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We sought to synthesize the available evidence regarding safety and efficacy of intermittent levosimendan (LEVO) infusions in ambulatory patients with end-stage heart failure (HF). Safety and efficacy of ambulatory intermittent LEVO infusion in patients with end-stage HF are yet not established. We systematically searched MEDLINE, EMBASE, SCOPUS, Web of Science, and Cochrane databases, from inception to January 30, 2021 for studies reporting outcome of adult ambulatory patients with end-stage HF treated with intermittent LEVO infusion. Fifteen studies (8 randomized and 7 observational) comprised 984 patients (LEVO [N = 727] and controls [N = 257]) met the inclusion criteria. LEVO was associated with improved New York Heart Association (NYHA) functional class (weighted mean difference [WMD] −1.04, 95%CI: −1.70 to −0.38, p I2 = 93%), improved left ventricular (LV) ejection fraction (WMD 4.0%, 95%CI: 2.8% to 5.3%, p I2 = 9%), and reduced BNP levels (WMD −549 pg/mL, 95%CI −866 to −233, p I2 = 66%). All-cause death was not different (RR 0.65, 95%CI: 0.38 to 1.093, p = 0.10, 6 studies, I2 = 0), but cardiovascular death was lower on LEVO (RR 0.34, 95%CI: 0.13 to 0.87, p = 0.02, 3 studies, I2 = 0) compared to controls. Furthermore, health-related quality of life (HRQoL) was improved alongside with reduced LV size following LEVO infusions. Major adverse events were not different between LEVO and placebo. In conclusion, intermittent LEVO infusions in ambulatory patients with end-stage HF is associated with less frequent cardiovascular death alongside with improved NYHA class, quality of life, BNP levels, and LV function. However, the current evidence is limited by heterogeneous and relatively small studies.

Background: The Xeltis biorestorative transcatheter heart valve (BTHV) leaflets are made from an electrospun bioabsorbable supramolecular polycarbonate-urethane and are mounted on a self-expanding nitinol frame. The acute haemodynamic performance of this BTHV was favourable. Aims: We sought to demonstrate the preclinical feasibility of a novel BTHV by evaluating the haemodynamic performances of five pilot valve designs up to 12 months in a chronic ovine model. Methods: Five design iterations (A, B, B', C, and D) of the BTHV were transapically implanted in 46 sheep; chronic data were available in 39 animals. Assessments were performed at implantation, 3, 6, and 12 months including quantitative aortography, echocardiography, and histology. Results: At 12 months, greater than or equal to moderate AR on echocardiography was seen in 0%, 100%, 33.3%, 100%, and 0% in the iterations A, B, B', C, and D, respectively. Furthermore, transprosthetic mean gradients on echocardiography were 10.0±2.8 mmHg, 19.0±1.0 mmHg, 8.0±1.7 mmHg, 26.8±2.4 mmHg, and 11.2±4.1 mmHg, and effective orifice area was 0.7±0.3 cm2, 1.1±0.3 cm2, 1.5±1.0 cm2, 1.5±0.6 cm2, and 1.0±0.4 cm2 in the iterations A, B, B', C, and D, respectively. On pathological evaluation, the iteration D demonstrated generally intact leaflets and advanced tissue coverage, while different degrees of structural deterioration were observed in the other design iterations. Conclusions: Several leaflet material iterations were compared for the potential to demonstrate endogenous tissue restoration in an aortic valve in vivo. The most promising iteration showed intact leaflets and acceptable haemodynamic performance at 12 months, illustrating the potential of the BTHV.

Background Appropriate size selection of transcatheter heart valves (THVs) is fundamental to reduce transcatheter aortic valve implantation (TAVI) related complications, particularly paravalvular aortic regurgitation, new permanent pacemaker implantation, and annular rupture. We sought to investigate the frequency of operator selection of intermediate-size balloon-expandable Myval THVs (Meril Life Sciences Pvt. Ltd., India) for TAVI in a real-world dataset. Methods In this retrospective survey of patients treated with TAVI using the Myval THV, 20, 23, 26, and 29 mm are conventional-size THVs, 21.5, 24.5 and 27.5 mm are intermediate-size THVs, and 30.5 and 32 mm are extra-large THVs. Operator size selection for implantation was based on multislice computed tomography (MSCT) derived aortic-root dimensions. Results A total of 1115 patients underwent Myval THV implantation in 27 countries worldwide. The Myval intermediate-size THVs were used in 468 (42.0%) patients. MSCT data were available in 562 patients. There was no statistical difference between the Intermediate/Upsized and Appropriately sized groups or Intermediate/Downsized and Appropriately sized groups in terms of different variables measured with MSCT except for annular dimensions and degree of calcification. Conclusions Intermediate-size Myval balloon-expandable THVs are used in nearly half of all cases in contemporary real-world TAVI practice, addressing the unmet need of TAVI operators for a more calibrated THV choice. Our hypothesis should be tested in randomized prospective studies currently initiated in Europe, including clinical outcomes of patients treated with both conventional- and intermediate-size THVs.

This study aimed to validate a dedicated software for quantitative videodensitometric angiographic assessment of mitral regurgitation (QMR).Quantitative videodensitometric aortography of aortic regurgitation using the time-density principle is a well-documented technique, but the angiographic assessment of mitral regurgitation (MR) remains at best semi-quantitative and operator dependent.Fourteen sheep underwent surgical mitral valve replacement using 2 different prostheses. Pre-sacrifice left ventriculograms were used to assess MR fraction (MRF) using QMR and MR volume (MRV). In an independent core lab, the CAAS QMR 0.1 was used for QMR analysis. In vitro MRF and MRV were assessed in a mock circulation at a comparable cardiac output to the in vivo one by thermodilution. The correlations and agreements of in vitro and in vivo MRF, MRV, and interobserver reproducibility for QMR analysis were assessed using the averaged cardiac cycles (CCs).In vivo derived MRF by QMR strongly correlated with in vitro derived MRF, regardless of the number of the CCs analyzed (best correlation: 3 CCs y = 0.446 + 0.994x; R = 0.784; p =0.002). The mean absolute difference between in vitro derived MRF and in vivo derived MRF from 3 CCs was 0.01 ± 4.2% on Bland-Altman analysis. In vitro MRV and in vivo MRV from 3 CCs were very strongly correlated (y = 0.196 + 1.255x; R = 0.839; p 0.001). The mean absolute difference between in vitro MRV and in vivo MRV from 3 CCs was -1.4 ± 1.9 ml. There were very strong correlations of in vivo MRF between 2 independent analysts, regardless of the number of the CCs.In vivo MRF using the novel software is feasible, accurate, and highly reproducible. These promising results have led us to initiate the first human feasibility study comprising patients undergoing percutaneous mitral valve edge-to-edge repair.

Objectives The aim of this study was to investigate the online assessment feasibility of aortography using videodensitometry in the catheterization laboratory during transcatheter aortic v...

