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.

Long-term durability of self-expanding and balloon-expandable transcatheter aortic valve prostheses: UK TAVI registry.

BACKGROUND: With expansion of transcatheter aortic valve implantation (TAVI) into younger patients, valve durability is critically important. AIMS: We aimed to evaluate long-term valve function and incidence of severe structural valve deterioration (SVD) among patients ≥ 10-years post-TAVI and with echocardiographic follow-up at least 5-years postprocedure. METHODS: Data on patients who underwent TAVI from 2007 to 2011 were obtained from the UK TAVI registry. Patients with paired echocardiograms postprocedure and ≥5-years post-TAVI were included. Severe SVD was determined according to European task force guidelines. RESULTS: 221 patients (79.4 ± 7.3 years; 53% male) were included with median echocardiographic follow-up 7.0 years (range 5-13 years). Follow-up exceeded 10 years in 43 patients (19.5%). Valve types were the supra-annular self-expanding CoreValve (SEV; n = 143, 67%), balloon-expandable SAPIEN/XT (BEV; n = 67, 31%), Portico (n = 4, 5%) and unknown (n = 7, 3%). There was no difference between postprocedure and follow-up peak gradient in the overall cohort (19.3 vs. 18.4 mmHg; p = NS) or in those with ≥10-years follow-up (21.1 vs. 21.1 mmHg; p = NS). Severe SVD occurred in 13 patients (5.9%; median 7.8-years post-TAVI). Three cases (23.1%) were due to regurgitation and 10 (76.9%) to stenosis. Valve-related reintervention/death occurred in 5 patients (2.3%). Severe SVD was more frequent with BEV than SEV (11.9% vs. 3.5%; p = 0.02), driven by a difference in patients treated with small valves (BEV 28.6% vs. SEV 3.0%; p < 0.01). CONCLUSIONS: Hemodynamic function of transcatheter heart valves remains stable up to more than 10 years post-TAVI. Severe SVD occurred in 5.9%, and valve-related death/reintervention in 2.3%. Severe SVD was more common with BEV than SEV.

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.

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.

Patent foramen ovale closure prior to surgery in the sitting position.

Previously, patent foramen ovale (PFO) was an absolute contraindication to surgery in the sitting position. We report two patients with PFO who underwent surgery in the sitting position after percutaneous PFO closure. To our knowledge this is the first report of this technique.

Standalone balloon aortic valvuloplasty: indications and outcomes from the UK in the transcatheter valve era.

OBJECTIVES: We sought to characterize UK-wide balloon aortic valvuloplasty (BAV) experience in the TAVI era. BACKGROUND: BAV for acquired calcific aortic stenosis is in a phase of renaissance, largely due to the development of transcatheter aortic valve implantation (TAVI). METHODS: Data from 423 patients at 14 centers across the UK were analyzed. RESULTS: Patients were aged 80.9 ± 9.5 years; 52.5% were male. Mean logistic EuroScore was 27.3% ± 16.8%. Mean peak transaortic gradient fell from 62.0 ± 26.3 to 28.3 ± 16.2 mm Hg. Aortic valve area increased from 0.58 ± 0.19 to 0.80 ± 0.25 cm(2) echocardiographically. Procedural complication rate was 6.3%, comprising death (2.4%), blood transfusion ≥ 2 U (1.2%), cardiac tamponade (1.0%), stroke (1.0%), vascular surgical repair (1.0%), coronary embolism (0.5%), and permanent pacemaker (0.2%). Mortality was 13.8% at 30 days and 36.3% at 12 months. Subsequently, 18.3% of patients underwent TAVI and 7.0% sAVR, with improved survival compared to those who had no further intervention (logrank < 0.0001). Multivariate Cox proportional hazard analysis demonstrated that survival was adversely effected by the presence of coronary artery disease (HR 1.53, 95%CI 1.08-2.17, P = 0.018), poor LV function (HR 1.54, 95%CI 1.09-2.16, P = 0.014), and either urgent (HR 1.70, 95%CI 1.18-2.45; P = 0.004) or emergent presentation (HR 3.72, 95%CI 2.27-6.08; P < 0.0001). CONCLUSION: Balloon aortic valvuloplasty offers good immediate hemodynamic efficacy at an acceptable risk of major complications. Medium-term prognosis is poor in the absence of definitive therapy.

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.

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.

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.

Mitral annular calcification predicts mortality and coronary artery disease in end stage renal disease.

