Edwards-Sapien Valve Research Articles

Feasibility and mid-term results of transcatheter pulmonary valve replacement using Edwards-Sapien valves

Abstract Background Transcatheter pulmonary valve replacement (TPVR) is an alternative to surgery in certain patients with pulmonary valve dysfunction. When feasible, a percutaneous approach is increasingly common in congenital heart disease (CHD). There is paucity of data to support the use of the Edwards Sapien (ES) 3 or XT valves for TPVR. Purpose To describe the feasibility and outcomes of TPVR with the ES valve. Methods Consecutive patients who underwent TPVR between 2014 and 2021 in a tertiary referral center for CHD were retrospectively included. Outcomes assessed included complications during admission, echocardiographic parameters of ventricular remodeling after TPVR as well as mortality and valve-related complications during follow-up. Results During the study period, 70 patients underwent TPVR with the ES valve. Of them, 70% were men with a median age of 28.3 years. The underlying cardiac conditions were tetralogy of Fallot (N=35, 45.7%), pulmonary atresia or stenosis with ventricular septal defect (N=10, 14.3%), pulmonary stenosis (N=10, 14.3%) and Ross procedure (N=5, 7.1%). The main reason for TPVR was pulmonary regurgitation (N=23, 33.3%), pulmonary stenosis (N=10, 24.6%) or a combination of both (N=29, 42.0%). Transfemoral access (N=68, 97.1%) was more common than transjugular (N=2, 2.9%). TPVR was performed in a native or patch-extended right ventricular outflow tract (N=26, 37.1%), as a valve-in-valve procedure in a previous bioprosthetic valve (N=23, 32.9%) or within a conduit (N=21, 30.0%: 11 homografts, 9 heterografts and 1 Dacron conduit), and stenting before deploying the valve was performed in 48 (68.5%) cases. TPVR was successful in 69 (98.6%) patients with iatrogenic tricuspid damage in 2 cases, with a median hospital length of stay of 1 day, no deaths and 4 serious complications during admission (2 pulmonary edema, 1 femoral vein rupture and 1 pulmonary bleeding). Urgent surgery was not required in any case. No cardiovascular deaths, pulmonary thromboembolisms or strokes were observed during a median follow-up 25.9 months. During this period, there was 1 non-cardiac death, 1 heart transplant, 3 endocarditis (without valve dysfunction), 1 prosthetic valve degeneration and 1 subclinical prosthetic thrombosis. After 1 year, the mean echocardiographic transprosthetic peak gradient was 23 mmHg and there was a reduction in the number of patients presenting moderate-to-severe tricuspid regurgitation (22.9 to 14.8%). Conclusions TPVR with ES valves is feasible and safe in a variety of substrates and ACHD population, with a short length of stay and a low rate of adverse events both in the medium-term follow-up. Funding Acknowledgement Type of funding sources: None.

It’s Never too Late: Late-Stage Aortic Stenosis Treated With Transcatheter Aortic Valve In A Patient With Significant Aortic Root Enlargement With Measurements Beyond Those Recommended By The Valve Manufacturers

A patient with severe calcific bicuspid aortic valve stenosis, revealed by Transthoracic Echocardiogram (TEE), was markedly symptomatic with recurrent decompensation of diastolic heart failure. TEE also revealed moderate insufficiency with large annulus measurements beyond the parameters of currently available valve prostheses. Most valve companies initially declined to provide their device due to the size mismatch, raising concern about valve embolization and potential residual paravalvular leak (PVL). Ultimately, we decided that the calcification in both leaflets may be able to hold onto a 29 mm Edwards-SAPIEN valve, and after a prolonged informed consent the patient was considered for TAVR.

Permanent pacemaker dependency in patients with new left bundle branch block and new first degree atrioventricular block after transcatheter aortic valve implantation

Conduction disorders with need for permanent pacemaker (PPM) implantation remain frequent complications after transcatheter aortic valve implantation (TAVI). Up to 22% of PPM after TAVI are implanted for new onset left bundle branch block (LBBB) and atrioventricular block (AVB) I. However, clinical benefit and predictors of ventricular pacing in TAVI patients receiving PPM for this indication remain unclear. We retrospectively evaluated pacemaker interrogation data of patients who received a PPM post TAVI for new LBBB and new AVB I. The primary endpoint of this study was relevant ventricular pacing (ventricular pacing rate: Vp ≥ 1%) at the first outpatient pacemaker interrogation. Secondary endpoints were predictors for relevant ventricular pacing. At the first pacemaker interrogation (median follow up at 6.23 [2.8–14.8] months), median ventricular pacing frequency was 1.0% [0.1–17.8]. Out of 61 patients, 36 (59%) had Vp rates ≥ 1%. Patients with frequent ventricular pacing showed longer QRS duration (155 ms ± 17 ms vs. 144 ms ± 18 ms, p = 0.018) at the time of PPM implantation and were less likely treated with a balloon-expandable Edwards Sapiens Valve (39% vs. 12%, p = 0.040). Our findings suggest that the majority of patients with new LBBB and new AVB I after TAVI show relevant ventricular pacing rates at follow up. Further prospective studies are necessary to identify patients at higher risk of pacemaker dependency.

