Impact of Bioprosthetic Choice on Mortality After Transfemoral Transcatheter Aortic Valve Implantation in Patients With Reduced Versus Preserved Left-Ventricular Ejection Fraction.

The outcome of transfemoral transcatheter aortic valve implantation (TF-TAVI) with a self-expanding (SEP) versus a balloon-expandable prosthesis (BEP) in patients with a reduced ejection fraction (rEF, ≤40%) has not been previously investigated. Patients with rEF have an increased risk of death after TF-TAVI compared to patients with a preserved ejection fraction (pEF), and prosthesis choice might influence the outcome of these patients. We, therefore, sought to compare all-cause mortality of patients with rEF using a SEP versus a BEP. We retrospectively analyzed data of 679 single-center TF-TAVI patients. Patients were censored at death or completion of 1-year follow-up, whichever occurred first. Patients with rEF (n = 141, 21%) had an increased 1-year mortality compared to patients with pEF (28% vs 19%, p = 0.007). SEP were implanted in 149 patients (49 with rEF, 33%), while BEP were implanted in 530 patients (92 with rEF, 17%). In patients with pEF, 1-year mortality was similar after SEP- and BEP-implantation (16% vs 19%, p = 0.516). In patients with rEF, however, 1-year mortality was higher after SEP- than after BEP-implantation (43% vs 21%, p = 0.004). These patients had a higher incidence of new permanent pacemaker implantation (26.5% vs 13%, p = 0.046) and paravalvular leak ≥II° (21% vs 10%, p = 0.07), but both factors could not explain the excess mortality after SEP-implantation in the multivariate analysis. In patients with rEF, the use of a SEP was an independent predictor of 1-year mortality (HR 2.44, 95% CI 1.27 to 4.27, p = 0.007). In conclusion, patients with rEF had a higher 1-year mortality after TF-TAVI when a SEP instead of a BEP was used.

Remote monitoring of implantable cardiac devices in heart failure patients: a systematic review and meta-analysis of randomized controlled trials.

This study aims to determine whether the use of remote monitoring (RM) in implantable cardiac devices decreases all-cause mortality and heart failure (HF)-related hospitalization. We sought to conduct a systematic review and a meta-analysis of published randomized controlled studies. The population is adult patients with a diagnosis of HF with implantable devices. The intervention is RM using implantable cardiac devices whether added or used alone compared to standard of care. The outcomes are HF-related hospitalization and all-cause mortality. Risk of bias was assessed using the criteria defined in the Revised Cochrane Collaboration's tool for assessment of risk of bias. Data were extracted and validity was assessed independently by two reviewers. Electronic databases EMBASE and MEDLINE (Ovid) were searched up to 14th of October 2019, supplemented by a second search in CENTRAL (Cochrane Central Register of Controlled Trials) and clinicaltrials.gov. Only randomized controlled studies published in peer-reviewed journals with full format text in English of adult HF patients with a minimum follow-up of 6 months reporting mortality and/or hospitalization. Observational studies and studies that did not meet inclusion criteria were excluded. Thirteen randomized controlled studies that enrolled a total of 7015 patients were identified, 7 of which reported on all-cause mortality only and included 4460 patients. Compared with standard of care, the pooled relative risk (RR) of all-cause mortality and HF-related hospitalization in patients with RM compared to those receiving standard of care was 0.88 (95% confidence interval (CI) 0.69 to 1.11) and 0.95 (95% CI 0.78-1.16), respectively. In the subgroup analysis, using pulmonary pressure for RM was associated with a decrease in HF-related hospitalization (RR 0.73; 95% CI 0.60-0.88). RM showed benefit in reducing HF-related hospitalization when compared to standard of care only when using pulmonary pressure monitoring.

Impact of baseline left ventricular ejection fraction on outcome after transfemoral transcatheter aortic valve implantation in patients with and without low-gradient aortic stenosis.

