Continuation versus Interruption of Oral Anticoagulation during TAVI.

BACKGROUND: One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism. METHODS: We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI. RESULTS: A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P = 0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6). CONCLUSIONS: In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. (Funded by the Netherlands Organization for Health Research and Development and the St. Antonius Research Fund; POPular PAUSE TAVI ClinicalTrials.gov number, NCT04437303.).

Current applications, procedural and 1-year outcomes of Rotatripsy for the treatment of calcified coronary lesions.

BACKGROUND: Intravascular lithotripsy (IVL) combined with rotational atherectomy (RA), known as Rotatripsy, is used to treat severe coronary artery calcification (CAC), though data on efficacy, midterm safety and use sequence is limited. We aimed to identify indicators for Rotatripsy use and to assess its safety and success rates, both acutely and at 1-year follow-up. METHODS: Patients undergoing Rotatripsy for severe CAC across six centers from May 2019 to December 2023 were included. Demographic, clinical, procedural and follow-up data were collected. Efficacy endpoints included device success (delivery of the RA-burr and IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis <30% by quantitative coronary analysis) and procedural success [composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints comprised Rotatripsy-related complications and MACE at 1-year follow-up. RESULTS: A total of 114 patients (75 ± 9 years, 78% male) underwent Rotatripsy for 120 lesions. In the majority of procedures RA was followed by IVL, mostly electively (n = 68, 57%) but also for balloon underexpansion (n = 37, 31%) and stent crossing failure (n = 1, 1%). Diverse and complex target lesions were addressed with an average SYNTAX score of 24.6 ± 13.0. Device, technical and procedural success were 97%, 94% and 93%, respectively. Therapy-related complications included two (2%) coronary perforations, one (1%) coronary dissection and one (1%) burr entrapment. At 1-year follow-up(present in 77(67%) patients), MACE occurred in 7(9%) cases. CONCLUSIONS: Over a 1-year follow-up period, Rotatripsy was safe and effective, predominantly using RA electively before IVL.

Procedural and clinical impact of intracoronary lithotripsy in heavily calcified aorto-ostial coronary lesions.

BACKGROUND: Percutaneous coronary intervention of calcified aorto-ostial lesions (AOL) pose unique challenges due to anatomical propensity for recoil, leading to poorer outcomes compared to non-AOL. Although intravascular lithotripsy (IVL) has shown excellent success and safety in heavily calcified plaques, evidence specific to AOL is limited. This study aims to evaluate the efficacy and safety of IVL in AOL versus non-AOL. METHODS: Patients treated with IVL between 2019 and 2023 from an ongoing prospective multicenter registry were eligible for inclusion. Patients were therefore classified in AOL and non-AOL groups, based on anatomical location. The primary technical endpoint was device success, defined as the ability to deliver the IVL catheter and pulses at the target lesion, without angiographic complications. Secondary technical endpoint encompassed procedural success <30%, consisting of device success with residual stenosis <30%, final thrombolysis in myocardial infarction grade 3 flow, and no in-hospital major adverse cardiovascular events (MACE). The primary clinical endpoint was in-hospital MACE, including cardiac death, nonfatal myocardial infarction, or target lesion revascularization. RESULTS: A total of 321 patients underwent IVL, including 48 with AOL. Device success showed no significant difference between AOL and non-AOL groups (100% vs. 98.2%; p = 0.35). A nonsignificant trend toward worse procedural success with residual stenosis <30% was observed in the AOL arm (AOL 81.3% vs. non-AOL 90.5%, p = 0.06). In-hospital MACE was significantly higher in AOL (4.2% vs. 0.7%, p = 0.048), attributed entirely to cardiac deaths. At 6-month follow-up, the incidence of MACE (AOL 8.3% vs. non-AOL 4.0%, p = 0.19), and cardiac deaths (AOL 4.2% vs non-AOL1.1%, p = 0.11) were comparable between groups. CONCLUSION: IVL treatment for heavily calcified AOL demonstrates comparable procedural and 6-month clinical outcomes when compared to non-AOL, despite a higher incidence of in-hospital MACE.

Evolution and Prognostic Impact of Left Ventricular Myocardial Work Indices After Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis.

