Publications by authors named "Ariel Finkelstein"

174 Publications

Comparison of permanent pacemaker implantation rate after first and second generation of transcatheter aortic valve implantation-A retrospective cohort study.

Catheter Cardiovasc Interv 2021 Aug 4. Epub 2021 Aug 4.

Sackler School of Medicine, Tel-Aviv University, Ramat-Aviv, Israel.

Objectives: This study aimed to compare permanent pacemaker implantation (PPMI) rates among patients undergoing Trans-catheter Aortic Valve Implantation (TAVI) with first generation (G1) versus second generation (G2) valves and the impact of PPMI on long-term mortality.

Background: PPMI is a known adverse event after TAVI. Recently, two novel iterations of valve designs of both the balloon expandable valves (BEV) and self-expanding valves (SEV) were introduced as a second generation valves.

Methods: All patients included in the Israeli multicenter TAVI registry were grouped according to valve type (BEV vs. SEV) and generation (G1 vs. G2). A comparison was made for clinical and outcome indices of patients undergoing TAVI with G1 and G2 in each of the valve systems.

Results: A total of 1377 patients were included. The incidence of PPMI did not differ between G1-BEV versus G2-BEV (15.3% vs. 17.4%; p = 0.598) nor between G1-SEV versus G2-SEV (23.4% vs. 20.3%; p = 0.302). Depth of implantation and complete right bundle branch block were independently associated with PPMI post-TAVI in both valve systems. PPMI was not associated with an increased risk for 2-year mortality.

Conclusions: The incidence of PPMI remains a relevant adverse event post-TAVI even when the newer generation valves are used. Since the predictors for PPMI are well established, a standardized approach for the management of conduction disorders is much needed.
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http://dx.doi.org/10.1002/ccd.29891DOI Listing
August 2021

Increased Rate of New-onset Left Bundle Branch Block in Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation (From a National Registry).

Am J Cardiol 2021 10 31;156:101-107. Epub 2021 Jul 31.

Department of Cardiology, Rabin Medical Center, Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.

There is a growing interest in transcutaneous aortic valve implantation (TAVI) therapy among patients with bicuspid severe aortic stenosis (BAV). Conduction disturbances remain a frequent complication of TAVI, and new-onset permanent LBBB (NOP-LBBB) post-TAVI may be a marker of worse outcomes. We aimed to evaluate the rate of NOP-LBBB following TAVI among patients with BAV as compared to tricuspid severe aortic stenosis (TAV). Patients enrolled in the multicenter (5 centers) Bicuspid AS TAVI Registry were reviewed and compared with patients with TAV. Patients with previous aortic valve replacement, other valve morphologies and those with preprocedural LBBB or pacemaker were excluded. NOP-LBBB was defined as LBBB first detected and persisting 30-days following TAVI. A total of 387 patients (66 with BAV, 321 with TAV), age 80.3 ± 7.3, 47% females were analyzed. The device success rates were 95% in both groups without any conversions to surgery. The rate of NOP-LBBB was significantly higher among patients with BAV versus TAV (29.2% vs 16.9%, p = 0.02). However, the rate of post procedural pacemaker implantation was similar (14.8% vs 12.5%; respectively, p = 0.62). In BAV and TAV groups, 1-year mortality (6.1% vs 7.2%; respectively, p = 0.75) and stroke rates (6.1% vs 3.5%; respectively, p = 0.30) were not significantly different. Multivariate analysis identified BAV as an independent predictor of NOP-LBBB (AdjOR = 2.7, 95%CI 1.3 to 5.4). Furthermore, BAV subtypes with raphe (type 1) were identified as independent predictors of NOP-LBBB (AdjOR = 3.2, 95%CI: 1.5 to 6.7). In conclusion, patients with BAV undergoing TAVI have greater risk for developing NOP-LBBB compared with patients with TAV and the presence of raphe was associated with increased risk of NOP-LBBB. The prognostic significance for this finding warrants further evaluation in future studies.
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http://dx.doi.org/10.1016/j.amjcard.2021.06.046DOI Listing
October 2021

Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting: Results from the multicenter FORWARD study.

Catheter Cardiovasc Interv 2021 Jul 31. Epub 2021 Jul 31.

Department of Medicine, University of Bonn, Bonn, Germany.

Objectives: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study.

Background: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce.

Methods: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients.

Results: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low.

Conclusions: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.
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http://dx.doi.org/10.1002/ccd.29889DOI Listing
July 2021

Assessment of Kidney Function After Transcatheter Aortic Valve Replacement.

Can J Kidney Health Dis 2021 4;8:20543581211018029. Epub 2021 Jun 4.

Department of Cardiology, Tel Aviv Medical Center, Sackler School of Medicine, Tel Aviv University, Israel.

Background: Transcatheter aortic valve replacement (TAVR), although associated with an increased risk for acute kidney injury (AKI), may also result in improvement in renal function.

Objective: The aim of this study is to evaluate the magnitude of kidney function improvement (KFI) after TAVR and to assess its significance on long-term mortality.

Design: This is a prospective single center study.

Setting: The study was conducted in cardiology department, interventional unit, in a tertiary hospital.

Patients: The cohort included 1321 patients who underwent TAVR.

Measurements: Serum creatinine level was measured at baseline, before the procedure, and over the next 7 days or until discharge.

Methods: Kidney function improvement was defined as the mirror image of AKI, a reduction in pre-procedural to post-procedural minimal creatinine of more than 0.3 mg/dL, or a ratio of post-procedural minimal creatinine to pre-procedural creatinine of less than 0.66, up to 7 days after the procedure. Patients were categorized and compared for clinical endpoints according to post-procedural renal function change into 3 groups: KFI, AKI, or preserved kidney function (PKF). The primary endpoint was long-term all-cause mortality.

Results: The incidence of KFI was 5%. In 55 out of 66 patients patients, the improvement in kidney function was minor and of unclear clinical significance. Acute kidney injury occurred in 19.1%. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m was a predictor of KFI after multivariable analysis (odds ratio = 0.93 to develop KFI; confidence interval [95% CI]: 0.91-0.95, < .001). Patients in the KFI group had a higher Society of Thoracic Surgery (STS) score than other groups. Mortality rate did not differ between KFI group and PKF group (43.9% in KFI group and 33.8% in PKF group) but was significantly higher in the AKI group (60.7%, < .001).

