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Article: Monitoring Outcomes of Novel Interventions: The Case for Comprehensive Data Collection.

Fefer, Paul / Guetta, Victor

The Israel Medical Association journal : IMAJ

2019 Volume 21, Issue 5, Page(s) 353

MeSH term(s)	Data Collection ; Humans ; Patient Outcome Assessment
Language	English
Publishing date	2019-05-15
Publishing country	Israel
Document type	Editorial ; Comment
ZDB-ID	2008291-5
ISSN	1565-1088 ; 0021-2180
ISSN	1565-1088 ; 0021-2180
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Zs.A 5470: Show issues

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Article ; Online: Echocardiography vs hemodynamic assessment of diastolic dysfunction.

Shaham, Lital / Fisher, Lior / Segev, Amit / Falach, Batla / Maor, Elad / Barbash, Israel M / Hai, Ilan / Vaturi, Ori / Kuperstein, Rafi / Guetta, Victor / Fefer, Paul

The Journal of invasive cardiology

2024 Volume 36, Issue 1

Abstract: Objectives: Ostial CTOs can be challenging to revascularize. We aim to describe the outcomes of ostial chronic total occlusion (CTO) percutaneous coronary intervention (PCI).: Methods: We examined the clinical and angiographic characteristics and ... ...

Abstract	Objectives: Ostial CTOs can be challenging to revascularize. We aim to describe the outcomes of ostial chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Methods: We examined the clinical and angiographic characteristics and procedural outcomes of 8788 CTO PCIs performed at 35 US and non-US centers between 2012 and 2022. In-hospital major adverse cardiac events (MACE) included death, myocardial infarction, urgent repeat target-vessel revascularization, tamponade requiring pericardiocentesis or surgery, and stroke. Results: Ostial CTOs constituted 12% of all CTOs. Patients with ostial CTOs had higher J-CTO score (2.9 ± 1.2 vs 2.3 ± 1.3; P less than .01). Ostial CTO PCI had lower technical (82% vs. 86%; P less than .01) and procedural (81% vs. 85%; P less than .01) success rates compared with non-ostial CTO PCI. Ostial location was not independently associated with technical success (OR 1.03, CI 95% 0.83-1.29 P =.73). Ostial CTO PCI had a trend towards higher incidence of MACE (2.6% vs. 1.8%; P =.06), driven by higher incidence of in-hospital death (0.9% vs 0.3% P less than.01) and stroke (0.5% vs 0.1% P less than .01). Ostial lesions required more often use of the retrograde approach (30% vs 9%; P less than .01). Ostial CTO PCI required longer procedure time (149 [103,204] vs 110 [72,160] min; P less than .01) and higher air kerma radiation dose (2.3 [1.3, 3.6] vs 2.0 [1.1, 3.5] Gray; P less than .01). Conclusions: Ostial CTOs are associated with higher lesion complexity and lower technical and procedural success rates. CTO PCI of ostial lesions is associated with frequent need for retrograde crossing, higher incidence of death and stroke, longer procedure time and higher radiation dose.
MeSH term(s)	Humans ; Hospital Mortality ; Percutaneous Coronary Intervention/adverse effects ; Echocardiography ; Stroke/diagnosis ; Stroke/epidemiology ; Stroke/etiology ; Hemodynamics
Language	English
Publishing date	2024-01-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	1154372-3
ISSN	1557-2501 ; 1042-3931
ISSN (online)	1557-2501
ISSN	1042-3931
DOI	10.25270/jic/23.00106
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Article ; Online: Early Experience With the Innovalve Transcatheter Mitral Valve Replacement System.

Meerkin, David / Guetta, Victor / Shaburishvili, Tamaz / Gogorishvili, Irakli / Kipiani, Zviad / Orlov, Boris / Zirakashvili, Teona / Bachilava, Natia / Butnaru, Adi / Avner, Avi / Goitein, Orly / Raanani, Ehud

JACC. Cardiovascular interventions

2024 Volume 17, Issue 5, Page(s) 712–714

MeSH term(s)	Humans ; Mitral Valve/diagnostic imaging ; Mitral Valve/surgery ; Treatment Outcome ; Heart Valve Prosthesis Implantation/adverse effects ; Heart Valve Prosthesis ; Cardiac Catheterization/adverse effects ; Mitral Valve Insufficiency/diagnostic imaging ; Mitral Valve Insufficiency/surgery ; Transcatheter Aortic Valve Replacement
Language	English
Publishing date	2024-01-19
Publishing country	United States
Document type	Letter
ZDB-ID	2452157-7
ISSN	1876-7605 ; 1936-8798
ISSN (online)	1876-7605
ISSN	1936-8798
DOI	10.1016/j.jcin.2024.01.013
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Article ; Online: The boy who cried wolf.