PURPOSE: Left ventricular myocardial work (LVMW) has been shown to better characterize LV function in patients with severe aortic stenosis by correcting LV afterload. The aim of this study was to evaluate the evolution in LVMW indices after transcatheter aortic valve replacement (TAVR) and their prognostic value. METHODS: The following LVMW indices were calculated before and immediately after TAVR in 255 patients (median age 82 years, 51% male): global work index (GWI), global constructive work (GCW), global wasted work (GWW) and global work efficiency (GWE). The study endpoint was all-cause mortality. RESULTS: After TAVR, LV ejection fraction and LV global longitudinal strain (GLS) did not change significantly (from 56% to 55%, p = 0.470 and from 13.6% to 13.2%, p = 0.068). Concerning LVMW indices, while LV GWW remained unchanged after TAVR (from 247 to 258 mmHg%, p = 0.080), LV GWI, LV GCW, and LV GWE significantly decreased (from 1882 to 1291 mmHg%, p < 0.001, from 2248 to 1671 mmHg%, p < 0.001, and from 89% to 85%, p < 0.001, respectively). During a median follow-up of 59 [40-72] months, 129 patients died. After correcting for potential confounders (sex, diabetes, renal function, atrial fibrillation, Charlson comorbidity index, and pacemaker implantation post-TAVR), post-TAVR LV GLS, GWI, and GCW remained independently associated with all-cause mortality. However, post-TAVR LV GWI demonstrated the highest increase in model predictivity. CONCLUSION: In patients undergoing TAVR, LVMW parameters significantly change after intervention. LV GWI after TAVR showed the strongest association with all-cause mortality among both conventional and advanced parameters of LV systolic function both pre- and post-TAVR and might enable better risk stratification of these patients after intervention.

Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.

BACKGROUND: The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied. METHODS: In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P<0.001; risk ratio, 0.74; 95% CI for superiority, 0.57 to 0.95; P = 0.04). A secondary composite 2 event occurred in 32 patients (9.7%) and 33 patients (9.9%), respectively (difference, -0.2 percentage points; 95% CI for noninferiority, -4.7 to 4.3; P = 0.004; risk ratio, 0.98; 95% CI for superiority, 0.62 to 1.55; P = 0.93). A total of 44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial. CONCLUSIONS: Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).

Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation.

BACKGROUND: The roles of anticoagulation alone or with an antiplatelet agent after transcatheter aortic-valve implantation (TAVI) have not been well studied. METHODS: We performed a randomized trial of clopidogrel in patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications. Patients were assigned before TAVI in a 1:1 ratio not to receive clopidogrel or to receive clopidogrel for 3 months. The two primary outcomes were all bleeding and non-procedure-related bleeding over a period of 12 months. Procedure-related bleeding was defined as Bleeding Academic Research Consortium type 4 severe bleeding, and therefore most bleeding at the puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: Bleeding occurred in 34 of the 157 patients (21.7%) receiving oral anticoagulation alone and in 54 of the 156 (34.6%) receiving oral anticoagulation plus clopidogrel (risk ratio, 0.63; 95% confidence interval [CI], 0.43 to 0.90; P = 0.01); most bleeding events were at the TAVI access site. Non-procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P = 0.02). Most bleeding occurred in the first month and was minor. A secondary composite 1 event occurred in 49 patients (31.2%) receiving oral anticoagulation alone and in 71 (45.5%) receiving oral anticoagulation plus clopidogrel (difference, -14.3 percentage points; 95% CI for noninferiority, -25.0 to -3.6; risk ratio, 0.69; 95% CI for superiority, 0.51 to 0.92). A secondary composite 2 event occurred in 21 patients (13.4%) and in 27 (17.3%), respectively (difference, -3.9 percentage points; 95% CI for noninferiority, -11.9 to 4.0; risk ratio, 0.77; 95% CI for superiority, 0.46 to 1.31). CONCLUSIONS: In patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel. (Funded by the Netherlands Organization for Health Research and Development; POPular TAVI EU Clinical Trials Register number, 2013-003125-28; ClinicalTrials.gov number, NCT02247128.).