TRANS-CATHETER AORTIC VALVE IMPLANTATION (TAVI)-A CASE SERIES AT AFIC/NIHD

Objective: To share our experience of percutaneous trans-catheter aortic valve implantation in patients with severe symptomatic aortic stenosis.
 Study Design: A retrospective cross sectional study.
 Place and Duration of Study: The study was conducted at Armed Forces Institute of Cardiology/National Institute of Heart Diseases (AFIC/NIHD) Rawalpindi, from Mar 2015 to Feb 2020.
 Methodology: Retrospective analysis of all consecutive patients who underwent percutaneous trans-catheter aortic valve implantation was done to assess its immediate, short and long term outcome and safety. Twenty patients have undergone trans-catheter aortic valve implantation since 2015 in the institute. Base line blood chemistry including creatinine clearance, ultra-sonography abdomen, carotid Doppler, chest X-ray, High-Resolution Computed Tomography chest was done in all cases as part of the protocol. Mean age of the patients was 73 ± 7.91. There were sixteen males (80.0%) and four females (20.0%). All patients under went procedure through transfemoral route. Valve structure and peripheral vasculature for suitability of the procedure was assessed by computerized coronary tomographic angiography with TAVI protocol. In eleven patients aortic valve was trileaflet (55.0%) and in remaining nine it was bicuspid (45.0%). Mean gradient across the valve pre-procedure was 56.37 ± 9.14. Thirteen patients (65.0%) presented with angina/dysnoea NYHA III, 6 patients with syncope (30.0%) and one (5.0%) had heart failure. Two patients had undergone previous coronary artery bypass surgery. Procedure was carried out under general anesthesia in all patients except one. Balloon expandable Edwards Sapienvalve was implanted in two patients and self-expandable Core Valve/Evolut R in eighteen patients.
 Results: Seventeen patients underwent the procedure successfully with reduction of the mean gradients immediately after valve implantation to less than 15 mmHg recorded in the cath labangiographically subsequently complemented by transthoracic echocardiography. There were 3 deaths during the index hospitalization. Two occurred in the catheterization laboratory, one death was due to development of severe acute aortic regurgitation and second was due to acute coronary obstruction. Third death occurred due to acute kidney injury after seven days. Five patients died in next three months during follow up. One patient required permanent pacemaker because of development of left bundle branch block and second degree atrio-ventricular block post procedure.
 Conclusion: Transcatheter aortic valve implantation in patients with severe symptomatic aortic stenosis is a very effective and procedurally safe option and reasonable alternative to surgical valve replacement in high operative risk individuals.

Complications after Transfemoral Transcatheter Aortic Valve Replacement with a Balloon‐Expandable Prosthesis: The Importance of Preventative Measures and Contingency Planning

Transcatheter aortic valve replacement (TAVR) with balloon-expandable Edwards-SAPIEN valve was superior to standard therapy in inoperable patients and noninferior to surgical aortic valve replacement in high surgical-risk, but operable patients, with severe symptomatic aortic stenosis in the randomized controlled PARTNER trial. Since the first case of TAVR with a balloon-expandable valve in 2002, several groups have reported their experience with balloon-expandable valves with high-procedural success. In the United States, the balloon-expandable Edwards-SAPIEN valve is the only transcatheter heart valve approved by the FDA for commercial use. Moreover, this is only in high-risk inoperable patients. Despite increasing experience with the TAVR procedure, it can be associated with complications, which can be technically challenging, even for an experienced operator. Complications associated with TAVR include vascular complications, valve malpositioning, regurgitation, embolization, coronary compromise, conduction abnormalities, stroke/transient ischemic attack, acute kidney injury, cardiac tamponade, and hemodynamic collapse. A thorough understanding of the procedure is essential for pre-emptive planning for procedural complications and early identification and management of complications are necessary for procedural success. We hereby review our experience of transfemoral TAVR with balloon-expandable valves, offer practical tips to maximize the likelihood of procedural success, describe pre-emptive strategies to prevent peri-procedural complications and bailout measures to manage them, should they occur. © 2018 Wiley Periodicals, Inc.

