High Device Success Research Articles

Meta-Analysis of Dedicated vs Off-Label Transcatheter Devices for Native Aortic Regurgitation.

Transcatheter aortic valve replacement (TAVR) for high surgical risk patients with severe native aortic regurgitation (AR) presents unique challenges. Dedicated devices such as the JenaValve (JenaValve Technology) and J-Valve (JC Medical Inc) show promising results in addressing these challenges. This study compares the safety and efficacy of dedicated vs off-label devices among high surgical risk patients with pure native AR. We systematically searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials through July 11, 2024, for studies on TAVR among patients with pure severe native AR. The primary endpoint was 30-day all-cause mortality. Secondary endpoints were device success, residual AR≥ moderate, valve embolization/migration, pacemaker implantation, reintervention, and all-cause mortality at 1 year. Summary estimates were constructed using a random effects model. A total of 34 studies encompassing 2,162 patients (mean age 75.4 ± 0.2, 42.8% women) were included in the meta-analysis. Patients undergoing TAVR with dedicated devices had a lower all-cause 30-day mortality rate (3% vs 9%; P< 0.01) and higher device success (93% vs 82%; P< 0.01) compared with off-label devices. The risk of AR≥ moderate (2% vs 5%; P=0.03), valve embolization/migration (2% vs 8%; P< 0.01), pacemaker implantation (11% vs 20%; P< 0.01), and reintervention (4% vs 10%; P< 0.01) at 30days and all-cause mortality at 1 year (6% vs 24%; P< 0.01) were lower in the dedicated device group. Dedicated TAVR devices for native AR show superior device success and reduced mortality, residual AR, and reintervention rates compared with off-label devices. These findings support the use of dedicated devices as a safer alternative for high-risk patients.

Decreasing pacemaker implantation rates with Evolut supra-annular transcatheter aortic valves in a large real-world registry

BackgroundPermanent pacemaker implantation (PPI) rates following transcatheter aortic valve replacement (TAVR) remain a concern. We assessed the PPI rates over time in patients implanted with an Evolut supra-annular, self-expanding transcatheter valve from the US STS/ACC TVT Registry. MethodsPatients who underwent TAVR with an Evolut R, Evolut PRO or Evolut PRO+ valve between July 2018 (Q3) and June 2021 (Q2) were included. PPI rates were reported by calendar quarter. In-hospital PPI rates were reported as proportions and 30-day rates as Kaplan-Meier estimates. A Cox regression model was used to determine potential predictors of a new PPI within 30 days of the TAVR procedure. ResultsFrom July 2018 to June 2021, 54,014 TAVR procedures were performed using Evolut valves. Mean age was 79.3 ± 8.8 years and 49.2 % were male. The 30-day PPI rate was 16.6 % in 2018 (Q3) and 10.8 % in 2021 (Q2, 34.9 % decrease, p < 0.001 for trend across all quarters). The in-hospital PPI rate decreased by 40.1 %; from 14.7 % in 2018 (Q3) to 8.8 % in 2021 (Q2) (p < 0.001 for trend across all quarters). Significant predictors of a new PPI within 30 days included a baseline conduction defect, history of atrial fibrillation, home oxygen, and diabetes mellitus. ConclusionFrom 2018 to 2021, TAVR with an Evolut transcatheter heart valve in over 50,000 patients showed a significant decreasing trend in the rates of in-hospital and 30-day PPI, representing the lowest rate of PPI in any large real-world registry of Evolut. During the same evaluated period, high device success and shorter length of stay was also observed.

Safety and Effectiveness of a Novel Microcatheter in Coronary Chronic Total Occlusions—The BIOMICS Study