Bail out lithotripsy to treat delayed valve-in-valve TAVR-related coronary obstruction.

Coronary access difficulty and stent compression by the juxtaposed aortic valve leaflet hamper percutaneous management of delayed coronary artery obstruction (CAO) after valve-in-valve (Edwards Sapien 3 in St. Jude Trifecta) transcatheter aortic valve replacement (TAVR). Here, we present a case of delayed post-TAVR CAO treated with intravascular lithotripsy and multistenting to overcome stent compression by the adjacent calcified leaflet.

COMPARE LAAO: Rationale and design of the randomized controlled trial "COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy".

BACKGROUND: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking. STUDY OBJECTIVES: To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications. STUDY DESIGN: This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA2DS2-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands. SUMMARY: The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use. NCT TRIAL NUMBER: NCT04676880.

Effects of Transcatheter Mitral Valve Repair With MitraClip on Left Ventricular and Atrial Hemodynamic Load and Myocardial Wall Stress.

AIMS: To evaluate the effects of MitraClip on left ventricular (LV) and left atrial (LA) myocardial wall stress as assessed with the use of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and strain imaging. METHODS AND RESULTS: Sixty-five patients with symptomatic moderate and severe mitral regurgitation (MR; age 75 ± 9 y, 57% male, 89% functional MR) treated with the use of MitraClip were evaluated. Patients were divided according to 6-month NT-proBNP tertiles. Changes in echocardiographic parameters over 6 months were assessed. Reductions in LV end-diastolic volumes (178 ± 77 mL to 170 ± 79 mL; P = .045) and LV end-systolic volumes (120 ± 70 mL to 111 ± 69 mL; P = .040) were observed in the overall population. Interestingly, low-NT-proBNP-tertile patients showed slight improvements in LV and LA longitudinal strain, whereas high-NT-proBNP-tertile patients showed impairment. CONCLUSIONS: Although MitraClip induces hemodynamic unloading in patients with predominantly functional MR, myocardial wall stress is not consistently improved. In patients with reduced NT-proBNP, improvements in LA volume index and LV and LA strains were observed. Patients who showed an increase in NT-proBNP exhibited impairment in LV and LA strain, suggesting an increase of myocardial wall stress.

Computed tomography for planning transcatheter tricuspid valve therapy.

AIMS: Percutaneous transcatheter tricuspid valve therapy is an evolving treatment option for patients with significant tricuspid regurgitation (TR) deemed too fragile for open heart surgery. The present study proposes comprehensive anatomical evaluation of the tricuspid valve, right ventricle (RV), and vena cavae and its spatial relationships with the right coronary artery (RCA) using computed tomography (CT) and investigates the implications for suitability for current technologies. METHODS AND RESULTS: A total of 250 patients (mean age 80 ± 7.2 years, 52.4% men) undergoing CT were divided according to the presence of moderate or severe TR (≥3+, n = 40) and less than moderate TR (<3+, n = 210). Tricuspid valve annulus, RV, and vena cavae dimensions and the course of the RCA relative to the tricuspid annulus were evaluated. Patients with TR ≥ 3+ showed significantly larger dimensions of the tricuspid annulus, RV and vena cavae. In 64.8% of patients, the RCA coursed along the tricuspid valve annulus. Patients with TR <3+ showed more frequently a course of the RCA superior to the tricuspid annulus at the levels of the anterior and the posterior tricuspid leaflet compared with their counterparts (12.4% vs. 0%, P = 0.019). A less favourable course of the RCA (≤2.0 mm distance to the annulus) for current annuloplasty techniques was observed at the level of the anterior tricuspid and posterior leaflets in respective 12.5 and 27.5% of patients with TR ≥3+. CONCLUSION: The present study proposes a first systematic approach based on CT to define the patient suitability for current transcatheter tricuspid valve devices.

Transcatheter aortic valve thrombosis: the relation between hypo-attenuated leaflet thickening, abnormal valve haemodynamics, and stroke.

