Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study.

BACKGROUND: Transcatheter aortic valve implantation is an effective treatment for patients with aortic stenosis; however, complications related to paravalvular leakage (PVL) persist, including increased risk of mortality, cardiovascular mortality, and rehospitalisation. AIMS: We sought to evaluate the clinical outcomes and valve performance at 1 year in patients with severe aortic stenosis treated with the ACURATE neo2 valve in a post-market clinical setting. METHODS: Valve Academic Research Consortium-2 safety events were assessed up to 1 year. Independent core laboratories evaluated echocardiographic measures of valve performance and hypoattenuated leaflet thickening (HALT; as measured by four-dimensional computed tomography). RESULTS: The study enrolled 250 patients (64% female; mean age: 81 years; baseline Society of Thoracic Surgeons risk score: 2.9±2.0%); 246 patients were implanted with ACURATE neo2. All-cause mortality was 0.8% at 30 days and 5.1% at 1 year. The 1-year rates for stroke and disabling stroke were 3.0% and 1.3%, respectively. Overall, HALT of >50% leaflet involvement of at least one leaflet was present in 9% of patients at 30 days and in 12% of patients at 1 year. No association was observed between the presence of HALT and 1-year clinical or haemodynamic outcomes. Early haemodynamic improvements were maintained up to 1 year (mean aortic valve gradient: 47.6±14.5 mmHg at baseline, 7.6±3.2 mmHg at 1 year; mean aortic valve area: 0.7±0.2 cm2 at baseline, 1.7±0.4 cm2 at 1 year). At 1 year, 99% of patients had mild or no/trace PVL (<1% had moderate PVL; no patient had severe PVL). CONCLUSIONS: The study outcomes confirm favourable performance and safety up to 1 year in patients treated with ACURATE neo2 in routine clinical practice. (ClinicalTrials.gov: NCT04655248).

Restoration of von Willebrand factor after transcatheter aortic valve replacement-A possible cause for posttranscatheter aortic valve replacement thrombocytopenia?

OBJECTIVES: The aim of the current study was to analyze the clinical and procedural predictors of thrombocytopenia and the relationship between the decrease in platelet count (DPC) and change in vWF function (ΔvWF) after transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR often causes temporary thrombocytopenia. At the same time, TAVR leads to a restoration of von Willebrand factor (vWF) function. METHODS: One hundred and forty-one patients with severe aortic stenosis undergoing TAVR were included in the study. Platelet count and vWF function (vWF:Ac/Ag ratio) were assessed at baseline and 6 h after TAVR. Thrombocytopenia was defined as platelet count <150/nL. RESULTS: Median platelet count at baseline was 214/nL (interquartile range [IQR]: 176-261) and decreased significantly to 184/nL (IQR: 145-222) 6 h after TAVR. The number of patients with thrombocytopenia increased from 12.8% at baseline to 29.1% after 6 h. DPC 6 h after TAVR showed a significant correlation with ΔvWF (r = - 0.254, p = 0.002). Patients with DPC > 20% had significantly higher ΔvWF (10.9% vs. 6.5%, p = 0.021). Obese patients showed a significantly lower DPC (11.8% vs. 19.9%, p = 0.001). In multivariate analysis, ΔvWF 6 h after TAVR was the only significant predictor for DPC > 20% (p = 0.017). CONCLUSIONS: The restoration of vWF after TAVR is a significant predictor for DPC after TAVR. An increased platelet consumption due to vWF restoration could play a key role in the development of thrombocytopenia after TAVR.

Performance of the 32 mm Myval transcatheter heart valve for treatment of aortic stenosis in patients with extremely large aortic annuli in real-world scenario: First global, multicenter experience.

