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600 Predictive Model Of Iliofemoral Vascular Complications Following Transfemoral Transcatheter Aortic Valve Replacement: Development And Initial Validation [Meeting Abstract]

Koren, O; Patel, V; Natanzon, S; Tamir, Y; Koseki, K; Kaewkes, D; Naami, R; Naami, E; Chakravarty, T; Cheng, W; Nakamura, M; Jilaihawi, H; Makkar, R
Introduction: Iliofemoral vascular complications (IVC) following TAVR are common and associated with higher adverse events. However, there is no acceptable method to predict IVC.
Method(s): We used the data from 3,706 eligible transfemoral-TAVR patients treated at Cedars-Sinai medical center between 2013 and 2021. We analyzed reconstructed computed tomography images of 516 matched patients to formulate a novel score index (Cedars-Sinai Index, CSI) and a predictive model and validated it on new data of 609 consecutive patients. Pre-procedural alternative access or non-iliofemoral vascular complications were the main exclusion criteria.
Result(s): IVC occurred in a total of 352 (9.1%) patients. The model design cohort includes 516 matched patients (by age, sex, and year of procedure) in a 2:1 ratio of control and study group. Sheath size, the sum of angles, number of curves, minimal lumen diameter (MLD), and sheath-to-femoral artery diameter ratio (SFAR) were significant predictors for IVC. The CSI formula consisting of the multiplication of the sum of angles and the number of curves divided by the MLD had an 84.3% sensitivity and 96.8% specificity (C-stat 0.936, 95% CI 0.911-0.959, p<0.001) for predicting IVC. Setting CSI score > 100 and SFAR >1.0 increased overall accuracy and correctly predicted 97.7% of the complications. The validated model showed a 89.5% sensitivity, 98.9% specificity and 94.2% accuracy (C-stat 0.942, 95% CI 0.904-0.980, p<.0001).
Conclusion(s): Our proposed model is simple-to-use and accurately identifies patients at high risk for IVC. The model may be useful to implement in the pre-procedural planning of TAVR. [Formula presented] [Formula presented] [Formula presented]
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EMBASE:2019317572
ISSN: 1876-861x
CID: 5291852

The PARTNER 3 Bicuspid Registry for Transcatheter Aortic Valve Replacement in Low-Surgical-Risk Patients

Williams, Mathew R; Jilaihawi, Hasan; Makkar, Raj; O'Neill, William W; Guyton, Robert; Malaisrie, S Chris; Brown, David L; Blanke, Philipp; Leipsic, Jonathon A; Pibarot, Philippe; Hahn, Rebecca T; Leon, Martin B; Cohen, David J; Bax, Jeroen J; Kodali, Susheel K; Mack, Michael J; Lu, Michael; Webb, John G
OBJECTIVES/OBJECTIVE:The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patients with bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology. BACKGROUND:There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patients with severe, symptomatic aortic stenosis and bicuspid anatomy. METHODS:Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization. RESULTS:Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P = 0.96). CONCLUSIONS:Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid aortic stenosis.
PMID: 35272777
ISSN: 1876-7605
CID: 5177622

The safety of early discharge following transfemoral transcatheter aortic valve replacement under general anesthesia

Koren, Ofir; Patel, Vivek; Kohan, Siamak; Naami, Robert; Naami, Edmund; Allison, Zev; Natanzon, Sharon Shalom; Shechter, Alon; Nagasaka, Takashi; Al Badri, Ahmed; Devanabanda, Arvind Reddy; Nakamura, Mamoo; Cheng, Wen; Jilaihawi, Hasan; Makkar, Raj R
Background/UNASSIGNED:There is growing evidence of the safety of same-day discharge for low-risk conscious sedated TAVR patients. However, the evidence supporting the safety of early discharge following GA-TAVR with routine transesophageal echocardiography (TEE) is limited. Aims/UNASSIGNED:To assess the safety of early discharge following transcatheter aortic valve replacement (TAVR) using General Anesthesia (GA-TAVR) and identify predictors for patient selection. Materials and methods/UNASSIGNED:We used data from 2,447 TEE-guided GA-TAVR patients performed at Cedars-Sinai between 2016 and 2021. Patients were categorized into three groups based on the discharge time from admission: 24 h, 24-48 h, and >48 h. Predictors for 30-day outcomes (cumulative adverse events and death) were validated on a matched cohort of 24 h vs. >24 h using the bootstrap model. Results/UNASSIGNED:= 0.04). Our formulated predictors showed a good discrimination ability for patient selection (AUC: 0.78, 95% CI 0.75-0.81). Conclusion/UNASSIGNED:Discharge within 24 h following GA-TAVR using TEE is safe for selected patients using our proposed validated predictors.
PMCID:9634245
PMID: 36337882
ISSN: 2297-055x
CID: 5356992

New adverse coronary events in valve-in-valve TAVR and native TAVR-A 2-year matched cohort

