SAPIEN XT Valve Research Articles

Transcatheter aortic valve replacement failure: surgical valve explantation after more than a decade.

Transcatheter aortic valve replacement (TAVR) has become an established alternative to surgical aortic valve replacement for severe aortic stenosis. However, the long-term outcomes and need for surgical reintervention following TAVR remain uncertain. This case report describes a 76-year-old woman who underwent surgical explantation of a SAPIEN-XT valve more than a decade after initial TAVR implantation due to late valve failure. The patient presented with severe aortic insufficiency and heart failure symptoms. Surgical intervention involved concomitant ascending aortic replacement, tricuspid annuloplasty, and coronary artery bypass grafting. The TAVR valve was successfully explanted using careful blunt dissection to avoid annulus damage. Postoperative recovery was uneventful, with the patient discharged after 4 weeks. This case highlights the potential need for long-term surgical management of patients after TAVR, and emphasizes the importance of surgical preparedness as TAVR indications expand. It also provides valuable insights for surgeons encountering similar cases of late TAVR failure requiring explantation.

Depth of implantation in relation to membranous septum as a predictor of conduction disturbances after transcatheter aortic valve implantation

BackgroundConduction disturbances remain one of the most common complications occurring post TAVI. We aim to determine the predictors of cardiac conduction disturbances after Transcatheter Aortic Valve Implantation (TAVI) and propose a relevant predictive model.We included 70 consecutive patients with severe symptomatic AS who underwent TAVI using the self-expanding valve Evolut R or the balloon expandable Sapien XT valve. All patients were subjected to electrocardiographic evaluation pre- and post-TAVI and at 30 days. Clinical, echocardiographic, CT-derived, and procedural parameters were collected and analyzed. ResultsConduction disturbances affected 28 patients (40%): 16 patients (22.9 %) developed Left Bundle Branch Block (LBBB), 7 patients (10%) experienced transient Complete Heart Block (CHB), and 5 patients (7.1%) experienced permanent CHB requiring Permanent Pacemaker Implantation (PPI). We classified predictors into preprocedural and procedural predictors. Multivariate logistic regression analysis of pre-procedural predictors showed that the presence of basal septal calcification is the most powerful independent predictor (OR: 28.63, 95% CI: 4.59–178.68, p < 0.001). Multivariate logistic regression analysis for pre and post procedural predictors showed that the relationship between depth of implantation at the septum and membranous septum expressed in percentage (sDIMS) with cut-off >70.42% is the most powerful independent procedural predictor (OR: 1.11, 95% CI: 1.03–1.2, p 0.006). ConclusionConduction disturbances remain a common complication of TAVI. Presence of basal septal calcification is a non-modifiable risk factor that increase patient propensity of development such complication after TAVI. A depth of implantation exceeding 70% of the membranous septal length has been found to strongly predict conduction disturbances post TAVI. sDIMS can be used in planning the depth of implantation to reduce incidence of conduction disturbances post TAVI.

Long-term outcomes of balloon-expandable transcatheter aortic valve replacement in Japanese patients

BackgroundData on long-term outcomes of transcatheter aortic valve replacement (TAVR) in Japanese patients beyond 5 years are limited. MethodsBetween June 2010 and December 2014, 55 consecutive inoperable or high surgical risk patients underwent TAVR with SAPIEN XT valves (Edwards Lifesciences, Irvine, CA, USA) for severe aortic stenosis at our institution. Among them, 2 patients were excluded from the analysis because one was converted to open surgery during the TAVR procedure and the other could not undergo TAVR due to device delivery failure. We retrospectively analyzed long-term clinical outcomes of these 53 patients (mean age: 84.1 years; mean STS score: 8.4) who had at least a 7-year follow-up after TAVR. ResultsThe rates of freedom from all-cause and cardiovascular deaths at 7 years were 35.8 % and 79.3 %, respectively. The moderate or severe structural valve deterioration (SVD) rate at 5 and 7 years was 7.2 % and 11.4 %, respectively. The rate of bioprosthetic valve failure (BVF) at 7 years was 6.2 %. ConclusionsThe 7-year mortality rate of inoperable or high surgical risk patients treated with SAPIEN XT was high, while the cardiovascular mortality rate was acceptable. Although the poor survival rate limited the long-term assessment of SAPIEN XT valve durability, the incidence of SVD and BVF was not rare.

