Self-expanding Transcatheter Aortic Valve Implantation Research Articles

Real-world experience with the cusp overlap deployment technique for procedural optimization during self-expanding transcatheter aortic valve implantation: our city best practice trial

Abstract Background Aortic valve stenosis treated by transcatheter aortic valve implantation (TAVI) is a fast-growing section in interventional cardiology. Optimal implantation depth (ID) of self-expanding TAVI devices is an important condition for hemodynamic and clinical outcomes. The cusp overlap technique (COT) offers optimized fluoroscopic projections for TAVI with self-expanding devices due to improved anatomic discrimination by elongation of the left ventricular outflow tract and isolation of the non-coronary cusp (NCC) for better assessment of ID. Purpose This single-center observational study aims to investigate short-term clinical performance, safety, and efficiency outcomes regarding optimized ID in patients undergoing transfemoral TAVI with self-expanding prostheses and COT. Methods From September 2020 to December 2020, a total of 71 patients underwent TAVI with a newer-generation self-expanding device and COT. The optimal fluoroscopic projection was generated by overlapping the right (RCC) and left coronary cusps (LCC) on the multidetector computed tomography annular plane. Final ID was assessed by the arithmetic mean of distances measured from NCC and LCC to the distal prosthesis end. Outcomes were compared with a control cohort of 339 patients who underwent TAVI from January 2016 to August 2020 with a three-cusp coplanar view only during valve deployment. Results ID was significantly reduced in the COT cohort (4.3±1.9 vs. 5.0±2.3 mm; p=0.012) with better achievement of optimal ID (2–4 mm) (63.4% vs. 49.9%; p=0.03) and optimization of delta NCC-LCC ID symmetry (1.4±1.3 vs. 1.7±1.3 mm; p=0.026). The rate of pacemaker implantation following TAVI could be reduced (9.9% vs. 19.4%; p=0.05). Six of the seven patients receiving pacemaker in the COT cohort (85.7%) showed ID above membranous septum length. COT resulted in notably higher rates of device repositioning by recapturing (57.8% vs. 16.2%; p<0.001) compared to control cohort. Though, procedure time was prolonged in the COT cohort (82.0±26.5 vs. 74.9±27.5 min; p=0.05) while radiation dose and amount of contrast medium did not differ between the cohorts. No difference was observed in hemodynamic outcomes regarding transvalvular pressure gradients and at least moderate paravalvular leak. Patients implanted with COT had a shorter length of hospital stay (7.1±6.0 vs. 10.3±6.8 days; p<0.001), possibly due to a lower complication rate regarding new conduction disturbances and pacemaker implantation. Conclusion TAVI using the cusp overlap deployment technique is associated with an optimized implantation depth and a low rate of procedural complications. Therefore, a reduction of new pacemaker implantations and shortened length of hospital stay could be achieved. Funding Acknowledgement Type of funding sources: None.

The timing and mechanism of high-grade AV block post-TAVI: knowing your enemy

Abstract Background Complete atrioventricular block (AVB) requiring permanent pacemaker implantation (PPMI) is still a major limitation of transcatheter aortic valve implantation (TAVI) procedures. Although right-bundle branch block (RBBB), membranous septum (MS) length and self-expandable prothesis are recognizable risk factors, their predictability to PPMI is far from satisfactory. While some patients develop persistent intra-procedure high-grade AVB (H-AVB), others present much later with severe bradycardia. Purpose This study aims to describe and compare the characteristics of patients who develop AVB during or after TAVI. Methods Single centre prospective registry of 506 consecutive patients submitted to TAVI with no previous pacemaker between 2017 and 2020. Post-procedure PPMI (up to 30 days after discharge) was studied and divided into two groups according to the development of persistent intra-procedure H-AVB (Group A) or post procedure H-AVB (Group B). Baseline ECG, computed tomography and TAVI-related characteristics were analyzed. Results A total of 88 patients (17,3%), aging 83±6 years, 36.4% male, underwent post-TAVI PPMI (6 after discharge). Previous conduction disturbances were present in 50 (56.8%) patients and 25 (28.4%) had RBBB. 83% were submitted to self-expandable TAVI. Forty-two patients (47.7%) had persistent intra-procedure H-AVB (Group A) whereas 52.3% had post-procedure H-AVB (Group B). In patients with persistent intra procedure H-AVB previous RBBB was significantly more frequent (45.2%, n=19) when compared to patients with post-procedure H-AVB (13%, n=6; p=0.001). Contrarily, AF and previous left-bundle branch block (LBBB) were more likely in Group B. No difference in valvular calcification, MS length, prosthesis type or implantation technique was noted (picture 1). In the group with post-procedure H-AVB, 21.7% had transient AVB during TAVI and all developed de novo LBBB or first-degree AVB post-TAVI. Among these, 33 patients (71.7%) developed delayed H-AVB (>48h post-procedure) while the remaining presented earlier. Conclusions In patients with PPMI post-TAVI, those with persistent intra-procedure H-AVB had higher rates of previous RBBB, while those with post-procedure H-AVB frequently had a normal baseline ECG. Anatomical and procedural characteristics did not differ between groups. Further studies are needed to confirm these results. Funding Acknowledgement Type of funding sources: None.

