Eyal Ben-Assa | Ben Gurion University of the Negev (original) (raw)

Papers by Eyal Ben-Assa

Research paper thumbnail of Effect of Residual Interatrial Shunt on Migraine Burden After Transcatheter Closure of Patent Foramen Ovale

JACC: Cardiovascular Interventions, 2020

OpenBU http://open.bu.edu Biomedical Engineering BU Open Access Articles 2020-02-10 Effect of res... more OpenBU http://open.bu.edu Biomedical Engineering BU Open Access Articles 2020-02-10 Effect of residual interatrial shunt on migraine burden after transcatheter closure...

Research paper thumbnail of Telemedicine for lowering 30-day readmission rates following acute myocardial infarction: an observational study

European Heart Journal, 2013

Heart failure treatment / Cardiac rehabilitation: various 625 136.3mmHg ±30.8 vs. 130.6mmHg ±23.2... more Heart failure treatment / Cardiac rehabilitation: various 625 136.3mmHg ±30.8 vs. 130.6mmHg ±23.2 (p<0.05), higher left ventricul ejection fraction 47.4% ±13.2 vs. 39.0% ±13.6 (p<0.05), longer QTc 401.9ms ±38.7 vs. 389.7ms ±45.8 (p<0.05), higher NYHA functional class 2.9 vs. 2.7 (p<0.05), higher incidence of hypertension (p<0.05), thyroid dysfunction (p<0.05) and depression (p<0.05), frequenter proteinuria (p<0.05), higher level of BNP 1826.9 pg/ml, vs. 1183.2 pg/ml (p<0.05), lower level of bilirubin 4.7 md/dl vs. 7.2 mg/dl (p<0.05). Women were longer hospitalized in ICCU 4.1days vs. 2.8 days (p<0.05). Women compared to men were more often treated by ARB and CCB, but less frequently by ACEI, BB and Eplerenone. There were no significant differences in the rate of deaths in the in the one-year follow-up between men and women: 99 (11%) subjects died. Conclusions: 1.The results of ESC-HF Pilot Survey from Polish Centers showed significant gender-related differences in clinical presentation and pharmacological treatment of heart failure. 2. In spite of differences in clinical characteristics and pharmacotherapy, clinical outcomes were similar in men and women with heart failure in the one-year followup.

Research paper thumbnail of Target hemoglobin can be achieved with intravenous iron alone in cardio-renal patients

European Heart Journal, 2013

SMILE-4) showed the superiority of Zofenopril (Z) associated with Acetylsalicylic Acid (ASA) as r... more SMILE-4) showed the superiority of Zofenopril (Z) associated with Acetylsalicylic Acid (ASA) as respect to Ramipril (R) plus ASA in reducing the occurrence of major cardiovascular events, in patients with left ventricular dysfunction (LVD) following Acute Myocardial Infarction (AMI). The objective of this retrospective analysis was the evaluation of cost-effectiveness of Z compared to R. Methods: 771 patients with LVD and AMI were randomized, double-blind to Z 60 mg/day (n=389) or R 10 mg/day (n=382) plus ASA 100 mg/day and followed-up for 1 year. The primary study end-point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. The economic analysis was based on the evaluation of cost of medications and hospitalizations and was applied to the intention-to-treat population (n=716). Cost data were drawn from the database of the Italian National Health Service. The Incremental Cost-Effectiveness Ratio (ICER) was used to quantify the cost per event prevented with Z vs. R. Results: Z significantly (p=0.028) reduced the risk of the primary study end-point by 30% as compared to ramipril (95% confidence interval: 49%, 4%). The number needed to treat to prevent a major cardiovascular event with Z was 13 less than with R. The cost of drug therapies was higher with Z (313.90 Euros per patient per year, n=365) than with R (160.60 Euros per patient per year, n=351). The cost related to the occurrence of major cardiovascular events requiring hospitalization, averaged 3195.47 Euros for Z and 3071.37 Euros for R. The ICER of Z vs. R was 1990.88 Euros per event prevented. Conclusions: Z is a viable and cost-effective treatment for managing patients with LVD after AMI. P3294 | BEDSIDE High-sensitivity assay of plasma cardiac troponin T predicts the effects of pitavastatin in patients with chronic heart failure: a subgroup analysis from the pitavastatin heart failure study (PEARL)

Research paper thumbnail of When Virchow Meets Da Vinci

Circulation: Cardiovascular Imaging, 2016

Research paper thumbnail of Ventricular stroke work and vascular impedance refine the characterization of patients with aortic stenosis

Science Translational Medicine, 2019

Aortic stenosis (AS) management is classically guided by symptoms and valvular metrics. However, ... more Aortic stenosis (AS) management is classically guided by symptoms and valvular metrics. However, the natural history of AS is dictated by coupling of the left ventricle, aortic valve, and vascular system. We investigated whether metrics of ventricular and vascular state add to the appreciation of AS state above valve gradient alone. Seventy patients with severe symptomatic AS were prospectively followed from baseline to 30 days after transcatheter aortic valve replacement (TAVR). Quality of life (QOL) was assessed using the Kansas City Cardiomyopathy Questionnaire. Left ventricular stroke work (SWLV) and vascular impedance spectrums were calculated noninvasively using in-house models based on central blood pressure waveforms, along with hemodynamic parameters from echocardiograms. Patients with higher preprocedural SWLV and lower vascular impedance were more likely to experience improved QOL after TAVR. Patients fell into two categories: those who did and those who did not exhibit i...

