Baseline NT-proBNP predicts acute kidney injury following transcatheter aortic valve implantation.

BACKGROUND/PURPOSE: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) increases morbidity and mortality. Our study aimed to investigate the role of baseline N-terminal pro B-type natriuretic peptide (NT-proBNP) as a predictor of AKI following TAVI. METHODS: All consecutive TAVI patients were included in the analysis, except patients with dialysis and those with a GFR < 15 ml/min/1.73 m2 at baseline. Rates of AKI after TAVI were assessed according to the updated valve academic research consortium definitions using AKIN classification in three stages. NT-proBNP was measured at baseline. One-year mortality rates were assessed. RESULTS: We included 1973 patients treated with TAVI between January 2006 and December 2016. Median [IQR] age was 81.0 [77.0;84.0] years, the STS score was 6.2 [3.9;9.0], and the logEuroScore was 14.5 [9.0;23.0]. 30-day and one-year mortality was 5.1 % and 16.1 % for all patients, respectively. Multivariate analysis revealed that patients with NT-proBNP levels higher than two times above the upper level of normal (ULN) had an increased risk for AKI after TAVI compared to patients with NT-proBNP levels < 2× ULN (OR 1.40 [1.03-1.91]). CONCLUSIONS: Routine assessment of baseline NT-proBNP levels might be an additional tool to identify patients at increased risk for AKI after TAVI.

Early and long-term outcomes following redo mitral valve surgery in patients with prior minimally invasive mitral valve surgery.

OBJECTIVES: The frequency of minimally invasive mitral valve surgery (MVS) has steadily increased over the last decades and therefore surgeons are now encountering an increasing number of patients requiring mitral valve (MV) reoperations post-minimally invasive MVS. The aim of this study was to analyse the early postoperative outcomes and the long-term survival in patients who undergo reoperative MVS following previous minimally invasive surgery. METHODS: Patients who underwent redo MVS following prior minimally invasive MVS between January 2002 and December 2021 were included in our analysis. Study data were prospectively collected and retrospectively analysed. The primary outcomes were 30-day mortality and long-term survival. RESULTS: Among the 187 included patients, 34 (18.2%) underwent repeat MV repair and 153 (81.8%) MV replacement. The median age was 66 years (interquartile range 56-74) and 80 (42.8%) patients were female. Redo MVS was performed through median sternotomy in 169 patients (90.4%). A total of 77 (41.2%) patients had additional concomitant procedures. The median intensive care unit stay was 1 day (1-5). The 30-day mortality was 6.4% (12/187). Estimated survival at 5 and 12 years was 61.8% and 38.3%, respectively. Preoperative stroke (hazard ratio 3.28, 95% confidence interval 1.37-7.85, P = 0.007) as well as infective endocarditis (hazard ratio 1.85; 95% confidence interval 1.09-3.11, P = 0.021) were independent predictors of long-term mortality. CONCLUSIONS: Redo MVS following prior minimally invasive MVS can be performed safely with low early perioperative mortality and acceptable long-term survival. Preoperative stroke, infective endocarditis and concomitant tricuspid valve surgery are independent predictors of long-term mortality.

Aortic arch redo surgery: early and mid-term outcomes in 120 patients.

OBJECTIVES: The aim of this study was to analyse the indications, surgical extent and results of treatment, as well as determine the risk factors for adverse outcomes after redo arch surgery. METHODS: Between January 1996 and December 2022, 120 patients underwent aortic arch reoperations after primary proximal aortic surgery. We retrospectively analysed perioperative data, as well as early and mid-term outcomes in these patients. RESULTS: Indications for arch reintervention included new aortic aneurysm in 34 patients (28.3%), expanding post-dissection aneurysm in 36 (30.0%), aortic graft infection in 39 (32.5%) and new aortic dissection in 9 cases. Two patients underwent reoperation due to iatrogenic complications. Thirty-one patients (25.8%) had concomitant endocarditis. In-hospital and 30-day mortality rates were 11.7% and 15.0%, respectively. Stroke was observed in 11 (9.2%) and paraplegia in 1 patient. Prior surgery due to aneurysm [odds ratio 4.5; 95% confidence interval (CI) 1.4-17.3] and critical preoperative state (odds ratio 5.9; 95% CI 1.5-23.7) were independent predictors of 30-day mortality. Overall 1- and 5-year survival was 65.8 ± 8.8% and 51.2 ± 10.6%, respectively. Diabetes mellitus (hazard ratio 2.4; 95% CI 1.0-5.1) and peripheral arterial disease (hazard ratio 4.7; 95% CI 1.1-14.3) were independent predictors of late death. The cumulative incidence of reoperations was 12.6% (95% CI 6.7-20.4%) at 5 years. Accounting for mortality as a competing event, connective tissue disorders (subdistribution hazard ratio 4.5; 95% CI 1.6-15.7) and interval between primary and redo surgery (subdistribution hazard ratio 1.04; 95% CI 1.02-1.06) were independent predictors of reoperations after redo arch surgery. CONCLUSIONS: Despite being technically demanding, aortic arch reoperations are feasible and can be performed with acceptable results.