AIMS: The presence of hypo-attenuated leaflet thickening (HALT) and/or reduced leaflet motion on multi-detector row computed tomography (MDCT) has been proposed as a possible marker for early transcatheter aortic valve thrombosis. However, its association with abnormal valve haemodynamics on echocardiography (another potential marker of thrombosis) and clinical outcomes (stroke) remains unclear. The present study evaluated the prevalence of HALT on MDCT and abnormal valve haemodynamics on echocardiography. In addition, the occurrence of ischemic stroke and/or transient ischemic attack (TIA) was assessed. METHODS AND RESULTS: A total of 434 patients (mean age 80 ± 7 years, 51% male) who underwent transcatheter aortic valve replacement (TAVR) were evaluated. Transcatheter valve haemodynamics were assessed on echocardiography at discharge, 6 months, and thereafter yearly (up to 3 years post-TAVR). The presence of HALT and/or reduced leaflet motion was assessed on MDCT performed 35 days [interquartile range 19-210] after TAVR in 128 of these 434 patients. Possible TAVR valve thrombosis was defined by mean transvalvular gradient ≥20 mmHg and aortic valve area (AVA) ≤1.1cm2 on echocardiography or by the presence of HALT or reduced leaflet motion on MDCT. The occurrence of ischemic stroke/TIA at follow-up was recorded. HALT and/or reduced leaflet motion was present in 12.5% of 128 patients undergoing MDCT, and was associated with a slightly higher mean transvalvular gradient (12.4 ± 8.0 mmHg vs. 9.4 ± 4.3 mmHg; P = 0.026) and smaller AVA (1.49 ± 0.39 cm2 vs. 1.78 ± 0.45 cm2, P = 0.017). Only one patient with HALT on MDCT revealed abnormal valve haemodynamics on echocardiography. At 3-year follow-up, abnormal valve haemodynamics on echocardiography were observed in 3% of patients. HALT on MDCT and abnormal valve haemodynamics on echocardiography were not associated with increased risk of ischemic stroke/TIA. CONCLUSION: On MDCT, 12.5% of patients showed HALT or reduced leaflet motion, whereas only one of these patients had abnormal valve haemodynamics on echocardiography. Neither HALT nor increased transvalvular gradient were associated with stroke/TIA.

Feasibility and safety of early discharge after transfemoral transcatheter aortic valve implantation - rationale and design of the FAST-TAVI registry.

BACKGROUND: There is an increasing trend towards shorter hospital stays after transcatheter aortic valve implantation (TAVI), in particular for patients undergoing the procedure via transfemoral (TF) access. Preliminary data suggest that there exists a population of patients that can be discharged safely very early after TF-TAVI. However, current evidence is limited to few retrospective studies, encompassing relatively small sample sizes. METHODS: The Feasibility And Safety of early discharge after Transfemoral TAVI (FAST-TAVI) registry is a prospective observational registry that will be conducted at 10 sites across Italy, the Netherlands and the UK. Patients will be included if they have been scheduled to undergo TF-TAVI with the balloon-expandable SAPIEN 3 transcatheter heart valve (THV; Edwards Lifesciences, Irvine, CA). The primary endpoint is a composite of all-cause mortality, vascular-access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding, occurring during the first 30 days after hospital discharge. Patients will be stratified according to whether they were high or low risk for early discharge (≤3 days) (following pre-specified criteria), and according to whether or not they were discharged early. Secondary endpoints will include time-to-event (Kaplan-Meier) analysis for the primary outcome and its individual components, analysis of the relative costs of early and late discharge, and changes in short- and long-term quality of life. Multivariate logistic regression will be used to identify factors that indicate that a patient may be suitable for early discharge. DISCUSSION: The data gathered in the FAST-TAVI registry should help to clarify the safety of early discharge after TF-TAVI and to identify patient and procedural characteristics that make early discharge from hospital a safe and cost-effective strategy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02404467 (registration first received March 23rd 2015).

