SAPIEN XT Valve Research Articles

Parallel suture technique with ProGlide: a novel method for management of vascular access during transcatheter aortic valve implantation (TAVI).

The aim of this study was to evaluate vascular complications using the "parallel suture technique" in patients receiving an Edwards SAPIEN XT (SXT) or SAPIEN S3 (S3) transcatheter heart valve (THV). Two hundred consecutive patients with symptomatic severe aortic stenosis treated with TF-TAVI were included in this study where the "parallel suture technique" was applied for vascular access-site closure. This was achieved by placing the sutures medial and lateral to the puncture site. Vascular access-site complications were defined as vascular dissection, perforation, obstruction, arteriovenous fistula or pseudoaneurysms, and classified according to the Valve Academic Research Consortium-2 (VARC-2) criteria. Duplex sonography was performed routinely in every patient. In patients receiving the S3, the sheath to femoral and iliac artery ratio was significantly lower than in the SXT group, reflecting reduction in sheath sizes for S3. More endovascular interventions were required after SXT implantation as compared to S3 (4% versus 1%, p=0.02). This was due to vascular obstruction or device failure. Moreover, increased life-threatening, major bleedings, and pseudoaneurysms were found in the SXT group (6% versus 1%, p=0.06, 13% versus 3%, p=0.009, 7% versus 1%, p=0.03, respectively). The "parallel suture technique" using the ProGlide is associated with a low number of vascular complications, even when using larger sheath sizes.

Pulmonic Valve Disease: Review of Pathology and Current Treatment Options.

Our review is intended to provide readers with an overview of disease processes involving the pulmonic valve, highlighting recent outcome studies and guideline-based recommendations; with focus on the two most common interventions for treating pulmonic valve disease, balloon pulmonary valvuloplasty and pulmonic valve replacement. The main long-term sequelae of balloon pulmonary valvuloplasty, the gold standard treatment for pulmonic stenosis, remain pulmonic regurgitation and valvular restenosis. The balloon:annulus ratio is a major contributor to both, with high ratios resulting in greater degrees of regurgitation, and small ratios increasing risk for restenosis. Recent studies suggest that a ratio of approximately 1.2 may provide the most optimal results. Pulmonic valve replacement is currently the procedure of choice for patients with severe pulmonic regurgitation and hemodynamic sequelae or symptoms, yet it remains uncertain how it impacts long-term survival. Transcatheter pulmonic valve replacement is a rapidly evolving field and recent outcome studies suggest short and mid-term results at least equivalent to surgery. The Melody valve® was FDA approved for failing pulmonary surgical conduits in 2010 and for failing bioprosthetic surgical pulmonic valves in 2017 and has been extensively studied, whereas the Sapien XT valve®, offering larger diameters, was approved for failing pulmonary conduits in 2016 and has been less extensively studied. Patients with pulmonic valve disease deserve lifelong surveillance for complications. Transcatheter pulmonic valve replacement is a novel and attractive therapeutic option, but is currently only FDA approved for patients with failing pulmonary conduits or dysfunctional surgical bioprosthetic valves. New advances will undoubtedly increase the utilization of this rapidly expanding technology.

PO7-29 - Safety and efficacy of Sapien 3 valve for percutaneous pulmonary valve implantation

