Treatment of late paravalvular regurgitation after transcatheter aortic valve implantation: prognostic implications.

AIMS: Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated. METHODS AND RESULTS: A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]. CONCLUSION: This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation.

Optimization of Enzymatic and Chemical Decellularization of Native Porcine Heart Valves for the Generation of Decellularized Xenografts.

One of the most important medical interventions for individuals with heart valvular disease is heart valve replacement, which is not without substantial challenges, particularly for pediatric patients. Due to their biological properties and biocompatibility, natural tissue-originated scaffolds derived from human or animal sources are one type of scaffold that is widely used in tissue engineering. However, they are known for their high potential for immunogenicity. Being free of cells and genetic material, decellularized xenografts, consequently, have low immunogenicity and, thus, are expected to be tolerated by the recipient's immune system. The scaffold ultrastructure and ECM composition can be affected by cell removal agents. Therefore, applying an appropriate method that preserves intact the structure of the ECM plays a critical role in the final result. So far, there has not been an effective decellularization technique that preserves the integrity of the heart valve's ultrastructure while securing the least amount of genetic material left. This study demonstrates a new protocol with untraceable cells and residual DNA, thereby maximally reducing any chance of immunogenicity. The mechanical and biochemical properties of the ECM resemble those of native heart valves. Results from this study strongly indicate that different critical factors, such as ionic detergent omission, the substitution of Triton X-100 with Tergitol, and using a lower concentration of trypsin and a higher concentration of DNase and RNase, play a significant role in maintaining intact the ultrastructure and function of the ECM.

BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs: design and rationale of the BASELINE trial.

BACKGROUND: Surgical aortic valve bioprostheses may degenerate over time and require redo intervention. Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to redo surgery. The BAlloon Expandable vs. SElf Expanding Transcatheter VaLve for Degenerated BioprosthesIs (BASELINE) trial was designed to compare the performance of the balloon-expandable SAPIEN-3 Ultra and the self-expanding EVOLUT PRO+ valve systems in symptomatic patients with a failing surgical bioprosthesis. METHODS: The BASELINE trial is an investigator-initiated, non-funded, prospective, randomized, open-label, superiority trial enrolling a total of 440 patients in up to 50 sites in 12 countries in Europe and North-America. The primary endpoint is device success at 30-days defined by the Valve Academic Research Consortium-3 Criteria as the composite of technical success, freedom from mortality, freedom for surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication with an intended performance of the valve (mean gradient <20 mmHg and less than moderate aortic regurgitation). The co-primary endpoint at 1 year is defined as the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems. Independent Core Laboratories will conduct uniform analyses of echocardiography (pre-, post-, 1-year post-procedure), multi-sliced computed tomography (pre-, and if available post-procedure) and cine-fluoroscopy studies. CONCLUSIONS: The BASELINE trial is a head-to-head comparative trial investigating the 2 most used contemporary transcatheter heart valves for the treatment of a failing surgical aortic bioprosthesis. (ClinicalTrials.gov number NCT04843072).

