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The initially reported periprocedural neurological events rates associated with transcatheter aortic valve replacement raised concerns that ultimately led to the development and to the clinical research of novel embolic protection devices. Although the reduction of clinical stroke is a desired goal, the current research design of embolic protection devices focuses on surrogate markers of the clinical disease, primarily on silent central nervous system lesions observed in postprocedural diffuse-weighted magnetic resonance imaging and cognitive function testing. As the mere presence of particulate debris in brain matter may not correlate with the extent of brain injury, cognitive function, or quality of life, the clinical significance of embolic protection devices has yet to be determined, and interpretation of study results with regard to real-life clinical use should be viewed accordingly. The purpose of this article is to provide an overview of the updated ongoing clinical research on embolic protection devices and present its major caveats., (© 2016 American Heart Association, Inc.)

Objectives: Our aim was to analyze the prevalence and predictors of Carotid artery stenosis (CAS) in patients undergoing transcatheter aortic valve implantation (TAVI)., Background: CAS is associated with the risk of periprocedural stroke in patients undergoing cardiac surgery. However, little is known about the prevalence of and clinical significance of CAS in the setting of TAVI., Methods: Consecutive patients undergoing a carotid Doppler study the day before TAVI were followed prospectively. CAS was defined in accordance with current practice guidelines. Logistic regression models were used to identify independent correlates of CAS., Results: The study included 171 patients (age 82 ± 6, male gender 47%). Carotid atherosclerosis (CA, defined as any carotid plaque) was present in 164 (96%) of patients, and CAS (peak systolic velocity [PSV] ≥ 125 cm/sec; ≥50% diameter stenosis) in 57 (33%) patients. Severe CAS (PSV ≥ 230 cm/sec; ≥70% stenosis, or near occlusion) was found in 15 (9%) patients. By multivariate analysis, smoking and a higher Euroscore independently predicted the presence of CAS. Patients in the present TAVI cohort had a significantly higher prevalence of both unilateral and bilateral CAS ≥ 50% than those in a previously reported cohort (n = 494 patients, age ≥ 70) undergoing clinically driven coronary angiography (33% vs. 20%, OR = 1.9, P = 0.001; and, 13% vs. 6%, OR = 2.3, P = 0.003, respectively). CAS was not independently associated with 30-day mortality or stroke rates., Conclusions: The prevalence of CAS in patients undergoing TAVI is high, exceeding that observed in patients undergoing catheterization for coronary indications. The impact of CAS on clinical outcomes following TAVI merits further research., (© 2014 Wiley Periodicals, Inc.)

Background: Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality. The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI., Methods/design: Reduce-AKI is a randomized sham-controlled study designed to examine the effect of an automated matched hydration system in the prevention of AKI in patients undergoing TAVI. Patients will be randomized in a 1:1 fashion to the RenalGuard system (active group) versus non-matched saline infusion (sham-controlled group). Both arms receive standard overnight saline infusion and N-acetyl cysteine before the procedure., Discussion: The Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI., Trial Registration: Clinicaltrials.gov: NCT01866800, 30 April 30 2013.

Aims: Percutaneous coronary intervention (PCI) may be perceived as a frightening experience. Some psychological factors are known correlates of recovery and rehabilitation of cardiac patients. Our objective was to investigate the emotional, cognitive and behavioral effects of patient guidance during their cardiac catheterization., Methods: We performed a randomized trial comparing a patient group that was instructed while watching the monitor screen during their PCI (study group) and another group that was not (controls). Replies to questionnaires measuring emotional, cognitive and behavioral variables known to be associated with cardiac patients' health status, rehabilitation and quality of life were collected 1 day and 1 month after the procedure., Results: The study group included 57 patients and the control group included 51 patients. Most patients (∼87%) were men at the mean age of 60. They were well matched for reasons for referral to PCI. The study group reported less pain, a more positive affect, greater self-efficacy and stronger intentions to change health-related behaviors than the control group. At 1 month following the procedure, the study group evaluated their general health as significantly better, and reported a less negative affect, less cardiac anxiety, greater functional self-efficacy and more positive outcome expectancies regarding diet, and quitting smoking than the controls., Conclusion: A simple adjustment in the standard PCI protocol can become a highly beneficial psychological intervention for enhancing patient outcomes.