The Presence of Calcified Raphe Is an Independent Predictor of Adverse Long-Term Clinical Outcomes in Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.

ObjectiveCurrent guidelines recommend that transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve (BAV) with aortic stenosis (AS) should only be performed in selected patients. However, we consider it even more crucial to identify what the really important factors are while determining long-term outcomes in patients with BAV undergoing TAVR, which is precisely the aim of this study.MethodsWe retrospectively evaluated consecutive patients who underwent TAVR with balloon-expandable Sapien XT or Sapien 3 valves (Edwards Lifesciences, Irvine, CA) for the treatment of severe bicuspid AS. The primary end points were major adverse cardiac and cerebral events (MACCE), that is, mortality, non-fatal myocardial infarction (MI), disabling stroke, valve failure needing reintervention, or clinically relevant valve thrombosis during follow-up.ResultsA total of 56 patients who underwent TAVR with Sapien XT (n = 20) or Sapien 3 (n = 36) were included. The device and procedural success rates were similar between the two TAVR valves; however, the newer-generation Sapien 3 yielded a trend toward better long-term clinical outcomes than the early-generation Sapien XT did (MACCE rates 35 vs. 11%, p = 0.071). In the multivariate Cox proportional hazards analyses, the presence of calcified raphe > 4 mm was the only independent predictor of long-term MACCE (hazard ratio: 6.76; 95% confidence interval: 1.21–37.67, p = 0.029).ConclusionTAVR performed by a skilled heart team, while using newer-generation balloon-expandable Sapien 3 valve, may yield better long-term clinical outcomes compared to TAVR using early-generation Sapien XT valve. Moreover, the presence of calcified raphe >4 mm is an independent determinant of adverse clinical outcomes.

Percutaneous pulmonary valve implantation: Long term outcomes

Percutaneous pulmonary valve implantation (PPVI) is effective to treat right ventricle outflow (RVOT) dysfunction. Long term results and risk factors of valve dysfunction remain little known. We studied long term results of PPVI. All consecutive patients who had successful PPVI between January 2008 and January 2020 in one tertiary center were prospectively included. Follow-up was updated in 2020. 212 patients were included (Melody Valve, n = 32 (15.1%); Sapien XT Valve, n = 47 (22.2%); Sapien 3 valve, n = 133 (62.7%). Median age was 28 years (range 10-81). Patched native pulmonary artery was the most frequent RVOT type (44.4%). Mean follow-up was 2.8 years (range 3 months to 11.4 years). Pulmonary valve replacement (PVR) was performed in 23 cases (10.8%), related to stenotic degeneration ( n = 22 cases, 95%) and severe regurgitation ( n = 1, 4.3%). PVR was performed in 17 Melody valves (53.1%) and 6 Sapien valves (3.3%), with an incidence of 7.6% per patient-year and 1.3% per patient-year respectively ( P = 0.05). Mean interval between PPVI and PVR was 4.7 years (range 1.1-10.1 year). Infective endocarditis (IE) was reported in 13 patients (Melody valve, n = 12, 37.5%; Sapien valve, n = 1, 0.5%) with an incidence of 5.5% per patient-year and 0.2% per patient-year respectively ( P < 0.0001). In an univariate Cox regression analysis, risk factors of PVR were RV obstruction before PPVI ( P = 0.04), transpulmonary maximal velocity > 2.7 m/s after PPVI ( P = 0.05), tricuspid regurgitation doppler maximal gradient >50 mmHg after PPVI ( P < 0.001), valve diameter < 22 mm ( P < 0.003), IE ( P < 0.0001) and age < 25 ( P = 0.04). Risk factors of IE were Melody valve ( P < 0.0001), RV obstruction before ( P = 0.03) or after PPVI ( P = 0.05), valve diameter < 22 mm ( P < 0.03), and younger age ( P = 0.02). PPVI is effective to treat RVOT dysfunction. Implanted Valve durability is shorter when residual RV obstruction is observed, in smaller RVOT, and when IE occurs.