The Feasibility of Less-Invasive Bentall Surgery: A Real-World Analysis.

OBJECTIVE: Minimally invasive approaches are being used increasingly in cardiac surgery and applied in a wider range of operations, including complex aortic procedures. The aim of this study was to examine the safety and feasibility of a partial upper sternotomy approach for isolated elective aortic root replacement (a modified Bentall procedure). METHODS: We performed a retrospective analysis of 768 consecutive patients who had undergone isolated Bentall surgery between January 2000 and January 2021 at our institution, with the exclusion of re-operations, endocarditis, acute aortic dissections, and root replacement with major concomitant procedures such as multi-valve or coronary bypass surgery. A total of 98 patients were operated on via partial sternotomy (PS) and were matched 2:1 to 196 patients operated on via full sternotomy (FS). RESULTS: The procedure time was 12 min longer in the PS group (205 min vs. 192.5 min in the FS group, p = 0.002), however, cardiopulmonary bypass and aortic cross-clamp times were comparable between groups. Eight PS-procedures were converted to full sternotomy, predominantly for bleeding complications (n = 6). Re-exploration for acute bleeding was necessary in 11% of the PS group and 4.1% of the FS group (p = 0.02). Five FS patients and none in the PS group required emergency coronary bypass grafting for postoperative coronary obstruction (p = 0.2). PS patients were hospitalized for a significantly shorter period (9.5 days vs. 10.5 days in the FS group, respectively). There were no significant differences regarding in-hospital (p = 0.4) and mid-term mortality (p = 0.73), as well as for other perioperative complications. CONCLUSIONS: Performing Bentall operations via partial upper sternotomy is associated with similar perfusion and cross-clamp times, as well as overall mortality, when compared to a full sternotomy approach. A low threshold for conversion to full sternotomy should be accepted if limited access proves insufficient for the handling of intraoperative complications, particularly bleeding.

Genetic identification of Trichinella species found in wild carnivores from the territory of Kazakhstan.

Trichinellosis, also called trichinosis, is a foodborne parasitic disease caused by eating raw or undercooked meat from animals infected with Trichinella spp. larvae and affects both animals and humans. Although on the territory of Kazakhstan, the species characteristics and prevalence of this helminth were studied back in the 90s, the data have not been updated since then. Given the above, our study was aimed at identifying Trichinella spp. using parasitological and molecular genetics methods. In our work, we studied 160 samples of muscle tissue of wild animals living in the natural zones of steppes and semi-deserts. Of the animals examined, 32 were positive for Trichinella spp., including 1 lynx (Lynx lynx), 17 wolves (Canis lupus), 11 foxes (Vulpes vulpes), 1 jackal (Canis aureus) and 2 corsac foxes (Vulpes corsac). Helminths were extracted using the digestion method. DNA was extracted using a Gene Jet commercial kit (Thermo Fisher Scientific, United Kingdom). For species identification a multiplex PCR, amplification of ESV, ITS1, and ITS2 genes regions was performed. After that, uniplex PCR was performed on the 5S rDNA and ITS1 genes region for sequencing analysis. The resulting sequences were subsequently used to construct a phylogenetic tree and the studied samples were identified as Trichinella nativa and Trichinella britovi. Thus, we can conclude that there is a circulation of two species of Trichinella in Kazakhstan, highlighting that constant control and monitoring of wild animals are necessary to prevent transmission and protect the health of people.

Short-Term Effects of Different Transcatheter Edge-to-Edge Devices on Mitral Valve Geometry.

