Intraoperative haemoadsorption for antithrombotic drug removal during cardiac surgery: initial report of the international safe and timely antithrombotic removal (STAR) registry.

Intraoperative antithrombotic drug removal by haemoadsorption is a novel strategy to reduce perioperative bleeding in patients on antithrombotic drugs undergoing cardiac surgery. The international STAR registry reports real-world clinical outcomes associated with this application. All patients underwent cardiac surgery before completing the recommended washout period. The haemoadsorption device was incorporated into the cardiopulmonary bypass (CPB) circuit. Patients on P2Y12 inhibitors comprised group 1, and patients on direct-acting oral anticoagulants (DOAC) group 2. Outcome measurements included bleeding events according to standardised definitions and 24-hour chest-tube-drainage (CTD). 165 patients were included from 8 institutions in Austria, Germany, Sweden, and the UK. Group 1 included 114 patients (62.9 ± 11.6years, 81% male) operated at a mean time of 33.2 h from the last P2Y12 inhibitor dose with a mean CPB duration of 117.1 ± 62.0 min. Group 2 included 51 patients (68.4 ± 9.4years, 53% male), operated at a mean time of 44.6 h after the last DOAC dose, with a CPB duration of 128.6 ± 48.4 min. In Group 1, 15 patients experienced a BARC-4 bleeding event (13%), including 3 reoperations (2.6%). The mean 24-hour CTD was 651 ± 407mL. In Group 2, 8 patients experienced a BARC-4 bleeding event (16%) including 4 reoperations (7.8%). The mean CTD was 675 ± 363mL. This initial report of the ongoing STAR registry shows that the intraoperative use of a haemoadsorption device is simple and safe, and may potentially mitigate the expected high bleeding risk of patients on antithrombotic drugs undergoing cardiac surgery before completion of the recommended washout period.Clinical registration number: ClinicalTrials.gov identifier: NCT05077124.

EGFR and MMP-9 are associated with neointimal hyperplasia in systemic-to-pulmonary shunts in children with complex cyanotic heart disease.

Systemic-to-pulmonary shunt malfunction contributes to morbidity in children with complex congenital heart disease after palliative procedure. Neointimal hyperplasia might play a role in the pathogenesis increasing risk for shunt obstruction. The aim was to evaluate the role of epidermal growth factor receptor (EGFR) and matrix-metalloproteinase 9 (MMP-9) in the formation of neointimal within shunts. Immunohistochemistry was performed with anti-EGFR and anti-MMP-9 on shunts removed at follow-up palliative or corrective procedure. Whole-genome single-nucleotide polymorphisms genotyping was performed on DNA extracted from patients´ blood samples and allele frequencies were compared between the group of patients with shunts displaying severe stenosis (≥ 40% of lumen) and the remaining group. Immunohistochemistry detected EGFR and MMP-9 in 24 of 31 shunts, located mainly in the luminal area. Cross-sectional area of EGFR and MMP-9 measured in median 0.19 mm2 (IQR 0.1-0.3 mm2) and 0.04 mm2 (IQR 0.03-0.09 mm2), respectively, and correlated positively with the area of neointimal measured on histology (r = 0.729, p < 0.001 and r = 0.0479, p = 0.018, respectively). There was a trend of inverse correlation between the dose of acetylsalicylic acid and the degree of EGFR, but not MMP-9, expression within neointima. Certain alleles in epidermal growth factor (EGF) and tissue inhibitor of metalloproteinases 1 (TIMP-1) were associated with increased stenosis and neointimal hyperplasia within shunts. EGFR and MMP-9 contribute to neointimal proliferation in SP shunts of children with complex cyanotic heart disease. SP shunts from patients carrying certain risk alleles in the genes encoding for EGF and TIMP-1 displayed increased neointima.

Surgical explantation of failed transcatheter heart valves: indications and results.