Is the outcome of elective vs non-elective patients undergoing transcatheter aortic valve implantation different? Results of a single-centre, observational assessment of outcomes at a large university clinic.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) can either be conducted as an elective (scheduled in advance) or a non-elective procedure performed during an unplanned hospital admission. The objective of this study was to compare the outcomes of elective and non-elective TAVI patients. METHODS: This single-centre study included 512 patients undergoing transfemoral TAVI between October 2018 and December 2020; 378 (73.8%) were admitted for elective TAVI, 134 (26.2%) underwent a non-elective procedure. Our TAVI programme entails an optimized fast-track concept aimed at minimizing the total length of stay to ≤ 5 days for elective patients which in the German healthcare system is currently defined as the minimal time period to safely perform TAVI. Clinical characteristics and survival rates at 30 days and 1 year were analysed. RESULTS: Patients who underwent non-elective TAVI had a significantly higher comorbidity burden. Median duration from admission to discharge was 6 days (elective group 6 days versus non-elective group 15 days; p < 0.001), including a median postprocedural stay of 5 days (elective 4 days versus non-elective 7 days; p < 0.001). All-cause mortality at 30 days was 1.1% for the elective group and 3.7% for non-elective patients (p = 0.030). At 1 year, all-cause mortality among elective TAVI patients was disproportionately lower than in non-elective patients (5.0% versus 18.7%, p < 0.001). In the elective group, 54.5% of patients could not be discharged early due to comorbidities or procedural complications. Factors associated with a failure of achieving a total length of stay of ≤ 5 days comprised frailty syndrome, renal impairment as well as new permanent pacemaker implantation, new bundle branch block or atrial fibrillation, life-threatening bleeding, and the use of self-expanding valves. After multivariate adjustment, new permanent pacemaker implantation (odds ratio 6.44; 95% CI 2.59-16.00), life-threatening bleeding (odds ratio 4.19; 95% confidence interval 1.82-9.66) and frailty syndrome (odds ratio 5.15; 95% confidence interval 2.40-11.09; all p < 0.001, respectively) were confirmed as significant factors. CONCLUSIONS: While non-elective patients had acceptable periprocedural outcomes, mortality rates at 1 year were significantly higher compared to elective patients. Approximately only half of elective patients could be discharged early. Improvements in periprocedural care, follow-up strategies and optimized treatment of both elective and non-elective TAVI patients are needed.

TAVR in TAVR: Where Are We in 2023 for Management of Failed TAVR Valves?

PURPOSE OF REVIEW: As TAVR is increasingly performed on younger patients with a longer life expectancy, the number of redo-TAVR procedures is likely to increase in the coming years. Limited data is currently available on this sometimes challenging procedure. We provide a summary of currently published literature on management of patients with a failed transcatheter aortic valve. RECENT FINDINGS: Recent registry data have increased the clinical knowledge on redo-TAVR. Additionally, numerous bench studies have provided valuable insights into the technical aspects of redo-TAVR with various combinations of valve types. Redo-TAVR can be performed safely in selected cases with a high procedural success and good short-term outcomes. However, at present, the procedure remains relatively infrequent and many patients are not eligible. Bench testing can be useful to understand important concepts such as valve expansion, neoskirt, leaflet overhang, and leaflet deflection as well as their potential clinical implications.

Update on Transcatheter Treatment of Mitral and Tricuspid Valve Regurgitation.

PURPOSE OF REVIEW: Mitral and tricuspid regurgitation represents a clinical challenge. They are associated with a poor prognosis, and many patients are not eligible for conventional surgery. Transcatheter therapies have been the focus of numerous studies and devices over the past decade. Here, we provide a summary of current options for transcatheter treatment of these 2 entities. RECENT FINDINGS: Recent studies have demonstrated the benefits of edge-to-edge repair for increasing numbers of patients. Encouraging early results with transcatheter valve replacement are also becoming available. To date, transcatheter edge-to-edge repair is currently the first-line transcatheter treatment for both mitral and tricuspid regurgitation for many patients who are not candidates for surgery. A number of transcatheter replacement devices are under development and clinical investigation but, for the most part, their current use is limited to compassionate cases or clinical trials.

Producing and Testing Prototype Tissue-Engineered 3D Tri-Leaflet Valved Stents on Biodegradable Poly-ε-Caprolactone Scaffolds.