Edwards SAPIEN XT Transcatheter Pulmonary Valve Implantation: 5-year follow-up in a French Registry

This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve. The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported. From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively. The primary efficacy outcome was met for 87,1% patients after a mean follow-up of 55 ± 21 months, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8–95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular insufficiency was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01–2.00%). At 5 years freedom from infective endocarditis was 98.4% (95% CI 89.1–99.8%) ( Fig. 1 ). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35. This study confirms the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.

Percutaneous pulmonary valve implantation: Long term outcomes

Percutaneous pulmonary valve implantation (PPVI) is effective to treat right ventricle outflow (RVOT) dysfunction. Long term Results and risk factors of valve dysfunction remain little known. We aimed to study long term Results of PPVI. All consecutive patients who had successful PPVI between January 2008 and January 2020 in one single tertiary center were prospectively included. Follow-up was updated in 2020. Two hundred and twelve patients were included (Melody Valve, n = 32 (15.1%); Sapien XT Valve, n = 47 (22.2%); Sapien 3 valve, n = 133 (62.7%). Median age was 28 years old (range 10-81). Patched native pulmonary artery was the most frequent RVOT type (44.4%). Mean follow-up was 2.8 years (range 3 months to 11.4 years). Pulmonary valve replacement (PVR) was performed in 23 cases (10.8%), related to stenotic degeneration ( n = 22 cases, 95%) and severe regurgitation ( n = 1, 4.3%). PVR was performed in 17 Melody valves (53.1%) and 6 Sapien valves (3.3%), with an incidence of 7.6% per patient-year and 1.3% per patient-year respectively ( P = 0.05). Mean interval between PPVI and PVR was 4.7 years (range 1.1–10.1 year) ( Fig. 1 ). Infective endocarditis (IE) was reported in 13 patients (Melody valve, n = 12, 37.5%; Sapien valve, n = 1, 0.5%) with an incidence of 5.5% per patient-year and 0.2% per patient-year respectively ( P < 0.0001) ( Fig. 2 ). In an univariate Cox regression analysis, risk factors of PVR were RV obstruction before PPVI ( P = 0.04), transpulmonary maximal velocity > 2.7 m/s after PPVI ( P = 0.05), tricuspid regurgitation doppler maximal gradient > 50 mmHg after PPVI ( P < 0.001), valve diameter < 22 mm ( P < 0.003), IE ( P < 0.0001) and age < 25 ( P = 0.04). Risk factors of IE were Melody valve ( P < 0.0001), RV obstruction before ( P = 0.03) or after PPVI ( P = 0.05), valve diameter < 22 mm ( P < 0.03), and younger age ( P = 0.02). PPVI is effective to treat RVOT dysfunction. Implanted Valve durability is shorter when residual RV obstruction is observed, in smaller RVOT, and when IE occurs.

Evaluation of structural valve deterioration and bioprosthetic valve failure utilizing the new European consensus definition in patients undergoing TAVI with first-generation devices: Outcomes beyond 5 years from a single center in Turkey.

The long-term durability of transcatheter aortic bioprosthetic valves continues to be a major concern. Standardized criteria of the structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) have recently been defined. Limited studies have evaluated the long-term durability of transcatheter aortic valve implantation (TAVI) according to these new definitions. We aim to analyze the durability of TAVI beyond 5 years and to report the frequency of SVD and BVF. A total of 89 patients who had undergone TAVI and had theoretically completed at least 5 years after the procedure were included. Either a Medtronic CoreValve or an Edwards SAPIEN XT valve were implanted in the patients. New standardized definitions were used to evaluate SVD and BVF. The mean age of the patients was 78.70±6.95 years. SVD occured in 4 (4.5%) patients during 6 years of follow-up. Severe SVD was observed in 2 patients (2.2%), and these patients had the New York Heart Association class II symptoms. Both patients with severe SVD also met the criteria of BVF. Moderate SVD was observed in 2 patients (2.2%), and these patients had no valve-related symptoms. Of the 4 SVD cases, 2 were associated with increased mean transaortic gradients, whereas the remaining 2 cases were associated with intraprosthetic aortic regurgitation. All patients with SVD are still alive, and none of them have required aortic valve reintervention. Although first-generation TAVI devices were used, we determined the low rate of SVD and BVF at the 6-year follow-up. It may be suggested that there is no major concern associated with TAVI even with first-generation devices regarding long-term durability.

Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5‐year follow‐up in a French Registry

This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve. The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported. From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively. The primary efficacy outcome was met for 87.1% patients after a mean follow-up of 4.6 ± 1.8 years, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8-95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular regurgitation was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01-2.00%). At 5 years, freedom from infective endocarditis was 98.4% (95% CI 89.1-99.8%). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35. This study documents the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.

Midventricular obstruction and left ventricular remodeling after transcatheter aortic valve implantation

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Grant of Russian Foundation for Basic Research Introduction Long existing pressure overload results in left ventricular (LV) hypertrophy in severe aortic stenosis (AS). Post-TAVI left ventricular remodeling after relief of the high-pressure overload could lead to manifestation of postprocedural midventricular obstruction caused mostly by marked LV wall hypertrophy with the interposition of the hypertrophic papillary muscle in small LV chamber. Our aim was to evaluate the incidence and predictors of midventricular obstruction during 1-year follow-up in patients with AS who underwent transcatheter aortic valve implantation. Methods 30 consecutive patients (mean age: 82.3 ± 5.6 years) with symptomatic severe AS who underwent TAVI in 2018-2019 in Almazov centre and survived &amp;gt;12 months were enrolled in our observational, prospective, single-center study. Evolut R and Sapien-XT valves were used. All patients underwent transthoracic echocardiography before TAVI and at 3, 6, and 12 months after the procedure. There were no patients with baseline midventricular obstruction or concomitant hypertrophic obstructive cardiomyopathy. Results Procedure was successful in all cases. During 1 year of follow-up after TAVI, 3 patients (10%) demonstrated postprocedural midventricular obstruction with peak gradient ­– 36,3 ± 24,3 mm Hg. There was no difference in prosthetic diameter between obstructive and non-obstructive patients (27.0 ± 3,4 vs. 27.7 ± 5,1 mm, p = 0.85 - nonparametric Mann-Whitney U test for all comparisons). At baseline echocardiography, patients with midventricular obstruction had a significantly thicker interventricular septum (14.7 ± 2.5 vs. 11.5 ± 1.6mm, p &amp;lt; 0.05), higher LV mass index (170.3 ± 63.6 vs. 121.0 ± 39.5 g/m2, p &amp;lt; 0.05) and relative wall thickness (0.59 ± 0.03 vs. 0.49 ± 0.05 mm, p &amp;lt; 0.02) compared with non-obstructive patients. Reductions in LV mass index were more significant in non-obstructive patients (49.8 ± 27.3 vs. 15.3 ± 15.0 g/m2, p &amp;lt; 0.04); however, obstructive patients demonstrated higher reductions in end-systolic diameter (8.7 ± 7.1 vs. 0.3 ± 3.9 mm, p &amp;lt; 0.05) and volume (21.7 ± 20.0 vs. 1.2 ± 8.4 mm, p &amp;lt; 0.01) than non-obstructive patients throughout the 1-year follow-up. Midventricular obstruction peak gradient correlates strongly with preoperative relative wall thickness (rs=.73; p &amp;lt; 0.001), moderate negatively with end-systolic LV diameter (rs=-.45; p &amp;lt; 0.05). In the multiple regression analyses, preoperative relative wall thickness (p &amp;lt; 0.001), reductions in interventricular septum (p &amp;lt; 0.05) and posterior wall (p &amp;lt; 0.05) thickness were identified as risk factors of postprocedural midventricular obstruction. Conclusions 10% of patients during 1 year of follow-up after TAVI demonstrate midventricular obstruction of various severity with poor reverse LV remodeling. Patients with a small hypertrophic left ventricle and high preoperative relative wall thickness, are at greater risk of development of the postprocedural midventricular obstruction.