OBJECTIVES Data on the impact and course of uncorrected tricuspid regurgitation (TR) during left ventricular assist device (LVAD) implantation are scarce and inconsistent. This study explores the clinical impact and natural course of uncorrected TR in patients after LVAD implantation. METHODS The European Registry for Patients with Mechanical Circulatory Support was used to identify adult patients with LVAD implants without concomitant tricuspid valve surgery. A mediation model was developed to assess the association of TR with 30-day mortality via other risk factors. Generalized mixed models were used to model the course of post-LVAD TR. Joint models were used to perform sensitivity analyses. RESULTS A total of 2496 procedures were included (median age: 56 years; men: 83%). TR was not directly associated with higher 30-day mortality, but mediation analyses suggested an indirect association via preoperative elevated right atrial pressure and creatinine (P = 0.035) and bilirubin (P = 0.027) levels. Post-LVAD TR was also associated with increased late mortality [hazard ratio 1.16 (1.06–1.3); P = 0.001]. On average, uncorrected TR diminished after LVAD implantation. The probability of having moderate-to-severe TR immediately after an implant in patients with none-to-mild TR pre-LVAD was 10%; in patients with moderate-to-severe TR pre-LVAD, it was 35% and continued to decrease in patients with moderate-to-severe TR pre-LVAD, regardless of pre-LVAD right ventricular failure or pulmonary hypertension. CONCLUSIONS Uncorrected TR pre-LVAD and post-LVAD is associated with increased early and late mortality. Nevertheless, on average, TR diminishes progressively without intervention after an LVAD implant. Therefore, these data suggest that patient selection for concomitant tricuspid valve surgery should not be based solely on TR grade.

Objectives: The aim of this study was to assess acute regurgitation following transcatheter aortic valve replacement, comparing different implanted transcatheter heart valves. Background: Regurgitation following transcatheter aortic valve replacement influences all-cause mortality. Thus far, no quantitative comparison of regurgitation among multiple commercially available transcatheter heart valves has been performed. Methods: Aortograms from a multicenter cohort of consecutive 3,976 transcatheter aortic valve replacements were evaluated in this pooled analysis. A total of 2,258 (58.3%) were considered analyzable by an independent academic core laboratory using video densitometry. Results of quantitative regurgitation are shown as percentages. The valves evaluated were the ACURATE (n = 115), Centera (n = 11), CoreValve (n = 532), Direct Flow Medical (n = 21), Evolut PRO (n = 95), Evolut R (n = 295), Inovare (n = 4), Lotus (n = 546), Lotus Edge (n = 3), SAPIEN XT (n = 239), and SAPIEN 3 (n = 397). For the main analysis, only valves with more than 50 procedures (7 types) were used. Results: The Lotus valve had the lowest mean regurgitation (3.5 ± 4.4%), followed by Evolut PRO (7.4 ± 6.5%), SAPIEN 3 (7.6 ± 7.1%), Evolut R (7.9 ± 7.4%), SAPIEN XT (8.8 ± 7.5%), ACURATE (9.6 ± 9.2%) and CoreValve (13.7 ± 10.7%) (analysis of variance p < 0.001). The only valves that statistically differed from all their counterparts were Lotus (as the lowest regurgitation) and CoreValve (the highest). The proportion of patients presenting with moderate or severe regurgitation followed the same ranking order: Lotus (2.2%), Evolut PRO (5.3%), SAPIEN 3 (8.3%), Evolut R (8.8%), SAPIEN XT (10.9%), ACURATE (11.3%), and CoreValve (30.1%) (chi-square p < 0.001). Conclusions: In this pooled analysis stemming from daily clinical practice, the Lotus valve was shown to have the best immediate sealing. This analysis reflects the objective evaluation of regurgitation by an academic core laboratory (nonsponsored) in a real-world cohort of patients using a quantitative technique.

Background: Many patients undergoing durable left ventricular assist device (LVAD) implantation suffer from chronic kidney disease (CKD). Therefore, we investigated the effect of LVAD support on CKD. Methods: A retrospective multicenter cohort study, including all patients undergoing LVAD (HeartMate II (n = 330), HeartMate 3 (n = 22) and HeartWare (n = 48) implantation. In total, 227 (56.8%) patients were implanted as bridge-to-transplantation; 154 (38.5%) as destination therapy; and 19 (4.7%) as bridge-to-decision. Serum creatinine measurements were collected over a 2-year follow-up period. Patients were stratified based on CKD stage. Results: Overall, 400 patients (mean age 53 ± 14 years, 75% male) were included: 186 (46.5%) patients had CKD stage 1 or 2; 93 (23.3%) had CKD stage 3a; 82 (20.5%) had CKD stage 3b; and 39 (9.8%) had CKD stage 4 or 5 prior to LVAD implantation. During a median follow-up of 179 days (IQR 28–627), 32,629 creatinine measurements were available. Improvement of kidney function was noticed in every preoperative CKD-stage group. Following this improvement, estimated glomerular filtration rates regressed to baseline values for all CKD stages. Patients showing early renal function improvement were younger and in worse preoperative condition. Moreover, survival rates were higher in patients showing early improvement (69% vs 56%, log-rank P = 0. 013). Conclusions: Renal function following LVAD implantation is characterized by improvement, steady state and subsequent deterioration. Patients who showed early renal function improvement were in worse preoperative condition, however, and had higher survival rates at 2 years of follow-up.

Objective The aim of the present study was to evaluate the efficacy of inhaled milrinone in controlling pulmonary arterial hypertension (PAH) in paediatric cardiac surgery and its effect on weaning from cardiopulmonary bypass (CPB). Methods A total of 40 patients with congenital heart diseases complicated by PAH submitted to cardiac surgery requiring CPB were included in the present study and were randomly classified into the control group (n=20) who received intravenous milrinone 0.5 μg kg-1 min-1 and the inhaled group (n=20) who received inhaled milrinone 50 μg kg-1 before initiation and just before weaning off CPB. Mean pulmonary artery pressure (mPAP), mean systemic arterial pressure (MAP), heart rate (HR), MAP/mPAP ratio, vasoactive drug requirements and time needed to wean the patients from CPB were collected. Results mPAP and HR were significantly lower, and MAP and MAP/mPAP ratio were significantly higher in the inhaled group than in the control group. Vasoactive drug requirements were significantly lesser, and the time needed to wean the patients was significantly shorter in the inhaled group than in the control group. Conclusion Milrinone inhalation facilitated the weaning from CPB as it significantly reduced mPAP and maintained MAP with subsequently less needs for vasoactive drugs.