Limitations: The following are the limitations: heterozygous definitions of KFI within different studies and a single center study. Although data were collected prospectively, analysis plan was defined after data collection.

Conclusions: Improvement in kidney function following TAVR was not a common phenomenon in our cohort and did not reduce overall mortality rate.
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http://dx.doi.org/10.1177/20543581211018029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8182180PMC
June 2021

Incidence, Causes, and Outcomes Associated With Urgent Implantation of a Supplementary Valve During Transcatheter Aortic Valve Replacement.

JAMA Cardiol 2021 Aug;6(8):936-944

Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.

Importance: Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR.

Objective: To examine the incidence, causes, and outcomes of 2V-TAVR.

Design, Setting, And Participants: A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients.

Exposures: Urgent implantation of a supplementary valve during TAVR.

Main Outcomes And Measures: Mortality at 30 days and 1 year.

Results: The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P = .02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P < .001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; P = .02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; P < .001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; P < .001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; P = .004) were associated with higher 2V-TAVR risk. In 165 patients (80%), the supplementary valve was implanted because of residual aortic regurgitation after primary valve malposition (94 [46.4%] too high and 71 [34.2%] too low). In the matched 2V-TAVR vs 1V-TAVR cohorts, the rate of device success was 147 (70.4%) vs 783 (92.2%) (P < .001), the rate of coronary obstruction was 5 (2.3%) vs 3 (0.4%) (P = .10), stroke rate was 9 (4.6%) vs 13 (1.6%) (P = .09), major bleeding rates were 25 (11.8%) vs 46 (5.5%) (P = .03) and annular rupture rate was 7 (3.3%) vs 3 (0.4%) (P = .03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45; P = .04) at 30 days, 1.45 (95% CI, 0.84-2.51; P = .18) at 1 year, and 1.20 (95% CI, 0.77-1.88; P = .42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR.

Conclusions And Relevance: In this cohort study, valve malposition was the most common indication for 2V-TAVR. Incidence decreased over time and was low overall, although patients with a bicuspid or regurgitant aortic valve, nontransfemoral access, and early-generation or self-expandable valve were at higher risk. These findings suggest that compared with 1V-TAVR, 2V-TAVR is associated with high burden of complications and mortality at 30 days but not at 1 year.
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http://dx.doi.org/10.1001/jamacardio.2021.1145DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8135057PMC
August 2021

Effect of Transcatheter Aortic Valve Replacement on Concomitant Mitral Regurgitation and Its Impact on Mortality.

JACC Cardiovasc Interv 2021 Jun 12;14(11):1181-1192. Epub 2021 May 12.

Servicio de Cardiología, Hospital Álvaro Cunqueiro, Vigo, Spain.

Objectives: The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR).

Background: MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited.

Methods: The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared.

Results: In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score-matched cohort (91 patients' pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097).

Conclusions: Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274).
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http://dx.doi.org/10.1016/j.jcin.2021.02.030DOI Listing
June 2021

Prognostic implication of right ventricular dysfunction and tricuspid regurgitation following transcatheter aortic valve replacement.

Catheter Cardiovasc Interv 2021 Mar 7. Epub 2021 Mar 7.

Department of Cardiology, Tel Aviv Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.

Objectives: Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) are associated with adverse outcomes in severe aortic stenosis (AS) patients. Our aim was to evaluate the association between ≥moderate TR and RV dysfunction on long-term mortality following transcatheter aortic valve replacement (TAVR).

Methods: A retrospective analysis of the Israeli multicenter TAVR registry among 4,344 consecutive patients, with all-cause mortality as the main outcome measure.

Results: Echocardiographic assessment of TR grade and RV dysfunction was available for 3,733 and 1,850 patients, of whom ≥moderate TR and RV dysfunction was noted for 478(13%) and 78(4%), respectively. The mean follow-up time was 2.9 ± 2.3 years. In univariate models, ≥Moderate TR and ≥moderate RV dysfunction were associated with increased long-term mortality (HR 1.45, 95% CI 1.24-1.69, p < .001 and HR 1.73, 95% CI 1.21-2.47, p = 0.003, respectively). These finding did not remained significant after adjusting to echocardiographic parameters. A subset of patients with no improvement in RV function had the highest long-term mortality risk (HR 3.3, 95% CI 1.95-5.7, p < .001).

Conclusion: When adjusted to multiple echocardiographic characteristics baseline ≥Moderate TR and ≥moderate RV dysfunction were not associated with long-term mortality following TAVR. Persistent RV dysfunction following TAVR was associated with the highest risk for mortality.
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http://dx.doi.org/10.1002/ccd.29639DOI Listing
March 2021

The effect of clinically recommended Evolut sizes on anchorage forces after BASILICA.

J Biomech 2021 03 8;118:110303. Epub 2021 Feb 8.

School of Mechanical Engineering, Tel Aviv University, Tel Aviv, Israel. Electronic address:

Coronary artery obstruction (CAO), a fatal complication of transcatheter aortic valve replacement (TAVR), is commonly found after Valve-in-Valve implantation inside a degenerated bioprosthetic valve. Leaflet laceration (BASILICA technique) has been proposed to prevent CAO and to potentially reduce the risk of leaflet thrombosis. We have previously demonstrated that this technique can reduce the anchorage forces of the TAVR device, which may lead to future complications. In this short communication, we hypothesize that the anchorage force reduction can be minimized by implanting a TAVR with a larger diameter, if two sizes are clinically recommended. We evaluated this hypothesis by employing finite element models of the deployments of the Evolut 26 and 29 mm inside a 27 mm Mitroflow valve, with and without leaflet lacerations. The results show that a laceration substantially decreases the contact area between the Evolut stent and the Mitroflow valve. The larger Evolut has a larger contact area and stronger anchorage forces. Additionally, the anchorage forces are less sensitive to additional lacerations in the larger Evolut (29 case). The results suggest that a larger self-expending device can ensure stronger anchorage and can lower the risk of possible migration, when TAVR is performed in a lacerated bioprosthesis.
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http://dx.doi.org/10.1016/j.jbiomech.2021.110303DOI Listing
March 2021

Impact of BASILICA on the thrombogenicity potential of valve-in-valve implantations.