Rationale and design of POPular-TAVI: antiPlatelet therapy fOr Patients undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: Despite improving experience and techniques, ischemic and bleeding complications after transcatheter aortic valve implantation (TAVI) remain prevalent and impair survival. Current guidelines recommend the temporary addition of clopidogrel in the initial period after TAVI to prevent thromboembolic events. However, explorative studies suggest that this is associated with a higher rate of major bleeding without a decrease in thromboembolic complications. METHODS: The POPular TAVI trial is a prospective randomized, controlled, open-label multicenter clinical trial to test the hypothesis that monotherapy with aspirin or oral anticoagulation (OAC) after TAVI is safer than the addition of clopidogrel for 3 months, without compromising clinical benefit. This trial encompasses 2 cohorts: cohort A, patients are randomized 1:1 to aspirin vs aspirin + clopidogrel, and cohort B, patients on OAC therapy are randomized 1:1 to OAC vs OAC + clopidogrel. Primary outcome is freedom from non-procedure-related bleeding at 1 year. Secondary net-clinical benefit outcome is freedom from the composite of cardiovascular death, non-procedural-related bleeding, myocardial infarction, or stroke at 1 year. The primary outcome is analyzed for superiority, whereas the secondary outcome is analyzed for noninferiority. Recruitment began in February 2014, and the trial will continue until a total of 1,000 patients (684 expected in cohort A and 316 in cohort B) are included and followed up for 1 year. SUMMARY: The POPular TAVI trial (NCT02247128) is the first large randomized controlled trial to test if monotherapy with aspirin or OAC vs additional clopidogrel after TAVI reduces bleeding with a favorable net-clinical benefit.

Low gradient severe aortic stenosis with preserved ejection fraction: reclassification of severity by fusion of Doppler and computed tomographic data.

AIMS: Low gradient severe aortic stenosis (AS) with preserved left ventricular ejection fraction (LVEF) may be attributed to aortic valve area index (AVAi) underestimation due to the assumption of a circular shape of the left ventricular outflow tract (LVOT) with 2-dimensional echocardiography. The current study evaluated whether fusing Doppler and multidetector computed tomography (MDCT) data to calculate AVAi results in significant reclassification of inconsistently graded severe AS. METHODS AND RESULTS: In total, 191 patients with AVAi < 0.6 cm2/m2 and LVEF ≥ 50% (mean age 80 ± 7 years, 48% male) were included in the current analysis. Patients were classified according to flow (stroke volume index <35 or ≥35 mL/m2) and gradient (mean transaortic pressure gradient ≤40 or >40 mmHg) into four groups: normal flow-high gradient (n = 72), low flow-high gradient (n = 31), normal flow-low gradient (n = 46), and low flow-low gradient (n = 42). Left ventricular outflow tract area was measured by planimetry on MDCT and combined with Doppler haemodynamics on continuity equation to obtain the fusion AVAi. The group of patients with normal flow-low gradient had significantly larger AVAi and LVOT area index compared with the other groups. Although MDCT-derived LVOT area index was comparable among the four groups, the fusion AVAi was significantly larger in the normal flow-low gradient group. By using the fusion AVAi, 52% (n = 24) of patients with normal flow-low gradient and 12% (n = 5) of patients with low flow-low gradient would have been reclassified into moderate AS due to AVAi ≥ 0.6 cm2/m2. CONCLUSION: The fusion AVAi reclassifies 52% of normal flow-low gradient and 12% of low flow-low gradient severe AS into true moderate AS, by providing true cross-sectional LVOT area.

Position of Edwards SAPIEN transcatheter valve in the aortic root in relation with the coronary ostia: implications for percutaneous coronary interventions.

OBJECTIVES: To determine the implications of stable coverage of the coronary ostia by the Edwards SAPIEN valve frame in terms of myocardial ischemia and subsequent percutaneous coronary intervention (PCI), following transcatheter aortic valve implantation (TAVI). BACKGROUND: Edwards SAPIEN frame is frequently deployed relatively higher than recommended and may overlap the coronary ostia. METHODS: A total of 142 patients (age 81 ± 7 years, male 49%) treated with Edwards SAPIEN valve and with multi-detector row computed tomography at 1 month follow-up were evaluated. The position of the frame in relation to the coronary ostia was assessed. Levels of troponin T were measured 12-24 hr after TAVI. PCI events at follow-up were recorded. RESULTS: The left coronary ostium was fully covered in three (2.1%) patients and the right coronary ostium in 11 (7.7%). There were no differences in troponin T levels between patients with fully covered ostia versus patients with partly or non-covered ostia (0.24 (0.13-0.50) µg/L versus 0.35 (0.15-0.55) µg/L, respectively; P = 0.377). At 30 ± 15 months follow up, 10 (7%) patients underwent successful PCI. Rate of subsequent PCI was similar between patients with any covered ostium and patients with non-covered ostia [4 (7.8%) vs. 6 (6.5%), P = 0.780, respectively]. CONCLUSIONS: Full overlap of the coronary ostia by Edwards SAPIEN frame is infrequent and in most cases does not limit subsequent PCI.

