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The incidence of postoperative thrombocytopenia after aortic valve replacement (AVR) with the Perceval S Sutureless bioprosthesis remains unclear. The aim of this study was to report thrombocytopenia associated with the use of sutureless AVR. The data was collected retrospectively for patients who had isolated AVR with sutureless Perceval S valve (Group A: 72 patients) and was compared with patients who underwent isolated sutured AVR with Perimount Magna Ease Bioprosthesis (Group B: 101 patients) in our institution between June 2014 and January 2017. Cardiopulmonary bypass and cross-clamp time were significantly shorter in group A. Maximum drop in platelet count was 58% mean (day 2.3) in group A versus 44% mean (day 1.7) in group B (P=0.0001). Absolute platelet count on postoperative day 1-6 in group A was significantly less than in group B (P≤0.05). Platelet count recovered to preoperative value in 44% patients in group B versus only in 26% patients in group A at discharge (P=0.018). Moderate thrombocytopenia occurs more often in group A (41% vs. 26%) (P=0.008) while severe thrombocytopenia (<50 x 109) was observed in 6% in group A but never in group B. Platelets (P=0.007) and packed red blood cells (P=0.009) transfusion was significantly higher in the group A. The implantation of sutureless Perceval aortic valves was associated with a significant drop in platelet count postoperatively with slow recovery and higher platelets and packed red blood cells transfusion requirements. A prospective randomised trial is needed to confirm our findings.

In a trial of TAVR in patients with a small aortic annulus, a self-expanding valve was noninferior to a balloon-expandable valve for clinical outcomes and was superior for bioprosthetic-valve dysfunction through 12 months.

Valve-replacement outcomes were examined with statewide data in California. Bioprostheses were associated with higher long-term mortality than mechanical valves among patients up to 55 years of age for aortic-valve replacement and up to 70 years of age for mitral-valve replacement.

Reduced leaflet motion was detected on computed tomography in 22 patients in a clinical trial of transcatheter aortic-valve replacement (TAVR) and in 17 patients in two registries. The condition resolved with anticoagulation. Transcatheter aortic-valve replacement (TAVR) is a recent innovation in the management of aortic stenosis. The efficacy and safety of this therapeutic intervention have been studied in several randomized clinical trials. 1 – 6 The Portico Re-sheathable Transcatheter Aortic Valve System U.S. Investigational Device Exemption (PORTICO IDE) study is an ongoing, prospective clinical trial to evaluate TAVR with either a Portico valve (St. Jude Medical) or a commercially available valve. As specified in the PORTICO IDE protocol, computed tomography (CT) was performed in a subgroup of patients to assess the stent frame of the implanted valve. A finding of reduced leaflet motion on . . .