BACKGROUND: We sought to determine whether mitral annular calcification (MAC) predicts mortality and cardiac disease in a group of renal transplant candidates. METHODS: Hundred and forty patients were prospectively studied. All had echocardiography and coronary angiography. Significant coronary artery disease (CAD) was defined as luminal stenosis >70% by visual estimation in at least one coronary artery. RESULTS: There were 21 deaths over a follow-up period of 2.2+/-0.7 years. MAC occurred in 56 patients (40%) and was associated with higher mortality (p=0.04). Patients with MAC were older (p=or<0.001), had larger left ventricular (LV) end systolic (p=0.005) and LV end diastolic (p=0.04) diameter, larger left atrial diameter (p=0.001), lower LV fractional shortening (p=0.003), larger LV mass index (p=0.04) and higher mitral E/Ea ratio (p=0.03) compared to those without. Plasma calcium (p=0.002), phosphate (p=0.004), cardiac troponin T (p=0.03), N-terminal Pro-B-type natriuretic peptide (p=0.004) concentrations were higher in those with MAC but gender, total cholesterol, haemoglobin and creatinine were similar in the two groups. The proportion diabetic (p=0.03), on dialysis (p=0.05), with significant CAD (p=or<0.001), taking calcium containing phosphate binders (p=0.02) and Vitamin D3 (p=0.04) was significantly higher in those with MAC. Significant CAD (OR 12, 95% CI 3.25, p=0.001) was the only independent associate of MAC. CONCLUSIONS: MAC is associated with increased mortality and significant CAD in ESRD. These patients have increased LV cavity size, poorer LV systolic function, higher LV filling pressures compared to patients without MAC.

The detection of myocardial ischemia in end-stage renal disease.

The outcome of acute coronary syndromes is usually poor in patients with end-stage renal disease (ESRD), and the early detection of myocardial ischemia is therefore essential in this group. However, the diagnosis of ischemina is often problematic in patients with ESRD, as cardiac symptoms and electrocardiography are not reliable predictors in this context. Silent ischemia is common and resting ECG is often abnormal in patients with ESRD. Therefore, alternatives to these predictors have been sought, and this review explores the role of myocardial perfusion imaging, dobutamine stress echocardiography and biochemical markers for use in the diagnosis of ischemia and risk stratification in patients with ESRD.

Evaluation of ischaemia-modified albumin as a marker of myocardial ischaemia in end-stage renal disease.

The early diagnosis of myocardial ischaemia is problematic in patients with ESRD (end-stage renal disease). The aim of the present study was to determine whether IMA (ischaemia-modified albumin) increases during dobutamine stress and detects myocardial ischaemia in patients with ESRD. A total of 114 renal transplant candidates were studied prospectively, and all received DSE (dobutamine stress echocardiography). IMA levels were taken at baseline and 1 h after cessation of DSE. A total of 35 patients (31%) had a positive DSE result. Baseline IMA levels were not significantly different in the DSE-positive and -negative groups. The increase in IMA was significantly higher in the DSE-positive group compared with those with no ischaemic response (26.5 +/- 19.1 compared with 8.2 +/- 9.6 kU/l respectively; P = 0.007; where kU is kilo-units). From ROC (receiver operator charactertistic) curve analysis, the optimal IMA increase to predict an ischaemic response was 20 kU/l, with a sensitivity of 81% and a specificity of 72% [area under the curve, 0.80 (95% confidence interval, 0.44-0.94); P = 0.03]. There were 18 deaths, ten of which were cardiac in nature over a follow up period of 2.25 +/- 0.71 years. An increase in IMA > or = 20 kU/l was associated with significantly worse survival (P = 0.02). In conclusion, IMA is a moderately accurate marker of myocardial ischaemia in ESRD. Patients with an increase in IMA > or = 20 kU/l during DSE had significantly worse survival.

Initial Experience of a Second-Generation Self-Expanding Transcatheter Aortic Valve: The UK & Ireland Evolut R Implanters' Registry.

OBJECTIVES: The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve. BACKGROUND: The Evolut R is a self-expanding, repositionable, and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications. METHODS: Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland. RESULTS: A total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%. CONCLUSIONS: This registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.

Ischemia-modified albumin predicts mortality in ESRD.

BACKGROUND: The primary study aim is to determine whether ischemia-modified albumin (IMA) levels predict mortality in patients with end-stage renal disease (ESRD). The secondary aim is to determine characteristics of patients with elevated IMA levels. METHODS: A prospective observational study of 114 renal transplantation candidates was performed. All underwent coronary angiography and dobutamine stress echocardiography. The primary end point is total mortality. RESULTS: During a follow-up period of 2.25 +/- 0.71 years, there were 18 deaths; 10 were cardiac related. Diabetes, severe coronary artery disease, positive dobutamine stress echocardiography result, cardiac troponin T (cTnT) level, IMA level, left ventricular (LV) end-systolic diameter, LV ejection fraction, left atrial size, and mitral peak velocity of early filling (E)/early diastolic velocity (Ea) ratio all predicted mortality. The receiver operating characteristic area under the curve for mortality prediction was similar for IMA and cTnT levels. An IMA level of 95 KU/L or greater (n = 46) predicted mortality with a sensitivity of 76% and specificity of 74%. cTnT level of 0.06 ng/mL or greater (> or = 0.06 microg/L; n = 51) predicted mortality with a sensitivity of 75% and specificity of 72%. Thirty-eight patients (33%) had both IMA and cTnT levels elevated. With multivariate analysis, a positive dobutamine stress echocardiography result (P = 0.003), combined elevated IMA and cTnT levels (P = 0.005), and E/Ea ratio (P = 0.009) were independent prognostic factors. IMA and cTnT levels alone were not independent predictors of mortality. Patients with an elevated IMA level had a significantly larger LV size, decreased LV systolic function, and greater E/Ea ratio compared with those without an increased level. CONCLUSION: IMA level predicts mortality in patients with ESRD. Patients with elevated levels have larger LV size, decreased systolic function, and greater estimated LV filling pressures.