Background Short-term effects on mitral valve (MV) anatomy after transcatheter edge-to-edge repair using the PASCAL system remain unknown. Precise quantification might allow for an advanced analysis of predictors for mean transmitral gradients. Methods and Results Consecutive patients undergoing transcatheter edge-to-edge repair for secondary mitral regurgitation using PASCAL or MitraClip systems were included. Quantification of short-term MV changes throughout the cardiac cycle was performed using peri-interventional 3-dimensional MV images. Predictors for mean transmitral gradients were identified in univariable and multivariable regression analysis. Long-term results were described during 1-year follow-up. A total of 100 patients undergoing transcatheter edge-to-edge repair using PASCAL (n=50) or MitraClip systems (n=50) were included. Significant reductions of anterior-posterior diameter, annular circumference, and area throughout the cardiac cycle were found in both cohorts (P<0.05 for all). Anatomic MV orifice area remained larger in the PASCAL cohort in mid (2.8±1.0 versus 2.4±0.9 cm2; P=0.049) and late diastole (2.7±1.1 versus 2.2±0.8 cm2; P=0.036) compared with the MitraClip cohort. Besides a device-specific profile of independent predictor of mean transmitral gradients, reduction of middiastolic anatomic MV orifice area was identified as an independent predictor in both the PASCAL (ß=-0.410; P=0.001) and MitraClip cohorts (ß=-0.318; P=0.028). At follow-up, reduction of mitral regurgitation grade to mild or less was more durable in the PASCAL cohort (90% versus 72%; P=0.035). Conclusions PASCAL and MitraClip showed comparable short-term effects on MV geometry. However, PASCAL might better preserve MV function and demonstrated more durable mitral regurgitation reduction during follow-up. Identification of independent predictors for mean transmitral gradients might potentially help to guide device selection in the future.

Mid-term outcomes following the Hemi-Commando procedure for complex infective endocarditis involving the aortomitral junction.

OBJECTIVES: Perivalvular abscesses with destruction of the aortomitral junction (AMJ) are a severe complication of infective endocarditis (IE) and are associated with high mortality and complex management. The Hemi-Commando procedure is a mitral valve-sparing alternative to the Commando procedure in suitable patients with complex IE and paravalvular destruction. This study reviews the mid-term outcomes in patients undergoing the Hemi-Commando procedure for treating IE with destruction of the AMJ. METHODS: The clinical outcomes of patients with IE and AMJ involvement who underwent the Hemi-Commando procedure between 2015 and 2021 at the Leipzig Heart Center were retrospectively analysed. Primary outcomes were 30-day mortality and 1-year survival. Secondary outcome was 1-year freedom from reoperation. RESULTS: A total of 22 patients underwent the Hemi-Commando procedure during the study period. The patients' mean age was 59.8 ± 18.3 years. The study population was predominantly male (86.4%). Preoperative sepsis was present in 6 (27.3%) patients, and the median EuroSCORE II was 28.5%. Almost two-thirds (N = 14; 63.6%) of the patients presented with native IE. Streptococci were the most common pathogens (N = 8; 36.4%). Paravalvular abscess was found intraoperatively in 16 (72.7%) patients. The 30-day mortality was 13.6%. The estimated 1- and 3-year survival rates were 77.5% and 66.4%, respectively. The estimated freedom from reoperation at 1 and 3 years was 92.3%. CONCLUSIONS: The Hemi-Commando procedure offers an acceptable mid-term survival chance with low reoperation rates and is, therefore, a reasonable mitral valve-sparing alternative to the Commando procedure in suitable patients with extensive IE and perivalvular involvement.

Incidence and outcomes of emergency intraprocedural surgical conversion during transcatheter aortic valve implantation: Insights from a large tertiary care centre.