BackgroundChronic total occlusion (CTO) remains the most complex anatomical subset of lesions in percutaneous coronary intervention (PCI), often requiring advanced techniques and technologies, including the use of microcatheters. MethodsThe BIOMICS study is a premarket first-in-human prospective, multicenter, open-label, single-arm trial investigating the safety and efficacy of a novel coronary microcatheter (BioMC, Biosensors International) in 100 patients with symptoms of ischemia undergoing elective CTO-PCI. The primary efficacy end point of the study was device success defined according to the CTO-ARC (Chronic Total Occlusion Academic Research Consortium) criteria namely the ability of the microcatheter to successfully facilitate placement of a guide wire beyond the occluded coronary segment. The primary safety end point was the incidence of in-hospital cardiac death or myocardial infarction at hospital discharge. ResultsHundred patients were recruited between March 2022 and January 2023. The primary efficacy end point was achieved in 75% of patients (95% CI, 65.3%-83.1%; P < .0001 for superiority compared to the prespecified performance goal of 54%). The primary safety end point of in-hospital cardiac death or myocardial infarction was observed in 2% of the patients. There were no study device-related coronary perforations or device failures. ConclusionsThe use of a novel coronary microcatheter during CTO-PCI was associated with a high device success and an excellent safety profile.

Clinical and structural outcomes of neocommissural alignment in transaxillary and transcarotid transcatheter aortic valve implantation with a self-expandable transcatheter heart valve

ObjectivesThis study analyzes neocommissural alignment and the clinical and hemodynamic outcomes after transaxillary and transcarotid implantation of the Acurate neo2 transcatheter heart valve. MethodsWe performed a retrospective, single-center analysis of early outcomes after transaxillary and transcarotid implantation of the Acurate neo2 transcatheter heart valve. Primary outcomes were neocommisural alignment, in-hospital mortality, and valve hemodynamic performance. Commissural alignment between native and transcatheter heart valves was assessed by transesophageal echocardiogram before and after the procedure. ResultsBetween October 2021 and November 2022, 40 consecutive patients were treated with the Acurate neo2 through a transaxillary or transcarotid approach. Access was achieved via the left subclavian artery in 30 cases and the left common carotid artery in 10 cases, with a mean vessel diameter of 6.7 mm. Implants most commonly used were size M (37.5%), L (35%), and S (27.5%). On the basis of transesophageal echocardiogram analysis, there was no significant difference in mean commissural orientation between native (mean, 65.1°; SD, 41.3°) and neocommissures (mean, 64°; SD, 44.1°) (P = .661). Mean commissural orientation did not significantly differ between native and neocommissures (P = .661). Optimal alignment or mild commissural misalignment was achieved in 99.5% of cases. There were no cases of severe commissural misalignment. Postprocedural mean values for peak and mean gradients were 12.7 mm Hg and 5.2 mm Hg, respectively. There were 2 cases of moderate paravalvular leak and 4 cases of mild paravalvular leak. ConclusionsThis patient-specific technique for transaxillary and transcarotid insertion of the Acurate neo2 delivery system prevents implantations with more than mild commissural misalignment and with a high device success rate.

Transcatheter aortic valve implantation in patients with extra-small aortic annuli.

A small aortic annulus (SAA) is a risk factor for prosthesis-patient mismatch (PPM) in patients undergoing surgical or transcatheter aortic valve implantation (TAVI). Data regarding TAVI in patients with extra-SAA are scarce. The aim of this study was to analyse the safety and efficacy of TAVI in patients with extra-SAA. A multicentre registry study including patients with extra-SAA (defined as an aortic annulus area <280 mm2 and/or perimeter <60 mm) undergoing TAVI was established. Primary efficacy and safety endpoints were defined as device success and early safety at 30 days, respectively, using the Valve Academic Research Consortium-3 criteria, and were analysed according to valve type: self-expanding (SEV) versus balloon-expandable (BEV). A total of 150 patients were included, of which 139 (92.7%) were women, and 110 (73.3%) received an SEV. Intraprocedural technical success was 91.3%, with a higher rate in patients receiving an SEV (96.4% vs 77.5% with BEV; p=0.001). Overall, 30-day device success was 81.3%, (85.5% with SEV vs 70.0% with BEV; p=0.032). The primary safety endpoint occurred in 72.0% of patients (with no difference between groups; p=0.118). Severe PPM occurred in 12% (9.0% with SEV and 24.0% with BEV; p=0.039), with no impact on all-cause mortality, cardiovascular mortality, or heart failure readmission at 2-year follow-up. TAVI is a safe and feasible treatment in patients with extra-SAA with a high rate of technical success. The use of SEV was associated with a lower rate of intraprocedural complications, higher device success at 30 days and better haemodynamic outcomes compared to BEV.