Purpose Efficacy of Sapien XT valve has been reported for percutaneous pulmonary valve implantation (PPVI). Implantation is complex given the rigidity and the of the Novaflex® delivery system. Sapien 3 valve is the latest evolution of Edwards valves with a more flexible Commander® delivery system. We report our results of off-label use of Sapien 3 for PPVI. Methods Between September 2016 and April 2017, 16 procedures were performed with the Sapien 3 and compared to 26 procedures performed with the Sapien XT between January 2015 and July 2016. Results Sapien 3 were implanted in 16 patients [26 years old (23–38)]. Conduit were native patched valves (n = 6), bioprosthesis (n = 4), tube (n = 4), homograft (n = 1) and Melody valve (n = 1). All patients had pulmonary prestenting (Andrastent XXL, n = 12; eV3 LDmax, n = 4). Valve implantation was performed during a second procedure in 5 cases. Valve diameters were 23 (n = 3), 26 (n = 4) and 29 mm (n = 9). Valves were successfully implanted in all cases. After procedure, one patient had minor pulmonary valve regurgitation. Peak-to-peak gradient across the valves was ≤ 15 mmHg in 14 cases. Two patients had minor valve mismatch. Nor valve dysfunction nor infective endocarditis was reported during follow-up. Procedure duration, fluoroscopy time, dose-length product and kerma were lower with Sapien 3 compared to Sapien XT procedures (0.002, 0.01, 0.006, and 0.007 respectively). Conclusion Sapien 3 valve implantation in pulmonary position with the Commander delivery system is efficient and faster. However, the lack of valve covering onto the delivery system remains an issue.

Clinical outcomes and prognostic factors of transcatheter aortic valve implantation in bicuspid aortic valve patients.

The purpose of this study was to evaluate the outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). From April 2012 and December 2016, 108 patients with bicuspid AS underwent TAVR using the Sapien XT (34 patients) and Sapien 3 (74 patients) valves. Procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between the two devices. In the overall cohort, the majority of patients were male (71.3%) with an intermediate surgical risk and a mean Society of Thoracic Surgeons (STS) score of 5.2%. Compared to the Sapien XT group, the Sapien 3 group had a significantly lower STS score (3.3%±2.0% vs. 6.7%±3.6%; P=0.001). Compared to the Sapien XT group, the Sapien 3 group had a significantly lower rate of moderate or severe paravalvular leak (2.7% vs. 14.7%; P=0.03) and higher device success (97.3% vs. 82.4%; P=0.006). There were no significant differences between the two groups in terms of 30-day all-cause mortality, stroke, life-threatening bleeding, major vascular complication and acute kidney injury (stage 2 or 3). Cumulative all-cause mortality at 1-year follow-up was 6.9%. There were no significant differences in cumulative event rates for all-cause mortality at 1-year follow-up between the two groups (9.4% vs. 4.6%; log-rank P=0.47). By univariate analysis, major vascular complication was significantly associated with overall all-cause mortality [hazard ratios (HR): 7.57; 95% confidence interval (CI): 1.51-37.86; P=0.014]. TAVR using the balloon-expandable valves provided acceptable procedural and clinical outcomes in patients with bicuspid AS. The new-generation Sapien 3 valves showed improved procedural outcomes compared to the early-generation Sapien XT valves.

Outcome of transcatheter aortic valve implantation in high risk patients with severe aortic stenosis.

AimTo assess outcome of TAVI in high risk patients with severe symptomatic aortic stenosis.Patients and methods40 patients with symptomatic severe aortic stenosis and high risk underwent TAVI with implantation of either Sapien XT valve or Core Valve and followed for 6 months. Device success, cardiovascular mortality, myocardial infarction, stroke, life-threatening bleeding and vascular complications were defined according to Valve Academic Research Consortium definitions.ResultsThe study included 40 patients, their mean age was 73.98 ± 8.40, procedural success was 97.5%. One patient need valve in valve due to moderately severe paravalvular leak. Total mortality was 7.5%, cardiovascular death occurred in 2.5% and non cardiovascular death occurred in 5%. Myocardial infarction occurred in one patient (2.5%), stroke occurred in 2 patients (5%), minor bleeding occurred in 6 patients (15%), major bleeding occurred in 3 patients (7.5%), minor vascular complications occurred in 4 patients (10%) while major vascular complications occurred in 3 patients (7.5%). Permanent pacemaker was inserted for 5 patients (12.5%), new onset AF occurred in 4 patients (10%). Re hospitalization was needed for 2 patients (5%) due to heart failure. After TAVI there were significant improvement in NYHA functional class (p < 0.001), mean LV ejection fraction and LV mass index (p < 0.001), mean aortic valve area, mean and peak pressure gradient (p < 0.001), severity of aortic and mitral regurgitation (p < 0.001). When comparing types of valves used, both were nearly comparable.ConclusionTAVI is a safe and effective procedure in selected high-risk patients with severe symptomatic aortic stenosis without significant difference between used valves.