Self-Expandable Transcatheter Aortic Valve Implantation Outcomes: Findings From the Western Region of Saudi Arabia.

Background and objectiveThe prevalence of aortic stenosis in Saudi Arabia is expected to increase owing to the rise in the life expectancy of the population. Such increase is expected to be met with higher demand for interventions including transcatheter aortic valve implantation (TAVI). In this study, we aimed to identify the outcomes of this procedure among the population of the Western region of Saudi Arabia.MethodsThis was a retrospective observational study involving patients who underwent TAVI at the King Faisal Cardiac Center (KFCC), Jeddah, Saudi Arabia from June 2018 to January 2020. All patients who had undergone TAVI were included, and patients who were lost to follow-up for more than 90 days were excluded. The collected data included sociodemographic characteristics, peri-procedural assessment, and outcomes within 90 days.ResultsThe study included a total of 52 patients. There were 28 males (53.8%) and 24 females (46.2%). The mean age of the cohort was 78 years. Type two diabetes mellitus was present in 67.3%, and hypertension and dyslipidemia were seen in 80.8% of patients. Coronary diseases were seen in 55.8%. The majority had prior percutaneous coronary intervention (PCI) (53.8%) and 3.8% had coronary artery bypass grafting (CABG). Twenty patients (38.5%) had heart failure. Atrial fibrillation was encountered in 13 patients (25%). Chronic kidney disease was described in nine (17.3%) patients, and four (7.7%) were on regular hemodialysis. The median Society of Thoracic Surgery (STS) risk score was 2.4 (IQR: 1.97-5). High STS scores (>8) were only seen in 9% of the patients. The success rate was 98%, and the in-hospital mortality rate was 3.8%. Vascular complications were seen in eight patients (15.4%), and the majority of them were minor. One patient (1.9%) had a major vascular complication. There was a tendency toward high blood transfusions (19.2%). Clinically manifest stroke was seen in three patients (5.8%). Eight patients (15.4%) had post-procedure complete heart block (CHB). Endocarditis was seen in two patients (3.8%). Thirty-day cardiac readmission was observed in 17.3% of patients, and acute kidney injury was seen in eight patients (15.4%). Mild aortic regurgitation was seen in 51.9% of the patients, but moderate or severe aortic insufficiency (AI) was not encountered.ConclusionTransfemoral TAVI using a self-expandable valve is a safe and feasible procedure at KFCC, an intermediate-sized center. Our data is comparable to local and international centers of similar size. Program sustainability depends on the development of robust referral networks and implementing regulatory quality and patient safety standards.

Self‐expanding transcatheter aortic valve infolding: Current evidence, diagnosis, and management

Prosthetic valve infolding is a rare but severe complication of transcatheter aortic valve implantation (TAVI) with self-expanding valves. However, currently available clinical data are limited and fragmented. This report aims to provide a comprehensive overview of this complication focusing on predisposing factors, clinical presentation, diagnostic findings, treatment and clinical outcomes. A systematic review of the literature was performed to identify cases of infolding occurring during TAVI with self-expanding valves published until August 2020. These data were pooled with all the retrospectively identified infolding cases occurred at San Raffaele Scientific Institute between December 2014 and August 2020. A total of 34 cases were included. Among patients with available data, 38% received a first-generation CoreValve, and 62% a second-generation Evolut R (82%) or Evolut PRO (18%). Infolding occurred mostly with ≥29-mm valves (94%). Predisposing factors included resheathing of a second-generation valve (82%), heavy calcification of the native valve (65%), lack of predilatation (16%), Sievers type-1 bicuspid aortic valve (11%), and improper valve loading (5%). Infolding resulted in severe PVL causing hemodynamic instability (29%) or cardiac arrest (12%). Postdilatation was the treatment strategy in 68%, while prosthesis replacement with a new device in 23% of cases. Device success rate was 82%. Death and stroke occurred in 3% and 12% of cases. Prosthetic valve infolding is typically observed after resheathing of a large-size self-expanding TAVI. When infolding is timely diagnosed, prosthesis removal and replacement should be pursued. Further studies are required to precisely define predisposing factors to prevent this complication.