Updates on transcatheter pulmonary valve replacement

In the 20 years following the first described transcatheter pulmonary valve replacement (TPVR), there has been significant progress made in understanding the application and performance of this technology. For the Melody TPV (Medtronic, Minneapolis, MN) there is now over 10 years of follow-up data from prospective studies and multicenter registries that provide insight on acute procedural results, long-term valve performance, and risks to valve function such as stent fracture and infection. For the Sapien XT and S3 valves (Edwards Lifesciences, Irvine, CA) the duration of follow-up is shorter, but the breadth of experience is growing. Our understanding of procedural risks such a conduit injury and coronary compression has improved, as have our techniques for managing these potential complications. Studies have demonstrated that small conduits can be over-expanded and small bioprosthetic valves can be fractured to extend TPVR to a broader population of patients than originally envisioned. TPVR has been successfully applied to the patient with the native or patched right ventricular outflow tract (RVOT) and our understanding of pre-procedural imaging and screening for the native RVOT continues to improve. Future investigations should focus on the impact of TPVR on survival and long term health of the right ventricle as well as identifying and reducing risk factors that lead to infective endocarditis which continues to be a challenge in this patient population.

Outcomes of Percutaneous and Surgical Pulmonary Valve Implantation

BackgroundThe objective of this study is to describe the recent trends and in-hospital outcomes with percutaneous pulmonic valve implantation (PPVI) and surgical pulmonic valve replacement (SPVR) in adult hospitals in the US after the availability of both the Melody valve (Medtronic Inc., Minneapolis, Minnesota) and the Sapien XT valve (Edwards Lifesciences, Irvine, CA). MethodsWe queried the National Inpatient Sample database (NIS) from January 2016 to December 2017 to identify hospitalizations for PPVI and SPVR. ResultsWe identified 5455 weighted discharges with PPVI and SPVR (PPVI=1140, SPVR=4305). PPVI procedures had increased in number over 2016 and 2017 (115 procedure at the first quarter of 2016, 195 procedures in the final quarter of 2017, P-trend=0.086), while SPVR volume remained constant. The incidence of in-hospital mortality was low with both procedures (SPRV: 1.6% vs. PPVI: 0.9%, p=0.071). SPVR had worse in-hospital outcomes, was associated with a longer length of stay [5 days vs. 1 day, p<0.001], and comparable cost of index hospitalization [$51,657 vs. $51,193] compared with PPVI. ConclusionAfter approval of the Sapien valve for commercial use in 2016, PPVI procedures have increased in frequency. PPVI is associated with lower procedural complications than SPVR, however, both carry a low risk of mortality. Despite the higher cost of the valves and delivery systems, PPVI is associated with a slightly lower cost of index hospitalization compared with SPVR, likely due to the higher in-hospital complications and LOS of the latter.

Transcatheter Aortic Valve Thrombogenesis: A Foreign Materials Perspective.

The initiation of thrombus formation in transcatheter aortic valves (TAVs) is not well understood. The foreign material components of a TAV may play a key role in TAV thrombogenesis. The goal of this study was to evaluate the thrombogenic potential of a TAV (entire valve) and its stent (with skirt). Blood was collected from eight human donors with citrate anticoagulation and later reconstituted with calcium chloride. A low-volume steady flow loop (flow rate = 0.8 L/min) was designed to facilitate three separate conditions (experimental duration = 1h) per donor blood: (1) control (n = 8), (2) stent-with-skirt (leaflets removed from a 23mm SAPIEN XT valve; n = 8) and (3) entire valve (an intact 23mm SAPIEN XT valve; n = 8). Samples were collected at the start and end of each experiment. Serum D-Dimer and thrombin-antithrombin (TAT) concentrations were measured as markers of thrombogenicity. There was no significant change in serum D-Dimer and TAT concentration with time for the control group. An increasing trend in D-Dimer and TAT concentration was observed with time for the stent-with-skirt group. Interestingly, there was a decreasing trend in serum D-Dimer and TAT concentration with time for the entire valve (leaflet dominating) group. Moreover, changes in D-Dimer and TAT concentration were significantly different between the stent-with-skirt and entire valve (leaflet dominating) groups. Stent-with-skirt was found to impart the most prominent thrombogenic effect, indicating the significance of blood-stent and blood-skirt interactions in TAV thrombosis.

Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis

BackgroundThere are limited published data focused on outcomes of transcatheter pulmonary valve replacement (TPVR) with either a Sapien XT or Sapien 3 (S3) valve. ObjectivesThis study sought to report short-term outcomes in a large cohort of patients who underwent TPVR with either a Sapien XT or S3 valve. MethodsData were entered retrospectively into a multicenter registry for patients who underwent attempted TPVR with a Sapien XT or S3 valve. Patient-related, procedural, and short-term outcomes data were characterized overall and according to type of right ventricular outflow tract (RVOT) anatomy. ResultsTwenty-three centers enrolled a total of 774 patients: 397 (51%) with a native/patched RVOT; 183 (24%) with a conduit; and 194 (25%) with a bioprosthetic valve. The S3 was used in 78% of patients, and the XT was used in 22%, with most patients receiving a 29-mm (39%) or 26-mm (34%) valve. The implant was technically successful in 754 (97.4%) patients. Serious adverse events were reported in 67 patients (10%), with no difference between RVOT anatomy groups. Fourteen patients underwent urgent surgery. Nine patients had a second valve implanted. Among patients with available data, tricuspid valve injury was documented in 11 (1.7%), and 9 others (1.3%) had new moderate or severe regurgitation 2 grades higher than pre-implantation, for 20 (3.0%) total patients with tricuspid valve complications. Valve function at discharge was excellent in most patients, but 58 (8.5%) had moderate or greater pulmonary regurgitation or maximum Doppler gradients >40 mm Hg. During limited follow-up (n = 349; median: 12 months), 9 patients were diagnosed with endocarditis, and 17 additional patients underwent surgical valve replacement or valve-in-valve TPVR. ConclusionsAcute outcomes after TPVR with balloon-expandable valves were generally excellent in all types of RVOT. Additional data and longer follow-up will be necessary to gain insight into these issues.

A novel technique to avoid perforation of the right ventricle by the temporary pacing lead during transcatheter aortic valve implantation.

Cardiac tamponade is a life-threatening complication during transcatheter aortic valve implantation (TAVI), often caused by perforation of the right ventricle (RV) by the temporary pacemaker used for rapid pacing during valve deployment. We aimed to assess the feasibility of performing rapid pacing while maintaining inflation of the pacing lead balloon in the RV during TAVI. Among 749 consecutive patients who underwent TAVI with SAPIEN XT valves between October 2013 and July 2015, 726 treated using rapid pacing with a transvenous balloon-tip lead were enrolled in our study, and were stratified into three groups according to the extent of balloon inflation in the RV as follows: full inflation (n = 100), partial inflation (n = 196), and deflation (n = 430). We compared the following clinical outcomes: pacing lead-related RV perforation, rapid pacing failure, valve malpositioning due to rapid pacing failure, device success, and 30-day mortality. Pacing lead-related RV perforation occurred only in patients in the deflation group (6 cases, 1.4%), but the differences among the groups were not statistically significant (p = 0.13). Rapid pacing failure, but no valve malpositioning, occurred most frequently in patients in the full inflation group (4.0% vs. 0.5% in the other groups, p = 0.004). The rate of device success (> 94%) and the 30-day mortality (2.0%) were similar among the three groups. Partial inflation of the balloon of the pacing lead may reduce the risk of RV perforation without increasing the risk of pacing failure or valve malpositioning.

Outcomes After Transcatheter Mitral Valve-in-Valve Replacement in Patients With Degenerated Bioprosthesis: A Single-Center Experience.

