Jose F. Condado

First percutaneous transcatheter aortic valve-in-valve implant with three year follow-up.

Objectives: This study was conducted to report the clinical, hemodynamic, and iconographic outcomes of the longest survivor of the global CoreValve experience. Background: Early results of percutaneous heart valve (PHV) implantation for severe symptomatic aortic stenosis (AS) have been encouraging, with mid term survival up to 2 years; however longer durability term is unknown. Although a PHV has been implanted in a degenerated surgical bioprosthesis, the feasibility of a PHV‐in‐PHV has not been demonstrated. Methods: A patient with severe refractory heart failure due to severe aortic regurgitation (AR) and moderate AS, underwent CoreValve prosthesis implantation. The PHV was deployed too proximal into the left ventricular outflow tract, resulting in severe AR through the frame struts. Using the first PHV as a landmark, a second CoreValve was then deployed slightly distal to the first, with trivial residual paravalvular leak. Results: The second CoreValve expanded well with proper function. Transvalvular gradient was 8 mmHg. Both coronary ostia were patent. New mild to moderate mitral regurgitation occurred due to impingement of the anterior mitral leaflet by the first PHV. NYHA functional class improved from IV to II, maintained over the past 3 years. Echocardiography at 3 years showed normal functioning CoreValve‐in‐CoreValve prostheses, without AR or paravalvular leaks. Transvalvular gradient was 10 mmHg. Cardiac CT showed stable valve‐in‐valve protheses with no migration. Conclusion: The CoreValve prosthesis has maintained proper function up to 3 years, with no structural deterioration or migration. Treating mixed aortic valve disease with predominant AR is feasible. The concept as well as durability of the first PHV‐in‐PHV has also been demonstrated.

The Fluid Mechanics of Transcatheter Heart Valve Leaflet Thrombosis in the Neosinus

Background: Transcatheter heart valve (THV) thrombosis has been increasingly reported. In these studies, thrombus quantification has been based on a 2-dimensional assessment of a 3-dimensional phenomenon. Methods: Postprocedural, 4-dimensional, volume-rendered CT data of patients with CoreValve, Evolut R, and SAPIEN 3 transcatheter aortic valve replacement enrolled in the RESOLVE study (Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Dysfunction With Multimodality Imaging and Its Treatment with Anticoagulation) were included in this analysis. Patients on anticoagulation were excluded. SAPIEN 3 and CoreValve/Evolut R patients with and without hypoattenuated leaflet thickening were included to study differences between groups. Patients were classified as having THV thrombosis if there was any evidence of hypoattenuated leaflet thickening. Anatomic and THV deployment geometries were analyzed, and thrombus volumes were computed through manual 3-dimensional reconstruction. We aimed to identify and evaluate risk factors that contribute to THV thrombosis through the combination of retrospective clinical data analysis and in vitro imaging in the space between the native and THV leaflets (neosinus). Results: SAPIEN 3 valves with leaflet thrombosis were on average 10% further expanded (by diameter) than those without (95.5±5.2% versus 85.4±3.9%; P<0.001). However, this relationship was not evident with the CoreValve/Evolut R. In CoreValve/Evolut Rs with thrombosis, the thrombus volume increased linearly with implant depth (R2=0.7, P<0.001). This finding was not seen in the SAPIEN 3. The in vitro analysis showed that a supraannular THV deployment resulted in a nearly 7-fold decrease in stagnation zone size (velocities <0.1 m/s) when compared with an intraannular deployment. In addition, the in vitro model indicated that the size of the stagnation zone increased as cardiac output decreased. Conclusions: Although transcatheter aortic valve replacement thrombosis is a multifactorial process involving foreign materials, patient-specific blood chemistry, and complex flow patterns, our study indicates that deployed THV geometry may have implications on the occurrence of thrombosis. In addition, a supraannular neosinus may reduce thrombosis risk because of reduced flow stasis. Although additional prospective studies are needed to further develop strategies for minimizing thrombus burden, these results may help identify patients at higher thrombosis risk and aid in the development of next-generation devices with reduced thrombosis risk.

How Can We Help a Patient With a Small Failing Bioprosthesis?: An In Vitro Case Study.