OBJECTIVES: To evaluate the impact of baseline left ventricular ejection fraction (LVEF) and its interaction with low-gradient aortic stenosis (LGAS) on all-cause mortality after transfemoral aortic valve implantation (TF-TAVI). METHODS: We reviewed mortality data of 624 consecutive single center TF-TAVI patients and categorized LVEF according to current ASE/EACVI recommendations (normal, mildly-, moderately-, and severely abnormal). RESULTS: Baseline LVEF was normal in 336 (53.8%), mildly abnormal in 160 (25.6%), moderately abnormal in 91 (14.6%), and severely abnormal in 37 (5.9%) patients, and 1-year mortality was 19%, 17%, 23%, and 43% (P = 0.002), respectively. Patients with LGAS had a similar 1-year mortality compared to those without LGAS in groups with normal (19% vs 19%, P = 0.899) and mildly abnormal LVEF (16% vs 17%, P = 0.898). One-year mortality of patients with LGAS was significantly greater than in those without LGAS in presence of moderately abnormal LVEF (31% vs 11%, P = 0.022), and it was numerically greater than in those without LGAS in presence of severely abnormal LVEF (48% vs 25%, P = 0.219). In multivariate analysis, only the combination of moderately/severely abnormal LVEF and LGAS predicted increased 1-year mortality (HR: 2.12, 95% CI: 1.4-3.2, P < 0.001). Other variables, including EuroSCORE I did not affect this result. CONCLUSIONS: Moderately/severely abnormal LVEF (≤40%) at baseline is associated with increased mortality after TF-TAVI, especially when the mean transvalvular aortic gradient is <40 mm Hg (LGAS), while outcomes in patients with normal and mildly abnormal LVEF are comparable regardless of the pressure gradient across the native aortic valve. (DRKS00013729).

Impact of Liver Indicators on Clinical Outcome in Patients Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: Liver dysfunction increases death and morbidity after cardiac operations. There are currently no data evaluating liver function in patients undergoing transcatheter aortic valve replacement (TAVR). We aimed therefore to evaluate our TAVR results in regard to liver function. METHODS: A total of 640 consecutive TAVR patients were evaluated. Of those, 11 patients presented with chronic liver disease before TAVR. The Model for End-Stage Liver Disease score was used to measure liver function in these patients. The primary study end point was 30-day mortality in patients presenting with liver dysfunction. Secondary study end point was liver enzymes after TAVR. RESULTS: The mean Model for End-Stage Liver Disease score in patients with chronic liver disease was 16.8 ± 6.2 (median, 18; range, 7 to 26). The 30-day mortality was 9.1% (57 of 629) in patients presenting without liver disease and 9.1% (1 of 11) in patients with liver disease (p = 1.00). Patients with chronic liver disease showed significantly higher preoperative levels of γ-glutamyl transpeptidase (p < 0.001). After TAVR, we observed a significant increase in alanine aminotransferase on postoperative day 3 compared with preoperative values (p < 0.001), accompanied by a decrease in albumin (p < 0.001). CONCLUSIONS: Liver cirrhosis per se is not considered as a contraindication for cardiac operations. In the present study, we did not observe a higher 30-day mortality rate in liver cirrhotic patients undergoing TAVR, suggesting TAVR as a feasible alternative with acceptable outcomes in patients with chronic liver disease. Moreover, the present study is the first to evaluate liver variables in patients undergoing TAVR.

Left ventricular diastolic dysfunction in patients with chronic obstructive pulmonary disease: Impact of methods of assessment.

BACKGROUND: The prevalence of left ventricular (LV) diastolic dysfunction in patients with chronic obstructive pulmonary disease (COPD), using different echocardiographic parameters, varies widely in the literature. The highest prevalence of LV diastolic dysfunction was detected using the mitral inflow indexes that are commonly altered in these patients due to the associated tachycardia, reduced preload, and ventricular septal shift. In this study, we aimed at evaluating the impact of the used echocardiographic method of assessment on the prevalence of LV diastolic dysfunction in patients with COPD and normal LV systolic function. METHODS: We studied 35 patients with COPD and 18 age-matched controls. A comprehensive approach to diagnose and grade the LV diastolic dysfunction was performed in accordance with the recommendations of the American Society of Echocardiography published in 2009. The results were compared with those of mitral inflow indexes. RESULTS: LV diastolic dysfunction was reported in 20 patients using the mitral inflow indexes while in only 12 patients using the comprehensive approach (P=.021). Compared to the controls, LV diastolic dysfunction was significantly more common in patients using the mitral inflow indexes (P=.001), while no statistically significant difference was detected between both groups using the comprehensive approach (P=.1). CONCLUSION: The prevalence of LV diastolic dysfunction in patients with COPD varies according to the used echocardiographic approach. Further studies are recommended to determine which approach is the most accurate in estimating the true prevalence of LV diastolic dysfunction among this group of patients.

Cardiac findings in patients with Behçet's disease: Facts and controversies.