Transcatheter valvular therapies in patients with left ventricular assist devices.

Aortic, mitral and tricuspid valve regurgitation are commonly encountered in patients with continuous-flow left ventricular assist devices (CF-LVADs). These valvular heart conditions either develop prior to CF-LVAD implantation or are induced by the pump itself. They can all have significant detrimental effects on patients' survival and quality of life. With the improved durability of CF-LVADs and the overall rise in their volume of implants, an increasing number of patients will likely require a valvular heart intervention at some point during CF-LVAD therapy. However, these patients are often considered poor reoperative candidates. In this context, percutaneous approaches have emerged as an attractive "off-label" option for this patient population. Recent data show promising results, with high device success rates and rapid symptomatic improvements. However, the occurrence of distinct complications such as device migration, valve thrombosis or hemolysis remain of concern. In this review, we will present the pathophysiology of valvular heart disease in the setting of CF-LVAD support to help us understand the underlying rationale of these potential complications. We will then outline the current recommendations for the management of valvular heart disease in patients with CF-LVAD and discuss their limitations. Lastly, we will summarize the evidence related to transcatheter heart valve interventions in this patient population.

Study Level Meta-Analysis of Transcatheter Aortic Valve Implantation With the ACURATE neo Self-Expanding Transcatheter Heart Valve.

The ACURATE neo transcatheter aortic valve is a self-expanding device. Several studies have investigated safety and efficacy, but meta-analysis and pooled data are lacking. We aimed to provide a comprehensive systematic review and meta-analysis on the clinical outcomes of transcatheter aortic valve implantation with the ACURATE neo valve. A systematic literature search for eligible records was conducted. The primary endpoint was device success as designated by Valve Academic Research Consortium-2 criteria. The secondary endpoints (time frame: 30 days) were all-cause mortality, stroke, myocardial infarction, need for new permanent pacemaker, major vascular complications, major bleeding, acute kidney injury stage II or III, and paravalvular regurgitation grade moderate or severe (II or III). Our search yielded a total of 355 records, 20 of those (n = 5858 ACURATE neo receivers) were included in our meta-analysis. Device success was achieved in 94.5% (95% confidence interval [CI], 91.4-96.5%) of the patients. The 30-day all-cause mortality incidence proportion was 1.8% (95% CI, 1.3-2.4%). New pacemaker implantation was required in 7.7% (95% CI, 6.4-9.2%) of the patients, stroke occurred in 1.9% (95% CI, 1.6-2.3%), myocardial infarction in 0.5% (95% CI, 0.3-0.7%), major bleeding in 5.0% (95% CI, 3.9-6.5%), major vascular complication in 5.6% (95% CI, 4.0-7.8%), acute kidney injury stage ≥2 in 2.5% (95% CI, 1.8-3.4%), and paravalvular leak grade ≥moderate was observed in 4.3% (95% CI, 3.0-6.2%). Balloon predilatation and postdilatation incidence was 93.9% (95% CI, 87.0-97.3%) and 43.2% (95% CI, 37.9-48.6%), respectively. ACURATE neo appears to be safe and effective in our analysis with high device success incidence, low mortality, and low new pacemaker implantations.

Outcomes of Redo Transcatheter Aortic Valve Replacement According to the Initial and Subsequent Valve Type

As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome. The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV. Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n=115] vs sTAV [n=106]) and subsequent valve type (bTAV [n=130] vs sTAV [n=91]). Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P< 0.001), with smaller effective orifice area (1.0 ± 0.7cm2 vs 1.3 ± 0.8cm2; P=0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P< 0.001). Mortality at 30days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P=0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P=0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P=0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P=0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P=0.045), primarily because of lower residual gradients (10.3mmHg [8.9-11.7 mmHg] vs 15.2mmHg [13.2-17.1 mmHg]; P< 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P=0.176). In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR.

Efficacy and Safety of a Polytetrafluoroethylene Membrane Wrapped a Single Layer of Sirolimus-Eluting Stent in a Porcine Coronary Perforation Model.