Immediate and long-term outcomes of percutaneous transcatheter pulmonary valve implantation.

Transcutaneous pulmonary valve replacement (TPVR) has become an alternative to heart surgery for patients after previous right ventricular outflow tract (RVOT) or pulmonary artery (PA) surgical interventions. The objective was to present immediate and long-term outcomes of trans¬cutaneous pulmonary valve replacement. Between 06/2009 and 06/2016, 46 patients underwent TPVR. Initial diagnoses included tetralogy of Fallot, common arterial trunk, transposition of great arteries post Rastelli correction, left ventricle outflow obstruction after Ross operation, pulmonary atresia, and isolated dysplastic pulmonary valve stenosis. Thirty eight (78%) patients had previously implanted conduits in the pulmonary position, the rest had either RVOT patch reconstruction (n = 6; 13%) or biological valve implantation (n = 2; 4%). They presented primarily with pulmonary stenosis (n = 18; 39%) or regurgitation (n = 28; 60%). All procedures were successful - 44 Melody and 2 Edwards-Sapien valves were implanted. Before each procedure exclusion of potential coronary compression and RVOT prestenting was performed. Significant RVOT systolic gradient reduction (from 35.3 ± 19.5 to 13.5 ± 7.1 mm Hg; p < 0.001) and decrease of right to left ventricle systolic pressure ratio from 0.58 ± 0.18 to mean 0.37 ± 0.1 (p < 0.001) was achieved. Also, in every patient PA-RVOT competence was restored, with minor in¬competence in only a few patients. Post procedure follow-up ranged from 2 to 86 (mean 35.2) months. Follow-up fluoroscopy or chest X-ray revealed 6 stent fractures (2 stent defragmentation - with only 1 significant valve stenosis). Transcutaneous pulmonary valve replacement is a safe procedure with encouraging results, it also enables deferring surgical reintervention in the majority of patients.

P27 An evaluation of patient outcomes following percutaneous pulmonary valve implantation from a single centre

Background Congenital right ventricular outflow tract (RVOT) dysfunction can now be treated percutaneously. There is demonstrable evidence that percutaneous pulmonary valve implantation PPVI effectively restores conduit graft viability with a consequent improvement in right ventricular pressures and exercise tolerance. Aim This study evaluates early and late peri-procedural factors in patients with RVOT dysfunction, following PPVI using Medtronic Melody (MM) and Edwards SAPIEN (ES) valves. Methodology This was a single-centre retrospective study of a cohort of 41 consecutive men (n = 18) and women (n = 23), mean age 26.1 ± 10.2 (±SD) years who underwent PPVI between December 2007 and November 2014. Indications for PPVI were significant homograft dysfunction in the context of previously corrected pulmonary atresia (n = 10), pulmonary stenosis (PS) or regurgitation (Ross procedure, n = 9), Transposition of Great arteries (n = 4), Tetralogy of Fallot (n = 15), and truncus arteriosus (n = 3). Patients were categorised as having pulmonary stenosis (44%), regurgitation (34%) or mixed pulmonary valve disease (22%). Invasive haemodynamic, echocardiographic, electrocardiographic (ECG) and cardiopulmonary exercise test (CPET) parameters were assessed pre and post-procedure, at 1, 6 and 12 months (and at 2 or 3 years respectively in some patients). Differences between the measurements were tested by ANOVA or with χ2 test for proportions. Results PPVI significantly reduced the mean baseline RVOT gradients in stenosis (45 vs18.4 mmHg); regurgitation (19.2 vs. 7.6 mmHg) and mixed disease (32.5 vs. 12mmHg). Mean right ventricular (RV) systolic pressures fell (61.6 ± 2.3 vs. 41.9 ± 2mmHg, p Discussion Implantation of MM and ES valves in patients with pulmonary stenosis, regurgitation or mixed pulmonary diseases appear to be effective. Immediate improvement in right ventricular pressures and functional improvements demonstrated by echocardiography suggest PPVI is a worthwhile treatment option for patients with dysfunctional RVOT homografts. Multi-centre collaborations are essential to further determine long-term effects of PPVI on cardiac function, exercise tolerance and quality of life in RVOT dysfunction.

Outcomes of transcatheter aortic valve implantation in high surgical risk and inoperable patients with aortic stenosis: a single Australian Centre experience.