Given the recent surge in transcatheter heart valve replacement (THVR), cardiac surgeons will surely face the challenge of eventual explantation. The aim of this study was to determine indications for reoperation, while exploring pertinent technical aspects and survival after THV explantation in a cohort originally deemed high risk or even inoperable. Between February 2008 and March 2019, 31 patients with failed transcatheter aortic valve replacement (TAVR) underwent surgical explantations at our facility. Data were prospectively collected for retrospective analysis of procedural indications, technical issues, and postoperative survival. The major reason for TAVR removal was bioprosthetic valve failure (BVF) due to infective endocarditis (IE: 16/31 [51.6%]), non-structural (NSVD: 14/31 [45.2%]) and structural (SVD: 1/31 [3.2%]) valve deterioration accounting for the rest. Mean age at THV explantation was 76.3 ± 8.3 years, and median time from TAVR to explantation was 153 days (0 days-56.6 months). Median ICU and hospital stay were 6 days (1-44 days) and 23 days (8-62 days), respectively. Thirty-day and 1-year survival rates were 74.2% and 67.2%, respectively. Median follow-up interval after explantation was 364 days (3 days-80 months). Mean cardiopulmonary bypass time was 124.6 ± 46.8 min, and mean aortic cross-clamp time was 84.3 ± 32.9 min. There was no need for unplanned aortic root repair owing to tissue damage during dissection of the TAVR from surrounding tissue. The most common reason for THV explantation was (a) BVF for IE and (b) BVF secondary to NSVD. Although 30-day and 1-year mortality rates in this multimorbid cohort were predictably high, no procedural mortalities occurred.

Hemodynamic Comparison between the Avalus and the Perimount Magna Ease Aortic Bioprosthesis up to 5 Years.

BACKGROUND: We aimed to compare hemodynamic performance of the Avalus (Medtronic) and the Perimount Magna Ease (PME, Edwards Lifesciences) bioprosthesis up to 5 years by serial echocardiographic examinations. METHODS: In patients undergoing aortic valve replacement, 58 received PME prostheses between October 2007 and October 2008, and another 60 received Avalus prostheses between October 2014 and November 2015. To ensure similar baseline characteristics, we performed a propensity score matching based on left ventricular ejection fraction, age, body surface area, and aortic annulus diameter measured by intraoperative transesophageal echocardiography. Thereafter, 48 patients remained in each group. Mean age at operation was 67 ± 6 years and mean EuroSCORE-II was 1.7 ± 1.1. Both values did not differ significantly between the two groups. RESULTS: At 1 year the mean pressure gradient (MPG) was 15.4 ± 4.3 mm Hg in the PME group and 14.7 ± 5.1 mm Hg in the Avalus group (p = 0.32). The effective orifice area (EOA) was 1.65 ± 0.45 cm2 in the PME group and 1.62 ± 0.45 cm2 in the Avalus group (p = 0.79). At 5 years the MPG was 16.6 ± 5.1 mm Hg in the PME group and 14.7 ± 7.1 mm Hg in the Avalus group (p = 0.20). The EOA was 1.60 ± 0.49 cm2 in the PME group and 1.51 ± 0.40 cm2 in the Avalus group (p = 0.38). Five-year survival was 88% in the PME group and 91% in the Avalus group (p = 0.5). In the PME group, there were no reoperations on the aortic valve, whereas in the Avalus group three patients required a reoperation due to endocarditis. CONCLUSION: Both bioprostheses exhibit similar hemodynamic performance during a 5-year follow-up.

Aortic valve neocuspidization using autologous pericardium compared to surgical aortic valve replacement.

INTRODUCTION: Aortic valve neocuspidization (AVNeo) for trileaflet aortic valve reconstruction using autologous pericardium (Ozaki procedure) depicts an encouraging new technique for the surgical treatment of aortic valve pathologies. The current study analyzes the early hemodynamic outcome of AVneo compared with surgical aortic valve replacement (SAVR) using the Abbott/St. Jude Trifecta aortic valve biological prostheses. METHODS: All patients who underwent either AVNeo or SAVR between March 2017 and April 2020 were included. Exclusion criteria were emergency cases, endocarditis, redo- or additional root procedures. Main endpoints were differences between the two groups in terms of the effective orifice area (EOA) and the effective orifice area index (EOAI) at discharge. RESULTS: During the study period, 105 AVNeo patients and 458 SAVR patients met the inclusion criteria. EOA was significantly higher in the AVNeo group (2.4 cm2 ± 0.8 vs. 2.1 cm2 /m2 ± 0.6 in the SAVR group, respectively; p < .001). Multiple regression analysis, including AVNeo, annulus size, bicuspid valve, preoperative stenosis, left ventricular ejection fraction (LVEF), and diastolic diameter (LVEDD) found two factors, which favor larger EOA: Annulus size (p < .0001) and AVneo (p = .005). EOAI was significantly higher in the AVNeo group (1.23 ± 0.4 vs. 1.02 cm2 /m2 ± 0.3, respectively; p < .001). Multiple regression analysis for EOAI showed effects for AVneo (p = .005) and bicuspid valve (p = .029). Mean pressure gradients (MPG) were lower in the AVNeo group than in the SAVR group (AVNeo: MPG = 8.0 mmHg ± 3.6 vs. SAVR: MPG = 8.3 mmHg ± 3.6), but this finding did not reach statistical significance (p = .091). CONCLUSIONS: AVNeo shows significantly larger EOA and EOAI compared to SAVR using the Abbott/St. Jude Trifecta aortic valve biological prostheses.