BACKGROUND: Extremely large aortic valve anatomy is one of the remaining limitations leading to exclusion of patients for transcatheter aortic valve replacement (TAVR). AIMS: The newly approved Myval 32 mm device is designed for use in aortic annulus areas up to 840 mm2 . Here we want to share the initial worldwide experience with the device. METHODS AND RESULTS: Retrospective data were collected from 10 patients with aortic stenosis and very large annular anatomy (mean area 765.5 mm2 ), who underwent implantation with 32 mm Myval transcatheter heart valve at eight centers. Valve Academic Research Consortium-2 device success was achieved in all cases. Mild paravalvular leak was observed in three patients and two patients required new pacemaker implantation. One patient experienced retroperitoneal hemorrhage caused by the contralateral 6 F sheath and required surgical revision. No device-related complications, stroke, or death from any cause occurred within the 30-day follow-up period. In a studied cohort of 2219 consecutive TAVR-screened patients from a central European site, only 0.27% of patients showed larger anatomy than covered by the 32 mm Myval device by instructions for use without off-label use of overexpansion. This rate was significantly higher for the 34 mm Evolut Pro (1.8%) and 29 mm Sapien 3 (2.1%) devices. CONCLUSIONS: The Myval 32 mm prosthesis showed promising initial results in a cohort of patients who previously had to be excluded from TAVR. It is desirable that all future TAVR systems accommodate larger anatomy to allow optimal treatment of all patients.

Intraoperative suggestions to prevent postoperative delirium in patients undergoing transaortic valvular replacement: a randomized placebo-controlled trial.

BACKGROUND: Postoperative delirium (POD) is a serious complication following anaesthesia and surgery and significantly influences postoperative outcome especially in the elderly population. Intraoperative music and positive suggestions influence postoperative outcomes by attenuating analgesic demand and increasing patient satisfaction. AIMS: Here, we examined the effect of intraoperative music and positive suggestions on the development of POD in aged patients undergoing transcatheter aortic valve replacement (TAVR) procedure under general anaesthesia. METHODS: For this randomized placebo-controlled study, eligible patients without cognitive deficit, indicated by a MMSE < 10 points, were anesthetized using remifentanil and sevoflurane. Anaesthetic depth was guide with bispectral index. An audiotape with positive suggestions was applied from a MP3 player via headphones. POD, pain and PONV was assessed. CAM-ICU and Nu-DESC were done twice daily for the first 5 days. RESULTS: Of 140 patients 118 patients could be analysed (57 male, 80.6 ± 5.1 years). POD was diagnosed in 16 patients (12.7%). POD was significantly more often observed in male (12, 21.1%) than in female (4, 6.6%, p = 0.02) and in patients with a low MMSE (23.6 ± 4.5 vs. 26.8 ± 2.8, p = 0.001). Anaesthetic depth did not influence the incidence of POD. Intraoperative music and suggestions did not affect the rate of POD, pain, analgesic requirement or PONV. DISCUSSION: In patients undergoing TAVR male sex and low MMSE scoring are associated with an increase in POD. CONCLUSIONS: Intraoperative music and positive suggestions do not influence the incidence of POD in this patient group. STUDY REGISTRATION: DRKS: 00024444, start of registration: 4.02.202, final registration: 17.09.2021.

Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve.

BACKGROUND: In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation. METHODS: Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort. RESULTS: Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 (25%) in the S3 group at 3 years. Comparing NEO with S3, the 3-year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73-1.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56-1.92]), and hospitalization for congestive heart failure (subhazard ratio, 0.74 [95% CI, 0.51-1.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [95% CI, 0.30-5.85]). New York Heart Association functional class ≤II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg; P<0.001). CONCLUSIONS: Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years. REGISTRATION: URL: https://clinicaltrials.gov, Unique identifier: NCT03011346.

Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI.

BACKGROUND: The MANTA vascular closure device (VCD) is a novel collagen plug-based VCD for large bore arteriotomies. The current literature regarding complication rates of this device is quite variable and mostly limited to relatively small case series. METHODS: This study is retrospective analysis of the MANTA VCD-related main access site complications according to Valve Academic Research Consortium-2 (VARC-2) criteria during the hospital stay. Particular attention was paid to the detailed analysis of multislice computed tomography with regard to the anatomy of the access vessel and the puncture site itself. RESULTS: A total of 524 patients underwent transfemoral transcatheter aortic valve implantation (TF TAVI) including the use of the MANTA device (18F) for percutaneous vascular closure. A group of 22 patients was excluded from the study due to incomplete imaging data. During the study period, we observed 28 major (5.6%) and five minor (1.0%) MANTA device-related vascular complications. There was no patient death related to these adverse events. Female gender, vessel angulation at the puncture site, and at least moderate calcification of the dorsal vessel segment were identified as independent predictors for major complications. CONCLUSIONS: The MANTA device is a feasible option for vascular closure of large bore arteriotomies in patients undergoing TF TAVI or other percutaneous transfemoral interventions. Furthermore, we have identified novel predictors for device failure/complications that should be taken into account for selection of the appropriate closure device. To our knowledge, this report is one of the largest case series analyzing the use of the MANTA VCD.

Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicenter, observational, post-market surveillance study.

BACKGROUND: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device. AIMS: To collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS). METHODS: ACURATE neo2 PMCF is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30-days. The primary imaging endpoint was hypo-attenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included VARC safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography. RESULTS: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean STS score: 2.9±2.0%); 246 (98.4%) were successfully treated with ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%. CONCLUSIONS: The study results support the safety and efficacy of TAVI with ACURATE neo2 in patients in routine clinical practice.

The impact of bicuspid aortic valve morphology on von Willebrand factor function in patients with severe aortic stenosis and its change after TAVI.

BACKGROUND: Aortic stenosis (AS) can cause acquired von Willebrand syndrome (AVWS) and valve replacement has been shown to lead to von Willebrand factor (vWF) recovery. The aim of the current study was to investigate the prevalence of AVWS in different severe AS phenotypes and its course after transcatheter aortic valve implantation (TAVI). METHODS: 143 patients with severe AS undergoing TAVI were included in the study. vWF function was assessed at baseline, 6 and 24 h after TAVI. AVWS was defined as a reduced vWF:Ac/Ag ratio ≤ 0.7. Phenotypes were classified by tricuspid (TAV) and bicuspid (BAV) valve morphology, mean transvalvular gradient (Pmean), stroke volume index (SVI), ejection fraction (EF) and indexed effective orifice area (iEOA). RESULTS: AVWS was present in 36 (25.2%) patients before TAVI. vWF:Ac/Ag ratio was significantly lower in high gradient compared to low-gradient severe AS [0.78 (IQR 0.67-0.86) vs. 0.83 (IQR 0.74-0.93), p < 0.05] and in patients with BAV compared to TAV [0.70 (IQR 0.63-0.78) vs. 0.81 (IQR 0.71-0.89), p < 0.05]. Normalization of vWF:Ac/Ag ratio was achieved in 61% patients 24 h after TAVI. As in the overall study cohort, vWF:Ac/Ag ratio increased significantly in all severe AS subgroups 6 h after TAVI (each p < 0.05). Regarding binary logistic regression analysis, BAV was the only significant predictor for AVWS. CONCLUSIONS: BAV morphology is a strong predictor for AVWS in severe AS. TAVI restores vWF function in most patients with severe AS independently of AS phenotype and valve morphology.

Diagnostic value of FDG PET/CT imaging in patients with surgically managed infective endocarditis: results of a retrospective analysis at a tertiary center.

BACKGROUND: We assessed the diagnostic value of FDG PET/CT in a real-world cohort of patients with surgically managed infective endocarditis (IE). METHODS: We performed a retrospective analysis of all patients hospitalized in a tertiary IE referral medical center from January 2014 to October 2018 fulfilling the following criteria: ICD-10 code for IE and OPS code for both, heart surgery and FDG PET/CT. RESULTS: Final analysis included 29 patients, whereof 28 patients had surgically proven IE. FDG PET/CT scan was true-positive in 15 patients (sensitivity (SEN) 56%) and false-negative in 12 patients. Combination of Duke criteria (DC) with FDG PET/CT scan resulted in gain of SEN for all patients with confirmed IE (SEN of DC 79% vs SEN of combination DC and FDG PET/CT 89%), driven by a relevant gain in PVE patients only (SEN of DC 78% vs SEN of combination DC and FDG PET/CT 94%). Interestingly, higher prosthesis age was observed in patients with false-negative scans. CONCLUSIONS: We found a SEN of 56% for FDG PET/CT in a real-world cohort of patients with surgically proven IE which was associated with a 16% gain of IE diagnosis in patients with PVE when combined with DC.

