0245: Echocardiographic and clinical outcome in patients undergoing trans-catheter aortic valve replacement with concomitant mitral regurgitation

BackgroundSevere aortic stenosis (AS) is commonly associated with mitral regurgitation (MR) in patients undergoing transcatheter aortic valve replacement (TAVR). The natural history of MR is not well defined in this population.MethodsConsecutive high risk, inoperable patients undergoing TAVR between 2007 and 2011 for AS has echos at baseline and 1 year and were followed for clinical outcomes. MR severity was graded and patients were grouped as having minimal (none-mild) or significant (moderate- severe) MR.Results164 patients underwent TAVR, reducing gradients from 47 to 10mHg. LVEF increased from 48% to 52% while pulmonary aretry systolic pressure (PAPS), LVESD and LVEDD were unchanged. Signficant MR patents had a median 1 grade reduction (p<0,0001) in MR at 1 year. Median LVEF increased by 2% (p=0.0412). Median LVESD decreased by 2.3mm±7.5 (p=0.039). Univariate analysis showed no significant predictors of MR reduction in significant MR patients. Functional and organic significant MR decreased after TAVR but only functional MR patients had improved LVEF (6%, p=0.034), PAPS (5.9mmHg, p=0.022) and LVESD (3.8mm, p=0.013). Multivariate analysis showed functional MR to be a predictor of improved LVEF and PAPS. Clinical outcomes at a mean follow-up of 925 days were not different in patients with significant vs minimal MR; however organic MR patients tended to have more events than functional MR patients (p=0.06).Conclusion:Significant MR patients undergoing TAVR for severe AS improved in LVEF and LVESD, particularly patients with functional MR. Organic MR is marginally predictive of cardiac complications in AS patients

Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter

BACKGROUND: Inaccurate aortic valve sizing and selection is linked to paravalvular leakage in transcatheter aortic valve replacement (TAVR). Here, a novel sizing valvuloplasty conductance balloon (SVCB) catheter is shown to be accurate, reproducible, unbiased, and provides real-time tool for aortic valve sizing that fits within the standard valvuloplasty procedure. METHODS AND RESULTS: The SVCB catheter is a valvuloplasty device that uses real-time electrical conductance measurements based on Ohm's Law to size the balloon opposed against the aortic valve at any given inflation pressure. Accuracy and repeatability of the SVCB catheter was performed on the bench in phantoms of known dimension and ex vivo in three domestic swine aortic annuli with comparison to computed tomography (CT) and dilator measurements. Procedural workflow and safety was demonstrated in vivo in three additional domestic swine. SVCB catheter measurements had negligible bias or error for bench accuracy considered as the gold standard (Bias: -0.11 ± 0.26 mm; Error: 1.2%), but greater disagreement in ex vivo versus dilators (Bias: -0.3 ± 1.1 mm; Error: 4.5%), and ex vivo versus CT (Bias: -1.0 ± 1.6 mm; Error: 8.7%). The dilator versus CT accuracy showed similar agreement (Bias: -0.9 ± 1.5 mm; Error: 7.3%). Repeatability was excellent on the bench (Bias: 0.02 ± 0.12 mm; Error: 0.5%) and ex vivo (Bias: -0.4 ± 0.9 mm; Error: 4.6%). In animal studies, the device fit well within the procedural workflow with no adverse events or complications. CONCLUSIONS: Due to the clinical relevance of this accurate, repeatable, unbiased, and real-time sizing measurement, the SVCB catheter may provide a useful tool prior to TAVR. These findings merit a future human study

Transcatheter aortic valve implantation in the United States: Predictors of early hospital discharge

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/136358/1/joic12373-sup-0001-SuppTab-S1.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/136358/2/joic12373.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/136358/3/joic12373_am.pd

Impact of varying degrees of renal dysfunction on transcatheter and surgical aortic valve replacement

BackgroundRenal impairment portends adverse outcomes in patients undergoing valvular heart surgery. The relationship between renal dysfunction in patients undergoing transcatheter aortic valve replacement (TAVR) is incompletely understood.MethodsA retrospective review of 1336 patients undergoing surgical aortic valve replacement (SAVR; 2002-2012) and 321 patients undergoing TAVR (2007-2012) was performed. Patients were divided into 3 glomerular filtration rate (GFR) groups: GFR greater than 60 mL/min, GFR 31 to 60 mL/min, and GFR 30 mL/min or less. Logistic and linear regression analysis was performed to estimate the TAVR effect on outcomes. Risk adjustments were made using the Society for Thoracic Surgeons (STS) predicted risk of mortality (PROM).ResultsTAVR patients were older (82 vs 65 years; P < .001), had a poorer ejection fraction (48% vs 53%; P < .001), were more likely female (45% vs 41%; P = .23), and had a higher STS PROM (11.9% vs 4.6%; P < .001). In-hospital mortality rates for TAVR and SAVR were 3.5% and 4.1%, respectively (P = .60), a result that marginally favors TAVR after risk adjustment (adjusted odds ratio = .52, P = .06). In SAVR patients, worsening preoperative renal failure was associated with increased in-hospital mortality (P = .004) and hospital (P < .001) and intensive care unit (ICU) (P < .001) lengths of stay. In contrast, worsening renal function did not influence in-hospital mortality (P = .78) and hospital (P < .23) and ICU (P = .88) lengths of stay in TAVR patients.ConclusionsWorsening renal function was associated with increased in-hospital mortality, hospital length of stay, and ICU length of stay in SAVR patients, but not in TAVR patients. This unexpected finding may have important clinical implications in patients with aortic stenosis and preoperative renal dysfunction