Research paper thumbnail of Aortic regurgitation assessment by cardiovascular magnetic resonance imaging and transthoracic echocardiography: intermodality disagreement impacting on prediction of post-surgical left ventricular remodeling

The International Journal of Cardiovascular Imaging, 2019

Transthoracic echocardiography (TTE) is the primary clinical imaging modality for the assessment ... more Transthoracic echocardiography (TTE) is the primary clinical imaging modality for the assessment of patients with isolated aortic regurgitation (AR) in whom TTE's linear left ventricular (LV) dimension is used to assess disease severity to guide aortic valve replacement (AVR), yet TTE is relatively limited with regards to its integrated semi-quantitative/qualitative approach. We therefore compared TTE and cardiovascular magnetic resonance (CMR) assessment of isolated AR and investigated each modality's ability to predict LV remodeling after AVR. AR severity grading by CMR and TTE were compared in 101 consecutive patients referred for CMR assessment of chronic AR. LV end-diastolic diameter and end-systolic diameter measurements by both modalities were compared. Twenty-four patients subsequently had isolated AVR. The pre-AVR estimates of regurgitation severity by CMR and TTE were correlated with favorable post-AVR LV remodeling. AR severity grade agreement between CMR and TTE was moderate (ρ = 0.317, P = 0.001). TTE underestimated CMR LV end-diastolic

Research paper thumbnail of A Mechanical Approach for Smooth Surface Fitting to Delineate Vessel Walls in Optical Coherence Tomography Images

IEEE Transactions on Medical Imaging, 2018

Automated analysis of vascular imaging techniques is limited by the inability to precisely determ... more Automated analysis of vascular imaging techniques is limited by the inability to precisely determine arterial borders. Intravascular optical coherence tomography (OCT) offers unprecedented detail of artery wall structure and composition, but does not provide consistent visibility of the outer border of the vessel due to limited penetration depth. Existing interpolation and surface fitting methods prove insufficient to accurately fill the gaps between the irregularlyspaced and sometimes unreliably identified visible segments of the vessel outer border. This paper describes an intuitive, efficient, and flexible new method of three dimensional surface fitting and smoothing suitable for this task. An anisotropic linear-elastic mesh is fit to irregularly-spaced and uncertain data points corresponding to visible segments of vessel borders, enabling the fullyautomated delineation of the entire inner and outer borders of diseased vessels in OCT images for the first time. In a clinical dataset, the proposed smooth surface fitting approach had great agreement when compared to human annotations: areas differed by just 11±11% (0.93±0.84 mm 2), with a coefficient of determination of 0.89. Overlapping and nonoverlapping area ratios were 0.91 and 0.18, respectively, with sensitivity of 90.8 and specificity of 99.0. This spring mesh method of contour fitting significantly outperformed all alternative surface fitting and interpolation

Research paper thumbnail of Optimized computer-aided segmentation and 3D reconstruction using intracoronary optical coherence tomography

IEEE journal of biomedical and health informatics, Jan 27, 2017

We present a novel and time-efficient method for intracoronary lumen detection which produces thr... more We present a novel and time-efficient method for intracoronary lumen detection which produces three-dimensional (3D) coronary arteries using Optical Coherence Tomographic (OCT) images. OCT images are acquired for multiple patients and longitudinal cross-section (LOCS) images are reconstructed using different acquisition angles. The lumen contours for each LOCS image are extracted and translated to 2D cross-sectional images. Using two angiographic projections the centerline of the coronary vessel is reconstructed in 3D and the detected 2D contours are transformed to 3D and placed perpendicular to the centerline. To validate the proposed method, 613 manual annotations from medical experts were used as gold standard. The 2D automatically detected contours were compared to the annotated contours and the 3D reconstructed models produced using the detected contours were compared to the models produced by the annotated contours. Wall shear stress (WSS), as dominant hemodynamics factor, was...

Research paper thumbnail of Prevention of post procedural acute kidney injury in the catheterization laboratory in a real-world population

International Journal of Cardiology, 2017

Background: Radiologists and cardiologists have a remarkably different approach to the clinical i... more Background: Radiologists and cardiologists have a remarkably different approach to the clinical importance and to the need for prophylactic treatment of contrast-induced acute kidney injury (CI-AKI). Objectives: To evaluate the efficacy of forced diuresis with matched controlled hydration (FMH) in a real-world, high risk population. Methods: This is an investigator-driven, single-center, retrospective analysis of prospectively collected data. A total of 150 consecutive patients undergoing coronary angiography, angioplasty or TAVR who were treated with FMH were compared to a matched historical control cohort. Results: In the FMH treated patients, eGFR improved following the procedure from 37 ml/min per 1.73 m 2 at baseline to 39 ml/min per 1.73 m 2 (p b 0.001); the net creatinine decreased from 1.85 mg/dl to 1.78 mg/dl (p b 0.001). Among the matched control group, eGFR deteriorated from a baseline value of 36.7 ml/min per 1.73 m 2 to 33.2 ml/min per 1.73 m 2 post procedurally (p b 0.001); the net creatinine increased from 1.88 mg/dl to 2.14 mg/dl (p b 0.001). The incidence of post procedural AKI was substantially lower in the FMH treated group (2.7%) compared to the control group (26.7%). By multivariable analysis FMH treatment was independently correlated with reduced incidence of post procedural AKI compared with the control group (OR 0.06, p b 0.001). Contrast volume did not correlate with AKI in neither univariate nor multivariate analyses. Conclusions: In patients undergoing coronary angiography, angioplasty or TAVR, who are considered high risk to develop post procedural AKI, forced diuresis with matched controlled hydration resulted in a significant net creatinine decrease, eGFR increase and a decrease in the incidence of AKI.