OBJECTIVE: During a transcatheter aortic valve implant (TAVI) procedure, intraprocedural complications that are manageable only by conversion to emergency open-heart surgery (E-OHS) occasionally occur. Contemporary data on the incidence and outcome of TAVI patients undergoing E-OHS are scarce. This study aimed to evaluate early and midterm outcomes following E-OHS of patients undergoing TAVI in a large tertiary care centre with immediate surgical backup availability for all TAVI procedures over a 15-year period. METHODS: Data from all patients undergoing transfemoral TAVI between 2006 and 2020 at the Heart Centre Leipzig were analysed. The study time was divided into 3 periods: 2006-2010 (P1), 2011-2015 (P2) and 2016-2020 (P3). Patients were grouped according to their surgical risk (high risk: EuroSCORE II ≥ 6%; low/intermediate risk: EuroSCORE II <6%). Primary outcomes were intraprocedural and in-hospital death and 1-year survival. RESULTS: During the study period, a total of 6903 patients underwent transfemoral TAVI. Among them, 74 (1.1%) required E-OHS [high risk, n = 66 (89.2%); low/intermediate risk, n = 8 (10.8%)]. The rate of patients requiring E-OHS was 3.5% (20/577 patients), 1.8% (35/1967 patients) and 0.4% (19/4359 patients) in study periods P1 to P3, respectively (P < 0.001). The proportion of patients who had E-OHS who were low/intermediate risk increased considerably over time (P1:0%; P28.6%; P3:26.3%; P = 0.077). Intraprocedural deaths occurred in 10 patients (13.5%), all of whom were high-risk. In-hospital mortality was 62.1% in high-risk patients and 12.5% in low/intermediate risk patients (P = 0.007). One-year survival was 37.8% in all patients undergoing E-OHS, 31.8% in high-risk patients and 87.5% in low/intermediate risk patients (log-rank P = 0.002). CONCLUSIONS: In-hospital and 1-year survival rates following E-OHS are higher in low/intermediate risk than in high-risk patients undergoing TAVI. An on-site cardiac surgical department with immediately available E-OHS capabilities is an important component of the TAVI team.

The Frozen Elephant Technique Using a Novel Hybrid Prosthesis for Extensive Aortic Arch Disease: A Multicentre Study.

INTRODUCTION: The frozen elephant trunk technique (FET) has become routine for aortic arch and descending aortic repair. New hybrid prosthesis models are constantly being developed to increase effectiveness and durability of aortic repair. Recently, concerns were raised regarding increased post-operative bleeding using a new-generation hybrid prosthesis (E-vita® OPEN NEO, CryoLife Inc. JOTEC GmbH, Hechingen, Germany). We report the outcomes of a multi-centre experience of using the E-vita OPEN NEO. METHODS: All patients undergoing aortic surgery at five European centres using the E-vita OPEN NEO from 2020 to 2022 were included (n = 22). The primary endpoint was the amount of chest drain fluid after 24 h and re-thoracotomy rate for bleeding. RESULTS: Median patient age was 62.5 ± 12.6 years, 50.0% (11/22 patients) were female and 27.3% (6/22) of procedures were re-operative cardiac surgeries. Aortic dissection was present in 54.5% (12/22). The median cardiopulmonary bypass time was 148 min and ischaemia time was 84 min. Mortality at 30 days was 4.5% (1/22) and the stroke rate was 18.2% (4/22). The rate of re-thoracotomy for bleeding was 4.5% (1/22) with a median amount of chest drain fluid within 24 h of 569 (IQR 338-910) ml. There were no device-associated adverse events. CONCLUSIONS: Use of this new-generation hybrid prosthesis for FET was safe and effective. Patient follow-up was largely uneventful given the extent of the procedures performed. In particular, bleeding events were uncommon in this cohort of patients comprising many aortic dissections and re-operative procedures. No increase in oozing was observed.

Early Intraluminal Frozen Elephant Trunk Stent Graft Thrombosis After Aortic Arch Surgery.

BACKGROUND: Partial intraluminal thrombosis of the frozen elephant trunk (FET) stent graft is a poorly described but not infrequent complication after aortic arch surgery. This study aims to describe and analyze the occurrence of early FET stent graft thrombosis. METHODS: Retrospective single-center analysis including patients who underwent aortic arch replacement with FET technique between 2006 and 2020. Stent graft thrombosis was diagnosed through computed tomography scan. Several computed tomography scan parameters and clinical variables were analyzed as predictors of this event. RESULTS: A total of 125 patients were included for analysis. Among these, 21 (16.8%) patients developed early postoperative FET stent graft thrombosis. Mean volumetric size of the aorta was 12.2 ± 2.0 mL in patients with FET stent graft thrombosis and 10.1 ± 2.8 mL in patients without thrombosis (P < .01). Thrombosis occurred more frequently among patients requiring thoracic endovascular aortic repair completion (15 of 21 [71.4%] patients) than in patients with completely excluded aneurysms (6 of 21 [28.6%] patients) (P = .01). Mean stent-to-aneurysm diameter ratio was 0.8 ± 0.2 among patients with thrombosis and 1.0 ± 0.2 among patients without thrombosis (P < .01). Thrombosis was more frequently observed among patients with conservative management of postoperative bleeding (P = .04). Patients with early FET thrombosis had a nonsignificantly higher in-hospital all-cause mortality than patients without thrombosis (19.0% vs 8.7%; P = .3). CONCLUSIONS: Early postoperative intraluminal thrombosis is a frequent complication post FET surgery. Smaller stent graft sizes, larger or partially covered aneurysms, and major bleeding are associated with early thrombosis. Slight FET oversizing, prompt thoracic endovascular aortic repair completion, and early reintervention for major bleeding may prevent early thrombosis.