Covered stents are effective in treating coronary artery perforation (CAP), however, the high rate of immediate device deployment failure and in-stent restenosis have limited the application of the currently covered stents. We designed a covered stent system consisting of a single layer of drug-eluting stent and a layer of polytetrafluoroethylene (PTFE) membrane wrapped at the outer layer of the stent. The immediate sealing effect of our novel covered stent was observed by using an Ellis type III CAP model. The device's success was defined as its ability to seal the perforation, assessed by visual estimation and final thrombolysis in myocardial infarction (TIMI) 3 flow. The antiproliferative effect was evaluated in 12 swine, which were randomly assigned to treatment (sirolimus-eluting covered stents) and control (bare metal covered stents) groups. Coronary angiography and optical coherence tomography (OCT) were performed at index procedure, 1- and 6-month after stent implantation. All swine were sacrificed for histopathological analyses at 6-month. The device success rate was 100%. All swine were alive at 6-month follow-up. At 1-month, the treatment group had a larger minimal luminal diameter (MLD) (1.89 0.29 mm vs. 0.63 0.65 mm, p = 0.004) and lower late luminal loss (LLL) (0.47 0.15 mm vs. 1.80 0.34 mm, p 0.001) compared with control group. At 6-month, the treatment group had a numerically higher MLD (0.94 0.75 mm vs. 0.26 0.46 mm; p = 0.230) and lower LLL (1.43 0.85 mm vs. 2.17 0.28 mm; p = 0.215) compared with control group. Histological analyses revealed the mean plaque area was lower in the treatment group (2.99 0.81 vs. 4.29 0.77 , p = 0.035) than in the control group. No in-stent thrombosis was observed in either group. In the porcine model of coronary perforation, the PTFE membrane wrapped sirolimus-eluting stent showed a high device success rate in sealing the perforation. The drug-eluting covered stent demonstrated a relatively sustained antiproliferative effect up to 6 months post-implantation.

C31 UPDATE ON SUPRA–ANNULAR SIZING OF TRANSCATHETER AORTIC VALVE PROSTHESES IN RAPHE–TYPE BICUSPID AORTIC VALVE DISEASE ACCORDING TO THE LIRA METHOD

Abstract Aims Recent evidences have shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe–level, known as the LIRA (Level of Implantation at the RAphe) plane. A novel supra–annular sizing method based on the measurement of the perimeter at the raphe–level (LIRA–method) was shown to be safe and effective in 20 consecutive BAV patients with severe aortic stenosis. The purpose of this study was to confirm the safety and the efficacy of the LIRA method in a larger study population. Methods the LIRA plane method was applied to all consecutive patients with raphe–type BAV disease between November 2018 to October 2021 in our centre. We prospectively sized TAVI prosthesis according to the manufacture recommendations on the basis of baseline CT scan perimeters at the LIRA plane. Post–procedural device success, defined according to Valve Academic Research Consortium–2 (VARC–2) criteria, was evaluated in the overall cohort. Results 50 patients were identified as having a raphe–type BAV disease at pre–TAVI CT scans. Mean patient age was 80 ± 6.2 years. Three different BAV anatomies (47 patients with BAV type 1 and 3 patients with BAV type 2) were implanted with different types of TAVI prostheses (28 Acurate Neo/Neo 2, 21 Core Valve Evolut R/Pro,1 Lotus) sized prospectively according to the LIRA plane method. In all patients, there was a significant discrepancy between LIRA and virtual basal ring (VBR) (mean perimeter LIRA 73.1 ± 8.3 mm vs mean perimeter VBR 81.5 ± 6.6 mm; p &amp;lt; 0.001). The median prosthesis size was 26 mm (23–27). Pre–dilatation was frequently performed (88%) with a median balloon size of 20 mm (20–23), whereas post–dilatation was applied in 26% of the cases with a median balloon size of 23 mm (22–24). The LIRA plane method appeared to be highly successful (100% VARC–2 device success) with no procedural mortality, no valve migration, residual trivial/mild paravalvular leak with no cases of moderate–severe regurgitation and no cases of mean gradient &amp;gt;20 mmHg pre–discharge. The rate of new pacemaker implantation was 10%. Conclusions Supra–annular sizing according to the LIRA plane method confirmed to be safe with a high device success in a larger study population. The application of the LIRA plane method might optimize TAVI prosthesis sizing in patients with raphe–type BAV disease.