Surgical treatment of isolated tricuspid valve endocarditis: Midterm data.

BACKGROUND: Isolated tricuspid valve endocarditis (TVE) is a rare disease which is managed medically in most patients. Only in specific cases, surgical intervention becomes necessary. Hence, data about surgical outcomes are sparse. This study reports on the operative experience in patients with isolated TVE over a period of 20 years. METHODS: We retrospectively analyzed 32 patients with isolated TVE who underwent surgery from February 2001 to June 2021 at the German Heart Centre Munich. RESULTS: Thirty-day mortality was 3.1%. Overall survival was 89.9± 5.5% at 1 year and 76.9 ± 8.5% at 5 years. Cumulative incidence for reoperation was 11.1 ± 6.0% at 5 years. Four patients (12.5%) were treated for recurrent endocarditis. Tricuspid valve repair (TVr) was achieved in 16 patients (50%). If the subvalvular apparatus (n = 10) was involved, tricuspid valve replacement was performed more frequently. CONCLUSIONS: Mortality in patients with isolated TVE undergoing cardiac surgery is high. In half of the cases, TVr was achieved but was less likely in patients with affected subvalvular apparatus.

Oral bacteria in infective endocarditis requiring surgery: a retrospective analysis of 134 patients.

OBJECTIVES: It has been reported that bacteria associated with infective endocarditis originate from the oral cavity in 26-45% of cases. However, little is known on the counts and species of periodontal microbiota in infected heart valves. The aim of this study was to identify these aspects of periodontal microbiota in infective endocarditis and to potentially initiate a dental extraction concept for periodontally compromised teeth concerning patients requiring heart valve surgery. MATERIALS AND METHODS: The retrospective study group consisted of tissue samples from infected heart valves of 683 patients who had undergone heart valve surgery. Before patients had undergone cardiac surgery, the following laboratory tests confirmed the occurrence of endocarditis in all patients: blood cultures, echocardiography, electrocardiography, chest X-ray, and electrophoresis of the serum proteins. The specimens were aseptically obtained and deep frozen immediately following surgery. Microbiological diagnosis included proof of germs (dichotomous), species of germs, and source of germs (oral versus other). RESULTS: Microbiota was detected in 134 (31.2%) out of 430 enrolled patients. Oral cavity was supposed to be the source in 10.4% of cases, whereas microbiota of the skin (57.5%) and gastrointestinal tract (GIT, 24.6%) were detected considerably more frequently. Moreover, periodontal bacteria belonged mostly to the Streptococci species and the yellow complex. None of the detected bacteria belonged to the red complex. CONCLUSION: Most frequently, the skin and GIT represented the site of origin of the microbiota. Nevertheless, the oral cavity represented the source of IE in up to 10%. Consequently, it needs to be emphasized that a good level of oral hygiene is strongly recommended in all patients undergoing heart valve surgery in order to reduce the bacterial load in the oral cavity, thereby minimizing the hematogenous spread of oral microbiota. The prerequisites for conservative dental treatment versus radical tooth extraction must always be based on the patient's cooperation, and the clinical intraoral status on a sense of proportion in view of the overall clinical situation due to the underlying cardiac disease. CLINICAL RELEVANCE: The oral cavity is a source of oral microbiota on infected heart valves. Patients requiring heart valve surgery should always undergo a critical evaluation of dental treatment affecting periodontally compromised teeth, favoring a systematic, conservative-leaning recall.

