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Vainrib, A; Jilaihawi, H; Nakashima, M; Paschke, S; Tovar, J; Staniloae, C; Ibrahim, H; Querijero, M; Hisamoto, K; L, L L; Gonzalez, C; Fuentes, J; Saric, M; Williams, M
Background Transesophageal echocardiography (TEE) is the gold standard for determining mitral regurgitant (MR) leaflet morphology and suitability for edge-to-edge (E2E) repair. Computed tomography (CT) has become essential for evaluation for transcatheter mitral valve replacement (TMVR) and has the temporal and spatial resolution to show leaflet abnormalities with great clarity (figure) but the correlation of findings with TEE has not been well studied. Methods A consecutive series of patients attending clinic for moderate-severe or greater mitral regurgitation underwent CT and TEE. Data was analyzed for leaflet morphology with blinded independent analyses by CT and TEE expert readers. Results A study flow diagram is shown (figure). Mean age was 79.6 (SD 10.9) and mean STS score (repair) was 4.8% (SD3.7). Analyses were independently performed (figure). There was a strong correlation between mitral valve orifice area (MVOA) by CT and TEE (r=0.86, p<0.001), however MVOA was on average 0.45 cm2 larger (p=0.003) on CT (5.24cm2, SD 1.84) than TEE (4.79cm2, SD 1.91). For those cases where CT could make an interpretation on suitability for E2E repair there was 100% concordance between CT and TEE (figure). Conclusion In this preliminary retrospective analysis, a comparison of CT and TEE suggested that CT may be a useful non-invasive modality for the assessment of mitral leaflet morphology and suitability for E2E repair. A prospective comparison is ongoing and will be completed at the time of presentation. [Figure presented]
ISSN: 1558-3597
CID: 4381072


Ibrahim, H; Tovar, J; Pushkar, I; Lengua, C G; Fuentes, J; Jilaihawi, H; Querijero, M; Vainrib, A; Staniloae, C; Saric, M; Williams, M
Background Mitral valve (MV) repair using the MitraClip system is indicated for patients with severe mitral regurgitation (MR) and high surgical risk. However, patients with small MV area are at risk of post procedural mitral stenosis (MS) and have typically been excluded from this therapy. We evaluated MitraClip feasibility in patients with small MV area. Methods Consecutive patients with severe MR were identified. MV area was measured using 3D planimetry. Small MV area was defined as < 4 cm2. Procedural success defined as reduction to >= 2+ MR in absence of surgery, or mortality. Primary endpoint was clinically significant MS defined as residual MV gradient >= 5 mmHg and NYHA class III or IV symptoms. NYHA class at 30 days was evaluated. Results 295 patients were treated from Mar 2016 to Jul 2019. Procedural success was seen in 281 of 295 patients (95%). 63 patients (21%) had a small MV area [Median 3.5 cm2, range 2.0-3.9]. Mean age (85 +/- 7), female (65%). At baseline NYHA class was: II: 11, III: 39, and IV: 13 patients. Median post procedure MV gradient was 4 mmHg (range 2-7) at a median heart rate of 70. 13/63 patients had MV gradient >= 5 mmHg, of those only two patients had no improvement in NYHA class despite a reduction in MR. 30-day NYHA class I, II, III, and IV symptoms were seen in 30, 24, 8, and 1 patients (P<0.01 for trend). (Figure) Conclusion MV repair using MitraClip is feasible for patients with small MV area. Post procedural clinically significant MS was rare. Studies with long term outcomes are warranted. [Figure presented]
ISSN: 1558-3597
CID: 4381082