Evaluation of flow after transcatheter aortic valve replacement in patients with low-flow aortic stenosis : a secondary analysis of the PARTNER randomized clinical trial

Importance: Low-flow (LF) severe aortic stenosis (AS) is an independent predictor of mortality in patients undergoing aortic valve replacement (AVR). Little is known about improvement in flow after AVR and its effects on survival. Objective: To determine whether higher flow (left-ventricular stroke volume index [LVSVI]) after transcatheter AVR (TAVR) would indicate better clinical outcomes in this at-risk population. Design, Setting, and Participants: A substudy analysis of data from the Placement of Aortic Transcatheter Valves (PARTNER) randomized clinical trial and continued-access registry was conducted. A total of 984 participants with evaluable echocardiograms and baseline LF AS (LVSVI =35 mL/m2) were included. The trial was conducted at 26 sites in the United States and Canada. Patients were stratified after TAVR into tertiles by discharge LVSVI status (severe low flow [SLF], moderate low flow [MLF], and normal flow [(NF]). The present study was conducted from May 11, 2007, to January 9, 2012, with data analysis performed from April 25, 2014, to January 21, 2016. Main Outcomes and Measures: The primary end point was all-cause mortality at 1 year. Results: Baseline characteristics of 984 patients with LF AS included mean (SD) age, 84 (7) years; 582 (59.1%) men; mean Society of Thoracic Surgeons (STS) score, 11.4% (4.0%); and mean LVSVI, 27.6 (5.0) mL/m2. The discharge LVSVI values by group were SLF, 23.1 (3.5) mL/m2; MLF, 31.7 (2.2) mL/m2; and NF, 43.1 (7.0). All-cause mortality at 1 year was SLF, 26.5%; MLF, 20.1%; and NF, 19.6% (P¿=¿.045). Mean LVSVI normalized by 6 months in the MLF (35.9 [9.3] mL/m2) and NF (38.8 [11.1] mL/m2) groups, but remained low in the SLF group at 6 months and 1 year (31.4 [8.4] and 33.0 [8.3] mL/m2], respectively) (P¿<¿.001 for all groups). Reported as multivariate hazard ratio, mortality at 1 year was higher in the SLF group compared with the other groups (1.61; 95% CI, 1.17-2.23; P¿=¿.004). In addition to SLF, sex (1.59; 95% CI, 1.18-2.13; P¿=¿.002), presence of atrial fibrillation (1.41; 95% CI, 1.06-1.87; P¿=¿.02), STS score (1.03; 95% CI, 1.01-1.06; P¿=¿.02), presence of moderate or severe mitral regurgitation at discharge (1.65; 95% CI, 1.21-2.26; P¿=¿.001), pre-TAVR mean transvalvular gradient (0.98; 95% CI, 0.97-0.99; P¿=¿.004), and effective orifice area index (1.87; 95% CI, 1.09-3.19; P¿=¿.02) were independent predictors of 1-year mortality.CONCLUSIONS AND RELEVANCE: Severe LF at discharge is associated with an increased risk of mortality following TAVR in patients with severe AS and preexisting LF. The identification of remedial causes of persistent LF after TAVR may represent an opportunity to improve the outcome of these patients

BASILICA Trial: One-Year Outcomes of Transcatheter Electrosurgical Leaflet Laceration to Prevent TAVR Coronary Obstruction

Background: Coronary artery obstruction is a rare, devastating complication of transcatheter aortic valve replacement. Transcatheter electrosurgical aortic leaflet laceration (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) is a novel technique to prevent coronary artery obstruction. We report the 1-year outcomes of the BASILICA trial. Primary end points of 30-day success and safety have been reported previously. Methods: The BASILICA trial was a prospective, multicenter, single-arm safety and feasibility study. Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and high risk of coronary artery obstruction, were included. End points at 1 year included death, stroke, and myocardial infarction. Source data was independently verified and end points independently adjudicated. Results: Thirty subjects were enrolled between February 2018 and July 2018. At 30 days, BASILICA was successful in 28 subjects (93.3%), there were 3 strokes (10%), including 1 disabling stroke (3.3%), 1 death (3.3%), and 1 periprocedural myocardial infarction (3.3%). Between 30 days and 1 year, there were no additional strokes, no myocardial infarction, and 2 deaths (10% 1-year mortality). No subject needed repeat intervention for aortic valve or coronary disease. Two subjects had infective endocarditis (6.7%), but neither was isolated to the aortic valve. There were no hospital admissions for heart failure. Fourteen (46.7%) subjects required repeat hospital admission for other causes. Aortic valve gradients on echocardiography, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire scores improved from baseline to 30 days and were maintained at 1 year. Conclusions: In these subjects with multiple comorbidities and restrictive anatomy that underwent transcatheter aortic valve replacement, there was no late stroke, myocardial infarction, or death related to BASILICA. Mitigation of coronary obstruction remained intact at 1 year and was not related to recurrent readmission. These results are reassuring for patients and physicians who wish to avoid the long-term complications related to snorkel stenting