Transcatheter Aortic Valve Replacement Prosthesis Research Articles

Cusp-overlap view reduces conduction disturbances and permanent pacemaker implantation after transcatheter aortic valve replacement even with balloon-expandable and mechanically-expandable heart valves.

Conduction disturbances demanding permanent pacemaker implantation (PPI) remain a common complication after transcatheter aortic valve replacement (TAVR). Optimization of the implantation depth (ID) by introducing the cusp-overlap projection (COP) technique led to a reduced rate of PPI when self-expanding valves were used. The aim of the present study was to determine if using the novel COP view is applicable for all types of TAVR prosthesis and results in a higher ID and reduced incidence of new conduction disturbances and PPI. In this prospective case-control study 586 consecutive patients undergoing TAVR with either balloon-expandable Edwards SAPIEN S3 (n = 280; 47.8%), or mechanically expandable Boston LOTUS Edge heart valve prostheses (n = 306; 52.2%) were included. ID as well as rates of periprocedural PPI and left bundle branch block (LBBB) were compared between the conventional three-cusp coplanar (TCC) projection and the COP view for implantation. Of 586 patients, 282 (48.1%) underwent TAVR using COP, whereas in 304 patients (51.9%) the TCC view was applied. Using COP a significantly higher ID was achieved in Edwards SAPIEN S3 TAVR procedures (ID mean difference -1.0 mm, 95%-CI -1.9 to -0.1 mm; P = 0.029), whereas the final platform position did not differ significantly between both techniques when a Boston LOTUS Edge valve was used (ID mean difference -0.1 mm, 95%-CI -1.1 to +0.9 mm; P = 0.890). In Edwards SAPIEN S3 valves, higher ID was associated with a numerically lower post-procedural PPI incidence (4.9% vs. 7.3%; P = 0.464). Moreover, ID was significantly deeper in patients requiring PPI post TAVR compared to those without PPI [8.7 mm (6.8-10.6 mm) vs. 6.5 mm (6.1-7.0 mm); P = 0.005]. In Boston LOTUS Edge devices, COP view significantly decreased the incidence of LBBB post procedure (28.1% vs. 47.9%; P < 0.001), while PPI rates were similar in both groups (21.6% vs. 25.7%; P = 0.396). The present study demonstrates the safety, efficacy and reproducibility of the cusp-overlap view even in balloon-expandable and mechanically-expandable TAVR procedures. Application of COP leads to significantly less LBBB in repositionable Boston LOTUS Edge valves and a numerically lower PPI rate in Edwards SAPIEN S3 valves post TAVR compared to the standard TCC projection. The results should encourage to apply the COP view more widely in clinical practice.