Behçet's disease (BD) is a systemic vasculitis of unknown etiology. It is characterized by recurrent oral and genital ulcers, uveitis, and a number of systemic manifestations. Although the disease is recognized worldwide, its prevalence is highly variable. A detailed review and analysis of the worldwide published reports on BD showed that not only the prevalence of the disease but also its cardiac complications differ according to the geographic distribution of the studied population. With the exception of France, Greece, Spain, and Italy, very few reports and studies regarding BD have been published from the western countries. Cardiovascular complications are an important cause of poor outcome in patients with BD. Over the past few years, many case reports and studies have been published, providing more facts about these complications. For example, peculiar echocardiographic findings in patients with aortic valve regurgitation and intracardiac thrombi secondary to BD were recently described. The role of these findings in the initial diagnosis of the disease, however, remains to be evaluated. On the other hand, some reports present contradictory results, especially concerning the left ventricular diastolic function, pathogenesis of coronary artery disease, and proper management of the cardiac complications in BD. Importantly, management of these complications is based mainly on the discretion of the treating physician due to the absence of large controlled studies and clear guidelines. This approach sometimes creates inconsistent data and allows controversies to persist. The review presented here will discuss some of the facts and controversies related to cardiac complications in BD.

Predictors of aortic pulse wave velocity in the elderly with severe aortic stenosis.

UNLABELLED: Predictors of aortic pulse wave velocity (AoPWV) were not previously studied in the elderly with severe aortic stenosis (AS). We aimed to compare the AoPWV in these patients with matched controls and to study the predictors of AoPWV in this population. We measured the AoPWV during cardiac catheterisation in 40 patients with severe AS and 20 matched controls. AoPWV in both groups was similar (p = 0.198) and lied within normal reference value for age in 68 % of elderly with severe AS. Central systolic blood pressure (SBP) (adjusted ß = 0.45, p = 0.001) and glomerular filtration rate (GFR) (adjusted ß = -0.29, p = 0.023) were the only independent predictors of AoPWV in AS group. Central SBP >140 mmHg was the best predictor of abnormal AoPWV (≥14.6 m/s) with 100 % sensitivity and 70 % specificity, p < 0.001. CONCLUSION: AoPWV is not increased in the elderly with severe AS compared to controls, and lies within the reference value for age in the majority of these patients. Central SBP >140 mmHg best predicts abnormal AoPWV in the elderly with severe AS.

Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation.

PURPOSE: Transcatheter aortic valve implantation (TAVI) results in the dislodgement of debris with risk of cerebral lesions or stroke. The EMBOL-X protection device (Edwards Lifesciences, Irvine, CA) is positioned within the ascending aorta to capture such debris. DESCRIPTION: Between July 2012 and April 2014 we randomly assigned 30 high-risk patients to undergo transaortic TAVI with the SAPIEN XT prosthesis (Edwards Lifesciences) combined with either the EMBOL-X device (group-1, n = 14) or without (group-2, n = 16). Periprocedural cerebral lesions were assessed by diffusion-weighted magnetic resonance imaging (DW-MRI) at baseline and within 7 days post-procedurally. EVALUATION: New foci of restricted diffusion on cerebral DW-MRI were found in 69% in group-2 and 50% in group-1. Lesion size was smaller in patients treated with the EMBOL-X device than in those without (88 ± 60 vs 168 ± 217 mm(3), p = 0.27, t = 1.2, degrees of freedom = 10). Transaortic TAVI patients treated with the EMBOL-X device had significantly smaller lesion volumes in the supply region of the middle cerebral artery (33 ± 29 vs 76 ± 67 mm(3), p = 0.04). There were no neurologic events after transaortic TAVI. CONCLUSIONS: The intraaortic protection device seems to reduce both the incidence and the volume of new cerebral lesions (ClinicalTrials.gov number, NCT01735513).

Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve.