Feasibility and applicability of static vascular outline roadmapping during transcatheter aortic valve implantation.

We investigated the application and feasibility of a novel software tool designed for the visualization of the aortic root during transcatheter aortic valve implantation (TAVI). The final positioning of the device prior deployment remains the most critical phase during TAVI. Philips "Vascular Outlining" prototype application was used during balloon expandable Edwards Lifesciences SapienXT valve deployment. It processes any angiographic sequences, extracting the static outline of vessels and projecting the two-dimensional vessel margins as a roadmap on live fluoroscopy. Preoperational planning, sizing and anatomical assessment of access routes were performed using computed tomography scans and the Philips "HeartNavigator" software. Fifteen high-risk aortic stenosis patients (mean age 82.0±6.6 years) underwent TAVI via transfemoral (N.=8), transapical (N.=4), and transaortic (N.=3) access routes. Mean logistic EuroSCOREs and STS-scores were 19.7±4.3% and 7.9±3.1%, respectively, mean aortic gradient was 66.3±18.3 mmHg. All valves were implanted successfully with none or trivial paravalvular regurgitation in 11 patients, mild in 3 patients, and moderate in 1 patient. TAVI was performed in all cases with only one aortic root contrast media injection during valve deployment. No major stroke or cardiovascular death occurred within 30 days. "Vascular Outlining"-guided implantation of the SapienXT valve is feasible. This new feature might increase the accuracy of valve placement and also may reduce the need for extra contrast media use during valve deployment. However, the lack of real-time motion compensation limits its wide application, as the overlay does not move together with respiratory and cardiac motion.

Procedural Characteristics and Outcomes of Transcatheter Aortic Valve Implantation: A Single-Center Experience of the First 100 Inoperable or High Surgical Risk Patients with Severe Aortic Stenosis.

This is the first study of a Taiwanese population reporting transcatheter aortic valve implantation (TAVI) outcomes of the first 100 cases from a single center offering two different transcatheter heart valve technologies via six types of approaches. We herein report the 30-day and one-year outcomes in our first 100 TAVI patients at Taipei Veterans General Hospital. From May 2010 to April 2016, 100 consecutive patients with severe aortic stenosis (AS) who were considered unsuitable or at high risk for surgical aortic valve replacement underwent TAVI. Patient outcomes were classified according to the Valve Academic Research Consortium-2 (VARC-2) definitions. The device performance was assessed using transthoracic echocardiography by independent investigators. The mean patient age was 81.1 years, where 54% were female, and the mean Logistic EuroSCORE was 21.5%. The Medtronic CoreValve was used in 84 patients and the Edwards Sapien or Sapien XT valve (ESV) in 16. The transfemoral approach was the most frequently used route (83%), followed by transapical (9%) access. Overall, there was no procedural death. The VARC-2 outcomes were as follows: device success, 95%; stroke, 1%; major vascular complication, 3%; a need for pacemaker implantation, 5.1%. At discharge, the incidence of postoperative mild, moderate or severe paravalvular leak was 30%, 3% and 0%, respectively. At one year, the all-cause mortality rate was 14.0%, and no valve-related dysfunction was observed. Through multivariable analysis, non-transfemoral access [hazard ratios (HR) 4.81; 95% confidence interval (CI) 1.66-14.09; p = 0.004] and advanced chronic kidney disease (stages 4-5), (HR 3.13; 95% CI 1.07-9.09; p = 0.036) were independently associated with an increased risk of one-year mortality. We demonstrated that TAVI shows good early and mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance in high-risk patients with severe AS.