Sin, D; Ibrahim, H; Pushkar, I; Gaiha, P; Vainrib, A; Jilaihawi, H; Staniloae, C; Williams, M
Background Software to fuse transesophageal echocardiography (TEE) images onto live fluoroscopy (FL) allows for fluoroscopic visualization of TEE-derived anatomic landmarks. We compared transcatheter Paravalvular Leak (PVL) Closure using TEE / Truefusion versus TEE / FL guidance only. Methods This prospective pilot study evaluated the safety and feasibility of the TrueFusion software in subjects scheduled for paravalvular leak (PVL) closure. Immediately prior to the procedure, TEE and FL systems were co-registered and anatomical markers for the source of PVL were generated. Procedural outcomes recorded were the reduction in regurgitant grade, procedural time, FL time, and radiation exposure. They were compared between patients who underwent PVL closure with and without TrueFusion. Results The cohort (n=27), Male (60%), age 72 +/- 15 years. 15 subjects underwent TrueFusion-guided PLV closure (10 mitral and 5 aortic). Eleven subjects had non-TrueFusion PVL closure (5 mitral and 2 aortic). TrueFusion-guided PVL closures demonstrated significantly greater achievement of at least one grade reduction in PVL severity (p=0.02). Use of TrueFusion group also showed a non-statistically significant trend toward lower median FL time, mean dose area product, and mean procedural time when compared to PVL closures without TrueFusion guidance (Figure). Conclusion The co-registration of TEE and fluoroscopy images using the TrueFusion software potentially improves efficiency outcomes. [Figure presented]
ISSN: 1558-3597
CID: 4381092


Staniloae, C; Ibrahim, H; Sin, D; Fuentes, J; Gonzalez-Lengua, C A; Pushkar, I; Nakashima, M; Jilaihawi, H; Williams, M
Background Transfemoral (TF) Transcatheter Aortic Valve Replacement (TAVR) has been shown to be at least equivalent to surgery. Nevertheless, many patients do not qualify for TF approach due to severe ilio-femoral (I-F) occlusive disease. The use of an atherectomy device in order to facilitate TF-TAVR has only been reported in case reports. We describe our experience using orbital atherectomy in preparation for TF-TAVR. Methods We searched our prospective database for the last 1000 TAVR procedures. Patient demographics, procedural characteristics, CT characteristics and short-term outcomes were recorded. CT scans were reviewed to assess access. Hostile access was defined as luminal size less than 5 mm, or less than 5.5mm and the presence of more than 270degree calcification. The primary end-point was the ability to successfully deliver a transcatheter valve via the intended, pre-treated access site. Secondary end-points were procedural vascular complications including mortality, stroke, bleeding requiring transfusion, and urgent vascular repair at 30 days. Results From April 2016 to July 2019, 1000 TAVR procedures were performed. Six subjects (0.6%) required alternative access; 68 patients (6.8%) were labeled as having a hostile I-F anatomy that required vessel preparation prior to TAVR. 48 (70.6%) had angioplasty only and 20 (29.4%) required atherectomy and angioplasty. Atherectomy was performed in a range of 5-21 days prior to TAVR; transradial approach was used in 90% of the time. Out of 20 patients treated with atherectomy successful TF delivery of the valve was achieved in 19 (95%). The mean vessel reference diameter in atherectomy group was 4.0+/-0.9mm. All had near-circumferential calcification. There was no in-hospital mortality or stroke. There were no perforations. One subject required placement of a self-expandable stent due to severe dissection. None of the end-points occurred between hospital discharge and 30-day follow-up. Conclusion Orbital atherectomy used for vessel preparation is a safe and very effective technique to facilitate TF-TAVR in patients with hostile peripheral anatomy.
ISSN: 1558-3597
CID: 4381122

Sex-Related Differences in the Outcomes of Endovascular Interventions for Chronic Limb-Threatening Ischemia: Results from the LIBERTY 360 Study

