Faculty Bibliography
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234
Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement
BACKGROUND:Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. OBJECTIVES/OBJECTIVE:This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. METHODS:Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. RESULTS:A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). CONCLUSIONS:Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).
PMID: 32854836
ISSN: 1558-3597
CID: 4581542
Therapeutic blockade of inflammation in severe COVID-19 infection with intravenous n-acetylcysteine
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
The COVID-19 Pandemic and Acute Aortic Dissections in New York: A Matter of Public Health [Letter]
PMCID:7228708
PMID: 32422182
ISSN: 1558-3597
CID: 4443832
Journal of the American College of Cardiology. 2020:75(24):3003-3015.DOI: 10.1016/j.jacc.2020.04.043
Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves: PARTNER 3 Cardiac Computed Tomography Substudy
BACKGROUND:Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction. OBJECTIVES/OBJECTIVE:The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes. METHODS:The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory. RESULTS:The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04). CONCLUSIONS:Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.
PMID: 32553252
ISSN: 1558-3597
CID: 4486472
Journal of thoracic & cardiovascular surgery. 2020:159(6):2230-2240.e15.DOI: 10.1016/j.jtcvs.2019.06.040
Cost-effectiveness of coronary artery bypass grafting plus mitral valve repair versus coronary artery bypass grafting alone for moderate ischemic mitral regurgitation
OBJECTIVE:The Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival. METHODS:We used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty. RESULTS:In-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; -0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year. CONCLUSIONS:The addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.
PMID: 31375378
ISSN: 1097-685x
CID: 5451272
Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial
Background: The objective of this study is to compare echocardiographic findings in low risk patients with severe aortic stenosis (AS) following surgical (SAVR) or transcatheter aortic valve replacement (TAVR). Methods: The Placement of Aortic Transcatheter Valves 3 (PARTNER 3) trial randomized 1000 patients with severe AS and low surgical risk to undergo either transfemoral TAVR with the balloon-expandable SAPIEN 3 valve or SAVR. Transthoracic echocardiograms obtained at baseline, and at 30 days and 1 year post-procedure were analyzed by a consortium of 2 echocardiography core laboratories. Results: The percentage of moderate/severe aortic regurgitation (AR) was low and not statistically different between TAVR vs. SAVR groups (30 days: 0.8% vs. 0.2%; p=0.38). However, mild AR was more frequent following TAVR vs. SAVR (30 days: 28.8% vs. 4.2 %; p<0.001). At 1 year, mean transvalvular gradient (13.7±5.6 vs. 11.6±5.0 mmHg; p=0.12) and aortic valve area (1.72±0.37 vs. 1.76±0.42 cm2; p=0.12) were similar in TAVR vs. SAVR. The percentage of severe prosthesis-patient mismatch (PPM) at 30 days was low and similar between TAVR and SAVR (4.6 vs. 6.3%, p=0.30). Valvulo-arterial impedance (Zva), which reflects total left ventricular hemodynamic burden, was lower with TAVR vs. SAVR at 1 year (3.7±0.8 vs. 3.9±0.9 mmHg/mL/m2 ; p<0.001). Tricuspid annulus plane systolic excursion (TAPSE) decreased and the percentage of moderate/severe tricuspid regurgitation increased from baseline to 1 year in SAVR, whereas remained unchanged in TAVR. Irrespective of treatment arm, high Zva and low TAPSE, but not moderate/severe AR or severe PPM, were associated with increased risk of the composite endpoint of mortality, stroke and re-hospitalization at 1 year. Conclusions: In patients with severe AS and low surgical risk, TAVR with the SAPIEN 3 valve was associated with similar percentage of moderate/severe AR compared with SAVR, but higher percentage of mild AR. Transprosthetic gradients, valve areas, percentage of severe PPM, and LV mass regression were similar in TAVR versus SAVR. SAVR was associated with significant deterioration of RV systolic function and greater tricuspid regurgitation, which persisted at 1 year. High Zva and low TAPSE were associated with worse outcome at 1 year whereas AR or severe PPM were not. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02675114.
PMID: 32272848
ISSN: 1524-4539
CID: 4379032
Journal of the American College of Cardiology. 2020:Conference:(ACC).DOI: 10.1016/S0735-2D1097-252820-252931950-2D1
DYNAMIC CHANGES IN THE MITRAL ANNULUS IMPLICATIONS FOR SCREENING FOR TRANSCATHETER MITRAL VALVE REPLACEMENT [Meeting Abstract]
Background Computed tomography (CT) has become the standard of care for assessment for the suitability for transcatheter mitral valve replacement (TMVR); however, variation in mitral annular measurements across the cardiac cycle has thus far been poorly studied. Because of this, currently TMVR assessment is cumbersome and involves the assessment of multiple phases. We sought to further understand variation in mitral annular dimensions with the cardiac cycle and assess its potential implications for Methods A total of 118 patients presented to the heart valve clinic and underwent CT for possible TMVR assessment and were consecutively studied with multiphase CT. The mitral annulus was measured in 10 phases using 3mensio mitral planning software and several parameters collected including perimeter, area, anterior-posterior (AP) dimension and commissure-commissure (CC) dimension. Results Of the 118 patients screened, 83.9% had predominant MR, 10.2% mixed MS/MR and 5.9% predominant MS. Changes in perimeter, Area, AP and CC dimensions are shown (figure). Comparison of largest and smallest mean measurements for each phase for perimeter, Area, AP and CC dimensions showed a 2.02%, 4.36%, 8.09% and 2.86% variation respectively. Conclusion In contrast to the dynamism of the aortic annulus and neo-LVOT, the mitral annulus does not vary significantly. This may allow limitation of radiation restricting CT acquisitions to mid-systole where the neo-LVOT is smallest. [Figure presented]
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EMBASE:2005039219
ISSN: 1558-3597
CID: 4381172
Journal of the American College of Cardiology. 2020:Conference:(ACC).DOI: 10.1016/S0735-2D1097-252820-252932064-2D7
LONG TERM MORTALITY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATINTS WITH CHRONIC KIDNEY DISEASE NOT ON HEMODIALYSIS [Meeting Abstract]
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]
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EMBASE:2005039522
ISSN: 1558-3597
CID: 4381162
Journal of the American College of Cardiology. 2020:Conference:(ACC).DOI: 10.1016/S0735-2D1097-252820-252932448-2D7
IMAGING EVALUATION FOR MITRAL LEAFLET MORPHOLOGY CORRELATION OF COMPUTED TOMOGRAPHY WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY [Meeting Abstract]
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]
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EMBASE:2005042357
ISSN: 1558-3597
CID: 4381072
Journal of the American College of Cardiology. 2020:Conference:(ACC).DOI: 10.1016/S0735-2D1097-252820-252931942-2D2
PROCEDURAL AND CLINICAL OUTCOMES OF TRANSCATHETER MITRAL VALVE REPAIR USING THE MITRACLIP SYSTEM IN PATIENTS WITH SEVERE MITRAL REGURGITATION AND SMALL MITRAL VALVE AREA [Meeting Abstract]
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]
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EMBASE:2005041849
ISSN: 1558-3597
CID: 4381082