This study sought to describe a single center's experience with transcatheter mitral valve-in-valve (TM-ViV) implantation. Consecutive patients who had TM-ViV due to degenerative biological valve prosthesis at a single center during a 4-year period were identified from a prospectively maintained database. Operative outcomes were assessed both in-hospital and at 30 days. The primary outcome was in-hospital mortality. Secondary outcomes included valve function, functional status, and quality of life at follow-up. Mean (± standard deviation) patient age was 69 ± 12 years and all patients were high risk for redo surgery (STS risk score, 9.6 ± 6.2%). The primary mechanism of bioprosthetic valve failure was stenosis in 7 patients (47%) and regurgitation in 8 patients (53%). Mean duration between mitral valve replacement (MVR) and transcatheter MVR was 89 months (range, 66-72 months). Failed bioprosthetic valves were replaced with Sapien XT (n = 10; 67%), Sapien (n = 4; 26%), or Sapien S3 valves (n = 1; 7%) (all valves manufactured by Edwards Lifesciences). Procedural success was 100%. No intraoperative deaths were recorded. Postimplantation valve hemodynamics was satisfactory, with a significant improvement in mean valvular gradient (Δ = -12 mm Hg; P<.001) and mitral valve area (Δ = 0.9 cm²; P<.01). At 30-day follow-up, no reports of death, disabling stroke, or rehospitalization for cardiac reasons was recorded. Health status scores were available for 11 of the 15 study patients (73%). Except for 1 patient, significant improvements were seen for all components of the health assessment survey. TM-ViV for failing biological mitral prosthesis can be performed with minimal operative morbidity and acceptable mid-term clinical and hemodynamic outcomes.

Implantation of the Edwards SAPIEN XT and SAPIEN 3 valves for pulmonary position in enlarged native right ventricular outflow tract.

Percutaneous pulmonary valve implantation (PPVI) into right ventricle-to-pulmonary artery conduits is increasingly being performed, but a few options are available for patients with a dilated native right ventricular outflow tract (RVOT), among which is the off-label use of Ed-wards SAPIEN® valves. This study reviews the results of the SAPIEN XT and SAPIEN 3 (S3) valve implantations in the pulmonary position in patients with a dilated native RVOT. Between January 2015 and March 2020, PPVI procedures were performed on 129 patients. Among them, 103 (80%) had dilated native RVOT, 86 of whom were eligible for PPVI prestenting and valve implantation. Retrospective analysis was performed on 84 patients who have undergone successful PPVI implantation using the SAPIEN XT or S3 valves with dilated native RVOT. The procedural success rate was 84/86 (98%). The median age was 18.7 years (8-46 years), and the median weight was 57 kg (22-102 kg). The primary underlying diagnosis was tetralogy of Fallot (n=77/84). Stenting was performed simultaneously with valve implantation in 50/84 (60%) cases-six of which were hybrid procedures-whereas prestenting was performed 3 to 14 weeks earlier in 34/84 cases. Before valve im-plantation, the median right anterior oblique and lateral diameters of the stents were 26 mm (20-32 mm) and 28 mm (21-32 mm). Valve sizes were 26 mm (n=13) and 29 mm (n=64) for XT and 29 mm (n=7) for S3. In 59 patients, an additional 1-5 ml (median 2 ml) volume was added to the valves' balloons for stabilization. In all hybrid procedures, the stent and valve were implanted in the same session. During follow-ups of 1 to 59 months (median 14 months), no deaths were reported, 3 patients developed tricuspid regurgitation secondary to the procedure, and valves continued to function in all patients. The Edwards SAPIEN XT and S3 valves may be an alternative to PPVI in patients with dilated native RVOT.

Comparing the Procedural and Clinical Outcomes of Sapien XT and Sapien 3 Valves in Transcatheter Aortic Valve Replacement in Korean Patients.

Background and ObjectivesThe Sapien 3 (S3) valve has not been compared to the Sapien XT (SXT) valve in Korea. We compared procedural and clinical outcomes between the 2 devices.MethodsA total of 189 patients who underwent transcatheter aortic valve replacement (TAVR) with S3 (n=95) or SXT (n=94) valve was analyzed. The primary endpoint was cardiovascular mortality at 1 year. The median follow-up duration was 438 days.ResultsThe Society of Thoracic Surgeons score was similar between the 2 groups. The device success rate (90.4% vs. 97.9%; p=0.028) was higher in the S3 than in the SXT. The S3 showed significantly fewer cases of moderate or severe paravalvular leakage (PVL) (16.7% vs. 0.0%; p=0.001) than the SXT. However, effective orifice area (EOA) (2.07±0.61 vs. 1.70±0.49 cm2; p<0.001) was smaller in the S3. Multivariable Cox regression analysis showed the S3 was associated with significantly fewer cardiovascular mortality at 1 year compared to the SXT (5.4% vs. 1.1%; hazard ratio, 0.031; 95% confidence interval, 0.001–0.951; p=0.047). Periprocedural complication rates, composite of disabling stroke or all-cause mortality, all-cause mortality, and disabling stroke at 1 year were similar between the 2 groups.ConclusionsCardiovascular mortality was lower in the S3 group than in the SXT group over 1 year of follow-up. The reduction in PVL was attributed to the higher device success rate of TAVR with the S3 valve. However, the benefit of S3 obtained at the expense of reduced EOA should be meticulously re-evaluated in larger studies during long-term follow-up.