Health Status Benefits of Transcatheter vs Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk

In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar 2-year survival. The effect of TAVR vs SAVR on health status in patients at intermediate surgical risk is unknown. To compare health-related quality of life among intermediate-risk patients with severe AS treated with either TAVR or SAVR. Between December 2011 and November 2013, 2032 intermediate-risk patients with severe AS were randomized to TAVR with the Sapien XT valve or SAVR in the Placement of Aortic Transcatheter Valve 2 Trial and were followed up for 2 years. Data analysis was conducted between March 1, 2016, to April 30, 2017. Health status was assessed at baseline, 1 month, 1 year, and 2 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ) (23 items covering physical function, social function, symptoms, self-efficacy and knowledge, and quality of life on a 0- to 100-point scale; higher scores indicate better quality of life), Medical Outcomes Study Short Form-36 (36 items covering 8 dimensions of health status as well as physical and mental summary scores; higher scores represent better health status), and EuroQOL-5D (assesses 5 dimensions of general health on a 3-level scale, with utility scores ranging from 0 [death] to 1 [ideal health]). Analysis of covariance was used to examine changes in health status over time, adjusting for baseline status. Of the 2032 randomized patients, baseline health status was available for 1833 individuals (950 TAVR, 883 SAVR) who formed the primary analytic cohort. A total of 1006 (54.9%) of the population were men; mean (SD) age was 81.4 (6.8) years. Over 2 years, both TAVR and SAVR were associated with significant improvements in both disease specific (16-22 points on the KCCQ-OS scale) and generic health status (3.9-5.1 points on the SF-36 physical summary scale). At 1 month, TAVR was associated with better health status than SAVR, but this difference was restricted to patients treated via transfemoral access (mean difference in the KCCQ overall summary [KCCQ-OS] score, 14.1 points; 95% CI, 11.7 to 16.4; P < .01) and was not seen in patients treated via transthoracic access (mean difference in KCCQ-OS, 3.5 points; 95% CI, -1.4 to 8.4; P < .01 for interaction). There were no significant differences between TAVR and SAVR in any health status measures at 1 or 2 years. Among intermediate-risk patients with severe AS, health status improved significantly with both TAVR and SAVR through 2 years of follow up. Early health status improvement was greater with TAVR, but only among patients treated via transfemoral access. Longer term follow-up is needed to assess the durability of quality-of-life improvement with TAVR vs SAVR in this population. clinicaltrials.gov Identifier: NCT01314313.

122 Mid-term echocardiographic follow up of trans-catheter aortic valve implantation and incidence of valvular degeneration

PurposeTrans-catheter Aortic Valve Implantation (TAVI) is a well-established procedure in severe aortic stenosis with high surgical risk. However an understanding of the longer-term haemodynamic flow profile of these valves is...

Surgical Aortic Valve Replacement Following Early Sapien-XT Valve Failure: A First

Early degeneration of prosthetic aortic valve in transcatheter aortic valve replacement (TAVR) is a rare complication. We report the case of a 75-year-old woman who presented with severe calcific stenosis of Edwards SAPIEN-XT valve implanted only 4 years previously. She is a Jehovah's Witness and has background of Sjogren's syndrome with secondary cryoglobulinaemic vasculitis. She was not a suitable candidate for valve-in-valve TAVR in view of early prosthetic valve failure by calcification. She underwent surgical explantation of the Sapiens XT valve and mechanical aortic valve replacement. To our knowledge, this is the first time that early TAVR valve degeneration and failure of an Edwards SAPIEN-XT valve was reported which required surgical replacement with a mechanical valve.

Aorto-right ventricular fistula following transcatheter aortic valve implantation using a 29 mm SAPIEN XT valve

An 83-year-old man with severe symptomatic aortic valve stenosis underwent transcatheter aortic valve implantation (TAVI) using a 29 mm SAPIEN XT valve. He was haemodynamically stable, but developed haemolytic anaemia....

Late Paravalvular Aortic Regurgitation: Migration of the Valve or Late Recoil?