J Biomech 2021 03 8;118:110309. Epub 2021 Feb 8.

School of Mechanical Engineering, Tel Aviv University, Tel Aviv, Israel. Electronic address:

Subclinical leaflet thrombosis is becoming a major concern in valve-in-valve procedures, whereby a transcatheter aortic valve device is deployed inside a failed bioprosthetic surgical valve. Blood flow stagnation and prolonged residence times in the neo-sinuses have been suggested as possible explanations for leaflet thrombosis. The BASILICA technique, which was originally developed to treat coronary flow obstruction, has also been proposed as an alternative to reduce the risk of thrombus formation. The aim of this study is to understand the impact of BASILICA on the valve-in-valve thrombogenicity using computational fluid dynamics simulations. To this end, two Eulerian and two Lagrangian approaches were employed to estimate near-wall stagnation measures in eight valve-in-valve models. The models included an intact or lacerated Sorin Mitroflow surgical valve, and either a SAPIEN or Evolut transcatheter aortic valve device. The Lagrangian approaches predicted a high number of particles and vortices concentration in the proximal areas of the neo-sinuses, while the Eulerian approaches did so in the distal areas. As a consequence, this study demonstrated that Lagrangian approaches are better predictors of subclinical leaflet thrombosis, since they match experimental and clinical findings. Additionally, the SAPIEN valve possess a higher risk for developing leaflet thrombosis, and two lacerations are shown to provide the best results in terms of development of vortices and accumulation of particles within the neo-sinuses. This study highlights the potential of computational modeling in aiding clinicians in their decision-making in valve-in-valve and BASILICA procedures.
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http://dx.doi.org/10.1016/j.jbiomech.2021.110309DOI Listing
March 2021

Long-term Implications of Post-Procedural Left Ventricular End-Diastolic Pressure in Patients Undergoing Transcatheter Aortic Valve Implantation.

Am J Cardiol 2021 05 1;146:62-68. Epub 2021 Feb 1.

From the Department of Cardiology, Tel Aviv Medical Center, Tel Aviv; affiliated with the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv; Israel.

Current risk models have only limited accuracy in predicting transcatheter aortic valve Implantation (TAVI) outcomes and there is a paucity of clinical variables to guide patient management after the procedure. The prognostic impact of elevated left ventricular end-diastolic pressure (LVEDP) in TAVI patients is unknown. The aim of the present study was to evaluate the prognostic value of after-procedural LVEDP in patients who undewent TAVI. Consecutive patients with severe symptomatic aortic stenosis who undewent TAVI were divided into 2 groups according to after-procedural LVEDP above and below or equal 12 mm Hg. Collected data included baseline clinical, laboratory and echocardiographic variables. We evaluated the impact of elevated vs. normal LVEDP on in-hospital outcomes, short- and long-term mortality. Eight hundred forty-five patients were included in the study with complete in-hospital and late mortality data available for all survivors (median follow-up 29.5 months [IQR 16.5 to 48.0]). The mean age (±SD) was 82.3±6.2 years and mean Society of Thoracic Surgery score was 4.0%±3.0%. Patients with LVEDP>12 mm Hg (n = 591, 70%) and LVEDP≤12 mm Hg (n = 254, 30%) had a 6-months mortality rate of 6.8% and 2%, respectively (P=0.004) and a 1-year mortality rate of 10.1% vs 4.9%, respectively (p = 0.017). By multivariable analysis, after-procedural LVEDP>12 mm Hg was independently associated with all-cause mortality (HR 2.45, 95% CI 1.58 to 3.76, p <0.001) during long-term follow-up. In conclusion, elevated after-procedural LVEDP in patients who undewent TAVI is an independent predictor of mortality following TAVI. Further research regarding the use of LVEDP as a tool for after-procedural medical management is warranted.
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http://dx.doi.org/10.1016/j.amjcard.2021.01.022DOI Listing
May 2021

Numerical models for assessing the risk of leaflet thrombosis post-transcatheter aortic valve-in-valve implantation.

R Soc Open Sci 2020 Dec 23;7(12):201838. Epub 2020 Dec 23.

School of Mechanical Engineering, Tel Aviv University, Tel Aviv, Israel.

Leaflet thrombosis has been suggested as the reason for the reduced leaflet motion in cases of hypoattenuated leaflet thickening of bioprosthetic aortic valves. This work aimed to estimate the risk of leaflet thrombosis in two post-valve-in-valve (ViV) configurations, using five different numerical approaches. Realistic ViV configurations were calculated by modelling the deployments of the latest version of transcatheter aortic valve devices (Medtronic Evolut PRO, Edwards SAPIEN 3) in the surgical Sorin Mitroflow. Computational fluid dynamics simulations of blood flow followed the dry models. Lagrangian and Eulerian measures of near-wall stagnation were implemented by particle and concentration tracking, respectively, to estimate the thrombogenicity and to predict the risk locations. Most of the numerical approaches indicate a higher leaflet thrombosis risk in the Edwards SAPIEN 3 device because of its intra-annular implantation. The Eulerian approaches estimated high-risk locations in agreement with the wall sheer stress (WSS) separation points. On the other hand, the Lagrangian approaches predicted high-risk locations at the proximal regions of the leaflets matching the low WSS magnitude regions of both transcatheter aortic valve implantation models and reported clinical and experimental data. The proposed methods can help optimizing future designs of transcatheter aortic valves with minimal thrombotic risks.
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http://dx.doi.org/10.1098/rsos.201838DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813235PMC
December 2020

Double S-Curve Versus Cusp-Overlap Technique: Defining the Optimal Fluoroscopic Projection for TAVR With a Self-Expanding Device.

JACC Cardiovasc Interv 2021 01;14(2):185-194

McGill University Health Centre, McGill University, Montreal, Quebec, Canada. Electronic address:

Objectives: The purpose of this study was to assess the concordance between transcatheter aortic valve implantation angles generated by the "double S-curve" and "cusp-overlap" techniques.

Background: The "double S-curve" and "cusp-overlap" methods aim to define optimal fluoroscopic projections for transcatheter aortic valve replacement (TAVR) with a self-expandable device.