Supplemental material, sj-docx-1-smo-10.1177_20503121221139563 for Disrespect and abuse during focused antenatal care and associated factors among pregnant women who visited public health facilities in Awsi Rasu of Afar Region Northeast Ethiopia by Ibrahim Mohammed Ibrahim, Osman Ahmed Mohammed, Kusse Urmale Mare, Mohammed Wagris Mohammed and Setognal Birara Aychiluhm in SAGE Open Medicine

Background: Radiofrequency catheter ablation is a well-established treatment for several cardiac arrhythmias. Arrhythmias originating from the left side of the heart including ventricular and supraventricular tachycardia and ectopy can be successfully ablated through either transseptal or retrograde aortic approach. Although these techniques have a generally low rate of complications, aortic valve injury is a potential complication of ablation at the left cardiac side that warrants more investigation. Objective: The purpose of this review is to evaluate the incidence of iatrogenic aortic valve regurgitation and explore the potential mechanisms and risk factors that might contribute to aortic valve injury during radiofrequency ablation. Additionally, the course and progression of aortic regurgitation in the reported cases will be described. Methods: Authors searched PubMed for articles using the keywords “ablation” AND “aortic insufficiency” OR “aortic valve injury” OR “aortic regurgitation”. Case reports and series as well as retrospective and prospective studies were included, and relevant review articles and editorial comments were used as a supplementary source of data. A total of 19 references were used and a detailed description of patient characteristics, procedural techniques, and incidence, predictors, and fate of aortic regurgitation were reported by 11 clinical studies. Results: There is a small risk of significant iatrogenic aortic regurgitation after radiofrequency ablation of left-sided cardiac arrhythmias, especially techniques performed via a retrograde aortic approach. Conclusion: Although the risk is not confined to procedures applying direct energy to the aortic cusp region, a more aggressive ablation applied in the vicinity of the valvular complex seems to be associated with a higher risk. Routine post-procedural surveillance should be adopted to detect de novo aortic valve injury following radiofrequency ablation techniques.

Background: In clinical trials, the optimal method of adjudicating revascularization events as clinically or nonclinically indicated (CI) is to use an independent Clinical Events Committee (CEC). However, the Academic Research Consortium-2 currently recommends using physiological assessment. The level of agreement between these methods of adjudication remains unknown. Methods: Data for all CEC adjudicated revascularization events among the 3457 patients followed-up for 2-years in the TALENT trial, and 3-years in the DESSOLVE III, PIONEER, and SYNTAX II trial were collected and readjudicated according to a quantitative flow ratio (QFR) analysis of the revascularized vessels, by an independent core lab blinded to the results of the conventional CEC adjudication. The κ statistic was used to assess the level of agreement between the 2 methods. Results: In total, 351 CEC-adjudicated repeat revascularization events occurred, with retrospective QFR analysis successfully performed in 212 (60.4%). According to QFR analysis, 104 events (QFR ≤0.80) were adjudicated as CI revascularizations and 108 (QFR >0.80) were not. The agreement between CEC and QFR based adjudication was just fair (κ=0.335). Between the 2 methods of adjudication, there was a disagreement of 26.4% and 7.1% in CI and non-CI revascularization, respectively. Overall, the concordance and discordance rates were 66.5% and 33.5%, respectively. Conclusions: In this event-level analysis, QFR based adjudication had a relatively low agreement with CEC adjudication with respect to whether revascularization events were CI or not. CEC adjudication appears to overestimate CI revascularization as compared with QFR adjudication. Direct comparison between these 2 strategies in terms of revascularization adjudication is warranted in future trials. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: TALENT trial: NCT02870140, DESSOLVE III trial: NCT02385279, SYNTAX II: NCT02015832, and PIONEER trial: NCT02236975.

Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial. info:eu-repo/semantics/publishedVersion

Objectives: The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloon-expandable valves.Background: Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI.Methods: This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database.Results: The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246).Conclusion: The Myval THV, in comparison with other BEV's analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.

Purpose The aim of the study was to analyze early mortality after continuous-flow left ventricular assist device (LVAD) implantation which remains high. Methods We analyzed consecutive (n = 2689) patients from the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) undergoing continuous-flow LVAD implantation. The primary outcome was early (

BACKGROUND: Patients with end stage heart failure are increasingly being bridged to heart transplant (BTT) with mechanical circulatory support (MCS), however the association between a left ventricular assist device (LVAD) BTT strategy and post-transplant renal outcomes is unclear. The aim of this study was to analyze the association of LVAD BTT with the development of post-transplant renal failure using a large national registry. METHODS: We queried the 2009-2018 United Network for Organ Sharing (UNOS) registry for all adults undergoing first-time heart or heart-kidney transplantation and stratified patients by use of pre-transplant durable LVAD. The primary outcome of interest was post-transplant renal failure, which was evaluated with multivariable logistic regression. RESULTS: 18,307 patients met inclusion criteria including 7,887 (43%) and 10,420 (57%) that were and were not bridged to transplant with an LVAD, respectively. BTT patients had slightly better baseline renal function (eGFR 68.7 vs 65.8 mL/min, p

Heart failure is a growing epidemic, which is associated with increased morbidity and mortality alongside increasing healthcare costs. Left ventricular assist devices (LVADs) are increasingly used as an acceptable alternative to heart transplantation. The 2-year survival using the most technologically advanced LVAD design is nearly similar to that of heart transplantation. The pathophysiological basis of heart failure includes compromised central hemodynamics, and impaired organ perfusion and, consequently, microvascular perfusion. Previous studies on microcirculation imaging have shown that alterations in the microcirculation have important prognostic value in patients with advanced heart failure (cardiogenic shock) as well as those receiving mechanical circulatory support. Postoperative care of LVAD patients is typically associated with prolonged ICU stay due to the high surgical risk as well as the high rate of operative and device-related complications. Anticipation and handling of post-LVAD complications require hemodynamic monitoring as well as possibly adjustment of pump settings. A key marker of optimal LVAD settings is improved organ perfusion. Therefore, monitoring of end-organ function to optimize pump settings could improve care of LVAD patients and possibly avoid repeated and lengthy hospitalizations. Microcirculatory imaging is evolving as an important bedside tool for the assessment of hemodynamic coherence and microcirculatory monitoring. Several imaging techniques, such as handheld microscopes based on incident dark-field illumination (IDF), have been introduced for clinical use. In this chapter, we discuss optimal approaches to microcirculatory monitoring from the ICU to the outpatient clinic in patients with an LVAD.