Research paper thumbnail of Elimination of Transcoarctation Pressure Gradients Has No Impact on Left Ventricular Function or Aortic Shear Stress After Intervention in Patients With Mild Coarctation

JACC: Cardiovascular Interventions, 2016

Research paper thumbnail of Target Hemoglobin May Be Achieved with Intravenous Iron Alone in Anemic Patients with Cardiorenal Syndrome: An Observational Study

Cardiorenal Medicine, 2015

Background: The treatment of anemia in patients with cardiorenal syndrome (CRS) is based mainly o... more Background: The treatment of anemia in patients with cardiorenal syndrome (CRS) is based mainly on intravenous (IV) iron therapy and/or erythropoiesis-stimulating agents (ESAs). There are concerns about the safety of ESAs due to a potentially higher risk for stroke and malignancy. Objective: We aimed to explore whether IV iron alone is sufficient to improve anemia in CRS patients and to define the predictors of treatment response. Methods: We retrospectively analyzed data of 81 CRS patient treated for anemia at our clinic. All patients received IV iron for 6 weeks. A subset of patients was additionally given subcutaneous ESAs. The end point was the improvement from baseline in hemoglobin (Hb) and ferritin levels at week 7. Results: We retrieved the files of 81 patients; 34 received IV iron alone and 47 were given IV iron and ESAs (the combination group). The Hb levels significantly increased in both groups (in the IV iron alone group: 10.6 ± 1.1 to 11.9 ±1.1 g/dl, p < 0.001; in t...

Research paper thumbnail of Outcomes of Transfemoral Transcatheter Aortic Valve Implantation in Patients With Previous Coronary Bypass

The American Journal of Cardiology, 2015

Patients with previous coronary artery bypass grafting (CABG) are considered to be at increased p... more Patients with previous coronary artery bypass grafting (CABG) are considered to be at increased perioperative risk for a redo cardiac operation. In the era of transcatheter aortic valve implantation (TAVI), these patients constitute a considerable portion of those with severe aortic stenosis referred for TAVI. We evaluated the impact of previous CABG on transfemoral TAVI outcomes. Patients with severe symptomatic aortic stenosis (n [ 515) who underwent transfemoral TAVI were divided according to the presence of history of CABG. Patients with previous valvular surgery were excluded (n [ 12). TAVI clinical end points and adverse events were considered according to the Valve Academic Research Consortium 2 definitions. Survival was estimated using Cox regression models at the enter mode with the dependent variable defined as all-cause mortality. Of the total 503 patients who underwent TAVI, 91 (18.1%) had previous CABG. At baseline, patients with previous CABG were younger (80.8 vs 83.1 years, p <0.001), mostly men (85% vs 35%, p <0.001), had more cardiac and vascular co-morbidities, higher mean logistic EuroSCORE (32.8 vs 22; p <0.001), lower ejection fraction (53% vs 56%, p <0.001), and lower AV gradients and larger valve area. At a mean follow-up of 636 days, the overall Valve Academic Research Consortium 2eadjudicated end points did not differ. No differences in mortality were observed at 30 days, 6 months, and 1 year after TAVI (hazard ratio 1.34, p [ 0.55, Cox regression). We conclude that patients with previous CABG who underwent TAVI do not have increased risk of periprocedural complications or mortality, although having distinct clinical features compared with the total TAVI population.

Research paper thumbnail of Norton Scale for Predicting Prognosis in Elderly Patients Undergoing Primary Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction

Journal of the American College of Cardiology, 2015

Research paper thumbnail of TCT-777 The Predictive Value of Vascular Complications Following Transcatheter Aortic Valve Implantation Reevaluated by VARC-1 and 2 Definitions

Journal of the American College of Cardiology, 2014

Background: Haemodynamic instability (HI) represent the most important intra-operative manifestat... more Background: Haemodynamic instability (HI) represent the most important intra-operative manifestation of major complications occurring during TAVI. The aim of this study was to investigate the causes, risk factors and clinical significance of HI during TAVI. Methods: From November 2007 to September 2013 all patients consecutively treated in our center were included. HI was defined as a drop of mean arterial pressure ! 20 mmHg with a heart rate ! 100 or 50 beats/min for ! 1 min. Causes of HI were classified in those occuring post-preparatory balloon aortic valvuloplasty (PBAV) and post-valve implantation (VI). Each group was compared with a control group where HI did not occur. Outcomes were assessed according to VARC 2 criteria at 30 days, 1 and 2 years. Results: Overall, of 538 patients that underwent TAVI, 35 (7.4%) developed HI. Of these 18/453 (3.9%) developed HI after PBAV, while 19/538 (3.5%) developed HI after VI. Causes of HI after PBAV included severe aortic regurgitation (AR; n ¼ 12/ 18; 66.6%), new-onset tachy-or brady-arrhythmia (n ¼ 4/18; 22.2%), aortic annulus rupture (n ¼ 1/18; 5.5%) and cardiac tamponade (n ¼ 1/18; 5.5%). Causes of HI after VI included aortic dissection (n ¼ 2/19; 10.5%), cardiac tamponade (n ¼ 14/19; 73.6%), coronary obstruction (n ¼ 2/19; 10.5%) and severe AR (n ¼ 1/19; 5.2%). Patients that developed HI after PBAV had greater all-cause and cardiovascular mortality at 30 days (respectively, 11.1% vs. 3%, p ¼ 0.023; and 11.1% vs. 1.8%, p ¼ 0.009) while no differences were found in all-cause and cardiovascular mortality at 2 years of follow-up. Conversely patients that developed HI after implantation had higher rates of all-cause and cardiovascular mortality at 30 days (respectively, 26.3% vs. 2.7%, p < 0.001; and 21.1% vs. 1.9%, p < 0.001) and at 2-year follow-up (respectively, 36.8% vs. 16.9%, p ¼ 0.025; and 26.3% vs. 9.3%; p ¼ 0.015). Conclusions: HI can occur both after PBAV and VI. The most common cause of HI after PBAV were severe AR. Conversely, the most common after VI was cardiac tamponade. HI after PBAV was associated with a higher 30-day mortality but did not affected long-term survival.

