Structural Degeneration of a 9-Year-Old Tendyne: Treatment by Transfemoral Transseptal SAPIEN in Tendyne.

An 83-year-old woman presented 9 years after Tendyne transcatheter mitral valve replacement with acute severe decompensated heart failure. Transesophageal echocardiography reported severe transvalvular mitral regurgitation caused by degenerated Tendyne leaflets. A transfemoral transseptal valve-in-Tendyne procedure using a 26-mm SAPIEN device resulted in significant mitral regurgitation reduction and symptomatic recovery.

Thrombocytopenia after sutureless and standard stented aortic valve replacement: a retrospective analysis of risk factors, clinical course, and early outcome.

OBJECTIVES: Thrombocytopenia following Perceval aortic valve replacement has been described previously with variable outcome. Studies have lacked a robust analysis of platelet fluctuation and factors affecting it. We aimed to statistically describe the trend in thrombocyte variability as compared with conventional aortic valve replacement, and to assess predictors as well as impact on associated outcomes. METHODS: One hundred consecutive patients with first-time Perceval were retrospectively compared to 219 patients after Perimount Magna Ease valve replacement. The primary outcome was the serial thrombocyte count on day 0-6. Generalized estimating equations were used to analyse the data using fixed-effect models: for the effect of the post-operative day on platelet count, and random-effect models estimating both time-variant (platelets) and time in-variant variables (valve type, age, LV function, pre-op platelet level). RESULTS: Perceval patients were older (72 ± 1 vs 68 ± 1 years, p < 0.01) with higher NYHA status (3(2-3) vs 2(1-2), p < 0.001). Mean platelet count in the sutureless group was lowest on day 2 (91.9 ± 31.6 vs 121.7 ± 53.8 × 103 µl-1), and lower on day 4 (97.9 ± 44) and 6 (110.6 ± 61) compared to the conventional group (157.2 ± 60 and 181.7 ± 79) but did not result in a higher number of transfusions, bleeding or longer hospital stay (p > 0.05). Reduced platelet count was a strong predictor of red cell transfusion in the conventional (p = 0.016), but not in the sutureless group (p = 0.457). Age (Coef -1.025, 95%CI-1.649--0.401, p < 0.001) and CPB-time (Coef 0.186, 95%CI-0.371--0.001, p = 0.048) were predictors for lower platelet levels. CONCLUSION: Considering the older patient profile treated with Perceval, postoperative thrombocytopenia does not impact on outcome in terms of transfusions, complications or hospital stay.

Perceval sutureless bioprosthesis versus Perimount sutured bioprosthesis for aortic valve replacement in patients with aortic stenosis: a retrospective, propensity-matched study.

BACKGROUND: Rapid-deployment aortic valve replacement (RDAVR) is an alternative to conventional AVR (cAVR) for aortic stenosis. Benefits include a reduction in operative times, facilitation of minimal access surgery and superior haemodynamics compared to conventional valves. However, further evidence is required to inform guidelines, preferably in the form of propensity-matched studies that include mid-term follow-up data. METHODS: This was a single-centre, retrospective, propensity-matched cohort study comparing the Perceval and conventional Perimount Magna Ease valve for short- and mid-term clinical parameters and size-matched mid-term echocardiographic parameters (n = 102 in both groups) from 2014 to 2020. Data were extracted from a nationally managed dataset. RESULTS: There were no demographic differences between the matched groups. The Perceval group had shorter cross-clamp time (Perceval 62 [49-81] minutes; Perimount 79 [63-102] minutes, P < 0.001), shorter bypass time (Perceval 89 [74-114] minutes; Perimount 104 [84-137] minutes, P < 0.001), and more frequent minimally-invasive approaches (Perceval 28%; Perimount 5%, P < 0.001). Size-matched haemodynamics showed initially higher gradients in the Perceval group, but haemodynamics equalised at 12 + months. The Perceval group had a more favourable % change in the left ventricular posterior wall dimension at 2 + years (Perceval - 4.8 ± 18; Perimount 17 ± 2). CONCLUSIONS: The Perceval facilitated shorter operations, which may benefit intermediate-high-risk, elderly patients with comorbidities requiring concomitant procedures. It also facilitated minimally invasive surgery. Size-matched haemodynamic performance was similar at mid-term follow-up, with the Perceval possibly better facilitating regression of left ventricular hypertrophy.

