Emergency Transcatheter Repair for Anterior Leaflet Tear Following Percutaneous Balloon Mitral Valvuloplasty.

We present the case of a 66-year-old woman who developed severe mitral regurgitation from rupture of the anterior mitral valve leaflet following percutaneous balloon mitral valvuloplasty. Emergency transcatheter mitral valve repair was used to reduce the severity of mitral regurgitation and facilitate definitive surgical treatment. (Level of Difficulty: Advanced.).

Clinical value of CT-derived simulations of transcatheter-aortic-valve-implantation in challenging anatomies the PRECISE-TAVI trial.

BACKGROUND: Preprocedural computed tomography planning improves procedural safety and efficacy of transcatheter aortic valve implantation (TAVI). However, contemporary imaging modalities do not account for device-host interactions. AIMS: This study evaluates the value of preprocedural computer simulation with FEops HEARTguideTM on overall device success in patients with challenging anatomies undergoing TAVI with a contemporary self-expanding supra-annular transcatheter heart valve. METHODS: This prospective multicenter observational study included patients with a challenging anatomy defined as bicuspid aortic valve, small annulus or severely calcified aortic valve. We compared the heart team's transcatheter heart valve (THV) planning decision based on (1) conventional multislice computed tomography (MSCT) and (2) MSCT imaging with FEops HEARTguideTM simulations. Clinical outcomes and THV performance were followed up to 30 days. RESULTS: A total of 77 patients were included (median age 79.9 years (IQR 74.2-83.8), 42% male). In 35% of the patients, preprocedural planning changed after FEops HEARTguideTM simulations (change in valve size selection [12%] or target implantation height [23%]). A new permanent pacemaker implantation (PPI) was implanted in 13% and >trace paravalvular leakage (PVL) occurred in 28.5%. The contact pressure index (i.e., simulation output indicating the risk of conduction abnormalities) was significantly higher in patients with a new PPI, compared to those without (16.0% [25th-75th percentile 12.0-21.0] vs. 3.5% [25th-75th percentile 0-11.3], p < 0.01) The predicted PVL was 5.7 mL/s (25th-75th percentile 1.3-11.1) in patients with none-trace PVL, 12.7 (25th-75th percentile 5.5-19.1) in mild PVL and 17.7 (25th-75th percentile 3.6-19.4) in moderate PVL (p = 0.04). CONCLUSION: FEops HEARTguideTM simulations may provide enhanced insights in the risk for PVL or PPI after TAVI with a self-expanding supra-annular THV in complex anatomies.

Percutaneous Treatment of an Aorto-Right Ventricular Fistula Following Balloon-Expandable Transcatheter Aortic Valve Replacement.

We present the case of a 71-year-old man who experienced congestive cardiac failure after transcatheter aortic valve replacement with a balloon-expandable transcatheter heart valve. Echocardiography and cardiac computed tomography demonstrated an aorto-right ventricular fistula, and successful percutaneous closure was performed with a vascular plug. (Level of Difficulty: Advanced.).

Ongoing Experience With Patient-Specific Computer Simulation of Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used to treat younger, lower-risk patients with bicuspid aortic valve (BAV). Patient-specific computer simulation may identify patients at risk for developing paravalvular regurgitation (PVR) and major conduction disturbance. Only limited prospective experience of this technology exist. We wished to describe our ongoing experience with patient-specific computer simulation. METHODS: Patients who were referred for consideration of TAVR with a self-expanding transcatheter heart valve (THV) and had BAV identified on pre-procedural cardiac computed tomography imaging underwent patient-specific computer simulation. The computer simulations were reviewed by the Heart Team and used to guide surgical or transcatheter treatment approaches and to aid in THV sizing and positioning. Clinical outcomes were recorded. RESULTS: Between May 2019 and May 2021, 16 patients with BAV were referred for consideration of TAVR with a self-expanding THV. Sievers Type 1 morphology was present in 15 patients and Type 0 in the remaining patient. Two patients were predicted to develop moderate-to-severe PVR with a TAVR procedure and these patients underwent successful surgical aortic valve replacement. In the remaining 14 patients, computer simulation was used to optimize THV sizing and positioning to minimise PVR and conduction disturbance. One patient with a low valve implantation depth developed moderate PVR and this complication was correctly predicted by the computer simulations. No patient required insertion of a new permanent pacemaker. CONCLUSION: Patient-specific computer simulation may be used to guide the most appropriate treatment modality for patients with BAV. The usage of computer simulation to guide THV sizing and positioning was associated with favourable clinical outcomes.