OBJECTIVES The aim of this study was to investigate the hemodynamic performance of a transcatheter heart valve (THV) deployed at different valve-in-valve positions in an in vitro model using a small surgical bioprosthesis. BACKGROUND Patients at high surgical risk with failing 19-mm surgical aortic bioprostheses are not candidates for valve-in-valve transcatheter aortic valve replacement, because of risk for high transvalvular pressure gradients (TVPGs) and patient-prosthesis mismatch. METHODS A 19-mm stented aortic bioprosthesis was mounted into the aortic chamber of a pulse duplicator, and a 23-mm low-profile balloon-expandable THV was deployed (valve-in-valve) in 4 positions: normal (bottom of the THV stent aligned with the bottom of the surgical bioprosthesis sewing ring) and 3, 6, and 8 mm above the normal position. Under controlled hemodynamic status, the effect of these THV positions on valve performance (mean TVPG, geometric orifice area, and effective orifice area), thrombotic potential (sinus shear stress), and migration risk (pullout force and embolization flow rate) were assessed. RESULTS Compared with normal implantation, a progressive reduction of mean TVPG was observed with each supra-annular THV position (normal: 33.10 mm Hg; 3 mm: 24.69 mm Hg; 6 mm: 19.16 mm Hg; and 8 mm: 12.98 mm Hg; p < 0.001). Simultaneously, we observed increases in geometric orifice area (normal: 0.83 cm(2); 8 mm: 1.60 cm(2); p < 0.001) and effective orifice area (normal: 0.80 cm(2); 8 mm: 1.28 cm(2); p < 0.001) and reductions in sinus shear stresses (normal: 153 dyne/cm(2); 8 mm: 40 dyne/cm(2); p < 0.001), pullout forces (normal: 1.55 N; 8 mm: 0.68 N; p < 0.05), and embolization flow rates (normal: 32.91 l/min; 8 mm: 26.06 l/min; p < 0.01). CONCLUSIONS Supra-annular implantation of a THV in a small surgical bioprosthesis reduces mean TVPG but may increase the risk for leaflet thrombosis and valve migration. A 3- to 6-mm supra-annular deployment could be an optimal position in these cases.

Percutaneous tricuspid valve-In-ring replacement for the treatment of recurrent severe tricuspid regurgitation

Percutaneous tricuspid valve‐in‐ring replacement can be an alternative to surgery for high‐risk patients with symptomatic severe tricuspid regurgitation that recurs after surgical ring repair. Practitioners must pay attention to the specific technical details associated with this procedure that include: using the ring as a fluoroscopic landmark, sizing the valve area with multi‐modality imaging, choosing the appropriate device based on the patients anatomy, and dealing with the inevitable paravalvular leak (created by the ring deformation in the absence of valve‐specific devices). Our case demonstrates that percutaneous tricuspid valve‐in‐ring replacement is a feasible treatment that can result in both hemodynamic and symptomatic improvement.

Transcatheter Aortic Valve Replacement Results in Improvement of Pulmonary Function in Patients With Severe Aortic Stenosis.

BACKGROUND Chronic obstructive pulmonary disease (COPD) has been identified as a risk factor for morbidity and mortality after transcatheter aortic valve replacement (TAVR). We hypothesized that a portion of pulmonary dysfunction in patients with severe aortic stenosis may be of cardiac origin, and has potential to improve after TAVR. METHODS A retrospective analysis was made of consecutive TAVR patients from April 2008 to October 2014. Of patients who had pulmonary function testing and serum B-type natriuretic peptide data available before and after TAVR, 58 were found to have COPD (26 mild, 14 moderate, and 18 severe). Baseline variables and operative outcomes were explored along with changes in pulmonary function. Multiple regression analyses were performed to adjust for preoperative left ventricular ejection fraction and glomerular filtration rate. RESULTS Comparison of pulmonary function testing before and after the procedure among all COPD categories showed a 10% improvement in forced vital capacity (95% confidence interval: 4% to 17%) and a 12% improvement in forced expiratory volume in 1 second (95% confidence interval: 6% to 19%). There was a 29% decrease in B-type natriuretic peptide after TAVR (95% confidence interval: -40% to -16%). An improvement of at least one COPD severity category was observed in 27% of patients with mild COPD, 64% of patients with moderate COPD, and 50% of patients with severe COPD. There was no 30-day mortality in any patient group. CONCLUSIONS In patients with severe aortic stenosis, TAVR is associated with a significant improvement of pulmonary function and B-type natriuretic peptide. After TAVR, the reduction in COPD severity was most evident in patients with moderate and severe pulmonary dysfunction.