Aortic Regurgitation Index Ratio Is a Strong Predictor of 1-Year Mortality After Transcatheter Aortic Valve Implantation Using Self-Expanding Devices

Grading paravalvular leak (PVL) at the time of transcatheter aortic valve implantation (TAVI) deployment is challenging. Per-procedural invasive hemodynamic measurements could serve to optimize PVL grading and predict outcome after TAVI. The aim of this study was to compare hemodynamic measures of paravalvular leak and their prognostic relevance in self-expanding TAVI devices. Between December 2008 and December 2017 consecutive patients treated for severe symptomatic aortic valve stenosis with self-expanding devices were prospectively studied. Peri-procedural hemodynamic measurements, echocardiographic data as well as clinical follow-up according to VARC-2 criteria were prospectively collected. Diastolic delta (DD), heart rate adjusted DD, aortic regurgitation index (ARI) and ARI ratio were calculated and assessed for their association with 1-year mortality. A total of 651 patients were studied. Moderate or severe paravalvular leakage was found in 4.8% of patients. ARI ratio < 0.6 (hazard ratio 1.96 [1.23-3.12], P = 0.005) was the best independent predictor of 1-year mortality. This study confirms the value of hemodynamic measures, specifically ARI ratio, for prognostication, potentially supporting procedural decision-making with regard to PVL.

Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis

Recent studies have shown that transcatheter aortic valve implantation (TAVI) is non-inferior to surgical aortic valve replacement (SAVR) for treatment of low-risk patients with severe aortic stenosis (AS). However, the cost-effectiveness of TAVI in this population is unknown. We sought to evaluate the cost-effectiveness of both balloon-expandable and self-expanding TAVI compared to SAVR in patients with severe AS at low operative risk. We developed a Markov model comparing TAVI to SAVR over a lifetime horizon. Key data inputs were drawn from the Placement of AoRTic TraNscathetER Valve (PARTNER) 3 trial for balloon-expandable TAVI and the Evolut Low-Risk trial for self-expanding TAVI. Costs were obtained from Australian sources. The perspective was that of the Australian health care system. Although procedural costs were higher for TAVI compared to SAVR, these were offset by a shorter length of hospitalisation and lower acute complication costs in the TAVI group. Over a lifetime horizon, balloon-expandable TAVI was associated with increased costs of A$702 compared to SAVR, and increased quality-adjusted survival by 0.20 years, yielding an incremental cost-effectiveness ratio of A$3,521 per quality-adjusted life year (QALY) saved. Self-expanding TAVI was associated with lower lifetime costs compared to SAVR, and increased quality-adjusted survival by 0.08 years, and was therefore economically dominant. In probabilistic sensitivity analyses, balloon-expandable TAVI was cost-effective in 78% of iterations (at a cost-effectiveness threshold of A$50,000 per QALY gained) and self-expanding TAVI was cost-effective in 70% of iterations. Among low-risk AS patients, both balloon-expandable and self-expanding TAVI are likely to be cost-effective relative to SAVR.

Long term follow up of percutaneous treatment for degenerated Mitroflow prosthesis with self-expanding transcatheter aortic valve implantation