25 Years' Experience with Redo Operations in Cardiac Surgery-Third-Time Sternotomy Procedures.

BACKGROUND: Over the years, open heart surgery has become more complex, and especially reoperative surgery, more demanding. The risk of third-time or more sternotomy procedures is unclear. METHODS: We reviewed our institutional experience of 25 years based on two generations of cardiac surgeons in a German university medical center to document frequency, outcome, and complications of the various types of open heart procedures. RESULTS: Overall, we included 104 patients with a mean age of 64 ± 13 years. The EuroSCORE II (European System for Cardiac Operative Risk Evaluation) calculated an average mortality risk of 15.7 ± 15.4%. Subgroup comparison of isolated coronary artery bypass grafting (CABG), aortic valve replacement, and mitral valve replacement procedures did not delineate significantly different risk profiles except for the incidence of acute myocardial infarction, which was present in every second patient (53.3%) scheduled for CABG surgery. The time interval to previous surgery was 4.7 ± 6.3 years on average. Most frequent surgical procedures were valve operations, which were accomplished in 72 patients (69.2%), whereas coronary bypass surgery was performed in 23 patients (22.1%) only. Combined procedures were performed in 27 patients. Complex aortic arch replacement with a frozen elephant trunk procedure was necessary in six patients. Overall, 30-day survival was 81.7%. CONCLUSION: In conclusion, third-time and more sternotomy procedures offer acceptable outcome and should therefore be considered in appropriate patients.

Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study.

BACKGROUND: A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE neo bioprosthetic aortic valve. METHODS AND RESULTS: This single-arm post-market study had a planned enrolment of 200 subjects; enrolment was terminated early due to declining TA-TAVR procedures at participating centers. Final enrolment was 107 patients (mean age: 79.3 years; 54.2% female; mean STS score at baseline: 6.2%). The mortality rate in the intent-to-treat population was 11.2% at 30 days (primary endpoint) and 25.6% at 12 months. The VARC-2 composite endpoint for 30-day safety occurred in 24.3% of patients. Six patients (5.6%) received a permanent pacemaker within 30 days. Site-reported echocardiographic data showed early improvements in mean aortic valve gradient (baseline: 38.8 [SD 13.1] mmHg, discharge: 6.7 [SD 3.7] mmHg) and effective orifice area (baseline: 0.7 [SD 0.2] cm2, discharge: 1.9 [SD 0.6] cm2), and the discharge rate of paravalvular regurgitation was low (74.7% none/trace, 24.2% mild, 1.1% severe). CONCLUSIONS: TA-TAVR with the ACURATE neo valve system yields acceptable clinical outcomes, providing an alternative for patients with aortic stenosis who are not candidates for TF-TAVR.

The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. METHODS: The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. RESULTS: The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. CONCLUSIONS: One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve.

Protected complex percutaneous coronary intervention and transcatheter aortic valve replacement using extracorporeal membrane oxygenation in a high-risk frail patient: a case report.