Objectives: To explore the rate, the determinants of success, and the hemodynamic impact of balloon postdilatation (BPD) of self-expanding transcatheter heart valves (SE-THVs). Background: BPD is commonly used to optimize valve expansion and reduce paravalvular leakage (PVL) after transcatheter aortic valve implantation (TAVI) without clearly knowing its hemodynamic benefits. Methods: Patients (n = 307) who received a SE-THV were stratified according to whether a BPD was performed or not. Patients who received BPD were stratified according to the severity of PVL remaining after BPD into two groups: Successful BPD (≤mild PVL + BPD) and Failed BPD (moderate-severe PVL + BPD). Results: BPD was performed in 121 patients (39.4%) and was successful in 106 patients (87.6% of attempts). A ratio of the postdilatation balloon diameter to the annulus diameter ≤0.95 was an independent predictor of BPD failure (OR: 10.72 [2.02-56.76], P =.005). Peak transvalvular pressure gradient (PG) was lower in the Successful BPD group (14[12-22] mm Hg) than in the Failed BPD group (18[16-23] mm Hg, P =.029), and did not rise in either group during follow-up (median [IQR], 364[161-739] days). Conclusion: BPD was performed in 39% of patients who received a SE-THV, and was successful in the majority of attempts. BPD failure was more likely in patients with a small postdilatation balloon-to-annulus diameter ratio. Effective BPD improved THV hemodynamic performance, and this was maintained in the intermediate-term post-TAVI.

Aims: Videodensitometric assessment of aortography provides a periprocedural quantitation of prosthetic valve regurgitation (PVR) after transcatheter aortic valve implantation. We sought to compare the videodensitometric parameters of PVR severity to the regurgitation fraction (RF) in a controlled in vitro setting. Methods and results: In a mock circulation system, a transcatheter balloon-expandable valve inserted at the aortic valve position was gradually deformed to induce different grades of paravalvular leakage and the RF was measured with a transonic flow probe. Contrast aortography was performed and the following videodensitometric parameters were generated: left ventricle aortic regurgitation (LV-AR), LV outflow tract AR (LVOT-AR), quantitative regurgitation assessment (qRA) index, relative maximum density (relative max), and maximum upslope of the LV time-density curve. The correlation was substantial between videodensitometric parameters (LV-AR, LVOT-AR, qRA index, relative max, and maximum upslope) and RF (r 2=0.96, 0.96, 0.93, 0.87, and 0.93; p2=0.99) with a mean difference of 1.92% (95% limits of agreement: ±2.83). The correlations of LV-AR and LVOT-AR with RF were stronger when more than one cardiac cycle was included in the analysis (one cycle: r 2=0.85 and r 2=0.83; four cycles: r 2=0.96 and r 2=0.96, for LV-AR and LVOT-AR, respectively). Including more cycles beyond four did not improve accuracy. Conclusions: Quantitative assessment of PVR by videodensitometry of aortograms strongly correlates with the actual RF in a controlled in vitro setting. Accuracy is improved by including more than one cardiac cycle in the analysis.

Aims Patients with a left ventricular assist device (LVAD) are challenging to evaluate using conventional imaging techniques, such as standard echocardiography (SE). The aim of this pilot study was to evaluate the potential of contrast echocardiography (CE) for the evaluation of the left ventricle (LV). Methods and results This prospective study included 14 ambulatory patients (mean age 58 ± 9 years, 79% male) with a LVAD (all HeartMate 3, Abbott Laboratories, Chicago, IL, USA). Nine (64%) patients had an ischaemic cardiomyopathy, and 5 (36%) had a non-ischaemic cardiomyopathy. All patients underwent SE and CE using intravenous administration of Sonovue contrast agent (Bracco, Milan, Italy). The echocardiograms were assessed by three observers, using a standard 17-segment model of the LV. Left ventricular end-diastolic volume (LVEDV) was assessed using the biplane Simpson method. The contrast agent was well tolerated by all patients, without any side effects. Overall, SE allowed visualization of 57% of LV segments (135/238) and CE allowed visualization of 79% of LV segments (187/238), P < 0.001. Per patient, SE resulted in visualization of 9.6 ± 5.2 segments and CE was able to visualize 13.4 ± 5.8 segments (P < 0.001). Administration of contrast agent significantly improved the assessment of LVEDV (feasibility SE: 36% vs. CE: 79%, P < 0.05). Conclusion Routine use of a contrast agent appears safe when used in patients having a new third generation LVAD and may enhance the diagnostic accuracy of transthoracic echocardiography in these patients. LV size determination can be obtained more often due to improved LV visualization using contrast agent.

Background: Balloon post-dilatation (BPD) is often needed for optimizing transcatheter heart valve (THV) implantation, since paravalvular leak (PVL) after transcatheter aortic valve implantation is associated with poor outcome and mortality. Quantitative assessment of PVL severity before and after BPD is mandatory to properly assess PVL, thus improving implantation results and outcomes. Objective: To investigate a quantitative angiographic assessment of aortic regurgitation (AR) by videodensitometry before and after BPD. Methods: Videodensitometric-AR assessments (VD-AR) before and after BPD were analysed in 61 cases. Results: VD-AR decreased significantly from 24.0[18.0-30.5]% to 12.0[5.5-19.0]% (p < 0.001, a two-tailed p < 0.05 defined the statistical significance). The relative delta of VD-AR after BPD ranged from -100% (improvement) to +40% (deterioration) and its median value was -46.2%. The frequency of improvement, no change, and deterioration were 70% (n = 43), 25% (n = 15) and 5% (n = 3), respectively. Significant AR (VD-AR > 17%) was observed in 47 patients (77%) before and in 19 patients (31%) after BPD. Conclusions: VD-AR after THV implantation provides a quantitative assessment of post-TAVI regurgitation and can help in the decision-making process on performing BPD and in determining its efficacy. Resumo Fundamento: A pós-dilatação com balão (PDB) é normalmente necessária para otimização do implante da válvula cardíaca transcateter (THV), uma vez que o “escape” ou leak paravalvar (PVL) após implante de valva aórtica transcateter está associada com desfecho ruim e mortalidade. A avaliação quantitativa da gravidade do PVL antes e após a PDB é mandatória para se avaliar adequadamente o PVL e, assim, melhorar os resultados e os desfechos do implante. Objetivo: Investigar uma avalição angiográfica quantitativa da regurgitação aórtica (RA) por videodensitometria (VD-RA) antes e após a PDB. Métodos: Resultados da VD-RA antes e após a PDB foram analisados em 61 casos. Resultados Houve diminuição significativa da VD-RA de 24,0(18,0-30,5)% para 12,0(5,5-19,0)% (p < 0,001; p < 0,05 bilateral foi definido como significância estatística). O delta relativo de VD-RA após a PDB variou de -100% (melhora) a +40% (piora) e o valor mediano foi -46,2%. As frequências de melhora, ausência de mudança, e piora foram 70% (n = 43), 25% (n = 15) e 5% (n = 3), respectivamente. Observou-se RA significativo (VD-RA > 17%) em 47 pacientes (77%) antes e em 19 pacientes (31%) após a PDB. Conclusões: A VD-RA após o implante de THV possibilita a avaliação quantitativa da regurgitação pós-TAVI, e pode auxiliar na tomada de decisão quanto à realização ou não da PDB, bem como na avaliação de sua eficácia.