Predictors of radial to femoral artery crossover during primary percutaneous coronary intervention in ST-elevation myocardial infarction: A systematic review and meta-analysis.

BACKGROUND: In contrast to traditional femoral artery access, radial artery access for primary percutaneous coronary intervention (PPCI) in ST-elevation myocardial infarction (STEMI) is associated with reduced mortality and bleeding but has higher crossover rates. Therefore, factors associated with crossover warrant exploration as crossover due to technical challenges associated with the radial route may be mitigated. OBJECTIVE: The objective of this study was to identify predictors of radial access failure or crossover to femoral access in PPCI. METHODS: A systematic review and meta-analysis was undertaken according to the Joanna Briggs Institute Systematic Reviews Checklist with searches conducted in Medline, EMBASE, CINAHL, and SCOPUS databases. Inclusion criteria for this study included patients with STEMI; PPCI; and primary research identifying predictors of radial access failures and/or crossovers, published in English, and after 2010. This study was registered with PROSPERO (CRD42020167122). Statistical analysis was performed using IBM SPSS Statistics for Windows version 26.0 (IBM Corp, Armonk, NY) and RevMan version 5.4 (Cochrane Collaboration, London, United Kingdom) with meta-analysis conducted by using the DerSimonian and Laird random-effects method. The National Heart, Lung, and Blood Institute Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies was utilised for quality and risk of bias assessment, with EndNote software used for citations. RESULTS: Eight observational studies met inclusion criteria, comprising 12,621 patients. Risk of bias of these studies was assessed using the National Heart, Lung, and Blood Institute Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. The mean age was 61.2 ± 12.0 years, and 75.3% were male. Crossover from transradial to transfemoral artery occurred in 529 (4.2%) patients. Reasons for radial access failure included failed puncture (35.3%), peripheral occlusion or tortuosity (24.5%), and radial artery spasm (20.1%). Predictors of crossover included older age (odds ratio [OR], 1.95; 95% confidence interval [CI], 1.44-2.65; p < 0.001), female sex (OR, 2.10; 95% Cl, 1.58-2.80; p < 0.001), weight ≤65 kg (OR, 2.95; 95% CI, 1.95-4.46; p < 0.001), and previous percutaneous coronary intervention (OR, 2.80; 95% Cl, 1.74-4.52; p < 0.001). CONCLUSION: Older age, female sex, weight ≤65 kg, and previous percutaneous coronary intervention were predictors of crossover or failure from the radial to femoral artery. As these predictors are known to be associated with high bleeding and mortality, they should not preclude attempting a radial-first approach in all patients with STEMI. However, as these results were unadjusted, this study warrants further research to thoroughly investigate predictors of radial artery crossover.

Quantitative flow ratio to predict long-term coronary artery bypass graft patency in patients with left main coronary artery disease.