BACKGROUND: Transcatheter aortic valve replacement has become a routine procedure for patients with severe symptomatic aortic stenosis at increased surgical risk. Not much is known about using prophylactic support with venoarterial extracorporeal membrane oxygenation in patients undergoing transcatheter aortic valve replacement and eventually concomitant complex percutaneous coronary intervention. CASE PRESENTATION: We present a successful procedure of transcatheter aortic valve replacement and high-risk percutaneous coronary intervention utilizing venoarterial extracorporeal membrane oxygenation for hemodynamic support in a very frail 88-year-old Caucasian woman with severe symptomatic aortic stenosis and coronary bypass grafting in the past. Echocardiography revealed a "low-flow low-gradient" aortic stenosis (mean transvalvular gradient 30 mmHg, aortic valve area 0.4 cm2, significant calcification), a left ventricular ejection fraction of 35%, severe mitral regurgitation with moderate stenosis (mean transvalvular gradient 7 mmHg), with a systolic pulmonary artery pressure of 80 mmHg. Moreover, pre-interventional coronary angiography exposed a severe left main ostial stenosis and sequential subtotal heavily calcified stenosis of the left anterior descending artery . Computed tomographic angiography showed no heavy tortuosity but moderate calcification of the iliofemoral arteries. The procedure was performed under general anesthesia in our hybrid operating room. Extracorporeal membrane oxygenation was established by left femoral percutaneous cannulation using a 21-Fr venous and 15-Fr arterial cannula. Subsequently, complex percutaneous coronary intervention with implantation of two drug-eluting stents from the left main into the left anterior descending artery was performed via a right femoral arterial 7F sheath. Thereafter, a 23-mm Sapien 3 aortic valve prosthesis (Edwards, Irvine, CA, USA) was implanted via right femoral artery in the usual manner, whereby the arterial pigtail catheter for marking the aortic annulus during transcatheter aortic valve replacement was inserted over a Check-Flo® Hemostasis Assembly (Cook Medical, Bloomington, IN, USA) on a Y-adapter via the arterial extracorporeal membrane oxygenation cannula. After extracorporeal membrane oxygenation decannulation, vascular closure was easily performed using the MANTA vascular closure device in order to reduce procedural time and risk of access site complications. CONCLUSIONS: In summary, we demonstrate the feasibility of elective prophylactic extracorporeal membrane oxygenation implementation in selected very high-risk and frail patients undergoing transcatheter aortic valve replacement and percutaneous coronary intervention in order to avoid intraprocedural complications.

Inhibition of NaV1.8 prevents atrial arrhythmogenesis in human and mice.

Pharmacologic approaches for the treatment of atrial arrhythmias are limited due to side effects and low efficacy. Thus, the identification of new antiarrhythmic targets is of clinical interest. Recent genome studies suggested an involvement of SCN10A sodium channels (NaV1.8) in atrial electrophysiology. This study investigated the role and involvement of NaV1.8 (SCN10A) in arrhythmia generation in the human atria and in mice lacking NaV1.8. NaV1.8 mRNA and protein were detected in human atrial myocardium at a significant higher level compared to ventricular myocardium. Expression of NaV1.8 and NaV1.5 did not differ between myocardium from patients with atrial fibrillation and sinus rhythm. To determine the electrophysiological role of NaV1.8, we investigated isolated human atrial cardiomyocytes from patients with sinus rhythm stimulated with isoproterenol. Inhibition of NaV1.8 by A-803467 or PF-01247324 showed no effects on the human atrial action potential. However, we found that NaV1.8 significantly contributes to late Na+ current and consequently to an increased proarrhythmogenic diastolic sarcoplasmic reticulum Ca2+ leak in human atrial cardiomyocytes. Selective pharmacological inhibition of NaV1.8 potently reduced late Na+ current, proarrhythmic diastolic Ca2+ release, delayed afterdepolarizations as well as spontaneous action potentials. These findings could be confirmed in murine atrial cardiomyocytes from wild-type mice and also compared to SCN10A-/- mice (genetic ablation of NaV1.8). Pharmacological NaV1.8 inhibition showed no effects in SCN10A-/- mice. Importantly, in vivo experiments in SCN10A-/- mice showed that genetic ablation of NaV1.8 protects against atrial fibrillation induction. This study demonstrates that NaV1.8 is expressed in the murine and human atria and contributes to late Na+ current generation and cellular arrhythmogenesis. Blocking NaV1.8 selectively counteracts this pathomechanism and protects against atrial arrhythmias. Thus, our translational study reveals a new selective therapeutic target for treating atrial arrhythmias.

Transcatheter aortic valve implantation with the ACURATE neo valve: indications, procedural aspects and clinical outcomes.

The ACURATE neo aortic valve system is a self-expanding transcatheter device that was granted CE mark in 2014 and has since been widely adopted in the treatment of patients with severe aortic stenosis. The ACURATE neo can be used in a wide clinical spectrum, but there are some specific indications and anatomies where this device is particularly suitable. Recently, it was shown that, with appropriate patient screening, size selection, and optimised positioning, results can be improved substantially. This review provides an overview of existing data and compiles a standardised manual of best practice for the implantation of this device based on both evidence and individual experience.