Anatomical reasons for failure of dual-filter cerebral embolic protection application in TAVR: A CT-based analysis.

BACKGROUND: The dual-filter Sentinel™ Cerebral Protection System (Sentinel-CPS) is increasingly used during transcatheter aortic valve replacement (TAVR). However, complex vascular anatomy may challenge Sentinel-CPS deployment. AIM OF THE STUDY: We sought to investigate the impact of anatomic features of the aortic arch and the supra-aortic arteries on technical device failure of Sentinel-CPS application. METHODS: Analysis of the multislice computed tomography pre-TAVR aortograms of all patients undergoing TAVR with Sentinel-CPS between 2016 and 2020 (n = 92) was performed. We investigated the impact of aortic arch anatomy, configuration, and the angles of the supra-aortic arteries, including the determination of vascular tortuosity index on device failure of Sentinel-CPS application. RESULTS: The Sentinel-CPS was applied successfully in 83 patients (90.2%). Device failure in nine patients (9.8%) was due to the infeasibility to perform correct deployment of both filters (n = 7) and to obtain peripheral radial access (n = 2). Patients with a failure of Sentinel-CPS application had a higher right subclavian tortuosity index (217 [92-324] vs. 150 [42-252], p = .046), a higher brachiocephalic tortuosity index (27 [5-51] vs. 10 [0-102], p = 0.033) and a larger angulation of the brachiocephalic artery (59° [22-80] vs. 39° [7-104], p = .014) compared with patients with successful application. A brachiocephalic angle more than 59° was predictive for device failure. No differences in aortic arch anatomy or common carotid artery tortuosity were detected between the groups. CONCLUSIONS: Brachiocephalic tortuosity was found to be associated with failure of Sentinel-CPS application. Filter-based usage should be avoided in TAVR patients with a brachiocephalic angle more than 59°.

Reasons for Failure of Systemic-to-Pulmonary Artery Shunts in Neonates.

BACKGROUND: Systemic-to-pulmonary artery shunt placement is an established palliative procedure for congenital heart disease. Although it is thought to be a simple operation, it is associated with significant morbidity and mortality. METHODS: Data for all neonates who underwent surgery for a systemic-to-pulmonary artery shunt between 2000 and 2016 were reviewed. The study endpoints were shunt failure and shunt-related mortality. Shunt failure was defined as a shunt dysfunction because of thrombosis or stenosis requiring intervention or reoperation; shunt mortality was defined as death because of a shunt dysfunction. RESULTS: A total of 305 shunts (central shunt, n = 135; Blalock-Taussig shunt, n = 170) were implanted in 280 patients. The median patients' age at the time of surgery was 9 days (1-31 days). The median shunt size was 3.5 mm (3-4 mm). Twenty-four patients (8%) were diagnosed with a shunt failure, with a median time of 7 days (0-438 days). Freedom from shunt failure at 1 year was 91.6% ± 2%. A shunt-related mortality was ascertained for 12 patients (4%). Freedom from shunt-related mortality at 1 year was 96% ± 1%. Perioperative platelet transfusion (p = 0.01), central shunt (p = 0.02), 3-mm shunt size (p = 0.02), and postoperative extra corporeal membrane oxygenation (ECMO) (p < 0.01) were identified as risk factors for shunt failure. Platelet transfusion (p = 0.04) and postoperative ECMO (p < 0.01) were further identified as risk factors for shunt mortality. CONCLUSION: Based on these data, we recommend implanting a modified Blalock-Taussig shunt of at least 3.5 mm in neonates. Perioperative platelet transfusion and postoperative ECMO increase the risk of shunt failure.

Incidence and Risk Factors for Right Ventricular Outflow Tract Obstruction after the Arterial Switch Operation.