Research paper thumbnail of Usefulness of Urine Output Criteria for Early Detection of Acute Kidney Injury after Transcatheter Aortic Valve Implantation

Cardiorenal Medicine, 2014

Background: Previous studies demonstrated that acute kidney injury (AKI) following transcatheter ... more Background: Previous studies demonstrated that acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI) is frequent and associated with adverse outcomes. However, these studies only applied the serum creatinine (sCr) criteria while ignoring the urine output criteria. We hypothesized that adding the urine output criteria might contribute to an earlier diagnosis of AKI. Methods: We included 143 patients with severe aortic stenosis who underwent transfemoral TAVI between December 2012 and April 2014. Urine output was assessed hourly for at least 24 h following TAVI, and sCr was assessed at least daily until discharge. Based on the Valve Academic Research Consortium-2 (VARC-2), AKI was determined using both sCr and urine output criteria. We compared the incidence of AKI and time to AKI diagnosis based on these two methods. Results: The mean age was 81 ± 6 years (range 61-94) and 56% were male. AKI occurred in 27 (19%) patients, 13 (9%) of whom had AKI defined by sCr criteria. Twenty (14%) patients had AKI defined by urine output criteria, only 6 of whom had AKI also defined by sCr criteria. The use of urine output criteria resulted in earlier identification of AKI (18 ± 4 vs. 64 ± 57 h, p = 0.02) and was associated with lower sCr elevation in patients having AKI defined by only urine output criteria (0.03 ± 0.12 vs. 0.37 ± 0.06 mg/dl, p < 0.001). Conclusion: The use of the VARC-2 urine output criteria significantly increased the incidence of AKI and shortened the time to AKI diagnosis.

Research paper thumbnail of Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial

Trials, 2014

Background: Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcathet... more 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.

Research paper thumbnail of Association between time to reperfusion and echocardiography assessed left ventricular filling pressure in patients with first ST-segment elevation myocardial infarction undergoing primary coronary intervention

Research paper thumbnail of Periprocedural Bleeding, Acute Kidney Injury, and Long-term Mortality After Transcatheter Aortic Valve Implantation

Canadian Journal of Cardiology, 2015

Background: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is fre... more Background: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is frequent and is associated with adverse outcomes. Past studies have attributed AKI to impaired kidney function at baseline, amount of contrast medium used, major bleeding, and hemodynamic instability during the procedure. Because major bleeding might play a role in the development of AKI, we analyzed the relationship between periprocedural bleeding and the development of AKI and assessed the impact of these 2 important procedure-related complications on outcome. Methods: Consecutive patients undergoing transfemoral TAVI for severe aortic stenosis were prospectively recruited. AKI and bleeding events during hospitalization were recorded, defined, and classified according to the Valve Academic Research Consortium 2 definitions. Logistic and Cox regression was used for predictor and survival analyses. R ESUM E

Research paper thumbnail of The Obesity Paradox in Patients Undergoing Transcatheter Aortic Valve Implantation

Clinical Cardiology, 2015

Background: Obesity is a major risk factor for cardiovascular morbidity and mortality. A consider... more Background: Obesity is a major risk factor for cardiovascular morbidity and mortality. A considerable number of studies, however, showed better outcomes for overweight patients undergoing cardiovascular interventions-the so called obesity paradox. Hypothesis: Increased body mass index (BMI) is independently associated with improved survival following transcatheter aortic valve implantation (TAVI). Methods: We analyzed the data of 409 consecutive patients undergoing TAVI in our medical center. Patients were categorized into 4 groups according to BMI: underweight (≤18.4 kg/m 2), normal weight (18.5-24.9 kg/m 2), overweight (25-29.9 kg/m 2), and obese (≥30 kg/m 2). Procedure-related complications were recorded, as well as 30-day and 1-year all-cause mortality rates. Results: Obese patients had a higher prevalence of comorbidities and higher incidence of vascular complications compared with the normal-weight patients (16% vs 7%, P = 0.013). Nevertheless, 30-day mortality was similar among the groups, whereas 1-year mortality was lower among the overweight and obese patients (BMI >25) (P = 0.038). After adjusting for differences in baseline characteristics, increase in BMI was found to be independently associated with improved survival following TAVI (hazard ratio: 0.94, confidence interval: 0.89-0.99, P = 0.043). Conclusions: In our single-center study, obesity and overweight were independently associated with better outcome, supporting the obesity paradox in the TAVI population. The authors have no funding, financial relationships, or conflicts of interest to disclose. Considering the well-documented association between obesity and cardiovascular morbidity and mortality, 16-18 and the expanding nature of obesity as an endemic healthcare problem, it is reasonable to expect an increasing number of obese patients with severe aortic stenosis being referred for transcatheter aortic valve implantation (TAVI). In the present study we analyzed the effect of body mass index (BMI) on outcomes of elderly high-risk patients with severe aortic valve stenosis undergoing transfemoral TAVI, and examined the validity of the obesity paradox in this population. Methods Study Population The data for the present study were prospectively collected in the period between March 2009

Research paper thumbnail of Vascular Complications After Transcatheter Aortic Valve Replacement

Journal of the American College of Cardiology, 2012

This study sought to identify incidence, predictors, and impact of vascular complications (VC) af... more This study sought to identify incidence, predictors, and impact of vascular complications (VC) after transfemoral (TF) transcatheter aortic valve replacement (TAVR). Background VC after TF-TAVR are frequent and may be associated with unfavorable prognosis. Methods From the randomized controlled PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a total of 419 patients (177 from cohort B [inoperable] and 242 from cohort A [operable high-risk]) were randomly assigned to TF-TAVR and actually received the designated treatment. First-generation Edwards-Sapien valves and delivery systems were used, via a 22-or 24-F sheath. The 30-day rates of major and minor VC (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortality were assessed. Results Sixty-four patients (15.3%) had major VC and 50 patients (11.9%) had minor VC within 30 days of the procedure. Among patients with major VC, vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%) were the most frequent modes of presentation. Major VC, but not minor VC, were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, and with a significantly higher rate of 30-day and 1-year mortality. The only identifiable independent predictor of major VC was female gender (hazard ratio [HR]: 2.31 [95% confidence interval (CI): 1.08 to 4.98], p ϭ 0.03). Major VC (HR: 2.31 [95% CI: 1.20 to 4.43], p ϭ 0.012), and renal disease at baseline (HR: 2.26 [95% CI: 1.34 to 3.81], p ϭ 0.002) were identified as independent predictors of 1-year mortality. Conclusions Major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1-year mortality decreased with lower-risk populations.