Valve-in-Valve Implantation Using the ACURATE Neo in Degenerated Aortic Bioprostheses: An International Multicenter Analysis.

OBJECTIVES: This study reports an international experience using the transfemoral ACURATE neo transcatheter heart valve (Boston Scientific, Marlborough, Massachusetts) for the treatment of degenerated surgical aortic bioprostheses. BACKGROUND: Transcatheter valve-in-valve procedures have emerged as an alternative to redo surgery. Supra-annular prostheses might be particularly useful in this indication. METHODS: This is an international multicenter analysis including 85 patients from 14 centers in Europe and Canada undergoing an ACURATE neo valve-in-valve procedure from March 2015 to February 2019. RESULTS: Internal diameter of the degenerated bioprosthesis was 20.3 ± 2.1 mm. Prosthesis size S was used in 70 (82%) procedures. The median depth of implantation was 3 mm and the upper crown of the ACURATE neo was positioned above the stent posts of the degenerated bioprosthesis in 54 (64%) and inside in 31 (36%). Mean transvalvular gradient before discharge was significantly lower if the upper crown was above the degenerated bioprosthesis (13.7 ± 5.9 mm Hg vs. 19.5 ± 10.0 mm Hg; p = 0.001). However, a high position of the ACURATE neo resulted in embolization in 1 patient, conversion to open-heart surgery in 1, and need for reintervention due to transcatheter heart valve failure within the first 18 months of follow-up in 4. CONCLUSIONS: This early experience shows that a high implantation of the ACURATE neo with the upper crown above the stent posts of the degenerated bioprosthesis resulted in lower mean transvalvular gradients but a higher rate of malpositioning and early valve degeneration.

Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy. METHODS: In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346) and is ongoing but not recruiting. FINDINGS: Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6-5·0]) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% [upper 95% confidence limit 12·0%], p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference -1·3 to -12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group. INTERPRETATION: TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems. FUNDING: Boston Scientific (USA).

Transcatheter Valve SELECTion in Patients With Right Bundle Branch Block and Impact on Pacemaker Implantations.

OBJECTIVES: This study sought to evaluate the impact of the ACURATE neo (NEO) (Boston Scientific, Marlborough, Massachusetts) versus SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) on permanent pacemaker implantation (PPI) in patients with pre-existing right bundle branch block (RBBB) after transcatheter aortic valve replacement. BACKGROUND: Pre-existing RBBB is the strongest patient-related predictor for PPI after transcatheter aortic valve replacement. No comparison of newer-generation transcatheter heart valves with regard to PPI in these patients exists. METHODS: This multicenter registry includes 4,305 patients; 296 (6.9%) had pre-existent RBBB and no pacemaker at baseline and formed the study population. The primary endpoint was new PPI at 30 days. The association of NEO versus S3 with PPI was assessed using binary logistic regression analyses and inverse probability treatment weighting in a propensity-matched population. RESULTS: The 30-day PPI rate was 39.2%. The S3 and NEO were used in 66.9% and 33.1%, respectively. The NEO was associated with lower rates of PPI compared with the S3 (29.6% vs. 43.9%; p = 0.025; odds ratio [OR]: 0.54; 95% confidence interval [CI]: 0.32 to 0.89; p = 0.018), after multivariable adjustment (OR: 0.48; 95% CI: 0.26 to 0.86; p = 0.014), and in the inverse probability treatment weighting analysis (OR: 0.37; 95% CI: 0.25 to 0.55; p < 0.001). There was no difference in device failure (8.2% vs. 6.6%; p = 0.792) or in-hospital course. In the propensity-matched population, PPI rate was also lower in the NEO versus S3 (23.1% vs. 44.6%; p = 0.016; OR: 0.37; 95% CI: 0.17 to 0.78; p = 0.010), with no difference in device failure (9.2% vs. 6.2%; p = 0.742). CONCLUSIONS: In patients with RBBB, risk of PPI was significantly lower with the NEO compared with the S3, suggesting the possibility of a patient tailored transcatheter heart valve therapy.