BackgroundThe durability of aortic valve bioprosthesis and the structural valve deterioration (SVD) are could be treated with valve-in-valve (VIV) transcatheter aortic valve implantation (TAVI). This technique has been proven to be a feasible procedure with good results in selected patients. The aim of this work was to assess the long-term results of this TAVI with an autoexpandable valve in patients with failed Mitroflow (MF) bioprosthetic aortic valves.MethodsSingle center, observational and prospective study that included 65 consecutive patients with symptomatic failed MF bioprosthetic aortic valve, treated with VIV-TAVI. The primary endpoints were clinical long-term events including all-cause mortality, cardiovascular mortality, re-hospitalization due to heart failure, stroke/transient ischemic attack (TIA) and endocarditis. Secondary endpoints were the absence of SVD or patient-prosthesis mismatch (PPM) and valve hemodynamics analysis at follow-up.ResultsBetween March 2012 to July 2019, 65 symptomatic patients (age 80.4±5.9 years) with degenerated MF valves (numbers 19: 27.7%; 21: 38.5%; 23: 21.5%; 25: 12.3%) underwent CoreValve (n=11) or Evolut R (n=54) implantation (23, 26 and 29 mm sizes). The STS predicted risk of mortality was 6.39%±5.62%. The primary combined endpoint occurred in 32.3% of the cases. A total of 13 patients (20%) died during follow-up, but 4 (7.3%) from cardiovascular causes. Two patients were reported of having a stroke/TIA and 5 readmissions for cardiovascular causes were reported (2 of them within the first 30 days). Twenty-five patients (38.5%) presented PPM during follow-up, being PPM severe in 15 (23.1%).ConclusionsSelf-expanding TAVI for degenerated MF bioprosthesis has favourable long-term outcomes. It is a good option in order to avoid the risks of redo surgery in selected patients.

Intravascular haemolysis after transcatheter aortic valve implantation with self-expandable prosthesis: incidence, severity, and impact on long-term mortality.

We aimed to determine the incidence, severity, and long-term impact of intravascular haemolysis after self-expanding transcatheter aortic valve implantation (TAVI). We believe this should be evaluated before extending the indications of TAVI to younger low-risk patients. Prospective, academic, single centre study of 94 consecutive patients treated with supra-annular self-expandable TAVI prosthesis between April 2009 and January 2014. Haemolysis at 1-year post-TAVI was defined per the published criteria based on levels of haemoglobin, reticulocyte and schistocyte count, lactate dehydrogenase (LDH), and haptoglobin. All patients had long-term clinical follow-up (6 years). The incidence of haemolysis at 1-year follow-up varied between 9% and 28%, based on different haemolysis definitions. Haemolysis was mild in all cases, no patient had markedly increased LDH levels. The presence of moderate/severe paravalvular aortic regurgitation was associated with haemolysis (7.7% vs. 23.1%, P = 0.044) and aortic valve area post-TAVI did not differ between groups with or without haemolysis (1.01 vs. 0.92 cm2/m2, P = 0.23) (definition including schistocyte count). The presence of haemolysis did not have any impact on patient prognosis after 6 years with log-rank test P = 0.80. Intravascular haemolysis after TAVI with self-expandable prosthesis is present in 9–28% of patients depending on the definition of haemolysis. The presence of haemolysis is associated with moderate/severe paravalvular aortic regurgitation but not with post-TAVI aortic valve area. Haemolysis is mild with no impact on prognosis.

Impact of device landing zone calcification patterns on paravalvular regurgitation after transcatheter aortic valve replacement with different next-generation devices

ObjectiveResidual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on...

892 TAVI in TAVI- A Single Centre Experience

The use of transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is well established in clinical practice. However, there is a paucity in the literature of the procedural feasibility of repeat TAVI for late valve degeneration. Here we discuss three cases of patients who underwent TAVI in TAVI procedures. A 81 year old female who had a transapical balloon-expandable TAVI inserted 9 years prior presented with NYHA class 3 symptoms and recurrent admissions with decompensated heart failure. Echocardiography showed severe mixed aortic valve degeneration, and she subsequently underwent successful transfemoral valve in valve (ViV) TAVI. On 6 month follow-up she has NYHA class 1-2 symptoms with normal aortic valve hemodynamics. A 85 year old male with a self-expanding TAVI three years prior presented with recurrent decompensated heart failure. Echocardiography revealed severe transvalvular aortic regurgitation. He underwent a BASILICA (bioprosthetic or native aortic scallop to prevent iatrogenic coronary artery obstruction) and successful ViV-TAVI with a balloon expandable prosthesis, with favourable echocardiographic and symptomatic outcomes at 6 month follow-up. A 76 year old female with a previous TAVI procedure 8 years prior presented with NYHA class III symptoms and declining exercise tolerance, with echocardiography demonstrating severe aortic stenosis (mean gradient 87mmHg). Anticoagulation with warfarin was trialled for 3 months with no improvement, and she subsequently underwent ViV-TAVI with improvement in symptoms and favourable post implantation valve hemodynamics. These cases demonstrates procedural safety with improvement in patient symptoms and favourable post implantation hemodynamics, suggesting repeat TAVI is a feasible treatment option.