BACKGROUND: The aim of this study was to evaluate the incidence and risk factors for the development of right ventricular outflow tract obstruction (RVOTO) after the arterial switch operation (ASO). METHODS: Between 1983 and 2014, a total of 688 patients underwent ASO. RVOTO was defined as any obstruction of the right ventricular outflow tract (RVOT) requiring reintervention. RESULTS: RVOTO developed in 79 patients (11%) at a median time of 3.8 years (range, 1 day-23.6 years) after ASO. Freedom from RVOT reintervention was 96 ± 1, 89 ± 1, and 83 ± 2% at 1, 10, and 25 years, respectively. Independent risk factors for the development of RVOTO in a Cox's regression model were side-by-side great arteries (p < 0.001), aortic arch anomalies (p < 0.001), use of a pericardial patch for augmentation of the coronary buttons (p < 0.001), and a peak gradient more than 20 mm Hg over the RVOT at discharge (p < 0.001). CONCLUSION: The incidence of RVOTO after ASO is not negligible. Complex morphology, such as side-by-side great arteries and aortic arch anomalies influences the development of RVOTO.

Impact of Characteristics at Stage-2-Palliation on Outcome Following Fontan Completion.

The optimal timing of stage-2-palliation (S2P) in single left ventricle is not clear. The aim of this study was to identify S2P related factors associated with outcomes after total cavopulmonary connection (TCPC), particularly relative to the dominant systemic ventricle. A total of 405 patients who underwent both S2P and TCPC at our institute between 1997 and 2017 was included. Patients were divided into two groups, dominant right ventricle (RV type, n = 235) and dominant left ventricle (LV type, n = 170). S2P related factors associated with mortality, postoperative ventricular function, and late exercise capacity following TCPC, were analyzed. The median age at S2P was 4 [3-7] and 6 [3-11] months in RV and LV type patients, respectively (p = 0.092). Survival after TCPC was similar in RV and LV type patients (p = 0.280). In those with RV type, risk factors for mortality following TCPC were older age (p < 0.001), heavier weight (p = 0.001), higher PAP (p < 0.001), higher TPG (p = 0.010), and lower SO2 (p = 0.008) at S2P. In those with LV type, no risk factor was identified. Risk factors for postoperative impaired ventricular function were older age and higher weight at S2P in both RV and LV type patients. Older age at S2P was also identified as a risk for inferior peak oxygen uptake (VO2) years after TCPC both in RV and LV type patients. Older age at S2P was associated with higher mortality after Fontan completion only in RV type patients. However, it was associated with postoperative ventricular dysfunction and lower exercise capacity after TCPC in both RV and LV type patients.

Risk Factors for Failure of Systemic-to-Pulmonary Artery Shunts in Biventricular Circulation.

Systemic-to-pulmonary artery shunt placement is an established palliative procedure for congenital heart disease, but it is associated with high morbidity and mortality. Data of all patients with biventricular circulation who underwent systemic-to-pulmonary artery shunt implantation between 2000 and 2016 were reviewed. Endpoints of the study were shunt failure and shunt-related mortality. Shunt failure was defined as any shunt dysfunction requiring intervention or reoperation. Shunt-related mortality was defined as death due to shunt dysfunction. A total of 217 shunts (central shunt, n = 131, Blalock-Taussig shunt, n = 86) were implanted in 178 patients. The median age of the patients was 98 days [1 day to 1.2 years]. Corrective surgery was performed at a median time of 0.6 years [3 months to 7 years] after shunt placement. Shunt failure was diagnosed in 21 patients (9.6%) at a median time of 14.6 days [0 days to 2 years]. Causes of shunt failure were stenosis (n = 11; 5%) and thrombosis (n = 10; 4.6%). The rate of freedom from shunt failure was 89.9 ± 2.6% at 1 year, the rate of shunt-related mortality was 3% (n = 5), and the rate of freedom from shunt-related mortality at 1 year was 97.5 ± 1%. Platelet transfusion was required in 43 patients (20%), all for postoperative thrombocytopenia. Perioperative platelet transfusion (p = 0.03) and shunt size of 3 mm (p = 0.03) were identified as risk factors for shunt failure. Shunt size of 3 mm was also identified as a risk factor for shunt-related mortality. The ideal shunt size in patients with biventricular circulation requiring a systemic-to-pulmonary artery shunt is 3.5 mm or larger. Platelet transfusion increases the risk of shunt failure and should be avoided. Type of shunt and diagnosis have no influence on morbidity or mortality after shunt placement.

Functional Mitral Valve Regurgitation: Mitral Valve Repair or Replacement? Our "Road Map" for the Appropriate Strategy.