Methods: The study included 100 consecutive patients undergoing TAVR with self-expanding device planned by multidetector computed tomography. TAVR was performed using the double S-curve model, as a view in which both the aortic valve annulus and delivery catheter planes are displayed perpendicularly on fluoroscopy. Optimal projection according to the cusp-overlap technique was retrospectively generated by overlapping the right and left cups on the multidetector computed tomography annular plane. The angular difference between methods was assessed in spherical 3 dimensions and on the left and right anterior oblique (RAO) and cranial and caudal (CAU) axes.

Results: The double S-curve and cusp-overlap methods provided views located in the same quadrant, mostly the RAO and CAU, in 92% of patients with a median 3-dimensional angular difference of 10.0° (interquartile range: 5.5° to 17.9°). The 3-dimensional deviation between the average angulation obtained by each method was not statistically significant (1.49°; p = 0.349). No significant differences in average coordinates were noted between the double S-curve and cusp-overlap methods (RAO: 14.7 ± 15.2 vs. 12.9 ± 12.5; p = 0.36; and CAU: 27.0 ± 9.4 vs. 26.9 ± 10.4; p = 0.90). TAVR using the double S-curve was associated with 98% device success, low complication rate, and absence of moderate-to-severe paravalvular leak.

Conclusions: The double S-curve and cusp-overlap methods provide comparable TAVR projections, mostly RAO and CAU. TAVR using the double S-curve model is associated with a high rate of device success and low rate of procedural complications.
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http://dx.doi.org/10.1016/j.jcin.2020.10.033DOI Listing
January 2021

Heart Team/Guidelines Discordance Is Associated With Increased Mortality: Data From a National Survey of Revascularization in Patients With Complex Coronary Artery Disease.

Circ Cardiovasc Interv 2021 01 11;14(1):e009686. Epub 2021 Jan 11.

Sackler school of Medicine, Tel-Aviv University, Israel (G.W., A.S., Y.D.B., E.R., A.A., A.F., H.V.-A., R.K., I.G., R.K.).

Background: Practice guidelines emphasize the role of the SYNTAX score (SS; Synergy Between PCI With TAXUS and Cardiac Surgery) in choosing between percutaneous coronary intervention and coronary artery bypass graft surgery in cases of complex coronary artery disease. There is paucity of data on the implementation of these recommendations in daily practice, and on the consequences of guideline discordant revascularization.

Methods: This was a retrospective analysis of a prospective national survey of consecutive real world patients undergoing coronary revascularization for complex coronary artery disease according to decisions of local heart team at each center. SS was calculated at a dedicated CoreLab, and patients were classified as heart team/guidelines agreement/discordant.

Results: Nine hundred seventy-nine patients (571 percutaneous coronary intervention and 408 coronary artery bypass graft) were included. Mean age was 65 years and the mean SS was 22. Heart team/guidelines discordance occurred in 170 (17.3%) patients. Independent predictors of heart team/guidelines discordance were age, admission to a center with no cardiac surgery service, SS, and previous percutaneous coronary intervention/myocardial infarction. A multivariate model based on these characteristics had a C statistic of 0.83. Thirty-day outcomes were similar in the agreement/discordance groups, however, heart team/guidelines discordance was associated with a significant increase in 3 year mortality (17.6% versus 8.4%; hazard ratio, 2.05; =0.002) after multivariate adjustment.

Conclusions: Heart team/guidelines discordance is not infrequent in real world patients with complex coronary artery disease undergoing revascularization. This is more likely to occur in elderly patients, those with more complex coronary disease (as determined by the SS), and those treated at centers with no cardiac surgery service. These patients have a higher risk for mid-term mortality.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009686DOI Listing
January 2021

Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses.

J Am Coll Cardiol 2021 01;77(1):1-14

Herzzentrum Duisburg, Duisburg, Germany.

Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions.

Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs).

Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year.

Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm vs. 1.37 ± 0.5 cm; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003).

Conclusions: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
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http://dx.doi.org/10.1016/j.jacc.2020.10.053DOI Listing
January 2021

The impact of normal range estimated glomerular filtration rate on mortality in selected patients undergoing coronary angiography - a long-term follow-up.

Coron Artery Dis 2021 Jun;32(4):302-308

Departments of Cardiology.

Background: Estimated glomerular filtration rate (eGFR) predicts mortality and adverse cardiovascular events in people with chronic kidney disease. The significance of eGFR within the normal range and its long-term effect on clinical adverse events is unknown. We examined the effect of normal range or mildly reduced eGFR on long-term mortality in a large prospective registry.

Methods: The study included consecutive patients undergoing clinically-driven coronary angiography who had an eGFR ≥60 ml/min/1.73 m2. Baseline clinical characteristics were assessed, and patients were followed-up for the occurrence of all-cause mortality. Cox regression analysis was used to evaluate the impact of eGFR.

Results: A total of 4186 patients were recruited. Median follow-up time was 2883 days (7.9 years). Mean age was 62.0 ± 11.3 years with 77.4% males. Clinical presentation included acute coronary syndrome and stable angina. In a multivariable model adjusted for possible confounding factors, decreasing eGFR within the normal and mildly reduced range was inversely associated with long-term all-cause mortality with a hazard ratio (HR) of 1.32 for every decrease of 10 ml/min/1.732 in eGFR. Compared to eGFR > 100 ml/min/1.732, there was a graded association between lower eGFR values and increased long term mortality with a HR of 1.16 (0.59-2.31) for eGFR 90-100 ml/min/1.732, HR 1.54 (0.81-2.91) for eGFR 80-90 ml/min/1.732, HR 2.62 (1.41-4.85) for eGFR 70-80 ml/min/1.732 and HR 2.93 (1.58-5.41) for eGFR 60-70 ml/min/1.732.

Conclusion: eGFR within the normal and mildly reduced range is an independent predictor of long-term all-cause mortality in selected patients undergoing clinically driven coronary angiography.
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http://dx.doi.org/10.1097/MCA.0000000000000985DOI Listing
June 2021

Short membranous septum length in bicuspid aortic valve stenosis increases the risk of conduction disturbances.

J Cardiovasc Comput Tomogr 2021 Jul-Aug;15(4):339-347. Epub 2020 Oct 29.

Department of Cardiology, Rabin Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.