P3693Self-expandable transcatheter aortic valve implantation is associated with frequent periprocedural stroke detected by diffusion-weighted magnetic resonance imaging -Insight from propensity score match

Abstract Background Little evidence is available regarding the risk of peri-procedural stroke detected by diffusion-weighted magnetic resonance imaging (DW-MRI) after transcatheter aortic valve implantation (TAVI). Our purpose was to evaluate stroke risk after TAVI using DW-MRI by enrolling consecutive patients who underwent transfemoral TAVI and post-procedural DW-MRI. Methods We prospectively enrolled 113 consecutive patients who underwent transfemoral TAVI and post-procedural DW-MRI. We used balloon-expandable valves as first-line therapy and selected self-expandable valves only for patients with narrow sinotubular junctions or annuli. We set the primary endpoint as the number of high intensity areas (HIA) detected by DW-MRI regardless of the size of the area. To evaluate the risks of the primary endpoint, we employed a multivariable linear regression model, setting the primary endpoint as an objective variable and patient and clinical backgrounds as explanatory variables. In addition, the relationship between valve type and the number of HIAs on DW-MRI was also confirmed by the propensity score matching analysis to evaluate the robustness of the result, using a multivariable linear regression model with the protocol described in the previous manuscript. Shortly, the propensity score was calculated with a logistic regression model by setting the treatment as the response variable and baseline characteristics and procedural information that were significantly different between 2 groups (balloon expandable and self-expandable) as explanatory variables, which included age, estimated glomerular filtration rate, oversizing rate, and BAV before THV deployment. Results Median patient age was 84 years, and 36.3% were men. Ninety-three patients underwent balloon-expandable TAVI and 20 underwent self-expandable TAVI. Symptomatic stroke occurred in 6 (5.3%) whereas asymptomatic stroke occurred in 59 (52.2%) patients. The incidence of symptomatic and total stroke was higher in patients who underwent self-expandable TAVI than those who underwent balloon-expandable TAVI (30.0% vs 0.0%, p&lt;0.001 and 90.0% vs 50.5%, p=0.001, respectively). A multivariable linear regression model demonstrated an increased primary endpoint when self-expandable TAVI was performed (p&lt;0.001). The other covariates had no significant relationship to the primary endpoint. Akaike information criterion-based stepwise statistical model selection revealed that valve type was the only explanatory variable for the best predictive model. This result was also confirmed with the propensity score matching analysis (estimate, 2.359; 95% CI, 0.426–4.292; p=0.019) after adjustments of propensity score, in which 28 patients were matched (n=14 in each group). Conclusions Self-expandable valves were associated with increased numbers of HIA on DW-MRI after TAVI in patients with severe aortic stenosis.

Self-Expanding Valve System for Treatment of Native Aortic Regurgitation by Transcatheter Aortic Valve Implantation (from the STS/ACC TVT Registry)

Transcatheter aortic valve implantation (TAVI) is approved for treatment of symptomatic aortic stenosis in patients at increased risk for surgical valve replacement, but outcomes data in patients with severe native aortic regurgitation (AR) treated with TAVI remain limited. The objective of this analysis was to evaluate outcomes among patients identified in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent TAVI for native AR with a commercially available self-expanding valve system. From January 2014 to December 2017, 230 patients in the TVT Registry underwent TAVI for primary severe native AR using a commercially available self-expanding valve (n = 81, CoreValve; n = 149, Evolut R). For inclusion, AR was either pure or mixed with predominantly moderate/severe AR and mean aortic valve gradient ≤20 mm Hg. Thirty-day outcomes were evaluated using time-to-event methods. Device success was reported in 81.7% of patients (CoreValve, 72.2%; Evolut R, 86.9%; p = 0.0.01). Thirty-day all-cause mortality was 13.3%. All patients presented with moderate/severe AR at baseline; at 30 days, 9.1% of implanted patients with data continued to have moderate and 1.4% severe AR. There was a significant reduction in residual moderate/severe AR from the CoreValve to Evolut R device (19.1% vs 6.3%, p = 0.02). Multivariable analysis revealed factors associated with 30-day all-cause mortality include number of valves used (hazard ratio [HR] 2.361, 1.643 to 3.391, p <0.001), albumin < 3.3 mg/dL (HR 3.358, 1.551 to 7.273, p=0.002), and left ventricular ejection fraction (HR 0.978, 0.957 to 1.000, p = 0.047). Despite higher 30-day all-cause mortality, self-expanding TAVI may be an option in selected patients with AR who have no surgical options.