Concomitant Transapical Aortic/Mitral Transcatheter Valve Replacement for Severe Aortic Stenosis and Mitral Annular Calcification.

Mitral regurgitation (MR) associated with mitral annular calcification (MAC) is surgically challenging, and valve-in-MAC procedures using transcatheter aortic valve replacement (TAVR) devices have poor outcomes. Transcatheter mitral valve replacement (TMVR) may be an option. Concomitant TAVR and TMVR are limited to 2 reports. We describe the first case of concomitant TAVR and TMVR-in-MAC procedures. (Level of Difficulty: Advanced.).

How to test adhesive strength: a biomechanical testing for aortic glue used in type a dissection repair.

OBJECTIVES: The aim of this study was to develop a method to quantify the peel force in an in vitro model simulating repair of ascending aortic dissections with tissue glue (Bioglue). METHODS: This study adapted an adhesive T-Peel test for the determination of the peel strength of adhesives by measuring the peeling force of a T-shaped bonded tissue. Measurements were performed on iatrogenic dissected ascending porcine aorta, which has been repaired with Bioglue using different pressure levels. Four conditions were tested: zero sample pressure according to the manufacturer's recommendation (n = 10), low (504 Pa; n = 11), moderate pressure (1711 Pa; n = 24) and pressure applied by a round shaped vascular 'Borst clamp' (1764 Pa; n = 23). Non-parametric one-way analysis of variance was applied for statistical significance. RESULTS: The median peel force (lower quartile, upper quartile) of aortic samples increased depending on the applied pressure: [no pressure 0.030 N/mm (0.016, 0.057), low pressure 0.040 N/mm (0.032, 0.070) and moderate pressure 0.214 N/mm (0.050, 0.304)]. Samples pressurized with the Borst clamp reached 0.078 N/mm (0.046, 0.152), which was comparable to the peel force of the unpeeled controls [0.107 N/mm (0.087, 0.124)]. Compared to samples without pressure, Bioglue with the application of the Borst clamp (P = 0.021) and with moderate pressure (P = 0.0007) performed significantly better. CONCLUSIONS: The novel T-Peel test offers an attractive method to test tissue glues in defined in vitro environments. Bioglue peel force increased with pressure on the aortic sample in contrast to low or no pressure as per the manufacturer's recommendation. Modifying current recommended use may aid in increasing effectiveness of this approach.

Midterm Outcomes in Patients With Aortic Stenosis Treated With Contemporary Balloon-Expandable and Self-Expanding Valves: Does Valve Size Have an Impact on Outcome?

Background No data currently exist comparing the contemporary iterations of balloon-expandable (BE) Edwards SAPIEN 3/Ultra and the self-expanding (SE) Medtronic Evolut PRO/R34 valves. The aim of the study was the comparison of these transcatheter heart valves with emphasis on patients with small aortic annulus. Methods and Results In this retrospective registry, periprocedural outcomes and midterm all-cause mortality were analyzed. A total of 1673 patients (917 SE versus 756 BE) were followed up for a median of 15 months. A total of 194 patients died (11.6%) during follow-up. SE and BE groups showed similar survival at 1 (92.6% versus 90.6%) and 3 (80.3% versus 85.2%) years (Plog-rank=0.136). Compared with the BE group, patients treated with the SE device had lower peak (16.3±8 mm Hg SE versus 21.9±8 mm Hg BE) and mean (8.8±5 mm Hg SE versus 11.5±5 mm Hg BE) gradients at discharge. Conversely, the BE group demonstrated lower rates of at least moderate paravalvular regurgitation postoperatively (5.6% versus 0.7% for SE and BE valves, respectively; P<0.001). In patients treated with small transcatheter heart valves (≤26 mm for SE and ≤23 mm for BE; N=284 for SE and N=260 for BE), survival was higher among patients treated with SE valves at both 1 (96.7% SE versus 92.1% BE) and 3 (91.8% SE versus 82.2% BE) years (Plog-rank=0.042). In propensity-matched patients treated with small transcatheter heart valve, there remained a trend for higher survival among the SE group at both 1 (97% SE versus 92.3% BE) and 3 years (91.8% SE versus 78.7% BE), Plog-rank=0.096). Conclusions Real-world comparison of the latest-generation SE and BE devices demonstrated similar survival up to 3 years' follow-up. In patients with small transcatheter heart valves, there may be a trend for improved survival among those treated with SE valves.