Giannopoulos, Stefanos; Shammas, Nicolas W; Cawich, Ian; Staniloae, Cezar S; Adams, George L; Armstrong, Ehrin J
Introduction/UNASSIGNED:Previous studies have suggested that women with chroniclimb-threatening ischemia (CLTI) may have worse outcomes than men. The aim of this study was to determine whether there are sex-related differences in outcomes of patients with CLTI undergoing endovascular treatment with current endovascular technologies. Patients and Methods/UNASSIGNED:Data were derived from the LIBERTY 360 study (NCT01855412). Hazard ratios and the respective 95% confidence intervals were synthesized to examine the association between sex and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE) and major amputation/death up to 3 years of follow-up. Results/UNASSIGNED:A total of 689 patients with CLTI (female: N=252 vs male: N=437) treated with any FDA approved or cleared device were included. The mean lesion length was 126.9±117.3mm and 127.4±113.3mm for the female and male patients, respectively. Although a slightly higher incidence of in-hospital mortality was observed in the female group (1.2% vs 0.0%, p=0.049), there was no difference in female vs male survival rates during follow-up. However, the risk of major amputation at 18 months was higher for the male group (male vs female: HR: 2.36; 95% CI: 1.09-5.12; p=0.030). No difference between the two groups was detected in terms of TVR or MAE during follow-up. Discussion/UNASSIGNED:Data regarding sex-related disparity in outcomes after endovascular therapy of patients with CLTI are conflicting. Gender-related characteristics rather than biological sex characteristics might be the cause of these conflicting findings. Further studies are needed to evaluate the role of sex in revascularization outcomes among this high-risk population.
PMID: 32753875
ISSN: 1178-2048
CID: 4554012

Preprocedural P2Y12 inhibition and decrease in platelet count following transcatheter aortic valve replacement

Ibrahim, Homam; Vapheas, Eleonora; Shah, Binita; AlKhalil, Ahmad; Querijero, Michael; Jilaihawi, Hasan; Neuburger, Peter; Staniloae, Cezar; Williams, Mathew R
BACKGROUND:inhibition prevents postprocedural thrombocytopenia is uncertain. METHODS: platelets/μL; n = 14), or without baseline platelet count (n = 4) were excluded. The primary outcome was proportion of patients who developed >20% decrease in platelet count from baseline to day 1 post-TAVR. RESULTS:inhibition developed thrombocytopenia on day 1 post-TAVR (25.5% vs. 36.4%, p = .1). CONCLUSION/CONCLUSIONS:inhibition prior to TAVR were less likely to demonstrate a decrease in platelet count after TAVR. Prospective studies to further understand the clinical implication of these findings are warranted.
PMID: 31062487
ISSN: 1522-726x
CID: 3928742

Factors predicting persistence of AV nodal block in post-TAVR patients following permanent pacemaker implantation

Lader, Joshua M; Barbhaiya, Chirag R; Subnani, Kishore; Park, David; Aizer, Anthony; Holmes, Douglas; Staniloae, Cezar; Williams, Mathew R; Chinitz, Larry A
INTRODUCTION/BACKGROUND:A common complication of TAVR is development of conduction defects requiring pacemaker (PPM) implantation. These defects are not universally permanent. OBJECTIVE:To determine the incidence and predictors of persistent device dependency in patients with PPM implantation following TAVR with a self-expanding prosthesis. METHODS:Records of patients who underwent post-TAVR PPM implantation were reviewed. Patients with persistent complete AV block (AVBIII) one month post-TAVR were compared to those regaining conduction. RESULTS:Between September 2014 and March 2017, 485 patients underwent TAVR with a self-expanding prosthesis; 77 (15.9%) underwent PPM implantation for AVBIII. Device interrogation at one month was available for 61 patients (79%): 22 (36.1%) had resolution of AVBIII while 39 (63.9%) remained pacemaker-dependent. Pre-TAVR RBBB was more frequent in device-dependent patients (19 of 38, 50% vs 4 of 22, 18%; RR 2.75; p = 0.01). Device-dependence was associated with AVBIII as the first post-procedural rhythm (37 of 39, 95% vs 12 of 22, 55%; RR 1.74; p<0.0001), earlier implantation (median 1d, IQR: 0-1.5d vs 2d, IQR: 1.0-4.0d, p = 0.0004), and a shorter duration of hospitalization (median 3d, IQR: 2-3.5d vs 4d, IQR: 2-5.75d, p = 0.03). Pacemaker dependence was also associated with a higher prosthesis-to-LVOT diameter (1.45±0.11 vs 1.39±0.07; p = 0.02) and the lack of prior aortic valvuloplasty (5 of 39, 13% vs 8 of 22, 36%; RR 0.35; p = 0.03). CONCLUSIONS:In patients receiving a PPM following self-expanding TAVR, a long-term pacing requirement can be predicted from the timing of AV block, existing conduction-system disease, larger prosthesis-to-LVOT diameter, and the lack of aortic valvuloplasty. This article is protected by copyright. All rights reserved.
PMID: 31429947
ISSN: 1540-8159
CID: 4046752