Propensity-matched comparison of balloon-expandable and self-expanding valves for transcatheter aortic valve replacement in a Chinese population.

BackgroundBalloon-expandable valves (BEV) and self-expanding valves (SEV) for transcatheter aortic valve replacement (TAVR) have shown promising results in Western populations. Herein, we comparatively evaluated their hemodynamics and early clinical outcomes in a Chinese population.MethodsOne hundred seventy-eight patients with symptomatic aortic stenosis who had undergone transfemoral TAVR using SEV (n=153; Venus-A, 97; VitaFlow, 56) or BEV (n=25; Sapien3) from September 2020 to April 2021 were retrospectively enrolled, and 25 pairs were propensity-score matched for 10 baseline variables. The primary study outcomes were aortic valve hemodynamics and postoperative complications at discharge and 3-month follow-up.ResultsTAVR was successful in all patients. Compared with SEV group, the BEV group had similarly distributed baseline characteristics, procedural time, hospital stay, new pacemaker implantation, and paravalvular regurgitation grade. We also observed that the BEV group had lower rates of balloon pre-dilation (60% vs. 92%, P=0.018), post-dilation (0 vs. 20%, P=0.050) and second valve implantation (0 vs. 24%, P=0.022); higher mean transaortic gradient (14.3±6.1 vs. 10.8±4.9, P=0.030) and proportion of patients with elevated gradients (20% vs. 0, P=0.050) at discharge; and similar rehospitalization, mean transaortic gradient, new pacemaker implantation, and paravalvular regurgitation grade than the SEV group at the 3-month follow-up. There were no deaths in either group. However, the proportion of patients with elevated gradients in SEV group was higher at 3 months than before discharge (24% vs. 0, P=0.022).ConclusionsBEV and SEV for transfemoral TAVR appear comparably safe and effective, with high device success and favorable 3-month clinical outcomes. However, the transaortic gradient and new pacemaker implantation in the SEV group increased during follow-up, warranting larger studies with longer-term follow-up.

467 Update on supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease according to the LIRA method

Abstract Aims Transcatheter Aortic Valve Replacement (TAVR) in patients with bicuspid aortic valve (BAV) still represents a challenge due to the peculiar anatomy and the lack of consensus for the optimal CT scan sizing method for prosthesis selection. Recent evidences have shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe-level, known as the LIRA (Level of Implantation at the RAphe) plane. Furthermore, a novel supra-annular sizing method based on the measurement of the perimeter at the raphe-level (LIRA-method) was shown to be safe and effective in 20 consecutive BAV patients with severe aortic stenosis. The purpose of this study was to confirm the safety and the efficacy of the LIRA method in a larger study population. Methods and results the LIRA plane method was applied to all consecutive patients with raphe-type BAV disease between November 2018 to September 2021 in our centre. We prospectively sized TAVI prosthesis according to the manufacture recommendations on the basis of baseline CT scan perimeters at the LIRA plane. Post-procedural device success, defined according to Valve Academic Research Consortium-2 (VARC-2) criteria, was evaluated in the overall cohort. Forty-four patients were identified as having a raphe-type BAV disease at pre-TAVI CT scans. Mean patient age was 80 ± 6.2 years and 74% were males; median Society of Thoracic Surgeons (STS) predicted risk of mortality score was 4.3 (3.0–6.5). Three different BAV anatomies (36 patients with BAV type 1 with calcific raphe, 5 patients with BAV type 1 with fibrotic raphe, and 3 patients with BAV type 2) were implanted with different types of TAVI prostheses (6 Acurate Neo 2,16 Acurate Neo, 21 Core Valve Evolut R/Pro , 1 Lotus) sized prospectively according to the LIRA plane method. In all patients, there was a significant discrepancy between LIRA and virtual basal ring (VBR) measurements with LIRA plane perimeter smaller than VBR perimeter (mean perimeter LIRA 73.1 ± 8.3 mm vs. mean perimeter VBR 81.5 ± 6.6 mm; P &amp;lt; 0.001). The prostheses were sized according to the manufacture recommendations on the basis of the LIRA plane perimeter (diameter prosthesis implanted/diameter prosthesis according to LIRA plane = 1) (DPI/DP LIRA = 1) and significantly downsized according to the VBR perimeter (DPI/DP VBR 0.89; P &amp;lt; 0.001). The median prosthesis size was 25 mm (23–27). Pre-dilatation was frequently performed (86%) with a median balloon size of 20 mm (18–22), whereas post-dilatation was applied in 27% of the cases with a median balloon size of 23 mm (20–26). The LIRA plane method appeared to be highly successful (100% VARC-2 device success) with no procedural mortality, no valve migration, residual trivial/mild paravalvular leak with no cases of moderate-severe regurgitation and low transprosthetic gradient (residual mean gradient of 8.3 ± 3.5 mmHg) with no cases of mean gradient &amp;gt;20 mmHg pre-discharge. The rate of new pacemaker implantation was 9%. Conclusions Supra-annular sizing according to the LIRA plane method confirmed to be safe with a high device success in a larger study population. The application of the LIRA plane method might optimize TAVI prosthesis sizing in patients with raphe-type BAV disease.