Clinical outcomes of self-expandable vs. balloon-expandable TAVI for severe aortic stenosis

Background: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic stenosis (AS). There is limited data exploring differences in outcomes post-TAVI SEV vs. BEV. This study compared procedural success and 30-d clinical outcomes self-expandable valves (SEV), vs. balloon-expandable valves (BEV) for patients with severe AS.Methods: Retrospective analysis was undertaken of patients receiving TAVI at St Vincent’s Hospital, Melbourne between August 2009 and May 2018. The primary endpoints included procedural success, clinical outcomes and complication rates at 30-d.Results: Out of 151 patients undergoing TAVI, 70 received (46.3%) SEV (Medtronic CoreValve & Evolut-R) and 81 (53.6%) BEV (Edwards SAPIEN-XT & S3). The mean Society of Thoracic Surgery (STS) risk score did not differ between the groups, SEV (83.6 ± 4.9 years, STS 4.4 ± 3.8) compared to BEV (82.3 ± 5.8 years, STS 4.9 ± 4.9). Procedural success was similar SEV 67 (95.7%) vs. BEV 78 (96.3%). Rates of ≥ moderate paravalvular aortic regurgitation (PAR) at 30-d were significantly higher in SEV compared to BEV (6.7 vs. 0.0%; p = .02). SEV patients had higher rates of pacemaker insertion (36.4 vs. 9.5%; p = .001) and stroke rates (12.4 vs. 1.4%; p = .04) compared to BEV patients. The difference in 30-d mortality between the two groups was similar (SEV 4.6% vs. BEV 1.3%; p = .23).Conclusions: This real-world retrospective analysis demonstrates higher rates of ≥ moderate PAR, stroke and pacemaker insertion with SEV compared to BEV at 30 d post-TAVI for severe symptomatic AS.

Self-expanding transcatheter aortic valve implantation for degenerated Mitroflow bioprosthesis: Early outcomes

BackgroundThe aim of this study was to assess the safety and effectiveness of valve in valve (VIV) TAVI with the autoexpandable valve, specifically in patients with failed Mitroflow (MF) bioprosthetic aortic valves. MethodsPilot, single center, observational and prospective study that included 45 consecutive patients with symptomatic failed MF bioprosthetic aortic valve, referred for VIV TAVI. The safety primary endpoint was a composite of early events at 30 days, defined by VARC-2 criteria. The efficacy primary endpoint was the device success (no procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location and absence of moderate/severe prosthetic aortic valve regurgitation). We also analysed patient-prosthesis mismatch (PPM) parameters. ResultsBetween March 2012 to December 2017, 45 symptomatic patients (age 79.9 ± 6.5 years) with degenerated MF valves (numbers 19: 33.3%; 21: 28.9%; 23: 24.4%; 25: 13.3%) underwent CoreValve (n = 11) or Evolut R (n = 34) implantation (23 and 26 mm sizes). The STS predicted risk of mortality was 6.3 ± 6.3%. The safety primary endpoint occurred in 4 patients (8.8%). The efficacy endpoint was present in all patients (100%). There were no coronary occlusions or procedural deaths. The number of patients with any degree of PPM raised from 51.1% (pre-TAVI) to 60% (post-TAVI). ConclusionsSelf-expanding TAVI for degenerated MF bioprosthesis has favourable early outcomes. The VIV procedure has provided an important gateway to avoiding high-risk redo surgery and is now a potential option for MF failed surgically aortic implanted valves.

Sizing for self-expanding transcatheter aortic valve implantation.

Sizing for self-expanding transcatheter aortic valve implantation.

Prospective multicentre evaluation of a novel, low-profile transapical delivery system for self-expandable transcatheter aortic valve implantation: 6-month outcomes.