Objectives The aim of this post hoc analysis from the RESPOND (Repositionable Lotus Valve System–Post-Market Evaluation of Real World Clinical Outcomes) post-market study was to assess the final implantation depth on the contrast aortogram after Lotus valve (Boston Scientific, Marlborough, Massachusetts) transcatheter aortic valve replacement (TAVR) and to correlate with permanent pacemaker implantation (PPI) and paravalvular leak (PVL). Background Contrast aortography allows for the assessment of implantation depth and PVL during and after TAVR. Previous reports suggested an association between final device position and rates of PPI and PVL. Methods The RESPOND study was a prospective, open-label, single-arm study in 41 centers evaluating outcomes after Lotus TAVR in routine clinical practice. Aortograms were collected at the Erasmus Medical Center and analyzed by researchers who were blinded to clinical outcomes. The primary analysis correlated implantation depth with PPI and PVL and required aortograms in a coaxial projection. The relation between implantation depth and need for PPI was assessed by multivariate logistic regression, adjusting for pre-defined confounders. A secondary analysis compared PVL analysis by contrast aortography with transthoracic echocardiography (TTE) performed by the independent core laboratory. Results A total of 724 angiographic studies were included in this analysis. Mean Lotus implantation depth was 6.67 ± 2.19 mm. The overall PPI rate was 35%. PPI rate was lower with shallow implants ( Conclusions In this post hoc analysis of the RESPOND study PPI was highly correlated with implantation depth, whereas PVL was not. Higher Lotus implantation may reduce need for PPI.

With the rise and consolidation of the minimalistic approach era for transcatheter aortic valve replacement (TAVR) procedures without general anesthesia, the use of intraprocedural transesophageal or transthoracic echocardiogram (TTE) becomes limited. However, this high-risk group of patients

Aims: In the minimalist transcatheter aortic valve implantation (TAVI) era, the usage of transoesophageal echocardiography has become restricted. Conversely, aortography has gained clinical ground in quantifying prosthetic valve regurgitation (PVR) during the procedure. In a mock circulation system, we sought to compare the contrast volume required and the accuracy of aortographic videodensitometric PVR assessment using a synchronised diastolic and standard (non-synchronised) injection aortography. Methods and results: Synchronised diastolic injection triggered by the signal stemming from the mock circulation was compared with standard non-synchronised injection. A transcatheter heart valve was implanted and was deformed step by step by advancing a screw perpendicularly to the cage of the valve in order to create increasing PVR. Quantitative measurement of PVR was derived from time-density curves of both a reference area (aortic root) and a region of interest (left ventricle) developed by a videodensitometric software. The volume of contrast required for the synchronised diastolic injection was significantly less than in the non-synchronised injection (8.1 [7.9-8.5] ml vs. 19.4 [19.2-19.9] ml, p

Objective: To investigate the accuracy and interobserver variability of Quantitative videodensitometric assessment of Mitral Regurgitation (QMR) after mitral valve replacement in a preclinical ovin...

Objectives We sought to investigate a new angiographic method for aortic regurgitation (AR) severity assessment in the setting of transcatheter aortic valve implantation (TAVI). Background AR after TAVI is common but challenging to quantitate, especially in the cath-lab. Methods In 228 patients, AR was quantitated before and after TAVI by echocardiography and by video-densitometric analysis of aortograms. Contrast time–density curves for the aortic root (the reference region) and the left ventricular outflow tract, LVOT were generated. LVOT-AR was calculated as the area under the curve of the LVOT as a fraction of the area under the curve of the reference region. Results LVOT-AR was 0.10 ± 0.08, 0.13 ± 0.10 and 0.28 ± 0.14 in none-trace, mild and moderate-severe post-TAVI AR as defined by echocardiography (P 0.17 corresponded to moderate-severe AR on echocardiography (area under the curve = 0.84). At follow-up (median, 496 days), patients with LVOT-AR ≤ 0.17 showed a significant reduction of LV mass index (LVMi; 121 [95–148] vs. 140 [112–169] g/m2, P = 0.009) and the prevalence of LV hypertrophy (LVH; 64 vs. 88%, P = 0.001) compared to baseline. In patients with LVOT-AR > 0.17, LVMi (149 [121–178] vs. 166 [144–188] g/m2, P = 0.14) and the prevalence of LVH (74 vs. 87%, P = 0.23) did not show a significant change. Compared to patients with LVOT-AR ≤ 0.17, those with LVOT-AR > 0.17 had an increased 30-day (16.4% vs. 7.1%, P = 0.035) and one year mortality (32.9 vs. 14.2%, log rank P value = 0.001; HR: 2.690 [1.461–4.953], P = 0.001). Conclusions LVOT-AR > 0.17 corresponds to greater than mild AR as defined by echocardiography and predicts impaired LV reverse remodeling and increased early and midterm mortality after TAVI. © 2017 Wiley Periodicals, Inc.

Aims The aim of this prospective study was to evaluate the feasibility and establish normal values of functional right ventricle (RV) parameters as assessed in our four, long-axis view RV model using iRotate echocardiography. Furthermore, we evaluated the potential use of this model in patients with abnormally loaded RVs. Method and results One hundred and fifty-five healthy subjects aged 20-72 years (≥28 subjects per decile) were prospectively recruited. We used non-dedicated RV speckle-tracking software to test the feasibility and to establish normal range values of peak systolic global longitudinal RV strain (RV-GLS) from the RV free-walls (septum was excluded). Also normal range values for: dimensions, tricuspid annular plane systolic excursion (TAPSE) and tricuspid annular peak systolic velocity (TDI-S') were established. The feasibility of RV-GLS was 88, 84, and 62%, respectively, in the lateral, inferior, and anterior free wall. Mean RV-GLS normal values were -24.5 ± 4.9% for lateral wall and -25.4 ± 5.0% for anterior wall. Mean RV-GLS in the inferior wall was -23.2 ± 4.4% in the aortic (Ao) view and -20.7 ± 5.0% in the coronal (CV) view. The feasibility of mean RV-GLS was 100% in the anterior, lateral, and inferior walls in abnormally dilated RVs. Conclusion The feasibility of all RV parameters assessed in the four-view iRotate model is good to excellent. Normal values for RV dimension and function of the anterior, inferior, and lateral RV walls have been established. Further studies and dedicated RV speckle-tracking software are warranted to discover the full potential of this new technique.