A 79-year-old man underwent trans-catheter aortic valve replacement for symptomatic severe aortic stenosis with a 26-mm Edwards SAPIEN XT valve. Immediately after valve deployment there was moderate amount of paravalvular leak. Post-dilation was performed with an additional 2 cc of volume, and the paravalvular leak was reduced to trace. Nine months later, trans-thoracic echocardiography revealed moderate to severe paravalvular leak and possible aortic migration of the valve. The patient was brought back for the treatment of the paravalvular leak which was suspected to be due to valve migration. However, fluoroscopy and trans-esophageal echocardiography showed good valve position. Measurement of late valve recoil in the Coplanar view using cine-angiographic analysis software showed that the lower third of the valve had the greatest late recoil (−1.74 mm, 6.55%), which presumably accounted for the progression of the paravalvular leak. Valve-in-valve trans-catheter aortic valve replacement was performed with a 26-mm SAPIEN 3 valve and the paravalvular leak was reduced to trace. This case displays late recoil as a likely mechanism for development of paravalvular leak after SAPIEN XT valve implantation. Our case illustrates that late recoil needs to be systematically evaluated in future studies, especially when trans-catheter aortic valve replacement is being expanded to lower risk and younger patients for whom the longevity and long-term performance of these valves is of critical importance.

SAPIEN XT ve LOTUS Kapakları Kullanılarak Transfemoral Aort Kapak İmplantasyonu Uygulanan Yüksek Riskli Aort Darlığı Olan Hastalarda Klinik Sonuçların Karşılaştırılması

Objective: The aim of this study was to compare the procedural, 30-day, and one-year follow-up Valve Academic Research Consortium-2 (VARC-2) defined outcomes using either the LOTUS valve or the conventional the SAPIEN XT valve. Material and Methods: 50 patients (25 with LOTUS and 25 with SAPIEN XT) with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) were included in this study. We evaluated the procedural outcomes, early safety, and clinical efficacy endpoints of patients who were treated with the LOTUS or the SAPIEN XT valve delivered via the transfemoral route. Results: Accordingly, the Valve Academic Research Consortium-2-defined safety endpoints within 30 days and combined efficacy endpoints at one-year follow-up were the same in both groups (p=0.569, p=0.529, respectively). The need for permanent pacemaker implantation in the LOTUS group was higher than in the SAPIEN XT group at 30 days (20% vs. 8%, p=0.221, respectively) and at one-year (24.0% vs. 16%, p=0.480, respectively). Echocardiography upon discharge demonstrated that trivial or mild paravalvular leakage in SAPIEN XT patients was significantly higher than in LOTUS patients (52% vs. 24%, p=0.041, respectively). Moderate or severe paravalvular leakage was observed in only one patient in a SAPIEN group. Conclusion: 30 days and one-year follow-up results according to Valve Academic Research Consortium-2 were similar in both groups. The permanent pacemaker rate was higher in LOTUS group despite an insignificant difference between the groups. LOTUS was associated significantly lower rate of trivial or mild paravalvular leakage compared with the SAPIEN XT. TAVI with LOTUS valve was associated with no moderate or severe paravalvular leakage and a low rate of mild paravalvular leakage.

Impact of femoral artery puncture using digital subtraction angiography and road mapping on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation.

The use of large-diameter sheaths carries the risk of significant vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI). In this analysis, we sought to assess the impact of a modified femoral artery puncture technique using digital subtraction angiography (DSA) and road mapping during transfemoral TAVI on periprocedural vascular and bleeding events. This is a retrospective analysis of transfemoral TAVI patients included in a prospective institutional database. The modified femoral artery puncture technique using DSA-derived road mapping guidance was introduced in October 2012. Before the introduction of this technique, vascular puncture was acquired based on an integration of angiographic data, the bony iliofemoral landmarks and a radiopaque object. Consecutive patients who underwent TAVI with the road mapping technique (RM group, n=160) were compared with consecutive patients who underwent TAVI without road mapping (control group, n=160) prior to its introduction. A standardised strategy of periprocedural anticoagulation was adopted in both groups as well as the use of a single suture-based closure device. All endpoints were defined according to the VARC-2 criteria for event definition. The mean age in the RM group was 80±7.7 years compared to 81±5.9 years in the control group (p=0.19), and females were equally distributed between both groups (63.1% vs. 58.1%, p=0.36). The baseline logistic EuroSCORE was 20.7±14.4% vs. 24.9±15.2% in the RM and control group, respectively (p=0.01). Notably, sheath size was significantly larger in the RM compared to the control group due to the more frequent use of the 20 Fr sheath (23.8% vs. 1.8%, p<0.001, respectively) associated with the more frequent implantation of the 29 mm Edwards SAPIEN XT valve in the RM group (43.8% vs. 7%, respectively, p<0.001). Despite the latter finding, both major vascular complications and major bleeding at 30 days were significantly lower in the RM group compared to the control group (4.3% vs. 11.8%, p=0.01, and 14.4% vs. 25.6%, p=0.01). An analysis limited to access site-related complications also revealed lower events in the road map group but did not reach statistical significance (8.1% vs. 13.8%, p=0.1). Other forms of vascular and bleeding complications as well as all-cause mortality were comparable in both groups. A modified femoral artery puncture technique using DSA and road mapping was associated with a reduction in major vascular and bleeding complications after transfemoral TAVI, and provides a simple and effective strategy for potentially improving patient outcomes.