Subclinical leaflet thrombosis of bioprosthetic aortic valves after transcatheter valve replacement (TAVR) and surgical aortic valve replacement (SAVR) has been found with CT imaging. The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR. Patients enrolled between Dec 22, 2014, and Jan 18, 2017, in the RESOLVE registry, and between June 2, 2014, and Sept 28, 2016, in the SAVORY registry, had CT imaging done with a dedicated four-dimensional volume-rendered imaging protocol at varying intervals after TAVR and SAVR. We defined subclinical leaflet thrombosis as the presence of reduced leaflet motion, along with corresponding hypoattenuating lesions shown with CT. We collected data for baseline demographics, antithrombotic therapy, and clinical outcomes. We analysed all CT scans, echocardiograms, and neurological events in a masked fashion. Of the 931 patients who had CT imaging done (657 [71%] in the RESOLVE registry and 274 [29%] in the SAVORY registry), 890 [96%] had interpretable CT scans (626 [70%] in the RESOLVE registry and 264 [30%] in the SAVORY registry). 106 (12%) of 890 patients had subclinical leaflet thrombosis, including five (4%) of 138 with thrombosis of surgical valves versus 101 (13%) of 752 with thrombosis of transcatheter valves (p=0·001). The median time from aortic valve replacement to CT for the entire cohort was 83 days (IQR 33–281). Subclinical leaflet thrombosis was less frequent among patients receiving anticoagulants (eight [4%] of 224) than among those receiving dual antiplatelet therapy (31 [15%] of 208; p<0·0001); NOACs were equally as effective as warfarin (three [3%] of 107 vs five [4%] of 117; p=0·72). Subclinical leaflet thrombosis resolved in 36 (100%) of 36 patients (warfarin 24 [67%]; NOACs 12 [33%]) receiving anticoagulants, whereas it persisted in 20 (91%) of 22 patients not receiving anticoagulants (p<0·0001). A greater proportion of patients with subclinical leaflet thrombosis had aortic valve gradients of more than 20 mm Hg and increases in aortic valve gradients of more than 10 mm Hg (12 [14%] of 88) than did those with normal leaflet motion (seven [1%] of 632; p<0·0001). Although stroke rates were not different between those with (4·12 strokes per 100 person-years) or without (1·92 strokes per 100 person-years) reduced leaflet motion (p=0·10), subclinical leaflet thrombosis was associated with increased rates of transient ischaemic attacks (TIAs; 4·18 TIAs per 100 person-years vs 0·60 TIAs per 100 person-years; p=0·0005) and all strokes or TIAs (7·85 vs 2·36 per 100 person-years; p=0·001). Subclinical leaflet thrombosis occurred frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. Anticoagulation (both NOACs and warfarin), but not dual antiplatelet therapy, was effective in prevention or treatment of subclinical leaflet thrombosis. Subclinical leaflet thrombosis was associated with increased rates of TIAs and strokes or TIAs. Despite excellent outcomes after TAVR with the new-generation valves, prevention and treatment of subclinical leaflet thrombosis might offer a potential opportunity for further improvement in valve haemodynamics and clinical outcomes. RESOLVE (Cedars-Sinai Heart Institute) and SAVORY (Rigshospitalet).

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

IntroductionArthroscopic superior capsule reconstruction (ASCR) using fascia lata autograft is a new surgical technique developed to overcome irreparable rotator cuff tears. There is little information about graft tear after ASCR and its impact on clinical outcome. This study is to investigate the graft tear rate, pattern of failure, and its correlation with clinical outcomes after arthroscopic superior capsule reconstruction (ASCR).Materials and methodsFrom June 2013 to June 2016, 31 shoulders in 31 consecutive patients (mean 65.3 years) underwent ASCR using fascia lata autograft for irreparable large-to-massive tears. Magnetic resonance imaging (MRI) was performed before surgery and at mean 12.8 months (12–24 months) after surgery to assess fatty infiltration progression and graft integrity. Graft tear was defined as the loss of graft continuity and was categorized as medial and lateral rows according to the failure location. Acromiohumeral distance (AHD) was pre- and postoperatively measured with the standard radiograph. Pain visual analog scale (VAS) score, American Shoulder and Elbow Surgeons (ASES) score, constant score, and physical examination were used to assess clinical outcomes. Average follow-up was 15 months (range 12–24 months) after surgery.ResultsMean active forward elevation increased from 133° to 146° (P = 0.011). Mean VAS score, ASES score, and constant score significantly improved: from 6 to 2.5, 54.4 to 73.7, and 51.7 to 63.7, respectively (P < 0.001). There was no remarkable progression of fatty infiltration after surgery. AHD increased from 5.3 mm preoperatively to 6.4 mm postoperatively (P < 0.016). Nine patients (29%) showed graft tear on follow-up MRI: 7 and 2 at the medial and lateral rows, respectively. Although the intact graft group showed better outcomes than the graft tear group (pain VAS score 2.3 vs. 3.0; ASES score 74.1 vs. 69.8; constant score 63.4 vs. 57.9), the results were not statistically significant.ConclusionsGraft tear rate after ASCR assessed by MRI was 29%, and failures mostly occurred at the medial row. The graft tear group showed clinical improvement despite the recurred superior capsule defect.Level of evidenceIV, case series, treatment study.