Degenerative aortic stenosis is the most common valvular heart disease in the elderly, and many patients are not suitable for aortic valve replacement surgery. Transcatheter aortic valve implantation (TAVI) is a new therapeutic option for selected patients at high risk for surgery. To evaluate the safety and efficacy of TAVI in Australian patients. This is a prospective study of patients undergoing TAVI for severe symptomatic aortic stenosis at The Prince Charles Hospital, Brisbane, Australia between August 2008 and July 2013. Patients were at high risk of surgical aortic valve replacement, or inoperable, as deemed by a multidisciplinary 'heart team'. Outcomes include procedural success and complications, 30-day and 1-year mortality and stroke, combined end-points as outlined by the Valve Academic Research Consortium 2 consensus document. Two hundred and nine patients underwent TAVI during the study period. The mean age was 83.7 ± 6.7 years, and 101 (48%) were men. The valve systems utilised were as follows: Edwards-SAPIEN valve in 104 (49.5%), Medtronic CoreValve in 86 (41.2%) and Boston Scientific Lotus valve in 19 (9.3%) patients. Thirty-day and 1-year mortality rates were 5.7% and 11.5% respectively. Thirty-day and 1-year stroke rates were 4.3% and 6.2% respectively. The composite end-points of device success, early safety and clinical efficacy occurred in 80.4%, 27.3% and 68.4%. TAVI with various valve systems, delivered through several approaches, is feasible in high surgical risk and inoperable patients with severe aortic stenosis, with acceptable outcomes at short-term and intermediate-term follow up.

Abstract 15174: Failing Aortic Tissue Valves in Patients at High Surgical Risk: Comparison of Outcomes After Transcatheter Aortic Valve-in-valve Procedures and Redo Surgical Aortic Valve Replacement

Objectives: Transcatheter aortic valve-in-valve implantation (ViV) is an innovative treatment for failed tissue valves (TV) in patients at high surgical risk. However, direct comparative data with standard repeat surgical aortic valve replacement (RE-SAVR) is scarce. We aimed to compare outcomes after ViV to conventional RE-SAVR in two European centers with established interventional programs. Methods: Retrospectively we explored in-hospital databases for patients ≥60 years, treated for degenerated TV. Patients with endocarditis and combined procedures were excluded. Primary endpoints were adjudicated according to VARC-2 criteria. Results: Between 2002 and 2015, 130 patients were treated for isolated failure of aortic TV’s (ViV: n=71, RE-SAVR: n=59). In ViV, Edwards Sapien valve (ESV) was most frequently used (n=36) but implanted into larger TV’s (CoreValve TV size: 22.2±1.3mm vs. ESV TV size: 24.1±2.0mm, p&lt;0.01). Both age and logistic EuroSCORE I were higher in ViV compared to RE-SAVR (78.6±7.5 vs. 72.9±6.5 ys, p&lt;0.01; 25.1±18.9 vs. 16.8±9.4%, p&lt;0.01). Thirty-day mortality was not significantly different with 4.2% (3/71) after ViV vs. 5.1% (3/59) post RE-SAVR (p=1.0). Device success was achieved in 54.9% (n=39) in ViV and all RE-SAVR patients (p&lt;0.01). Perioperative stroke was not observed after ViV and in 2 patients after RE-SAVR (3.4%, p=0.2). Intensive-care stay was longer after RE-SAVR (3.4±2.9d vs. 1.9±1.8d, p&lt;0.01). Following ViV, 22.5% (n=16) of patients had mild aortic regurgitation, vs. 11.3% (n=8; p=0.25) after RE-SAVR. Mean transvalvular pressure gradients at discharge were higher post ViV (19.3±7.3 vs.12.2±5.6mmHg, p&lt;0.01). Rate of permanent pacemaker implantation was lower after ViV (9.9% vs. 27.1%, p&lt;0.01). Survival at 90- and 180-days was 93.8% and 91.8% vs. 94.4% and 94.4% after ViV and RE-SAVR respectively (p=0.87). Conclusion: Despite a higher risk profile, early mortality was not different between the two treatment arms. Although ViV resulted in elevated postoperative transvalvular pressure gradients and therefore a lower rate of device success, mortality after 180-days was similar to RE-SAVR. At present, both techniques serve as complementary approaches and allow individualized patient care.

Abstract 20126: Associations of Known Complications of Transcatheter Implantation of Balloon-expandable Edwards-Sapien XT Aortic Valves With Peri-procedural Mortality - An Insight From the 2014-2015 Reports From the FDA MAUDE Database