Barbash, Israel M / Guetta, Victor

Cardiovascular revascularization medicine : including molecular interventions

2016 Volume 17, Issue 4, Page(s) 217–218

MeSH term(s)	Diagnostic Errors ; Humans ; Myocardial Infarction/diagnosis ; Myocardial Infarction/therapy ; Patient Care Team ; Percutaneous Coronary Intervention
Language	English
Publishing date	2016
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	2212113-4
ISSN	1878-0938 ; 1553-8389
ISSN (online)	1878-0938
ISSN	1553-8389
DOI	10.1016/j.carrev.2016.05.004
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Zs.A 5562: Show issues

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Article ; Online: Patent Foramen Ovale Closure among Patients with Hypercoagulable States Maintained on Antithrombotic Therapy.

Buber, Jonathan / Guetta, Victor / Orion, David / Lubetsky, Aharon / Borik, Sharon / Vatury, Ori / Israel, Ariel

Cardiology

2021 Volume 146, Issue 3, Page(s) 375–383

Abstract: Background: Percutaneous device closure was shown to effectively prevent recurrent strokes in patients with patent foramen ovale (PFO). Whether this protective effect is relevant for patients with hypercoagulable states (HCSs) is unknown as they were ... ...

Abstract	Background: Percutaneous device closure was shown to effectively prevent recurrent strokes in patients with patent foramen ovale (PFO). Whether this protective effect is relevant for patients with hypercoagulable states (HCSs) is unknown as they were not represented in prior studies. Methods: Data on 136 consecutive patients with a PFO and clinically significant HCS were retrospectively collected. PFO closure and antithrombotic regimen were decided on an individual basis by the treating physicians, and adherence to therapy was routinely evaluated. The outcome was the occurrence of cerebrovascular accident (CVA) or transient ischemic attack (TIA). Results: HCS types consisted of antiphospholipid syndrome (31%), factor-5 Leiden mutation (22%), prothrombin mutation (18%), protein S deficiency (15%), protein C deficiency (7%), methyl-tetra-hydro folate reductase mutation (5%), and essential thrombocytosis (2%). 102 patients (75%) were maintained on anticoagulants and the remaining on antiplatelet therapy. PFO closure was undertaken in 85 (63%); antithrombotic therapy was not interrupted prior to or after the procedures. At a mean follow-up of 46 ± 8 months, 23 patients (17%; 95% confidence interval, 9.3-22%) experienced an outcome event, mainly in the form of CVAs (n = 15, 65%). In multivariable analysis, PFO closure was associated with a 5-fold decrease in the risk of CVA/TIA (p = 0.02). This effect was independent of the type of HCS or antithrombotic therapy. Conclusions: Among patients with HCSs maintained on anticoagulant or antiplatelet therapies, PFO closure was associated with a significantly lower risk of CVA or TIA.
MeSH term(s)	Cardiac Catheterization ; Fibrinolytic Agents/therapeutic use ; Foramen Ovale, Patent/complications ; Foramen Ovale, Patent/surgery ; Humans ; Ischemic Attack, Transient/prevention & control ; Recurrence ; Retrospective Studies ; Stroke/drug therapy ; Stroke/etiology ; Stroke/prevention & control ; Treatment Outcome
Chemical Substances	Fibrinolytic Agents
Language	English
Publishing date	2021-02-12
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	80092-2
ISSN	1421-9751 ; 0008-6312
ISSN (online)	1421-9751
ISSN	0008-6312
DOI	10.1159/000512184
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Article ; Online: A Fully Percutaneous Transeptal Transcatheter Mitral Valve Replacement With a Novel Device.

Mangieri, Antonio / Cannata, Francesco / Cozzi, Ottavia / Monti, Lorenzo / Regazzoli, Damiano / Guetta, Victor / Fumero, Andrea / Bragato, Renato M / Brizzi, Stefano / Reimers, Bernhard / Colombo, Antonio

JACC. Cardiovascular interventions

2023 Volume 16, Issue 16, Page(s) 2050–2052

MeSH term(s)	Humans ; Mitral Valve/diagnostic imaging ; Mitral Valve/surgery ; Treatment Outcome ; Heart Valve Prosthesis Implantation/adverse effects ; Heart Valve Prosthesis ; Ventricular Outflow Obstruction/surgery ; Cardiac Catheterization/adverse effects ; Mitral Valve Insufficiency/diagnostic imaging ; Mitral Valve Insufficiency/surgery
Language	English
Publishing date	2023-05-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	2452157-7
ISSN	1876-7605 ; 1936-8798
ISSN (online)	1876-7605
ISSN	1936-8798
DOI	10.1016/j.jcin.2023.04.040
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Article: Virtual reality utilization for left atrial appendage occluder device size prediction.