Minimizing Permanent Pacemaker Following Repositionable Self-Expanding Transcatheter Aortic Valve Replacement

Jilaihawi, Hasan; Zhao, Zhengang; Du, Run; Staniloae, Cezar; Saric, Muhamed; Neuburger, Peter J; Querijero, Michael; Vainrib, Alan; Hisamoto, Kazuhiro; Ibrahim, Homam; Collins, Tara; Clark, Emily; Pushkar, Illya; Bamira, Daniel; Benenstein, Ricardo; Tariq, Afnan; Williams, Mathew
OBJECTIVES/OBJECTIVE:This study sought to minimize the risk of permanent pacemaker implantation (PPMI) with contemporary repositionable self-expanding transcatheter aortic valve replacement (TAVR). BACKGROUND:Self-expanding TAVR traditionally carries a high risk of PPMI. Limited data exist on the use of the repositionable devices to minimize this risk. METHODS:At NYU Langone Health, 248 consecutive patients with severe aortic stenosis underwent TAVR under conscious sedation with repositionable self-expanding TAVR with a standard approach to device implantation. A detailed analysis of multiple factors contributing to PPMI was performed; this was used to generate an anatomically guided MInimizing Depth According to the membranous Septum (MIDAS) approach to device implantation, aiming for pre-release depth in relation to the noncoronary cusp of less than the length of the membranous septum (MS). RESULTS:Right bundle branch block, MS length, largest device size (Evolut 34 XL; Medtronic, Minneapolis, Minnesota), and implant depth > MS length predicted PPMI. On multivariate analysis, only implant depth > MS length (odds ratio: 8.04 [95% confidence interval: 2.58 to 25.04]; p < 0.001) and Evolut 34 XL (odds ratio: 4.96 [95% confidence interval: 1.68 to 14.63]; p = 0.004) were independent predictors of PPMI. The MIDAS approach was applied prospectively to a consecutive series of 100 patients, with operators aiming to position the device at a depth of < MS length whenever possible; this reduced the new PPMI rate from 9.7% (24 of 248) in the standard cohort to 3.0% (p = 0.035), and the rate of new left bundle branch block from 25.8% to 9% (p < 0.001). CONCLUSIONS:Using a patient-specific MIDAS approach to device implantation, repositionable self-expanding TAVR achieved very low and predictable rates of PPMI which are significantly lower than previously reported with self-expanding TAVR.
PMID: 31473236
ISSN: 1876-7605
CID: 4066832