Interrater variability of ML-based CT-FFR during TAVR-planning: influence of image quality and coronary artery calcifications.

Objective: To compare machine learning (ML)-based CT-derived fractional flow reserve (CT-FFR) in patients before transcatheter aortic valve replacement (TAVR) by observers with differing training and to assess influencing factors. Background: Coronary computed tomography angiography (cCTA) can effectively exclude CAD, e.g. prior to TAVR, but remains limited by its specificity. CT-FFR may mitigate this limitation also in patients prior to TAVR. While a high reliability of CT-FFR is presumed, little is known about the reproducibility of ML-based CT-FFR. Methods: Consecutive patients with obstructive CAD on cCTA were evaluated with ML-based CT-FFR by two observers. Categorization into hemodynamically significant CAD was compared against invasive coronary angiography. The influence of image quality and coronary artery calcium score (CAC) was examined. Results: CT-FFR was successfully performed on 214/272 examinations by both observers. The median difference of CT-FFR between both observers was -0.05(-0.12-0.02) (p < 0.001). Differences showed an inverse correlation to the absolute CT-FFR values. Categorization into CAD was different in 37/214 examinations, resulting in net recategorization of Δ13 (13/214) examinations and a difference in accuracy of Δ6.1%. On patient level, correlation of absolute and categorized values was substantial (0.567 and 0.570, p < 0.001). Categorization into CAD showed no correlation to image quality or CAC (p > 0.13). Conclusion: Differences between CT-FFR values increased in values below the cut-off, having little clinical impact. Categorization into CAD differed in several patients, but ultimately only had a moderate influence on diagnostic accuracy. This was independent of image quality or CAC.

Iatrogenic Type A Aortic Dissection: Challenges and Frontiers-Contemporary Single Center Data and Clinical Perspective.

Iatrogenic aortic dissection (IAD) is a rare but devastating complication in cardiac surgery and related procedures. Due to its rarity, published data on emergency surgery following IAD are limited. Herein, we discuss IAD occurring intra- and postoperatively, including those occurring during transcatheter aortic valve replacement and cardiac catheterization, and present benchmark data from our consecutive, single-center experience. We demonstrate changes in patient characteristics, surgical approaches, and outcomes over a 23-year period.

Aortic root replacement in bicuspid versus tricuspid aortic valve patients.

Background: Concomitant replacement of the aortic root and aortic valve is a widely used treatment strategy in elective patients with aortic valve stenosis and root aneurysm. It is also a strategy frequently employed in patients with acute aortic dissection type A (AADA), involving the aortic root. Although more patients have undergone valve sparing procedures over the past decades, the classic 'modified Bentall technique' remains a valid option, particularly for patients with a bicuspid aortic valve (BAV). We aimed to compare the results of elective and emergency modified Bentall procedures in patients with bicuspid and tricuspid aortic valves (TAVs). Methods: We retrospectively reviewed our database for patients undergoing either elective or emergency modified Bentall procedures between 2000 and 2018 and identified 827 elective cases (44% BAV) and 258 emergency cases (15% BAV). Analysis of intra- and postoperative outcomes and early mortality was performed. Due to inequality of the groups, a matching analysis was performed. Results: We found BAV patients to be significantly younger (elective: 58±18 vs. 65±14, P<0.001; emergency: 49±17 vs. 62±19, P<0.001) and healthier at time of surgery. In the AADA cohort, malperfusion rate was not different between bicuspid and tricuspid patients, however bicuspid AADA patients presented more often with an entry in the aortic root. After matching, procedure times and early outcomes did not differ between the groups, except for significantly higher rates of respiratory failure in elective TAV patients (10% vs. 5%, P=0.033). The 30-day mortality was 2% in elective cases and 22% in emergency AADA surgery. A subgroup analysis of elective patients with aortic diameter <55 mm also showed excellent outcomes. Conclusions: After adjustment for preoperative inequalities, no differences in early mortality and outcomes were found between bicuspid and tricuspid patients receiving elective or emergency modified Bentall surgery.