Objectives: To assess the safety and effectiveness of performing percutaneous coronary intervention (PCI) before transcatheter aortic valve implantation (TAVI)., Background: The presence of coronary artery disease (CAD) negatively impact procedural outcomes and long-term survival after (TAVI). The management of obstructive CAD before TAVI is not yet well established., Methods: Patients with severe symptomatic aortic stenosis (AS) (n = 249) that underwent TAVI were divided into two groups: patients with CAD (subdivided to patients treated with TAVI alone and to patients that underwent PCI before TAVI) and patients with isolated AS. Procedural endpoints, device success and adverse events were considered according to the Valve Academic Research Consortium (VARC) definitions., Results: Of a cohort of 249 consecutive patients with mean age of 83.2 ± 5.5 years, 83 patients with AS + CAD were treated with TAVI alone, 61 patients with AS + CAD underwent PCI before TAVI and 105 patients underwent TAVI for isolated AS. The mean duration of follow-up was 17 months (range: 6-36 months). Despite a significantly higher logistic EuroScore of the AS+CAD group compared to the AS alone group (30.1 vs. 21.1 P < 0. 001), the overall VARC-adjudicated endpoints did not differ between the groups. All-cause mortality at 30-days was 1.6% for patients with AS+CAD treated with PCI compared to 2.9% for patients with AS alone (P = 1)., Conclusions: Performing PCI before TAVI in high-risk elderly patients with significant CAD and severe AS is feasible and safe. This combined treatment approach did not increase the periprocedural risk for complications or the all-cause mortality., (Copyright © 2013 Wiley Periodicals, Inc.)

We aimed to evaluate the clinical and hemodynamic impact of transcatheter aortic valve implantation in patients with typical low-gradient severe aortic stenosis (LGSAS) and at high operative risk for surgical valve replacement. Prospectively collected clinical and echo Doppler data were retrospectively analyzed in 112 and 86 patients, respectively. Follow-up period was 31 months (21 to 38). Thirty-eight patients died; combined long-term cardiovascular events were identified in 68 patients. The 30-day mortality rate was 2.4% in patients with typical severe aortic stenosis (AS) and 3.3% in patients with LGSAS (p = 1.0). Two-year survival rate was 77 ± 5% for the former (n = 82) and 68 ± 8% for the latter (n = 30; hazard ratio 1.4, 95% confidence interval 0.7 to 2.7 for LGSAS; p = 0.3). Two-year cardiovascular event-free survival rates were 56.5 ± 5.0% and 48.4 ± 9.0%, respectively, (hazard ratio 1.4, 95% confidence interval 0.78 to 2.3 for LGSAS; p = 0.25). Patients with typical severe AS (n = 64) and those with LGSAS (n = 23) demonstrated similar increases in left ventricular ejection fraction and stroke volume (7 ± 10% vs 6 ± 6% and p = 0.67; 12 ± 22% vs 12 ± 16%, p = 0.88, respectively) and reduction in systolic pulmonary artery pressure (5 ± 14 vs 5 ± 9 mm Hg, respectively, p = 0.83). In conclusion, transcatheter aortic valve implantation appears to result in similar hemodynamic and long-term clinical outcomes for high-risk surgical patients with LGSAS as those with typical severe AS., (Copyright © 2014 Elsevier Inc. All rights reserved.)

