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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

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

Postoperative Atrial Fibrillation or Flutter Following Transcatheter or Surgical Aortic Valve Replacement: PARTNER 3 Trial

Shahim, Bahira; Malaisrie, S Chris; George, Isaac; Thourani, Vinod H; Biviano, Angelo B; Russo, Mark; Brown, David L; Babaliaros, Vasilis; Guyton, Robert A; Kodali, Susheel K; Nazif, Tamim M; Kapadia, Samir; Pibarot, Philippe; McCabe, James M; Williams, Mathew; Genereux, Philippe; Lu, Michael; Yu, Xiao; Alu, Maria; Webb, John G; Mack, Michael J; Leon, Martin B; Kosmidou, Ioanna
OBJECTIVES/OBJECTIVE:The aim of this study was to assess the incidence and prognostic impact of early and late postoperative atrial fibrillation or flutter (POAF) in patients with severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). BACKGROUND:There is an ongoing controversy regarding the incidence, recurrence rate, and prognostic impact of early (in-hospital) POAF and late (postdischarge) POAF in patients with AS undergoing TAVR or SAVR. METHODS:In the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial, patients with severe AS at low surgical risk were randomized to TAVR or SAVR. Analyses were performed in the as-treated population excluding patients with preexistent atrial fibrillation or flutter. RESULTS:Among 781 patients included in the analysis, early POAF occurred in 152 (19.5%) (18 of 415 [4.3%] and 134 of 366 [36.6%] following TAVR and SAVR, respectively). Following discharge, 58 new or recurrent late POAF events occurred within 1 year following the index procedure in 55 of 781 patients (7.0%). Early POAF was not an independent predictor of late POAF following discharge (odds ratio: 1.04; 95% CI: 0.52-2.08; P = 0.90). Following adjustment, early POAF was not an independent predictor of the composite outcome of death, stroke, or rehospitalization (hazard ratio: 1.10; 95% CI: 0.64-1.92; P = 0.72), whereas late POAF was associated with an increased adjusted risk for the composite outcome (hazard ratio: 8.90; 95% CI: 5.02-15.74; P < 0.0001), irrespective of treatment modality. CONCLUSIONS:In the PARTNER 3 trial, early POAF was more frequent following SAVR compared with TAVR. Late POAF, but not early POAF, was significantly associated with worse outcomes at 2 years, irrespective of treatment modality.
PMID: 34294398
ISSN: 1876-7605
CID: 4965942

Atrial Fibrillation and Outcomes After Transcatheter or Surgical Aortic Valve Replacement (from the PARTNER 3 Trial)

Shahim, Bahira; Malaisrie, S Chris; George, Isaac; Thourani, Vinod H; Biviano, Angelo B; Russo, Mark J; Brown, David L; Babaliaros, Vasilis; Guyton, Robert A; Kodali, Susheel K; Nazif, Tamim M; McCabe, James M; Williams, Mathew R; Généreux, Philippe; Lu, Michael; Yu, Xiao; Alu, Maria C; Webb, John G; Mack, Michael J; Leon, Martin B; Kosmidou, Ioanna
The prognostic impact of preexisting atrial fibrillation or flutter (AF) in low-risk patients with severe aortic stenosis treated with transcatheter (TAVR) or surgical aortic valve replacement (SAVR) remains unknown. In this sub-analysis of the PARTNER 3 trial of patients with severe aortic stenosis at low surgical risk randomized 1:1 to TAVR versus SAVR, clinical outcomes were analyzed at 2 years according to AF status. Among 948 patients included in the analysis (452 [47.7%] in the SAVR vs 496 [52.3%] in the TAVR arm), 168 (17.6%) patients had AF [88/452 (19.5%) and 80/496 (16.1%) treated with SAVR and TAVR, respectively]. At 2 years, patients with AF had higher unadjusted rates of the composite outcome of death, stroke or rehospitalization (21.2% vs 12.9%, p = 0.007) and rehospitalization alone (15.3% vs 9.4%, p = 0.03) but not all cause death (3.8% vs 2.6%, p = 0.45) or stroke (4.8% vs 2.6%, p = 0.12). In adjusted analyses, patients with AF had a higher risk for the composite outcome of death, stroke or rehospitalization (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.20-2.71, p = 0.0046) and rehospitalization alone (HR 1.8, 95% CI 0.12-2.9, p = 0.015), but not death or stroke. There was no interaction between treatment modality and AF on the composite outcome (Pinter = 0.83). In conclusion, preexisting AF in patients with severe AS at low surgical risk was associated with increased risk of the composite outcome of death, stroke or rehospitalization at 2 years, irrespective of treatment modality.
PMID: 33691183
ISSN: 1879-1913
CID: 4862072