BACKGROUND: We evaluated the clinical and hemodynamic performance of the new balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA) transcatheter heart valve (S3 THV). METHODS: Between April 2013 and January 2015, 54 consecutive high-risk patients presenting with aortic stenosis were treated with the new S3 THV. Clinical and hemodynamic data as well as device and procedure variables were obtained at baseline, intraoperatively and at 30-days according to Valve Academic Research Consortium-2. RESULTS: The S3 THV was implanted in 41 patients (44% female) via transapical access and in 13 patients via transaortic access. Patients were a mean ± standard deviation age of 80.3 ± 6.0 years. The mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of all patients was 33.3% ± 13.4%, the mean The Society of Thoracic Surgeons Score was 6.7% ± 5.3%, and the mean EuroSCORE II was 7.0% ± 5.5%. All patients underwent successful implantation (23 mm, n = 12; 26 mm, n = 22; 29 mm, n = 20), without any intraprocedural complications or repeat ballooning. At 30 days, 53 patients (97.8%) showed no or mild paravalvular aortic regurgitation, 1 patient (2.2%) showed moderate regurgitation, and no patients had more than moderate postprocedural aortic regurgitation. Stroke incidence was 3.7% (2 of 54), and all-cause mortality was 3.7% (2 of 54, sepsis and multiorgan failure). Two patients required a new pacemaker. At 30 days, all patients were in New York Heart Association Functional Class I or II, and the mean pressure gradients were 10.8 ± 3.6 mm Hg. CONCLUSIONS: The present study shows excellent clinical and hemodynamic outcomes of high-risk transapical valve replacement patients treated with the new S3 THV. The S3 THV shows a low incidence of postoperative aortic regurgitation, with 98% presenting with less than mild aortic regurgitation.

Conventional aortic valve replacement or transcatheter aortic valve implantation in patients with previous cardiac surgery.

BACKGROUND: Clinical outcomes were compared among patients with previous cardiac surgery undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (AVR). METHODS: Between 2007 and 2014 a total of 142 consecutive patients with previous cardiac surgery were treated by TAVI either by the transfemoral (n=68) or transapical access (n=74), and 236 patients underwent a surgical redo-AVR. Of these patients, propensity analysis (m:n) matched 62 (group 1, TAVI) and 51 patients (group 2, redo-AVR). A multivariate logistic regression model was constructed. Moreover, mortality was compared between both groups by Cox regression. RESULTS: Both groups differed significantly (p<0.01) in regard to age and preoperative risk scores (EuroSCORE and STS-Score). Thirty-day mortality was 14.5% (9/62) in group 1 and 5.8% (3/51) in group 2 (p=0.23). Risk-adjusted multivariable analysis revealed only the logistic EuroSCORE to be strongly correlated with 30-day mortality (p=0.01). Multivariate analysis showed no difference in 30-day mortality between both groups (p=0.21). Multivariate Cox regression revealed New York Heart Association functional class (p=0.001), logistic EuroSCORE (p=0.01), and STS-Score (p=0.03) to be strongly associated with overall mortality. Moreover, evaluating overall mortality, Cox regression showed no difference between both groups (p=0.36). CONCLUSIONS: The present study shows that in patients with cardiac reoperation, TAVI comes with similar outcomes when compared to surgical AVR. On the other hand, conventional redo-AVR is still a valuable and safe treatment option.

Transapical transcatheter aortic valve for severe aortic regurgitation: expanding the limits.

OBJECTIVES: This study sought to evaluate the self-expandable ACURATE TA device (Symetis SA, Ecublens, Switzerland) in a cohort of patients with pure aortic regurgitation (AR). BACKGROUND: Transcatheter aortic valve replacement (TAVR) has been initially considered as an alternative for high-risk patients with aortic stenosis. Although the current experience is limited, TAVR might be also an alternative to treat patients with pure, severe AR. METHODS: Between April 2012 and December 2013, a total of 8 high-risk patients with pure, severe AR were enrolled (grade III+). Clinical and hemodynamic data as well as data on device and procedure parameters and outcomes were collected. RESULTS: Patient mean was 72.5 ± 8.4 years, and 37.5% of patients were female. Logistic EuroSCORE was 34.0 ± 7.9% and the Society of Thoracic Surgeons score was 7.3 ± 3.3% on average. Two patients had undergone emergency aortic operation before due to acute type A aortic dissection, and both were treated by replacement of the ascending aorta (including root reconstruction) and the aortic arch combined with or without E-vita Open stent graft (Jotec GmbH, Hechingen, Germany) (January 2011 and March 2012), whereas the other patients experienced primary AR. All patients underwent successful transapical TAVR with the transapical ACURATE TA device (size small, n = 1, size medium, n = 3, size large, n = 4) without any intraprocedural complications according to the Valve Academic Research Consortium 2 criteria. Post-procedure AR grade I+ or lower, as revealed by transoesophageal echocardiography and angiography, was present in all 8 patients. At 30 days, the stroke incidence and all-cause mortality rate were 0%. CONCLUSIONS: This small single-center series demonstrates the feasibility of transapical TAVR with the self-expandable ACURATE TA device in high-risk patients with severe AR.