Background: Distinct anatomical features predispose bicuspid AS patients to conduction disturbances after TAVR. This study sought to evaluate whether the incidence of permanent pacemaker implantation (PPMI) and left bundle branch block (LBBB) in patients with bicuspid aortic stenosis (AS) following transcatheter aortic valve replacement (TAVR) is related to an anatomical association between bicuspid AS and short membranous septal (MS) length.

Methods: Sixty-seven consecutive patients with bicuspid AS from a Bicuspid AS TAVR multicenter registry and 67 propensity-matched patients with tricuspid AS underwent computed tomography before TAVR.

Results: MS length was significantly shorter in bicuspid AS compared with tricuspid AS (6.2 ± 2.5 mm vs. 8.4 ± 2.7 mm, respectively; p < 0.001). In patients with bicuspid AS, MS length and aortic valve calcification were the most powerful pre-procedural independent predictors of PPMI or LBBB (odds ratio [OR]: 1.38, 95% confidence interval [CI]: 1.15 to 1.55, p = 0.003 and OR: 1.92, 95% CI: 1.1 to 3.34, p = 0.022, respectively). When taking into account pre- and post-procedural parameters, aortic valve calcification and the difference between MS length and implantation depth were the most powerful independent predictors of PPMI or LBBB in patients with bicuspid AS (OR: 1.82, 95%: 1.1 to 3.1, p = 0.027; OR: 1.25, 95% CI: 1.10 to 1.38, p = 0.003).

Conclusion: MS length, which was significantly shorter in bicuspid AS compared with tricuspid AS, aortic valve calcification, and device implantation deeper than MS length predict PPMI or LBBB in bicuspid AS after TAVR.
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http://dx.doi.org/10.1016/j.jcct.2020.10.002DOI Listing
October 2020

Coronary Access After TAVR-in-TAVR as Evaluated by Multidetector Computed Tomography.

JACC Cardiovasc Interv 2020 11;13(21):2528-2538

Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Objectives: The aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)-in-TAVR using multidetector computed tomography.

Background: Expanding TAVR to patients with longer life expectancy may involve more frequent bioprosthetic valve failure and need for redo TAVR. Coronary access after TAVR-in-TAVR may be challenging, particularly as the leaflets from the initial transcatheter heart valve (THV) will form a neo-skirt following TAVR-in-TAVR.

Methods: In 45 patients treated with different combinations of CoreValve and Evolut (CV/EV) THVs with supra-annular leaflet position and SAPIEN THVs with intra-annular leaflet position, post-TAVR-in-TAVR multidetector computed tomographic scans were analyzed to examine coronary accessibility.

Results: After TAVR-in-TAVR, the coronary arteries originated below the top of the neo-skirt in 90% of CV/EV-first cases compared with 67% of SAPIEN-first cases (p = 0.009). For these coronary arteries originating below the top of the neo-skirt, the distance between the THV and the aortic wall was <3 mm in 56% and 25% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.035). Coronary access may be further complicated by THV-THV stent frame strut misalignment in 53% of CV/EV-in-CV/EV cases. The risk for technically impossible coronary access was 27% and 10% in CV/EV-first and SAPIEN-first cases, respectively (p = 0.121). Absence of THV interference with coronary accessibility can be expected in 8% and 33% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.005).

Conclusions: Coronary access after TAVR-in-TAVR may be challenging in a significant proportion of patients. THVs with intra-annular leaflet position or low commissural height and large open cells may be preferable in terms of coronary access after TAVR-in-TAVR.
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http://dx.doi.org/10.1016/j.jcin.2020.06.016DOI Listing
November 2020

Effect of pacemaker implantation after transcatheter aortic valve replacement on long- and mid-term mortality.

Heart Rhythm 2021 02 20;18(2):199-206. Epub 2020 Oct 20.

Department of Cardiology, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.

Background: Transcatheter aortic valve replacement (TAVR) has become quite common. Atrioventricular conduction defects remain a frequent complication resulting with permanent pacemaker (PPM) implantation. Past studies showed conflicting results regarding PPM effect on mortality.

Objective: The purpose of this study was to assess the influence of PPM implantation on mid- and long-term mortality in a large cohort of patients who underwent TAVR.

Methods: Patients undergoing TAVR between 2009 and 2019 were categorized into groups: no PPM implanted (no-PPM), PPM implanted before the procedure (pre-PPM), and PPM implanted postprocedure (post-PPM). All-cause mortality up to 6 years was compared. Subanalyses were performed according to pacing burden. Proportion of patients who had decreased left ventricular ejection fraction within 1 year of the procedure after TAVR was also recorded.

Results: A total of 1489 patients were followed. Unadjusted mortality was similar for patients regardless of PPM status within 12 months (P > .187), yet within 72 months, mortality was similar for the post-PPM (P = .257) and higher for pre-PPM (hazard ratio 1.53; P = .002) groups. Analysis adjusted by clinical characteristics did not show any independent long- or mid-term survival effects of PPM (P > .563). Analysis according to pacing burden showed no significant mortality difference (P > .8). Analysis of post-PPM patients with "high" or "near constant" (>40%) pacing burden vs no-PPM patients showed similar mortality for both mid- and long-term mortality (P = .055 and P = .513). Left ventricular ejection fraction decrease within 1 year was more common in both PPM groups, with a higher proportion with higher pacing burden (P < .001).

Conclusion: This cohort of consecutive patients undergoing TAVR showed that postprocedure PPM was not associated with increased long-term mortality. This conclusion was not altered by ventricular pacing burden.
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http://dx.doi.org/10.1016/j.hrthm.2020.10.013DOI Listing
February 2021

Blood acetylcholinesterase activity is associated with increased 10 year all-cause mortality following coronary angiography.

Atherosclerosis 2020 11 9;313:144-149. Epub 2020 Oct 9.

Department of Cardiology, Tel Aviv Medical Center, Affiliated with the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Background And Aims: Parasympathetic dysfunction is associated with increased risk for major adverse cardiovascular events (MACE). However, clinically validated biomarkers that reflect parasympathetic activity are not yet available. We sought to assess the ability of serum cholinesterase activity to predict long term survival in patients undergoing coronary angiography.