Objectives This study sought to investigate the differences in detecting (e.g., triggering) periprocedural myocardial infarction (PMI) among 3 current definitions. Background PMI is a frequent component of primary endpoints in coronary device trials. Identification of all potential suspected events is critical for accurate event ascertainment. Automatic triggers based on study databases prevent underreporting of events. Methods We generated automated algorithms to trigger PMI based on each definition and compared results using data from the RESOLUTE all comers trial. Results The operationalization of current PMI definitions was achieved by defining programmable algorithms used to interrogate the study database. From a total of 636 PMI triggers, we identified 234 for the World Health Organization extended definition, 382 for the Third Universal definition, and 216 for the Society for Cardiovascular Angiography and Interventions definition. Differences among the biomarkers used, different cutoff values, and in the hierarchy among biomarkers within definitions, yielded a different number of triggers, and identified unique triggers for each definition. Only 38 triggers were consistently identified by all definitions. Availability of ECG data, eCRF data on clinical presentation, and the reporting of >2 post-procedural values of the same biomarker influenced considerably the number of PMI triggers identified. Conclusions PMI definitions are not interchangeable. The number of triggers identified and consequently the potential number of events varies significantly, highlighting the importance of rigorous methodology when PMI is a component of a powered endpoint. Emphasis on collection of biomarkers, ECG data, and clinical status at baseline may improve the correct identification of PMI triggers.

Aims Paravalvular aortic leakage (PVL) after transcatheter aortic valve implantation (TAVI) is a complication with potentially severe consequences. The relation between native aortic root calcium burden, stent frame eccentricity and PVL was not studied before. Methods and results Two-hundred-and-twenty-three consecutive patients with severe aortic stenosis who underwent TAVI with a Medtronic CoreValve SystemVC and who had available pre-discharge transthoracic echocardiography were studied. Echocardiographic stent inflow frame eccentricity was defined as major-minor diameter in a short-axis view >2 mm. PVL was scored according to the updated Valve Academic Research Consortium (VARC-2) recommendations. In a subgroup of 162 (73%) patients, the calcium Agatston score was available. Stent frame eccentricity was seen in 77 (35%) of patients. The correlation between the Agatston score and stent frame eccentricity was significant (q = 0.241, P = 0.003). Paravalvular leakage was absent in 91 cases (41%), mild in 67 (30%), moderate in 51 (23%), and severe in 14 (6%) cases. The correlation between stent frame eccentricity and PVL severity was significant (q = 0.525, P < 0.0001). There was a relation between particular eccentric stent frame shapes and the site of PVL. Conclusion Calcification of the aortic annulus is associated with a subsequent eccentric shape of the CoreValve prosthesis. This eccentric shape results in more PVL, with the localization of PVL related to the shape of stent frame.

Aims: The Xeltis aortic valve leaflets are made from a bioabsorbable supramolecular polymer that guides the tissue to restoring itself. It is mounted on a self-expanding nitinol frame that includes three feelers and a native leaflet clipping mechanism. We sought to investigate the acute valve performance in a preclinical setting. Methods and results: In 33 sheep, 26 mm Xeltis aortic valves were transapically implanted in a 23 mm native annulus. Aortography (analysable, n = 28) and echocardiography (analysable, n = 20) images were acquired immediately after implantation of the Xeltis aortic valve to assess the acute device performance. On echocardiography, transvalvular peak pressure gradient (PG) was 7.4 (IQR: 6.0-8.9) mmHg, mean PG was 4.0 (IQR: 3.0-5.0) mmHg, and effective orifice area was 2.2 (IQR: 1.6-2.5) cm(2). Trace (n = 6), mild (n = 2) and no (n = 12) transvalvular aortic regurgitation (AR) were seen. Likewise, no paravalvular AR was detected in 7 cases, whereas trace, mild and moderate were seen in 7, 5 and 1 cases, respectively. On quantitative videodensitometric AR (VD-AR) assessment, a median value of 6% (IQR: 1-12%) of AR was seen. Three cases had a VD-AR superior to 17%, which has a prognostic significance. Out of these three cases, two had echocardiographic assessment available, which showed mild and moderate paravalvular regurgitation due to inadequate leaflet clipping. Conclusions: In a transapical ovine model, the novel restorative transcatheter aortic valve with bioabsorbable leaflets demonstrated good haemodynamic performance comparable to commercially available devices. The highly porous polymeric leaflets demonstrated good competence immediately after implantation with no cases having > mild transvalvular AR

Aims The feasibility and accuracy of an automated adaptive algorithm (Heart Model) for the quantification of left heart chamber volumes and left ventricular ejection fraction has been reported earlier. An improved version of the algorithm is available, and we aimed to test its accuracy compared with manual 3D echocardiography. Methods and Results Apical 3D transthoracic datasets were obtained in 67 patients. Acquisitions covering ventricles and atria were performed for analysis using the automated software (Heart Model, Philips Healthcare). In addition, acquisitions focused on the left ventricle were acquired for left ventricle manual 3D measurements (QLAB 10 3DQA, Philips Healthcare). Automated results using endocardial contouring settings at 50% showed a strong correlation with manual 3D measurements (r=.84-.97). Left ventricular end-diastolic volumes were underestimated (bias −5.9 mL, LOA ±38.5 mL), with no significant differences in other parameters. Intra-observer variability using the automated algorithm was zero for all parameters given the lack of human interaction. Manual corrections of the automatic algorithm introduced small but significant differences in volumes but not in ejection fraction when compared with automatic results. Manually corrected results of the automatic algorithm were not significantly different from those obtained with manual 3D echocardiography, except for a small underestimation of left atrial volumes (bias −2.1 mL, LOA ±15.2 mL). Conclusions The current improved version of the automated adaptive algorithm is accurate for the assessment of left heart chamber volumes, albeit a small underestimation of left ventricular end-diastolic volume is seen, when compared with manual 3D echocardiography.

The aim of this study was to evaluate the intermediate-term clinical impact of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using a novel quantitative angiographic method taking into account the influence of pre-existing AR. AR after TAVI was quantified in 338 patients (age 82 [78-86] years; 55% male) and the influence on intermediate-term all-cause mortality was evaluated. In 228 aortograms, AR was quantitated using a dedicated videodensitometric method focused in the left ventricular outflow tract (LVOT-AR). Patients with LVOT-AR >0.17 had a significantly increased all-cause mortality at three years, compared with patients who had LVOT-AR ≤0.17 (adjusted hazard ratio [HR]: 1.73, 95% confidence interval [CI]: 1.05-2.86, p=0.032). Taking the influence of pre-existing AR into account, patients with post-procedural LVOT-AR >0.17 and ≤mild pre-existing AR had a significantly increased mortality at two years, compared to patients with LVOT-AR >0.17 and >mild pre-existing AR (HR: 2.55, 95% CI: 1.16-5.58, p=0.029). In those with >mild pre-existing AR (n=70), post-TAVI LVOT-AR >0.17 was not associated with increased mortality (HR: 0.77, 95% CI: 0.31-1.91, p=0.578). AR after TAVI could be quantitated utilising LVOT-AR. The cut-point of >0.17 indicates a significant AR pertaining to increased intermediate-term mortality, especially in those with no significant pre-existing AR

Transcatheter aortic valve implantation (TAVI) is undeniably invading the “surgical” space and expanding its indication. Over the last five years, there has been a real revolution in TAVI technology with the introduction of newer devices that aimed to simplify the procedure1. These swift advances have transformed the landscape in structural heart disease and culminated in a broader use of TAVI in clinical practice2,3. The procedure is not only spreading worldwide but is also becoming less aggressive for the patient with the so-called “minimalist approach”.