We assessed the safety and efficacy of a novel low-profile, 22-Fr transapical delivery system together with the ACURATE neo™ resheathable transcatheter heart valve. This prospective, single-arm, multicentre study enrolled 60 patients with severe symptomatic aortic stenosis and high surgical risk ineligible for transfemoral access. Primary end points were 6-month mortality and procedural success. The mean age of patients was 79.8 ± 4.7 years, and the patients had severe comorbidities including coronary artery disease (71.7%), diabetes (38.3%), atrial fibrillation (30.0%) and chronic obstructive pulmonary disease (21.7%); logistic EuroSCORE-I, -II and the Society of Thoracic Surgeons (STS) scores were 20.9 ± 8.9%, 6.1 ± 5.0% and 4.3 ± 2.9%, respectively. A non-rib spreading approach using soft tissue retractors only was used in 88.3% of patients (n = 53). Resheathing and repositioning of transcatheter heart valve were performed in 6.7% of cases (n = 4); the device implantation time was 3 ± 2 min. Apical access site complications occurred in 1.7% (n = 1). Procedural success was 98.3% (n = 59), and procedural success in the absence of major adverse cardiac and cerebrovascular events at 30 days was 90.0% (n = 54). At 30 days, cardiovascular and overall mortality were 8.3% (n = 5), stroke rate was 1.7% (n = 1), and 17.2% of patients (n = 10) received a permanent pacemaker implant. No paravalvular leakage ≥2+ was observed, and the mean transvalvular gradient was 5.9 ± 2.7 mmHg. At 6 months, survival was 84.3% with sustained haemodynamic results. This study indicates safety and efficacy of transapical aortic valve implantation using a novel low-profile delivery system. High procedural success, short implantation times and a low rate of apical access site complications underline the favourable safety profile and ease of use. ClinicalTrials.gov: NCT02950428.

Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico™ valve†

To examine the incidence and timing of new-onset left bundle branch block (LBBB) and new permanent pacemaker implantation (PPI) in patients undergoing transcatheter aortic valve implantation (TAVI) using the repositionable, self-expanding Portico™ TAVI system (St. Jude Medical, St Paul, MN, USA). Clinical impact and periprocedural factors associated with new PPI were also assessed. A total of 198 high-risk patients without pre-existing pacemaker [83.1 ± 4.7 years, 77.3% women, mean Society of Thoracic Surgeons (STS) 5.8%] from the Pre-CE Mark Portico TAVI system study were prospectively analysed. Twelve-lead electrocardiographic and echocardiographic data were collected prior to, during and after the procedure. Clinical follow-up was performed at 1 year. Transfemoral implantation of the Portico valve was associated with a new PPI rate of 15.2% at 30 days and 16.7% at 1 year. Overall, 53 of the 187 patients without pre-existing LBBB developed new-onset LBBB at 1 year (28.3%); 23 occurred during the procedure. At 30 days, new-onset LBBB spontaneously resolved in 61.0% of patients. New-onset LBBB post-TAVI was not associated with new PPI (P = 0.64); 8 of the 53 patients required new PPI. Multivariable regression analyses revealed pre-existing right bundle branch block (P = 0.004) and aortic annulus diameter (P = 0.001) as independent predictors of new PPI. New PPI at discharge (n = 29) was not associated with increased freedom from all-cause (odds ratio 92.7%, 95% confidence interval 73.7-98.1%; P = 0.49) and cardiovascular (odds ratio 96.6%, 95% confidence interval 77.9-99.5%; P = 0.47) mortality at 1 year. The Portico TAVI system demonstrated an acceptable rate of new PPI at 1 year without increased mortality risk to patients. New-onset LBBB was common during the procedure, with the majority of events spontaneously resolving by 30 days. No intraprocedural factors were shown to independently predict new PPI. NCT01493284.

Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study.

The aim of the Portico TAVI (transcatheter aortic valve implantation) system study was to evaluate outcomes ≤1 year after implantation of a novel resheathable, self-expanding TAVI system in a multicenter patient population with severe aortic stenosis (AS). High-risk patients (n=222) with symptomatic severe AS (mean age, 83.0±4.6 years; 74.3% women) were enrolled across 12 centers in Europe and Australia. The study's primary end point was all-cause mortality at 30 days. A total of 209 patients who received the Portico TAVI system were available for follow-up after the 30-day visit. Data collection included hemodynamic assessment by echocardiography with core laboratory evaluation and assessment of functional status. Valve Academic Research Consortium-defined adverse events were adjudicated by an independent Clinical Events Committee. TAVI using the Portico valve led to a significant and persistent improvement in aortic valve function at 1 year. More than mild paravalvular leak was present in 5.7% and 7.5% of patients at 30 days and 1 year, respectively. Kaplan-Meier estimates at 30 days and 1 year were 3.6% and 13.8% for all-cause mortality, 3.6% and 9.6% for cardiovascular mortality, and 3.2% and 5.8% for major (disabling) stroke. After 30 days and ≤1 year of follow-up, adverse events included stage 3 acute kidney injury (n=3), major vascular complications (n=5), and life-threatening/disabling bleeding (n=3). Overall permanent pacemaker rate was 14.7%. At 1 year, 74.8% improved ≥1 New York Heart Association class compared with baseline (P<0.0001). The Portico TAVI system is safe and effective at 1 year, yielding low mortality and stroke rates in high-risk patients with severe AS. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01493284.