Transcatheter pulmonary valve replacement is a minimally-invasive alternative treatment for right ventricular outflow tract dysfunction and has been rapidly evolving over the past years. Heart valve prostheses currently available still have major limitations. Therefore, one of the significant challenges for the future is the roll out of transcatheter tissue engineered pulmonary valve replacement to more patients. In the present study, biodegradable poly-ε-caprolactone (PCL) nanofiber scaffolds in the form of a 3D leaflet matrix were successfully seeded with human endothelial colony-forming cells (ECFCs), human induced pluripotent stem cell-derived MSCs (hMSCs), and porcine MSCs (pMSCs) for three weeks for the generation of 3D tissue-engineered tri-leaflet valved stent grafts. The cell adhesion, proliferation, and distribution of these 3D heart leaflets was analyzed using fluorescence microscopy and scanning electron microscopy (SEM). All cell lineages were able to increase the overgrown leaflet area within the three-week timeframe. While hMSCs showed a consistent growth rate over the course of three weeks, ECFSs showed almost no increase between days 7 and 14 until a growth spurt appeared between days 14 and 21. More than 90% of heart valve leaflets were covered with cells after the full three-week culturing cycle in nearly all leaflet areas, regardless of which cell type was used. This study shows that seeded biodegradable PCL nanofiber scaffolds incorporated in nitinol or biodegradable stents will offer a new therapeutic option in the future.

[Tricuspid regurgitation in 2023 : Where are we with the treatment of the forgotten valve?] / Insuffisance tricuspide en 2023 : modalités de traitement pour la valve oubliée.

The negative impact of tricuspid regurgitation on prognosis in now well established. It also appears clear that surgical and possibly percutaneous treatment should be performed before reaching a point of no return with advanced heart failure and deterioration of right ventricle function. Percutaneous treatment has been divided into coaptation restoration devices, annuloplasty devices, and ortho- or heterotopic valve replacement. The present article offers a brief review of diagnostic modalities beyond echocardiography, surgical treatment as well as of the multiple recent development in the percutaneous treatment of this frequent condition.

L'impact pronostique défavorable de l'insuffisance tricuspide (IT) est maintenant bien établi, ainsi que la nécessité d'intervenir chirurgicalement ou de manière percutanée lorsque le traitement médicamenteux est insuffisant. Des données récentes suggèrent par ailleurs qu'il est probablement judicieux d'intervenir avant qu'un stade trop avancé d'insuffisance cardiaque et d'atteinte du ventricule droit ne soit atteint. Le traitement percutané est divisé en dispositifs de restauration de la coaptation valvulaire, d'annuloplastie et de remplacement de valve ortho ou hétérotopique. Cet article propose une brève revue des modalités diagnostiques au-delà de l'échocardiographie, du traitement chirurgical ainsi que des multiples développements récents dans le traitement percutané de cette pathologie fréquente.

Bespoke valve sizing avoids annular rupture in patients treated with a balloon-expandable transcatheter heart valve.

BACKGROUND: Annular and left ventricular outflow tract (LVOT) calcification increase the risk of annular rupture following transcatheter aortic valve replacement (TAVR). The outcomes of a strategy of routine use of a balloon-expandable valve (BEV) for all patients irrespective of annular or LVOT calcium is unknown. OBJECTIVES: We evaluated the impact of bespoke sizing on annular rupture in patients treated with a BEV. METHODS: All consecutive patients undergoing TAVR at a single centre (February 2020-February 2022) were treated only with a BEV. No other valve design was used. Annular/LVOT calcification was assessed using a standardized grading system. For each annular area, we determined the percentage valve oversizing with nominal deployment. The balloon deployment volume was then adjusted when required (over-/underfilled) to achieve over-sizing of approximately 5% in the presence of annular/LVOT calcium and 5%-10% in the absence of annular/LVOT calcium. Adjusted valve areas were assumed to change proportionately to the change in balloon deployment volume. RESULTS: Among 533 TAVR treated patients, annular/LVOT calcification was present in 166 (31.1%) and moderate or severe in 90 (16.9%). In patients with annular/LVOT calcification, the adjusted oversizing was 3.5 ± 3.6% and in patients without annular/LVOT calcification, the adjusted oversizing was 6.8 ± 4.7% (p < 0.001). There were no cases of annular rupture and no cases with more than mild paravalvular leak (PVL). Mild PVL was more frequent in patients with annular/LVOT calcium (10.8% vs 4.6%, p = 0.01). CONCLUSION: Bespoke BEV sizing by adjustment of balloon deployment volume avoided annular rupture in patients undergoing TAVR.