Koren, Ofir; Patel, Vivek; Naami, Robert; Naami, Edmund; Nagasaka, Takashi; Shechter, Alon; Natanzon, Sharon Shalom; Kohan, Siamak; Allison, Zev; Lerner, Addee; Cheng, Daniel Eugene; Chakravarty, Tarun; Nakamura, Mamoo; Cheng, Wen; Jilaihawi, Hasan; Makkar, Raj R
Objective/UNASSIGNED:To assess the incidence of new adverse coronary events (NACE) following transcatheter aortic valve replacement (TAVR) and valve-in-valve TAVR (ViV-TAVR). Background/UNASSIGNED:ViV-TAVR is an accepted treatment for degenerative prostheses among patients with high surgical-risk. TAVR studies have suggested an increased risk of coronary artery obstruction and flow stasis causing thrombus formation. Whether contemporary ViV-TAVR is associated with higher rate of coronary events compared to TAVR is unknown. Methods/UNASSIGNED:We used data from 1,224 TAVR patients between 2016 and 2021. We propensity-matched patients following ViV-TAVR and TAVR by significant predictors to overcome confounders in patients' baseline characteristics and procedural factors. Results/UNASSIGNED:< 0.0001, respectively). Conclusion/UNASSIGNED:At 2-year follow-up, ViV-TAVR was not associated with a higher rate of myocardial infarction, unplanned catheterization, coronary artery bypass grafting, or hypoattenuated leaflet thickening.
PMCID:9532571
PMID: 36211543
ISSN: 2297-055x
CID: 5360792

Transcatheter Aortic Valve Leaflet Thrombosis: Prevalence, Management, and Future Directions

Nakashima, Makoto; Jilaihawi, Hasan
PURPOSE OF REVIEW/OBJECTIVE:We review the pathology, prevalence, diagnosis, hemodynamics, risk factors, prognosis, and treatment of leaflet thrombosis (LT), and suggest future directions in this field. RECENT FINDINGS/RESULTS:The latest meta-analysis showed the prevalence of overall LT is 5.4% (clinical LT of 1.2% and subclinical LT of 15.1%). Either subclinical or clinical LT is not associated with risk of mortality; however, clinical LT is associated with increased risk of stroke. Although LT can be reduced by oral anticoagulation therapy (OAT), routine use of OAT as primary prevention for high-risk patients is not recommended due to increased risk of mortality. Four-dimensional computed tomography plays an important role in the diagnosis of LT and the accumulation of qualitative or qualitative assessments of hypoattenuated leaflet thickening would provide more clues to clarify effective OAT strategies. In addition, further studies are warranted to evaluate the efficacy of other anticoagulants in low-intermediate risk patients.
PMID: 34762219
ISSN: 1534-3170
CID: 5050672

Multiphase Assessment of Mitral Annular Dynamics in Consecutive Patients With Significant Mitral Valve Disease

Nakashima, Makoto; Williams, Mathew; He, Yuxin; Latson, Larry; Saric, Muhamed; Vainrib, Alan; Staniloae, Cezar; Hisamoto, Kazuhiro; Ibrahim, Homam; Querijero, Michael; Tovar, Joseph; Kalish, Chloe; Pushkar, Illya; Jilaihawi, Hasan
OBJECTIVES/OBJECTIVE:The aim of this study was to clarify the dynamics of the mitral annulus throughout the cardiac cycle and its relevance to transcatheter mitral valve replacement (TMVR) sizing and case selection. BACKGROUND:Limited data are available regarding the relevance of mitral annular (MA) and neo-left ventricular outflow tract (LVOT) dynamics in the overall population presenting with significant mitral valve disease. METHODS:Patients attending a combined surgical-transcatheter heart valve clinic for severe symptomatic mitral valve disease were assessed using multiphase computed tomography. The relative influence of MA and neo-LVOT dynamics to TMVR case selection was studied. RESULTS:A total of 476 patients with significant mitral valve disease were evaluated. In 99 consecutive patients with severe mitral regurgitation, a 10-phase assessment showed that the mitral annulus was on average largest in late systole. On comparing maximal MA dimension with late systolic dimension, TMVR size assignment changed in 24.2% of patients. If the average MA perimeter was used to determine sizing, 48.5% were excluded because of MA dimension being too large; in a multiphase assessment of the neo-LVOT, an additional 16.2% were excluded on the basis of neo-LVOT dimension. In an expanded series of 312 consecutive patients, selection protocol influenced anatomical exclusion: a manufacturer-proposed early systolic approach excluded 69.2% of patients, whereas a late systolic approach excluded 82.7% of patients, the vast majority because of large mitral annuli. CONCLUSIONS:Contemporary TMVR can treat only a minority of patients with severe mitral regurgitation, principally because of limitations of large MA dimension.
PMID: 34600871
ISSN: 1876-7605
CID: 5026992

Conduction Disturbances and Pacing in Transcatheter Aortic Valve Replacement

Nakashima, Makoto; Jilaihawi, Hasan
Conduction disturbances (CDs) after transcatheter artic replacement remain a clinical concern and relatively common complication. A recent meta-analysis showed both new-onset persistent left bundle branch block and new permanent pacemaker implantation were related to all-cause death with risk ratio 1.32 (95% confidence interval [CI] 1.17 to 1.49; P<.001) and 1.17 (95% CI 1.11-1.25; P<.001) at 1 year, respectively. Preprocedural computed tomography imaging can highlight potential risk factors for CDs, such as membranous septum length, device landing zone calcium, and the annulus size/degree of device oversizing.
PMID: 34593109
ISSN: 2211-7466
CID: 5039472