The impact of age on baseline characteristics and outcomes in patients with severe aortic stenosis who undergo transcatheter aortic valve implantation (TAVI) has not been thoroughly investigated. To describe the baseline clinical profile of TAVI patients aged >85 and ≤85 years and to evaluate the influence of age differences on outcomes, we evaluated a consecutive cohort of 293 patients who underwent transfemoral TAVI at the Tel Aviv Medical Center. The cohort was divided into 2 groups: patients aged >85 years (n = 93) and patients aged ≤85 years (n = 200). Mean age was 83 ± 5.3 years (range 63 to 98) for the entire cohort. Women comprised 70% of the older group and 57.5% of the younger age group (p = 0.043). Baseline clinical profile, including EuroSCORE index and preprocedural aortic valve area were similar in both age groups. Thirty-day mortality, major vascular complications, need for permanent pacemaker implantation, length of hospital stay, and improvement in functional class after the procedure showed no differences between the 2 groups. Adjustment for baseline clinical differences between groups did not change the results. In conclusion, among patients who underwent transfemoral TAVI, older patients (>85 years) experience similar benefits and outcomes regarding functional status, complication rates, and 30-day mortality., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) frequently requires postprocedural permanent pacemaker (PPM) implantation. We evaluated clinical and hemodynamic impact of PPM after TAVI. Clinical and echocardiographic data were retrospectively analyzed in 230 consecutive patients who underwent TAVI and echocardiography at baseline and after 6 months. Echocardiographic parameters included left ventricular ejection fraction (LVEF), left ventricular (LV) stroke volume, early mitral velocity/annulus velocity ratio (E/e'), right ventricular index of myocardial performance, systolic pulmonary artery pressure (SPAP), and aortic, mitral, and tricuspid regurgitation grades. Clinical outcomes included 2-year survival and cardiovascular and PPM-related event-free survival. The Medtronic CoreValve and Edwards Sapien prosthesis were used in 201 and 29 patients, respectively. PPM was required in 58 patients (25.4%). Two-year and event-free survival rates were similar between patients with and without PPM. At 6 months, patients with PPM demonstrated attenuated improvement in LVEF (-0.9 ± 8.7% vs 2.3 ± 10.8%, respectively, p = 0.03) and LV stroke volume (-2 ± 16 vs 4 ± 10 ml/m(2), respectively, p = 0.015), a trend toward smaller reduction in systolic pulmonary artery pressure (-1 ± 12 vs -6 ± 10 mm Hg, respectively, p = 0.09), and deterioration of right ventricular index of myocardial performance (-3 ± 17% vs 5 ± 26%, respectively, p = 0.05). The differences in post-TAVI aortic, mitral, and tricuspid regurgitation grades were insignificant. In conclusion, PPM implantation after TAVI is associated with reduced LVEF and impaired LV unloading. However, this unfavorable hemodynamic response does not affect the 2-year clinical outcome. The maintenance of clinical benefit appears to be driven by TAVI-related recovery of LV and right ventricular performance that mitigates unfavorable impact of PPM., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is frequent and associated with adverse outcomes. We aimed to identify the incidence and risk factors for AKI after TAVI using the updated Valve Academic Research Consortium-2 classification criteria. We performed a retrospective analysis of 300 consecutive patients undergoing TAVI using either Edwards SAPIEN XT or CoreValve bioprostheses at our medical center. Change in serum creatinine from base line to 48 to 72 hours after TAVI was used to define AKI stages 1 to 3. The final study cohort included 251 patients. Overall incidence of AKI was 16.7% (42 of 251); of which, stage 1 AKI was 15.1% (38 of 251), stage 2 AKI was 1.6% (4 of 251), and none had stage 3 AKI or required hemodialysis. All-cause mortality at 30 days and 1 year was greater among patients with AKI (9.5% vs 1%, p <0.01% and 25.7% vs 12.3%, p = 0.041, respectively). Despite greater volume of contrast media used in Edwards SAPIEN versus CoreValve (162 ml vs 142 ml, p = 0.02), there was no difference in the incidence of AKI between the 2 valve types (23.7% vs 15.5%, p = 0.238) or when comparing larger (29 to 31 mm) versus smaller size valves (23 to 26 mm; 17.7% vs 16.1%, p = 0.745). AKI was associated with chronic kidney disease, history of peripheral vascular disease, blood transfusion, and higher EuroSCORE (p <0.05 for all). In conclusion, according to the new Valve Academic Research Consortium-2 classification, 1 in every 6 patients in our cohort developed AKI after TAVI (most were stage 1 AKI). AKI was associated with increased mortality. No difference in AKI incidence was observed between different types and sizes of bioprostheses used., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: The relative radiation dose (RD) of patients undergoing transcatheter aortic valve implantation (TAVI) with either the Edwards Sapien XT (ESX) or the Medtronic CoreValve (MCV) prostheses has not been studied in depth. Our aim was to quantify RD in uncomplicated transfemoral TAVI with either prosthesis., Methods: We analyzed 248 consecutive patients undergoing uncomplicated transfemoral TAVI between March 2009 and September 2012, at a single tertiary care facility. Total air Kerma, cumulated dose area product (DAP), and fluoroscopy time were determined in each case., Results: The ESX and MCV prostheses were implanted in 44 and 204 patients, respectively. Though mean fluoroscopy time was higher during ESX valve implantation, overall RD per total air Kerma and DAP was significantly higher during MCV implantation (P < 0.05 for both comparisons). By multivariate regression analyses, prosthesis type was an independent predictor of RD according to both total air Kerma and DAP (r(2) = 0. 498; P < 0.01 and r(2) = 0.363; P < 0.01, respectively)., Conclusion: In uncomplicated transfemoral TAVI, RD is greater during MCV implantation than during ESX implantation., (Copyright © 2013 Wiley Periodicals, Inc.)

