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Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017

Villablanca, Pedro A; Vemulapalli, Sreekanth; Stebbins, Amanda; Dai, Dadi; So, Chak-Yu; Eng, Marvin H; Wang, Dee Dee; Frisoli, Tiberio M; Lee, James C; Kang, Guson; Szerlip, Molly; Ibrahim, Homam; Staniloae, Cezar; Gaba, Prakriti; Lemor, Alejandro; Finn, Matthew; Ramakrishna, Harish; Williams, Mathew R; Leon, Martin B; O'Neill, William W; Shah, Binita
BACKGROUND:Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. METHODS:The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. RESULTS:<0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex. CONCLUSIONS:No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.
PMID: 34784236
ISSN: 1941-7632
CID: 5049102

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

Acquired pulmonary vein stenosis resulting in haemoptysis: a case series [Case Report]

Talmor, Nina; Massera, Daniele; Small, Adam; Ramachandran, Abhinay; Argilla, Michael; Staniloae, Cezar S; Latson, Larry A; Halpern, Dan G
Background/UNASSIGNED:Acquired pulmonary vein stenosis (PVS) is an infrequent complication of atrial fibrillation ablation that is often misdiagnosed due to predominant respiratory symptoms. It can result in pulmonary venous hypertension, with varying presentations, ranging from shortness of breath to haemoptysis. Case summary/UNASSIGNED:We report two patients with a history of paroxysmal atrial fibrillation treated with radiofrequency ablation and pulmonary vein (PV) isolation, who subsequently developed PVS. Case 1 initially presented with indolent symptoms of shortness of breath and cough. He was initially diagnosed with and treated for pneumonia. In contrast, Case 2 presented with massive haemoptysis, requiring intubation and intensive care unit admission. Both patients were eventually diagnosed with PVS by computed tomography. They were treated with PV angioplasty and stenting. Discussion/UNASSIGNED:While previously limited to the congenital heart disease population, PVS is occurring more frequently now in adult patients as a complication of ablation procedures. It is most effectively treated with angioplasty and stent implantation but has a high rate of recurrence.
PMCID:8243221
PMID: 34222784
ISSN: 2514-2119
CID: 4932892

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-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

Therapeutic blockade of inflammation in severe COVID-19 infection with intravenous n-acetylcysteine

Ibrahim, Homam; Perl, Andras; Smith, Deane; Lewis, Tyler; Kon, Zachary; Goldenberg, Ronald; Yarta, Kinan; Staniloae, Cezar; Williams, Mathew
Glucose 6-phosphate dehydrogenase (G6PD) deficiency facilitates human coronavirus infection due to glutathione depletion. G6PD deficiency may especially predispose to hemolysis upon coronavirus disease-2019 (COVID-19) infection when employing pro-oxidant therapy. However, glutathione depletion is reversible by N-acetylcysteine (NAC) administration. We describe a severe case of COVID-19 infection in a G6PD-deficient patient treated with hydroxychloroquine who benefited from intravenous (IV) NAC beyond reversal of hemolysis. NAC blocked hemolysis and elevation of liver enzymes, C-reactive protein (CRP), and ferritin and allowed removal from respirator and veno-venous extracorporeal membrane oxygenator and full recovery of the G6PD-deficient patient. NAC was also administered to 9 additional respirator-dependent COVID-19-infected patients without G6PD deficiency. NAC elicited clinical improvement and markedly reduced CRP in all patients and ferritin in 9/10 patients. NAC mechanism of action may involve the blockade of viral infection and the ensuing cytokine storm that warrant follow-up confirmatory studies in the setting controlled clinical trials.
PMCID:7374140
PMID: 32707089
ISSN: 1521-7035
CID: 4539812

LONG TERM MORTALITY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATINTS WITH CHRONIC KIDNEY DISEASE NOT ON HEMODIALYSIS [Meeting Abstract]

Rzucidlo, J; Jaspan, V; Shah, B; Paone, D; Pushkar, I; Kapitman, A; Ibrahim, H; Hisamoto, K; Neuburger, P; Saric, M; Staniloae, C; Vainrib, A; Bamira, D; Jilaihawi, H; Querijero, M; Williams, M
Background Patients with chronic kidney disease (CKD) have poor short-term outcomes after transcatheter aortic valve replacement (TAVR). Methods Retrospective review identified 575 consecutive patients not on hemodialysis (HD) who underwent TAVR at a single center between September 2014 and January 2017. Patients were stratified by pre-procedural glomerular filtration rate (GFR) [>60 (n=297), 30-60 (n=242), and <30 (n=36)]. Outcomes were defined by VARC-2 criteria. Median follow-up was 811 days. Results Transfemoral artery access (TFA), used in 98.8%, and VARC-2 defined procedural success, achieved in 81.4%, did not differ between groups. However, rates of peri-procedural stroke (0.7%, 2.1%, 11.1%; p<0.001) and acute kidney injury (0%, 1.7%, 8.3%; p<0.001) were higher with lower GFR. When compared to GFR >60, risk of all-cause mortality was higher with GFR 30-60 (Hazard ratio (HR) 1.61 [1.00-2.59]) and GFR <30 (HR 2.41 [1.06-5.49]). After adjustment for differences in baseline and procedural characteristics, all-cause mortality remained higher with GFR <60 (adjusted HR 1.67 [1.03-2.70]) compared with GFR >60. Rate of long-term all-cause mortality was higher with lower GFR (10.1%, 16.5%, 19.4%). Kaplan-Meier mortality estimates are shown. Conclusion Few patients with a pre-procedural GFR <30 but not HD undergo TAVR. Despite high use of TFA and no difference in procedural success rate, long-term all-cause mortality after TAVR is higher in patients with pre-procedural CKD. [Figure presented]
Copyright
EMBASE:2005039522
ISSN: 1558-3597
CID: 4381162

IMAGING EVALUATION FOR MITRAL LEAFLET MORPHOLOGY CORRELATION OF COMPUTED TOMOGRAPHY WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY [Meeting Abstract]

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]
Copyright
EMBASE:2005042357
ISSN: 1558-3597
CID: 4381072