Valve-in-valve transcatheter mitral valve replacement (ViV-TMVR) and redo surgical mitral valve replacement (redo-SMVR) are 2 treatment strategies for patients with bioprosthetic mitral valve dysfunction. We conducted a systematic review and meta-analysis to compare the outcomes of ViV-TMVR versus redo-SMVR. We searched PubMed, EMBASE, Cochrane, and Google Scholar for studies comparing outcomes of ViV-TMVR versus redo-SMVR in degenerated bioprosthetic mitral valves. We used a random-effects model to calculate odd ratios (ORs) with 95% confidence intervals (CIs). Outcomes included in-hospital, 30-day, 1-year, and 2-year mortality, stroke, bleeding, acute kidney injury, arrhythmias, permanent pacemaker insertion, and hospital length of stay (LOS). A total of 6 observational studies with 707 subjects were included. The median follow-up was 2.7 years. Despite their older age and greater co-morbidity burden, patients who underwent ViV-TMVR had a similar in-hospital mortality (OR 0.52, 95% CI 0.22 to 1.23, p = 0.14), 30-day mortality (OR 0.65, 95% CI 0.36 to 1.17, p = 0.15), 1-year mortality (OR 0.97, 95% CI 0.63 to 1.49, p = 0.89), and 2-year mortality (OR 1.17, 95% CI 0.65 to 2.13, p = 0.60) compared with redo-SMVR. ViV-TMVR was associated with significantly lower periprocedural complications, including stroke, bleeding, acute kidney injury, arrhythmias, and permanent pacemaker insertion, and shorter hospital LOS than redo-SMVR. In conclusion, ViV-TMVR was associated with better outcomes than redo-SMVR in patients with degenerated bioprosthetic mitral valves, including lower complication rates and shorter hospital LOS, with no significant difference in mortality rates. Large-scale randomized trials are needed to mitigate biases and confirm our findings. [Display omitted]

Purpose Most data regarding infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) comes from TAVI registries, rather than IE dedicated cohorts. The objective of our study was to compare the clinical and microbiological profile, imaging features and outcomes of patients with IE after SAVR with a biological prosthetic valve (IE-SAVR) and IE after TAVI (IE-TAVI) from 6 centres with an Endocarditis Team (ET) and broad experience in IE. Methods Retrospective analysis of prospectively collected data. From the time of first TAVI implantation in each centre to March 2021, all consecutive patients admitted for IE-SAVR or IE-TAVI were prospectively enrolled. Follow-up was monitored during admission and at 12 months after discharge. Results 169 patients with IE-SAVR and 41 with IE-TAVI were analysed. Early episodes were more frequent among IE-TAVI. Clinical course during hospitalization was similar in both groups, except for a higher incidence of atrioventricular block in IE-SAVR. The most frequently causative microorganisms were S. epidermidis , Enterococcus spp. and S. aureus in both groups. Periannular complications were more frequent in IE-SAVR. Cardiac surgery was performed in 53.6% of IE-SAVR and 7.3% of IE-TAVI (p=0.001), despite up to 54.8% of IE-TAVI patients had an indication. No differences were observed about death during hospitalization (32.7% vs 35.0%), and at 1-year follow-up (41.8% vs 37.5%), regardless of whether the patient underwent surgery or not. Conclusion Patients with IE-TAVI had a higher incidence of early prosthetic valve IE. Compared to IE-SAVR, IE-TAVI patients underwent cardiac surgery much less frequently, despite having surgical indications. However, in-hospital and 1-year mortality rate was similar between both groups.

Bioprosthetic heart valves (BHVs) are commonly used as heart valve replacements but they are prone to fatigue failure; estimating their remaining life directly from medical images is difficult. Analyzing the valve performance can provide better guidance for personalized valve design. However, such analyses are often computationally intensive. In this work, we introduce the concept of deep learning (DL) based finite element analysis (DLFEA) to learn the deformation biomechanics of bioprosthetic aortic valves directly from simulations. The proposed DL framework can eliminate the time-consuming biomechanics simulations, while predicting valve deformations with the same fidelity. We present statistical results that demonstrate the high performance of the DLFEA framework and the applicability of the framework to predict bioprosthetic aortic valve deformations. With further development, such a tool can provide fast decision support for designing surgical bioprosthetic aortic valves. Ultimately, this framework could be extended to other BHVs and improve patient care.