S-37-4: TRANSCATHETER AORTIC VALVE REPLACEMENT DOES NOT RESULT IN SUSTAINED LOAD TRANSFER WITH INCREASED VASCULAR LOAD

Objectives: Transcatheter aortic valve replacement (TAVR) is an effective treatment for aortic stenosis (AS) by reducing the load placed on the left ventricle (LV) by the stenotic valve. Although systolic pressure is reported to increase in 50% of individuals after TAVR, its effects on steady and pulsatile vascular load represented by the systemic vascular resistance (SVR) and impedance of the proximal ascending aorta (Zc) respectively is less well understood. Using a previously validated non-invasive load estimation technique, we investigated the valvulo-arterial interaction in AS patients pre- and post-TAVR. Design and Method: In AS patients being assessed for TAVR, the proximal thoracic aorta flows, LV volume and function were recorded using 3T cardiac magnetic resonance (CMR) using phase-contrast velocity quantification. Simultaneous radial tonometric pressure was acquired during CMR and brachial cuff pressure was recorded. Aortic pressure was derived offline using SphygmoCor 8.1 (AtCor Medical, Sydney) from radial pressure, and calibrated to brachial pressure. Flow was acquired at 5 cm above the aortic valve at the level of the pulmonary artery bifurcation to avoid flow artefact from the TAVR prosthesis. Baseline and follow-up measurements were made before and after treatment with TAVR. Values pre- and post-TAVR were compared, and indices of pulsatile arterial load were calculated using frequency domain analysis. Results: A total of 17 patients (mean age 80 ± 6 years, 7 females) were recruited, with a median follow up of 54.5 days post-TAVR. In the post-TAVR measurements, a significant improvement in aortic peak volumetric flow (336 ± 79 ml/s vs 389 ± 110 ml, P = 0.011) was observed with an associated reduction in peak aortic velocity (189 ± 65 cm/s vs 126 ± 24 cm/s, P = 0.002). However, there was no statistical difference in heart rate (70 ± 9 beats per minute vs 68 ± 12 beats per minute), mean central aortic pressure (98 ± 13mmHg vs 99 ± 11mmHg), or the steady vascular load parameters of SVR (1860 ± 513 dynes.s/cm5 vs 1999 ± 561 dynes. s/cm5, P = 0.284) and pulsatile load Zc of the aorta (119 ± 51 dynes.s/cm5 vs 106 ± 43 dynes.s/cm5, P = 0.102). Conclusion: TAVR relieves valvular obstruction but does not result in significant alterations of vascular load in the short to medium term. The previously reported acute load transfer immediately following TAVR appears to resolve with time. Further study examining the effect of TAVR on external LV work may help to elucidate the energy consumption by the vascular system after correction of valvular obstruction from AS.

Pearls, pitfalls, and surgical indications of the Intuity TM heart valve:A rapid deployment bioprosthesis. A systematic review of the literature.

To highlight short- and long-term clinical outcomes of the Intuity TM rapid deployment prosthesis for surgical aortic valve replacement. We reviewed on PubMed/MEDLINE, Embase, SciELO, LILACS, CCTR/CENTRAL, and Google Scholar for clinical trials, retrospective clinical studies, meta-analysis, and gray literature. Fourty-five clinical studies with 12.714 patients were included in the analysis. Thirty-day mortality ranged from 3.8% for Intuity and 3.9% for transcatheter aortic valve replacement(TAVR). The incidence of paravalvular leak(PVL) (Intuity 0% and TAVR 2.17%), permanent pacemaker implantation(Intuity 11.11% and TAVR 12.5%), stroke (Intuity 2.2% and TAVR 2.6%), myocardial infarction(MI) (Intuity 0% and TAVR 1%), were all higher in the TAVR group. Compared to other sutured bioprosthesis (SB), mortality ranged from 0% to 3.9% for Intuity and 0%-6.9% for SB. Long-term cardiac mortality ranged from 0.9% to 1.55% for Intuity and 1.4%-3.3% for the Perceval valve. The incidence of PVL (Intuity 0.24%-0.7% and Perceval 0%-1%), endocarditis (Intuity 0.2%-0.7% and Perceval 1.6%-6.6%), stroke (Intuity 0.36%-1.4% and Perceval 0%-0.8%), MI (Intuity 0.07%-0.26%), and SVD (Intuity 0.12%-0.7% and Perceval 0%) were comparable. Compared to standard full sternotomy (SFS), minimally invasive surgery (MINV) mortality ranged from 0% to 4.3% for MINV and 0%-2.1% for SFS. Hospital costs outcomes ranged from $37,187-$44,368 for the Intuity, $69,389 for TAVR, and $13,543 for SB. Intuity short-term mortality ranged between 0.9% and 12.4% while long-term mortality ranged between 2.6% and 20%. This manuscript provides a 360° overview of the current rapid deployments, sutureless, and TAVR prosthesis.

Deformation of Transcatheter Aortic Valve Prostheses: Implications for Hypoattenuating Leaflet Thickening and Clinical Outcomes.