Outcomes and feasibility of redo-TAVR after Sapien 3 Ultra TAVR in extremely-undersized versus nominally-sized annuli.

OBJECTIVES: To compare outcomes in Sapien 3 Ultra (S3U) transcatheter aortic valve replacement (TAVR) with extreme annular undersizing (EAU) versus nominal annular sizing (NAS). BACKGROUND: The Edwards S3U valve has reduced paravalvular leak (PVL) in TAVR but outcomes remain unknown in extremely undersized anatomy. Implanting a smaller S3U valve may facilitate future redo-TAVR but risk compromising hemodynamics. METHODS: From December 2019 to July 2021, 366 patients with native aortic stenosis underwent S3U TAVR. Patients with EAU (annular areas >430 mm2 for 23 mm or >546 mm2 for 26 mm) were compared to NAS (338-430 mm2 for 23 mm or 430-546 mm2 for 26 mm). In-hospital and 30-day outcomes, and redo-TAVR feasibility were determined. RESULTS: There were 79 (21.6%) EAU patients, with more bicuspid (p = 0.0014) and ≥moderate annular/left ventricular outflow tract calcification (p < 0.001). The EAU group had less annular oversizing than NAS group (23 mm: -8.2 ± 2.6% vs. 4.0 ± 7.0%, p < 0.001; 26 mm: -8.9 ± 2.2% vs. 6.7 ± 6.9%, p < 0.001), more balloon overfilling (71.3% vs. 11.6%, p < 0.001), and postdilatation (15.0% vs. 5.8%, p = 0.016). No differences were found in in-hospital or 30-day mortality and stroke (p > 0.05). Mild PVL (13.4% EAU vs. 11.5% NAS, p = 0.56) and mean gradients (23 mm: 13.0 ± 4.5 vs. 14.1 ± 5.4 mmHg, p = 0.40; 26 mm: 11.4 ± 4.1 vs. 11.5 ± 3.9 mmHg, p = 1.0) were similar at 30 days. Had the EAU group undergone NAS with the larger Sapien 3/S3U, by computed tomography analysis simulating 80:20 or 90:10 target implant depth, 33.3%-60.9% (vs. 4.3%-23.2%) would not be feasible for redo-TAVR due to high risk of coronary obstruction. CONCLUSIONS: In this first report of EAU with S3U TAVR, similar excellent short-term outcomes can be achieved compared to NAS, and may preserve future redo-TAVR option.

Complete revascularization in stable multivessel coronary artery disease: A real world analysis from the British Columbia Cardiac Registry.

BACKGROUND: More than half of patients undergoing percutaneous coronary intervention (PCI) have multivessel disease (MVD). The prognostic significance of PCI in stable patients has recently been debated, but little data exists about the potential benefit of complete revascularization (CR) in stable MVD. We investigated the prognostic benefit of CR in patients undergoing PCI for stable disease. METHODS: We compared CR versus incomplete revascularization (IR) in 8,436 patients with MVD. The primary outcome was all-cause mortality at 5 years. RESULTS: A total of 1,399 patients (17%) underwent CR during the index PCI procedure for stable disease. CR was associated with lower mortality (6.2 vs. 10.7%, p < .001) and lower repeat revascularization at 5 years (12.7 vs. 18.4%, p < .001). Multivariable-adjusted analyses indicated that CR was associated with lower mortality (HR = 0.73, 95% CI: 0.58-0.91, p = .005) and repeat revascularization at 5 years (HR = 0.78, 95% CI: 0.66-0.93, p = .005). These findings were also confirmed in propensity-matched cohorts. Subgroup analyses indicated that CR conferred survival in older patients, male patients, absence of renal disease, greater angina (CCS Class III-IV) and heart failure (NYHA Class III-IV) symptoms, and greater burden of coronary disease. In sensitivity analyses where patients with subsequent repeat revascularization events were excluded, CR remained a strong predictor for lower mortality (HR = 0.69, 95% CI: 0.54-0.89, p = .004). CONCLUSIONS: In this study of stable patients with MVD, CR was an independent predictor of long-term survival. This benefit was specifically seen in higher risk patient groups and indicates that CR may benefit selected stable patients with MVD.