Tejman-Yarden, Shai / Freidin, Dor / Nagar, Netanel / Parmet, Yisrael / Abed, Muhamed / Vazhgovsky, Oliana / Yogev, David / Ganchrow, Dov / Mazor-Drey, Efrat / Chatterji, Sumit / Beinart, Roy / Barbash, Israel / Guetta, Victor / Goitein, Orly

Heliyon

2023 Volume 9, Issue 4, Page(s) e14790

Abstract: Aim: To explore the feasibility and accuracy of virtual reality (VR) derived from cardiac computed angiography (CCTA) data to predict left atrial appendage occlusion (LAAO) device size.: Method: Retrospective data of patients who underwent LAAO ... ...

Abstract	Aim: To explore the feasibility and accuracy of virtual reality (VR) derived from cardiac computed angiography (CCTA) data to predict left atrial appendage occlusion (LAAO) device size. Method: Retrospective data of patients who underwent LAAO according to clinical indication were reviewed; all patients underwent a pre-procedural CCTA. Measurements of the left atrial appendage (LAA) orifice diameters by CCTA, VR, and transesophageal echocardiography (TEE) (acquired during the procedure) were compared to the implanted device size. The LAA perimeter was calculated using the Ramanujan approximation. Statistical analyses included Lin's Concordance Correlation Coefficient ( Results: The sample was composed of 20 patients (mean age 75.7 ± 7.5 years, 60% males) who underwent successful LAAO insertion (ACP™ N = 8, Watchman™ N = 12). The CCTA, VR, and TEE maximal diameter Discussion: A VR visualization of the LAA ostium in different perspectives allows for a better understanding of its funnel-shaped structure. VR measurement of the maximal ostium diameter had the strongest correlation with the diameter of the inserted device. VR may thus provide new imaging possibilities for the evaluation of complex pre-procedural structures such as the LAA.
Language	English
Publishing date	2023-04-04
Publishing country	England
Document type	Journal Article
ZDB-ID	2835763-2
ISSN	2405-8440
ISSN	2405-8440
DOI	10.1016/j.heliyon.2023.e14790
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Article: Left Atrial Appendage Occlusion versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation-One-Year Survival.

Tiosano, Shmuel / Banai, Ariel / Mulla, Wesam / Goldenberg, Ido / Bayshtok, Gabriella / Amit, Uri / Shlomo, Nir / Nof, Eyal / Rosso, Raphael / Glikson, Michael / Guetta, Victor / Barbash, Israel / Beinart, Roy

Journal of clinical medicine

2023 Volume 12, Issue 20

Abstract: Aim To compare the 1-year survival rate of patients with atrial fibrillation (AF) following left atrial appendage occluder (LAAO) implantation vs. treatment with novel oral anticoagulants (NOACs).: Methods: We have conducted an indirect, retrospective ...

Abstract	Aim To compare the 1-year survival rate of patients with atrial fibrillation (AF) following left atrial appendage occluder (LAAO) implantation vs. treatment with novel oral anticoagulants (NOACs). Methods: We have conducted an indirect, retrospective comparison between LAAO and NOAC registries. The LAAO registry is a national prospective cohort of 419 AF patients who underwent percutaneous LAAO between January 2008 and October 2015. The NOACs registry is a multicenter prospective cohort of 3138 AF patients treated with NOACs between November 2015 and August 2018. Baseline patient characteristics were retrospectively collected from coded diagnoses of hospitalization and outpatient clinic notes. Follow-up data was sorted from coded diagnoses and the national civil registry. Subjects were matched according to propensity score. Baseline characteristics were compared using Chi-Square and student's Results: This study included 114 subjects who underwent LAAO implantation and 342 subjects treated with NOACs. The mean age of participants was 77.9 ± 7.44 and 77.1 ± 11.2 years in the LAAO and NOAC groups, respectively ( Conclusions: In a pooled analysis of two registries, we found a significantly lower risk for 1-year mortality in patients with AF who were implanted with LAAO than those treated with NOACs. This finding was more prominent in patients with impaired renal function. Future prospective direct studies should further investigate the efficacy and adverse effects of both treatment strategies.
Language	English
Publishing date	2023-10-23
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm12206693
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Article ; Online: Evaluation of coronary disease among patients undergoing transcatheter aortic valve implantation: propensity score matching analysis.

Berkovitch, Anat / Finkelstein, Ariel / Barbash, Israel M / Fefer, Paul / Maor, Elad / Banai, Shmuel / Brodov, Yafim / Goitein, Orly / Aviram, Galit / Halkin, Amir / Guetta, Victor / Steinvil, Arie / Segev, Amit

Clinical research in cardiology : official journal of the German Cardiac Society

2023 Volume 113, Issue 1, Page(s) 11–17

Abstract: Background: Chronic coronary syndrome (CCS) is common among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Current guidelines recommend performance of percutaneous coronary intervention (PCI) of ... ...