Abstract 13096: The Impact of Left Ventricular Outflow Tract Calcium on Hemodynamics and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement With a Contemporary Self-Expanding Valve

Introduction: Left ventricular outflow tract (LVOT) calcium remains a challenge for transcatheter aortic valve replacement (TAVR). Initial data suggests that self-expanding transcatheter heart valve (THV) confer a lower risk. Data on contemporary self-expanding THVs are lacking. We report the results of the CoreValve Evolut Pro Prospective Registry (EPROMPT), which sought to evaluate the real-world performance of the CoreValve Evolut PRO THV in a multi-center prospective observational registry. Hypothesis: We hypothesized that the CoreValve Evolut PRO THV would perform well across the entire spectrum of LVOT calcium. Methods: The EPROMPT registry (NCT03423459) examined patients across the entire surgical risk spectrum who underwent TAVR using the CoreValve Evolut PRO/PRO+ THV system. Patients were dichotomized based on the degree of their LVOT calcium (none/mild vs. moderate/severe). Patients were followed with 30-day clinical assessment and echocardiography. Results: Of the 238 patients included, 151 (63.4%) had CT-defined none/mild LVOT calcium and 87 (36.6%) had moderate/severe LVOT calcium prior to TAVR. Device success was numerically lower in patients with moderate/severe LVOT calcium (98.0% vs. 94.3%; p=0.121). Acute annular rupture occurred in two patients, one with mild and one with severe LVOT calcium. Rates of stroke were very low in both cohorts, with a trend towards more stroke in the moderate/severe LVOT calcium cohort (in-hospital: 2.0% vs. 4.6%; p=0.251 and 30-day: 2.1% vs. 4.9%; p=0.244). Patients with none/mild LVOT calcium saw higher rates of PPM implantation in-hospital (21.2% vs. 9.2%; p=0.017) with a trend at 30 days (22.2% vs. 13.4%; p=0.105). At 30 days there was a trend towards higher rates of &gt;mild PVL in patients with moderate/severe LVOT calcium (1.3% vs. 3.4%; p=0.271). Mean gradients were low and similar in both cohorts (in-hospital: 8.6 vs. 8.2mmHg; p=0.663 and 30 day: 7.6 vs. 7.7mmHg; p=0.797). Conclusions: The presence of and degree of LVOT calcium did not significantly impact outcomes using the CoreValve Evolut PRO/PRO+ THV with high device success, excellent clinical outcomes, and hemodynamics.

Short midline catheters: High success rates for antibiotic therapy in children with cystic fibrosis.