Transcatheter mitral valve repair in osteogenesis imperfecta associated mitral valve regurgitation.

OBJECTIVES: Osteogenesis imperfecta is associated with increased prevalence of significant mitral valve regurgitation. Surgical mitral valve repair and replacement are feasible but are associated with increased risk of bleeding and dehiscence of implanted valves may occur more frequently. The present case report describes the outcomes of transcatheter mitral valve repair in a patient with osteogenesis imperfecta. PATIENTS/METHODS: A 60 year-old patient with osteogenesis imperfecta and associated symptomatic moderate to severe mitral regurgitation underwent transthoracic echocardiography which showed a nondilated left ventricle with preserved systolic function and moderate to severe mitral regurgitation. On transoesophageal echocardiography the regurgitant jet originated between the anterolateral scallops of the anterior and posterior leaflets (A1-P1). Considering the comorbidities associated with osteogenesis imperfecta the patient was accepted for transcatheter mitral valve repair using the Mitraclip device (Abbott vascular, Menlo, CA). RESULTS: Under fluoroscopy and 3D transoesophageal echocardiography guidance, a Mitraclip device was implanted between the anterolateral and central scallops with significant reduction of mitral regurgitation. The postoperative evolution was uneventful. At one month follow-up, transthoracic echocardiography showed a stable position of the Mitraclip device with no mitral regurgitation. CONCLUSIONS: Transcatheter mitral valve repair is feasible and safe in patients with osteogenesis imperfecta and associated symptomatic significant mitral regurgitation.

Changes in Global Longitudinal Strain after TAVI: Additional Prognostic Value over Cardiac Damage in Patients with Severe Aortic Stenosis.

Background: Previous studies demonstrated the prognostic value of baseline cardiac damage staging as well as left ventricular global longitudinal strain (LVGLS) in patients undergoing transcatheter aortic valve implantation (TAVI). The aim of the present study was to evaluate the changes in cardiac damage stage and LVGLS after TAVI and to investigate their prognostic values when integrated into the follow-up assessment. Methods: Patients with severe aortic stenosis undergoing TAVI were hierarchically classified into cardiac damage stages based on echocardiographic criteria before TAVI and at a 6-month follow-up. At the same time, LVGLS was measured. The staging system included stage 0 = no signs of cardiac damage; stage 1 = LV damage; stage 2 = mitral or left atrial damage; stage 3 = pulmonary vasculature or tricuspid damage; and stage 4 = right ventricular damage. The primary endpoint was all-cause mortality. Results: A total of 620 patients were included. At follow-up, LVGLS significantly improved, and the improvement was similar among each baseline cardiac damage stage. Follow-up LVGLS values were divided into quintiles, and each quintile was integrated into the cardiac damage staging, leading to a reclassification of 308 (50%) patients. At the time of a median follow-up at 48 (IQR 31-71) months starting from the 6-month follow-up after TAVI, 262 (38%) patients had died. A multivariable Cox regression model showed that LVGLS-integrated cardiac damage staging at follow-up had an incremental prognostic value over the baseline assessment (HR per 1-stage increase 1.384; 95% CI 1.152-1.663; p < 0.001). Conclusions: The integration of LVGLS with conventional echocardiographic parameters of cardiac damage at a 6-month follow-up after TAVI can improve patient risk-stratification.

Procedural and clinical impact of intravascular lithotripsy for the treatment of peri-stent calcification.

