), pneumonia in 12 patients (20.7%), and access-site infections in 7 patients (12.1%). In 12 patients (20.7%), the site of infection could not be determined, and 2 patients (3.4%) had multiple infection sites. Multivariate analysis revealed that surgical access through the femoral artery was the most important determinant of infection (odds ratio [OR] 4.18, 95% confidence interval [CI] 1.02 to 17.19), followed by perioperative major stroke (OR 3.21, 95% CI 1.01 to 9.52) and overweight (body mass index ≥25 kg/m²; OR 2.27, 95% CI 1.12 to 4.59). The length of hospital stay in patients with IHIs was 15.0 days (interquartile range 8.0 to 22.0) compared with 7.0 days (interquartile range 4.0 to 10.0) in patients without infections (p <0.0001). Kaplan-Meier estimates of survival at 1 year were 76.6% and 74.4% (log-rank, p = 0.61), respectively. Unadjusted and adjusted OR analysis revealed that IHI did not predict mortality at 30 days (OR 1.27, 95% CI 0.49 to 3.30) or at 1 year (hazard ratio 1.24, 95% CI 0.68 to 2.25). In conclusion, IHI occurred in 19.5% of the patients. Patient-related and, more important, procedure-related variables play a role in the occurrence of infection, indicating that improvements in the execution of TAVI may lead to a reduction of this complication.

Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation.

BACKGROUND: The objective of this study was to evaluate the timing, predictive factors, and prognostic value of cerebrovascular events (CVEs) after transcatheter aortic valve implantation. METHODS AND RESULTS: The study included 1061 consecutive patients who underwent transcatheter aortic valve implantation with a balloon-expandable (64%) or self-expandable (36%) valve. CVEs were classified as acute (≤24 hours), subacute (1-30 days), or late (>30 days). CVEs occurred in 54 patients (5.1%; stroke, 4.2%) within 30 days after transcatheter aortic valve implantation (acute in 54% of cases). The predictors of acute CVEs were balloon postdilation of the valve prosthesis (odds ratio, 2.46; 95% confidence interval,1.07-5.67) and valve dislodgment/embolization (odds ratio, 4.36; 95% CI, 1.21-15.69); new-onset atrial fibrillation (odds ratio, 2.76; 95% CI, 1.11-6.83) was a predictor of subacute CVEs. Late CVEs occurred in 35 patients (3.3%; stroke, 2.1%) at a median follow-up of 12 months (3-23 months). The predictors of late CVEs were chronic atrial fibrillation (2.84; 95% CI, 1.46-5.53), peripheral vascular disease (hazard ratio, 2.02; 95% CI, 1.02-3.97), and prior cerebrovascular disease (hazard ratio, 2.04; 95% CI, 1.01-4.15). Major stroke was associated with 30-day (odds ratio, 7.43; 95% CI, 2.45-22.53) and late (hazard ratio, 1.75; 95% CI, 1.01-3.04) mortality. CONCLUSIONS: In a large cohort of patients undergoing transcatheter aortic valve implantation, the rates of acute and subacute CVEs were 2.7% and 2.4%, respectively. While balloon postdilation and valve dislodgment/embolization were the predictors of acute CVEs, new-onset atrial fibrillation determined a higher risk for subacute events. Late events were determined mainly by a history of chronic atrial fibrillation and peripheral and cerebrovascular disease. The occurrence of major stroke was associated with increased early and late mortality. These results provide important insights for the implementation of preventive measures for CVEs after transcatheter aortic valve implantation.

Blood transfusion and the risk of acute kidney injury after transcatheter aortic valve implantation.

BACKGROUND: Blood transfusion is associated with acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI). We sought to elucidate in more detail the relation between blood transfusion and AKI and its effects on short- and long-term mortality. METHODS AND RESULTS: Nine hundred ninety-five patients with aortic stenosis underwent TAVI with the Medtronic CoreValve or the Edwards Valve in 7 centers. AKI was defined by the Valve Academic Research Consortium (absolute increase in serum creatinine ≥0.3 mg/dL [≥26.4 µmol/L] or ≥50% increase ≤72 hours). Logistic and Cox regression was used for predictor and survival analysis. AKI occurred in 20.7% (n=206). The number of units of blood transfusion ≤24 hours was the strongest predictor of AKI (≥5 units, OR, 4.81 [1.45-15.95], 3-4 units, OR, 3.05 [1.24-7.53], 1-2 units, OR, 1.47 [0.98-2.22]) followed by peripheral vascular disease (OR, 1.48 [1.05-2.10]), history of heart failure (OR, 1.43 [1.01-2.03]), leucocyte count ≤72 hours after TAVI (OR, 1.05 [1.02-1.09]) and European System for Cardiac Operative Risk Evaluation (EuroSCORE; OR, 1.02 [1.00-1.03]). Potential triggers of blood transfusion such as baseline anemia, bleeding-vascular complications, and perioperative blood loss were not identified as predictors. AKI and life-threatening bleeding were independent predictors of 30-day mortality (OR, 3.15 [1.56-6.38], OR, 6.65 [2.28-19.44], respectively), whereas transfusion (≥3 units), baseline anemia, and AKI predicted mortality beyond 30 days. CONCLUSIONS: AKI occurred in 21% of the patients after TAVI. The number of blood transfusions but not the indication of transfusion predicted AKI. AKI was a predictor of both short- and long-term mortality, whereas blood transfusion predicted long-term mortality. These findings indicate that outcome of TAVI may be improved by more restrictive use of blood transfusions.