Tissue Engineered Transcatheter Pulmonary Valved Stent Implantation: Current State and Future Prospect.

Patients with the complex congenital heart disease (CHD) are usually associated with right ventricular outflow tract dysfunction and typically require multiple surgical interventions during their lives to relieve the right ventricular outflow tract abnormality. Transcatheter pulmonary valve replacement was used as a non-surgical, less invasive alternative treatment for right ventricular outflow tract dysfunction and has been rapidly developing over the past years. Despite the current favorable results of transcatheter pulmonary valve replacement, many patients eligible for pulmonary valve replacement are still not candidates for transcatheter pulmonary valve replacement. Therefore, one of the significant future challenges is to expand transcatheter pulmonary valve replacement to a broader patient population. This review describes the limitations and problems of existing techniques and focuses on decellularized tissue engineering for pulmonary valve stenting.

Biodegradable Poly-ε-Caprolactone Scaffolds with ECFCs and iMSCs for Tissue-Engineered Heart Valves.

Clinically used heart valve prostheses, despite their progress, are still associated with limitations. Biodegradable poly-ε-caprolactone (PCL) nanofiber scaffolds, as a matrix, were seeded with human endothelial colony-forming cells (ECFCs) and human induced-pluripotent stem cells-derived MSCs (iMSCs) for the generation of tissue-engineered heart valves. Cell adhesion, proliferation, and distribution, as well as the effects of coating PCL nanofibers, were analyzed by fluorescence microscopy and SEM. Mechanical properties of seeded PCL scaffolds were investigated under uniaxial loading. iPSCs were used to differentiate into iMSCs via mesoderm. The obtained iMSCs exhibited a comparable phenotype and surface marker expression to adult human MSCs and were capable of multilineage differentiation. EFCFs and MSCs showed good adhesion and distribution on PCL fibers, forming a closed cell cover. Coating of the fibers resulted in an increased cell number only at an early time point; from day 7 of colonization, there was no difference between cell numbers on coated and uncoated PCL fibers. The mechanical properties of PCL scaffolds under uniaxial loading were compared with native porcine pulmonary valve leaflets. The Young's modulus and mean elongation at Fmax of unseeded PCL scaffolds were comparable to those of native leaflets (p = ns.). Colonization of PCL scaffolds with human ECFCs or iMSCs did not alter these properties (p = ns.). However, the native heart valves exhibited a maximum tensile stress at a force of 1.2 ± 0.5 N, whereas it was lower in the unseeded PCL scaffolds (0.6 ± 0.0 N, p < 0.05). A closed cell layer on PCL tissues did not change the values of Fmax (ECFCs: 0.6 ± 0.1 N; iMSCs: 0.7 ± 0.1 N). Here, a successful two-phase protocol, based on the timed use of differentiation factors for efficient differentiation of human iPSCs into iMSCs, was developed. Furthermore, we demonstrated the successful colonization of a biodegradable PCL nanofiber matrix with human ECFCs and iMSCs suitable for the generation of tissue-engineered heart valves. A closed cell cover was already evident after 14 days for ECFCs and 21 days for MSCs. The PCL tissue did not show major mechanical differences compared to native heart valves, which was not altered by short-term surface colonization with human cells in the absence of an extracellular matrix.

Contemporary Evidence-Based Diagnosis and Management of Severe Coronary Artery Calcification.

Percutaneous treatment of heavily calcified coronary lesions remains a challenge for interventional cardiologists with increased risk of incomplete lesion preparation, suboptimal stent deployment, procedural complications, and a higher rate of acute and late stent failure. Adequate lesion preparation through calcium modification is crucial in optimising procedural outcomes. Several calcium modification devices and techniques exist, with rotational atherectomy the predominant treatment for severely calcified lesions. Novel technologies such as intravascular lithotripsy are now available and show promise as a less technical and highly effective approach for calcium modification. Emerging evidence also emphasises the value of detailed characterisation of calcification severity and distribution especially with intracoronary imaging for appropriate device selection and individualised treatment strategy. This review aims to provide an overview of the non-invasive and invasive evaluation of coronary calcification, discuss calcium modification techniques and propose an algorithm for the management of calcified coronary lesions.