Background: Transcatheter implantation of aortic valves (TAVR) has revolutionized the management of severe aortic stenosis. However, specific complications have been noted with the valves. Details of such were sought from the US Food and Drug Administration (FDA) maintained MAUDE database which houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. Methods: A detailed search was conducted in PubMed, Cochrane Library, EMBASE and CINAHL to identify adverse events reported with the implantation of the Edwards-Sapien XT valves. Then the FDA MAUDE database was queried from June 2014 to May 2015 to identify prevalence of the same complications as reported to the FDA. Individual patient reports were identified and relevant data on such complications were abstracted. Finally, mortality outcomes from such patients were abstracted, and associations of these for each individual reported complication were identified in a multivariate logistic regression model. Results: FDA MAUDE revealed 730 unique reports of complications with the first- generation Edwards-Sapien valves. A total of 106 patients died peri-procedurally. The complications most strongly associated with peri-procedural mortality were development of peri-procedural vascular complications, need for permanent pacemaker, renal failure, atrial fibrillation, stroke, need for surgical valve implantation and need for valve in valve procedure. (Table 1) Conclusions: Specific complications with the new Edwards XT valves were strongly associated with mortality, and focused strategies to mitigate these complications may improve outcomes with future generations of this exciting new technology.

0318 : Left bundle branch block after transcatheter aortic valve implantation: incidence, predictive factors and outcome

Conduction disorders are frequent after transcatheter aortic valve implantation (TAVI). The aim of the study was to assess the incidence, the clinical impact and the predictive factors of new-onset left bundle branch block (LBBB) after TAVI. Between 2010 and 2014, 198 consecutive patients underwent TAVI in our center and 156 were prospectively followed during 1 year (62 CoreValve (CV), 94 Edwards Sapiens valve (ES)). 42 patients were excluded because of a pre-existing PM before TAVI, death or surgery after TAVI. After 156 TAVI, 40 patients (26%) required pacemaker implantation. CV patients were more frequently implanted than ES (35% vs 19%; p=0.03). Out of 116 non-implanted patients, 53 (46%) patients presented with LBBB which persisted in 35 (30%) patients. QRS width increased +27ms in post-procedure, +21ms at hospital discharge, +15ms at 1 month, +11ms at 1 year in the whole cohort. There was no clinical nor echocardiographic difference between the LBBB group and no-LBBB group. Ischemic neurological complication were more frequent during hospitalization in the LBBB group (8.6% vs 3.7%; p=0.007). On multivariate analysis, a pre-existing incomplete LBBB (OR 4.15; IC 1.31-13.11; p=0.015) and a long pre-procedure PR interval (OR 1.023; IC 1.001-1.046; p=0.038) were predictive factors of new persistent LBBB after TAVI and a trend with CV implantation was observed (OR 2.35; IC 0.99- 5.53; p=0.051). NYHA grade was increased in the LBBB group compared to non-LBBB group at 1 (2,1 ± 0,8 vs 1,7 ± 0,6 ; p=0.006), 6 (2,21 ± 0,7 vs 1,53±0,6 ; p=0.001) and 12 months (2.2 vs 1.7, p=0.04). On univariate analysis, a pre-existing atrial fibrillation (OR 2.1; IC 1.12- 4.01; p=0.021), an initial mean aortic gradient (OR 0.78; IC 0.65-0.93; p=0.006) and new LBBB after TAVI (OR 2.06; IC 1.05-4.04; p=0.036) were predictive factors of mortality at 12 months. On multivariate analysis, LBBB after TAVI was an independent predictor of mortality (OR 3.52; IC 1.17- 10.58, p=0.025). New-onset LBBB is frequent after TAVI and persists in a great proportion of patients. In our study, LBBB after TAVI was an independent predictor of mortality.

0315 : Atrioventricular conduction disturbance after transcatheter aortic valve implantation: incidence and predictive factors

Atrioventricular (AV) conduction disturbance leading to pacemaker (PM) implantation is frequent after transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the incidence and the predictors of PM implantation after TAVI. Between 2010 and 2014, 198 consecutive patients underwent TAVI in our center. 42 patients were excluded from the study because of a pre-existing PM before TAVI. 156 patients (62 Corevalve (CV), 94 Edwards Sapiens valve (ES) were included and prospectively followed during 1 year. Complete AV block occurred after TAVI in 29 patients (19%), second degree AV block in 3 (0.05%), new left bundle branch block (LBBB) in 53 (34%). A PM was implanted in 40 patients (26%). CV patients were more frequently implanted than ES (35% vs 19%; p=0.03). Post-procedure PR, QRS duration were longer in the PM group (227 vs 196ms; 159 vs 129ms, respectively, p<0.001). LBBB was also more frequent (79% vs 53%; p=0.01). At hospital discharge, 83% of the PM group was stimulated. At 1 month, 10% were PM dependent and 4% at 6 months. At 1 month, 29% were stimulated less than 5% of the time and 25% at 6 months. Multivariate analysis showed that the predictors of PM implantation were a pre-existing RBBB (OR 4.7, IC 1.43-15.52, p=0.01), a pre-existing LBBB (OR 7.28, IC 2.34-22.6, p<0.001), a per-TAVI complete AV block (OR 4.21, IC 1.52-11.63, p=0.006), a high prosthesis/annulus diameter ratio (OR 1.1, IC 1.04-1.18, p=0.003) and postprocedure PR and QRS long duration (OR 1.03, IC 1.01-1.06, p=0.009; OR 1.04, IC 1.01-1.07, p=0.009 respectively). PM implantation had no impact on survival after TAVI (Logrank=0.92). The increase in LVEF post-TAVI was lower in PM group: 0.2 vs 8%, p=0.05 at 6 months and -5 vs 9.6%, p=0.004 at 1 year. The NYHA class was similar in both groups at follow up. TAVI is associated in a great proportion of patients with AV disturbances which are mostly regressive over time. Patients with pre-existing RBBB, LBBB and high prosthesis/annulus diameter ratio are at increased risk of complete AV block. LVEF increase was lower in PM group even with a low percentage of stimulation time.