Research paper thumbnail of Effect of Residual Interatrial Shunt on Migraine Burden After Transcatheter Closure of Patent Foramen Ovale

JACC: Cardiovascular Interventions, 2020

OpenBU http://open.bu.edu Biomedical Engineering BU Open Access Articles 2020-02-10 Effect of res... more OpenBU http://open.bu.edu Biomedical Engineering BU Open Access Articles 2020-02-10 Effect of residual interatrial shunt on migraine burden after transcatheter closure...

Research paper thumbnail of Telemedicine for lowering 30-day readmission rates following acute myocardial infarction: an observational study

European Heart Journal, 2013

Heart failure treatment / Cardiac rehabilitation: various 625 136.3mmHg ±30.8 vs. 130.6mmHg ±23.2... more Heart failure treatment / Cardiac rehabilitation: various 625 136.3mmHg ±30.8 vs. 130.6mmHg ±23.2 (p<0.05), higher left ventricul ejection fraction 47.4% ±13.2 vs. 39.0% ±13.6 (p<0.05), longer QTc 401.9ms ±38.7 vs. 389.7ms ±45.8 (p<0.05), higher NYHA functional class 2.9 vs. 2.7 (p<0.05), higher incidence of hypertension (p<0.05), thyroid dysfunction (p<0.05) and depression (p<0.05), frequenter proteinuria (p<0.05), higher level of BNP 1826.9 pg/ml, vs. 1183.2 pg/ml (p<0.05), lower level of bilirubin 4.7 md/dl vs. 7.2 mg/dl (p<0.05). Women were longer hospitalized in ICCU 4.1days vs. 2.8 days (p<0.05). Women compared to men were more often treated by ARB and CCB, but less frequently by ACEI, BB and Eplerenone. There were no significant differences in the rate of deaths in the in the one-year follow-up between men and women: 99 (11%) subjects died. Conclusions: 1.The results of ESC-HF Pilot Survey from Polish Centers showed significant gender-related differences in clinical presentation and pharmacological treatment of heart failure. 2. In spite of differences in clinical characteristics and pharmacotherapy, clinical outcomes were similar in men and women with heart failure in the one-year followup.

Research paper thumbnail of Target hemoglobin can be achieved with intravenous iron alone in cardio-renal patients

European Heart Journal, 2013

SMILE-4) showed the superiority of Zofenopril (Z) associated with Acetylsalicylic Acid (ASA) as r... more SMILE-4) showed the superiority of Zofenopril (Z) associated with Acetylsalicylic Acid (ASA) as respect to Ramipril (R) plus ASA in reducing the occurrence of major cardiovascular events, in patients with left ventricular dysfunction (LVD) following Acute Myocardial Infarction (AMI). The objective of this retrospective analysis was the evaluation of cost-effectiveness of Z compared to R. Methods: 771 patients with LVD and AMI were randomized, double-blind to Z 60 mg/day (n=389) or R 10 mg/day (n=382) plus ASA 100 mg/day and followed-up for 1 year. The primary study end-point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. The economic analysis was based on the evaluation of cost of medications and hospitalizations and was applied to the intention-to-treat population (n=716). Cost data were drawn from the database of the Italian National Health Service. The Incremental Cost-Effectiveness Ratio (ICER) was used to quantify the cost per event prevented with Z vs. R. Results: Z significantly (p=0.028) reduced the risk of the primary study end-point by 30% as compared to ramipril (95% confidence interval: 49%, 4%). The number needed to treat to prevent a major cardiovascular event with Z was 13 less than with R. The cost of drug therapies was higher with Z (313.90 Euros per patient per year, n=365) than with R (160.60 Euros per patient per year, n=351). The cost related to the occurrence of major cardiovascular events requiring hospitalization, averaged 3195.47 Euros for Z and 3071.37 Euros for R. The ICER of Z vs. R was 1990.88 Euros per event prevented. Conclusions: Z is a viable and cost-effective treatment for managing patients with LVD after AMI. P3294 | BEDSIDE High-sensitivity assay of plasma cardiac troponin T predicts the effects of pitavastatin in patients with chronic heart failure: a subgroup analysis from the pitavastatin heart failure study (PEARL)

Research paper thumbnail of When Virchow Meets Da Vinci

Circulation: Cardiovascular Imaging, 2016

Research paper thumbnail of Ventricular stroke work and vascular impedance refine the characterization of patients with aortic stenosis

Science Translational Medicine, 2019

Aortic stenosis (AS) management is classically guided by symptoms and valvular metrics. However, ... more Aortic stenosis (AS) management is classically guided by symptoms and valvular metrics. However, the natural history of AS is dictated by coupling of the left ventricle, aortic valve, and vascular system. We investigated whether metrics of ventricular and vascular state add to the appreciation of AS state above valve gradient alone. Seventy patients with severe symptomatic AS were prospectively followed from baseline to 30 days after transcatheter aortic valve replacement (TAVR). Quality of life (QOL) was assessed using the Kansas City Cardiomyopathy Questionnaire. Left ventricular stroke work (SWLV) and vascular impedance spectrums were calculated noninvasively using in-house models based on central blood pressure waveforms, along with hemodynamic parameters from echocardiograms. Patients with higher preprocedural SWLV and lower vascular impedance were more likely to experience improved QOL after TAVR. Patients fell into two categories: those who did and those who did not exhibit i...