Ten year follow-up of high-risk patients treated during the early experience with transcatheter aortic valve replacement.

BACKGROUND: The long-term clinical performance of transcatheter heart valves (THV) is unknown. AIMS: This study assessed the clinical outcomes, rate of structural valve deterioration (SVD) and bioprosthetic valve failure in patients after transcatheter aortic valve replacement (TAVR) to 10-year follow-up. METHODS: Consecutive patients undergoing TAVI for native aortic valve stenosis or failed aortic surgical bioprosthesis, between 2005 and 2009 at our institution were included. A total of 235 consecutive patients. RESULTS: At the time of TAVI mean age was 82.4 ± 7.9 years. All patients were judged to be high risk, with a STS score > 8 in 53.6%. THVs implanted were the Cribier-Edwards (20.9%), Edwards SAPIEN (77.4%) or CoreValve (1.7%). Mortality at 1, 5, and 10-year follow-up was 23.4%, 63%, and 91.6%, respectively. Of the total cohort, 15 patients had structural valve deterioration/bioprosthetic valve failure, with a cumulative incidence at 10-years of 6.5% (95% CI 3.3%, 9.6%). The rate of SVD/BVF at 4, 6, 8, and 10 years was 0.4%, 1.7%, 4.7%, and 6.5%, respectively. Nine patients had moderate SVD and six patients had severe SVD. Of the six patients with severe SVD, two patients had reintervention (one patient had redo TAVR, and the second had surgical aortic valve replacement). Survivors (n = 19) at 10-year follow-up, had a mean gradient of 14.0 ± 7.6 mmHg and aortic regurgitation ≥moderate in 5%. Quality of life measures in 10-year survivors demonstrated ADLs 6/6 in 43.8%, and ambulation without a mobility aid of 62.5%. CONCLUSION: Using early generation balloon expandable THVs in a high-risk population, there was a low rate of structural valve deterioration and valve failure at 10-year follow-up. This study provides insights into the long-term performance of transcatheter heart valves and patients self-reported derived benefits.

Prognostic implications of baseline 6-min walk test performance in intermediate risk patients undergoing transcatheter aortic valve replacement.

BACKGROUND: While slow gait speed is known to be associated with poor outcomes in patients at high surgical risk who undergo transcatheter aortic valve replacement (TAVR), the prognostic significance of slow gait speed in intermediate risk TAVR patients is poorly understood. OBJECTIVES: We assessed the association between baseline 6-min walk test (6MWT) performance and both 2-year mortality and health status in intermediate risk patients undergoing TAVR as a part of the PARTNER II/S3i studies. METHODS: The association of baseline 6MWT with mortality over 2-years after TAVR was examined using Cox regression; both unadjusted and adjusted for age, left ventricular ejection fraction, coronary artery disease, pulmonary disease, renal insufficiency, and STS score. Patients were divided into four groups according to baseline 6MWT: unable to walk and in three equal tertiles of slow, medium, and fast walkers. Among surviving patients, improvement in 6MWT and quality of life were compared. RESULTS: Among 2,037 intermediate risk TAVR patients (mean age 81.7 years, STS score 5.6%), 8.2% were unable to walk. Baseline 6MWT was associated with all-cause mortality over 2 years (Hazard ratio (HR) 0.87 per 50 m, 95% confidence interval [CI] 0.83 to 0.92, p < .0001). Among surviving patients, the adjusted absolute change in 6MWT at 2 years improved for patients unable to walk (+134.1 m, 95% CI 102.1 to 166 m, p < .0001) and slow walkers (+60.5 m, 95% CI 42.8 to 78.2 m, p < .0001), but was unchanged for medium walkers (-7.3 m, 95% CI -24.3 to 9.6 m, p = .4), and declined for fast walkers (-41.3 m, 95% CI -58.7 to -23.9 m, p < .0001). CONCLUSION: Poor functional capacity is predictive of 2-year mortality in elderly intermediate risk patients undergoing TAVR. However, surviving patients with poor baseline functional capacity had significant improvement in 6MWT performance and quality of life at 2-years following TAVR.