Although transcatheter aortic valve replacement (TAVR) therapy continues to grow, there have been concerns about the occurrence of hypoattenuating leaflet thickening (HALT), which may affect prosthesis function or durability. This study aimed to examine prosthesis frame factors and correlate their extent to the frequency of HALT and clinical outcomes. We prospectively examined 565 patients with cardiac computed tomography screening for HALT at 30 days after balloon-expandable SAPIEN3 and self-expanding EVOLUT TAVR. Deformation of the TAVR prostheses, asymmetric prosthesis leaflet expansion, prosthesis sinus volumes, and commissural alignment were analyzed on the postprocedural computed tomography. For descriptive purposes, an index of prosthesis deformation was calculated, with values >1.00 representing relative midsegment underexpansion. A time-to-event model was performed to evaluate the association of HALT with the clinical outcome. Overall, HALT was present in 21% of SAPIEN3 patients and in 16% of EVOLUT patients at 30 days after TAVR. The occurrence of HALT was directly associated with greater prosthesis frame deformation (P<0.001), worse asymmetry of the leaflets (P<0.001), and smaller TAVR neosinus volumes (P<0.001). These relations were present in both prosthetic types and in all of their size ranges (all P<0.05). In multivariable analyses that include clinical variables previously associated with HALT (eg, anticoagulant therapy), variables of TAVR prosthesis deformation remained predictive of HALT. Although HALT was not associated with changes in prosthetic hemodynamics, its presence was associated with the risk of mortality at 1 year, with respect to greater incidences of all-cause mortality (hazard ratio, 2.98 [95% CI, 1.57-5.63]; P=0.001), cardiac death (hazard ratio, 4.58 [95% CI, 1.81-11.6]; P=0.001), and a composite outcome of all-cause mortality and heart failure hospitalization (hazard ratio, 1.94 [95% CI, 1.14-3.30]; P=0.02) with adjustment for age, sex, and comorbidities. Nonuniform expansion of TAVR prostheses resulting in frame deformation, asymmetric leaflet, and smaller neosinus volume is related to occurrence of HALT in patients who undergo TAVR. These data may have implications for both prosthesis valve design and deployment techniques to improve clinical outcomes for these patients.

Left Main Protection During Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve.

Coronary obstruction during transcatheter aortic valve replacement (TAVR) is a rare, yet life-threatening, complication. The routine use of left main (LM) protection with or without stent placement in high-risk patients remains controversial. The aim of this study was to evaluate the outcomes of LM protection during TAVR and identify anatomic factors associated with need for stent placement. We retrospectively reviewed all TAVR cases (native and valve-in-valve) performed in our institution between 2014 and 2019 and identified patients who underwent LM protection with a coronary wire, balloon, and/or stent during the procedure. We compared the pre-TAVR computed tomography aortic root characteristics, procedural data, short-, and long-term outcomes among the patients who eventually received an LM stent and those who did not. Among 1925 TAVR patients, 41 (2.1%) underwent LM protection, and 10 of them (25%) had eventually a stent placed in the LM for threatened obstruction after valve deployment. In the native TAVR group (n = 35), 8 patients underwent LM stenting. A larger TAVR prosthesis, larger annular circumference (83.8 vs 76.1​mm; P = .038), lower ratio of sinotubular junction diameter to prosthesis size (1.02 vs 1.11; P = .032), and longer left coronary cusp (15.1 vs 13.9​mm; P = .18) were associated with higher incidence of LM stenting. In the valve-in-valve TAVR group (n = 6), 5 patients had a valve-to-coronary distance of less than 4​mm, and 2 of them received an LM stent. Both stent and nonstent groups had excellent outcomes with no major adverse cardiovascular events or coronary obstruction at 30​days. After a median follow-up of 351​days, 4 patients died (9.7%) (1 in the stent and 3 in the nonstent group), without any cases of late coronary obstruction or percutaneous coronary intervention in either group. LM protection with a coronary guidewire, balloon, or stent is a safe and effective method of coronary protection during TAVR in appropriately selected high-risk patients. Annular circumference, prosthesis size, left coronary cusp length, LM ostial height, and ratio of sinotubular junction to prosthesis size are important predictors of stent deployment.