Impact of Methodologic Differences in Three-Dimensional Echocardiographic Measurements of the Aortic Annulus Compared with Computed Tomographic Angiography Before Transcatheter Aortic Valve Replacement

Three-dimensional (3D) echocardiographic (3DE) imaging is an alternative to multi-detector row computed tomography (MDCT) for aortic annular measurement before transcatheter aortic valve replacement (TAVR). A commonly used direct planimetry from a reconstructed short-axis view has not been compared with semiautomated 3DE methods. Typically accepted optimal cutoffs for percent prosthesis-area oversizing of the balloon-expandable SAPIEN or SAPIEN XT valve to native annular size are approximately 5% to 15%. The aim of this study was to compare semiautomated and direct planimetric 3DE methods for aortic annular sizing with a gold standard of MDCT to determine predictive value for paravalvular regurgitation (PVR) and balloon postdilatation. In this retrospective analysis, aortic annular cross-sectional area was measured from pre-TAVR imaging using (1) MDCT (CT_Area), (2) a 3D transesophageal echocardiographic (TEE) semiautomated method(3DE_Area_SA), and (3) a 3D TEE direct planimetric method (3DE_Area_Direct). Annular area percent oversizing was calculated. PVR after TAVR was assessed from intraoperative TEE imaging. Need for balloon postdilatation was recorded. One hundred patients who underwent TAVR with either the SAPIEN or SAPIEN XT balloon-expandable prosthesis were analyzed. Twenty-three patients hadmild or greater PVR after TAVR. CT_Area was 442±79mm2, 3DE_Area_SA was 435±81mm2, and 3DE_Area_Direct was 429±82mm2. Both 3DE_Area_SA and 3DE_Area_Direct underestimated MDCT (P<.05). All methods were highly correlative (R=0.88-0.93, P<.0001). Percent oversizing obtained by the three methods significantly predictedmild or greater PVR and need for balloon postdilatation by receiver operating characteristic analysis, with optimal cutoffs for CT_Area (9%-10%) and 3DE_Area_SA (14%) within the recommended ranges for the studied transcatheter valves and for 3DE_Area_Direct higher than the recommended range (18%-19%). Inter- and intraobserver reproducibility were lowest for 3DE_Area_Direct. Caution must be used when using 3D TEE direct planimetry of the aortic annulus, as optimal percent oversizing ranges approach the level associated with root injury, and measurements are less reproducible. Therefore, semiautomated 3DE planimetry is preferred to 3DE direct planimetry for aortic annulus sizing.