PURPOSE: Fractional flow reserve (FFR) has been demonstrated in some studies to predict long-term coronary artery bypass graft (CABG) patency. Quantitative flow ratio (QFR) is an emerging technology which may predict FFR. In this study, we hypothesised that QFR would predict long-term CABG patency and that QFR would offer superior diagnostic performance to quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS). METHODS: A prospective study was performed on patients with left main coronary artery disease who were undergoing CABG. QFR, QCA and IVUS assessment was performed. Follow-up computed tomography coronary angiography and invasive coronary angiography was undertaken to assess graft patency. RESULTS: A total of 22 patients, comprising of 65 vessels were included in the analysis. At a median follow-up of 3.6 years post CABG (interquartile range, 2.3 to 4.8 years), 12 grafts (18.4%) were occluded. QFR was not statistically significantly higher in occluded grafts (0.81 ± 0.19 vs. 0.69 ± 0.21; P = 0.08). QFR demonstrated a discriminatory power to predict graft occlusion (area under the receiver operating characteristic curve, 0.70; 95% confidence interval [CI], 0.52 to 0.88; P = 0.03). At long-term follow-up, the risk of graft occlusion was higher in vessels with a QFR > 0.80 (58.6% vs. 17.0%; hazard ratio, 3.89; 95% CI, 1.05 to 14.42; P = 0.03 by log-rank test). QCA (minimum lumen diameter, lesion length, diameter stenosis) and IVUS (minimum lumen area, minimum lumen diameter, diameter stenosis) parameters were not predictive of long-term graft patency. CONCLUSIONS: QFR may predict long-term graft patency in patients undergoing CABG.

Diagnostic performance of quantitative flow ratio, non-hyperaemic pressure indices and fractional flow reserve for the assessment of coronary lesions in severe aortic stenosis.

Background: Quantitative flow ratio (QFR) may be used to assess the functional significance of coronary lesions. Only limited validation exists for this technology in the setting of severe aortic stenosis. Methods: A prospective study was performed on patients who were being considered for transcatheter aortic valve implantation. QFR analysis was performed (Medis Medical Imaging System, Leiden, The Netherlands) and compared to invasive measurements of haemodynamic assessment [fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), diastolic pressure ratio during the wave-free period (dPR) and distal arterial pressure/arterial pressure (Pd/Pa)]. Results: A total of 35 patients were included in the study. Mean age was 75.5±6.5 and mean aortic valve gradient was 44.3±11.8 mmHg. There were 57 vessels analysed. The mean FFR was 0.83±0.10 and 22 vessels (39%) had a functionally significant FFR ≤0.80. QFR demonstrated a discriminatory power to predict functionally significant FFR [area under the receiver operating characteristic curve (AUC), 0.92; 95% confidence interval (CI): 0.84 to 1.00], representing a sensitivity of 73%, specificity of 91%, positive predictive value of 84%, negative predictive value of 84% and an accuracy of 84%. QFR also demonstrated a discriminatory power to predict functionally significant iFR ≤0.89 (AUC =0.92; 95% CI: 0.85 to 0.99), dPR ≤0.89 (AUC =0.90; 95% CI: 0.83 to 0.98) and Pd/Pa ≤0.92 (AUC =0.89; 95% CI: 0.80 to 0.97). Conclusions: QFR demonstrates acceptable diagnostic performance in patients with severe aortic stenosis when both FFR and non-hyperaemic pressure indices are used as reference standards.

Patient-specific computer simulation to predict long-term outcomes after transcatheter aortic valve replacement.

BACKGROUND: Patient-specific computer simulation may predict the development of paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR). We hypothesised that patient-specific computer simulation might identify patients at risk for long-term adverse outcomes after TAVR. METHODS: A multi-centre retrospective study was performed on patients with symptomatic severe aortic stenosis who had undergone TAVR with a self-expanding transcatheter heart valve (THV). Pre-procedural cardiac computed tomography imaging was used to create finite element models of the aortic root. Finite element analysis (FEA) was performed in order to simulate the interaction between the THV and the native anatomy. The blood domain was extracted from the FEA output and computational fluid dynamics (CFD) simulation undertaken. Predicted PVR was recorded in the left ventricular outflow tract. Patients were classified into those where computer simulation predicted no significant PVR (predicted PVR from CFD <16.0 â€‹mL/s) and those where computer simulation predicted significant PVR (predicted PVR from CFD ≥16.0 â€‹mL/s). RESULTS: A total of 203 patients were included in the study. THVs implanted were CoreValve (n â€‹= â€‹20), Evolut R (n â€‹= â€‹90) and Evolut PRO (n â€‹= â€‹93). At 2 years, the Kaplan-Meier estimate of the rate of death from any cause was higher in the group where CFD simulation predicted significant PVR (35.8% vs. 16.3%; hazard ratio, 2.62; 95% confidence interval, 1.29 to 5.30; P â€‹= â€‹0.006 by log-rank test). CONCLUSIONS: Computer simulation may identify patients who are at a higher risk for death after TAVR.