Research paper thumbnail of Aortic regurgitation assessment by cardiovascular magnetic resonance imaging and transthoracic echocardiography: intermodality disagreement impacting on prediction of post-surgical left ventricular remodeling

The International Journal of Cardiovascular Imaging, 2019

Transthoracic echocardiography (TTE) is the primary clinical imaging modality for the assessment ... more Transthoracic echocardiography (TTE) is the primary clinical imaging modality for the assessment of patients with isolated aortic regurgitation (AR) in whom TTE's linear left ventricular (LV) dimension is used to assess disease severity to guide aortic valve replacement (AVR), yet TTE is relatively limited with regards to its integrated semi-quantitative/qualitative approach. We therefore compared TTE and cardiovascular magnetic resonance (CMR) assessment of isolated AR and investigated each modality's ability to predict LV remodeling after AVR. AR severity grading by CMR and TTE were compared in 101 consecutive patients referred for CMR assessment of chronic AR. LV end-diastolic diameter and end-systolic diameter measurements by both modalities were compared. Twenty-four patients subsequently had isolated AVR. The pre-AVR estimates of regurgitation severity by CMR and TTE were correlated with favorable post-AVR LV remodeling. AR severity grade agreement between CMR and TTE was moderate (ρ = 0.317, P = 0.001). TTE underestimated CMR LV end-diastolic

Research paper thumbnail of A Mechanical Approach for Smooth Surface Fitting to Delineate Vessel Walls in Optical Coherence Tomography Images

IEEE Transactions on Medical Imaging, 2018

Automated analysis of vascular imaging techniques is limited by the inability to precisely determ... more Automated analysis of vascular imaging techniques is limited by the inability to precisely determine arterial borders. Intravascular optical coherence tomography (OCT) offers unprecedented detail of artery wall structure and composition, but does not provide consistent visibility of the outer border of the vessel due to limited penetration depth. Existing interpolation and surface fitting methods prove insufficient to accurately fill the gaps between the irregularlyspaced and sometimes unreliably identified visible segments of the vessel outer border. This paper describes an intuitive, efficient, and flexible new method of three dimensional surface fitting and smoothing suitable for this task. An anisotropic linear-elastic mesh is fit to irregularly-spaced and uncertain data points corresponding to visible segments of vessel borders, enabling the fullyautomated delineation of the entire inner and outer borders of diseased vessels in OCT images for the first time. In a clinical dataset, the proposed smooth surface fitting approach had great agreement when compared to human annotations: areas differed by just 11±11% (0.93±0.84 mm 2), with a coefficient of determination of 0.89. Overlapping and nonoverlapping area ratios were 0.91 and 0.18, respectively, with sensitivity of 90.8 and specificity of 99.0. This spring mesh method of contour fitting significantly outperformed all alternative surface fitting and interpolation

Research paper thumbnail of Optimized computer-aided segmentation and 3D reconstruction using intracoronary optical coherence tomography

IEEE journal of biomedical and health informatics, Jan 27, 2017

We present a novel and time-efficient method for intracoronary lumen detection which produces thr... more We present a novel and time-efficient method for intracoronary lumen detection which produces three-dimensional (3D) coronary arteries using Optical Coherence Tomographic (OCT) images. OCT images are acquired for multiple patients and longitudinal cross-section (LOCS) images are reconstructed using different acquisition angles. The lumen contours for each LOCS image are extracted and translated to 2D cross-sectional images. Using two angiographic projections the centerline of the coronary vessel is reconstructed in 3D and the detected 2D contours are transformed to 3D and placed perpendicular to the centerline. To validate the proposed method, 613 manual annotations from medical experts were used as gold standard. The 2D automatically detected contours were compared to the annotated contours and the 3D reconstructed models produced using the detected contours were compared to the models produced by the annotated contours. Wall shear stress (WSS), as dominant hemodynamics factor, was...

Research paper thumbnail of Prevention of post procedural acute kidney injury in the catheterization laboratory in a real-world population

International Journal of Cardiology, 2017

Background: Radiologists and cardiologists have a remarkably different approach to the clinical i... more Background: Radiologists and cardiologists have a remarkably different approach to the clinical importance and to the need for prophylactic treatment of contrast-induced acute kidney injury (CI-AKI). Objectives: To evaluate the efficacy of forced diuresis with matched controlled hydration (FMH) in a real-world, high risk population. Methods: This is an investigator-driven, single-center, retrospective analysis of prospectively collected data. A total of 150 consecutive patients undergoing coronary angiography, angioplasty or TAVR who were treated with FMH were compared to a matched historical control cohort. Results: In the FMH treated patients, eGFR improved following the procedure from 37 ml/min per 1.73 m 2 at baseline to 39 ml/min per 1.73 m 2 (p b 0.001); the net creatinine decreased from 1.85 mg/dl to 1.78 mg/dl (p b 0.001). Among the matched control group, eGFR deteriorated from a baseline value of 36.7 ml/min per 1.73 m 2 to 33.2 ml/min per 1.73 m 2 post procedurally (p b 0.001); the net creatinine increased from 1.88 mg/dl to 2.14 mg/dl (p b 0.001). The incidence of post procedural AKI was substantially lower in the FMH treated group (2.7%) compared to the control group (26.7%). By multivariable analysis FMH treatment was independently correlated with reduced incidence of post procedural AKI compared with the control group (OR 0.06, p b 0.001). Contrast volume did not correlate with AKI in neither univariate nor multivariate analyses. Conclusions: In patients undergoing coronary angiography, angioplasty or TAVR, who are considered high risk to develop post procedural AKI, forced diuresis with matched controlled hydration resulted in a significant net creatinine decrease, eGFR increase and a decrease in the incidence of AKI.

Research paper thumbnail of Elimination of Transcoarctation Pressure Gradients Has No Impact on Left Ventricular Function or Aortic Shear Stress After Intervention in Patients With Mild Coarctation

JACC: Cardiovascular Interventions, 2016

Research paper thumbnail of Target Hemoglobin May Be Achieved with Intravenous Iron Alone in Anemic Patients with Cardiorenal Syndrome: An Observational Study

Cardiorenal Medicine, 2015

Background: The treatment of anemia in patients with cardiorenal syndrome (CRS) is based mainly o... more Background: The treatment of anemia in patients with cardiorenal syndrome (CRS) is based mainly on intravenous (IV) iron therapy and/or erythropoiesis-stimulating agents (ESAs). There are concerns about the safety of ESAs due to a potentially higher risk for stroke and malignancy. Objective: We aimed to explore whether IV iron alone is sufficient to improve anemia in CRS patients and to define the predictors of treatment response. Methods: We retrospectively analyzed data of 81 CRS patient treated for anemia at our clinic. All patients received IV iron for 6 weeks. A subset of patients was additionally given subcutaneous ESAs. The end point was the improvement from baseline in hemoglobin (Hb) and ferritin levels at week 7. Results: We retrieved the files of 81 patients; 34 received IV iron alone and 47 were given IV iron and ESAs (the combination group). The Hb levels significantly increased in both groups (in the IV iron alone group: 10.6 ± 1.1 to 11.9 ±1.1 g/dl, p < 0.001; in t...