Trends in the occurrence of new conduction abnormalities after transcatheter aortic valve implantation.

The aim of the study was to investigate trends over time in the occurrence of left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with the Medtronic CoreValve System (MCS) and Edwards SAPIEN Valve (ESV). TAVI-induced conduction abnormalities (TAVI-CAs) such as LBBB and the need for PPI are frequent postoperative complication. New techniques, procedural refinements, and increased awareness are focused on the reduction of these abnormalities. Electrocardiograms of 549 patients without preprocedural LBBB and/or pacemaker were assessed to determine the frequency and nature of TAVI-CAs. To study the effect of experience, patients were subdivided per center into tertiles based on the number of procedures. Univariate and multivariate logistic regression was used to study predictors of TAVI-induced LBBB (TAVI-LBBB) and PPI. TAVI-LBBB occurred in 185 patients (33.7%) and significantly decreased over time, from 42.6% to 27.3% (P=0.006). This effect was only significant after implantation of the MCS (59.6% vs. 46.5% vs. 31.1%, P=0.001, ESV: 22.6% vs. 13.1% vs. 24.8%, P=0.11). Between tertiles there was no difference in the frequency of PPI after TAVI (n=73, 13.1% vs. 14.8% vs. 12%, P=0.74). Multivariate analysis revealed that, independent from valve type, depth of implantation was the only significant predictor of TAVI-LBBB (OR [95% C.I.]: 1.16 [1.10-1.24], P<0.001). In case of PPI pre-existing RBBB (OR [95% C.I.]: 7.22 [3.28-15.88], P<0.001) was the only significant predictor. Over time the frequency of LBBB after TAVI decreased significantly, especially in patients undergoing TAVI with the MCS. Experience and the subsequent reduction in depth of implantation seem responsible for this reduction. Contrary to TAVI-LBBB, the incidence of PPI remained unchanged over time and was not affected by experience. Although experience has led to a decrease in new CAs after TAVI, elucidation of pathophysiologic mechanisms underlying these CAs and subsequent changes in patient stratification, valve design and the procedure are needed to further reduce this complication.

Abstract 17409: Comparison of Post-procedural Echocardiographic Valvular Performance after Transcatheter Aoritc Valve Implantation using Edwards SAPIEN valve versus Medtronic CoreValve for Severe Aortic Stenosis: a Meta-Analysis

Background: In patients with severe aortic stenosis (AS) who are at high risk for surgical aortic valve replacement, transcatheter aortic valve implantation (TAVI) is an emerged alternative procedure. TAVI can be performed using a balloon-expandable Edwards SAPIEN valve (EV) or self-expandable Medtronic CoreValve (CV). The objective of this meta-analysis is to compare post-procedural left ventricular ejection fraction and other echocardiographic valvular performance in patients who underwent TAVI using EV and CV. Methods: PubMed and the Cochrane Center Register of Controlled Trials were searched through May 2014. Eleven studies (n=1513) comparing TAVI procedures that used EV (n=774) and CV (n=739) were included. End points were left ventricular ejection fraction, aortic valve effective orifice area, and mean and peak trans-aortic pressure gradients. The mean difference (MD) with 95% confidence interval (CI) was computed and p&lt;0.05 was considered as a level of significance. Results: There was no significant difference in left ventricular ejection fraction (MD: 1.02, CI: -1.25 to 3.28, p=0.38) and aortic valve effective orifice area (MD: -0.06, CI: -0.17 to 0.06, p=0.04) between EV and CV groups. Mean and peak trans-aortic pressure gradient were significantly higher in CV group compared to EV group (MD: 1.42, CI: 0.4-2.44, p=0.007) (Figure) and (MD: 4.21, CI: 2.33-6.09, p&lt;0.0001) respectively. Conclusion: The results of our meta-analysis suggest that TAVI procedures using CV and EV provide clinically similar valvular performance with possibly clinically insignificant subtle differences in mean and peak trans-aortic pressure gradients in patients with severe aortic stenosis. Further randomized studies are needed for long term echocardiographic outcomes to evaluate valvular performance.