Abstract	Background: Chronic coronary syndrome (CCS) is common among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Current guidelines recommend performance of percutaneous coronary intervention (PCI) of any > 70% proximal coronary lesions prior to TAVI. Aims: To evaluate the outcomes of two diagnostic approaches for CCS clearance pre-TAVI and to determine the reduction in the need of invasive angiography (IA). Methods: We investigated 2219 patients undergoing TAVI for severe aortic stenosis at two large centers with different pre-procedural strategies for CCS assessment: pre-TAVI computed tomography angiography (CTA) with selective invasive angiography according to CTA results or mandatory IA. We preformed propensity score matching analysis using a 1:1 ratio. The final study cohort included 870 matched patients. Peri-procedural complications were documented according to the VARC-2 criteria. Mortality rates were prospectively documented. Results: Mean age of the study population was 82 ± 7, of whom 55% were female. Patients in the IA group had significantly higher rates of pre-TAVI PCI compared to the CTA group (39% vs. 22%, p < 0.001). Following TAVI, peri-procedural myocardial infarction (MI) rates were similar between the two groups (0.3% vs. 0.7%, p value = 0.41), but spontaneous MI were significantly lower among the IA group (0% vs. 1.3%, p value = 0.03). Kaplan-Meier's survival analysis found that the cumulative probability of 1-year morality was similar between the two groups (p value log rank = 0.65). Cox regression analysis did not find association between CCS clearance strategy and outcome. Conclusions: In elderly patients, CTA-driven approach for CCS evaluation pre-TAVI is a valid strategy with similar outcome as compared to invasive approach. CTA strategy significantly reduces invasive procedures rates without compromising patient's outcome.
MeSH term(s)	Humans ; Female ; Aged ; Male ; Transcatheter Aortic Valve Replacement/methods ; Percutaneous Coronary Intervention/adverse effects ; Aortic Valve Stenosis/surgery ; Propensity Score ; Heart Valve Prosthesis Implantation/methods ; Treatment Outcome ; Coronary Artery Disease/surgery ; Myocardial Infarction/complications ; Aortic Valve/surgery ; Retrospective Studies
Language	English
Publishing date	2023-03-30
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2213295-8
ISSN	1861-0692 ; 1861-0684
ISSN (online)	1861-0692
ISSN	1861-0684
DOI	10.1007/s00392-023-02175-7
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Article ; Online: Comparison of MANTA versus Perclose Prostyle large-bore vascular closure devices during transcatheter aortic valve implantation.

Barbash, Israel M / Wasserstrum, Yishay / Erlebach, Magdalena / Guetta, Victor / Ziegelmüller, Johannes / Segev, Amit / Fefer, Paul / Maor, Elad / Lange, Rüdiger / Ruge, Hendrik

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

2023 Volume 103, Issue 1, Page(s) 160–168

Abstract: Background: New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD.: Aim: To ... ...

Abstract	Background: New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD. Aim: To compare the safety and efficacy of suture-based Perclose Prostyle as compared to plug-based MANTA device. Methods: A total of 408 consecutive TAVI patients from two high volume TAVI centers were included in the present study. Patients were grouped according to VCD: Prostyle versus MANTA. Propensity score matching (PSM) and multivariable analysis were utilized to compare clinical endpoints between the two groups. The primary endpoint was any vascular complication (VC) according to VARC-3 criteria. Results: After PSM, a total of 264 patients were analyzed, of them 132 in each group. Overall baseline characteristics of the two groups were comparable. Primary end-point was similar between MANTA as compared to Prostyle (16.7% vs. 15.3% respectively, p = 0.888). The main driver for VC among MANTA group were minor vascular complications (15.2%). Conversely, minor and major VC contributed equally to the primary endpoint among Prostyle group (7.6%) (p = 0.013). No outcome predictors were identified in multivariate analysis. Conclusions: VCD for transfemoral TAVI using the new-generation Prostyle device or the MANTA device achieved comparable VARC-3 VC rates.
MeSH term(s)	Humans ; Vascular Closure Devices ; Transcatheter Aortic Valve Replacement/adverse effects ; Treatment Outcome ; Femoral Artery/diagnostic imaging ; Femoral Artery/surgery ; Catheterization, Peripheral/adverse effects ; Aortic Valve Stenosis/diagnostic imaging ; Aortic Valve Stenosis/surgery ; Aortic Valve/diagnostic imaging ; Aortic Valve/surgery ; Hemostatic Techniques/adverse effects
Language	English
Publishing date	2023-12-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	1459995-8
ISSN	1522-726X ; 1522-1946
ISSN (online)	1522-726X
ISSN	1522-1946
DOI	10.1002/ccd.30921
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