Patient-Specific Computer Simulation to Predict Conduction Disturbance With Current-Generation Self-Expanding Transcatheter Heart Valves.

Background: Patient-specific computer simulation may predict the development of conduction disturbance following transcatheter aortic valve replacement (TAVR). Validation of the computer simulations with current-generation devices has not been undertaken. Methods: A retrospective study was performed on patients who had undergone TAVR with a current-generation self-expanding transcatheter heart valve (THV). Preprocedural computed tomography imaging was used to create finite element models of the aortic root. Procedural contrast angiography was reviewed, and finite element analysis performed using a matching THV device size and implantation depth. A region of interest corresponding to the atrioventricular bundle and proximal left bundle branch was identified. The percentage of this area (contact pressure index [CPI]) and maximum contact pressure (CPMax) exerted by THV were recorded. Postprocedural electrocardiograms were reviewed, and major conduction disturbance was defined as the development of persistent left bundle branch block or high-degree atrioventricular block. Results: A total of 80 patients were included in the study. THVs were 23- to 29-mm Evolut PRO (n = 53) and 34-mm Evolut R (n = 27). Major conduction disturbance occurred in 27 patients (33.8%). CPI (28.3 ± 15.8 vs. 15.6 ± 11.2%; p < 0.001) and CPMax (0.51 ± 0.20 vs. 0.36 ± 0.24 MPa; p = 0.008) were higher in patients who developed major conduction disturbance. CPI (area under the receiver operating characteristic curve [AUC], 0.74; 95% CI, 0.63-0.86; p < 0.001) and CPMax (AUC, 0.69; 95% CI, 0.57-0.81; p = 0.006) demonstrated a discriminatory power to predict the development of major conduction disturbance. Conclusions: Patient-specific computer simulation may identify patients at risk for conduction disturbance after TAVR with current-generation self-expanding THVs.

Patient-specific Computer Simulation: An Emerging Technology for Guiding the Transcatheter Treatment of Patients with Bicuspid Aortic Valve.

Transcatheter aortic valve implantation (TAVI) is increasingly being used to treat younger, lower-risk patients, many of whom have bicuspid aortic valve (BAV). As TAVI begins to enter these younger patient cohorts, it is critical that clinical outcomes from TAVI in BAV are matched to those achieved by surgery. Therefore, the identification of patients who, on an anatomical basis, may not be suitable for TAVI, would be desirable. Furthermore, clinical outcomes of TAVI in BAV might be improved through improved transcatheter heart valve sizing and positioning. One potential solution to these challenges is patient-specific computer simulation. This review presents the methodology and clinical evidence surrounding patient-specific computer simulation of TAVI in BAV.

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

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

Transcatheter aortic valve replacement versus surgery for symptomatic severe aortic stenosis: A reconstructed individual patient data meta-analysis.