Predictive factor and clinical consequence of left bundle-branch block after a transcatheter aortic valve implantation

BackgroundAtrioventricular conduction disturbances can develop after transcatherter aortic valve implantations (TAVIs) with balloon-expandable valves because the conduction system exists adjacent to the aortic valve. However, the clinical consequence of patients with new onset conduction disturbances is not clear. ObjectiveThis study aimed to assess the incidence and progress of new-onset conduction disturbances following TAVIs and the cardiac function evaluated by echocardiography. MethodsThis study consisted of 90 consecutive patients that underwent TAVIs with Edwards SAPIEN XT valves in a single center. Atrioventricular conduction system disturbances were assessed by electrocardiography and echocardiography up to 6months post TAVI. ResultsTwenty patients (22%) developed new onset complete left bundle branch block (CLBBB) or received pacemaker implantations (PMIs) during the follow-up. At 6months after the procedure, 4 patients underwent PMIs for complete AV block (CAVB), and 4 patients had persistent CLBBB. Those that developed CLBBB and AVB had a higher morbidity from hypertension and lower estimated glomerular filtration rate (eGFR). The ECG, TTE, and CT parameters did not differ between the two groups. The ratio of the valve and LVOT area was significantly associated with a higher cumulative risk of events (HR, 3.005; 95% CI, 1.034–8.736; P<0.05). ConclusionsUp to 20% of patients developed new CLBBB or CAVB and more than half were expected to recover. However, it required attention because approximately 40% were persistent. The ratio of the valve to LVOT area was an independent predictor.

Valve-in-valve outcome: design impact of a pre-existing bioprosthesis on the hydrodynamics of an Edwards Sapien XT valve.

Bioprosthetic aortic heart valves are increasingly implanted in younger patients. Therefore, a strategy for potential valve failure should be developed before implanting the 'first valve'. The goal of this in vitro study was to provide insight into the effects of the design of a bioprosthesis on a valve-in-valve implanted Sapien XT valve. The hydrodynamic performance of a 23-mm Sapien XT valve implanted in Vascutek Aspire, Edwards Perimount, Medtronic Mosaic and St. Jude Medical Trifecta heart valves was investigated in a left heart simulator. In addition to the hydrodynamic results, the leaflet dynamics were analysed in high-speed video recordings of the tests. All valve-in-valve combinations in this study fulfilled the minimum acceptance criteria defined by relevant approval standards (e.g. ISO 5840) but displayed significant differences in their performances. Small inner diameters of the bioprostheses were associated with increased mean pressure gradients, decreased effective orifice areas and geometric opening areas as well as with pin-wheeling and uneven leaflet motion. In addition, implantation in bioprostheses with internally mounted leaflets was associated with lower paravalvular leakage. The results of this study suggest that a surgical bioprosthesis with a large inner diameter and internally mounted leaflets improves the heamodynamics and potentially the durability of a valve-in-valve combination. These results should give the attending physicians critical information to consider when deciding on a bioprosthesis for younger patients.

Prosthesis depth and conduction disturbances after last generation balloon-expandable transcatheter aortic valve implantation.

Preliminary data on Sapien 3 valve (S3-THV) use for transcatheter aortic valve implantation have shown an increased permanent pacemaker implantation (PPMI) rate with respect to Sapien XT valve. Aim of this study was to investigate the role of S3-THV position in the left ventricular outflow tract (LVOT) on electrocardiographic changes suggestive of atrioventricular (ΔPR) and/or intraventricular (ΔQRS) conduction abnormalities and 30 days PPMI rate. Eighty-six consecutive patients treated with S3-THV were included in the study. All patients underwent clinical and electrocardiogram evaluation. Left ventricular outflow tract prosthesis depth was assessed by fluoroscopy and expressed quantitatively (mm) and as aorto-ventricular ratio (AVR). Eight patients (9.3%) needed PPMI at 30 days. A low AVR (≤60/40) predicted PPMI (OR = 6.09, 95% CI 1.19-31.01, P = 0.030) and resulted into higher PPMI rate, compared with higher AVR (30.0 vs. 6.6%, P = 0.017). For each millimetre increase in the LVOT prosthesis depth PPMI risk increased by 1.41 times (95% CI 1.06-1.87, P = 0.017). In patients with low AVR, ΔPR was higher than in those with higher AVR (33.4 ± 56.7 vs. 12.1 ± 19.4 ms, P = 0.021) and ΔPR was associated to LVOT prosthesis depth (β = 0.286, P = 0.009). Furthermore, ΔPR was associated with risk of PPMI (OR = 1.03, 95% CI 1.01-1.06, P = 0.024). A low AVR is associated to higher ΔPR and PPMI rates. The correlation between LVOT prosthesis depth with ΔPR and higher PPMI rate suggests the need of a careful S3-THV implantation.