Abstract 17302: A Meta-Analysis of Major Adverse Cardiovascular and Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation Using Edwards SAPIEN valve versus Medtronic CoreValve for Severe Aortic Stenosis

Background: In patients with severe aortic stenosis (AS) who are at high risk for surgery, a transcatheter aortic valve implantation (TAVI) is an emerged alternative procedure using Edwards SAPIEN valve (EV) or Medtronic CoreValve (CV). The purpose of this meta-analysis is to compare early major adverse cardiovascular and cerebrovascular events (MACCE) between EV and CV. Methods: PubMed and the Cochrane Center Register of Controlled Trials were searched through May 2014. Seventeen studies (n=6211) comparing TAVI procedure that used EV (n=2693) and CV (n=3518) were included. End points were post-procedural all-cause mortality, cardiovascular mortality, myocardial infarction, stroke, major bleeding and major vascular events. The odds ratio (OR) with 95% confidence interval (CI) was computed and p&lt;0.05 was considered as a level of significance. Results: The studies were homogeneous for all outcomes except all-cause mortality. There was no significant difference between EV and CV for post-procedural all-cause mortality (OR: 0.82, CI: 0.6-1.13, p=0.23), cardiovascular mortality (OR: 0.7, CI: 0.41-1.2. p=0.2), myocardial infarction (OR: 1.13, CI: 0.51-2.51, p=0.76), stroke (OR: 0.97, CI: 0.66-1.42, p=0.86) (Figure), major bleeding (OR: 1.13, CI: 0.81-1.58, p=0.48) and major vascular complications (OR: 1.22, CI: 0.94-1.58, p=0.14). Conclusion: The results of our meta-analysis of 6211 patients suggest that the types of valve used to perform TAVI procedures do not affect early mortality and MACCE outcomes. Further studies are needed to evaluate long-term outcomes.

Prognostic influence of paravalvular leak following TAVI: is aortic regurgitation an active incremental risk factor or just a mere indicator?

This editorial refers to ‘Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes’[†][1], by S. Kodali et al ., on page 449. Transcatheter aortic valve implantation (TAVI) has become the treatment of choice for inoperable patients with severe aortic stenosis and is a valuable therapeutic option for patients at high risk.1,2 Recent data suggest that TAVI can also be adopted in intermediate risk patients with competitive results when compared with surgery.3 For further expansion of indications, TAVI should, however, be demonstrated to be safe and effective in the longer term, and reduce the rate of complications. Paravalvular leak (PVL) after TAVI is a frequent problem and is considered the Achille's heel of TAVI. A recent meta-analysis including 12 926 TAVI patients reported a pooled estimate incidence of moderate or severe PVL of 11.7%.4 Residual moderate/severe PVL has a relevant negative prognostic impact and has been associated with an increased risk of all-cause mortality.4 More recently, it has been suggested that mild PVR may also be a relevant predictor of mortality, but this association remains controversial.4 This report from Kodali et al .5 represents the largest published single study to evaluate the impact of PVL following TAVI with the Edwards Sapien valve (and one of the largest overall ever reported) on clinical and echocardiographic outcome. In this analysis, the impact of varying degrees of PVL on mortality as well as changes in ventricular function was evaluated in 2434 patients … [1]: #fn-2

Pacemaker implantation and need for ventricular pacing during follow-up after transcatheter aortic valve implantation.

To categorize indications of permanent pacemaker (PPM) implantation after transcatheter aortic valve implantation (TAVI), to determine predictors for conduction disturbances and to quantify the need for ventricular pacing during follow-up. We studied 97 patients (median age 83 years, 58% female) undergoing TAVI using the Medtronic CoreValve Revalving System (MCRS; Medtronic Inc., Minneapolis, MN, USA) or Edwards-Sapien Valve (Edwards Lifesciences, Irvine, CA, USA). During follow-up, no need for ventricular pacing was defined as <1% ventricular pacing and intrinsic 1:1 atrioventricular (AV) conduction. In the 35 patients (36.1%) undergoing PPM implantation three indication categories were identified: (1) high-grade AV block (Mobitz 2 or higher), (2) new-onset left bundle branch block (LBBB) with a prolonged PR interval, and (3) new-onset LBBB. The only independent predictors of high-grade AV block were the use of MCRS (odds ratio [OR] 79.25; 95% confidence interval [CI] 4.57-1373.31) and the presence of preprocedural right bundle branch block (OR 81.95; 95% 95% CI 8.72-770.46). Whereas high-grade AV block resolved only in 17% of cases, none of the patients receiving a PPM due to LBBB with or without PR prolongation required ventricular pacing during follow-up. Our findings justify early PPM implantation in patients with high-grade AV block and may suggest a more conservative approach to PPM implantation in patients with new-onset LBBB after TAVI.