Short midline catheter use in paediatric populations appears to be increasing, however data on success rates and efficacy are sparse. This study aims to describe the success rate when midline venous catheters are employed as a single device for intravenous antibiotic therapy in paediatric patients with cystic fibrosis. A retrospective cohort study was performed in a single institution, retrieving electronic medical record data from July 2017 through March 2020. The primary outcome was device success, defined as a catheter that remained functional until the end of antibiotic therapy. Reasons for device failure were categorized in a standard fashion. Primary outcome data were available for 116 catheter insertions, involving 49 patients and 55 proceduralists. The success rate was 84% (n = 98). Median age at insertion was 15 years (range 4-19) and median weight 52 kg (13-81). Soft, polyether block amide, Arrow® Seldinger Arterial Catheters were employed. Only 16 patients (14%) required general anaesthesia. Median time to failure was 6 days, and median time to successful completion of treatment was 13 days. Six of 18 failures occurred within 48 h and were likely insertion complications. The most common reasons for device failure were occlusion, extravasation, phlebitis and dislodgement. More than half of patients (56%) received antibiotic therapy at home. There is a high single device success rate when inserting short midlines for 13-day intravenous pulmonary antibiotic therapy in children with cystic fibrosis. These results should be confirmed with a prospective study.

Transcatheter Aortic Valve Implantation During the COVID-19 Pandemic

Transcatheter aortic valve implantation (TAVI) outcomes during the coronavirus disease 2019 (COVID-19) pandemic have not been fully evaluated and some structural programs in the world have been suspended during this period. We sought to evaluate and compare clinical outcomes in patients undergoing TAVI in pandemic versus nonpandemic era. In a single center, we compared 198 TAVI patients performed during 2019 to 59 patients performed during the COVID-19 pandemic period (March 1st to June 30th, 2020). Primary outcome was procedural success according to VARC criteria and 30-day mortality rates. VARC-defined procedural success was high in both groups (93.3% vs 96.6%; p = 0.53). There were no differences in any vascular complications (26% vs 19%; p = 0.3), permanent pacemaker implantation (11.8% vs 15.3%; p = 0.63), and length of hospital stay (5.2 vs 4.2 days; p = 0.29). Thirty-day mortality was similar (3% vs 3.4%; p = 1.0). We had no documented COVID-19 disease in our patients during follow up. In conclusion, TAVI procedures can be performed effectively and safely during the COVID-9 pandemic, using a minimalist approach, early discharge, and by maintaining proper use of personal protective equipment.

Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis

The outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic valve stenosis have not been studied in a large scale, multicentered, prospective fashion. To evaluate the procedural safety, efficacy, and 30-day outcomes of TAVR in patients with bicuspid aortic stenosis at low surgical risk. The Low Risk Bicuspid Study is a prospective, single-arm trial study with inclusion/exclusion criteria developed from the Evolut Low Risk Randomized Trial. Follow-up is planned for 10 years. Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement. Patients underwent attempted implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements. The prespecified primary end point was the incidence of all-cause mortality or disabling stroke at 30 days. The prespecified primary efficacy end point was device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure. A total of 150 patients underwent an attempted implant. Baseline characteristics include mean age of 70.3 (5.5) years, 48.0% female (n = 72), and a mean Society of Thoracic Surgeons score of 1.4 (0.6%). Most patients (136; 90.7%) had Sievers type I valve morphology. The incidence of all-cause mortality or disabling stroke was 1.3% (95% CI, 0.3%-5.3%) at 30 days. The device success rate was 95.3% (95% CI, 90.5%-98.1%). At 30 days, the mean (SD) AV gradient was 7.6 (3.7) mm Hg and effective orifice area was 2.3 (0.7) cm2. A new permanent pacemaker was implanted in 22 patients (15.1%). No patients had greater than mild paravalvular leak. Transcatheter aortic valve replacement in low-surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of death and stroke and high device success rate. ClinicalTrials.gov Identifier: NCT03635424.

Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry

To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self-expanding and balloon-expandable transcatheter heart valves (THVs) in patients with a small aortic annulus. Few studies have directly compared TAVR outcomes using third-generation THVs, focusing on patients with small aortic annuli. In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third-generation THVs. Propensity score matching was used to adjust baseline clinical characteristics. The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p=0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0-11.9] vs. 12.0 [IQR: 9.9-16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01-1.46] vs. 1.08 [IQR: 0.90-1.28] cm2 /m2 , p < .001}. However, no significant differences were reported in the incidence of severe prosthesis-patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all-cause mortality (log-lank test, p=.81). TAVR for patients with a small annulus using third-generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all-cause mortality at 1 year was similar between both groups.