A077 Incidence, Predictors and Prognostic Impact of Patient-Prosthesis Mismatch Following Transcatheter Aortic Valve Implantation

Patient-prosthesis mismatch (PPM) describes a state where the effective orifice area (EOA) of a valve prosthesis is too small relative to the patient's body surface area (BSA). We reviewed the incidence and prognostic impact of PPM following transcatheter aortic valve implantation (TAVI). A retrospective review of patients undergoing TAVI in the Auckland Region between October 2011 and December 2018 was performed. PPM was classified as severe (<0.65 cm2/m2), moderate (0.65-0.85 cm2/m2), or none (>0.85 cm2/m2) on post-TAVI echocardiography. Multivariable logistic regression analysis was used to determine independent predictors of PPM. One-year clinical outcomes were analysed. A total of 294 patients were included in this study (median age 81 years, interquartile range [IQR] 76 to 85 years], BSA 1.87m2, IQR 1.69 to 2.05m2). SAPIEN XT or S3 valves were used in 239 patients (81.3%) and 24 (8.2%) had valve-in-valve TAVI. Moderate and severe PPM were observed following TAVI in 42 (14.3%) and 26 (8.8%) patients respectively. In our multivariate analysis, larger BSA, smaller left ventricular outflow tract (LVOT) diameter and valve-in-valve procedures were identified as independent predictors of severe PPM. There was no significant difference in 30 day or 1-year mortality between PPM groups. Larger BSA, smaller LVOT diameter and valve-in-valve TAVI were predictors of moderate or severe PPM. PPM did not have a significant prognostic impact on mortality following TAVI, consistent with larger international registries.

Eight-year clinical outcome and valve durability after trans-catheter aortic-valve implantation

With the growing indications of trans-catheter aortic-valve implantation (TAVI) and beneficial results among lower risk patients, valve durability is become a crucial issue. To assess long-term evolution of different generations of percutaneous balloon-expandable prostheses, incidence and predictive factors of structural valve deterioration (SVD). All consecutive patients undergoing TAVI for severe aortic stenosis with balloon-expandable prosthesis between 2009 and 2014 were included in this monocentric prospective study. All echocardiograms were reviewed by two independent experts. Clinical events were defined according to the Valve Academic Research Consortium. SVD was defined according to the 2017 EAPCI-ESC-EACTS international consensus at the longest follow-up. A total of 160 patients were included with a median follow-up of 3.4 [1.5–4.9] years and a maximum of 8 years. Patients were mostly implanted with the first generation Sapien XT valve ( n = 138, 86.2%). Median age was 85 [79–86] years with a median logistic Euro-SCORE of 14.2% [10.6–23.2]. Immediately after TAVI, mean aortic gradient decreased dramatically from 51 ± 12 mmHg to 9 ± 2.6 mmHg ( P < 0.0001) and remained stable up to 8-year with a mean gradient of 12 ± 1 mmHg. SVD occurred in 5.6% of patients, of which 3.7% with severe deterioration. Clinical impact of SVD was limited with only 2 patients (1.3%) requiring reintervention. After multivariate analysis, size or generation of valves were not independent predictive factors of SVD. The eight-year survival rate was 12.9%. During follow-up, hospitalization for acute heart failure was required for 23.7% of patients, a myocardial infarction or a stroke occurred respectively among 1.9% and 5% of patients ( Fig. 1 ). Up to 8-year follow-up, SVD following balloon-expandable TAVI is very low. TAVI seems to be a safe alternative to surgery in severe aortic stenosis regardless of prosthesis generation.