Research paper thumbnail of Outcomes of Transfemoral Transcatheter Aortic Valve Implantation in Patients With Previous Coronary Bypass

The American Journal of Cardiology, 2015

Patients with previous coronary artery bypass grafting (CABG) are considered to be at increased p... more Patients with previous coronary artery bypass grafting (CABG) are considered to be at increased perioperative risk for a redo cardiac operation. In the era of transcatheter aortic valve implantation (TAVI), these patients constitute a considerable portion of those with severe aortic stenosis referred for TAVI. We evaluated the impact of previous CABG on transfemoral TAVI outcomes. Patients with severe symptomatic aortic stenosis (n [ 515) who underwent transfemoral TAVI were divided according to the presence of history of CABG. Patients with previous valvular surgery were excluded (n [ 12). TAVI clinical end points and adverse events were considered according to the Valve Academic Research Consortium 2 definitions. Survival was estimated using Cox regression models at the enter mode with the dependent variable defined as all-cause mortality. Of the total 503 patients who underwent TAVI, 91 (18.1%) had previous CABG. At baseline, patients with previous CABG were younger (80.8 vs 83.1 years, p <0.001), mostly men (85% vs 35%, p <0.001), had more cardiac and vascular co-morbidities, higher mean logistic EuroSCORE (32.8 vs 22; p <0.001), lower ejection fraction (53% vs 56%, p <0.001), and lower AV gradients and larger valve area. At a mean follow-up of 636 days, the overall Valve Academic Research Consortium 2eadjudicated end points did not differ. No differences in mortality were observed at 30 days, 6 months, and 1 year after TAVI (hazard ratio 1.34, p [ 0.55, Cox regression). We conclude that patients with previous CABG who underwent TAVI do not have increased risk of periprocedural complications or mortality, although having distinct clinical features compared with the total TAVI population.

Research paper thumbnail of Norton Scale for Predicting Prognosis in Elderly Patients Undergoing Primary Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction

Journal of the American College of Cardiology, 2015

Research paper thumbnail of TCT-777 The Predictive Value of Vascular Complications Following Transcatheter Aortic Valve Implantation Reevaluated by VARC-1 and 2 Definitions

Journal of the American College of Cardiology, 2014

Background: Haemodynamic instability (HI) represent the most important intra-operative manifestat... more Background: Haemodynamic instability (HI) represent the most important intra-operative manifestation of major complications occurring during TAVI. The aim of this study was to investigate the causes, risk factors and clinical significance of HI during TAVI. Methods: From November 2007 to September 2013 all patients consecutively treated in our center were included. HI was defined as a drop of mean arterial pressure ! 20 mmHg with a heart rate ! 100 or 50 beats/min for ! 1 min. Causes of HI were classified in those occuring post-preparatory balloon aortic valvuloplasty (PBAV) and post-valve implantation (VI). Each group was compared with a control group where HI did not occur. Outcomes were assessed according to VARC 2 criteria at 30 days, 1 and 2 years. Results: Overall, of 538 patients that underwent TAVI, 35 (7.4%) developed HI. Of these 18/453 (3.9%) developed HI after PBAV, while 19/538 (3.5%) developed HI after VI. Causes of HI after PBAV included severe aortic regurgitation (AR; n ¼ 12/ 18; 66.6%), new-onset tachy-or brady-arrhythmia (n ¼ 4/18; 22.2%), aortic annulus rupture (n ¼ 1/18; 5.5%) and cardiac tamponade (n ¼ 1/18; 5.5%). Causes of HI after VI included aortic dissection (n ¼ 2/19; 10.5%), cardiac tamponade (n ¼ 14/19; 73.6%), coronary obstruction (n ¼ 2/19; 10.5%) and severe AR (n ¼ 1/19; 5.2%). Patients that developed HI after PBAV had greater all-cause and cardiovascular mortality at 30 days (respectively, 11.1% vs. 3%, p ¼ 0.023; and 11.1% vs. 1.8%, p ¼ 0.009) while no differences were found in all-cause and cardiovascular mortality at 2 years of follow-up. Conversely patients that developed HI after implantation had higher rates of all-cause and cardiovascular mortality at 30 days (respectively, 26.3% vs. 2.7%, p < 0.001; and 21.1% vs. 1.9%, p < 0.001) and at 2-year follow-up (respectively, 36.8% vs. 16.9%, p ¼ 0.025; and 26.3% vs. 9.3%; p ¼ 0.015). Conclusions: HI can occur both after PBAV and VI. The most common cause of HI after PBAV were severe AR. Conversely, the most common after VI was cardiac tamponade. HI after PBAV was associated with a higher 30-day mortality but did not affected long-term survival.