OBJECTIVES: We wished to undertake a reconstructed individual patient data meta-analysis of randomized clinical trials comparing transcatheter aortic valve replacement (TAVR) and surgery for patients with severe symptomatic aortic stenosis. BACKGROUND: TAVR and surgery are both well-established methods for treating patients with symptomatic severe aortic stenosis who are at low, intermediate, and high risk for surgery. METHODS: Data were identified by searches of Medline, Embase, CENTRAL and ClinicalTrials.gov for all randomized clinical trials, which compared TAVR and surgery that had published at least 1 year of follow-up. Individual patient data were reconstructed from Kaplan-Meier curves. RESULTS: A total of 7,770 patients from seven randomized clinical trials were included in this meta-analysis. At 1 year, TAVR was associated with a lower risk of death from any cause (hazard ratio [HR], 0.85, 95% confidence interval [CI], 0.73-0.98; p = .03), disabling stroke (HR, 0.71; 95% CI, 0.54-0.93; p = .01) and the composite end point of death or disabling stroke (HR, 0.79; 95% CI, 0.67-0.92; p = .002). Significant interactions were found for access suitability, with TAVR associated with a lower risk of these end points in patients suitable for transfemoral access. TAVR was associated with a lower risk of periprocedural events, whereas the risk of late events was similar between TAVR and surgery. CONCLUSIONS: At 1 year, TAVR was associated with a lower risk of death, disabling stroke and the composite end point, when compared with surgery. These associations were strongest within the subgroup of patients in whom transfemoral access was feasible.

Initial experience of a self-expanding transcatheter aortic valve with an outer pericardial wrap: The United Kingdom and Ireland Implanters' registry.

OBJECTIVES: The United Kingdom and Ireland Implanters' registry is a multicenter registry which reports on real-world experience with new transcatheter heart valves. BACKGROUND: The Evolut PRO (Medtronic, Minneapolis, MN) transcatheter aortic valve is a self-expanding transcatheter aortic valve with an outer pericardial wrap, designed to minimize paravalvular regurgitation. METHODS: Between July 2017 and December 2018, clinical, procedural, and 30-day outcome data were prospectively collected from all patients receiving the Evolut PRO valve across nine participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2 (VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 317 patients underwent implantation. Mean age was 81.8 ± 6.4 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.5 ± 1.8%. Iliofemoral access was used in 99.1% of patients. Device success was 91.2%. Mean gradient was 7.6 ± 4.7 mmHg and effective orifice area 1.9 ± 0.7 cm2 . The incidence of moderate paravalvular regurgitation was 1.7% and there was no severe paravalvular regurgitation. A new permanent pacemaker was implanted in 17.8% of patients without a pacemaker at baseline. Early safety was demonstrated in 92.7%. At 30 days, all-cause mortality was 0.6%, stroke 3.8%, and major vascular complication 2.8%. CONCLUSIONS: Real-world experience of the Evolut PRO transcatheter aortic valve demonstrated favorable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

First-in-Human Experience With Patient-Specific Computer Simulation of TAVR in Bicuspid Aortic Valve Morphology.

OBJECTIVES: The aim of this study was to prospectively evaluate the clinical use of patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) morphology. BACKGROUND: Patient-specific computer simulation of TAVR in BAV may predict important clinical outcomes, such as paravalvular regurgitation and conduction disturbance. METHODS: Between May 2018 and April 2019, all patients who were referred for TAVR who had BAV identified on work-up cardiac multidetector computed tomographic imaging prospectively underwent patient-specific computer simulation with a self-expanding transcatheter heart valve (THV) using TAVIguide technology. RESULTS: Nine patients were included in the study. Sievers classification was type 0 in 2 patients and type 1 in 7 patients. The simulations altered the treatment strategy in 8 patients (89%). The simulations suggested moderate to severe paravalvular regurgitation in 3 patients, who were referred for consideration of surgery. The remaining 6 patients underwent TAVR with a self-expanding THV. In 5 of these patients (83%), THV size and/or implantation depth was altered to minimize paravalvular regurgitation and/or conduction disturbance. In 1 patient, simulations suggested significant conduction disturbance after TAVR, and a permanent pacemaker was implanted before the procedure. Following treatment, all 9 patients had no to mild paravalvular regurgitation. The patient who had a pre-procedure permanent pacemaker implanted became pacing dependent, with underlying third-degree atrioventricular block. CONCLUSIONS: Patient-specific computer simulation of TAVR in BAV can be used to identify those patients where TAVR may be associated with unfavorable clinical outcomes. Patient-specific computer simulation may be useful to guide THV sizing and positioning for potential favorable clinical outcomes.

Patient-Specific Computer Simulation of Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Morphology.