Long or redundant leaflet complicating transcatheter mitral valve replacement: Case vignettes that advocate for removal or reduction of the anterior mitral leaflet

Transcatheter mitral valve replacement (TMVR) procedures can be an alternative to surgical valve replacement for high surgical risk patients with bioprosthetic mitral valves, annuloplasty rings, or severe mitral annular calcification (MAC). TMVR can trigger acute left ventricular outflow tract (LVOT) obstruction from permanent displacement of the native anterior mitral leaflet toward the left ventricular septum, more often among patients undergoing valve‐in‐ring and valve‐in‐MAC procedures. Although acute LVOT obstruction is well described in the literature, there are important additional complications of TMVR related to the length and/or redundancy of the anterior mitral valve that have been recognized after mitral valve surgery and have not been previously reported in the setting of TMVR. These additional complications include acute mitral regurgitation secondary to prolapsing native leaflet through the TMVR, frozen TMVR leaflet secondary to overhanging native leaflet and late LVOT obstruction in the neo‐LVOT secondary to long native leaflet. Preprocedural planning with imaging (echocardiography and computed tomography) and measurement of anterior mitral leaflet length is critical important in understanding the risk for these complications. As transcatheter mitral valve technology proliferates, interactions with the anterior mitral leaflet after TMVR may be more frequent than initially anticipated. We believe that there is no advantage to an intact anterior leaflet and advocate removal or reduction of the leaflet prior to TMVR.

Assessment of Commonly Used Frailty Markers for High- and Extreme-Risk Patients Undergoing Transcatheter Aortic Valve Replacement

BACKGROUND The effect of frailty on outcomes after transcatheter aortic valve replacement (TAVR) remains incompletely understood. The objective of this study was to evaluate the performance of four commonly used frailty markers as predictors of early and late outcomes among patients undergoing TAVR. METHODS A review was performed of 361 high- and extreme-risk patients undergoing TAVR from 2011 to 2015. Four frailty variables were assessed: serum albumin (g/dL), 5-m walk (seconds), grip strength (kg), and Katz index of independence in activities of daily living. Logistic regression was used to examine the association between the frailty indicators and 30-day composite of mortality, stroke, new heart block requiring permanent pacemaker, major or life-threatening bleeding, acute renal failure, major vascular complication, and 30-day readmission rate. Minimum distance to the perfect point (0, 1) was performed to delineate a cutoff point for each frailty indicator, and risk models were compared using receiver-operating characteristics curves. RESULTS The composite of outcomes occurred in 28% of patients. Serum albumin, activities of daily living, and 5-m walk were independent predictors for 30-day composite outcomes, but only albumin was predictive of 30-day mortality. A new frailty model (four frailty indicators, age, and sex) to predict 30-day mortality was created and compared with The Society of Thoracic Surgeons predicted risk of mortality. Better discrimination was found with the new frailty model (area under the curve 0.74 versus 0.58). New individual frailty variable cutoff values were found to predict our composite of events. CONCLUSIONS Among high- and extreme-risk patients undergoing TAVR, our new frailty model was more discriminative of 30-day mortality than The Society of Thoracic Surgeons predicted risk of mortality. New cutoff values for frailty indicators were identified and will require further validation.

Paravalvular Regurgitation after Transcatheter Aortic Valve Replacement: Comparing Transthoracic versus Transesophageal Echocardiographic Guidance

Background: Transcatheter aortic valve replacement (TAVR) is increasingly being performed in cardiac catheterization laboratories using transthoracic echocardiography (TTE) to guide valve deployment. The risk of paravalvular regurgitation (PVR) remains a concern. Methods: We retrospectively reviewed 454 consecutive patients (mean age, 82 ± 8; 58% male) who underwent transfemoral TAVR at Emory Healthcare from 2007 to 2014. Two hundred thirty‐four patients underwent TAVR in the cardiac catheterization laboratory with TTE guidance (TTE‐TAVR; mean Society of Thoracic Surgeons score, 10%), while 220 patients underwent the procedure in the hybrid operating room with transesophageal echocardiography (TEE) guidance (TEE‐TAVR; mean Society of Thoracic Surgeons score, 11%). All patients received an Edwards valve (SAPIEN 55%, SAPIEN‐XT 45%). Clinical and procedural characteristics, echocardiographic parameters, and incidence of PVR were compared. Results: The incidence of at least mild PVR at discharge was comparable between TTE‐TAVR and TEE‐TAVR (33% vs 38%, respectively; P = .326) and did not differ when stratified by valve type. However, in the TTE‐TAVR group, there was a higher incidence of second valve implantation (7% vs 2%; P = .026) and postdilation (38% vs 17%; P < .001) during the procedure. Although not independently associated with PVR at discharge (odds ratio = 1.12; 95% CI, 0.69–1.79), TTE‐TAVR was associated with PVR‐related events: the combined outcome of mild PVR at discharge, intraprocedural postdilation, and second valve insertion (odds ratio = 1.58; 95% CI, 1.01–2.46). There were no significant differences in PVR at 30 days, 6 months, and 1 year between the two groups. Conclusions: TTE‐TAVR in a high‐risk group of patients was associated with increased incidence of intraprocedure PVR‐related events, although it was not associated with higher rates of PVR at follow‐up. Multicenter randomized trials are required to confirm the cost‐effectiveness and safety of TTE‐TAVR. HighlightsMinimalist transthoracic echocardiography (TTE)–guided transcatheter aortic valve replacement (TAVR) is increasingly performed in cardiac catheterization laboratories.Patients undergoing TTE‐TAVR were more likely to receive balloon postdilation and second valve placement.Paravalvular regurgitation at discharge was not increased with TTE‐guided TAVR.

Neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR) can risk stratify patients in transcatheter aortic-valve replacement (TAVR).

BACKGROUND Neutrophil-lymphocyte (NLR) and platelet-lymphocyte ratios (PLR) mark systemic inflammation. Patients with high NLR and PLR have worse cardiovascular disease and outcomes. We assessed the role of these ratios in predicting outcomes after transcatheter aortic valve replacement (TAVR). METHODS The association between NLR and PLR with baseline characteristics, 30-day outcomes, and 1-year readmission/survival was determined in patients that underwent TAVR between 2007 and 2014 and had baseline complete blood count with differential. A subgroup analysis determined the association between change in NLR and PLR (discharge-baseline) and 1-year outcomes. RESULTS In 520 patients that underwent TAVR, a higher NLR (p=0.01) and PLR (p=0.02) were associated with a higher STS-PROM score, and with increased occurrence of the 30-day early-safety outcome (by VARC-2), even after adjusting for STS-PROM score, valve generation (Sapien vs. Sapien XT), and access (transfemoral vs. non-transfemoral) (NLR: OR 1.29, 95% CI 1.04-1.61; PLR: OR 1.27, 95% CI 1.01-1.60) but not with 1-year readmission or survival. In our subgroup analysis (N=294), change in PLR was not associated with the 1-year outcomes but a high change in NLR was associated with worse 1-year survival/readmission and 1-year survival, even after adjusting for STS-PROM score, valve generation and access (HR 1.22, 95% CI 1.04-1.44 and HR 1.26, 95% CI 0.99-1.6, respectively). CONCLUSIONS NLR and PLR correlate with surgical risk. An elevated NLR and PLR were associated with the occurrence of 30-day adverse outcomes, similar to the STS-PROM score. A high variation of NLR from baseline to discharge may help stratify patients that underwent TAVR in addition to traditional risk factors.

Readmission rates after transcatheter aortic valve replacement in high- and extreme-risk patients with severe aortic stenosis

Objective In high‐ or extreme‐risk patients undergoing transcatheter aortic valve replacement, readmissions have not been adequately studied and are the subject of increased scrutiny by healthcare systems. The objectives of this study were to determine the incidence of 30‐day and 1‐year cardiac and noncardiac readmissions, identify predictors of readmission, and assess the association between readmission and 1‐year mortality. Methods A retrospective review was performed on 714 patients who underwent transcatheter aortic valve replacement from September 2007 to January 2015 at Emory University. Results Patients’ median age was 83 years, and 46.6% were female. Early all‐cause readmission for the cohort was 10.5%, and late readmission was 18.8%. Anemia was related to both early all‐cause (hazard ratio [HR], 0.74) and cardiovascular‐related readmission (HR, 0.60). A 23‐mm valve implanted was associated with early all‐cause readmission (HR, 1.73). Length of hospital stay was related to late all‐cause (HR, 1.14) and cardiovascular‐related readmission (HR, 1.21). Postoperative permanent stroke had an impact on late cardiovascular‐related readmission (HR, 3.60; 95% confidence interval, 1.13‐11.49). Multivariable analysis identified anemia as being associated with 30‐day all‐cause readmission, and anemia and postoperative stroke were associated with 30‐day cardiovascular‐related readmission. Readmissions seemed to be related to 1‐year mortality (HR, 2.04; 95% confidence interval, 1.33‐3.12). Conclusions We show some baseline comorbidities and procedural complications that are directly associated with early and late readmissions, and anemia and postoperative stroke were associated with an increase in mortality. Moreover, we found that readmission was associated with double the hazard of death within 1 year. Whether treatment of identified risk factors could decrease readmission rates and mortality warrants further investigation.