Prosthesis Geometrical Predictors of Leaflet Thrombosis Following Transcatheter Aortic Valve Replacement With Intra-Annular Prostheses

To determine the association between prosthesis geometry with leaflet thrombosis (LT). Leaflet thrombosis following transcatheter aortic valve replacement (TAVR) is a recognised entity. The association between prosthesis geometry with LT is unclear but maybe a potential modifiable factor in its prevention. Patients who received an intra-annular TAVR prosthesis and were prospectively planned to undergo post-procedural computed tomography (CT) imaging were included. Leaflet thrombosis was defined as at least 50% restricted leaflet motion on CT. Prosthesis expansion and eccentricity was measured at prosthesis inflow, annulus and outflow levels. Prosthesis misalignment was defined as the average angle deviation between native and prosthesis leaflet commissure, greater than 30°. Prevalence of LT was 13.7% in 117 patients. None of the patients with LT were on anticoagulation therapy. Patients with LT had reduced prosthesis annular expansion (89.4±5.2% vs 97.0±4.4%, p<0.01), greater prosthesis misalignment (81.3% vs 48.5%, p=0.02) and deeper implants (6.3±1.7 mm vs 4.3±1.5 mm, p<0.01). Threshold for the presence of LT on ROC analysis was an implant depth of 5.7 mm (AUC [area under curve]=0.81). Independent predictors of LT were annular under-expansion (Odds ratio [OR] 1.4, 95% confidence interval [CI] 1.2-1.7, p=0.03) prosthesis misalignment (OR 6.8, 95%CI 1.1-45.5, p=0.04) and implant depth (OR 1.9, 95%CI 1.1-3.2, p=0.03). Anticoagulation therapy was a protective factor (OR 0.2; 95%CI 0.1-0.4, p<0.01). Geometrical predictors of LT post intra-annular TAVR were reduced prosthesis expansion at the annular level, lower implant depth and greater prosthesis misalignment. These factors may be important considerations during procedural planning for TAVR.

Infective Endocarditis Caused by Staphylococcus aureus After Transcatheter Aortic Valve Replacement.

Staphylococcus aureus (SA) has been extensively studied as causative microorganism of surgical prosthetic-valve infective endocarditis (IE). However, scarce evidence exists on SA IE after transcatheter aortic valve replacement (TAVR). Data were obtained from the Infectious Endocarditis After TAVR International Registry, including patients with definite IE after TAVR from 59 centres in 11 countries. Patients were divided into 2 groups according to microbiologic etiology: non-SA IE vs SA IE. SA IE was identified in 141 patients out of 573 (24.6%), methicillin-sensitive SA in most cases (115/141, 81.6%). Self-expanding valves were more common than balloon-expandable valves in patients presenting with early SA IE. Major bleeding and sepsis complicating TAVR, neurologic symptoms or systemic embolism at admission, and IE with cardiac device involvement (other than the TAVR prosthesis) were associated with SA IE (P < 0.05 for all). Among patients with IE after TAVR, the likelihood of SA IE increased from 19% in the absence of those risk factors to 84.6% if ≥ 3 risk factors were present. In-hospital (47.8% vs 26.9%; P < 0.001) and 2-year (71.5% vs 49.6%; P < 0.001) mortality rates were higher among patients with SA IE vs non-SA IE. Surgery at the time of index SA IE episode was associated with lower mortality at follow-up compared with medical therapy alone (adjusted hazard ratio 0.46, 95% CI 0.22-0.96; P= 0.038). SA IE represented approximately 25% of IE cases after TAVR and was associated with very high in-hospital and late mortality. The presence of some features determined a higher likelihood of SA IE and could help to orientate early antibiotic regimen selection. Surgery at index SA IE was associated with improved outcomes, and its role should be evaluated in future studies.

Outcomes of Transcatheter Aortic Valve Replacement in Patients Treated With Systemic Steroids.

