Faculty Bibliography

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 (Z_va), 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 Z_va 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.

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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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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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]
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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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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.
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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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BACKGROUND:There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS:We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS:At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS:Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

OBJECTIVES/OBJECTIVE:The aim of this study was to assess the evolution of early outcomes for 3 iterative self-expanding transcatheter aortic valves. BACKGROUND:Over the past decade there have been rapid advancements in transcatheter aortic valve replacement (TAVR) technologies, including 3 generations of supra-annular self-expanding transcatheter systems. METHODS:Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry for patients undergoing TAVR with CoreValve, Evolut R, or Evolut PRO valves to treat tricuspid aortic stenosis between January 2014 and September 2017 were obtained. Patient risk and echocardiographic data are site reported. Valves analyzed included 23-, 26-, and 29-mm sizes to fit 18- to 26-mm annular diameters. Propensity score matching was performed using the Evolut PRO group as the common reference. RESULTS:Of 18,874 patients undergoing TAVR at 381 centers, 5,514 patients were implanted with CoreValve, 11,295 with Evolut R, and 2,065 with Evolut PRO valves. At 30 days, there were significantly fewer patients with more than mild aortic regurgitation for the unmatched (7.8% CoreValve, 5.2% Evolut R, and 2.8% Evolut PRO; p < 0.001) and matched populations (8.3% CoreValve, 5.4% Evolut R, and 3.4% Evolut PRO; p = 0.032). The mean aortic valve gradients at 30 days in the matched populations were <8 mm Hg for all 3 valves (7.3 mm Hg CoreValve, 7.5 mm Hg Evolut R, 7.2 mm Hg Evolut PRO). CONCLUSIONS:Advancements in transcatheter valve technologies and expanding indications for TAVR have resulted in improved outcomes for patients undergoing TAVR in the United States with self-expanding, supra-annular valves. In particular, the addition of an outer pericardial tissue wrap designed to enhance sealing at the level of the aortic annulus has resulted in very low rates of significant aortic regurgitation while maintaining excellent hemodynamic status.

Introduction: Cardiac function is known to be negatively impacted by sepsis. Monitoring Cardiac Output (CO) and Stroke volume (SV) trends over the course of treatment may provide insight into cardiac function and may be used to predict patient outcome.
Objective(s): The goal of this study was to explore the relationship between the change in cardiac output over time in septic shock.
Method(s): FRESH is randomized controlled study, evaluating hemodynamics in critically ill patients with sepsis or septic shock (NCT02837731). Patients randomized to PLR guided resuscitation received hemodynamic monitoring for 72 or until ICU discharge, whichever occurred first (Starling SV, Cheetah Medical). Patients that exhibited an improvement in stroke volume at 12, 24, 36 and 48 hours were compared to those who did not exhibit improvement. Overall improvement in stroke volume (first SV measurement compared to last SV measurement) was also compared between groups.
Result(s): 90 patients with septic shock received hemodynamic monitoring over a 72 hour monitoring period. 60 % were female, and the average age was 61 years. Overall, 44% of assessments demonstrated a fluid responsive positive response after receiving initial resuscitation fluid of 2.3 L. Patients who exhibited improved SV at 24 and 36 hours exhibited a decreased fluid balance over the course of their ICU stay at both 24 hours (1.06 +/- 3.40 vs 3.15 +/- 4.38, p=0.029) and 36 hours (1.18 +/- 2.58 vs 3.41 +/- 4.52, p=0.032). Notably, patients who exhibited an overall improvement in SV also required less hours on vasopressors (34.50 +/- 41.03 vs 64.28 +/- 65.07, p=0.05) and decreased ICU length of stay (3.93 +/- 3 vs 5.59 +/- 5.24 days, p=0.08) (Figure 1).
Conclusion(s): We have previously shown that patients who improve SV in response to the resuscitation exhibited improved outcome. Trending cardiac output over the 72 hour monitoring period revealed additional usefulness in predicting patients with improved outcome. The results highlight the importance of trending hemodynamics in therapy