Introduction Right sided heart failure (RVF) is recognized as a major cause of morbidity and mortality after left ventricular assist device (LVAD) implantation. Despite the publication of several risk scores and predication models, identifying patients at risk for RVF after LVAD implantation remains a challenge. The right ventricle is complex in structure and not possible to fully assess from one echocardiographic 2D plane. Our centre previously introduced a novel multi-plane approach whereby four different RV free wall segments (lateral, anterior, inferior and inferior coronal – figure 1) can be imaged from the same echocardiographic position using electronic plane rotation. Purpose The aim of the study was to determine the feasibility of using multi-plane echocardiography to quantify right ventricular function in a small cohort of advanced heart failure patients prior to LVAD implantation. Methods Twelve advanced heart failure patients underwent detailed RV assessment by multi-plane echocardiography prior to LVAD implantation (median -15 [6.3–29.8] days before). Feasibility and values of the established RV functional echo parameters tricuspid annular plane systolic excursion (TAPSE) and tissue Doppler imaging derived tricuspid annular peak systolic velocity (TDI S') were assessed by an experienced sonographer on each of the 4 free wall segments. Mean values were calculated from an average of 3 measurements. Conventional 2D echo parameters and clinical outcome data post LVAD implantation were also collected. Results Feasibility of TAPSE and TDI measurements in all four RV free wall segments was 100%, with the exception of the inferior coronal wall (91.7% – TDI S' only). Mean 4 wall averaged TAPSE was 13.9±5.1mm, whilst mean TDI S' was 9.4±2.6cm/s. Mean TAPSE and TDI values were lower in the inferior and inferior coronal walls (13.3±5.8mm; 8.8±3.1cm/s and 10.9±5.7mm; 8.9±3.7cm/s) than those of the lateral and anterior walls (15.6±5.1mm; 9.9±2.3cm/s and 15.9±5.1mm; 10.1±2.6cm/s). The cohort was split by using a four wall averaged TAPSE value of 16mm as a cutoff. Mean 4 wall averaged TAPSE was 20.6±1.9mm in the >16mm group compared to 10.5±1.7mm for the Conclusion Multi-plane echocardiographic evaluation of the right ventricle appears feasible in advanced heart failure with potential for a more comprehensive quantification of right ventricular function pre-LVAD implantation. Larger, ideally multi-centre studies are required to further assess these preliminary findings.

BackgroundWhile rheumatic mitral stenosis has been effectively treated percutaneously for more than 20 years, mitral and tricuspid regurgitation treatment appear as a contemporary unmet need. The advent of transcatheter therapies offer new treatment options to often elderly and frail patients at high risk for open surgery. We aimed at providing an updated review of fast-growing domain of transcatheter mitral and tricuspid technology.Main bodyWe reviewed the existing literature on mitral and tricuspid transcatheter therapies. Mitraclip is becoming an established therapy for secondary mitral regurgitation in selected patients with disproportionately severe regurgitation associated with moderate left ventricle dysfunction. Evidence is less convincing for primary mitral regurgitation. Transcatheter mitral valve replacement is a promising emerging alternative to transcatheter repair, for secondary as well as primary mitral regurgitation. But further development is needed to improve delivery. Transcatheter tricuspid intervention arrives late after similar technologies have been developed for aortic and mitral valves and is currently at its infancy. This is likely due in part to previously under-recognized impact of tricuspid regurgitation on patient outcomes. Edge-to-edge repair is the most advanced transcatheter solution in development. Data on tricuspid annuloplasty and replacement is limited, and more research is warranted.ConclusionThe future appears bright for transcatheter mitral therapies, albeit their place in clinical practice is yet to be clearly defined. Tricuspid transcatheter therapies might address the unmet need of tricuspid regurgitation treatment.

Purpose Mortality after veno-arterial extracorporeal membrane oxygenation (VA-ECMO) implantation remains a major problem in patients with cardiogenic shock. Our objective was to assess the utility of the SOFA score in combination with markers of right ventricular (RV) dysfunction in predicting mortality in the ICU. Materials and methods Data were retrospectively obtained from all adult patients (n=103) who were treated with VA-ECMO between November 2004 and January 2016. The primary outcome of this study was ICU mortality after VA-ECMO implantation. Using the clinical, demographic and echocardiographic data, we developed a novel mortality risk score, the SOFA-RV score, which combine RV-function to the SOFA score at the time of VA-ECMO implantation. Results Out of 103 patients, 37 (36%) died in the ICU. The median duration of VA-ECMO support was 7 days [IQR 4-11], mean age 49 ± 16 years, and 54% were male. SOFA-RV score has an AUC of 0.70, and was significantly better than SOFA alone (AUC of 0.57) in predicting ICU mortality. In addition, SAVE and MELD scores were not able to predict ICU mortality. Conclusion Adding RV-function to the existing SOFA score improves significantly the prediction of ICU mortality in patients on VA-ECMO. Dedicated evaluation of RV function in patients with VA-ECMO is therefore recommended.

Background The Lotus aortic valve system is a new generation transcatheter heart valve (THV) designed with a seal to minimize paravalvular leak (PVL). We evaluated hemodynamic performance, PVL and ventricular function up to 1-year after transcatheter aortic valve replacement (TAVR) using the Lotus THV in patients with severe aortic stenosis. Methods RESPOND was a prospective, single-arm, multicenter registry evaluating outcomes after Lotus TAVR in routine clinical practice. Core Laboratory adjudicated echocardiograms at baseline, discharge and 1-year were analyzed in a subgroup (N=550) of patients with paired transthoracic echocardiography (TTE) at the 3 timepoints. Results Mean effective aortic valve orifice area (EOA) in cm2 increased from 0.74±0.25 at baseline to 1.83±0.46 at discharge and to 1.78±0.45 at 1-year. Mean transvalvular gradient in mmHg was reduced from 38.7±15.2 at baseline to 10.9±4.2 at discharge and to 10.8±5.1 at 1-year. VARC-2 hemodynamic success ([EOA >1.1cm2 for BSA ≥1.6m2 or EOA >0.9cm2 for BSA2; and no moderate or severe PVL) was achieved in 92% and 95% of patients at discharge and 1-year, respectively. Mild or more PVL was seen in 7.3% and 5.5% and moderate or more PVL was seen in 0.6% and 0.4% of patients at discharge and 1-year, respectively. Stroke volume index (mL/m2) increased from 35±10 at baseline to 40±11 at discharge and to 41±11 at 1-year (pRepositionable Lotus Valve System–Post Market Evaluation of Real World Clinical Outcomes [RESPOND]; NCT02031302).