Chronic steroid therapy is associated with higher vascular complication rates in patients undergoing transcatheter aortic valve replacement (TAVR). The effect of corticosteroids on aortic annular complications has not been directly assessed in this population. A retrospective analysis of 1095 patients undergoing transfemoral TAVR was performed. Patients treated with chronic steroids at the time of the procedure (n = 99) were compared with those who received no steroids (n = 992). The primary outcome included a composite of aortic annular complications, defined as a combination of aortic annular rupture, aortic dissection/perforation, and left ventricular perforation. The primary outcome was significantly higher in the steroid group (4.0% vs 0.5%; P<.01). This finding was primarily driven by higher rates of acute annular rupture in the steroid group (2.0% vs 0.2%; P=.04). Steroid use was associated with higher rates of intraoperative cardiac arrest (5.1% vs 1.5%; P=.03), device capture/retrieval (4.0% vs 0.8%; P=.01), and emergent conversion to open heart surgery (4.0% vs 0.6%; P<.01). There were no differences with respect to in-hospital mortality, stroke, myocardial infarction, need for permanent pacemaker, bleeding complications, minor vascular complications, hospital length of stay, hospital 30-day readmission, or 30-day echocardiographic findings. Additionally, within the steroid group, there were no significant differences between balloon-expandable vs self-expanding TAVR prostheses with respect to composite aortic annular complications. Chronic steroid therapy increases the risk of aortic annular complications in patients undergoing TAVR, with detrimental consequences including intraoperative cardiac arrest and conversion to open heart surgery. Steroid use should be considered in patient selection and determination of procedural technique for TAVR.

Clinical predictors and sequelae of computed tomography defined leaflet thrombosis following transcatheter aortic valve replacement at medium-term follow-up.

The clinical predictors and sequelae of leaflet thrombosis (LT) following transcatheter aortic valve replacement (TAVR) is still unclear. Therefore, our aim was to determine the clinical predictors and sequelae at mid-term follow-up of computed tomography (CT)-defined LT following TAVR. We performed a prospective evaluation with a 320-multislice CT following TAVR for the presence of LT, defined as hypo-attenuated leaflet thickening (HALT). Four-dimensional CT image-rendering was performed to determine the presence of reduced leaflet motion (RELM). 172 patients [89 (51.7%) male, mean age 82.8 ± 5.7years] treated with commercially available TAVR device (Lotus 54%, CoreValve 32% and Sapien 3 14%) were included, with median CT-scan at 6.0weeks post-TAVR. Prevalence of HALT was 14.0% (24 cases) and RELM was 9.8% (17 cases). On multivariate analysis, patients with HALT were less prescribed oral anticoagulation (OAC) (OR 9.9), received larger TAVR prostheses (OR 5.7) and higher rates of moderate-severe para-valvular regurgitation (PVR) (OR 16.3). There was no difference in clinical outcomes at a median follow-up of 2.3years. Patients with RELM had significantly higher transvalvular gradients after discharge when compared to those without RELM. Absence of OAC, large TAVR prostheses and moderate-severe PVR were predictors for LT. Transvalvular gradients were higher in patients that developed RELM but not HALT. Further studies are warranted to determine the long-term impact of LT on TAVR durability. Prevalence of different sub-types of CT-defined LT (HALT and RELM) and the clinical predictors of developing LT following TAVR. CT computed tomography, HALT hypo-attenuated leaflet thickening, LT leaflet thrombosis, RELM reduced leaflet motion, TAVR transcatheter aortic valve replacement.

Association between prosthesis geometry and leaflet thrombosis following transcatheter aortic valve replacement