Transcatheter Aortic Valve Replacement With the HLT Meridian Valve

Rodés-Cabau, Josep; Williams, Mathew R; Wijeysundera, Harindra C; Kereiakes, Dean J; Paradis, Jean-Michel; Staniloae, Cezar; Saric, Muhamed; Radhakrishnan, Sam; Wilson, Robert F; Kubo, Spencer H
BACKGROUND:While most self-expanding transcatheter valves are repositionable, only one fully retrievable valve is currently available. The Meridian valve is a new self-expanding valve with full retrievability properties. The objective of our study was to evaluate the early feasibility, preliminary safety, and efficacy of transcatheter aortic valve replacement with the HLT Meridian valve (HLT, Inc). METHODS:This was a multicenter early feasibility study including patients with severe aortic stenosis at high surgical risk undergoing transfemoral transcatheter aortic valve replacement with the 25-mm Meridian valve. All serious adverse events were adjudicated by an independent clinical events committee according to Valve Academic Research Consortium-2 criteria. Echocardiography data were assessed by an independent echocardiography core laboratory. RESULTS:A total of 25 patients (mean age, 85±6 years; 80% of men) were included. The valve was successfully implanted in 22 (88%) patients (annulus too large and extreme horizontal aorta in 2 and 1 unsuccessful cases, respectively). Valve retrieval because of an initial nonadequate positioning was attempted and successfully performed in 10 (40%) patients. Echocardiography post-transcatheter aortic valve replacement showed a low mean residual gradient (10±4 mm Hg) and the absence of moderate-severe aortic regurgitation (none-trace and mild aortic regurgitation in 76% and 24% of patients, respectively). Mortality at 30 days was 8%, with no cases of disabling stroke, valve embolization, or major/life-threatening bleeding complications. At 6-month follow-up, the cumulative mortality rate was 12%, with no changes in echocardiographic parameters and no cases of valve dysfunction. The majority of patients (89%) were in New York Heart Association class I-II at 6 months. CONCLUSIONS:Transcatheter aortic valve replacement with the Meridian valve was feasible and associated with acceptable early and 6-month clinical results. Valve retrieval after full valve deployment was successfully performed in all attempted cases, and valve performance was excellent, with low residual gradients, no cases of moderate-severe aortic regurgitation, and none-trace residual aortic regurgitation in the majority of patients. CLINICAL TRIAL REGISTRATION/BACKGROUND:URL: Unique identifier: NCT02838680 (RADIANT-Canada); NCT02799823 (RADIANT-US).
PMID: 31362540
ISSN: 1941-7632
CID: 4010982

Outcomes After Transcatheter Mitral Valve Repair in Patients With Renal Disease

Shah, Binita; Villablanca, Pedro A; Vemulapalli, Sreekanth; Manandhar, Pratik; Amoroso, Nicholas S; Saric, Muhamed; Staniloae, Cezar; Williams, Mathew R
BACKGROUND:Renal disease is associated with poor prognosis despite guideline-directed cardiovascular therapy, and outcomes by sex in this population remain uncertain. METHODS AND RESULTS/RESULTS:Patients (n=5213) who underwent a MitraClip procedure in the National Cardiovascular Data Registry Transcatheter Valve Therapy registry were evaluated for the primary composite outcome of all-cause mortality, stroke, and new requirement for dialysis by creatinine clearance (CrCl). Centers for Medicare and Medicaid Services-linked data were available in 63% of patients (n=3300). CrCl was <60 mL/min in 77% (n=4010) and <30 mL/min in 23% (n=1183) of the cohort. Rates of primary outcome were higher with lower CrCl (>60 mL/min, 1.4%; 30-<60 mL/min, 2.7%; <30 mL/min, 5.2%; dialysis, 7.8%; P<0.001), and all low CrCl groups were independently associated with the primary outcome (30-<60 mL/min: adjusted odds ratio, 2.32; 95% CI, 1.38-3.91; <30 mL/min: adjusted odds ratio, 4.44; 95% CI, 2.63-7.49; dialysis: adjusted hazards ratio, 4.52; 95% CI, 2.08-9.82) when compared with CrCl >60 mL/min. Rates of 1-year mortality were higher with lower CrCl (>60 mL/min, 13.2%; 30-<60 mL/min, 18.8%; <30 mL/min, 29.9%; dialysis, 32.3%; P<0.001), and all low CrCl groups were independently associated with 1-year mortality (30-<60 mL/min: adjusted hazards ratio, 1.50; 95% CI, 1.13-1.99; <30 mL/min: adjusted hazards ratio, 2.38; 95% CI, 1.78-3.20; adjusted hazards ratio: dialysis, 2.44; 95% CI, 1.66-3.57) when compared with CrCl >60 mL/min. CONCLUSIONS:The majority of patients who undergo MitraClip have renal disease. Preprocedural renal disease is associated with poor outcomes, particularly in stage 4 or 5 renal disease where 1-year mortality is observed in nearly one-third. Studies to determine how to further optimize outcomes in this population are warranted.
PMID: 30704286
ISSN: 1941-7632
CID: 3626862