Background: Transcatheter aortic valve implantation (TAVI) has recently become an alternative to surgical aortic valve replacement in selected patients with high operative risk., Objectives: To investigate the 30 day clinical outcome of the first 300 consecutive patients treated with transfemoral TAVI at the Tel Aviv Medical Center., Methods: The CoreValve was used in 250 patients and the Edwards-Sapien valve in 50. The mean age of the patients was 83 +/- 5.3 years (range 63-98 years) and the mean valve area 0.69 +/- 0.18 cm2 (range 0.3-0.9 cm2); 62% were women., Results: The procedural success rate was 100%, and 30 day follow-up was done in all the patients. The average Euro-score for the cohort was 26 +/- 13 (range 1.5-67). Total in-hospital mortality and 30 day mortality were both 2.3% (7 patients). Sixty-seven patients (22%) underwent permanent pacemaker implantation after the TAVI procedure, mostly due to new onset of left bundle brunch block and prolonged PR interval or to high degree atrioventricular block. The rate of stroke was 1.7% (5 patients). Forty-one patients (13.7%) had vascular complications, of whom 9 (3%) were defined as major vascular complications (according to the VARC definition)., Conclusions: The 30 day clinical outcome in the first 300 consecutive TAVI patients in our center was favorable, with a mortality rate of 2.3% and low rates of stroke (1.7%) and major vascular complications (3%).

Abstract Background Multi-detector computed tomography (MDCT) predicted orthogonal projection angles have been introduced to guide valve deployment during transcatheter aortic valve replacement (TAVR). Our aim was to investigate the accuracy of MDCT prediction methods versus actual angiographic deployment angles. Methods Retrospective analysis of 2 currently used MDCT methods: manual multiplanar reformations (MR) and the semiautomatic optimal angle graph (OAG). Paired analysis was used to compare the 2-dimensional distributions and means. Results We included 101 patients with a mean (±SD) age of 81 ± 9 years. The MR and OAG methods were used in 46 and 55 patients, respectively. A ≥5% change from the predicted MDCT range in left anterior oblique/right anterior oblique (LAO/RAO) and the cranial/caudal (CRA/CAU) angle occurred in 42% and 58% of patients, respectively. The mean predicted versus actual deployment angles were significantly different (CRA/CAU: -2.6 ± 11.5 vs. -7.6 ± 10.7, p < 0.001; RAO/LAO 8.1 ± 10.9 vs. 9.5 ± 10.6, p = 0.048; respectively). The MR method resulted in a more accurate CRA/CAU angle (CRA/CAU: -4.6 ± 11.1 vs. -6.5 ± 11.8, p = 0.139; RAO/LAO 7.4 ± 11.2 vs. 10.4 ± 11.2, p = 0.008; respectively), whereas the use of the OAG resulted in a more accurate RAO/LAO angle (CRA/CAU: -0.9 ± 10.8 vs. -9±11.2, p < 0.001; RAO/LAO 9.05 ± 10.6 vs. 8.5 ± 9.9, p = 0.458; respectively). For the entire cohort, the 2-dimensional distributions and means of the predicted versus the actual angles were significantly different from each other (p < 0.001). We repeated our analysis using both MDCT methods and demonstrated similar results with each method. Conclusions Currently used MDCT methods for TAVR implantation angles are significantly modified before actual valve deployment. Thus, further refinement of these prediction methods is required. [ABSTRACT FROM AUTHOR]