Abstract Introduction Leaflet thrombosis (LT) following transcatheter aortic valve replacement (TAVR) is a recognised condition. The association between prosthesis geometry [expansion, implant depth and commissural alignment (CA)] and LT is unclear. Methods Patients that received intra-annular TAVR prosthesis and post-procedure computed tomography (CT) with a 320-slice scanner were included. LT, defined as at least 50% restricted leaflet motion, was assessed with a dedicated 3Mensio workstation by two experienced CT readers. Prosthesis expansion was defined as actual divided by expected prosthesis area as a percentage of expected area whilst eccentricity was [(maximum diameter − minimum diameter) / maximum diameter) × 100%], both measured at prosthesis inflow, annulus and outflow. Implant depth was the average distance between prosthesis inflow and nadir of each cusp. CA was the average angle between each native and prosthesis leaflet coaptations. Significant commissural misalignment (CMA) was defined as CA greater than 30 degrees. To exclude anticoagulation bias, similar analysis was also performed in the cohort of non-anticoagulated patients. Results 117 patients were included; the prevalence of LT was 13.7% [13/93 cases (14.0%) of Lotus valves and 3/24 cases (12.5%) of Sapien 3 valves]. Baseline demographics (age, STS score, cardiac risk factors) and procedural characteristics (access site, post-dilation, repositioning) were similar in both groups. None of the patients with LT were discharged on anticoagulation therapy (0.0% vs 22.8%, p&amp;lt;0.01). There were no differences in actual prosthesis area, perimeter or eccentricity at the three prosthesis levels. Patients with LT had reduced annulus expansion (89.3±9.8% vs 94.6±8.3%, p=0.02), lower implant depth (6.9±1.5mm vs 4.9±1.5mm, p&amp;lt;0.01) and more significant CMA (81.3% vs 48.5%, p=0.02). These findings were similar in patients that were not anticoagulated (94/117 patients). Conclusion Patients with LT had reduced annulus expansion, lower implant depth and greater CMA. These findings were not affected by presence or absence of anticoagulation. These factors may be important considerations during procedural planning for TAVR. Graphical abstract Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Health and Medical Research Council (NHMRC). National Heart Foundation (NHF) Australia.

Incidence, Characteristics, Predictors, and Outcomes of Surgical Explantation After Transcatheter Aortic Valve Replacement

BackgroundCurrently, there is a paucity of information on surgical explantation after transcatheter aortic valve replacement (TAVR). ObjectivesThe purpose of this study was to examine the incidence, patient characteristics, predictors, and outcomes of surgical explantation after TAVR using a population-based, nationally representative database. MethodsWe analyzed the Medicare Provider profile to include all U.S. patients undergoing TAVR from 2012 to 2017. Time to surgical explant was calculated from the index TAVR discharge to surgical explantation. Post-operative survival was assessed using time-dependent Cox proportional hazard regression analysis and landmark analysis. ResultsThe incidence of surgical explantation was 0.2% (227 of 132,633 patients), and was 0.28% and 0.14% in the early and newer TAVR era, respectively. The median time to surgical explant was 212 days, whereas 8.8% and 70.9% underwent surgical explantation within 30 days and 1 year, respectively. The primary indication for reintervention was bioprosthetic failure (79.3%). Compared with the no-explant cohort, the explant cohort was significantly younger (mean age 73.7 years vs. 81.7 years), with a lower prevalence of heart failure (55.9% vs. 65.8%) but more likely a lower-risk profile cohort (15% vs. 2.4%; all p < 0.05). The 30-day and 1-year mortality rates were 13.2% and 22.9%, respectively, and did not vary by either time to surgical explant or TAVR era, or between patients with versus without endocarditis (all p > 0.05). The time-dependent Cox regression analysis demonstrated a higher mortality in those with surgical explantation (hazard ratio: 4.03 vs. no-explant group; 95% confidence interval: 1.81 to 8.98). Indication, time-to-surgical-explant, and year of surgical explantation were not associated with worse post-explantation survival (all p > 0.05). ConclusionsThe present study provides updated evidence on the incidence, timing, and outcomes of surgical explantation of a TAVR prosthesis. Although the overall incidence was low, short-term mortality was high. These findings stress the importance of future mechanistic studies on TAVR explantation and may have implications on lifetime management of aortic stenosis, particularly in younger patients.