Evolut Self-Expanding Transcatheter Aortic Valve Replacement in Patients with Extremely Horizontal Aorta (Aortic Root Angle ≥ 70°).

Because of its rigidity and non-steerability, the presence of a horizontal aortic root poses a major anatomical issue during transcatheter aortic valve replacement (TAVR) with Evolut self-expanding valve. Previous studies have elucidated the difficulties of coaxial implantation of the self-expanding valve in patients with horizontal aorta, often resulting in increased complications and a lower device success rate. To date, most patients with extremely horizontal aorta (aortic root angle ≥ 70°) have been excluded from major TAVR clinical trials. Therefore, available data on TAVR with Evolut in this challenging anatomy are limited, and standardized treatment strategies and clinical results remain unknown. Herein, we report a clinical case series of TAVR with Evolut in extremely horizontal aorta. Among seven patients (aged 80-92 years; STS score, 12.6% ± 7.9%) who underwent TAVR with Evolut system, aortic root angle ranged from 71° to 83° (mean, 75.1°± 4.5°). All patients achieved device success with dedicated strategies and were clinically stable at 3-month follow-up. None of the patients had more than mild paravalvular leakage (PVL) at any point during follow-up.Complications in three patients included complete atrioventricular block requiring a permanent pacemaker implantation, cerebral infarction because of atrial fibrillation 3 days after TAVR, and cardiac tamponade requiring pericardiocentesis. In this case series, Evolut self-expanding TAVR in extremely horizontal aorta was effective and feasible with a high device success rate. Based on anatomical features, some dedicated strategies majorly contribute to the success of this procedure. Large-scale multicenter studies are required to confirm our findings.

Supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease: the LIRA method

BackgroundRecent evidence shows that THV prostheses anchoring occurs at the raphe-level, known as LIRA plane, in raphe-type bicuspid aortic valve (BAV) disease. The purpose of this study was to evaluate the application of a novel supra-annular sizing method, known as Level of Implantation at the RAphe (LIRA) method, to optimize transcatheter heart valve (THV) prosthesis sizing in raphe-type BAV disease. Methods and resultsThe LIRA method was applied to all consecutive patients with raphe-type BAV disease between November 2018 to January 2020 in our centre. THV prostheses were sized on the basis of baseline CT scan perimeters at the LIRA plane and at the virtual basal ring. In case of discrepancy between the two plane measurements, the plane with the smallest perimeter was considered the reference for prosthesis sizing. Post-procedural device success, defined according to Valve Academic Research Consortium–2 (VARC-2) criteria, was evaluated in the overall cohort. 20 patients (mean patient age 81 ± 5.4 years, 70% males) were identified as having a raphe-type BAV disease at pre-procedural CT scans and were implanted with different types of THV prostheses. The LIRA plane method appeared to be highly successful (100% VARC-2 device success) with no procedural mortality, no valve migration, no moderate-severe paravalvular leak and low transprosthetic gradient (residual mean gradient of 8.2 ± 2.9 mm Hg). ConclusionsSupra-annular sizing according to the LIRA method appeared to be safe with a high device success. The application of the LIRA method might optimize THV prosthesis sizing in patients with raphe-type BAV disease.

Transcatheter Aortic Valve Replacement With Next-Generation Self-Expanding Devices: A Multicenter, Retrospective, Propensity-Matched Comparison of Evolut PRO Versus Acurate neo Transcatheter Heart Valves

ObjectivesThe aim of this study was to compare transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) and Evolut PRO (PRO) devices. BackgroundThe NEO and PRO bioprostheses are 2 next-generation self-expanding devices developed for TAVR. MethodsThe NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity score matching resulted in 251 pairs. Pre-discharge and 30-day Valve Academic Research Consortium (VARC)–2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for propensity score quintiles. ResultsA total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After propensity score matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation. ConclusionsIn this multicenter registry, transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes. After adjusting for potential confounders, short-term outcomes were similar between the devices.