Methods: We prospectively followed 1002 consecutive patients undergoing clinically indicated coronary angiography (acute coronary syndrome or stable angina). We measured blood acetylcholinesterase (AChE) activity using the acetylcholine analog acetylthiocholine. Mortality rates were determined up to 10 years of follow-up. We divided our cohort into 3 groups with low, intermediate and high AChE activity by a Chi-square automatic interaction detection method (CHAID).

Results: Patients with lower than cutoff levels of AChE (<300 nmol/min/ml) had higher mortality rates over 10 years of follow-up, after adjusting for conventional risk factors, biomarkers, clinical indication, and use of medications (HR = 1.6, 95% CI 1.1-2.5, p = 0.02). Patients with intermediate levels of AChE (300-582 nmol/min/ml) were also at increased risk for death (HR = 1.4, 95% CI 1.1-1.9, p = 0.02). AChE was inversely correlated with C-reactive protein, troponin I, fibrinogen and neutrophil/lymphocyte ratio levels.

Conclusions: Patients presenting for coronary angiography with low levels of serum AChE activity are at increased risk for death during long term follow-up.
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http://dx.doi.org/10.1016/j.atherosclerosis.2020.10.004DOI Listing
November 2020

Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves.

Eur Heart J 2020 08;41(29):2731-2742

Dipartimento di Scienze Cardiologiche Toraciche e Vascolari, Università degli Studi di Padova, Via Giustiniani, 2 - 35128 Padova, Italy.

Aims: Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV.

Methods And Results: A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7 ± 9.7 years; 58.8% male; median STS-PROM score 7.3% (4.2-12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreValve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n = 523, 52.0%), Edwards balloon-expandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n = 435, 43.2%), and other devices (n = 48, 4.8%). Survival was lower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) ≤ 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P = 0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02-1.13)], age [HR 1.21 (95% CI 1.01-1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11-1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis-patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31-14.39)], device malposition [SHR 3.75 (95% CI 1.36-10.35)], EBEV [SHR 3.34 (95% CI 1.26-8.85)], and age [SHR 0.59 (95% CI 0.44-0.78)].

Conclusions: The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV.
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http://dx.doi.org/10.1093/eurheartj/ehaa544DOI Listing
August 2020

Echocardiographic L-wave as a prognostic indicator in transcatheter aortic valve replacement.

Int J Cardiovasc Imaging 2020 Oct 17;36(10):1897-1905. Epub 2020 Jun 17.

Department of Cardiology, Tel-Aviv Sourasky Medical Center, Affiliated to the Tel-Aviv University, 6 Weizzman St, 64239, Tel-Aviv, Israel.

This study applies L-wave measurements of mid-diastolic trans-mitral flow. Although considered to be a marker of elevated filling pressure or delayed myocardial relaxation, its clinical and prognostic value is yet to be completely elucidated. It has been shown that transcatheter aortic valve replacement (TAVR) induces reverse remodeling and improves diastolic function and prognosis in patients with severe aortic stenosis (AS). Our purpose was to evaluate the prognostic value of L-wave following TAVR. We examined clinical and echocardiographic data of patients undergoing TAVR. L-Wave presence and velocity were recorded at baseline and at 1 month and 6 months following TAVR. The effect of the procedure on L-wave measurements and its impact on mortality and other clinical outcomes were analyzed. A total of 502 patients (mean age 82.58 ± 5.9) undergoing TAVR were included. Patients with baseline L-wave (n = 68, 12%) had a smaller stroke volume index by 5.7 ± 2.3 ml/m (p = 0.01) as compared to patients without L-wave at baseline. L-waves disappeared In 35% and 70% of patients at 1 month and at 6 months respectively. Baseline L-wave velocity was 34.8 ± 11.5 (cm/s) and decreased significantly at follow-up examinations. Patients with persistent L-wave following TAVR had higher 3-year adjusted mortality rates (HR 5.7, 95% CI 3.7-8.9, p < 0.001). Multivariate analysis of survival was also statistically significant (p < 0.001). TAVR induces L-wave disappearance and a decrease in L-wave velocity in patients with severe AS. L-wave persistence following TAVR is an independent risk factor for mortality.
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http://dx.doi.org/10.1007/s10554-020-01903-8DOI Listing
October 2020

Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction.

J Am Coll Cardiol 2020 04;75(16):1882-1893

Herzzentrum Duisburg, Duisburg, Germany.

Background: Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail.

Objectives: The authors sought to examine outcomes following redo-TAVR.

Methods: The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively.

Results: Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis-regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm and 1.51 ± 0.57 cm; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively.

Conclusions: Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.
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http://dx.doi.org/10.1016/j.jacc.2020.02.051DOI Listing
April 2020

Chimney Stenting for Coronary Occlusion During TAVR: Insights From the Chimney Registry.

JACC Cardiovasc Interv 2020 03;13(6):751-761

Institut Cardiovasculaire de Paris, Massy, France.

Objectives: The aim of this study was to determine the safety and efficacy of chimney stenting, a bailout technique to treat coronary artery occlusion (CAO).

Background: CAO during transcatheter aortic valve replacement (TAVR) is a rare but often fatal complication.

Methods: In the international Chimney Registry, patient and procedural characteristics and data on outcomes are retrospectively collected from patients who underwent chimney stenting during TAVR.

Results: To date, 16 centers have contributed 60 cases among 12,800 TAVR procedures (0.5%). Chimney stenting was performed for 2 reasons: 1) due to the development of an established CAO (n = 25 [41.6%]); or 2) due to an impending CAO (n = 35 [58.3%]). The majority of cases (92.9%) had 1 or more classical risk factors for CAO. Upfront coronary protection was performed in 44 patients (73.3%). Procedural and in-hospital mortality occurred in 1 and 2 patients, respectively. Myocardial infarction (52.0% vs. 0.0%; p < 0.01), cardiogenic shock (52.0% vs. 2.9%; p < 0.01), and resuscitation (44.0% vs. 2.9%; p < 0.01) all occurred more frequently in patients with established CAO compared with those with impending CAO. The absence of upfront coronary protection was the sole independent risk factor for the combined endpoint of death, cardiogenic shock, or myocardial infarction. During a median follow-up time of 612 days (interquartile range: 405 to 842 days), 2 cases of stent failure were reported (1 in-stent restenosis, 1 possible late stent thrombosis) after 157 and 374 days.