Off-pump coronary artery bypass grafting is safe and effective in patients with severe left ventricular dysfunction.

OBJECTIVES: Severe left ventricular dysfunction (LVD) is associated with increased risk following coronary artery bypass grafting (CABG). Due to a dearth of reports on the choice of CABG technique in patients with LVD, this study aims to compare the outcomes of off-pump CABG (OPCAB) and conventional CABG (ONCAB) in such patients. METHODS: Retrospective single-centre propensity-matched analysis comparing early- and long-term outcomes of OPCAB and ONCAB in patients with severe LVD. Primary outcome was long-term all-cause mortality. RESULTS: Between 2002 and 2014, a total of 1161 consecutive patients with severe LVD underwent isolated CABG [442 patients underwent OPCAB and 719 ONCAB (430 matched pairs)]. Incomplete revascularization was observed more frequently among OPCAB than ONCAB patients (35.3% vs 21.6%; P < 0.01). The overall 30-day mortality was 5% and was comparable between the matched groups [OR 0.64 (0.34-1.22); P = 0.18]. OPCAB patients had shorter median hospital stay (11 vs 12 days; P = 0.02) and lower packed red blood cell transfusion rates [2.7 (2.21-3.19) vs 4.4 (3.56-5.24); P < 0.01]. Estimated adjusted survival was 86.0% vs 85.8%, 69.1% vs 65.5% and 59.9% vs 49.1% at 1, 5 and 10 years for OPCAB and ONCAB patients, respectively (P = 0.99). Long-term risk of mortality was similar between groups [hazard ratio (HR) 0.94 (0.66-1.32); P = 0.7]. Incomplete revascularization was weakly associated with increased risk of long-term all-cause mortality [HR 1.33 (0.99-1.77); P = 0.05]. CONCLUSIONS: OPCAB is safe and effective in patients with severe LVD. Although incomplete revascularization is more commonly observed in patients undergoing OPCAB, it is not associated with increased late mortality.

Manta versus Perclose ProGlide vascular closure device after transcatheter aortic valve implantation: Initial experience from a large European center.

BACKGROUND: Vascular and bleeding complications are common after transcatheter aortic valve implantation (TAVI) and are associated with worse outcomes. The plug-based Manta (M) vascular closure device (VCD) is a novel option to achieve haemostasis for large-bore arterial access sites. OBJECTIVE: We aimed to compare vascular and bleeding complications between the M-VCD and the established suture-based Perclose ProGlide (P)-VCD. METHODS: From February to September 2019 a total of 578 patients underwent transfemoral TAVI at a single high-volume centre. Access site closure was performed using M-VCD in 195 patients (33.7%) and P-VCD in 383 patients (66.3%). We assessed vascular and access site-related complications as well as bleeding events according to the Valve Academic Research Consortium-2 definition. RESULTS: Overall vascular complications occurred less frequently in the M-VCD group (10.7% vs. 19.0%, p = 0.011) driven by a significantly lower rate of major vascular events (2.0% vs. 6.5%, p = 0.025). Access site-related complications were significantly less frequent in the M-VCD cohort (10.7% vs. 16.6%, p = 0.048). The M-VCD was associated with significantly lower rates of major (0.5% vs. 4.4%, p = 0.009) and life-threatening bleeding (0% vs. 2.3%, p = 0.032). In multivariable analysis, the use of M-VCD was the only independent predictor of vascular complications (odds ratio 0.54, 95% confidence interval 0.32-0.91, p = 0.022). CONCLUSIONS: The M-VCD was associated with a reduction of vascular and access-site complications as well as severe bleeding after transfemoral TAVI compared to the P-VCD in this observational study.

Comparison of a Pure Plug-Based Versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial.