Long-term outcomes after transcatheter aortic valve replacement with minimal contrast in chronic kidney disease

Rzucidlo, Justyna; Jaspan, Vita; Paone, Darien; Jilaihawi, Hasan; Xia, Yuhe; Kapitman, Anna; Nakashima, Makoto; He, Yuxin; Ibrahim, Homam; Pushkar, Illya; Neuburger, Peter J; Saric, Muhamed; Bamira, Daniel; Paschke, Sonja; Kalish, Chloe; Staniloae, Cezar; Shah, Binita; Williams, Mathew
BACKGROUND:Patients with renal insufficiency have poor short-term outcomes after transcatheter aortic valve replacement (TAVR). METHODS:Retrospective chart review identified 575 consecutive patients not on hemodialysis who underwent TAVR between September 2014 and January 2017. Outcomes were defined by VARC-2 criteria. Primary outcome of all-cause mortality was evaluated at a median follow-up of 811 days (interquartile range 125-1,151). RESULTS:Preprocedural glomerular filtration rate (GFR) was ≥60 ml/min in 51.7%, 30-60 ml/min in 42.1%, and < 30 ml/min in 6.3%. Use of transfemoral access (98.8%) and achieved device success (91.0%) did not differ among groups, but less contrast was used with lower GFR (23 ml [15-33], 24 ml [14-33], 13 ml [8-20]; p < .001). Peri-procedural stroke (0.7%, 2.1%, 11.1%; p < .001) was higher with lower GFR. Core lab analysis of preprocedural computed tomography scans of patients who developed a peri-procedural stroke identified potential anatomic substrate for stroke in three out of four patients with GFR 30-60 ml/min and all three with GFR <30 ml/min (severe atheroma was the most common subtype of anatomical substrate present). Compared to GFR ≥60 ml/min, all-cause mortality was higher with GFR 30-60 ml/min (HR 1.61 [1.00-2.59]; aHR 1.61 [0.91-2.83]) and GFR <30 ml/min (HR 2.41 [1.06-5.48]; aHR 2.34 [0.90-6.09]) but not significant after multivariable adjustment. Follow-up echocardiographic data, available in 63%, demonstrated no difference in structural heart valve deterioration over time among groups. CONCLUSIONS:Patients with baseline renal insufficiency remain a challenging population with poor long-term outcomes despite procedural optimization with a transfemoral-first and an extremely low-contrast approach.
PMID: 33180381
ISSN: 1522-726x
CID: 4665422

Orbital Atherectomy of the Iliofemoral Arteries Facilitates Large-Bore Access Prior to Transfemoral Transcatheter Aortic Valve Replacement

Staniloae, Cezar; Ibrahim, Homam; Fuentes, Jorge; Gonzales, Carlos; Kapitman, Anna; Vidal, Samantha; Paschke, Sonja; Hisamoto, Kazuhiro; Jilaihawi, Hasan; Williams, Mathew
OBJECTIVES/OBJECTIVE:To describe the use of orbital atherectomy to prepare iliofemoral vessels for large-bore access prior to transcatheter aortic valve replacement (TAVR). BACKGROUND:Transfemoral (TF)-TAVR has been shown to be at least equivalent to surgery. Nevertheless, many patients do not qualify for the TF approach due to severe iliofemoral occlusive disease. The use of an atherectomy device in order to facilitate TF-TAVR has only been reported in case reports. METHODS:We performed 1000 TAVR procedures from June 2017 to October 2019. Patient demographics, procedural characteristics, computed tomography characteristics, and short-term outcomes were recorded. Hostile access was defined as luminal size <5 mm, or <5.5 mm along with the presence of >270° calcification. The primary endpoint was the ability to successfully deliver a transcatheter valve via the intended pretreated access site. RESULTS:During the study period, 6 subjects (0.6%) required alternative access and 68 patients (6.8%) were considered to have a hostile iliofemoral anatomy that required vessel preparation prior to TAVR. Forty-eight patients (70.6%) had angioplasty only and 20 patients (29.4%) required atherectomy and angioplasty. Out of 20 patients treated with atherectomy, successful TF delivery of the valve was achieved in 19 patients (95%). 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. CONCLUSION/CONCLUSIONS:Orbital atherectomy used for vessel preparation is a safe and very effective technique to facilitate TF-TAVR in patients with hostile peripheral anatomy.
PMID: 34280891
ISSN: 1557-2501
CID: 4947972

Novel Computed Tomography Classification for Bioprosthetic Aortic Valve Degeneration: Guiding Trial of Anticoagulation or Reintervention [Letter]

Nakashima, Makoto; Williams, Mathew; He, Yuxin; Du, Run; Saric, Muhamed; Staniloae, Cezar; Querijero, Michael; Pushkar, Illya; Kapitman, Anna; Jilaihawi, Hasan
PMID: 33640385
ISSN: 1876-7605
CID: 4800972