Sex disparities in left ventricular assist device implantation outcomes: A systematic review and meta-analysis of over 50 000 patients.

BACKGROUND: Left ventricular assist devices (LVAD) represent an important therapeutic option for patients progressing to end-stage heart failure. Women have been historically underrepresented in LVAD studies, and have been reported to have worse outcomes despite technological optimisation. We aimed to systematically explore the evidence on sex disparities in the use and outcomes of LVAD implantation. METHODS: A systematic database search with meta-analysis was conducted of comparative original articles of men versus women undergoing LVAD implantation, in EMBASE, MEDLINE, Cochrane database and Google Scholar, from inception to July 2022. Primary outcomes were stroke (haemorrhagic and ischaemic) and early/overall mortality. Secondary outcomes were LVAD thrombosis, right VAD implantation, major bleeding, kidney dysfunction, and device/driveline infection. RESULTS: Our search yielded 137 relevant studies, including 22 meeting the inclusion criteria with a total of 53 227 patients (24.2% women). Overall mortality was higher in women (odds ratio [OR] 1.35, 95% confidence interval [CI] 1.05-1.62, p = 0.02), as was overall stroke (OR 1.32, 95%CI 1.06-1.66, p = 0.01), including ischemic (OR 1.80, 95%CI 1.22-2.64, p = 0.003) and haemorrhagic (OR 1.72, 95%CI 1.09-2.70, p = 0.02). Women had more frequent right VAD implantation (OR 2.11, 95%CI 1.24-3.57, p = 0.006) and major bleeding (OR 1.40, 95%CI 1.06-1.85, p = 0.02). Kidney dysfunction, LVAD thrombosis, and device/driveline infections were comparable between sexes. CONCLUSIONS: Our analysis suggests that women face a greater risk of adverse events and mortality post-LVAD implantation. Although the mechanisms remain unclear, the difference in outcomes is thought to be multifactorial. Further research, that includes comprehensive pre-operative characteristics and post-operative outcomes, is encouraged.

Neuroprotective strategies with circulatory arrest in open aortic surgery - A meta-analysis.

OBJECTIVE: Deep hypothermic circulatory arrest (DHCA) in aortic surgery is associated with morbidity and mortality despite evolving strategies. With the advent of antegrade cerebral perfusion (ACP), moderate hypothermic circulatory arrest (MHCA) was reported to have better outcomes than DHCA. There is no standardised guideline or consensus regarding the hypothermic strategies to be employed in open aortic surgery. Meta-analysis was performed comparing DHCA with MHCA + ACP in patients having aortic surgery. METHODS: A systematic review of the literature was undertaken. Any studies with DHCA versus MHCA + ACP in aortic surgeries were selected according to specific inclusion criteria and analysed to generate summative data. Statistical analysis was performed using STATS Direct. The primary outcomes were hospital mortality and post-operative stroke. Secondary outcomes were cardiopulmonary bypass time (CPB), post-operative blood transfusion, length of ICU stay, respiratory complications, renal failure and length of hospital stay. Subgroup analysis of primary outcomes for Arch surgery alone was also performed. RESULTS: Fifteen studies were included with a total of 5869 patients. There was significantly reduced mortality (Pooled OR = +0.64, 95% CI = +0.49 to +0.83; p = 0.0006) and stroke rate (Pooled OR = +0.62, 95% CI = +0.49 to +0.79; p < 0.001) in the MHCA group. MHCA was associated significantly with shorter CPB times, shorter duration in ICU, less pulmonary complications, and reduced rates of sepsis. There was no statistical difference between the two groups in terms of circulatory arrest times, X-Clamp times, total operation duration, transfusion requirements, renal failure and post-op hospital stay. CONCLUSION: MHCA + ACP are associated with significantly better post-operative outcomes compared with DHCA for both mortality and stroke and majority of the secondary outcomes.

Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience.

AIMS: Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real-world data have not yet been reported. This study aimed to assess procedural and 30-day outcomes of TMVI in a real-world patient cohort. METHOD AND RESULTS: All consecutive patients undergoing implantation of a transapically delivered self-expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high-risk patients included (43% female, mean age 75 ± 7 years, mean STS-PROM 7.2 ± 5.3%), 25% was treated for an off-label indication (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (New York Heart Association [NYHA] functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 95% (38% primary, 37% secondary, and 25% mixed aetiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30-day all-cause mortality was 12%. At early clinical follow-up, MR reduction was sustained and there were significant reductions of pulmonary pressure (systolic pulmonary artery pressure 52 vs. 42 mmHg, p < 0.001), and tricuspid regurgitation severity (p = 0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p < 0.001). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off-label indication (74% vs. 81% for off- vs. on-label, p = 0.41). CONCLUSION: In a real-world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement.

Converging rapid deployment prostheses with minimal access surgery: analysis of early outcomes.

BACKGROUND: Sutureless prostheses may have added benefit when combined with minimal access surgery, although this has not been fully assessed in the literature. This study aims to provide a comparative analysis of the Perceval valve comparing median sternotomy (MS) with mini-sternotomy (MIS). METHODS: A retrospective analysis of prospectively collected data was conducted for all isolated aortic valve replacement (AVR), using the Perceval valve, for severe aortic stenosis cases in the period 2014 to 2019. Patients undergoing concomitant valve or revascularisation surgery were excluded. RESULTS: A total of 78 patients were included: MS group 41; MIS group 37. Operatively, bypass times were comparable between MS and MIS groups (mean 89.3 vs 83.4, p = 0.307), as were aortic cross clamp times (58.4 vs 55.9, p = 0.434). There were no operative deaths or new onset post-operative neurology. MIS was a predictor of reduced stay in the intensive care unit (coef - 3.25, 95% CI [- 4.93, - 0.59], p = 0.036) and hospital stay overall (p = 0.004). Blood transfusion units were comparable as were the incidence of heart block (n = 5 vs n = 3, p = 0.429) and new onset atrial fibrillation (n = 15 vs n = 9, p = 0.250). Follow-up echocardiography found a significant improvement in effective orifice area, left ventricular dimension and volume indices, and LVEF (p > 0.05) for all patients. Multivariate analysis found mini-sternotomy to be a predictor for reduced LV diastolic volume (coef - 0.35, 95% CI [- 1.02, - 0.05], p = 0.05). CONCLUSIONS: The combination of minimal access surgery and sutureless AVR may enhance patient recovery and provide early LV remodelling.

The impact of COVID-19 pandemic on aortic valve surgical service: a single centre experience.

BACKGROUND: The coronavirus-disease 2019 (COVID-19) pandemic imposed an unprecedented burden on the provision of cardiac surgical services. The reallocation of workforce and resources necessitated the postponement of elective operations in this cohort of high-risk patients. We investigated the impact of this outbreak on the aortic valve surgery activity at a single two-site centre in the United Kingdom. METHODS: Data were extracted from the local surgical database, including the demographics, clinical characteristics, and outcomes of patients operated on from March 2020 to May 2020 with only one of the two sites resuming operative activity and compared with the respective 2019 period. A similar comparison was conducted with the period between June 2020 and August 2020, when operative activity was restored at both institutional sites. The experience of centres world-wide was invoked to assess the efficiency of our services. RESULTS: There was an initial 38.2% reduction in the total number of operations with a 70% reduction in elective cases, compared with a 159% increase in urgent and emergency operations. The attendant surgical risk was significantly higher [median Euroscore II was 2.7 [1.9-5.2] in 2020 versus 2.1 [0.9-3.7] in 2019 (p = 0.005)] but neither 30-day survival nor freedom from major post-operative complications (re-sternotomy for bleeding/tamponade, transient ischemic attack/stroke, renal replacement therapy) was compromised (p > 0.05 for all comparisons). Recommencement of activity at both institutional sites conferred a surgical volume within 17% of the pre-COVID-19 era. CONCLUSIONS: Our institution managed to offer a considerable volume of aortic valve surgical activity over the first COVID-19 outbreak to a cohort of higher-risk patients, without compromising post-operative outcomes. A backlog of elective cases is expected to develop, the accommodation of which after surgical activity normalisation will be crucial to monitor.