Outcomes of Surgery After Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR) is now the most common therapy for severe aortic stenosis in the U.S., but when TAVR prostheses fail, the

Reoperation After Transcatheter Aortic Valve Replacement: An Analysis of the Society of Thoracic Surgeons Database

ObjectivesThis study sought to report the largest series of patients receiving a surgical reoperation after transcatheter aortic valve replacement (TAVR) using the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database. BackgroundTAVR has become an effective means of treating aortic stenosis. As TAVR is used in progressively lower-risk cohorts, management of device failure will become increasingly important. MethodsThe STS Adult Cardiac Surgery Database was queried for patients with a history of prior TAVR undergoing surgical aortic valve replacement from 2011 to 2015. Observed-to-expected (O/E) mortality ratios were determined to facilitate comparison across reoperative indications and timing from index TAVR procedure. ResultsA total of 123 patients met inclusion criteria (median age 77 years) with an STS Predicted Risk of Mortality of 4%, 4% to 8%, and >8% in 17%, 24%, and 59%, respectively. Median time to reoperation was 2.5 (interquartile range: 0.7 to 13.0) months, and the operative mortality rate was 17.1%. Common indications for reoperation included early TAVR device failures such as paravalvular leak (15%), structural prosthetic deterioration (11%), failed repair (11%), sizing or position issues (11%), and prosthetic valve endocarditis (10%). All pre-operative risk categories were associated with an increased O/E mortality ratio (Predicted Risk of Mortality <4%: O/E 5.5; 4% to 8%: O/E 1.7; >8%: O/E 1.2). ConclusionsSAVR following early failure of TAVR, while rare, is associated with worse-than-expected outcomes as compared with similar patients initially undergoing SAVR. Continued experience with this developing technology is needed to reduce the incidence of early TAVR failure and further define optimal treatment of failed TAVR prostheses.

Early clinical and procedural outcomes in large series of 34-mm self-expanding transcatheter aortic valve replacement.

We aimed to evaluate early clinical and procedural outcomes with the 34-mm Evolut R transcatheter aortic valve replacement (TAVR) prosthesis. The 34-mm Evolut R (Medtronic, Minneapolis, MN) self-expanding TAVR prosthesis was designed to treat patients with larger annuli. Clinical, demographic, procedural, and echocardiographic data on consecutive patients who underwent TAVR with a 34-mm Evolut R prosthesis at our institution were collected and analyzed. One hundred ninety-six patients underwent TAVR with this prosthesis from November 2016 to July 2018, a majority (n = 188, 96%) through transfemoral access and with conscious sedation (n = 182, 93%). Mean age, Society of Thoracic Surgery risk score, and follow-up were 82 ± 8 years, 5.4 ± 5%, and 8.2 ± 5.3 months, respectively. Mean aortic valve (AV) peak velocity was 4.0 ± 0.6 m/s, mean AV gradient was 38 ± 13 mmHg, AV area was 0.79 ± 0.23 cm2 ; calcium score was 3,503 ± 1,970 Agatston units, and perimeter was 85 ± 4.3 mm. Device implantation was successful in all but one patient. Postprocedure mean AV peak velocity, AV mean gradient, and AV area were 1.9 ± 0.4 m/s, 7 ± 3 mmHg, and 2.6 ± 0.7 cm2 , respectively. New pacemaker requirement rate was 16%, and moderate paravalvular leak was present in six patients (3%), which improved to mild in three patients at 6-month follow-up. In-hospital, 30-day, 6-month, and 12-month survival rates were 98%, 96% (hospital discharge), 96% (30-day), 89% (6-month), and 83% (12-month). These data demonstrate high success and good procedural, echocardiographic, and clinical outcomes of 34-mm Evolut R in patients with large annuli.

Invited Commentary

Invited Commentary

Developing process measures in value-based healthcare: the case of aortic valve disease

BackgroundAs process measures can be means to change practices, this article presents process measures that impact on outcome measures for surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement...

Comparison of Outcomes After Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement Among Patients With Aortic Stenosis at Low Operative Risk

Transcatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce. To compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS. This retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts. Primary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization. The primary outcomes were 30-day and 3-year survival. Overall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P = .12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P = .45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who received recent aortic valve prostheses vs those who did not. Transcatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients.

The prevalence of computed tomography-defined leaflet thrombosis in intra- versus supra-annular transcatheter aortic valve prostheses.