Objectives: The optimal surgical approach for the treatment of functional mitral regurgitation (FMR) remains controversial. Current guidelines suggest that the surgical approach has to be tailored to the individual patient. The aim of the present study was to clarify further aspects of this tailored treatment. Methods: From 01/2006 to 12/2015, 390 patients underwent mitral valve (MV) surgery for FMR (ischemic n = 241, non-ischemic n = 149) at our institution. A regression analysis was used to determine the effect of MV repair or replacement on survival. The patients were analyzed according to the etiology of the MR (ischemic or non-ischemic), different age groups (<65 years, 65-75 years, and >75 years), LV function, and LV dimensions, as well as the underlying heart rhythm. Results: The overall survival rates for the repair group at 1, 5, and 8 years were 86.1 ± 1.9%, 70.6 ± 2.6%, and 55.1 ± 3.1%, respectively. For the same intervals, the survival rates in patients who underwent MV replacement were 75.9 ± 4.5%, 58.6 ± 5.4%, and 40.9 ± 6.4%, respectively (p = 0.003). Patients younger than 65 years, with an ischemic etiology of FMR, poor ejection fraction (<30%), severe dilatation of left ventricle (LVEDD > 60mm), and presence of atrial fibrillation had significantly higher mortality rates after MV replacement (HR, 3.0; CI, 1.3-6.9; p = 0.007). Patients between 65 and 75 years of age had a higher risk of death when undergoing mitral valve replacement (HR, 1.7; CI, 1.0-2.8; p = 0.04). In patients older than 75 years, the surgical approach (MV repair or replacement) had no effect on postoperative survival (HR, 0.8; CI, 0.4-1.3; p = 0.003). Conclusions: Our data demonstrate that, in patients younger than 65 years, the treatment of choice for FMR should be MV repair. This advantage was even more evident in patients with an ischemic origin of MR, a poor ejection fraction, a severe LV dilatation, and atrial fibrillation.

Mechanical versus biological mitral valve replacement: Insights from propensity score matching on survival and reoperation rates.

OBJECTIVES: Patients with symptomatic mitral valve disease unsuitable for repair can be sufficiently treated with surgical mitral valve replacement. The decision between biological and mechanical mitral valve replacement can be difficult, especially due to the question of the lesser of 2 evils: anticoagulation versus reoperation. METHODS: This single-center, retrospective study included all patients undergoing mitral valve replacement between 2001 and 2020. Thirty-day mortality and periprocedural complications were analyzed. Propensity score matching adjusted for age, gender, weight, height, endocarditis, diabetes, hypertension, peripheral arterial occlusive disease, atrial fibrillation, chronic kidney disease, cancer, and history of neurological disorders was performed. After propensity score matching, survival and cumulative incidence of reoperation at time of follow-up were analyzed. RESULTS: The study included 2027 patients in 2 main groups: 1658 patients with biological mitral valve replacement and 369 patients with mechanical mitral valve replacement; 51.2% were male. Age at surgery was 65.9 ± 12.9 years. Median follow-up time was 6.83 years (interquartile range, 1.11-10.61 years). Concomitant procedures were performed in 1467 cases (72.4%). Propensity score matching yielded comparable groups of 339 pairs. Both groups showed comparable survival (P = .203). Survival after mechanical mitral valve replacement and biological mitral valve replacement was comparable for all analyzed time points over the course of 20 years. Patients with mechanical mitral valve replacement showed a significantly lower cumulative incidence for reoperation (20 years: 15% vs 59%, P < .001). CONCLUSIONS: Follow-up of 20 years at a high-volume center demonstrates comparable survival after mechanical or biological mitral valve replacement, whereas reoperation rates are significantly lower after mechanical mitral valve replacement.

Results of new-generation balloon vs. self-expandable transcatheter heart valves for bicuspid aortic valve stenosis.