Dedicated plug based closure for large bore access -The MARVEL prospective registry.

OBJECTIVES: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers. BACKGROUND: The MANTA is a novel plug-based device for large bore arteriotomy closure. METHODS: We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications. RESULTS: Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications. CONCLUSION: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions.

Distribution of C-arm projections in native and bioprosthetic aortic valves cusps: Implication for BASILICA procedures.

OBJECTIVES: We sought to document aortic cusps fluoroscopic projections and their distributions using leaflet alignment which is a novel concept to optimize visualization of leaflets and for guiding BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction) and determine whether these projections were feasible in catheter laboratory. BACKGROUND: Optimal fluoroscopic projections of aortic valve cusps have not been well described. METHODS: A total of 128 pre-transcatheter aortic valve replacement (pre-TAVR) computed tomographies (CT) (72 native valves and 56 bioprosthetic surgical valves) were analyzed. Using CT software (3Mensio, Pie medical imaging, the Netherlands), leaflet alignment was performed and the feasibility of these angles, which were defined as rate of obtainable with efforts (within LAO/RAO of 85° and CRA/CAU of 50°) were evaluated. RESULTS: High feasibility was seen in right coronary cusp (RCC) front view (100%) and left coronary cusp (LCC) side view (99.2%), followed by noncoronary cusp side view (95.3%). In contrast, low feasibility of RCC side view (7.8%) and LCC front view (47.6%) was observed. No statistical differences were seen between the distribution of native valves and bioprosthetic surgical valves. With patient/table tilt of 20°LAO and 10°CRA, the feasibility of RCC side view and LCC front view increased to 43.7 and 85.2%, respectively. CONCLUSION: Distributions of each cusp's leaflet alignment follows "sigmoid curve" which can provide better understanding of aortic valve cusp orientation in TAVR and BASILICA. RCC side view used in right cusp BASILICA is commonly unachievable in catheter laboratory and may improve with patient/table tilt.

Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves.

AIMS: Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV. METHODS AND RESULTS: A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7 ± 9.7 years; 58.8% male; median STS-PROM score 7.3% (4.2-12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreValve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n = 523, 52.0%), Edwards balloon-expandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n = 435, 43.2%), and other devices (n = 48, 4.8%). Survival was lower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) ≤ 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P = 0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02-1.13)], age [HR 1.21 (95% CI 1.01-1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11-1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis-patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31-14.39)], device malposition [SHR 3.75 (95% CI 1.36-10.35)], EBEV [SHR 3.34 (95% CI 1.26-8.85)], and age [SHR 0.59 (95% CI 0.44-0.78)]. CONCLUSIONS: The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV.

Fracture of small Mitroflow® aortic bioprosthesis following valve-in-valve transcatheter aortic valve replacement with ACURATE neo valve-From bench testing to clinical practice.

Valve-in-valve (ViV) transcatheter procedures have emerged as a feasible, less-invasive treatment option for bioprosthetic structural valve deterioration. However, in the presence of a small bioprosthesis, a significant residual gradient after ViV procedures often occurs and has been associated with poorer clinical outcomes. We report the use of the self-expandable supra-annular ACURATE neo™ valve to treat degenerated Mitroflow (Sorin) aortic bioprosthesis with severe residual elevated gradients followed by valve fracture with a postdilation using a noncompliant balloon leading to significant reduction in residual gradients. In conclusion, the use of ACURATE neo™ valve followed by the controlled fracture of the surgical bioprosthesis frame with a noncompliant balloon is a safe and effective approach for patients with Mitroflow® failing valves and residual elevated gradient after transcatheter aortic valve replacement.