Conclusions: Chimney stenting appears to be an acceptable bailout technique for CAO, with higher event rates among those with established CAO and among those without upfront coronary protection.
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http://dx.doi.org/10.1016/j.jcin.2020.01.227DOI Listing
March 2020

Long-term implications of left atrial appendage thrombus identified incidentally by pre-procedural cardiac computed tomography angiography in patients undergoing transcatheter aortic valve replacement.

Eur Heart J Cardiovasc Imaging 2021 04;22(5):563-571

Department of Cardiology, Tel Aviv Medical Center affiliated with the Sackler Faculty of Medicine, Tel Aviv University, 6 Weizmann Street, Tel Aviv 64239, Israel.

Aims: The prevalence and prognostic implications of left atrial appendage (LAA) thrombus (LAAT) in patients considered for transcatheter aortic valve replacement (TAVR) are incompletely defined. We, therefore, studied pre-procedural cardiac computed tomography angiography (CCTA) scans of TAVR candidates to determine the prevalence of LAAT and its association with late outcomes.

Methods And Results: Baseline clinical variables and CCTA findings from a prospective TAVR registry were analysed for the prevalence of pre-procedural LAAT and its impact on in-hospital outcomes and late mortality. LAAT was differentiated from LAA filling defects (LAAFD) reflecting stasis without clot. Patients (n = 561) with complete in-hospital and late mortality data were included in the study (median follow-up 31.6 months). LAAT and LAAFD were evidenced on pre-procedural CCTA in 24 (4.3%) and 26 (4.6%) patients, respectively. One hundred fourteen (20.3%) patients died during the study period. Though in-hospital adverse event rates (including stroke) did not differ among groups, mortality at long-term follow-up was higher among LAAT patients compared with those with or without LAAFD (58.3% vs. 11.5% vs. 19.0%, respectively; P < 0.003). By multivariable analysis, LAAT (but not LAAFD) was independently associated with all-cause mortality [hazard ratio (HR) = 3.33 (1.83-6.00), P < 0.001]. In patients with LAAT, oral anticoagulation at discharge was associated with lower mortality risk, independently of atrial fibrillation status.

Conclusions: LAAT visualized by pre-procedural CCTA is an independent predictor of late mortality following TAVR, but not peri-procedural stroke. When reporting TAVR-CCTA, particular note should be made of LAA features and presence of LAAT which may have prognostic and management implications.
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http://dx.doi.org/10.1093/ehjci/jeaa030DOI Listing
April 2021

Predicting the risk of late futile outcome after transcatheter aortic valve implantation.

Catheter Cardiovasc Interv 2020 12 5;96(7):E695-E702. Epub 2020 Feb 5.

Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel.

Background: Transcatheter aortic valve implantation (TAVI) for aortic stenosis (AS) risk assessment is still developing and mostly concerned with mortality in the periprocedural period. We therefore sought to develop and then validate a score to predict 1-year adverse outcome.

Methods: Patients that underwent TAVI for severe AS in the Israeli registry. Patients with unsuccessful/suboptimal implantation were excluded. The cohort was split to derivation/validation cohorts by a ratio of 70:30. The outcome was defined as 1-year composite of mortality, stroke, and no improvement in NYHA class (vs. baseline). Logistic regression was used to fit the prediction model.

Results: Out of 2,440 patients meeting inclusion criteria, 276 were excluded, leaving 2,160 patients for both cohorts. At 1 year, 299 (14%) patients experienced the adverse ("futile") outcome. The derived prediction model included mean aortic valve (AV) gradient, previous pacemaker, previous oncological disease, need for diuretics, baseline NYHA class, hemoglobin and creatinine levels, and nonfemoral access site. The model's area under the curve (AUC) was 0.69 in the derivation and 0.70 in the validation cohort. Performance of other scores in the validation cohort were lower (0.60 for STS, 0.55 for Euroscore2, 0.56 for TVT score, and 0.53 for TAVI2-score, p = .03). Based on three risk tiers, patients had a low risk (20/306, 7% futility), a medium risk (50/304, 17%), and high risk (18/37, 49%) for futility.

Conclusions: The TAVI futility risk model can be used to provide further insight regarding prediction measures and/or patients' outcomes outside of the periprocedural period (NCT02023060).
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http://dx.doi.org/10.1002/ccd.28761DOI Listing
December 2020

Validation of cardiac damage classification and addition of albumin in a large cohort of patients undergoing transcatheter aortic valve replacement.

Int J Cardiol 2020 04 15;304:23-28. Epub 2020 Jan 15.

Division of Cardiology, Leviev Heart and Vascular Center, Chaim Sheba Medical Center, Tel Hashomer, Israel; Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel. Electronic address:

Aims: We aimed to validate a new scoring system based on extent of cardiac damage for risk stratification in patients undergoing transcatheter aortic valve replacement (TAVR) in a real-world cohort and to examine the addition of baseline albumin in risk assessment.

Methods And Results: We investigated 2608 patients undergoing TAVR. Subjects were divided into five groups based on their echocardiography findings. Patients were further assessed by incorporating baseline albumin. Multivariable analysis demonstrated that each increase in stage was associated with significant increased risk of 1-year mortality (HR 1.37, 95%CI 1.23-1.54, p < .001). Among patients at increased stage (3-4), incorporation of baseline of albumin identified the highest risk group, such that each 1 decrement in albumin levels was associated with more than triple increase in mortality among patients at stage 3 and 4 (HR 2.77, 95% CI 1.48-5.18, p-value = .001).

Conclusions: Cardiac damage classification is validated in a real-world cohort of patients undergoing TAVR. Incorporation of low baseline albumin may further identify patients at the highest risk group.

Condensted Abstract: We evaluated 2608 patients undergoing transcatheter aortic valve replacement (TAVR) in order to validate a new scoring system dividing patients in to 5 stages (0-4) based on extent of cardiac damage. Patients were further assessed by incorporating baseline albumin. Multivariable analysis demonstrated that each increase in stage was associated with significant increased risk of 1-year mortality. Furthermore, among patients at increased stage (3-4), incorporation of baseline of albumin identified the highest risk group, such that each 1 decrement in albumin levels was associated with more than triple increase in mortality among patients at stage 3 and 4.
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http://dx.doi.org/10.1016/j.ijcard.2020.01.031DOI Listing
April 2020

Author's reply to: Worsening of mitral regurgitation following transcatheter aortic valve replacement.