Background: Data comparing new-generation self-expandable (SEV, Evolut R/PRO) vs. balloon-expandable (BEV, SAPIEN 3/3Ultra) transcatheter heart valve replacement (TAVR) in bicuspid aortic valve stenosis (BAV) is limited. Our aim was to compare 30-day results of SEV and BEV implantations in patients with BAV. Methods: A total of 2009 patients underwent TAVR between April 2015 and June 2021 at our Centre. From our institutional registry, we identified 106 consecutive patients with BAV who underwent TAVR using SEV and BEV. Results: A 106 patients (n = 68 BEV; n = 38 SEV) were included. Mean age was 74.6 ± 8.8 years (BEV) vs.75.3 ± 8.7 years (SEV) (p = 0.670) and Society of Thoracic Surgeons score was 2.6 ± 1.9 (BEV) vs. 2.6 ± 1.6 (SEV) (p = 0.374), respectively. Device landing zone calcium volume (DLZ-CV) was 1168 ± 811 vs. 945 ± 850 mm3 (p = 0.192). Valve Academic Research Consortium (VARC)-3 device success at 30 days was similar (BEV 80.9% vs. SEV 86.8%; p = 0.433). More post-dilatations were performed in SEVs (23.5% BEV vs. 52.6% SEV; p = 0.002). Overall mean gradient at 30 days follow-up was 11.9 ± 4.6 mmHG (BEV) vs. 9.2 ± 3.0 mmHG (SEV) (p = 0.002). A mild-moderate degree of paravalvular leak (PVL) was detected more often in the SEV group (7.4% vs. 13.2%; p = 0.305). A trend towards higher rate of permanent pacemaker implantation was observed in SEV (11.8% vs. 23.7%; p = 0.109). Conclusions: Treatment of BAV revealed similar performance using BEV and SEV. In this retrospective cohort study, hemodynamics were more favorable with the SEV, although there was a trend toward more PVL and significantly more post-dilations.

Continuous Risk Estimation of Acute Kidney Failure with Dense Temporal Data for ICU Patients.

Acute kidney failure is a dangerous complication for ICU patients, and it is difficult to identify at early stage with conventional medical analysis. In recent years, machine learning approaches have been applied to tackle medical diagnosis tasks with great performance. In this work, we deploy machine learning models for early detection of acute kidney failure that can handle static, temporal, sparse and dense data of ICU patients. We investigate different pre-processing methods for patient data to achieve higher prediction performance and how they influence the contribution of different physiological signals in the prediction process.

Risk Estimation for ICU Patients with Personalized Anomaly-Encoded Bedside Patient Data.

We propose a novel framework to estimate intensive care unit patients' health risk continuously with anomaly-encoded patient data. This framework consists of two modules. In the first module, we use Gaussian process models to learn change trend and day-night circulation in temporal patient data and annotate abnormal data. Such models provide dynamically adaptable bedside patient monitoring instead of conventional threshold-based monitoring. In the second module, we use the abnormal data together with the learned Gaussian models to estimate patients' risk level by predicting their in-hospital mortality and remaining length of stay in ICU ward. We show that prediction models with anomaly-encoded data have better performance than those with raw patient measurements, and they are comparable with state-of-art prediction models.

Beyond the 10-Year Horizon: Mitral Valve Repair Solely With Chordal Replacement and Annuloplasty.

BACKGROUND: The long-term outcomes of mitral valve repair by nonresection techniques, such as annuloplasty and chordal replacement, for degenerative mitral valve regurgitation were investigated. METHODS: All consecutive patients with degenerative mitral regurgitation who received solely chordal replacement and annuloplasty for mitral valve repair between 2003 and 2010 at the German Heart Center Munich were reviewed. The endpoints of this retrospective study were survival, cumulative incidence of reoperation on the mitral valve, and cumulative incidence of significant recurrent mitral regurgitation. RESULTS: A total of 346 patients were evaluated. The median follow-up period was 10.86 (range, 0.01-15.86) years. The 30-day mortality rate was 0.58% (n = 2 of 346), whereas the 5-year survival was 92.97% ± 1.41%. At 5 years, cumulative incidence of recurrent mitral regurgitation was 6.87% ± 1.57% and cumulative incidence of reoperation on the mitral valve was 3.69% ± 1.05%. Survival at 10 years was 83.35% ± 2.15%. At 10 years, cumulative incidence of recurrent mitral regurgitation was 13.31% ± 2.22% and cumulative incidence of reoperation was 7.84% ± 1.55%. Cox regression analysis identified age, diabetes mellitus, and reduced left ventricular ejection fraction <55% as independent risk factors for death. Left ventricular ejection fraction <55% was revealed as independent risk factor for significant recurrent mitral regurgitation. CONCLUSIONS: This study demonstrated excellent long-term outcomes with low incidence of reoperation after mitral valve repair using chordal replacement in a highly selected patient cohort. Our findings emphasized the importance of early intervention in severe degenerative mitral regurgitation, especially in patients with reduced left ventricular ejection fraction.