BACKGROUND: Transcatheter aortic valve replacement is an established treatment option for patients with severe symptomatic aortic stenosis and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce. METHODS: The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure during Transfemoral Transcatheter Aortic Valve Implantation) is an investigator-initiated, multicenter study, in which patients undergoing transfemoral transcatheter aortic valve replacement were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular) potentially complemented by a small plug. The primary end point consisted of access site- or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary end points included the rate of access site- or access-related bleeding, VCD failure, and time to hemostasis. RESULTS: A total of 516 patients were included and randomly assigned. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary end point occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk, 1.61 [95% CI, 1.07-2.44], P=0.029). Access site- or access-related bleeding occurred in 11.6% versus 7.4% (relative risk, 1.58 [95%CI: 0.91-2.73], P=0.133) and device failure in 4.7% versus 5.4% (relative risk, 0.86, [95% CI, 0.40-1.82], P=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32-180] versus 240 [174-316] seconds, P<0.001). CONCLUSIONS: Among patients treated with transfemoral transcatheter aortic valve replacement, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access site- or access-related vascular complications but a shorter time to hemostasis compared with a primary suture-based technique using the ProGlide VCD. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04459208.

Long-term Follow-up After Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become the standard of care in the majority of patients with symptomatic severe aortic stenosis. Data on long-term mortality and durability of transcatheter heart valves (THVs) beyond 5 years are limited. Our study aimed to assess elderly and high-risk patients' long-term outcomes treated with TAVR in a prospective single-centre registry focusing on the durability of THVs. METHODS: We included 795 patients with severe calcific aortic stenosis treated by transfemoral TAVR between 2006 and 2011. Echocardiography was performed at baseline; discharge; 1 year; and afterward, annually, until the longest available follow-up. Mortality rates were estimated for 1, 5, 6, 7, and 8 years. The rates of structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) were assessed in accordance with consensus definitions. Outcome measures were adjudicated according to Valve Academic Research Consortium-2 (VARC-2). RESULTS: Median (interquartile range) follow-up time was 1345 (316; 2015) days. One-year, 5-year, 6-year, 7-year, and 8-year overall mortality was 25.4%, 59.0%, 64.6%, 67.9%, and 69.2%, respectively. At 8 years, no significant differences in mortality were found comparing self-expanding vs balloon-expandable valves (69.5% vs 68.0%, P = 0.709) and postdilatation (PD) vs no-PD (69.4% vs 69.2%, P = 0.363). SVD was detected in 26 patients (3.3%), and 19 (2.4%) of the 795 patients had evidence of BVF during follow-up. CONCLUSIONS: Our study demonstrates good long-term results for high-risk patients who were alive up to 8 years after TAVR.

CONTEXTE: Le remplacement valvulaire aortique par cathéter (RVAC) est maintenant la norme de soins dans la majorité des cas de sténose de l'aorte grave symptomatique. On dispose de peu de données sur la mortalité à long terme et sur la durabilité des valves cardiaques transcathéter (VCT) au-delà de 5 ans. Nous avons donc évalué les résultats à long terme, notamment la durabilité des VCT, chez les patients âgés et les patients exposés à un risque élevé traités par RVAC figurant dans un registre prospectif unicentrique. MÉTHODOLOGIE: Notre étude comprenait 795 patients présentant une sténose calcifiée de l'aorte grave traitée par RVAC transfémoral entre 2006 et 2011. Une échocardiographie a été réalisée au départ, à la sortie de l'hôpital, 1 an plus tard et tous les ans par la suite, jusqu'au suivi le plus long disponible. Les taux de mortalité à 1, 5, 6, 7 et 8 ans ont été estimés. Les taux de détérioration structurelle des valves (DSV) et de défaillance de la bioprothèse valvulaire (DBV) ont été évalués selon des définitions établies par consensus. Les mesures des résultats ont été confirmées selon les critères du VARC-2 (Valve Academic Research Consortium-2). RÉSULTATS: La durée médiane (intervalle interquartile) du suivi était de 1 345 (316 à 2 015) jours. Les taux de mortalité globaux s'établissaient comme suit : taux à 1 an : 25,4 %; à 5 ans : 59,0 %; à 6 ans : 64,6 %; à 7 ans : 67,9 % et à 8 ans : 69,2 %. À 8 ans, on n'a noté aucune différence significative en ce qui concerne la mortalité chez les patients ayant reçu une valve auto-expansible comparativement à ceux ayant reçu une valve expansible par ballonnet (69,5 % vs 68,0 %; p = 0,709) et chez ceux ayant subi une post-dilatation ou non (69,4 % vs 69,2 %; p = 0,363). Une DSV a été détectée chez 26 patients (3,3 %), et 19 (2,4 %) des 795 patients ont présenté des signes de DBV pendant la période de suivi. CONCLUSIONS: Notre étude a révélé de bons résultats à long terme chez les patients présentant un risque élevé qui étaient toujours en vie 8 ans après le RVAC.