Young Investigator Award session - Clinical: 11/12/2013, 12:45-13:45 * Location: Bursa

Young Investigator Award session - Clinical: 11/12/2013, 12:45-13:45 * Location: Bursa

Transseptal antegrade transcatheter aortic valve replacement for patients with no other access approach—A contemporary experience

To assess the feasibility and outcomes in patients undergoing transvenous transseptal (TS) transcatheter aortic valve replacement (TAVR). TS approach for TAVR was abandoned in favor of retrograde transfemoral, transaortic, or transapical approaches. TS TAVR may still be warranted in patients for whom no other approach is feasible. Observational consecutive case series at a single center, to evaluate technical outcomes in inoperable patients with aortic stenosis who had contraindications for other approaches and who underwent TAVR via a transvenous TS antegrade approach using the Edwards-Sapien (ES) valve. Over a 4-month period, 9 patients underwent TS TAVR with 26 mm (n = 4) and 23 mm (n = 5) ES valves. Mean age was 84.5 ± 6.6 years and Society of Thoracic Surgeons predicted risk of mortality was 7.8 ± 2.8%. Specific contraindications for other access included iliofemoral arterial diameter <7 mm in 9 (100%), porcelain aorta in 6 (66%) patients, multiple (≥2) sternotomies in 2 (22%) patients, severe pulmonary disease in 3 (33%), extreme frailty in 1 (11%), spinal stenosis with impaired ability to rehabilitate postsurgery in 1 (11%) and apical left ventricular thrombus in 1 (11%) patient. Antegrade deployment of the ES prosthetic valve was technically feasible in 8 patients. Major bleeding occurred in 4 patients, two patients suffered acute kidney injury without need for dialysis and one patient required a permanent pacemaker. The median (25th, 75th percentiles) fluoroscopy time was 49 (34, 81) minutes and contrast volume was 150 (120, 225) ml. No patient had hemodynamically significant post-TAVR aortic insufficiency nor damage to the mitral valve. At 6 months follow-up, there were no cerebrovascular events or rehospitalizations and mean NYHA Class improved from 3.4 to 1.7. The antegrade TS approach to TAVR is a technically feasible option for "no-access" patients. Prospective assessment of the safety and efficacy of this approach in the current era warrants further study.

Comparison of Incidence and Predictors of Left Bundle Branch Block After Transcatheter Aortic Valve Implantation Using the CoreValve Versus the Edwards Valve

Conduction disorders and permanent pacemaker implantation are common complications in patients who undergo transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the incidence and clinical significance of new bundle branch block in patients who underwent TAVI with the Medtronic CoreValve Revalving System (MCRS) or the Edwards SAPIEN valve (ESV). Data from 238 patients with no previous pacemaker implantation, left bundle branch block (LBBB) or right bundle branch block at baseline electrocardiography who underwent TAVI with either MCRS (n = 87) or ESV (n = 151) bioprostheses from 2007 to 2011 were analyzed. New-onset LBBB occurred in 26.5% patients (n = 63): 13.5% with the ESV (n = 20) and 50.0% with the MCRS (n = 43) (p = 0.001). Permanent pacemaker implantation was required in 12.7% of patients (n = 8) because of complete atrioventricular block (ESV n = 2, MCRS n = 4), LBBB and first degree atrioventricular block (MCRS n = 1) and new-onset LBBB associated with sinus bradycardia (MCRS n = 1). At discharge, LBBB persisted in 8.6% of ESV patients (n = 13) and 32.2% of MCRS patients (n = 28) (p = 0.001). On multivariate analysis, the only predictor of LBBB was MCRS use (odds ratio 7.2, 95% confidence interval 2.9 to 17.4, p <0.001). Persistent new-onset LBBB at discharge was not associated with overall (log-rank p = 0.42) or cardiovascular (log-rank p = 0.46) mortality. New-onset right bundle branch block was documented in 4.6% of patients (n = 11), with no statistically significant differences between the ESV and MCRS. In conclusion, new-onset LBBB is a frequent intraventricular conduction disturbance after TAVI with a higher incidence with the MCRS compared with the ESV. LBBB persists in most patients, but in this cohort, it was not a predictor of overall or cardiovascular mortality or permanent pacemaker implantation.