Leaflet thrombosis (LT) defined by computed tomography (CT) following transcatheter aortic valve replacement (TAVR) has been shown to increase cerebrovascular events. The neo-sinus plays an important role in the development of LT. Intra-annular valves (IAV) have a larger neo-sinus when compared to supra-annular valves (SAV), and has been associated with larger thrombus burden. The prevalence of LT with IAV and SAV in a larger, diverse cohort is unknown. We performed a systematic review to assess the prevalence of LT in IAV versus SAV TAVR prostheses. Inclusion criteria were (1) reported CT-defined LT following TAVR, (2) comparison between LT and non-LT cohort, (3) separate registry/database, and (4) fully published status. A total of 2,013 citations were reviewed and 7 studies were included. Overall, 1,644 patients were included from 7 observational studies and the prevalence of LT following TAVR was 12.8%. The Portico valve system (IAV) had the highest prevalence of LT with 35.2%, followed by Symetis Acurate Neo (SAV) at 15.4% and the Lotus valve system (IAV) at 14.5%. LT occurred more frequently in IAV than SAV (13.5% vs. 7%, P = 0.02). Subanalysis of IAV versus SAV with the exclusion of the Portico valve was performed to ensure results were not influenced by this valve system and revealed IAV still had higher rates of LT (12.1% vs. 7%, P = 0.05). In summary, IAV prostheses appear to be associated with higher rates of LT when compared with SAV.

Development of a Novel Human Cell-Derived Tissue-Engineered Heart Valve for Transcatheter Aortic Valve Replacement: an In Vitro and In Vivo Feasibility Study.

Transcatheter aortic valve replacement (TAVR) is being extended to younger patients. However, TAVR-compatible bioprostheses are based on xenogeneic materials with limited durability. Off-the-shelf tissue-engineered heart valves (TEHVs) with remodeling capacity may overcome the shortcomings of current TAVR devices. Here, we develop for the first time a TEHV for TAVR, based on human cell-derived extracellular matrix and integrated into a state-of-the-art stent for TAVR. The TEHVs, characterized by a dense acellular collagenous matrix, demonstrated in vitro functionality under aortic pressure conditions (n = 4). Next, transapical TAVR feasibility and in vivo TEHV functionality were assessed in acute studies (n = 5) in sheep. The valves successfully coped with the aortic environment, showing normal leaflet motion, free coronary flow, and absence of stenosis or paravalvular leak. At explantation, TEHVs presented full structural integrity and initial cell infiltration. Its long-term performance proven, such TEHV could fulfill the need for next-generation lifelong TAVR prostheses.

Bioprosthetic structural valve deterioration: How do TAVR and SAVR prostheses compare?

BackgroundThe durability of TAVR prostheses has come under major scrutiny since the move towards lower risk patients. We sought to compare the rate of structural valve deterioration (SVD) over time between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). MethodsWe included all TAVR and SAVR patients (age ≥ 75 years) that were performed in our centre from 2005 until 2015. Applying the internationally “agreed on” definitions of SVD, we surveyed all available serial echocardiographic follow-ups. ResultsWe included 269 TAVR and 174 SAVR cases. Post-intervention, TAVR patients had lower mean and peak gradients but higher rate of mild aortic regurgitation. SAVR patients had longer follow-up (in months, SAVR: 53 (30, 85) Vs TAVR: 33.4 (23, 52)). SVD as per Valve Academic Research Consortium-2 (VARC-2) was similar between the two groups (TAVR 28% Vs SAVR 31%; P = 0.593) but moderate haemodynamic SVD (European Association of Percutaneous Cardiovascular Intervention (EAPCI) criteria) was more common among SAVR cases (TAVR 11.5% Vs SAVR 20.7%; P = 0.007). Using Kaplan-Meier estimates, the rate of SVD over time was not different between the two groups as per VARC-2 criteria but different when moderate haemodynamic SVD criteria were applied (Log Rank P = 0.022) in favour of TAVR. The mean gradient rose steadily over time but more so post-SAVR (β = 0.52 ± 0.24 in comparison to TAVR at every given time point; P = 0.032). ConclusionStructural valve deterioration is common on long-term follow-up post-TAVR. The rate is similar to post-SAVR cases according to VARC-2 criteria but less according to the moderate haemodynamic SVD criteria.