Abstract 21053: Single Centre Experience of Portico TM Transcatheter Aortic Valve Implantation

Background: The Portico TM nitinol based self-expanding transcatheter aortic valve implantation (TAVI) system has the capability of being fully repositioned and retrieved in situ. This study investigates the feasibility and performance of Portico TM valve in subjects with severe symptomatic aortic stenosis up to 6 months post procedure. Hypothesis: The Portico TM system is safe and feasible in the treatment of patients with severe aortic stenosis. Methods: TAVI with the Portico TM system was performed in 83 subjects with severe AS using transfemoral (n=78), subclavian (n=4) and transaortic (n=1) access. Valve sizes included 23mm (n=5), 25mm (n=12), 27mm (n=31) and 29mm (n=35). Transthoracic echocardiography (TTE) was conducted pre and post-procedure and at 1mth and 6months in outpatient clinical follow-ups to evaluate aortic valve (AV) gradients and paravalvular regurgitation. Major stroke, vascular complications and mortality were also assessed in this cohort. Results: The mean age was 82±9yrs, with mean STS score of 5.0% and mean Euroscore II of 5.7%. The mean AV gradient improved significantly from baseline 47±17mmHg to 11±6 mmHg at 1mth and this decrease was sustained at 6 months post procedure; p&lt;0.0001. There were no cases of severe paravalvular regurgitation by TTE at 6 months. The 30-day mortality was 1.2% (n=1) and 6 months mortality was 6.0% (n=5). Two patients (2.4%) had post procedure stroke and both were treated with intravenous thrombolysis with improvement in their symptoms, one patient (1.2%) had major vascular complications requiring vascular intervention and 10 patients (12%) required permanent pacemaker implantation. With regards to patients with impaired LV function, 12 patients (14.4%) had an EF &lt; 55% prior to the TAVI procedure. In this group, there was a 15% improvement in EF at 6 months. Furthermore, 89% of all subjects improved at least one NYHA class at 30 days post procedure and 84% of the subjects improved at least one NYHA class at 6 months follow up. Conclusion: From our single center experience, the repositionable transcatheter Portico TM valve is feasible, safe and promising in the management of severe symptomatic aortic stenosis.

Cost-Effectiveness and Projected Survival of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement for High Risk Patients in a European Setting: A Dutch Analysis Based on the CoreValve High Risk Trial

ABSTRACTBackground: Clinical and economic outcomes of self-expanding bioprosthetic transcatheter aortic valve implantation (TAVI) in high-risk surgical candidates are unknown in the European setting. The objective of this study was to project life expectancy and to estimate the cost-effectiveness of TAVI in a European setting.Methods: Cost-utility analysis via probabilistic Markov modeling was performed. A simulated cohort of 83-year-old men and women (53 and 47%, respectively) with severe aortic stenosis at high but not extreme surgical risk were observed in the CoreValve High Risk Trial. Costs were based on resource use data from a Dutch academic medical center and costing guidelines. Undiscounted life expectancy and discounted costs, quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICER), and proportion cost-effective at a willingness-to-pay threshold of €50,000/QALY were evaluated. Beyond the base case, further analyses explored a “lean scenario” that considered a shorter TAVI procedure time and hospital stay.Results: Mean projected survival increased by 0.65 life years (5.62 for TAVI vs. 4.97 for SAVR). TAVI was projected to add 0.41 (3.69 vs. 3.27) QALYs at an increased cost of €9048 (€51,068 vs. €42,020), resulting in an ICER of €21,946 per QALY gained. The probability of TAVI being cost-effective was 71%. Further cost reduction of approximately €5400 in addition to the “lean” assumptions would make TAVI the dominant strategy.Conclusion: A self-expanding TAVI system for high-risk surgical candidates increases quality-adjusted life expectancy at an economically acceptable cost in the Dutch setting. Reductions in procedure time and length of hospital stay will further improve the value of TAVI.