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

Three-year outcomes with a contemporary self-expanding transcatheter valve from the Evolut PRO US Clinical Study

Wyler von Ballmoos, Moritz C; Reardon, Michael J; Williams, Mathew R; Mangi, Abeel A; Kleiman, Neal S; Yakubov, Steven J; Watson, Daniel; Kodali, Susheel; George, Isaac; Tadros, Peter; Zorn, George L; Brown, John; Kipperman, Robert; Oh, Jae K; Qiao, Hongyan; Forrest, John K
BACKGROUND:Paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) is associated with increased morbidity and mortality. PVR continues to plague TAVR jeopardizing long-term results. New device iterations, such as the self-expandable Evolut PRO valve, aim to decrease PVR while maintaining optimal hemodynamics. This study sought to evaluate clinical and hemodynamic performance of the Evolut PRO system at 3 years. METHODS:The Evolut PRO US Clinical Study included 60 patients at high or extreme surgical risk undergoing TAVR with the Evolut PRO valve at 8 centers in the United States. Clinical outcomes were evaluated using Valve Academic Research Consortium (VARC)-2 criteria and included all-cause mortality, cardiovascular mortality, disabling stroke and valve complications. An independent core laboratory centrally assessed all echocardiographic measures. RESULTS:, and 88.2% of patients had no or trace PVR. The remaining patients had mild PVR. Most of the surviving patients (80.6%) had New York Heart Association class I symptoms at 3 years. CONCLUSION/CONCLUSIONS:Outcomes at 3-years following TAVR with a contemporary self-expanding prosthesis are favorable, with no signal of valve deterioration, excellent hemodynamics including very low prevalence of PVR.
PMID: 33199247
ISSN: 1878-0938
CID: 4684412

Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk

Leon, Martin B; Mack, Michael J; Hahn, Rebecca T; Thourani, Vinod H; Makkar, Raj; Kodali, Susheel K; Alu, Maria C; Madhavan, Mahesh V; Chau, Katherine H; Russo, Mark; Kapadia, Samir R; Malaisrie, S Chris; Cohen, David J; Blanke, Philipp; Leipsic, Jonathon A; Williams, Mathew R; McCabe, James M; Brown, David L; Babaliaros, Vasilis; Goldman, Scott; Herrmann, Howard C; Szeto, Wilson Y; Genereux, Philippe; Pershad, Ashish; Lu, Michael; Webb, John G; Smith, Craig R; Pibarot, Philippe
BACKGROUND:In low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year. OBJECTIVES/OBJECTIVE:This study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial. METHODS:This study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis. RESULTS:Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years. CONCLUSIONS:At 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114).
PMID: 33663731
ISSN: 1558-3597
CID: 4806972

Three-Dimensional Imaging and Dynamic Modeling of Systolic Anterior Motion of the Mitral Valve

Vainrib, Alan; Massera, Daniele; Sherrid, Mark V; Swistel, Daniel G; Bamira, Daniel; Ibrahim, Homam; Staniloae, Cezar; Williams, Mathew R; Saric, Muhamed
Left ventricular outflow tract (LVOT) obstruction in hypertrophic cardiomyopathy (HCM) is often caused by systolic anterior motion (SAM) of the mitral valve caused by the interplay between increased left ventricular (LV) wall thickness and an abnormal mitral valve anatomy and geometry. Three-dimensional (3D) echocardiographic imaging of the mitral valve has revolutionized the practice of cardiology, paving the way for new methods to see and treat valvular heart disease. Here we present the novel and incremental value of 3D transesophageal echocardiography (TEE) of SAM visualization. This review first provides step-by-step instructions on acquiring and optimizing 3D TEE imaging of SAM. It then describes the unique and novel findings using standard 3D TEE rendering as well as dynamic mitral valve modeling of SAM from 3D data sets, which can provide a more detailed visualization of SAM features. The findings include double-orifice LVOT caused by the residual leaflet, the dolphin smile phenomenon, and delineation of SAM width. Finally, the review discusses the essential role of 3D TEE imaging for preprocedural assessment and intraprocedural guidance of surgical and novel percutaneous treatments of SAM.
PMID: 33059963
ISSN: 1097-6795
CID: 4641632

Consensus Document on Non-Suitability for Transcatheter Mitral Valve Repair by Edge-to-Edge Therapy

Lim, D S; Herrmann, H C; Grayburn, P; Koulogiannis, K; Ailawadi, G; Williams, M; Ng, V G; Chau, K H; Sorajja, P; Smith, R L; Guerrero, M; Daniels, D; Granada, J F; Mack, M J; Leon, M B; McCarthy, P
EMBASE:2012308194
ISSN: 2474-8706
CID: 4909532