Aims To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). Methods and results In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48–0.85] and POCE (HR: 0.80, 95% CI: 0.69–0.93), but not in those with non-complex PCI (P interaction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67–1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69–0.92; P interaction = 0.011). Conclusion Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.

The long-term durability of transcatheter heart valves (THV) is becoming an important issue since the selection of patients for transcatheter aortic valve implantation (TAVI) has been expanded to lower-risk patients, thus younger. The main issue of the long durability of the current bioprosthetic valves is caused by the fact that they are made from animal-derived glutaraldehyde-fixed pericardial tissue, which leads to low biocompatibility and to chronic inflammation and calcification. Endogenous tissue restoration (ETR) is an approach by which a bioabsorbable material will progressively be replaced by endogenous tissue. Thus, a heart valve with ETR technology has the potential to improve biocompatibility and overcome the inflammation problem of the current valve provoked by the use of a foreign material. This novel technology has been tested in preclinical setting—for example, as a pulmonary valved conduit and aortic valve—and is currently under investigation in the clinical setting. This chapter introduces the technology of ETR and the current evidence of the valves with the ETR technology.

Aims: Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post-market registry. Methods and Results: The prospective, open-label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve-in-valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30-day follow-up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge (P < 0.001); mean effective orifice area (EOA) was increased from 0.6 ± 0.2 cm2 to 1.7 ± 0.4 cm2 (P < 0.001). There were no cases of moderate or severe paravalvular leak (PVL) adjudicated by the core laboratory; four subjects (13.8%) had mild PVL, 5 (17.2%) had trace PVL. The rate of pacemaker (PM) implantation for PM-naive patients was 22.2% (6/27). Conclusions: Data from the RESPOND registry demonstrate good clinical and echocardiographic outcomes up to 1 year postimplantation in patients with bicuspid aortic valves using the repositionable Lotus Valve.

Purpose The safety and efficacy of ambulatory intermittent LEVO infusions in patients with end-stage HF are yet not established. We sought to synthesize the available evidence regarding safety and efficacy of intermittent Levosimendan (LEVO) infusions in ambulatory patients with end-stage heart failure (HF). Methods We systematically searched MEDLINE, EMBASE, SCOPUS, Web of Science and Cochrane databases, from inception to September 27,2019 for studies reporting outcome of adult ambulatory patients with end-stage HF treated with intermittent LEVO infusion. Results Fifteen studies (8 randomized and 7 observational), comprised 984 patients (LEVO[N=727] and controls[N=257]) met the inclusion criteria. LEVO was associated with improved New York Heart Association(NYHA) functional class, (weighted mean difference [WMD] -1.04, 95%CI -1.70 to -0.38, p Conclusion Intermittent Levosimendan infusions in ambulatory patients with end-stage HF is associated with less frequent cardiovascular death alongside with improved NYHA class, quality of life, BNP levels and LV function. However, the current evidence is limited by heterogeneous and relatively small studies.

Aims Aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) is often first diagnosed by angiography and then confirmed and followed-up by transthoracic echocardiography (TTE). Consistency between both methods is important for follow-up. We sought to determine inter-technique reproducibility of the assessment of paravalvular AR after TAVI. Methods and results The study included 165 patients treated with a self-expanding bioprosthesis and had angiography and TTE performed at a median interval of 4 days. TTE parameters of AR severity included VARC score (the average AR grade determined by the echocardiographic VARC-II criteria), pressure half time (PHT), regurgitation jet features in long-axis views (LAX score) and colour Doppler (CD) score (=paravalvular AR jet circumferential extent (%) + LAX score). Using receiver-operating characteristics curves, the cut-points that best defined an angiographic >mild AR were identified. On TTE, AR was paravalvular in all cases, multi-jet in 28%, and predominantly (64%) detected in the commissural region between the right and left coronary sinuses. Using VARC-II criteria (combining at least two), TTE agreed with angiographic classification in 53% of cases ( k = 0.14). Greater than mild AR could better be defined by one of the following combinations of criteria: (i) LAX score >4.25 and VARC-II score >1.33; (ii) CD score >11.5 and PHT

Background Despite advances in pump technology, thromboembolic events/acute pump thrombosis remain potentially life-threatening complications in patients with continuous-flow left ventricular assist devices (CF-LVAD). We sought to determine early signs of thromboembolic event/pump thrombosis in patients with CF-LVAD, which could lead to earlier intervention. Methods We analysed all HeartMate II recipients (n = 40) in our centre between December 2006 and July 2013. Thromboembolic event/pump thrombosis was defined as a transient ischaemic attack (TIA), ischaemic cerebrovascular accident (CVA), or pump thrombosis. Results During median LVAD support of 336 days [IQR: 182-808], 8 (20 %) patients developed a thromboembolic event/pump thrombosis (six TIA/CVA, two pump thromboses). At the time of the thromboembolic event/pump thrombosis, significantly higher pump power was seen compared with the no-thrombosis group (8.2 +/- 3.0 vs. 6.4 +/- 1.4 W, p = 0.02), as well as a trend towards a lower pulse index (4.1 +/- 1.5 vs. 5.0 +/- 1.0, p = 0.05) and a trend towards higher pump flow (5.7 +/- 1.0 vs. 4.9 +/- 1.9 L m, p = 0.06). The thrombosis group had a more than fourfold higher lactate dehydrogenase (LDH) median 1548 [IQR: 754-2379] vs. 363 [IQR: 325-443] U/L, p = 0.0001). Bacterial (n = 4) or viral (n = 1) infection was present in 5 out of 8 patients. LDH > 735 U/L predicted thromboembolic events/pump thrombosis with a positive predictive value of 88 %. Conclusions In patients with a CF-LVAD (HeartMate II), thromboembolic events and/or pump thrombosis are associated with symptoms and signs of acute haemolysis as manifested by a high LDH, elevated pump power and decreased pulse index, especially in the context of an infection.

Left ventricular hypertrophy (LVH), defined by an increase in left ventricular mass (LVM), is a common cardiac finding generally caused by an increase in pressure or volume load. Assessing severity of LVH is of great clinical value in terms of prognosis and treatment choices, as LVH severity grades correlate with the risk for presenting cardiovascular events. The three main cardiac parameters for the assessment of LVH are wall thickness, LVM, and LV geometry. Echocardiography, with large availability and low cost, is the technique of choice for their assessment. Consequently, reference values for LVH severity in clinical guidelines are based on this technique. However, cardiac magnetic resonance (CMR) and computed tomography (CT) are increasingly used in clinical practice, providing excellent image quality. Nevertheless, there is no extensive data to support reference values based on these techniques, while comparative studies between the three techniques show different results in wall thickness and LVM measurements. In this paper, we provide an overview of the different methodologies used to assess LVH severity with echocardiography, CMR and CT. We argue that establishing reference values per imaging modality, and possibly indexed to body surface area and classified per gender, ethnicity and age-group, might be essential for the correct classification of LVH severity.