Research paper thumbnail of Usefulness of Urine Output Criteria for Early Detection of Acute Kidney Injury after Transcatheter Aortic Valve Implantation

Cardiorenal Medicine, 2014

Background: Previous studies demonstrated that acute kidney injury (AKI) following transcatheter ... more Background: Previous studies demonstrated that acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI) is frequent and associated with adverse outcomes. However, these studies only applied the serum creatinine (sCr) criteria while ignoring the urine output criteria. We hypothesized that adding the urine output criteria might contribute to an earlier diagnosis of AKI. Methods: We included 143 patients with severe aortic stenosis who underwent transfemoral TAVI between December 2012 and April 2014. Urine output was assessed hourly for at least 24 h following TAVI, and sCr was assessed at least daily until discharge. Based on the Valve Academic Research Consortium-2 (VARC-2), AKI was determined using both sCr and urine output criteria. We compared the incidence of AKI and time to AKI diagnosis based on these two methods. Results: The mean age was 81 ± 6 years (range 61-94) and 56% were male. AKI occurred in 27 (19%) patients, 13 (9%) of whom had AKI defined by sCr criteria. Twenty (14%) patients had AKI defined by urine output criteria, only 6 of whom had AKI also defined by sCr criteria. The use of urine output criteria resulted in earlier identification of AKI (18 ± 4 vs. 64 ± 57 h, p = 0.02) and was associated with lower sCr elevation in patients having AKI defined by only urine output criteria (0.03 ± 0.12 vs. 0.37 ± 0.06 mg/dl, p < 0.001). Conclusion: The use of the VARC-2 urine output criteria significantly increased the incidence of AKI and shortened the time to AKI diagnosis.

Research paper thumbnail of Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial

Trials, 2014

Background: Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcathet... more 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.

Research paper thumbnail of Association between time to reperfusion and echocardiography assessed left ventricular filling pressure in patients with first ST-segment elevation myocardial infarction undergoing primary coronary intervention

Research paper thumbnail of Periprocedural Bleeding, Acute Kidney Injury, and Long-term Mortality After Transcatheter Aortic Valve Implantation

Canadian Journal of Cardiology, 2015

Background: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is fre... more Background: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is frequent and is associated with adverse outcomes. Past studies have attributed AKI to impaired kidney function at baseline, amount of contrast medium used, major bleeding, and hemodynamic instability during the procedure. Because major bleeding might play a role in the development of AKI, we analyzed the relationship between periprocedural bleeding and the development of AKI and assessed the impact of these 2 important procedure-related complications on outcome. Methods: Consecutive patients undergoing transfemoral TAVI for severe aortic stenosis were prospectively recruited. AKI and bleeding events during hospitalization were recorded, defined, and classified according to the Valve Academic Research Consortium 2 definitions. Logistic and Cox regression was used for predictor and survival analyses. R ESUM E

Research paper thumbnail of The Obesity Paradox in Patients Undergoing Transcatheter Aortic Valve Implantation

Clinical Cardiology, 2015

Background: Obesity is a major risk factor for cardiovascular morbidity and mortality. A consider... more Background: Obesity is a major risk factor for cardiovascular morbidity and mortality. A considerable number of studies, however, showed better outcomes for overweight patients undergoing cardiovascular interventions-the so called obesity paradox. Hypothesis: Increased body mass index (BMI) is independently associated with improved survival following transcatheter aortic valve implantation (TAVI). Methods: We analyzed the data of 409 consecutive patients undergoing TAVI in our medical center. Patients were categorized into 4 groups according to BMI: underweight (≤18.4 kg/m 2), normal weight (18.5-24.9 kg/m 2), overweight (25-29.9 kg/m 2), and obese (≥30 kg/m 2). Procedure-related complications were recorded, as well as 30-day and 1-year all-cause mortality rates. Results: Obese patients had a higher prevalence of comorbidities and higher incidence of vascular complications compared with the normal-weight patients (16% vs 7%, P = 0.013). Nevertheless, 30-day mortality was similar among the groups, whereas 1-year mortality was lower among the overweight and obese patients (BMI >25) (P = 0.038). After adjusting for differences in baseline characteristics, increase in BMI was found to be independently associated with improved survival following TAVI (hazard ratio: 0.94, confidence interval: 0.89-0.99, P = 0.043). Conclusions: In our single-center study, obesity and overweight were independently associated with better outcome, supporting the obesity paradox in the TAVI population. The authors have no funding, financial relationships, or conflicts of interest to disclose. Considering the well-documented association between obesity and cardiovascular morbidity and mortality, 16-18 and the expanding nature of obesity as an endemic healthcare problem, it is reasonable to expect an increasing number of obese patients with severe aortic stenosis being referred for transcatheter aortic valve implantation (TAVI). In the present study we analyzed the effect of body mass index (BMI) on outcomes of elderly high-risk patients with severe aortic valve stenosis undergoing transfemoral TAVI, and examined the validity of the obesity paradox in this population. Methods Study Population The data for the present study were prospectively collected in the period between March 2009

Research paper thumbnail of Vascular Complications After Transcatheter Aortic Valve Replacement

Journal of the American College of Cardiology, 2012

This study sought to identify incidence, predictors, and impact of vascular complications (VC) af... more This study sought to identify incidence, predictors, and impact of vascular complications (VC) after transfemoral (TF) transcatheter aortic valve replacement (TAVR). Background VC after TF-TAVR are frequent and may be associated with unfavorable prognosis. Methods From the randomized controlled PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a total of 419 patients (177 from cohort B [inoperable] and 242 from cohort A [operable high-risk]) were randomly assigned to TF-TAVR and actually received the designated treatment. First-generation Edwards-Sapien valves and delivery systems were used, via a 22-or 24-F sheath. The 30-day rates of major and minor VC (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortality were assessed. Results Sixty-four patients (15.3%) had major VC and 50 patients (11.9%) had minor VC within 30 days of the procedure. Among patients with major VC, vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%) were the most frequent modes of presentation. Major VC, but not minor VC, were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, and with a significantly higher rate of 30-day and 1-year mortality. The only identifiable independent predictor of major VC was female gender (hazard ratio [HR]: 2.31 [95% confidence interval (CI): 1.08 to 4.98], p ϭ 0.03). Major VC (HR: 2.31 [95% CI: 1.20 to 4.43], p ϭ 0.012), and renal disease at baseline (HR: 2.26 [95% CI: 1.34 to 3.81], p ϭ 0.002) were identified as independent predictors of 1-year mortality. Conclusions Major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1-year mortality decreased with lower-risk populations.