Int J Cardiol 2020 03 30;302:42. Epub 2019 Nov 30.

Cardiology Division, Tel Aviv Sourasky Medical Center, Sackler faculty of Medicine, Tel Aviv, Israel. Electronic address:

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http://dx.doi.org/10.1016/j.ijcard.2019.11.145DOI Listing
March 2020

Impact of preprocedural left ventricle hypertrophy and geometrical patterns on mortality following TAVR.

Am Heart J 2020 02 30;220:184-191. Epub 2019 Nov 30.

Cardiology department, Tel Aviv Sourasky Medical Center, Israel; Affiliated to Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.

Background: In contrast to surgical aortic valve replacement, left ventricle (LV) hypertrophy (LVH) had not been clearly associated with mortality following transcatheter aortic valve replacement (TAVR).

Methods: We performed a retrospective analysis of patients enrolled in the Israeli multicenter TAVR registry for whom preprocedural LV mass index (LVMI) data were available. Patients were divided into categories according to LVMI: normal LVMI and mild, moderate, and severe LVH. Mild LVH was regarded as the reference group. Additionally, LV geometry patterns were examined (concentric and eccentric LVH, and concentric remodeling).

Results: The cohort consisted of 1,559 patients, 46.5% male, with a mean age of 82.2 (±6.8) years and mean LVMI of 121 (±29) g/m. Rates of normal LVMI and mild, moderate, and severe LVH were 31% (n = 485), 21% (n = 322), 18% (n = 279), and 30% (n = 475), respectively. Three-year mortality rates for normal LVMI and mild, moderate, and severe LVH were 19.8%, 18.3%, 23.7%, and 24.4%, respectively. Compared to mild LVH, moderate LVH and severe LVH were independently associated with an increased risk for all-cause mortality (hazard ratio [HR] 1.58, 95% CI 1.15-2.18, P = .005; HR 1.46, 95% CI 1.1-1.95, P = .009; respectively). Concentric LVH was independently associated with a decreased risk for mortality compared to normal LV geometry (HR 0.75, 95% CI 0.63-0.89, P = .001). Compared to concentric LVH, eccentric LVH was independently associated with a 33% increased risk for mortality (HR 1.33, 95% CI 1.11-1.60, P = .002).

Conclusions: Mild concentric LVH confers a protective effect among patients with severe aortic stenosis undergoing TAVR. However, hypertrophy becomes maladaptive, and an increased baseline LVMI, eccentric pattern particularly, may be associated with all-cause mortality in this population.
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http://dx.doi.org/10.1016/j.ahj.2019.11.013DOI Listing
February 2020

Effectiveness and Safety of Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis and Variable Ejection Fractions (<40%, 40%-49%, and >50%).

Am J Cardiol 2020 02 23;125(4):583-588. Epub 2019 Nov 23.

Department of Cardiology, Tel-Aviv Sourasky Medical Center affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address:

We evaluated the safety and efficacy of transcatheter aortic valve implantation (TAVI) in aortic stenosis patients with mid-range ejection fraction (ASmrEF) and compared it to aortic stenosis patients with reduced ejection fraction (ASrEF) and preserved ejection fraction (ASpEF). TAVI cases were stratified by baseline ejection fraction (ASrEF, ASmrEF, ASpEF) and compared for characteristics, procedural outcomes, and change in echocardiographic parameters at 1 year and mortality over a 5-year follow-up. The final study population included 708 patients who underwent TAVI. ASmrEF patients presented with improved EF at 1-year after procedure (49.0 ± 9.8 at 1 year vs 43.0 ± 2.5 at baseline, p <0.001) and showed improvements in left ventricular (LV) diameters (LV end-diastolic diameter: 50.4 ± 6.0 at 1 year vs 53.0 ± 5.5 at baseline and LV end-systolic diameter 34.7 ± 7.8 at 1 year vs 39.5 ± 5.9 at baseline, p <0.001 for both). LVEF improved for patients with ASrEF but not in ASpEF patients. LV diameters did not improve for patients in either group. Procedural safety and success rates were similar between all heart failure groups. Survival rates over a 5-year follow-up post-TAVI were not different between patients with ASmrEF, ASrEF, and ASpEF (ASrEF 78.4%, ASmrEF 81.9%, ASpEF 78.3%, p = 0.327). TAVI for patients with ASmrEF is safe and effective and results in marked improvement of LV function and structure.
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February 2020

The Utility of Prophylactic Pacemaker Implantation in Right Bundle Branch Block Patients Pre-Transcatheter Aortic Valve Implantation.

Isr Med Assoc J 2019 Dec;21(12):790-795

Background: Patients with right bundle branch block (RBBB) prior to transcatheter aortic valve implantation (TAVI) are at high risk for immediate post-procedural heart block and long-term mortality when discharged without a pacemaker.

Objectives: To test whether prophylactic permanent pacemaker implantation (PPI) is beneficial.

Methods: Of 795 consecutive patients who underwent TAVI, 90 patients had baseline RBBB. We compared characteristics and outcomes of the prophylactic PPI with post-TAVI PPI. Need for pacing was defined as  greater than 1% ventricular pacing.

Results: Forty patients with RBBB received a prophylactic PPI (group 1), and in 50 the decision was based on standard post-procedural indications (group 2). There were no significant differences in clinical baseline characteristics. One patient developed a tamponade after a PPI post-TAVI. A trend toward shorter hospitalization duration in group 1 patients was observed (P = 0.06). On long-term follow-up of 848 ± 56 days, no differences were found in overall survival (P = 0.77), the composite event-free survival of both mortality and hospitalizations (P = 0.66), or mortality and syncope (P = 0.65). On multivariate analysis, independent predictors of the need for pacing included baseline PR interval increase of 10ms (odds ratio [OR] 1.21 per 10 ms increment 95% confidence interval [95%CI] 1.02-1.44, P = 0.028), and the use of new generation valves (OR 3.92, 95%CI 1.23-12.46, P = 0.023).

Conclusions: In patients with baseline pre-TAVI RBBB, no outcome differences were found with prophylactic PPI. On multivariate analysis, predictors of the need for pacing included baseline long PR interval, and the use of newer generation valves.
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December 2019
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