Background Transcatheter aortic valve replacement ( TAVR) has become a treatment option for patients with severe aortic stenosis ( AS) and high surgical risk. Assessment of symptoms in these patients is challenging because of advanced age, comorbidities, and limited physical activity. Noninvasive quantification of pulmonary capillary wedge pressure ( PCWP) in candidates for TAVR may be helpful for risk stratification. The objective of the study was to create a model for estimation of PCWP by echo Doppler in patients with severe AS. Methods and Results Data from 80 patients with severe AS referred for TAVR were used to develop an echo Doppler model for predicting PCWP. Its performance was evaluated in the test cohort of 33 patients who had invasive and noninvasive evaluation. No single echo Doppler parameter estimated PCWP accurately. In the retrospective analysis, the multilinear regression provided an accurate estimate of PCWP (r2 = 0.74). The model included, in order of importance (all P < 0.05), the ratio of early transmitral velocity (E) to annular velocity (E'), the left ventricular ejection fraction, and the velocity time integral of tricuspid regurgitation signal. In the prospective cohort of patients with severe AS, the model demonstrated good predictive ability of PCWP (r = 0.77, P < 0.01). Conclusion In patients with severe AS, noninvasive estimation of PCWP is possible by integration of two-dimensional, spectral, and tissue Doppler variables. [ABSTRACT FROM AUTHOR]

Vascular complications (VC) after transcatheter aortic valve implantation (TAVI) are reported using various criteria and several access site approaches. We aimed to describe them in a solely percutaneous transfemoral TAVI approach and their association with survival using both the updated Valve Academic Research Consortium (VARC)-2 criteria and the former VARC-1 criteria. From March 2009 to September 2013, 403 consecutive patients at a mean age (±SD) of 83 ± 6 years underwent percutaneous transfemoral TAVI. VC were defined by both VARC-1 and VARC-2 criteria and analyzed separately. Cox proportional hazard ratio models for all-cause mortality were adjusted separately as defined by each criteria. VARC-1-defined and VARC-2-defined VC occurred in 71 (18%) and 78 (19%) patients, respectively, with 15 (4%) and 33 (8%) defined as major VC. The difference in frequency of major and minor VC was mainly driven by VARC-2 implementation of major bleeding events. With either VARC definition, patients with minor VC had similar mortality and complications rates as those patients without VC. In multivariate analyses, referenced to patients with minor or no VC, only VARC-1-defined major VC were significantly associated with increased mortality (hazard ratio 3.52; confidence interval 1.5 to 8.4; p = 0.005), whereas VARC-2-defined major VC were found to be only marginally significant (hazard ratio 1.9; confidence interval 0.9 to 3.9; p = 0.08). In conclusion, the implementation of the VARC-2 criteria resulted in a higher rate of reported major VC after TAVI compared with VARC-1 criteria, mainly by the inclusion of major bleeding events and a reduced association with patient mortality. [ABSTRACT FROM AUTHOR]

Abstract: Background: Anemia is associated with an unfavorable outcome in acute myocardial infarction (AMI). An acute phase response could contribute to the development of anemia in AMI patients. Methods: We have performed a cross-sectional analysis on prospectively collected data at a tertiary hospital catheterization laboratory. Multi-adjusted linear regression models were fitted for hemoglobin as the dependent variable. ANOVA tests were used to determine interactions between time cutoffs of the respective hemoglobin and the concentrations of two inflammatory proteins, namely C-reactive protein and fibrinogen. Anemia indices were analyzed in a subgroup of 138 male AMI patients for whom frozen serum samples were available. Results: Enrolled were 1017 patients (340 with unstable angina pectoris [UAP] and 677 with AMI). Correlates of hemoglobin in the AMI group included age, male gender, the inflammatory proteins, as well as time from symptom onset to angiography (r 2 =0.47; p <0.001). A significant decrease in the concentration of hemoglobin with a parallel increase in the inflammatory proteins was observed between the time cutoff from symptom onset to angiography only in the AMI group for males and females, respectively. A pattern suggestive of anemia of inflammation including higher ferritin, lower transferring, lower transferrin saturation, and lower serum iron concentrations has been observed in anemic AMI patients ( all p <0.05). Conclusions: Inflammation-sensitive proteins are associated with lower hemoglobin concentrations in AMI patients. We therefore suggest the possibility that at least part of the hemoglobin drop in AMI prior to angiography is related to the anemia of inflammation. [Copyright &y& Elsevier]