Aortic valve neocuspidization with autologous pericardium in adult patients: UK experience and meta-analytic comparison with other aortic valve substitutes.

OBJECTIVES: We sought to provide further evidence on the safety and efficacy of aortic valve neocuspidization (AVNeo) using autologous pericardium in adult patients with aortic valve disease by reporting clinical and echocardiographic results from the first UK experience and performing a meta-analytic comparison with other biological valve substitutes. METHODS: We reported clinical and echocardiographic outcomes of 55 patients (mean age 58 ± 15 years) undergoing AVNeo with autologous pericardium in 2 UK centres from 2018 to 2020. These results were included in a meta-analytic comparison between series on AVNeo (7 studies, 1205 patients, mean weighted follow-up 3.6 years) versus Trifecta (10 studies, 8705 patients, 3.8 years), Magna Ease (3 studies, 3137 patients, 4.1 years), Freedom Solo (4 studies, 1869 patients, 4.4 years), Freestyle (4 studies, 4307 patients, 7 years), Mitroflow (4 studies, 4760 patients, 4.1 years) and autograft aortic valve (7 papers, 3839 patients, 9.1 years). RESULTS: In the present series no patients required intraoperative conversion. After mean follow-up of 12.5 ± 0.9 months, 3 patients presented with endocarditis and 1 required reintervention. The remaining patients had absent or mild aortic valve insufficiency with very low peak and mean transvalvular gradients (16 ± 3.7 and 9 ± 2.2 mmHg, respectively). Meta-analytic estimates showed non-significant difference between AVNeo and all but Magna Ease valves with regards to structural valve degeneration, reintervention and endocarditis. When compared Magna Ease valve, AVNeo and other valve substitutes showed an excess of valve-related events. CONCLUSIONS: AVNeo is safe, associated with excellent haemodynamic profile. Its midterm risk of valve-related events is comparable to most biological valve substitutes. Magna Ease is potentially the best biological choice as far as risk of reintervention is concerned.

Leaflet thrombosis after valve-in-valve transcatheter aortic valve implantation: a case series.

BACKGROUND: Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) in degenerated surgical aortic valve replacement (SAVR) is an alternative to redo-SAVR. However, reports on leaflet thrombosis following ViV-TAVI are emerging and subclinical thrombosis has gained recent attention. Although the incidence of transcatheter heart valve (THV) thrombosis after TAVI for native aortic valve disease is low, current imaging studies suggest the incidence of subclinical THV thrombosis may be significantly higher. While anticoagulation strategies for THV patients for native aortic stenosis presenting with symptomatic obstructive thrombosis has been described, the optimal management and anticoagulation therapy of patients with THV thrombosis following ViV-TAVI are less evident. CASE SUMMARY: We report a case series of three patients presenting with early and late THV thrombosis after ViV-TAVI. Two patients presented clinically on single antiplatelet therapy and one patient presented with subclinical valve thrombosis whilst taking a non-vitamin K oral anticoagulation agent. DISCUSSION: Leaflet thrombosis after ViV-TAVI is an important cause of THV degeneration and may present subclinically. Imaging modalities such as serial transthoracic echocardiograms and multidetector computerized tomography aid diagnosis and guide management. Patient-individualized risk- vs. -benefit prophylactic post-procedural oral anticoagulation may be indicated.