BACKGROUND: A patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) in tricuspid aortic valve has been developed, which can predict paravalvular regurgitation and conduction disturbance. We wished to validate a patient-specific computer simulation of TAVR in bicuspid aortic valve and to determine whether patient-specific transcatheter heart valve (THV) sizing and positioning might improve clinical outcomes. METHODS: A retrospective study was performed on TAVR in bicuspid aortic valve patients that had both pre- and postprocedural computed tomography imaging. Preprocedural computed tomography imaging was used to create finite element models of the aortic root. Finite element analysis and computational fluid dynamics was performed. The simulation output was compared with postprocedural computed tomography imaging, cineangiography, echocardiography, and electrocardiograms. For each patient, multiple simulations were performed, to identify an optimal THV size and position for the patient's specific anatomic characteristics. RESULTS: A total of 37 patients were included in the study. The simulations accurately predicted the THV frame deformation (minimum-diameter intraclass correlation coefficient, 0.84; maximum-diameter intraclass correlation coefficient, 0.88; perimeter intraclass correlation coefficient, 0.91; area intraclass correlation coefficient, 0.91), more than mild paravalvular regurgitation (area under the receiver operating characteristic curve, 0.86) and major conduction abnormalities (new left bundle branch block or high-degree atrioventricular block; area under the receiver operating characteristic curve, 0.88). When compared with the implanted THV size and implant depth, optimal patient-specific THV sizing and positioning reduced simulation-predicted paravalvular regurgitation and markers of conduction disturbance. CONCLUSIONS: Patient-specific computer simulation of TAVR in bicuspid aortic valve may predict the development of important clinical outcomes, such as paravalvular regurgitation and conduction abnormalities. Patient-specific THV sizing and positioning may improve clinical outcomes of TAVR in bicuspid aortic valve.

Long-Term Durability of Transcatheter Aortic Valve Prostheses.

BACKGROUND: Very little is known about long-term valve durability after transcatheter aortic valve replacement (TAVR). OBJECTIVES: This study sought to evaluate the incidence of structural valve degeneration (SVD) 5 to 10 years post-procedure. METHODS: Demographic, procedural, and in-hospital outcome data on patients who underwent TAVR from 2007 to 2011 were obtained from the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry. Patients in whom echocardiographic data were available both at baseline and ≥5 years post-TAVR were included. Hemodynamic SVD was determined according to European task force committee guidelines. RESULTS: A total of 241 patients (79.3 ± 7.5 years of age; 46% female) with paired post-procedure and late echocardiographic follow-up (median 5.8 years, range 5 to 10 years) were included. A total of 149 patients (64%) were treated with a self-expandable valve and 80 (34.7%) with a balloon-expandable valve. Peak aortic valve gradient at follow-up was lower than post-procedure (17.1 vs. 19.1 mm Hg; p = 0.002). More patients had none/trivial aortic regurgitation (AR) (47.5% vs. 33%), and fewer had mild AR (42.5% vs. 57%) at follow-up (p = 0.02). There was 1 case (0.4%) of severe SVD 5.3 years after implantation (new severe AR). There were 21 cases (8.7%) of moderate SVD (mean 6.1 years post-implantation; range 4.9 to 8.6 years). Twelve of these (57%) were due to new AR and 9 (43%) to restenosis. CONCLUSIONS: Long-term transcatheter aortic valve function is excellent. In the authors' study, 91% of patients remained free of SVD between 5 and 10 years post-implantation. The incidence of severe SVD was <1%. Moderate SVD occurred in 1 in 12 patients.

Initial experience of a large, self-expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters' registry.

OBJECTIVES: The UK & Ireland Implanters' registry is a multicenter registry which reports on real-world experience with novel transcatheter heart valves. BACKGROUND: The 34 mm Evolut R transcatheter aortic valve is a self-expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. METHODS: Between January 2017 and April 2018, clinical, procedural and 30-day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2(VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm2 . Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all-cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%. CONCLUSIONS: Real-world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.