Colombian experience with transcatheter aortic valve implantation of medtronic CoreValve.

At our institutions, increasing numbers of aortic stenosis patients were not candidates for surgical aortic valve replacement. Accordingly, we initiated the Cali Colombian Transcatheter Aortic Valve Implantation (TAVI) program. From March 2008 through January 2011, 53 consecutive patients (mean age, 79 ± 6 yr; men, 58%) underwent TAVI with the Medtronic CoreValve System, and data were prospectively collected. Our study's endpoints conformed with Valve Academic Research Consortium recommendations. We report our clinical results.Predicted mortality rates were 25% (interquartile range, 17%-34%) according to logistic EuroSCORE and 6% (interquartile range, 3%-8%) according to the Society of Thoracic Surgeons score. The 30-day mortality rate was 9% (3 intraprocedural deaths, 5 total). The combined 30-day safety endpoint was 30% (major vascular sequelae, 23%; life-threatening bleeding, 12%; myocardial infarction, 4%; major stroke, 4%; and acute kidney injury [stage 3], 2%). Eight patients (15%) required post-implantation balloon dilation and 2 (4%) required valve-in-valve implantation, for a technical device success rate of 77%. Mean peak transvalvular gradient decreased from 74 ± 29 to 17 ± 8 mmHg and mean transvalvular gradient from 40 ± 17 to 8 ± 4 mmHg (both P=0.001). Moderate or severe aortic regurgitation decreased from 32% to 18% (P=0.12) and mitral regurgitation from 32% to 13% (P=0.002). The 1-year survival rate was 81%.We found that TAVI with the CoreValve prosthesis was safe and feasible, with sustained long-term results, for treating aortic stenosis in patients at excessive surgical risk; nonetheless, serious adverse events occurred in 30% of the patients.

Clinical outcome following Transcatheter Aortic Valve Implantation in patients with impaired left ventricular systolic function.

OBJECTIVES: To determine the prevalence of impaired left ventricular (LV) systolic function and its impact on the in-hospital and long-term outcome in patients who underwent Transcatheter Aortic Valve Implantation (TAVI). BACKGROUND: Although impaired LV function may be considered a contra-indication for aortic valve replacement, the hemodynamic characteristics of transcatheter valves may offer procedural and long-term clinical benefit in such patients. METHODS: 230 consecutive patients underwent TAVI with the Medtronic-CoreValve System. Impaired LV function was defined by a Left Ventricular Ejection Fraction (LVEF) ≤ 35% (European Multicenter Study on Operative Risk Stratification and Long-term Outcome in patients with Low-Flow/Low-Gradient Aortic Stenosis). Study endpoints were selected and defined according to the Valve Academic Research Consortium recommendations. RESULTS: Compared with patients with a LVEF > 35% (n = 197), those with LVEF ≤ 35% (n = 33) were more often male (78.8 % vs. 46.7%, P < 0.001), more symptomatic (NYHA class III or IV, 97.0% vs. 77.2%, P = 0.008) and had a higher prevalence of prior coronary artery disease (63.6% vs. 43.1%, P = 0.029). The Logistic EuroSCORE was 14.8% and 22.8, respectively (P = 0.012). No difference was observed between the two groups in in-hospital or 30-day mortality (3.0% vs. 9.6%, P = 0.21), the Combined Safety Endpoint at 30 days (24.2% and 24.4%, P = 0.99) and survival free from readmission at one year (69.2% and 69.7%, P = 0.85). After adjustment, LVEF ≤ 35% was not associated with an increased risk of 30-day mortality, in-hospital complications and survival free from readmission at follow-up. CONCLUSION: The immediate and long-term outcome after TAVI did not differ between patients with an impaired and preserved LVEF. LVEF ≤ 35% did not predict adverse immediate and long-term outcome. These findings suggest that TAVI should not be withheld in selected patients with impaired LV function.