Transaortic transcatheter aortic valve implantation: experience from the Kiel study

To evaluate the efficacy and safety of Edwards SAPIEN-XT or SAPIEN-3 transcatheter heart valves via transaortic (TAo) access. A total of 100 consecutive patients with severe symptomatic aortic stenosis undergoing TAo-transcatheter aortic valve implantation (TAVI) were included in this observational registry (November 2012-December 2014). Periprocedural and post-procedural outcomes were assessed. Of these 100 patients, 1 received a Medtronic CoreValve. Therefore, this patient was subsequently removed from the analysis. Ninety-nine consecutive TAo-TAVI patients received a balloon-expandable transcatheter heart valve (Sapien). The SAPIEN-XT valve was implanted in 53 patients and the SAPIEN-3 valve in 46 patients. Fluoroscopy time was shorter in the SAPIEN-3 cases (5.6 ± 2.5 vs 8.1 ± 5.1 min, SAPIEN-XT; P = 0.004), with fewer patients requiring dilatation after the operation (20.5% SAPIEN-3 vs 64.2% SAPIEN-XT; P < 0.0001). There were no other significant differences in procedural characteristics between the two valves. All-cause 30-day mortality was 5.1% overall, with comparable outcomes for the two valves (5.7 and 4.4% for SAPIEN-XT and SAPIEN-3 valves, respectively; OR: 1.32; 95% CI: 0.21-8.27; P = 1.0). New atrial fibrillation (13.1%) and acute kidney injury (11.1%) were the most common complications during the 30 days post-procedure. The number of new pacemakers was low (6.1%), with no differences found between the two valve groups. A comparison of 100 TAo- and 42 TA-TAVI implanted in the same period demonstrated similar results in short- (P = 0.31) and long-term (P = 0.99) mortality rates. The efficacy and safety of the Edwards SAPIEN-XT or SAPIEN-3 heart valves via TAo access were demonstrated by high procedural success and low complication rates. The data indicate that this approach is a viable alternative to established access routes.

Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic valve implantation: Difference of valve selection in the real world

BackgroundThe SAPIEN 3 (S3; Edwards Lifescience, Irvine, CA, USA) is a new-generation percutaneous aortic valve with better profile, more precise handling and positioning, designed to reduce the risk of post-procedural paravalvular aortic leak (PVL). The aim of this study was to compare the S3 valve and SAPIEN XT valve (SXT). MethodsThe last 89 transfemoral transcatheter aortic valve implantation (TAVI) cases using SXT were compared to the first 111 cases using the S3. ResultsPatient age and logistic EuroSCORE were similar (83.1 years vs 83.0 years and 18.2% vs 16.6%) in the S3 and SXT groups, respectively as were other baseline characteristics. The ratio of valve diameter/calculated annulus average diameter (CAAD) by multi-detector row computed tomography was significantly lower in the S3 group (1.06 vs 1.09, p<0.001) as was the annular area oversizing percentage (11.3% vs 20.5%, p<0.001). Furthermore, a smaller valve was selected in S3 cases with borderline CAAD compared to SXT cases. Nevertheless, the frequency of paravalvular aortic leakage (PVL) ≥2 tended to be reduced in the S3 group (5% vs 9%, p=0.339). The rate of major vascular complications was significantly lower with S3 (3% vs 12%, p=0.013). In addition, 30-day mortality was significantly lower in the S3 group (0% vs 5%, p=0.044). ConclusionsAlthough TAVI using S3 tended to be carried out with a less oversized valve compared to TAVI using SXT, the frequency of post-procedural PVL ≥2 tended to be lower in the S3 group. The outcomes including vascular complications and 30-day mortality showed a trend in favor of the S3 group.