BACKGROUND: Use of intravascular lithotripsy (IVL) for treating peri-stent calcification is increasing. However, this indication remains 'off-label'. We aimed to investigate the efficacy and clinical outcomes of in-stent IVL. METHODS: Patients from five European centers who underwent in-stent IVL were included between 2019 and 2023. Demographic, clinical, procedural and follow-up data were collected from electronic hospital records. Angiographic and intracoronary imaging (ICI) data were analyzed in a centralized core-laboratory. RESULTS: Of 101 patients (71.2 ± 9.2 years), 56(55 %) received in-stent IVL for late stent failure (median 109 days post-PCI) due to calcific neoatherosclerosis or extra-stent calcification(late-IVL), while 45(45 %) underwent bail-out IVL due to stent infraexpasion (immediate-IVL). Both late-IVL and immediate-IVL significantly improved angiographic %diameter stenosis (73.7[59.6-89.8]% to 16.4 [10.4-26.9]%;p < 0.0001 and 28.6[22.5-43.3]% to 14.1[10.3-29.4]%;p < 0.0001, and minimum lumen area (MLA) (3.4 ± 1.2 to 8.6 ± 2.5 mm2;p < 0.002 and 5.4 ± 1.9 to 7.3 ± 1.9;p < 0.0001).Device(98 %) and procedural success(80 %) were high. MACE rates in-hospital (2 %), 30-days (3 %),6-months(5 %) and 1-year(7 %) were low and comparable in both groups. Acute diameter gain was lower in immediate-IVL (2.1 ± 0.7 mm vs. 0.5 ± 0.4 mm;p < 0.0001). This, however, was explained by significant differences in pre-IVL angiographic and ICI parameters (%diameter stenosis 73.7[59.6-89.8] vs. 28.6[22.5-43.3]%; p < 0.0001 and MLA (3.4 ± 1.2 vs 5.4 ± 1.9 mm2; p < 0.0001), whereas post-IVL percentage diameter stenosis (16.4(10.4-26.9) vs. 14.1(10.3-29.4);p = 0.914) and MLA (8.6 ± 2.5vs. 7.4 ± 1.9 mm2;p = 0.064) in late- and immediate-IVL were comparable. CONCLUSIONS: IVL in-stent due to peri-stent calcification is an effective strategy, both late and immediately after stent implantation. Overall, MACE rates at short- and mid-term were low and comparable in both groups, although clinical findings should be taken with caution.

Prognostic Implications and Alterations in Left Atrial Deformation Following Transcatheter Aortic Valve Implantation.

AIMS: To evaluate the prognostic implications of left atrial reservoir strain-defined diastolic dysfunction (LARS-DD) grade in patients undergoing TAVI for severe aortic stenosis (AS) and to determine if post-TAVI LARS was more closely associated with new-onset atrial fibrillation than pre-TAVI LARS. METHODS AND RESULTS: Pre-TAVI LARS-DD was evaluated by speckle-tracking echocardiography and was assigned as grade 0 to 1 (LARS≥24%), grade 2 (LARS≥19 to <24%) and grade 3 (LARS<19%). Patients were followed-up for the primary endpoint of all-cause mortality from the date of TAVI. For the secondary endpoint, patients with pre- and post-TAVI LARS measurements and no history of atrial fibrillation were evaluated for the occurrence of new-onset atrial fibrillation. A total of 601 patients (median age 81 [76-85] years, 53% male) were included. Overall, 169 patients (28%) were LARS-DD grade 0/1, 96 patients (16%) were LARS-DD grade 2 and 336 (56%) were LARS-DD grade 3. Over a median follow-up of 40 (IQR 26-58) months, a total of 258 (43%) patients died. In a comprehensive multivariable Cox regression model, LARS-DD grade was independently associated with all-cause mortality (adjusted HR 1.28 per one-grade increase, 95%CI 1.07-1.53, P=0.007). For the secondary endpoint of new-onset atrial fibrillation, a total of 285 patients were evaluated. Post-TAVI LARS (SDHR 1.14 per 1%<20%, 95%CI 1.05-1.23, P=0.0009), but not pre-TAVI LARS (P=0.93) was independently associated with new-onset atrial fibrillation. CONCLUSIONS: Increasing LARS-DD grade was independently associated with long-term post-TAVI survival in patients with severe AS. Post-TAVI LARS was closely related to the occurrence of new-onset atrial fibrillation.