Aortic valve versus root surgery after failed transcatheter aortic valve replacement.

OBJECTIVE: We sought to determine outcomes of aortic valve replacement (AVR) versus root replacement after transcatheter AVR (TAVR) explantation because they remain unknown. METHODS: From November 2009 to September 2020, data from the EXPLANT-TAVR International Registry of patients who underwent TAVR explant were retrospectively reviewed, divided by AVR versus root replacement. After excluding explants performed during the same admission as the initial TAVR and concomitant procedures involving the other valves, 168 AVR cases were compared with 28 root replacements, and outcomes were reported at 30 days and 1 year. RESULTS: Among 196 patients (mean age, 73.5 ± 9.9 years) who had primary aortic valve intervention at TAVR explant, the median time from TAVR to surgical explant was 11.2 months (interquartile range, 4.4-32.9 months). Indications for explant were similar between the 2 groups. Compared with AVR, patients requiring root replacement had fewer comorbidities but more unfavorable anatomy for redo TAVR (52.6% vs 26.4%; P = .032), fewer urgent/emergency cases (32.1% vs 58.3%; P = .013), longer median interval from index TAVR to TAVR explant (17.6 vs 9.9 months; P = .047), and more concomitant ascending aortic replacement (58.8% vs 14.0%; P < .001). Median follow-up was 6.9 months (interquartile range, 1.4-21.6 months) after TAVR explant and 97.4% complete. Overall survival at follow-up was 81.2% with no differences between groups (log rank P = .54). In-hospital, 30-day, and 1-year mortality rates and stroke rates were not different between the 2 groups. CONCLUSIONS: In the EXPLANT-TAVR Registry, AVR and root replacement groups had different clinical characteristics, but no differences in short-term mortality and morbidities. Further investigations are necessary to identify patients at risk of root replacement in TAVR explant.

Subannular repair in secondary mitral regurgitation with restricted leaflet motion during systole.

OBJECTIVE: Ventricular secondary mitral regurgitation (SMR) (Carpentier type IIIb) results from left ventricular (LV) remodelling, displacement of papillary muscles and tethering of mitral leaflets. The most appropriate treatment approach remains controversial. We aimed to assess the safety and efficacy of standardised relocation of both papillary muscles (subannular repair) at 1-year follow-up (FU). METHODS: REFORM-MR (Reform-Mitral Regurgitation) is a prospective, multicentre registry that enrolled consecutive patients with ventricular SMR (Carpentier type IIIb) undergoing standardised subannular mitral valve (MV) repair in combination with annuloplasty at five sites in Germany. Here, we report survival, freedom from recurrence of MR >2+, freedom from major adverse cardiac and cerebrovascular events (MACCEs), including cardiovascular death, myocardial infarction, stroke, MV reintervention and echocardiographic parameters of residual leaflet tethering at 1-year FU. RESULTS: A total of 94 patients (69.1% male) with a mean age of 65.1±9.7 years met the inclusion criteria. Advanced LV dysfunction (mean left ventricular ejection fraction 36.4±10.5%) and severe LV dilatation (mean left ventricular end-diastolic diameter 61.0±9.3 mm) resulted in severe mitral leaflet tethering (mean tenting height 10.6±3.0 mm) and an elevated mean EURO Score II of 4.8±4.6 prior to surgery. Subannular repair was successfully performed in all patients, without operative mortality or complications. One-year survival was 95.5%. At 12 months, a durable reduction of mitral leaflet tethering resulted in a low rate (4.2%) of recurrent MR >2+. In addition to a significant improvement in New York Heart Association (NYHA) class (22.4% patients in NYHA III/IV vs 64.5% patients at baseline, p<0.001), freedom from MACCE was observed in 91.1% of patients. CONCLUSIONS: Our study demonstrates the safety and feasibility of standardised subannular repair to treat ventricular SMR (Carpentier type IIIb) in a multicentre setting. By addressing mitral leaflet tethering, papillary muscle relocation results in very satisfactory 1-year outcomes and has the potential to durably restore MV geometry; nevertheless, long-term FU is mandatory. TRIAL REGISTRATION NUMBER: NCT03470155.